How to implement seasonal influenza vaccination of health workers: an introduction manual for national immunization programme managers and policy makers

1An introduction manual for national immunization programme managers and policy makers Pilot version 2019 How to implement seasonal influenza vaccination of health workers Family, Womens’s and Children’s Health (FWC) DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS This document was produced by the Initiative for Vaccine Research (IVR) of the Department of Immunization, Vaccines and Biologicals How to implement seasonal influenza vaccination of health workers ISBN 978-92-4-151559-7 Published: May 2019 This publication is available on the Internet at: https://apps.who.int/iris/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: + 41 22 791 4227 • Email: vaccines@who.int © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific orga- nization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following dis- claimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. How to implement seasonal influenza vaccination of health workers. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. IAcknowledgements This manual was developed by Thomas Cherian and Carsten Mantel, MMGH Consulting and Philipp Lambach (WHO/IVR) with review and inputs of an Independent Expert Advisory Group: Salah Al Awaidy, Silvia Bino, Joseph S. Bresee (chair), Supamit Chunsuttiwat, Daouda Coulibaly, Luzhao Feng, Rachel Hale, Shabir A. Madhi, Helena C. Maltezou, Kelly Moore, Jonathan Nguyen- Van-Tam, Saad Omer, Gregory Poland, Sabine Wicker. Kelly Moore and Chris Morgan were consultant as representatives of the WHO Immunization Practices Advisory Committee, IPAC. Consultants: Thomas Cherian, Carsten Mantel. Additional experts: Birte Bödeker, Susan Y. Chu, Sara Hamid, Kathryn Lafond, Kathleen Morales, Julia Neufeind, Susan Wang. WHO: Philipp Lambach, Onyema Ajuebor, Ms Phionah Lynn Atuhebwe, Philip Gould, Shalini Desai, Julia Fitzner, Martin Howell Friede, Shoshanna Goldin, James Dawson Heffelfinger, Ray- mond Hutubessy, Ivan Dimov Ivanov, Pernille Jorgensen, Melanie Marti, Hasan Qamrul, Lisa Menning, Ann Moen, Liudmila Mosina, Andreas Alois Reis, Alba Maria Ropero Alvarez, Claudia Steulet, Nadia Teleb. Financial support for the development and pilot-testing of this manual is provided through the Centers for Disease Control and Prevention (CDC), which provides financial support to the World Health Organization Initiative for Vaccine Research (U50 CK000431). II Contents Executive summary 1 About this manual 2 Objective 2 Audience 2 Structure of the document 3 Key related documents 4 1. Background and rationale 5 Current status of influenza vaccination in health workers 5 Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers 6 Evidence for health worker risk of influenza and impact of vaccination 6 Evidence of transmission of infection from health workers to patients and the impact of vaccination 7 Evidence for interventions to increase health worker vaccination uptake 7 Global Action Plan for Influenza Vaccines 8 2. Establishing a policy to vaccinate health workers against seasonal influenza 10 The decision-making process 10 Considerations for decision-making 12 Defining the public health objectives for vaccination 12 Economic analysis for establishing national policies 13 Characterizing the target groups for vaccination 14 Framing an immunization policy for health workers 15 Integration with Occupational Health Policies 18 Choice of vaccine product, schedule and timing of vaccination 18 Defining monitoring and disease impact measurement objectives 20 III 3. Planning and managing vaccination of health workers 21 Planning for successful vaccine introduction 21 Costing and financing 22 Formative research to inform the planning process 24 Communication and vaccine acceptance 25 Communications at the health facility level 26 Demand Generation at the Health Facility Level 28 Vaccine procurement and supply chain management 30 Vaccine procurement 30 Selection of the vaccine product and presentation 30 Logistics and cold chain management 31 Vaccination of health workers 32 Training of the vaccination team 33 4. Monitoring and evaluation 34 Developing and updating information systems 34 Coverage monitoring 34 AEFI monitoring 37 Monitoring and evaluation of vaccine acceptance 38 Vaccine impact monitoring 38 Post-introduction evaluation 40 References 41 Annex 1. Sample non-participation form 45 Annex 2. Complementary checklist for planning health worker immunization: national level 46 Annex 3. Health facility checklist 48 Annex 4. Sample questionnaire for conducting a survey among health workers 49 Annex 5. Communications and demand generation: Stratification of approaches to developing the content 51 1Executive summary Health workers are at higher risk of influenza infection than the general population. In addition to morbidity among health workers, influenza infection may also lead to increased absenteeism, presenteeism1 and disruption of medical services. Moreover, influenza infected health workers may contribute to nosocomial transmission of infection to their patients, including those at high risk for developing severe influenza disease and complications. Hence, the World Health Orga- nization (WHO) considers health workers to be a priority target group for seasonal influenza vaccination. In addition, influenza vaccination of health workers contributes to influenza pan- demic preparedness. Finally, studies have shown that health workers who are vaccinated against influenza themselves are more likely to recommend vaccination to their patients. This manual serves as a resource to assist users in establishing a national policy for seasonal influenza vaccination of health workers. It provides guidance along with a catalogue of available tools to facilitate policy development, planning, implementation, monitoring and evaluation of influenza vaccination of health workers. The contents of the manual are meant to supplement the document titled “Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring”, published by WHO in 2014. The main target audiences for this manual include national policy makers; national health plan- ners; the national programme managers for immunization and occupational health; and those responsible for occupational health, health worker immunization and infection control in health facilities. Close collaboration between immunization managers, and occupational health and infection control programmes is essential to optimize vaccine uptake, and for a cohesive and comprehensive approach to influenza control in health facilities. This manual summarizes the evidence and rationale, provides guidance on key issues, and lists available tools for influenza vaccination of health workers, covering three main components of vaccine introduction and management: 1. Establishing an evidence-based national policy for seasonal influenza vaccination of health workers. 2. Planning and management of health worker influenza vaccination. 3. Monitoring and evaluation, including assessing vaccination coverage, monitoring for adverse events following immunization, impact assessment and post-introduction evaluation. 1 Presenteeism refers to health workers who work while ill, yet have reduced accuracy and effectiveness and pose a risk to vulnerable patients in their care. 2About this manual Objective This manual serves as a resource and catalogue of available tools to assist country officials in deciding upon, planning, implementing and monitoring health worker influenza vaccination in order to achieve optimal vaccination coverage. It is not meant to be a prescriptive document, but rather articulates general principles and key considerations to support policy formulation; planning and management of vaccination; and monitoring and evaluation of influenza vaccina- tion of health care workers. The manual also outlines measures to ensure integration of health worker influenza vaccination into existing national occupational health policies and occupational safety and health manage- ment systems of health facilities. It also addresses the opportunity for health worker influenza vaccination to promote an integrated approach for monitoring and optimizing the uptake of all interventions included in national occupational health policies. In addition, it refers to the rela- tionship and contribution of health worker vaccination to pandemic influenza preparedness. Seasonal influenza vaccination in health workers differs from other vaccine-preventable diseases in that vaccination is required annually. However, elements of this manual may be of relevance for health worker vaccination in general, particularly the sections on planning and management of vaccination and on monitoring and evaluation. Audience The main target audience for the manual include: 1. National policy-making bodies and health planners. 2. Programme managers for immunization, infection control and occupational health programmes at national and subnational levels and those responsible for occupational health and infection control in health facilities. 3. Organizations of health workers and employers. While the different sections of the document may be of greater relevance to one or the other group, it is advisable that the document be read as a whole because of the information on a par- ticular topic may be found in the different sections of the manual. The document may also be useful to other audiences with an interest in immunization or occu- pational health. 3Structure of the document The manual consists of four sections as outlined in Figure 1. However, for clarity and complete- ness there is some overlap between some of the sections, with cross-references made to the other relevant sections. Figure 1. Structure of the document Establishing a policy Planning & management of vaccination Monitoring & evaluation Introduction, background and rationale •About the manual, including objectives and target audience •WHO policy recommendations on influenza vaccination •Current status of health workers vaccination •Summary of evidence to support health worker vaccination •Global Action Plan for Influenza Vaccines •Considerations for making a decision •Defining the objectives for vaccination •Categorization and prioritization of health workers •Framing an immunization policy • Integration with Occupational Health Policies •Choice of product and timing for vaccination •Delivery options and strategies to optimize coverage •Defining monitoring and impact assessment objectives •Planning for successful vaccine introduction •Costing and financing •Formative research to inform planning process •Communication & vaccine acceptance •Demand generation at the health facility •Vaccine procurement and supply chain management •Vaccination of health workers •Training of vaccination team •Coverage monitoring •AEFI monitoring •Vaccine acceptance assessment •Vaccine impact monitoring •Post-introduction evaluation POLICY MAKERS IMPLEMENTERS 4Key related documents The following documents are important resource materials that complement the guidance in this manual. 1. The WHO policy recommendations on seasonal influenza vaccination, including health worker vaccination are published in WHO Position Papers. These position papers are peri- odically updated. Vaccines against influenza: WHO position paper – November 2012 https://www.who.int/wer/2012/wer8747.pdf (Accessed 14 Mai 2019) Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (Accessed 14 Mai 2019) 2. The following document provides detailed guidance to countries that already provide sea- sonal influenza vaccination to health workers on how to identify, analyse, and effectively target issues related to uptake: Tailoring immunization programmes for seasonal influenza (TIP FLU). A guide for increasing health care workers’ uptake of seasonal influenza vaccination (2015). Copenhagen: World Health Organization Regional Office for Europe; 2015. http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) 3. While the contents of this manual can help inform national policies, the manual does not provide an exhaustive review of the available evidence to inform decision-making. A more detailed review of such evidence in support of vaccination of health workers is found in the following document: Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. July 2019. https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (Accessed 12 July 2019) 4. This manual is part of a series of introduction manuals on seasonal influenza vaccination developed by WHO. A manual on the implementation of influenza vaccination of pregnant women has been published earlier. How to implement influenza vaccination of pregnant women: an introduction manual for national immunization programme managers and policy makers. http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (Accessed 14 Mai 2019) 51. Background and rationale Health workers are at risk of influenza virus infection and of transmitting infection to patients under their care who may be at high risk for severe disease, complications, and death (1). The increased risk in health workers compared to the general population may vary by occupation or setting (2). WHO considers health workers to be an important priority group for influenza vaccination, not only to protect themselves and maintain essential health-care services during influenza epidemics, but also to reduce the spread of influenza to vulnerable patient groups with whom they come into contact (1). Furthermore, many studies have found that a strong recom- mendation from health workers, especially from physicians, is highly likely to increase public uptake of vaccination (3–5). Health workers who have themselves been vaccinated are more likely to be knowledgeable about vaccination and be more effective in improving public acceptance of vaccination (3–5). Finally, because health workers are likely to be targets of vaccination programs during an influenza pandemic, establishing functional programs for seasonal influenza vaccina- tion of health workers will facilitate timely and effective vaccination during a pandemic (6). Current status of influenza vaccination in health workers Global adoption of a policy for influenza vaccination of health workers has been slow. In 2017, only 119 of the 194 countries reporting having a national influenza vaccination policy. Of these, 96 report targeting health care workers as a priority group. However, the proportion of Member States that reported having a policy varies by WHO region, with the majority of countries in the WHO regions of the Americas, Europe and Eastern Mediterranean reporting a national policy for influenza vaccination, whereas a lower proportion of countries report having such a policy in the Western Pacific, African and South-East Asian regions. Information on influenza vaccination coverage in health workers is not available for most coun- tries, though it varies widely and is reported to be low in many countries where such data are available. For example, data on coverage in health workers were available from only 26 (56%) countries in the European region for the 2014–15 season. The median coverage was 29.5% with a range of 2.6% to 99.5%; only three countries, namely Albania, Armenia and Belarus, reported coverage > 75% (7). More recent data from a systematic review through compulsory reporting from all hospitals in England showed an uptake of 69% in the 2017–18 season.2 An internet sur- vey of 2000 health workers in the United States demonstrated coverage to be 78% during the 2017–18 season, with higher coverage rates (95%) among those working in settings where they were required by their employers to be vaccinated (8). Higher vaccination coverage rates are reported when mandatory vaccination policies are implemented. In one systematic review that included eight studies, coverage rates exceeding 94% were achieved in all (9). 2 Seasonal influenza vaccine uptake in healthcare workers (HCWs) in England: winter season 2017 to 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/Sea- sonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf (Accessed 14 Mai 2019) 61. Background and rationale Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers A rapid evidence appraisal of materials available in the English language, published since 2006, and considered to be of medium or high quality, was conducted by WHO (10). The questions considered, and the main findings of this appraisal are summarized here. Readers are referred to the published report for the details and for the relevant citations. The review considered three issues, namely: 1. The evidence that health workers are at increased risk of influenza infection compared to the general population, and that vaccinating them reduces influenza or absenteeism and/or the wider economic impact of influenza in the health workforce. 2. The evidence that health workers transmit influenza to their patients in health care set- tings and, if so, whether vaccination protects the patients and the proportion of health workers who need to be protected to obtain this effect. 3. The evidence for successful practical interventions to increase vaccination uptake and the state of knowledge of social, behavioural and public health public policy research on vaccination uptake in health workers. Evidence for health worker risk of influenza and impact of vaccination Studies comparing the risk of influenza infection in health workers compared to the general population are challenging, may measure different outcomes, or are executed in different set- tings, limiting the comparability across studies or the pooling of data from these studies. Recent systematic reviews suggest that health workers are at an increased risk of influenza infection compared to the general population (Odds Ratio = 2.08, 95% CI = 1.73 to 2.51) (2), though the evi- dence is strongest for asymptomatic laboratory-confirmed infection (11). However, health workers with asymptomatic infection may still transmit influenza virus to highly vulnerable patients in a health-care setting. Respiratory illness is reported as a common cause of absenteeism among health workers. Epi- demics or pandemics of inf luenza have been associated with increased rates of absenteeism among health workers (12). Vaccine efficacy in health workers has been shown to be as high at 90% for well-matched seasonal influenza vaccines (13, 14), which suggests that vaccination of health workers will reduce influenza-related morbidity and absenteeism. A systematic review showed a protective effect against laboratory confirmed influenza and shorter absenteeism due to influenza-like illness (ILI) in vaccinated groups (15). A recent study among health workers in the United Kingdom showed that a 10% increase in vaccination uptake is associated with a 10% decrease in absence due to illness (12). However, there are observational studies that provide con- flicting results – though often constrained by poor study design, non-specific outcomes, high risk of bias, and failure to adjust for confounding factors (16–19). Since the risk of illness following infection is based on the level of exposure, and absence behaviours may vary between different categories of health workers, it is possible that the lack of sufficiently granular data on absenteeism, e.g. stratified by health worker categories, may account for the mixed results seen in the different studies. On the other hand, the lack of impact on absenteeism 71. Background and rationale observed in some studies, despite evidence of increased rates of infection in health workers, raises the question as to whether health workers nonetheless continue to work when infected and lead to heightened concerns about the consequent risk of nosocomial transmission (20). Several studies have documented presenteeism in health workers with influenza-like illness (21–23), including one instance which was associated with nosocomial transmission in an oncology unit (24). Evidence of transmission of infection from health workers to patients and the impact of vaccination Epidemiological studies using molecular subtyping approaches demonstrate evidence of trans- mission from health workers to patients. The use of automated collection of high-resolution contact data using wearable sensors combined with virologic data have allowed the identification of potential routes of transmission in cases of hospital-acquired influenza (25). The extent of direct transmission from health worker to patient in health care settings is difficult to capture because of the constant influx of visitors, interactions between patients, and the possibility of multiple simultaneous introductions of influenza (26–28). However, among those who may contribute to transmission of infection in the health care setting, health workers represent a sizeable vaccine- preventable portion since they are easier to target for vaccination. The direct patient benefit of health worker vaccination can be measured in several ways, as illus- trated in the literature. Several studies evaluate the impact on laboratory confirmed influenza, while others evaluate impact on non-specific outcomes such as ILI, respiratory illness, all-cause mortality, respiratory illness associated mortality, or incidence of nosocomial influenza infec- tion. The evidence is stronger for non-specific outcomes such as ILI, all-cause mortality (29), and incidence of nosocomial influenza infection (30, 31). Although some studies have attempted to measure the number of health workers that need to be vaccinated for optimal protection, the evidence in support of a coverage threshold is weak, leading to disputes in the literature (32). However, it is likely that patient protection is positively associated with increasing health worker vaccination coverage but would also depend on other factors including the type of patient contact, vulnerability of the patient, use of other infection control measures, and the effectiveness of vac- cination in a particular influenza season (33–35). Evidence for interventions to increase health worker vaccination uptake There is a substantial body of evidence on successful interventions to increase health worker influenza vaccination uptake, much of which has been incorporated into existing toolkits aimed at increasing vaccine uptake. Although the factors that contribute to the health worker decision-making pathway are diverse, some strategies appear to be more effective than others. No single intervention has been shown to rapidly and substantially increase and sustain vaccination uptake except for mandatory vaccina- tion. However, mandatory health worker vaccination is an issue that has been extensively debated with many different perspectives for and against its use (20, 32, 36). Successful mandatory vac- cination programmes require organizational and educational efforts to secure employee support prior to implementation (37). 81. Background and rationale A combination of one or more “soft mandates” such as active declination, required surgical mask use and exclusion of non-vaccinated staff from working with highly vulnerable patients may be used as alternatives to mandatory vaccination, although there are organizational, educational, monitoring and enforcement, and human and financial resource implications for applying such soft mandates. Additional components that contribute to increased uptake include the following: • Provision of free vaccine; • Convenient access to vaccination, including on-site vaccination in health facilities; • Knowledge and behaviour modification through education, reminders, and incentives tailored towards different health worker categories; • Management and organizational approaches such as personnel assigned to oversee vac- cination activities. The reasons for low vaccination uptake are heterogenous and vary across different health worker categories and cultures. Therefore, approaches to increase uptake need to be tailored for different groups. Some studies have demonstrated that formative research, including surveys and qualita- tive research, can provide insights that assist in tailoring interventions to optimize uptake. Conclusion Despite the ongoing debate in the literature, influenza vaccination is important for ensuring the safety of health workers, their patients, and the general population who rely on a functioning health system, especially during epidemic/pandemic periods. Studies to conclusively establish the value of health worker vaccination will be chal- lenging though the emerging data on this issue will be closely monitored to inform any changes to existing WHO policies.3 Global Action Plan for Influenza Vaccines In an influenza pandemic, most of the world’s population will be highly susceptible to infection and it is likely that infection will spread rapidly. Vaccination is considered one of the key strategies to mitigate the potential impact of a pandemic. While it is expected that there will be a delay in the development of strain-specific pandemic vaccines, insufficient production capacity will further restrict the global access to the vaccines, at least in the early phases of the pandemic. Resource-con- strained countries, especially those that lack local vaccine production capacity and those that do not have seasonal influenza vaccination policies, will face the greatest challenge in securing timely access to vaccines during a pandemic, and mitigating the substantial adverse effects of a pandemic. 3 A working group of the WHO Strategic Advisory Group of Experts (SAGE) on immunization will be reviewing the emerging data and updates to the existing WHO recommendations are expected in 2020. 91. Background and rationale To address this challenge a Global Action Plan for Pandemic Influenza vaccines was developed by WHO with short, medium and long term-strategies aimed at increasing influenza vaccine production and surge capacity before and during an influenza pandemic (38). The plan proposed three approaches to enhance access to pandemic vaccines: (i) an increase in the baseline use of seasonal influenza vaccination; (ii) an increase in global production capacity; and (iii) further research and development. The first of the above three approaches relies on countries establishing clear and effective immu- nization policies to increase the baseline use of seasonal influenza vaccines – providing industry with better demand forecasts and stimulate increased production capacity. While vaccination of health workers will only result in a modest increase in overall vaccine demand, it will establish a robust and functional platform for rapidly immunizing health workers and could contribute to achieving high coverage in the event of a pandemic, thereby protecting health service delivery during a pandemic. Furthermore, high uptake of vaccination by health workers is likely to build trust and increase the uptake of vaccination among other high-risk groups targeted for seasonal influenza vaccination in national policies. Health worker vaccination may also establish or strengthen processes that would allow rapid deployment of pandemic vaccines. Thus, seasonal influenza vaccination of health workers goes beyond the issue of immediate protection against seasonal influenza as outlined above and contributes to pandemic influenza preparedness. 10 2. Establishing a policy to vaccinate health workers against seasonal influenza The decision to establish a policy to vaccinate health workers against seasonal influenza should be evidence-based, with a clear rationale, and with the required investments for sustainable implementation. The general principles and considerations for adding a vaccine to a national immunization programme are articulated in the 2014 WHO guidance document titled “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: From Decision to Implementation and Monitoring” (39). Health workers comprise a target population not usually included in the national immunization programmes of many low and middle-income countries. While hepatitis B vaccination pro- grammes for health workers may exist, influenza vaccines are unique since vaccination for the foreseeable future must be repeated annually. This section of the manual deals primarily with additional considerations specific to annual seasonal influenza vaccination of health workers, building on the generic framework provided by the document cited above. The decision-making process As with any other vaccine for which policies have to be established, Ministries of Health (MoH) would request National Immunization Technical Advisory Groups (NITAGs) or equivalent national or regional bodies to conduct a review of the evidence and provide advice on establish- ing a policy for seasonal influenza vaccination of health workers, and to make recommendations on the content of the vaccination policy. Engagement of the many stakeholders affected by this policy is essential to secure their endorse- ment and facilitate high vaccination uptake, and is likely to result in a more coordinated approach to the control of influenza in health facilities. Stakeholder consultation should be broadly sought and include: 1. Professional associations and societies representing different health worker groups such as medical, nursing and allied health service associations, as well as representatives of private health care providers; 2. Medical and nursing councils and other health worker regulatory bodies; 3. Patient safety groups, where they exist, and organizations representing patients, since health worker immunization should also be regarded as a patient safety and quality of care issue; 4. Health worker unions, where they exist and when their participation is likely to be use- ful in promoting vaccination uptake. 5. Health facility managers. 11 2. Establishing a policy to vaccinate health workers against seasonal influenza The process should also include early engagement with the bodies that establish occupational health policies and regulations to ensure that the policies established for health worker vaccina- tion against influenza are also reflected in the national occupational safety and health policies. If vaccination policies for health workers exist for other vaccines, e.g. hepatitis B vaccination, a review of these policies may provide useful inputs for policy formulation for seasonal influenza vaccination and on strategies to optimize vaccination uptake. Where available, NITAGs could access the information required from data available from the national influenza surveillance, the National Influenza Centres or other institutions participating in the Global Influenza Surveillance and Response System (GISRS) (see Toolbox 1). In places where local evidence is not readily available, especially on rates of disease amongst health workers and on transmission of disease from health workers to patients, efforts to generate such evidence could be time- and resource-intensive. Policy-makers would have to consider whether it is necessary to conduct local studies or whether data from other countries with similar epide- miological profiles and health system characteristics could be used to infer the likely burden of disease and support decision-making. NITAGs would need to balance the desire to have national data against the costs and delays that would result in generating the data and the consequent health impacts of this delay. Toolbox 1 National Influenza Centers To monitor and respond to the changes in the influenza virus antigenic structure and the subsequent necessity to change vaccine compositions, many countries have established national influenza centers (NIC) to collect and characterize virus specimens in their country and perform other analyses to inform the decisions of WHO and partners on the composition of the next year’s influenza vaccine. In many countries, virologic surveillance is complemented by more systematic influenza surveillance for severe acute respiratory illness (SARI) and influenza-like illness (ILI). A NIC in a country – or in a neighbouring country – can support evidence-based recommendations by providing data on the influenza disease burden and seasonality to the NITAG or other relevant national decision-making body. Involving these and other centers in NITAG discussions is key to bringing together all relevant information that is needed for the decision-making process. A list of NICS, WHO collaborating centers and essential regulatory laboratories (ERLS) can be found at the following links:  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (Accessed 14 Mai 2019)  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (Accessed 14 Mai 2019) 12 2. Establishing a policy to vaccinate health workers against seasonal influenza Considerations for decision-making In addition to the general considerations outlined in the WHO document “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: from decision to implementation and monitoring” referred to earlier, other key issues need to be considered when framing a policy for health worker vaccination. These are listed in Figure 2. Figure 2. Key considerations in establishing a vaccination policy for health workers Defining the public health objectives for seasonal influenza vaccination of health workers Characterizing and prioritizing the target groups for vaccination Framing the vaccination policy for seasonal influenza vaccination of health workers Choice of vaccine product, schedule and timing of vaccination Defining the monitoring and impact assessment objectives Defining the public health objectives for vaccination A critical first step in establishing a policy for vaccinating health workers with seasonal influenza vaccination would be to clearly define the aims and objectives of the vaccination programme. Such objectives may vary between countries but would underlie the prioritization of the health worker groups to be targeted for vaccination, set vaccination coverage targets, and provide guid- ance on the outcomes and scope for measuring the impact of vaccination. Vaccination of health workers serves multiple objectives. These may include: 1. Prevention of infection in the health workers themselves, averting associated morbidity. 2. Prevention of transmission of infection from health workers to vulnerable patients, including those at high risk of severe disease, complications, and death. 3. Sustaining health services by reducing health worker absenteeism, especially during seaso- nal and pandemic influenza outbreaks, which is a period of increased health care demand. 4. Promoting uptake of seasonal influenza vaccination among other target groups and enhance public trust for influenza vaccination. 5. Contributing to influenza pandemic preparedness by: a) Establishing a mechanism for rapidly immunizing health workers during a pan- demic of influenza or epidemics of other vaccine-preventable diseases; 13 2. Establishing a policy to vaccinate health workers against seasonal influenza b) Contributing to increasing demand for influenza vaccine and thereby enhance pro- duction capacity to improve timely access to vaccine in case of a pandemic. c) Establishing or strengthening national capacity for vaccine regulation. One or more of the above could serve in defining the national objectives for health worker vac- cination. Important considerations when defining vaccination objectives include: 1. Review of the available data on the burden of disease among health workers and health care-related infections in patients and residents of long-term care facilities. National data, where available, complemented with representative regional or global data or esti- mates developed through the use of mathematical models may be used for this purpose. 2. The cost and impact of vaccination and availability of vaccine supply. 3. Review of the national pandemic preparedness plan and consideration of how health worker vaccination could contribute to pandemic preparedness. Economic analysis for establishing national policies While economic analysis is generally recommended prior to deciding on vaccination policies, lack of data for estimating and comparing the economic benefits of the different vaccination objectives may be a limiting factor, as will be the relatively small size of the target group. Toolbox 2 lists the available tools for conducting economic analysis for influenza vaccination. The costs and economic benefits of influenza vaccination of health workers are likely to depend on several factors, including the number and categories of health workers targeted, the incidence and severity of infection in the targeted health workers, their contribution to health care-associated transmission and the consequences of such infections. These factors may vary between different health facilities and will vary from one influenza season to another. A recent systematic review of the epidemiological and economic effects of seasonal influenza vaccination of health workers found that vaccination of health workers was cost-saving, based on crude estimates of absenteeism averted through vaccination (15). However, all the studies included Toolbox 2 Tools for the economic analysis of seasonal influenza vaccination Several tools are available for conducting economic analysis of influenza vaccination: WHO Guide for Stanardization of economic evaluations of immunization programmes (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf WHO Manual for Estimating the Economic Burden of Seasonal Influenza (WHO/IVB/16.04) ƥ http://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-eng.pdf Guidance on the economic evaluation of influenza vaccination (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. Establishing a policy to vaccinate health workers against seasonal influenza in this review were from high-income countries and took an employer perspective with a strong focus on absenteeism averted. Initial decisions could take vaccination costs and the impact of these costs to the immunization and health budgets into consideration, with the option of measuring cost-effectiveness post-intro- duction, if required. Further guidance on costing and budgeting of health worker influenza vaccination, with links to the available costing tools and resource materials on immunization financing are covered in the next section of this manual. Characterizing the target groups for vaccination Ideally all health workers should be targeted for vaccination, including those who may not come into direct contact with patients. Even if not in direct contact, health workers could potentially transmit infection acquired in the community to colleagues and, thereby, participate in the chain of health care-associated transmission of infection. However, in situations where there are resource constraints or limited or unstable vaccine supplies, categorization and prioritization of health workers for vaccination would be required. Prioritization of health workers would depend on assessment of risk of infection among the health workers themselves, transmission of infection to their patients and the consequences of health care-associated transmission. Even without financial resource constraints or limitations in vaccine supply, categorization of health workers would be useful when different policies are applied to different health worker cat- egories, based on risk assessment. For example, a mandatory vaccination policy may be applied to select categories of health workers who work with patients at high risk of severe influenza and who are more likely to accept mandatory vaccination, while vaccination may be voluntary for other categories (40, 41). Table 1 provides an example of risk categorization of health workers based on risk to themselves and of those for whom they care. Table 1. Risk categorization of health workers Risk category Health worker characteristics Very High • High risk health workers (see below) who work in clinical areas that admit patients at high risk for severe disease, complications, or death following influenza virus infection. These include intensive care units; transplant or oncology wards; antenatal, peri-natal or post- natal areas; and areas with elderly individuals, especially those with chronic diseases. High • Health workers who come into direct physical contact with patients, or with infectious materials, including surfaces or equipment contaminated by infectious materials. • Health workers who have contact which is not physical but that would allow the acquisi- tion or transmission of diseases that are spread at short range (1–2 m) by respiratory means, e.g., counsellors who have prolonged fact-to-face contact (42, 43). Low • Health workers who do not have contact with patients and whose normal work is not in a clinical area as defined above. 15 2. Establishing a policy to vaccinate health workers against seasonal influenza The very high-risk category is also the one where the evidence for risk and impact of vaccination is the strongest and where there is a stronger justification for vaccination (10). Those targeted for vaccination should also include part-time personnel, students, contractors, and volunteers at the health facility who have possible exposure to patients as health workers in the above categories. Risk categorization of individual health workers may be too complex and resource intensive in many settings, especially in low- and middle-income countries. In these situations, simpler approaches wherein health worker categories are classified into only two groups, i.e. at high risk group (targeted for vaccination) and low risk groups (not targeted for vaccination) may be used. To ensure targeted use of influenza vaccination of health workers and to address potential uptake issues, national policies for health worker vaccination should outline: 1. The classification of different health worker categories based on assessment of risk. 2. The policy for vaccination for each category, e.g. whether vaccination is recommended and whether the recommendation is for mandatory or voluntary vaccination. 3. Strategies for managing non-compliant health workers and vaccine refusers. The following document provides an example of a framework for the assessment, classification and prioritization of health workers: The policy directive of the New South Wales Ministry of Health on the Occupational Assessment, Screening and Vaccination Against Specified Infectious Diseases https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (Accessed 14 Mai 2019) Framing an immunization policy for health workers Recommendations for health worker vaccination could propose either mandatory vaccination, voluntary vaccination or a mixed approach depending on the risks in the specific clinical setting. Multiple studies across many countries has demonstrated that voluntary vaccination of health workers, even when accompanied by considerable efforts to educate them on the benefits and risks of vaccination and implementation of measures for convenient access to vaccination, results in low coverage that seldomly exceeds 70%. On the other hand, mandatory vaccination has resulted in close to 100% uptake in institutions in the United States where it has been applied (44–46). However, mandatory vaccination has been difficult to implement in some countries because of acceptability issues and because the attributable benefits of health worker vaccination have been a subject of debate (32). Furthermore, it may not be feasible to implement mandatory vaccination policies in resource-constrained settings. 16 2. Establishing a policy to vaccinate health workers against seasonal influenza Voluntary vaccination One option for a vaccination policy for health workers is voluntary vaccination wherein vaccina- tion is recommended for health workers and offered but acceptance is voluntary or optional, i.e. not a requirement. Such programmes often have low vaccination coverage. Hence, with voluntary vaccination, extra efforts are required to optimize the uptake of vaccination. These could include: 1. A robust communications strategy, specifically tailored to the needs of different health worker categories, to explain the benefits and risks of vaccination, including the benefits to patients, especially those at high risk for severe disease. It needs to be emphasized that some of these patients, including the elderly and immunocompromised patients may not themselves respond to vaccination and that vaccination of health workers who come into contact with them is an important means for protecting them from infection, i.e. a professional ethics and moral argument 2. Convenient access to vaccination that is free of charge, and available to workers in every shift. Those who work during evening or night shifts might be provided access to vacci- nation either at the beginning or the end or their shifts or on designated days and times to cover their shift. 3. Other demand generation activities as outlined in the next section of this manual. A number of soft mandates may also help in increasing vaccination uptake, including: 1. Requirement of active declination of vaccination through signing of forms indicating their non-participation with or without stating the reasons for not accepting vaccination (see Annex 1 for a sample of an active declination form). 2. Reassignment of health workers who refuse vaccination to areas where they are less likely to come into contact with high risk patients, if this is feasible, or a requirement to wear masks when they do care for patients at high risk of influenza complications. 3. Use of face masks while in the health care facility. Mandatory vaccination Mandatory vaccination makes vaccination of health workers a legal or regulatory requirement while allowing some exemptions, e.g. medical contraindications. There is no WHO or other uniformly applied definition for mandatory vaccination. Infant and childhood immunization programmes described as mandatory can vary widely, especially in terms of the exemptions allowed and the penalties for non-compliance (47). Several experts have argued that mandatory immunization policies should be implemented against vaccine-preventable diseases that can be transmitted in the health-care setting and cause significant risk of morbidity or mortality to patients (20, 44, 48–50), as part of the professional ethics of a health care provider. It has also been argued that few ethical mandates in the practice of medicine surpass the obliga- tion to do no harm. Hence, ensuring conditions for safe patient care by minimizing transmission of communicable diseases represents a minimum ethical standard in health care practice set- tings (20). However, if mandatory vaccination policies are to be established, legal liability issues will need to be addressed and consideration given to providing compensation in the rare event of an adverse event. 17 2. Establishing a policy to vaccinate health workers against seasonal influenza Mandatory vaccination could either be part of the national policy or implemented at individual health facilities as part of institutional policies. The enactment of legislation endorsing mandatory vaccination would facilitate the implementation of such a policy. The Code of Colorado Regulations provides an example of a mandatory vaccination policy: Code of Colorado Regulations: Standards for Hospitals and Health Facilities 02 – General Licensure Standards (Part 10, Page 46) https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20CCR%20 1011-1%20Chap%2002 (Accessed 14 Mai 2019) Several countries with voluntary health worker vaccination policies for influenza do have man- datory vaccination of health workers for other infections such as measles and hepatitis B. These existing mandatory vaccination policies could be leveraged to also justify and establish mandatory vaccination policies for influenza, based on the protection afforded to the health worker as well as to vulnerable high-risk patients with whom they come into contact. Published recommendations for the ethical implementation of mandatory vaccination policies are reproduced in Toolbox 3. These recommendations may be taken into consideration in framing the national policy based on the feasibility of implementation. Toolbox 3 Recommendations for ethically implementing mandatory vaccination policies — There must be a compelling employee and patient safety problem that is clearly communicated to employees. — The least restrictive means should be used to achieve the safety objective. — There should be clear opt-out criteria for medical reasons. — Opt-out criteria based on personal views of the health worker should be allowed for current employ- ees only. These determinations must be made in a transparent and objective manner. — For those who do meet medical or other exclusion criteria, or who refuse vaccination, institutions should offer alternative means for achieving transmission control, including temporary leave during peak times, mandatory mask wearing, re-assignment to non-clinical areas (if feasible) or frequent testing during peak influenza seasons. — Prospective employees should be notified of the mandatory policy and recognize that failure to comply could be grounds for termination of employment. — The process should be transparent, with a broad range of health worker perspectives involved in policy development. — Institutions should support healthcare workers by implementing vaccination procedures that are free, easy to access, and include complete comprehensive coverage of adverse events. Particular attention should be paid to not burdening less advantaged members of the healthcare team. Source : Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 18 2. Establishing a policy to vaccinate health workers against seasonal influenza Mixed approach A mixed approach could also be adopted where a mandatory vaccination policy is applied to only certain categories of health workers likely to have direct physical contact with high-risk patients, while a voluntary vaccination policy is applied to the remaining categories. Such a policy should clearly and unambiguously define the health worker groups to whom or work areas where mandatory and voluntary vaccination policies apply. Consideration should be given to the human and financial resource implications of mandatory vaccination policies or of soft mandates. Integration with Occupational Health Policies Policies on seasonal influenza vaccination of health workers should be an integral part of the national occupational safety and health policies and regulations and the occupational safety and health management systems in health facilities. Inclusion of seasonal influenza vaccination in occupational health policies will allow access to free vaccination for all the targeted health workers as per the Occupational Safety and Health Convention, 1981, Article 214 and the recommendations in the World Health Organization and International Labour Organization (WHO-ILO) Global Framework for National Occupational Health Programmes for Health Workers.5 Such a policy would also put the responsibility for health worker vaccination on employers, rather than on the health workers alone. An integrated policy will enable greater coordination and collaboration between occupational health and immunization programmes and promote a joint approach to control of influenza in health facilities wherein vaccination is part of an infection control program that includes other infection measures to protect both health workers and patients. The occupational health pro- gramme at the national level and the management system at the facility level also provide an enabling environment to create a culture for infection prevention within the workplace that will stimulate the implementation of the vaccination programmes. Choice of vaccine product, schedule and timing of vaccination Choice of product WHO provides recommendations for the composition of influenza vaccines based on the infor- mation provided by the WHO Global Influenza Surveillance and Response System.6 Based on these recommendations, manufacturers formulate Northern Hemisphere (NH) and Southern Hemisphere (SH) vaccines, which are generally accessible around September (NH) and April 4 C155-Occupational Safety and Health Convention, 1981 (No. 155). https://www.ilo.org/dyn/normlex/en/f?p=NO RMLEXPUB:12100:0::NO::p12100_instrument_id:312300 (Accessed 14 Mai 2019) 5 The sectoral dimension of the ILO’s work : Review of sectoral initiatives on HIV and AIDS Appendix II – WHO- ILO WHO-ILO Global Framework for National Occupational Health Programmes for Health Workers. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/wcms_145837.pdf (Accessed 14 Mai 2019) 6 Influenza: vaccines. http://www.who.int/influenza/vaccines (Accessed 14 Mai 2019) 19 2. Establishing a policy to vaccinate health workers against seasonal influenza (SH) of each year, respectively. A list of WHO prequalified vaccines with information on their characteristics is published on the WHO website.7 Several different types of vaccines are available, including inactivated influenza vaccines (triva- lent and quadrivalent composition), live attenuated influenza vaccines, adjuvanted vaccine, and recombinant vaccine. Being a health worker per se does not lead to a preference for any vaccine type (subject to country-specific marketing authorizations).8 Health workers who care for severely immunocompromised persons should preferably receive inactivated influenza vaccine (IIV). Price and supply availability of each product are additional considerations in informing the choice of product. Timing of vaccination In countries where influenza infection is seasonal and seasonality patterns are defined, vaccina- tion should ideally be scheduled before the start of the influenza season, allowing approximately 14 days for induction of protective antibodies. Where delays in securing vaccine supply does not allow ideal timing to be met, vaccination should be initiated as soon as supplies are made avail- able. Furthermore, individual health workers should never be refused vaccination at any time during the influenza season if they are late in seeking vaccination. In tropical and subtropical regions where several peaks may occur, vaccination should be timed before the main peak of transmission, using the most recent vaccine formulation available. Where no data on national influenza seasonality are available, countries could use data from epidemio- logically similar countries. Toolbox 4 provides published information of influenza seasonality in the tropics and subtropics. 7 WHO Prequalified Vaccines. https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 8 In some countries the quadrivalent vaccine is the product of choice. The WHO Strategic Advisory Group of Experts (SAGE) in immunization is currently reviewing the evidence and expected to make a recommendation in 2020. Toolbox 4 Guidance on choice of product and timing of seasonal influenza Seasonal influenza policy use and effectiveness in the tropics and subtropics. Geneva: World Health Organization; 2016. ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf (Accessed 14 Mai 2019) Influenza seasonality in the tropics and subtropics – when to vaccinate  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 (Accessed 14 Mai 2019) WHO list of prequalified vaccines  https://extranet.who.int/gavi/PQ_Web (Accessed 14 Mai 2019) 20 2. Establishing a policy to vaccinate health workers against seasonal influenza Defining monitoring and disease impact measurement objectives Ministries of Health would benefit from advice from the NITAG or other relevant advisory groups on the monitoring and impact measurement objectives so that they are taken into consideration during the planning and implementation of Monitoring and Evaluation (see chapter 4). NITAGs, with additional inputs from other relevant advisory groups and academia, should make recommendations on: 1. Monitoring and reporting of vaccination coverage, where possible by unit and type of care provided. 2. Measurement of vaccination impact, including: a) Target groups (health workers and or patients) for impact measurement. b) Outcomes to be monitored. e.g. influenza-like illness, laboratory-confirmed disease, severe disease, death, absenteeism, patient-related outcomes, etc. c) urveillance strategies for measuring impact; if at sentinel sites, the number and distribution of sites. d) Time periods for impact measurement, e.g. continued monitoring for an indefinite period or limited to a certain number of seasons. These measurements would be useful to the NITAG in reviewing the impact of vaccination and making recommendations for optimizing the impact and the cost-effectiveness of vaccination. Impact measurement could also generate empiric data to allow for estimation of cost-effectiveness of vaccination. It should be noted that any such measurements should include data collection for multiple seasons since the intensity of transmission, the severity of infection and vaccine effectiveness varies from one season to another. For further details, see the section on “Monitoring and evaluation” (chapter 4). 21 3. Planning and managing vaccination of health workers Planning for successful vaccine introduction Once a national vaccination policy has been established, it is necessary to convert the policy into operational plans that are fully costed, budgeted and include granular detail on the various pro- gramme components related to the introduction of a new vaccine into the national programme. The general concepts for addition of a new vaccine within the national immunization plans and the management of introduction are outlined in the WHO guide “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” (see Annex 3 for New Vaccine Introduction Plan Template). This section provides guidance on the additional elements specific to seasonal influenza vaccination of health workers. A vaccine introduction plan integrated into the annual plan for immunization along with the associated checklists enable programme planners to ensure that all the necessary preparations are in place for the timely and efficient introduction of a vaccine into the national programme. For easy access the links to the relevant Annexes of the WHO guide are provided in Toolbox 5. In addition to the generic vaccine introduction checklist, the complementary checklist in Annex 2 con- tains a list of issues specific to health worker immunization. The elements of this checklist should be added (as appropriate) to the more generic checklist of activities. A sample health facility checklist is also provided (Annex 3) to guide the preparations for vaccination at the health facility level. Toolbox 5 Links to templates and checklists for a new vaccine introduction plan in “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” Generic template to guide the development of a national introduction plan Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc (Accessed 14 Mai 2019) New vaccine introduction checklist, activity list and timeline of WHO new vaccine introduction guide provides advice on planning budgeting, activities, distribution of roles and responsibilities and timelines ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_ resources/nvi_guidelines/Annex4_Instructions.pdf (Accessed 14 Mai 2019) Corresponding checklist tool Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_checklist_en.xls (Accessed 14 Mai 2019) 22 3. Planning and managing vaccination of health workers The timelines for planning and introduction should be included in the checklists and/or as a sepa- rate Gantt chart to ensure that all the activities are completed in their appropriate order to allow timely implementation of vaccination activities. Cross-reference should be made to the relevant sections of the occupational health strategies and plans at both the national and health facility level (see previous chapter on integration of health worker influenza policies into occupational health policies and requirements) to facilitate a more cohesive approach to planning and implementation. The WHO-ILO Global Framework for National Occupational Health Programme for Health Workers recommends that all countries identify the responsible person(s) for occupational health, both at the national and workplace levels. These focal points should be a part of the planning team at the national and health facility levels, respectively. Inclusion of the occupational health focal points would allow for an integrated approach to prevention of influenza in the work place where vaccination forms part of a larger package of interventions for influenza control, including other infection control measures to protect both health workers and patients. The labour-management committees for occupational safety and health in health facilities, where they exist, can help in engaging the management and the workers’ representatives in the implementation of the vaccina- tion programme. In addition to the national operational plans for the implementation of health worker vaccination, the national comprehensive multi-year plan (cMYP) for immunization should also be updated to include health worker immunization (Toolbox 6). Costing and financing As with the addition of any new vaccine to the national vaccination schedule, the vaccine and deliv- ery costs should be estimated and included in the annual and multi-year immunization budgets. In addition to the costs of vaccines and supplies (syringes, needles, safety boxes etc.), costs for vaccine delivery (including human resources), annual communications/education and demand generation efforts at the national and health facility level, and monitoring and reporting would need to be included in the costs. Several tools and resources are available that could be used or adapted for costing, budgeting and securing finances for health workers vaccination (see Toolbox 7). Since communications and other activities/interventions to enhance vaccination uptake will be required each year, these costs should be incorporated into the annual vaccine delivery costs and not considered only as a one-time activity. In addition to costing and budgeting for annual health worker influenza vaccination, it may also be necessary to advocate with those responsible for allocating funds for health programmes to Toolbox 6 WHO-UNICEF guidelines for multi-year planning WHO-UNICEF guidelines for developing a comprehensive multi-year plan (cMYP)  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. Planning and managing vaccination of health workers ensure that financing for vaccination is sustained. Toolbox 8 provides links to resources for advo- cacy for sustainable financing. Toolbox 7 Resources for costing and financing cMYP Costing and Financing Tool  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (Accessed 14 Mai 2019) Immunization Costing Action Network (ICAN) Immunization Delivery Cost Catalogue This interactive website provides information on vaccine delivery costs across different low and middle- income countries through a variety of delivery strategies.  http://immunizationeconomics.org/ican-idcc (Accessed 14 Mai 2019) WHO Flu tool for planning and costing maternal influenza vaccination (new name: SIICT tool) This tool is being expanded to include all influenza risk groups, including health workers.  https://www.who.int/immunization/research/development/influenza_economics/ (Accessed 14 Mai 2019) Management Sciences for Health. Planning, costing and budgeting framework  http://www.msh.org/resources/planning-costing-and-budgeting-framework (Accessed 14 Mai 2019) Immunization financing: a resource guide for advocates, policy makers and program managers  https://immunizationeconomics.org/imfin (Accessed 14 Mai 2019) Toolbox 8 Resources for advocacy or sustainable financing Immunization advocacy library. Provides a number of tools and guides to convey the value of vaccination and the need to invest in vaccination  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/communication-and-advocacy/immunization-advocacy-library (Accessed 14 Mai 2019) Two specific documents in this library are of relevance: Workbook – advocacy for sustainable funding of immunization programmes  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/workbook-advocacy-for-sustainable-funding-of-immunization-programmes (Accessed 14 Mai 2019) How to prepare a financial profile of your immunization programme  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/how-to-prepare-a-financial-profile-of-your-immunization-programme (Accessed 14 Mai 2019) 24 3. Planning and managing vaccination of health workers Formative research to inform the planning process To prepare for the launch of influenza vaccination, several countries have used formative research to better understand the factors affecting uptake of seasonal influenza vaccination in health work- ers, including concerns, beliefs, information needs, cultural issues, and barriers to vaccination in order to develop a tailored plan to address them. Formative research can include both quantitative and qualitative research and, in some situations, might include a desk review. Quantitative research may be used to identify the main predictors for low uptake of vaccination among health workers and the main drivers for compliance with vacci- nation recommendations. Data may be collected through surveys and questionnaires administered to health workers. The sample should ideally include sufficient representation from the different categories of health workers since the perceptions and reasons for low uptake may vary between health worker groups, e.g. between doctors and nurses (40), as well as from a sample of primary, secondary and tertiary health care facilities and from different work areas within these facilities. Qualitative research is insight research, based on understanding the audience’s point of view. It elu- cidates new issues and provides a more in-depth understanding of the complex issues underlying the uptake of vaccination. Qualitative research methods commonly include focus group discus- sions and individual in-depth interviews. The WHO European Regional Office has published a step-by-step field guide to qualitative research for new vaccine introduction (see Toolbox 9). To be useful, formative research must be properly planned and well executed, failing which there is a risk of drawing wrong conclusions. This requires time and resources. While it is useful to con- duct such research to inform the planning process, if time and resources do not permit, the lack of such research should not delay seasonal influenza vaccine introduction, unless attitudes of health workers are expected to be an issue that may significantly and adversely impact vaccine uptake. When data from formative research are not available, data from such studies conducted in other countries may be used to inform the planning process. While the reasons for low uptake of vac- cine are heterogenous, available evidence suggests that there is broad convergence on the major influencers of vaccine uptake among health workers, especially between countries within the same sub-region, which may be used in the initial planning process. The rapid appraisal of evi- dence (10) summarizes the key findings from the published literature and this evidence could be used, as applicable and appropriate, in the absence of locally conducted research. Data from the published literature may be complemented with information obtained through quantitative formative research using rapid surveys in a sample of health workers, ideally including different health worker categories. These surveys may be less resource intensive than qualitative formative research and could be completed without resulting in any delays to vaccine introduc- tion. Annex 4 provides a sample questionnaire that may be used for such surveys. Toolbox 9 Field Guide for qualitative formative research A field guide to qualitative research for new vaccine introduction ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_VaccineIntro.pdf (Accessed 14 Mai 2019) 25 3. Planning and managing vaccination of health workers Further research may be conducted if vaccine uptake remains persistently low. The TIPflu tool is an important resource that may be used in such situations. Communication and vaccine acceptance Personal beliefs, cultural attitudes and perceptions about vaccination, in addition to official rec- ommendations, often guide the actions of many of those responsible for delivery of vaccines and many recipients (51, 52). This also holds true at the level of health workers. Available evidence shows that there are often misperceptions about vaccination as well as a gap between knowledge and behaviours (53, 54). Thus, simply improving knowledge about the risks and benefits of vac- cination among health workers has not proven to be sufficient to achieve optimal vaccination uptake. Achieving optimal vaccination coverage in health workers requires a multi-dimensional demand generation effort that is informed by a good understanding of the perception, motivators and barriers of vaccine acceptance among health workers, both as providers of vaccination and as recipients. Communications messages need to be tailored to address the needs of different health worker groups since available evidence suggests that perceptions about the need, risks and benefits of vaccination may vary between these groups (55). Current efforts mainly focus on preparing fact- based approaches to preparing communication messages. However, these types of messages may need to be framed according to the intended audiences based on their level of education and understanding. Taking the preferred cognitive decision-making styles of the individual groups to be targeted into account may have greater impact (54). Framing such messages will require an understanding of vaccine psychology and cognitive decision-making and may require engagement of communication specialists. A traditional approach to communications regarding immunization was through the use of mass media. However, research has shown that mass media alone and a one-way communication to health workers may not be sufficient to optimize the uptake of vaccination. Individual and group communications, in this instance at the health facility level, will be required to build trust and motivate health workers to accept vaccination. Including information on the relevance of vaccination of health workers (self-protection, responsi- bilities towards patients, pandemic preparedness in the case of influenza) in pre-service curricula for medical schools, nursing schools and other training institutions targeting health professionals may help to better establish health worker vaccination as an organizing concept and create better informed health worker generations providing immunization. Effective communications and demand generation activities are not a one-time event but need to be continuous and have the ability to quickly respond to the evolving perceptions about vaccina- tion and quell rumours and mis-perceptions. Front line vaccination staff responsible for health worker influenza vaccination will need to be trained to be able to deal with vaccine hesitant health workers as well as vocal vaccine deniers9 who may negatively impact the uptake of vaccination (56). 9 Vocal vaccine deniers are at the extreme end of the subgroup of vaccine refusers and actively advocate against vaccination, using science denialism techniques to justify their beliefs (reference 32). 26 3. Planning and managing vaccination of health workers A national vaccine communication working group that includes communications specialists will facilitate strong working relations with and collaboration among partners and allies, strengthen routine communication for immunization, and ensure well-coordinated and immediate response from all involved authorities to any safety event. Inclusion of members of the Occupational Safety and Health department and from professional societies in communicating with health work- ers contributes to building trust and improving acceptance of vaccination. Representation from health workers, professional associations, and unions and from the different health worker cat- egories targeted for vaccination would ensure that the viewpoints of each health worker category is taken into consideration in developing tailored communication materials. A number of tools and guidance documents are available that can be used for developing an effec- tive communications strategy and for framing the communications messages that are specifically tailored towards different health worker groups, including a template terms of reference for a vac- cine communication working groups (Toolbox 10). In addition to vaccination, the information and education and communication materials should also include information on other infection control measures to reduce transmission of influenza in the work place and steps to be taken should a health worker develop an influenza like illness. Communications at the health facility level Effective communications at the health facility level will benefit from a dedicated and well-trained team to deliver the communications strategy at the health facility level. Such a team should be established and trained well in advance of the planned introduction date and should include representation from the main health worker categories in the facility and an advocacy and communications specialist, if one is available. Ideally, communications for seasonal influenza vaccination should be part of a broader communications effort on control of influenza in health care settings. Toolbox 10 Tools and guides for developing communications strategy and messages Vaccination and trust library  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/vaccination-and-trust (Accessed 14 Mai 2019) New vaccine introduction: checklist for planning communications and advocacy (2017)  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2017/new-vaccine-introduction-checklist-for-planning-communication-and-advo- cacy-2017 (Accessed 14 Mai 2019) Template terms of reference for a vaccine communication working group ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_Sup- portDoc_TOR_Proof7.pdf (Accessed 14 Mai 2019) 27 3. Planning and managing vaccination of health workers Communication activities at the health facility level should begin sufficiently in advance of the planned date for the onset of vaccination, especially in countries introducing vaccination for the first time. Initial activities could include the display of information posters at all the relevant areas of the health facility. The manager of the health facility and the heads of all the relevant depart- ments and clinical areas should be sent a formal communication along with sufficient copies of all information materials about vaccination to be displayed in each clinical area. Where possible, relevant information on influenza vaccination could also be sent to all health workers using e-mail and/or local social media networks. In-person group briefings should complement the display and distribution of information materi- als. Existing staff meetings could be leveraged to conduct these briefings. The number of in-person group briefings will depend on the size of the health facility and the number of targeted health workers. Larger health facilities (e.g. secondary and tertiary level health facilities) may need to conduct several briefing sessions to cover all the targeted health workers. Since communications messages may differ between different categories of health workers, consideration should be given to holding separate briefing sessions for each health worker category using information and mate- rials relevant to them. To allow better communication and enough time for questions from health workers to be addressed, the size of each group should be designed to allow sufficient opportunity for interaction. Provision should be made to facilitate the participation of health workers working night shifts. The schedule for the briefings should be widely publicized within the health facility and reminders sent to promote high attendance. In-person meetings should: 1. Explain why vaccination is important for themselves, their patients and families and for wider society – with a particular focus on severe outcomes associated with influenza; 2. Inform health workers about national policies; 3. Provide information on the safety of seasonal influenza vaccines; 4. Provide information on the timing and venue(s) for vaccination; 5. Explain potential consequences of non-vaccination; 6. Allow sufficient time for questions. Consideration may be given to establishing a telephone hotline or web-based system to address questions from individual health workers. In addition to the display of posters and other com- munications materials, the use of visible and removable stickers that can be displayed by health workers who have been vaccinated (e.g. on their ID badges) would serve as a visible reminder to their colleagues who have not been vaccinated. In addition, text messages, generic e-mails and social media platforms could be used to provide periodic reminders on vaccination. Demand Generation at the Health Facility Level In addition to communication strategies, behavioural science-based demand generation efforts can be implemented prior to the availability of vaccines in order to prime health workers for vac- cination. These nudge-based interventions work by creating an environment that can influence behaviour in a predictable way but does not eliminate choice (57), and have proven effective in 28 3. Planning and managing vaccination of health workers a variety of healthcare settings (58). These interventions can narrow the gap between intention and actual behaviour, which is usually caused by individuals or health workers forgetting to get their vaccination or through barriers to convenient vaccination. Additionally, these interventions frequently can be implemented for relatively low cost (59). The figure below (Figure 3), adapted from the Nuffield Council on Bioethics, demonstrates the hierarchy of nudge-based interventions to improve vaccine uptake (60). Nudges lower on the ladder are less aggressive but can still have a measurable impact. By providing health-facility vaccination rate feedback, a process used in the United States to improve uptake of childhood vaccination, progress in health facilities can be monitored, and provide motivation to health workers to improve their own vaccination practices (61). Figure 3. Ladder of nudge interventions to increase vaccination rates Guide choice through default options Automatically set up appointment for vaccination unless individual opts out Enable choice Increase options to obtain vaccination such as at workplace or near home Prompt implementation intentions Ask individual to precommit to a time and location to obtain vaccination Frame information Deliver social comparsion feedback on vaccination rate among peers or healthier individuals Provide information Offer education on benefits of vaccination to self ant others Do nothing Simply monitor vaccination rates Source: Patel MS (ref. 32) Reminders to individuals to vaccinate can serve as a nudge, notifying individuals when they are due for a vaccine and prompting them to come to the vaccination site to receive the vaccine. These can be paper-based or mobile phone text message-based and have proven effective (62). In the health facility, health worker reminders through an immunization data collection tool (whether paper- or electronic-based) can help improve the delivery of vaccines by health workers (59). A successful nudge-based strategy to reduce barriers to convenient vaccination and enable choice is standing orders. Standing orders are a policy put in place in a health facility that permits non- physician health workers to administer vaccines without a prescription or explicit order from a physician and have proven one of the most effective strategies for improving vaccine uptake when applicable (63). All of these strategies can be combined with communication approaches to create demand in the community. 29 3. Planning and managing vaccination of health workers Going beyond nudges Nudges are a favoured method for influencing demand since they preserve choice and are not coercive. However, some experts have argued that when nudges fail to achieve optimal uptake of vaccination in health workers, and this failure results in harm to their patients, decision-makers should consider adopting more forceful policies (64). This is not to imply that when nudges fail one should immediately go to measures that eliminate choice. There are interventions that exist across a continuum leading up to restriction of choice. The use of “soft mandates” provide exam- ples of actions across this continuum. Case study: The «flulapalooza» campaign to increase uptake of seasonal influenza vaccination in health workers Vanderbilt University Medical Center in Nashville, Tennessee, in the United States, employs over 24,000 health workers. Since 2011, the cornerstone of its seasonal influenza vaccination campaign for health workers has been its mass influenza vaccination event, playfully named “flulapalooza”. This event vac- cinates, on average, over 14,000 people in a single day. The closed point-of-dispensing (c-pod) design has been evaluated and refined over time to substantially increase administration efficiency and cover- age rates. The event emphasizes a festive atmosphere while practicing critical pandemic vaccination skills among hospital occupational health and administrative leadership. This event achieves high coverage among categories of health workers who are present that day; how- ever, due to the structure of nursing shifts and ward responsibilities at the institution, less than 30% of nursing staff are typically vaccinated at the event. Thus, the medical center combines flulapalooza with ward visits, mobile carts and other strategies to achieve its annual target of greater than 90% overall health worker vaccine coverage. Notably, although institutional policy gradually increased the difficulty of declination and eventually included disciplinary action in response for unexcused failure to vacci- nate, it is notable that 92% coverage had been achieved in seasons before disciplinary policies were in place. Details of event design, workflow diagrams and practical, specific lessons learned are described in a publication available online. Source: Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168–76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 Annex 5 provides a table that lists the different communications and demand creation approaches, along with an indication of the effort required to implement the approach and the expected impact. Vaccine procurement and supply chain management Vaccine procurement Accessing vaccines at optimal prices requires a good understanding of procurement mechanisms and systems, vaccine market dynamics, and the elements of vaccine pricing. Procurement starts with forecasting vaccine demand, followed by tendering, contracting and procurement processes. The tools and resources for vaccine procurement are listed in Toolbox 11. Procurement of seasonal influenza vaccination may have some unique features and may require regulatory approvals and advance purchase commitments with specific manufacturers shortly after the publication of the 30 3. Planning and managing vaccination of health workers WHO recommendations on the seasonal vaccine formulation (in February for the northern and in September for the southern hemisphere) and well in advance of the influenza season. Selection of the vaccine product and presentation As with any other vaccine, the choice of product and presentation will depend on multiple fac- tors including supply availability, price, ease of use, storage and transport requirements, vaccine wastage and missed opportunities for vaccination (e.g. postponing vaccination due to reluctance to open a 10-dose vial for only one or two individuals). The choice of vial size should be based on the number of doses to be delivered at each vaccination point and the number of sessions to be held at each point. The currently prequalified injectable seasonal influenza vaccines are available in single dose pre-filled syringes and in single and 10-dose vials. All the 10-dose vial presentations contain thiomersal as a preservative. However, it may be noted that not all the currently available prequalified products in 10-dose vials have market authorization for storage up to 28 days once opened, and not all products have a vaccine vial monitor (VVM). These aspects should be taken into consideration in selecting the product and presentation. The specifications of each product and presentation should be checked to confirm that they meet the requirements of the programme before a procurement order is placed. Information on WHO prequalified vaccines may be found on the WHO website (see Toolbox 11). Forecasting vaccine demand is an important first step in vaccine procurement. Forecasting demand requires an estimate of the number of health workers who will be targeted for vaccination, the expected vaccination coverage, and an estimate of vaccine wastage. Ideally health workers in both public and private facilities would be targeted for vaccination. This process of estimating the size of the target population for health workers vaccination is likely to be more complex than for other vaccines targeting the general populations. The data to derive such estimates may also be more difficult to find, especially in low and middle-income countries. Toolbox 12 provides resources for estimating the size of the health work force and those that need to be targeted for vaccination. Toolbox 11 Vaccine procurement tools Procurement mechanisms and systems  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_systems (Accessed 14 Mai 2019) Vaccine product, price and procurement (V3P) web platform  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (Accessed 14 Mai 2019) Vaccine market  http://www.who.int/immunization/programmes_systems/procurement/market (Accessed 14 Mai 2019) List of WHO prequalified seasonal influenza vaccines  https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 31 3. Planning and managing vaccination of health workers The global health workforce databases may not carry information on all the health workers cate- gories that may be targeted for vaccination. For example, global databases may only have estimates of the numbers of doctors, nurses and midwives, but not other health worker categories. In such instances, rough estimates could be made based on ratios of those health workers for whom data are not available to those where data are available (e.g. ratio of physicians to laboratory workers). These ratios could be quickly obtained through a survey of a small representative sample (e.g. tertiary, secondary and primary) of health facilities. Since each health facility may be required to prepare beneficiary lists with the names of those targeted for vaccination, for tracking vaccination delivery, and for maintaining records of those vaccinated; the initial demand forecasts could be refined in subsequent years using data from these beneficiary lists and vaccination records. Logistics and cold chain management The handling of influenza vaccine is similar to most other vaccines in the national immunization programmes. It needs to be stored at 2–8 degrees Celsius. Since vaccination of health workers is expected to occur annually during a relatively short window period each year before the onset of the influenza season, a plan needs to be developed to ensure storage and transport of vaccine at the different levels involved in the supply chain during the window period chosen for vaccina- tion. Tools and resources for vaccine forecasting, management and logistics are available on the WHO website (Toolbox 13). The cold chain volume requirement for each WHO prequalified prod- uct and presentation are available on the WHO website (please select the vaccine type and click on the links for each individual product and presentation to obtain this information).10 At the health facility level, the focal point responsible for health worker vaccination should ensure that the vaccine doses required in the facility are included in the demand forecast and that sufficient storage space to accommodate the required vaccine doses is available prior to the anticipated date of vaccine arrival at the health facility. 10 WHO prequalified vaccines. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 Toolbox 12 Resources for estimating target population size Global Health Observatory: Health Workforce  http://www.who.int/gho/health_workforce Global Health Workforce Statistics database. Geneva: World Health Organization.  http://www.who.int/hrh/statistics/hwfstats Counting health workers: definitions, data, methods and global results. Geneva: World Health Organization; 2007. ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf 32 3. Planning and managing vaccination of health workers Vaccination of health workers Vaccination of health workers should ideally take place at the health facilities where the targeted health workers normally work to ensure convenient access to vaccination. Case study: Using an immunization champion to enhance uptake of influenza vaccination in health workers in Oman Oman has a universal free-of-charge, integrated health care system, which includes influenza vaccina- tion of health workers. Oman is one of the few high-income countries in the WHO Eastern Mediterranean Region (EMR) that has achieved high influenza coverage among health workers (>80%). This was made possible by immunization champions. The minister of health in Oman is passionate about protecting the health of health workers and is at the forefront in taking the first influenza seasonal vaccine. As the patron of health worker community and an influential person in the country, this action has reinforced the importance of vaccination and continually helps promote influenza immunization programs. He has also been personally involved in the communication of vaccination messages to the health worker community. Every health facility should prepare a health facility plan for implementing seasonal influenza vaccination of health workers well ahead of the influenza season. These plans should include measures to enable convenient access to vaccination for health workers in every shift. Different options may need to be determined at the health facility level to cover health workers during night shifts without resorting to 24-hour vaccination services, for example insuring the availability of vaccination just before or after a shift change. A vaccination team should be established at the level of the health facility to coordinate the vac- cination activities and optimize uptake under the overall supervision of the head of the facility. One person should be designated as the team leader. This could be either the occupational safety and health focal points, or the persons responsible for immunization activities in the health facil- ity. In larger facilities the staff medical services may be tasked with this activity. Experience from some organizations and health facilities have shown that using “vaccination champions” from among the health workers may contribute to improving vaccination uptake among their peers. In some countries, a mobile team that goes to each clinical area in the health facility and provides vaccination has been successfully used. Toolbox 13 Vaccine management and support resources The resources that can assist programme managers in supply chain and logistics support planning may be found at the WHO website at: ƥ http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ index4.html (Accessed 14 Mai 2019) 33 3. Planning and managing vaccination of health workers Training of the vaccination team Training workshops for health facility vaccination focal points should be conducted to conduct training in developing a health facility plan and in implementing and monitoring vaccination activities. A standardized agenda, curriculum, resource documents, checklists and model forms for recording data, as required, should be created at the national level for use in these workshops so that training is uniform across all health facilities. To further ensure uniform training, the workshops could be conducted using teams of trainers who are themselves trained centrally and are assigned to each region/subregion, using a cascade training approach. Short training videos may be used to achieve uniformity in content in the training. Web-based self-learning modules may be considered for those who were unable to attend the training sessions. The health facility vaccination team should have the capacity to classify health worker groups (see chapter 2 for sample risk categorization of health workers) and establish a list of health workers eligible for vaccination, with their designations, and areas of work. Where different vaccination policies apply to different risk categories, either separate lists should be created, or mechanisms established to easily identify and monitor the vaccination status of those in each category. The beneficiary lists should be developed sufficiently in advance of the start of vaccination activities and the relevant health workers informed on the need for vaccination. In addition to health workers employed at the health facility, provision may be made to include health workers in smaller facilities within their catchment area, including private facilities, as per the national policy, should vaccination not be available at all facilities. A mechanism for defaulter tracking and for sending reminders should be established at each health facility. For health workers who come into contact with high risk patients, (e.g. those in organ transplant, oncology, intensive care or perinatal units), the supervisors of those who have not been vaccinated before the start of the influenza season may need to be informed (local con- fidentiality norms permitting) so that they can reinforce the written reminders or, in case of refusals, get active declination forms signed and institute infection control measures applicable to active refusals, e.g. reassignment of duties, wearing of masks etc. as per the established national of health facility policy. 34 4. Monitoring and evaluation All countries should have a mechanism in place to monitor vaccine coverage as well as adverse events following immunization (AEFI) from the health facility to the national level and conduct at least one influenza vaccine post-introduction evaluation. However, measuring vaccine accep- tance and vaccine effectiveness or impact will be necessary and feasible only in a setting where immunization targets are not reached and if funding is available. Developing and updating information systems Appropriate forms and data entry modules for recording and reporting vaccination data at the health facility level and processes for reporting the data should be established. In developing tools and guidance for data collection, the need to include both public and private health systems should be considered. This may require mapping of existing health information systems and immunization data collection instruments as well as guidance on how these systems may be used to collect data on seasonal immunization of health workers. Data collection systems may vary across health facilities depending on the size and available infra- structure of the facility. However, each health facility must be provided with a standardized data reporting form to ensure that the data required for reporting to the national level are collected, irrespective of the data recording system used. This could include the name of the health worker, the health worker category, area of work, risk category, date of vaccination, the vaccine product and lot number. In developing the data reporting form, the advice provided by the NITAG on monitoring and impact assessment should be considered. All data collection systems, whether paper-based or electronic should have the capability for defaulter tracking and a system for generating and sending out reminders to defaulters. When using such reminder systems, protecting the confidentiality of data on the health and vaccination status of health workers will be critical and access to the data should be restricted to the facility vaccination coordinator. Coverage monitoring Several approaches for estimating health worker influenza vaccine coverage are available. The timing of such coverage measurement is important and should be coordinated with the timing of vaccination in the country. Given that influenza vaccine is usually administered in seasonal campaigns, frequent reporting (e.g. monthly) is recommended. Ideally, assessments should be done at the end of the season, when complete data are available and assessed and data cleaned for any inconsistencies. 35 4. Monitoring and evaluation Health facility registries Information on influenza vaccines administered to health workers should be included in existing records maintained as part of occupational health requirements and in vaccination registers as part of institutional monitoring mechanisms. Careful assessment of data discrepancies is requi- red if reporting is done from multiple sources, and data protection issues should be judiciously considered. The minimum set of data will include the number of people receiving influenza vac- cination during each annual season, the total number of targeted health workers, and the derived vaccination coverage (%). Often both numerator and denominator data can be obtained from the departments of occupational health at health facilities. For establishing more detailed denomina- tors, nominal health worker records e.g. based on payrolls can be used as a first step. A beneficiary list of those targeted for influenza vaccination can be selected from these records by applying criteria related to the health worker’s risk of infection or of transmitting the infection to those for whom they care (see section on “Characterizing the target groups for vaccination” and table 1). Depending on the capacity of the reporting system and program, this could include tallying numbers by health worker category and risk profile to allow coverage estimates by subcategories, such as doctors, nurses, laboratory workers, or staff working in Intensive Care Units or general (e.g. medicine or paediatric) wards, etc. If a vaccination registry does not exist, a crude estimate of coverage among health workers could be calculated by using the number of vaccine doses distributed to each facility minus the number of vaccine doses returned (unused) divided by the estimated number of health workers targeted for vaccination at the facility. A similar, rather imprecise method to assess coverage at the national level would be to use the regularly compiled data on health workers (as reported to WHO) to estimate the denominator (see Toolbox 12), as used for the vaccine demand forecast, and the overall number of vaccines adminis- tered as the numerator. This approach should only be used as a last resort where none of the other methods described are feasible. Administrative data If vaccines are provided free to health workers with government, national insurance system or employers bearing the costs, there may be regular, sometimes mandatory, reporting on the number of health workers who have received vaccinations at the institutional level. Such administrative data may be available from well-documented national vaccine programmes or from health insu- rance records. Surveys Surveys to obtain data on vaccinations and other interventions should be performed every 3 to 5 years and allow the identification of heterogeneity of coverage at the subnational level, important for the necessary adaptation of immunization practices. A representative sample of health workers can be selected though a stratified random sampling approach from national registries of health workers (e.g. professional organizations). If such registries are not available, a two-stage selection of health facilities and of health workers in these facilities can be done. If contact information is available, standardized interviews could be done face-to-face, by phone or via internet-based pla- tforms. Without such information, online survey links could be provided to all health workers in the selected facilities with an invitation to access the survey platform using their mobile phones or personal computers. It should be noted that when using this approach, self-reporting of vacci- nation may lead to overreporting.11 11 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394773/ 36 4. Monitoring and evaluation In all of these approaches to estimate coverage it will be important to specify the categories of health workers, e.g. those with or without direct patient contact, the latter including students, trainees, volunteers, maintenance, information technology, food service staff etc., who have been included in the numerators and denominators. It is also important to specify if part-time per- sonnel working during the influenza season were included in the coverage estimates. Where individuals for whom vaccination is not recommended are vaccinated, such as back office work- ers or staff relatives, etc., care must be taken not to count these in estimating vaccination coverage. Refusal and completion rates of surveys will need to be monitored and adjustments for possible selection biases made in the analysis. At times, influenza vaccination programs may merely set absolute number targets of health work- ers to be vaccinated, based on the number of vaccines procured and available in a specific area or location. Such an approach, while followed in some countries, will not allow the proper estimation of coverage rates, including coverage by risk category, or comparisons over time, which will be important for interpreting any data on impact. It will also not enable identification of determi- nants of vaccination or of refusers. If available, data as well as methods used to estimate vaccination coverage for other regular health worker vaccinations should be accessed, e.g. for hepatitis B, measles, polio, pertussis or tetanus vaccines. It must be noted, however, that these vaccines are not provided on an annual basis and will often only be checked at entry to service. Toolbox 14 lists available tools for collecting and reporting immunization data and for estimating coverage. Toolbox 14 Monitoring and evaluation tools and indicators Immunization in practice series, module 7: Monitoring and using your data. Describes how to collect and report data and how to monitor immunization performance. ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf (Accessed 14 Mai 2019) Training for mid-level managers. Module 7: The EPI coverage survey (Document WHO/IVB/08.07). Geneva: World Health Organization; 2008. Provides a step-by-step walkthrough, including relevant guidance and tools, to plan and conduct a coverage survey of a newly introduced vaccine. ƥ http://who.int/immunization/documents/MLM_module7.pdf (Accessed 14 Mai 2019) WHO reference for estimating influenza vaccination coverage among target groups. Outlines different methodologies that can be used to estimate national influenza vaccine coverage among high-risk groups targeted for vaccination. ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing-influenza- vaccination-coverage-target-groups.pdf (Accessed 14 Mai 2019) 37 4. Monitoring and evaluation AEFI monitoring As for any vaccine and target group, a functioning AEFI monitoring system is a basic requirement, since knowledge gaps and misperceptions about influenza vaccine safety among health workers are consistently identified in in the literature. The system utilized to monitor and investigate possible AEFIs when delivering influenza vaccine to health workers should ideally be integrated into existing AEFI surveillance systems in line with national regulations for the monitoring of vaccine safety. The NIP or other departments responsible for health worker influenza vaccination (e.g. occupational health) should work with the National Regulatory Authority to define roles and responsibilities in vaccine safety monitor- ing. In countries using influenza vaccines for the first time, it could be conceivable to intensify AEFI surveillance during the first year of influenza vaccine introduction in order to provide quick feedback to stakeholders to help assure them of the safety of the vaccines in use. A functioning AEFI monitoring system will detect and elucidate problems with vaccines, which could be due to the product itself, its quality, or errors in the administration of the vaccines. All vaccine recipients reported as having an event (including minor events) perceived to be related to the influenza vaccine should be reported to the AEFI surveillance system using standard report- ing forms (see Toolbox 15). Given adequate reporting, the monitoring system should be able to evaluate the observed rate of reactions to influenza vaccine and compare this to the expected rates reported in the literature. For serious AEFIs, causality will normally be assessed by a group of experts. Importantly, and as for any vaccine, such a system needs to be able to identify a previously unknown or unexpected vaccine reaction that should be investigated in more depth. Care must be taken to ensure that coincidental events are not mistaken for vaccine reactions. By establishing and enhancing AEFI systems, influenza vaccination can also be used to further improve the awareness of overall immunization safety in the health worker community. Toolbox 15 AEFI-related information sources AEFI core variables, including data on case, vaccine, event and reporter ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_Dec2015.pdf (Accessed 14 Mai 2019) Sample form for AEFI recording with detailed description of reporting elements ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (Accessed 14 Mai 2019) Causality assessment of an AEFI: Provides the detailed methodology in a four-step process with access to a related software tool  http://www.who.int/vaccine_safety/publications/gvs_aefi/ (Accessed 14 Mai 2019) Vaccine safety training resources providing access to vaccine and pharmacovigilance training packages  http://www.who.int/vaccine_safety/initiative/tech_support/ (Accessed 14 Mai 2019) 38 4. Monitoring and evaluation Monitoring and evaluation of vaccine acceptance Key determinants of vaccine acceptance among health workers have been investigated and include the desire for self-protection and to protect family and patients. (see also section on communica- tion and vaccine acceptance). As part of an initial situation analysis of health worker influenza vaccination programmes, available information on policy, programmes and practices, the factors affecting acceptance and participa- tion, and the influence of media and communications can be investigated through key informant interviews, or participatory workshops. Results of such an analysis could then be used to inform additional communication strategies addressing the identified concerns in a targeted manner. Other determinants can be explored through formative research. Both qualitative and quantita- tive research methods can be used to evaluate changes in health workers’ knowledge, attitudes, practices and behaviours. Behavioural determinants that differentiate health workers who get vaccinated from those who do not should be assessed regularly. Understanding the reasons and reasoning behind health workers’ attitudes towards annual flu vaccination is useful for the devel- opment of communications messages and products. Involving health workers in behavioural research related to their perceptions, beliefs, emotions and potential conflicts also provides an opportunity for the health worker community to be engaged in the approach, which can result in greater acceptance of the vaccination program. Vaccine impact monitoring After an influenza vaccine has been introduced in a population, additional studies may help in evaluating the impact of the immunization program. However, WHO does not recommend that vaccine impact or effectiveness studies be conducted by all countries with influenza vaccination programs, given their complexity and expense. A number of research networks worldwide conduct such studies and results can be expected to be applicable in other settings with similar influenza epidemiology and vaccination programs. The decision to carry out such studies should therefore be based on the need for country-specific estimates and on the local capacity to conduct such rigorous studies. If studies are not appropriately designed with ade- quate sampling of different health worker categories, there is a risk of arriving at wrong conclusions. Toolbox 16 Tools to assess vaccine acceptance among health workers TIP-FLU tool. Provides an approach and tools grounded in behavior change theories and health programme planning models to tailor seasonal influenza vaccination to the needs and attitudes of frontline HWs.  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) TIP FLU case study Montenegro. Provides a practical example of the use of the TIP FLU tool. ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization-Pro- grammes-Seasonal-Influenza-TIP-FLU.pdf (Accessed 14 Mai 2019) 39 4. Monitoring and evaluation Before-after studies to demonstrate vaccine effectiveness are not advised for influenza, given that influenza vaccine effectiveness for preventing influenza symptoms in seasonal influenza epi- demics display considerable heterogeneity.12 Studies to evaluate the impact of seasonal influenza vaccination in health workers can be even more complex, given the varying risk of infection and transmission to patients among different categories of health workers. In health workers, a general reduction in absenteeism or, if available, reduction in influenza-asso- ciated absenteeism is often used as a surrogate indicator for the impact of an influenza vaccination programme. For this, health facility institutional monitoring would need to include disease rates in health workers, and a measure of sickness absence. Where possible, reporting days of absen- teeism due to influenza-like illness (ILI) (or respiratory infections) should be recorded. This will include self-reported ILI with or without virological confirmation. Other non-specific outcomes include severe acute respiratory infection (SARI) and all-cause pneumonia requiring hospitaliza- tion. It is important to note that all these clinical syndromes include various other respiratory pathogens against which influenza vaccine does not protect. If such assessments are done, they should ideally cover multiple seasons, since impact can vary substantially by season, else such studies will be quite difficult to interpret. Laboratory-confirmed outcomes (e.g. by RT-PCR and other molecular diagnostic tests) improve the specificity of influenza disease classification. Where possible, establishment of sentinel sites with such capacity could be considered for collecting samples from health workers for laboratory confirmation. In these sites, vaccine effectiveness could be assessed using a case-control design and comparing vaccine coverage in laboratory-confirmed versus test-negative cases, if vaccine coverage is sufficiently high. Any of these approaches require sophisticated laboratory capacity which is not available everywhere. The screening method is a study design which could also be used for health worker vaccine impact assessment: it uses individual-level data on vaccination history from cases and data on vaccina- tion coverage in the health worker population from which the cases came. However, such a study requires accurate information on the vaccination status of the cases and of health worker vaccina- tion coverage. Given the indication that annual influenza vaccination for health workers could reduce illness among the patients they care for, studies can be designed to evaluate the effect of health worker influenza vaccination on mortality, hospitalization, and influenza cases in patients of healthcare facilities. Several research approaches have been used in this context such as randomized trials or case-control approaches. Given the complexity of study designs, the conduct of such studies should be limited to research institutions that have the capacity and experience to conduct such studies. Economic assessments and cost-effectiveness evaluations may be considered once sufficient cost and impact data are available following influenza vaccine introduction. WHO provides a number of relevant resource documents, which are being further developed to specifically estimate vaccine introduction costs for health worker vaccination (Toolbox 17; see also Toolbox 2). Relevant data are not easily available everywhere and assessments can be difficult to perform, given the limited size of the group of health workers. 12 Evaluation of influenza vaccine effectiveness: A guide to the design and interpretation of observational studies, WHO 2017. 40 4. Monitoring and evaluation Post-introduction evaluation National Immunization Program Reviews routinely assess the use of specific vaccines about every 5 years following a new vaccine introduction. Such NIP Reviews should include relevant items to identify possible programmatic areas related to the new vaccine use. As needed in-between NIP Reviews, a specific influenza-related Post-Introduction Evaluation (I-PIE) tool may be performed after the first or second influenza immunization season. The I-PIE package (Toolbox 18) includes a number of tools to support the planning and conduct of the evaluation, including standard questionnaires and data collection forms in paper or electronic format as well as reporting templates together with instructions on how to perform the I-PIE in a cost-efficient manner. These tools will need to be adapted to the specific country context and to the specifics of the vaccine formulation and presentations. The I-PIE is performed at all levels of the health system and includes observation of practices at the points of vaccine administration, vaccine storage areas as well as data and record reviews. An I-PIE can thus provide a more immediate approach to assess the programmatic challenges and impact of influenza vaccine use, and to compare results across countries, enabling them to share and learn from each other’s experiences. Toolbox 17 Influenza in health workers: Study methodologies Evaluation of flu vaccine effectiveness 2017. Provides detailed information for researchers who design observational influenza vaccine effectiveness studies and for public health scientists who interpret and apply the results of these studies. An annex will address the effectiveness of influenza vaccine in health workers. ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (Accessed 14 Mai 2019) Manual for estimating disease burden associated with seasonal influenza. Provides step-by-step approach to estimate influenza disease burden in the general population as well as those with specific conditions who are vulnerable to severe disease.  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (Accessed 14 Mai 2019) Toolbox 18 Influenza post-introduction evaluation tools I-PIE tool with instructions and recording and reporting templates  https://www.who.int/immunization/research/development/ipie_influenza_post_introduction_ evaluation (Accessed 14 Mai 2019) 41 References [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination accep- tance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during preg- nancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are count- ries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evi- dence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare wor- kers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-ana- lysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13(6):e0198685. 42 [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care wor- kers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epide- miol. 2002; 23(10):615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influen- za-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kin- dergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial out- break of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a mul- ti-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 43 [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vacci- nation of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12(1):e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vac- cination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection cont- rol and hospital epidemiology. 1998; 19(7):518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward man- datory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62(1):1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 44 [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing inter- vention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccination: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36(2):196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, ado- lescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertive- ness. N Engl J Med. 2019 Jan24; 380(4):309–11. 45 Annex 1. Sample non-participation form This form is to be used in cases of voluntary vaccination where health workers in the very high or high-risk categories who decline to participate in assessment, screening and vaccination in accordance with the national policy. Completion of the form is particularly important where failure to get vaccinated will result in reassign- ment or require the use of protective measures to protect patients as specified in the national policy. Non-participation in vaccination 1. I have read and understood the policy directive regarding seasonal influenza vaccination of health workers. 2. I decline to participate in vaccination against influenza. 3. I am aware of the potential risks to myself and/or others that my non-participation in vaccination may pose. 4. I am aware that my non-participation may result in my being reassigned to a non-high-risk area or in other requirements to protect others with whom I may come in contact, as per the national policy. 5. The reason for my non-participation is: Refusal to sign In circumstances where the health worker refuses to sign this form, it should be noted on the form and the health worker should be notified of consequences, if any, as per the policy. Name of health worker: Date of birth: Health service/ facility: Work area: Signature: Date: OFFICE USE ONLY I have discussed the potential risks that non-participation in vaccination may pose and the manage- ment of unvaccinated workers in accordance with the vaccination policy. Name of vaccination team staff: Designation: Health facility /agency: Signature: Date: 46 Annex 2. Complementary checklist for planning health worker immuniza- tion: national13 level (To be adapted for local use) To account for the specifics of seasonal influenza vaccination of health workers, the following ADDITIONAL elements may be added to the generic new vaccine introduction check list, see Annex 4 of the document “Principles and considerations for adding a vaccine to a national immunization programme” for the checklist structure. Health worker seasonal influenza vaccination policy 1. National policy on seasonal influenza vaccination of health workers are published and dissemi- nated to all relevant agencies and health facilities, including private health facilities and relevant professional societies. 2. The policy on seasonal influenza vaccination of health workers is reflected in the national occupational health policies. 3. The costs of seasonal influenza vaccination of health workers are included in either the immu- nization or occupational health budget, as appropriate. 4. Surveillance system is in place for influenza activity, including defining start and end of the influenza season, to inform selection of the most appropriate vaccine formulation and timing of influenza vaccination. Planning for successful vaccine introduction 5. A functional multidisciplinary coordination group is in place to discuss and promote access to a new target population of health workers, enabling the formation of partnerships which support and shape the national agenda. 6. The group includes focal points from the occupational health and immunization programs, professional organization representatives, and other relevant stakeholders. 7. A costed operational plan for health worker vaccination is developed and integrated into the national immunization plans and relevant occupational health plans. Formative research (optional and to be included only if formative research is planned) 8. The need and scope of any formative research to be conducted in preparation for vaccine introduction is defined. 9. A research group to conduct formative research has been identified and terms of reference for the research has been developed. Communications 10. National communications working group established for planning communications strategy and developing communications materials for health worker vaccination against seasonal influenza. 13 In some countries, especially large countries with decentralized system, elements of this checklist may also apply at relevant subnational levels, e.g. provincial level. 47 11. Tailored communications messages and materials developed along with an overall communications strategy. 12. Training for health facility communications teams is conducted. Vaccine procurement and supply chain management 13. Target population size estimate developed and included in demand forecast. 14. Individual health facility demand estimated, and vaccine distribution plan developed. 15. Sufficient storage space for vaccines and supplies for seasonal vaccination at all levels established to accommodate vaccine during vaccination period. Vaccine Delivery 16. Health facility vaccination delivery teams are established and trained. 17. System for management of vaccination refusals and implementation of infection control mea- sures in place for prevention of nosocomial transmission, e.g. reassignment, wearing of masks, mandatory leave in case of ILI. Monitoring and evaluation 18. Data recording and reporting tools developed and distributed including for coverage monitoring (updated administrative data and health worker surveys) and AEFI monitoring. 19. Post-introduction evaluation conducted within the first 2 seasons following vaccine introduction. 20. Possibilities reviewed for operational research to assess health worker vaccine acceptance. 48 Annex 3. Health facility checklist (To be adapted for local use) Person responsible Deadline Status Communications 1. Health facilities communications working groups are established and trained 2. Health facility communications plan and schedule for group communications with health workers finalized 3. Adequate supplies of posters and information materials for health worker vac- cination are available 4. Notification of vaccination sent out to targeted health workers and supervisors 5. Telephone hotline established to address individual queries from health workers Storage capacity for vaccines and supplies 6. Adequate storage capacity for influenza vaccines and supplies during vaccination window period established 7. Adequate supplies of influenza vaccines and supplies for health worker vaccination available 8. Provision to deal with extra injection waste during period of vaccination Vaccine Delivery 9. Vaccination delivery team established and trained and vaccination sites within health facility finalized 10. Categorization of health workers completed and beneficiary list for vaccination developed 11. System for management of vaccination refusals and implementation of infection control measures in place for prevention of nosocomial transmission, e.g. reas- signment, wearing of masks, mandatory leave in case of ILI Monitoring and evaluation 12. Data recording and reporting instruments available taking into account data protection issues 13. System for defaulter tracking and reminders established 14. Health facility registries updated to include influenza vaccination 15. AEFI monitoring and reporting systems updated to identify AEFI in health workers 16. Vaccine acceptance monitoring system to address uptake issues in health workers established (if uptake issues are observed) 49 Annex 4. Sample questionnaire for conducting a survey among health workers 1 Name (optional) 2 Age (years) 3 Sex ¨ Male ¨ Female 4 Job category14 ¨ Doctor ¨ Nurse/midwife ¨ Laboratory technician ¨ Other technical staff ¨ Other (specify) 5 Patient contact ¨ Direct ¨ Face-to-face but not direct ¨ None 6 Contact with high risk patients ¨ Yes ¨ No 7 Work area (name of clinical area of work) Statements Strongly agree Agree Neutral Disagree Strongly disagree 1 Vaccination of health workers against diseases such as hepatitis B and influenza are important 2 If I was unvaccinated exposure to influenza would be a risk to my health 3 Exposure to influenza poses a risk to my patients’ health 4 Influenza vaccination poses a risk to my health 5 The benefits of vaccination are greater than the risks 6 My receiving vaccination will protect my patients 7 The best way to protect my patients is to combine seasonal influenza vaccination with other infection control measures 8 I am sufficiently informed about risks of influenza infection I am sufficiently informed about the risks and benefits of influenza vaccination The following factors that would influence my decision to accept vaccination 9 Recommendations from the national policy-making body (e.g. NITAG) 14 Adapt for local use based on local health worker classification. 50 10 Endorsement of recommendation from the professional society to which I belong 11 If it is part of occupational health regulations/ requirements 12 Recommendation from my personal physician 13 Availability of vaccination at no cost to me 14 Easy access to vaccination at my place of work 15 Colleagues having been vaccinated 16 Previous experience with vaccination 17 Protecting my patients 18 Preventing/reducing absenteeism from work 19 Contributing to pandemic preparedness Other factors that would affect my decision to accept influenza vaccination (list below) 20 21 22 51 Annex 5. Communications and demand generation: Stratification of approaches to developing the content Approach Effort Impact Developing the content for communication messages Framing information by delivering social comparison feedback on vaccination rates among peers or healthier individuals Low Medium Tailored communication based on cognitive styles and cultural behaviours Medium High Communication methods Distribution and display of Information, Education and Communication (IEC) materials Low Medium Establish a specially trained communications team at health facility level to administer communications and demand generation approaches Medium High Web-based (including FAQs and chat groups) and social media communications Medium Medium Text message and e-mail reminders to health workers Low Medium Small group in-person briefing meetings High Medium Use immunization champions at national and health facility level Medium High Demand generation approaches Provision of free vaccines Medium High Provide vaccination in the work area using mobile teams Medium High Provide incentives or stimulate competition, e.g. awards to clinical areas with highest vaccination coverage Low Medium Visible reminders and peer-pressure, e.g. badges or stickers worn by those who have been vaccinated Low Medium Ask individual to commit to a time and location to obtain vaccination Low Medium Increase options to obtain vaccination, either near home or at workplace Medium High Guide choice through default options, e.g. automatically set up appointment for vaccina- tion unless individual opts out Low High Establish standing orders to facilitate vaccination Medium High 52 ISBN 978-92-4-151559-7

1An introduction manual for national immunization programme managers and policy makers How to implement seasonal influenza vaccination of health workers Family, Womens’s and Children’s Health (FWC) DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS This document was produced by the Initiative for Vaccine Research (IVR) of the Department of Immunization, Vaccines and Biologicals How to implement seasonal influenza vaccination of health workers ISBN 978-92-4-151559-7 Published: May 2019 This publication is available on the Internet at: https://apps.who.int/iris/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: + 41 22 791 4227 • Email: vaccines@who.int © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following dis- claimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. How to implement seasonal influenza vaccination of health workers. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. IAcknowledgements This manual was developed by Thomas Cherian and Carsten Mantel, MMGH Consulting and Philipp Lambach (WHO/IVR) with review and inputs of an Independent Expert Advisory Group: Salah Al Awaidy, Silvia Bino, Joseph S. Bresee (chair), Supamit Chunsuttiwat, Daouda Coulibaly, Luzhao Feng, Rachel Hale, Shabir A. Madhi, Helena C. Maltezou, Kelly Moore, Jonathan Nguyen- Van-Tam, Saad Omer, Gregory Poland, Sabine Wicker. Kelly Moore and Chris Morgan were consultant as representatives of the WHO Immunization Practices Advisory Committee, IPAC. Consultants: Thomas Cherian, Carsten Mantel. Additional experts: Birte Bödeker, Susan Y. Chu, Sara Hamid, Kathryn Lafond, Kathleen Morales, Julia Neufeind, Susan Wang. WHO: Philipp Lambach, Onyema Ajuebor, Ms Phionah Lynn Atuhebwe, Philip Gould, Shalini De- sai, Julia Fitzner, Martin Howell Friede, Shoshanna Goldin, James Dawson Heffelfinger, Raymond Hutubessy, Ivan Dimov Ivanov, Pernille Jorgensen, Melanie Marti, Hasan Qamrul, Lisa Menning, Ann Moen, Liudmila Mosina, Andreas Alois Reis, Alba Maria Ropero Alvarez, Claudia Steulet, Nadia Teleb. Financial support for the development and pilot-testing of this manual is provided through the Centers for Disease Control and Prevention (CDC), which provides financial support to the World Health Organization Initiative for Vaccine Research (U50 CK000431). II Contents Executive summary 1 About this manual 2 Objective 2 Audience 2 Structure of the document 3 Key related documents 4 1. Background and rationale 5 Current status of influenza vaccination in health workers 5 Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers 6 Evidence for health worker risk of influenza and impact of vaccination 6 Evidence of transmission of infection from health workers to patients and the impact of vaccination 7 Evidence for interventions to increase health worker vaccination uptake 7 Global Action Plan for Influenza Vaccines 8 2. Establishing a policy to vaccinate health workers against seasonal influenza 10 The decision-making process 10 Considerations for decision-making 12 Defining the public health objectives for vaccination 12 Economic analysis for establishing national policies 13 Characterizing the target groups for vaccination 14 Framing an immunization policy for health workers 15 Integration with Occupational Health Policies 18 Choice of vaccine product, schedule and timing of vaccination 18 Defining monitoring and disease impact measurement objectives 20 III 3. Planning and managing vaccination of health workers 21 Planning for successful vaccine introduction 21 Costing and financing 22 Formative research to inform the planning process 24 Communication and vaccine acceptance 25 Communications at the health facility level 26 Demand Generation at the Health Facility Level 28 Vaccine procurement and supply chain management 30 Vaccine procurement 30 Selection of the vaccine product and presentation 30 Logistics and cold chain management 31 Vaccination of health workers 32 Training of the vaccination team 33 4. Monitoring and evaluation 34 Developing and updating information systems 34 Coverage monitoring 34 AEFI monitoring 37 Monitoring and evaluation of vaccine acceptance 38 Vaccine impact monitoring 38 Post-introduction evaluation 40 References 41 Annex 1. Sample non-participation form 45 Annex 2. Complementary checklist for planning health worker immunization: national level 46 Annex 3. Health facility checklist 48 Annex 4. Sample questionnaire for conducting a survey among health workers 49 Annex 5. Communications and demand generation: Stratification of approaches to developing the content 51 1Executive summary Health workers are at higher risk of influenza infection than the general population. In addition to morbid- ity among health workers, influenza infection may also lead to increased absenteeism, presenteeism1 and disruption of medical services. Moreover, influenza infected health workers may contribute to nosocomial transmission of infection to their patients, including those at high risk for developing severe influenza disease and complications. Hence, the World Health Organization (WHO) considers health workers to be a priority target group for seasonal influenza vaccination. In addition, influenza vaccination of health workers contributes to influenza pandemic preparedness. Finally, studies have shown that health workers who are vaccinated against influenza themselves are more likely to recommend vaccination to their patients. This manual serves as a resource to assist users in establishing a national policy for seasonal influenza vaccination of health workers. It provides guidance along with a catalogue of available tools to facilitate policy development, planning, implementation, monitoring and evaluation of influenza vaccination of health workers. The contents of the manual are meant to supplement the document titled “Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring”, published by WHO in 2014. The main target audiences for this manual include national policy makers; national health planners; the na- tional programme managers for immunization and occupational health; and those responsible for occupational health, health worker immunization and infection control in health facilities. Close collaboration between immunization managers, and occupational health and infection control programmes is essential to optimize vaccine uptake, and for a cohesive and comprehensive approach to influenza control in health facilities. This manual summarizes the evidence and rationale, provides guidance on key issues, and lists available tools for influenza vaccination of health workers, covering three main components of vaccine introduction and management: 1. Establishing an evidence-based national policy for seasonal influenza vaccination of health workers. 2. Planning and management of health worker influenza vaccination. 3. Monitoring and evaluation, including assessing vaccination coverage, monitoring for adverse events following immunization, impact assessment and post-introduction evaluation. Complementing this manual, deliberations of an Independant Expert Advisory Group developing this manual are available in form of a meeting report summarizing critical issues. These include policy con- siderations, the evidence in support of health worker vaccination; categorization and prioritization of health workers; the choice of vaccination strategy; its integration into broader health worker vaccination and occupational health policies; planning and management of vaccination, particularly the approaches for communication and demand generation; and the challenges with monitoring and evaluation of health worker vaccination, especially in low and middle-income countries.2 1 Presenteeism refers to health workers who work while ill, yet have reduced accuracy and effectiveness and pose a risk to vulnerable patients in their care. 2 Cherian T. et al. Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16–17, Berlin, Germany. Vaccine. 2019;37(43):6255–6261. 2About this manual Objective This manual serves as a resource and catalogue of available tools to assist country officials in de- ciding upon, planning, implementing and monitoring health worker influenza vaccination in order to achieve optimal vaccination coverage. It is not meant to be a prescriptive document, but rather articulates general principles and key considerations to support policy formulation; plan- ning and management of vaccination; and monitoring and evaluation of influenza vaccination of health care workers. The manual also outlines measures to ensure integration of health worker influenza vaccination into existing national occupational health policies and occupational safety and health management systems of health facilities. It also addresses the opportunity for health worker influenza vaccina- tion to promote an integrated approach for monitoring and optimizing the uptake of all interven- tions included in national occupational health policies. In addition, it refers to the relationship and contribution of health worker vaccination to pandemic influenza preparedness. Seasonal influenza vaccination in health workers differs from other vaccine-preventable diseases in that vaccination is required annually. However, elements of this manual may be of relevance for health worker vaccination in general, particularly the sections on planning and management of vaccination and on monitoring and evaluation. Audience The main target audience for the manual include: 1. National policy-making bodies and health planners. 2. Programme managers for immunization, infection control and occupational health programmes at national and subnational levels and those responsible for occupational health and infection control in health facilities. 3. Organizations of health workers and employers. While the different sections of the document may be of greater relevance to one or the other group, it is advisable that the document be read as a whole because of the information on a particular topic may be found in the different sections of the manual. The document may also be useful to other audiences with an interest in immunization or occu- pational health. 3Structure of the document The manual consists of four sections as outlined in Figure 1. However, for clarity and complete- ness there is some overlap between some of the sections, with cross-references made to the other relevant sections. Figure 1. Structure of the document Establishing a policy Planning & management of vaccination Monitoring & evaluation Introduction, background and rationale •About the manual, including objectives and target audience •WHO policy recommendations on influenza vaccination •Current status of health workers vaccination •Summary of evidence to support health worker vaccination •Global Action Plan for Influenza Vaccines •Considerations for making a decision •Defining the objectives for vaccination •Categorization and prioritization of health workers •Framing an immunization policy • Integration with Occupational Health Policies •Choice of product and timing for vaccination •Delivery options and strategies to optimize coverage •Defining monitoring and impact assessment objectives •Planning for successful vaccine introduction •Costing and financing •Formative research to inform planning process •Communication & vaccine acceptance •Demand generation at the health facility •Vaccine procurement and supply chain management •Vaccination of health workers •Training of vaccination team •Coverage monitoring •AEFI monitoring •Vaccine acceptance assessment •Vaccine impact monitoring •Post-introduction evaluation POLICY MAKERS IMPLEMENTERS 4Key related documents The following documents are important resource materials that complement the guidance in this manual. 1. The WHO policy recommendations on seasonal influenza vaccination, including health worker vaccination are published in WHO Position Papers. These position papers are peri- odically updated. Vaccines against influenza: WHO position paper – November 2012 https://www.who.int/wer/2012/wer8747.pdf (Accessed 14 Mai 2019) Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (Accessed 14 Mai 2019) 2. The following document provides detailed guidance to countries that already provide sea- sonal influenza vaccination to health workers on how to identify, analyse, and effectively target issues related to uptake: Tailoring immunization programmes for seasonal influenza (TIP FLU). A guide for increasing health care workers’ uptake of seasonal influenza vaccination (2015). Copenhagen: World Health Organization Regional Office for Europe; 2015. http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) 3. While the contents of this manual can help inform national policies, the manual does not provide an exhaustive review of the available evidence to inform decision-making. A more detailed review of such evidence in support of vaccination of health workers is found in the following document: Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. July 2019. https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (Accessed 12 July 2019) 4. This manual is part of a series of introduction manuals on seasonal influenza vaccination developed by WHO. A manual on the implementation of influenza vaccination of pregnant women has been published earlier. How to implement influenza vaccination of pregnant women: an introduction manual for national immunization programme managers and policy makers. http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (Accessed 14 Mai 2019) 51. Background and rationale Health workers are at risk of influenza virus infection and of transmitting infection to patients under their care who may be at high risk for severe disease, complications, and death (1). The increased risk in health workers compared to the general population may vary by occupation or setting (2). WHO considers health workers to be an important priority group for influenza vaccina- tion, not only to protect themselves and maintain essential health-care services during influenza epidemics, but also to reduce the spread of influenza to vulnerable patient groups with whom they come into contact (1). Furthermore, many studies have found that a strong recommendation from health workers, especially from physicians, is highly likely to increase public uptake of vaccination (3–5). Health workers who have themselves been vaccinated are more likely to be knowledgeable about vaccination and be more effective in improving public acceptance of vaccination (3–5). Fi- nally, because health workers are likely to be targets of vaccination programs during an influenza pandemic, establishing functional programs for seasonal influenza vaccination of health workers will facilitate timely and effective vaccination during a pandemic (6). Current status of influenza vaccination in health workers Global adoption of a policy for influenza vaccination of health workers has been slow. In 2017, only 119 of the 194 countries reporting having a national influenza vaccination policy. Of these, 96 report targeting health care workers as a priority group. However, the proportion of Member States that reported having a policy varies by WHO region, with the majority of countries in the WHO regions of the Americas, Europe and Eastern Mediterranean reporting a national policy for influenza vaccination, whereas a lower proportion of countries report having such a policy in the Western Pacific, African and South-East Asian regions. Information on influenza vaccination coverage in health workers is not available for most coun- tries, though it varies widely and is reported to be low in many countries where such data are available. For example, data on coverage in health workers were available from only 26 (56%) countries in the European region for the 2014–15 season. The median coverage was 29.5% with a range of 2.6% to 99.5%; only three countries, namely Albania, Armenia and Belarus, reported coverage > 75% (7). More recent data from a systematic review through compulsory reporting from all hospitals in England showed an uptake of 69% in the 2017–18 season.3 An internet survey of 2000 health workers in the United States demonstrated coverage to be 78% during the 2017–18 season, with higher coverage rates (95%) among those working in settings where they were required by their employers to be vaccinated (8). Higher vaccination coverage rates are reported when man- datory vaccination policies are implemented. In one systematic review that included eight studies, coverage rates exceeding 94% were achieved in all (9). 3 Seasonal influenza vaccine uptake in healthcare workers (HCWs) in England: winter season 2017 to 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/Sea- sonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf (Accessed 14 Mai 2019) 61. Background and rationale Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers A rapid evidence appraisal of materials available in the English language, published since 2006, and considered to be of medium or high quality, was conducted by WHO (10). The questions considered, and the main findings of this appraisal are summarized here. Readers are referred to the published report for the details and for the relevant citations. The review considered three issues, namely: 1. The evidence that health workers are at increased risk of influenza infection compared to the general population, and that vaccinating them reduces influenza or absenteeism and/or the wider economic impact of influenza in the health workforce. 2. The evidence that health workers transmit influenza to their patients in health care set- tings and, if so, whether vaccination protects the patients and the proportion of health workers who need to be protected to obtain this effect. 3. The evidence for successful practical interventions to increase vaccination uptake and the state of knowledge of social, behavioural and public health public policy research on vaccination uptake in health workers. Evidence for health worker risk of influenza and impact of vaccination Studies comparing the risk of influenza infection in health workers compared to the general population are challenging, may measure different outcomes, or are executed in different set- tings, limiting the comparability across studies or the pooling of data from these studies. Recent systematic reviews suggest that health workers are at an increased risk of influenza infection compared to the general population (Odds Ratio = 2.08, 95% CI = 1.73 to 2.51) (2), though the evidence is strongest for asymptomatic laboratory-confirmed infection (11). However, health work- ers with asymptomatic infection may still transmit influenza virus to highly vulnerable patients in a health-care setting. Respiratory illness is reported as a common cause of absenteeism among health workers. Epidem- ics or pandemics of influenza have been associated with increased rates of absenteeism among health workers (12). Vaccine efficacy in health workers has been shown to be as high at 90% for well-matched seasonal influenza vaccines (13, 14), which suggests that vaccination of health work- ers will reduce influenza-related morbidity and absenteeism. A systematic review showed a pro- tective effect against laboratory confirmed influenza and shorter absenteeism due to influenza- like illness (ILI) in vaccinated groups (15). A recent study among health workers in the United Kingdom showed that a 10% increase in vaccination uptake is associated with a 10% decrease in absence due to illness (12). However, there are observational studies that provide conflicting results – though often constrained by poor study design, non-specific outcomes, high risk of bias, and failure to adjust for confounding factors (16–19). Since the risk of illness following infection is based on the level of exposure, and absence behav- iours may vary between different categories of health workers, it is possible that the lack of suf- ficiently granular data on absenteeism, e.g. stratified by health worker categories, may account for the mixed results seen in the different studies. On the other hand, the lack of impact on 71. Background and rationale absenteeism observed in some studies, despite evidence of increased rates of infection in health workers, raises the question as to whether health workers nonetheless continue to work when infected and lead to heightened concerns about the consequent risk of nosocomial transmis- sion (20). Several studies have documented presenteeism in health workers with influenza-like illness (21–23), including one instance which was associated with nosocomial transmission in an oncology unit (24). Evidence of transmission of infection from health workers to patients and the impact of vaccination Epidemiological studies using molecular subtyping approaches demonstrate evidence of transmis- sion from health workers to patients. The use of automated collection of high-resolution contact data using wearable sensors combined with virologic data have allowed the identification of potential routes of transmission in cases of hospital-acquired influenza (25). The extent of direct transmission from health worker to patient in health care settings is difficult to capture because of the constant influx of visitors, interactions between patients, and the possibility of multiple simultaneous introductions of influenza (26–28). However, among those who may contribute to transmission of infection in the health care setting, health workers represent a sizeable vaccine- preventable portion since they are easier to target for vaccination. The direct patient benefit of health worker vaccination can be measured in several ways, as il- lustrated in the literature. Several studies evaluate the impact on laboratory confirmed influenza, while others evaluate impact on non-specific outcomes such as ILI, respiratory illness, all-cause mortality, respiratory illness associated mortality, or incidence of nosocomial influenza infection. The evidence is stronger for non-specific outcomes such as ILI, all-cause mortality (29), and inci- dence of nosocomial influenza infection (30, 31). Although some studies have attempted to mea- sure the number of health workers that need to be vaccinated for optimal protection, the evidence in support of a coverage threshold is weak, leading to disputes in the literature (32). However, it is likely that patient protection is positively associated with increasing health worker vaccination coverage but would also depend on other factors including the type of patient contact, vulnerability of the patient, use of other infection control measures, and the effectiveness of vaccination in a particular influenza season (33–35). Evidence for interventions to increase health worker vaccination uptake There is a substantial body of evidence on successful interventions to increase health worker in- fluenza vaccination uptake, much of which has been incorporated into existing toolkits aimed at increasing vaccine uptake. Although the factors that contribute to the health worker decision-making pathway are diverse, some strategies appear to be more effective than others. No single intervention has been shown to rapidly and substantially increase and sustain vaccination uptake except for mandatory vaccina- tion. However, mandatory health worker vaccination is an issue that has been extensively debated with many different perspectives for and against its use (20, 32, 36). Successful mandatory vac- cination programmes require organizational and educational efforts to secure employee support prior to implementation (37). 81. Background and rationale A combination of one or more “soft mandates” such as active declination, required surgical mask use and exclusion of non-vaccinated staff from working with highly vulnerable patients may be used as alternatives to mandatory vaccination, although there are organizational, educational, monitoring and enforcement, and human and financial resource implications for applying such soft mandates. Additional components that contribute to increased uptake include the following: • Provision of free vaccine; • Convenient access to vaccination, including on-site vaccination in health facilities; • Knowledge and behaviour modification through education, reminders, and incentives tailored towards different health worker categories; • Management and organizational approaches such as personnel assigned to oversee vac- cination activities. The reasons for low vaccination uptake are heterogenous and vary across different health worker categories and cultures. Therefore, approaches to increase uptake need to be tailored for different groups. Some studies have demonstrated that formative research, including surveys and qualitative research, can provide insights that assist in tailoring interventions to optimize uptake. Conclusion Despite the ongoing debate in the literature, influenza vaccination is important for ensuring the safety of health workers, their patients, and the general population who rely on a functioning health system, especially during epidemic/pandemic periods. Studies to conclusively establish the value of health worker vaccination will be chal- lenging though the emerging data on this issue will be closely monitored to inform any changes to existing WHO policies.4 Global Action Plan for Influenza Vaccines In an influenza pandemic, most of the world’s population will be highly susceptible to infection and it is likely that infection will spread rapidly. Vaccination is considered one of the key strategies to mitigate the potential impact of a pandemic. While it is expected that there will be a delay in the development of strain-specific pandemic vaccines, insufficient production capacity will further restrict the global access to the vaccines, at least in the early phases of the pandemic. Resource- constrained countries, especially those that lack local vaccine production capacity and those that do not have seasonal influenza vaccination policies, will face the greatest challenge in securing timely access to vaccines during a pandemic, and mitigating the substantial adverse effects of a pandemic. 4 A working group of the WHO Strategic Advisory Group of Experts (SAGE) on immunization will be reviewing the emerging data and updates to the existing WHO recommendations are expected in 2020. 91. Background and rationale To address this challenge a Global Action Plan for Pandemic Influenza vaccines was developed by WHO with short, medium and long term-strategies aimed at increasing influenza vaccine production and surge capacity before and during an influenza pandemic (38). The plan proposed three approaches to enhance access to pandemic vaccines: (i) an increase in the baseline use of seasonal influenza vaccination; (ii) an increase in global production capacity; and (iii) further research and development. The first of the above three approaches relies on countries establishing clear and effective immu- nization policies to increase the baseline use of seasonal influenza vaccines – providing industry with better demand forecasts and stimulate increased production capacity. While vaccination of health workers will only result in a modest increase in overall vaccine de- mand, it will establish a robust and functional platform for rapidly immunizing health workers and could contribute to achieving high coverage in the event of a pandemic, thereby protecting health service delivery during a pandemic. Furthermore, high uptake of vaccination by health workers is likely to build trust and increase the uptake of vaccination among other high-risk groups tar- geted for seasonal influenza vaccination in national policies. Health worker vaccination may also establish or strengthen processes that would allow rapid deployment of pandemic vaccines. Thus, seasonal influenza vaccination of health workers goes beyond the issue of immediate protection against seasonal influenza as outlined above and contributes to pandemic influenza preparedness. 10 2. Establishing a policy to vaccinate health workers against seasonal influenza The decision to establish a policy to vaccinate health workers against seasonal influenza should be evidence-based, with a clear rationale, and with the required investments for sustainable implementation. The general principles and considerations for adding a vaccine to a national im- munization programme are articulated in the 2014 WHO guidance document titled “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: From Decision to Implementation and Monitoring” (39). Health workers comprise a target population not usually included in the national immunization programmes of many low and middle-income countries. While hepatitis B vaccination pro- grammes for health workers may exist, influenza vaccines are unique since vaccination for the foreseeable future must be repeated annually. This section of the manual deals primarily with additional considerations specific to annual seasonal influenza vaccination of health workers, building on the generic framework provided by the document cited above. The decision-making process As with any other vaccine for which policies have to be established, Ministries of Health (MoH) would request National Immunization Technical Advisory Groups (NITAGs) or equivalent na- tional or regional bodies to conduct a review of the evidence and provide advice on establishing a policy for seasonal influenza vaccination of health workers, and to make recommendations on the content of the vaccination policy. Engagement of the many stakeholders affected by this policy is essential to secure their endorse- ment and facilitate high vaccination uptake, and is likely to result in a more coordinated approach to the control of influenza in health facilities. Stakeholder consultation should be broadly sought and include: 1. Professional associations and societies representing different health worker groups such as medical, nursing and allied health service associations, as well as representatives of private health care providers; 2. Medical and nursing councils and other health worker regulatory bodies; 3. Patient safety groups, where they exist, and organizations representing patients, since health worker immunization should also be regarded as a patient safety and quality of care issue; 4. Health worker unions, where they exist and when their participation is likely to be use- ful in promoting vaccination uptake. 5. Health facility managers. 11 2. Establishing a policy to vaccinate health workers against seasonal influenza The process should also include early engagement with the bodies that establish occupational health policies and regulations to ensure that the policies established for health worker vaccina- tion against influenza are also reflected in the national occupational safety and health policies. If vaccination policies for health workers exist for other vaccines, e.g. hepatitis B vaccination, a review of these policies may provide useful inputs for policy formulation for seasonal influenza vaccination and on strategies to optimize vaccination uptake. Where available, NITAGs could access the information required from data available from the national influenza surveillance, the National Influenza Centres or other institutions participating in the Global Influenza Surveillance and Response System (GISRS) (see Toolbox 1). In places where local evidence is not readily available, especially on rates of disease amongst health workers and on transmission of disease from health workers to patients, efforts to generate such evidence could be time- and resource-intensive. Policy-makers would have to consider whether it is necessary to conduct local studies or whether data from other countries with similar epide- miological profiles and health system characteristics could be used to infer the likely burden of disease and support decision-making. NITAGs would need to balance the desire to have national data against the costs and delays that would result in generating the data and the consequent health impacts of this delay. Toolbox 1 National Influenza Centers To monitor and respond to the changes in the influenza virus antigenic structure and the subsequent necessity to change vaccine compositions, many countries have established national influenza centers (NIC) to collect and characterize virus specimens in their country and perform other analyses to inform the decisions of WHO and partners on the composition of the next year’s influenza vaccine. In many countries, virologic surveillance is complemented by more systematic influenza surveillance for severe acute respiratory illness (SARI) and influenza-like illness (ILI). A NIC in a country – or in a neighbouring country – can support evidence-based recommendations by providing data on the influenza disease burden and seasonality to the NITAG or other relevant national decision-making body. Involving these and other centers in NITAG discussions is key to bringing together all relevant information that is needed for the decision-making process. A list of NICS, WHO collaborating centers and essential regulatory laboratories (ERLS) can be found at the following links:  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (Accessed 14 Mai 2019)  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (Accessed 14 Mai 2019) 12 2. Establishing a policy to vaccinate health workers against seasonal influenza Considerations for decision-making In addition to the general considerations outlined in the WHO document “Principles and Consid- erations for Adding a Vaccine to a National Immunization Programme: from decision to implemen- tation and monitoring” referred to earlier, other key issues need to be considered when framing a policy for health worker vaccination. These are listed in Figure 2. Figure 2. Key considerations in establishing a vaccination policy for health workers Defining the public health objectives for seasonal influenza vaccination of health workers Characterizing and prioritizing the target groups for vaccination Framing the vaccination policy for seasonal influenza vaccination of health workers Choice of vaccine product, schedule and timing of vaccination Defining the monitoring and impact assessment objectives Defining the public health objectives for vaccination A critical first step in establishing a policy for vaccinating health workers with seasonal influenza vaccination would be to clearly define the aims and objectives of the vaccination programme. Such objectives may vary between countries but would underlie the prioritization of the health worker groups to be targeted for vaccination, set vaccination coverage targets, and provide guidance on the outcomes and scope for measuring the impact of vaccination. Vaccination of health workers serves multiple objectives. These may include: 1. Prevention of infection in the health workers themselves, averting associated morbidity. 2. Prevention of transmission of infection from health workers to vulnerable patients, including those at high risk of severe disease, complications, and death. 3. Sustaining health services by reducing health worker absenteeism, especially during seaso- nal and pandemic influenza outbreaks, which is a period of increased health care demand. 4. Promoting uptake of seasonal influenza vaccination among other target groups and enhance public trust for influenza vaccination. 5. Contributing to influenza pandemic preparedness by: a) Establishing a mechanism for rapidly immunizing health workers during a pandem- ic of influenza or epidemics of other vaccine-preventable diseases; 13 2. Establishing a policy to vaccinate health workers against seasonal influenza b) Contributing to increasing demand for influenza vaccine and thereby enhance pro- duction capacity to improve timely access to vaccine in case of a pandemic. c) Establishing or strengthening national capacity for vaccine regulation. One or more of the above could serve in defining the national objectives for health worker vac- cination. Important considerations when defining vaccination objectives include: 1. Review of the available data on the burden of disease among health workers and health care-related infections in patients and residents of long-term care facilities. National data, where available, complemented with representative regional or global data or esti- mates developed through the use of mathematical models may be used for this purpose. 2. The cost and impact of vaccination and availability of vaccine supply. 3. Review of the national pandemic preparedness plan and consideration of how health worker vaccination could contribute to pandemic preparedness. Economic analysis for establishing national policies While economic analysis is generally recommended prior to deciding on vaccination policies, lack of data for estimating and comparing the economic benefits of the different vaccination objectives may be a limiting factor, as will be the relatively small size of the target group. Toolbox 2 lists the available tools for conducting economic analysis for influenza vaccination. The costs and economic benefits of influenza vaccination of health workers are likely to depend on several factors, including the number and categories of health workers targeted, the incidence and severity of infection in the targeted health workers, their contribution to health care-associated transmission and the consequences of such infections. These factors may vary between different health facilities and will vary from one influenza season to another. A recent systematic review of the epidemiological and economic effects of seasonal influenza vaccination of health workers found that vaccination of health workers was cost-saving, based on crude estimates of absenteeism averted through vaccination (15). However, all the studies included Toolbox 2 Tools for the economic analysis of seasonal influenza vaccination Several tools are available for conducting economic analysis of influenza vaccination: WHO Guide for Stanardization of economic evaluations of immunization programmes (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf WHO Manual for Estimating the Economic Burden of Seasonal Influenza (WHO/IVB/16.04) ƥ http://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-eng.pdf Guidance on the economic evaluation of influenza vaccination (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. Establishing a policy to vaccinate health workers against seasonal influenza in this review were from high-income countries and took an employer perspective with a strong focus on absenteeism averted. Initial decisions could take vaccination costs and the impact of these costs to the immunization and health budgets into consideration, with the option of measuring cost-effectiveness post- introduction, if required. Further guidance on costing and budgeting of health worker influenza vaccination, with links to the available costing tools and resource materials on immunization financing are covered in the next section of this manual. Characterizing the target groups for vaccination Ideally all health workers should be targeted for vaccination, including those who may not come into direct contact with patients. Even if not in direct contact, health workers could potentially transmit infection acquired in the community to colleagues and, thereby, participate in the chain of health care-associated transmission of infection. However, in situations where there are resource constraints or limited or unstable vaccine supplies, categorization and prioritization of health workers for vaccination would be required. Prioritization of health workers would depend on as- sessment of risk of infection among the health workers themselves, transmission of infection to their patients and the consequences of health care-associated transmission. Even without financial resource constraints or limitations in vaccine supply, categorization of health workers would be useful when different policies are applied to different health worker cat- egories, based on risk assessment. For example, a mandatory vaccination policy may be applied to select categories of health workers who work with patients at high risk of severe influenza and who are more likely to accept mandatory vaccination, while vaccination may be voluntary for other categories (40, 41). Table 1 provides an example of risk categorization of health workers based on risk to themselves and of those for whom they care. Table 1. Risk categorization of health workers Risk category Health worker characteristics Very High • High risk health workers (see below) who work in clinical areas that admit patients at high risk for severe disease, complications, or death following influenza virus infection. These include intensive care units; transplant or oncology wards; antenatal, peri-natal or post- natal areas; and areas with elderly individuals, especially those with chronic diseases. High • Health workers who come into direct physical contact with patients, or with infectious materials, including surfaces or equipment contaminated by infectious materials. • Health workers who have contact which is not physical but that would allow the acquisi- tion or transmission of diseases that are spread at short range (1–2 m) by respiratory means, e.g., counsellors who have prolonged fact-to-face contact (42, 43). Low • Health workers who do not have contact with patients and whose normal work is not in a clinical area as defined above. 15 2. Establishing a policy to vaccinate health workers against seasonal influenza The very high-risk category is also the one where the evidence for risk and impact of vaccination is the strongest and where there is a stronger justification for vaccination (10). Those targeted for vaccination should also include part-time personnel, students, contractors, and volunteers at the health facility who have possible exposure to patients as health workers in the above categories. Risk categorization of individual health workers may be too complex and resource intensive in many settings, especially in low- and middle-income countries. In these situations, simpler ap- proaches wherein health worker categories are classified into only two groups, i.e. at high risk group (targeted for vaccination) and low risk groups (not targeted for vaccination) may be used. To ensure targeted use of influenza vaccination of health workers and to address potential uptake issues, national policies for health worker vaccination should outline: 1. The classification of different health worker categories based on assessment of risk. 2. The policy for vaccination for each category, e.g. whether vaccination is recommended and whether the recommendation is for mandatory or voluntary vaccination. 3. Strategies for managing non-compliant health workers and vaccine refusers. The following document provides an example of a framework for the assessment, classification and prioritization of health workers: The policy directive of the New South Wales Ministry of Health on the Occupational Assessment, Screening and Vaccination Against Specified Infectious Diseases https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (Accessed 14 Mai 2019) Framing an immunization policy for health workers Recommendations for health worker vaccination could propose either mandatory vaccination, voluntary vaccination or a mixed approach depending on the risks in the specific clinical setting. Multiple studies across many countries has demonstrated that voluntary vaccination of health workers, even when accompanied by considerable efforts to educate them on the benefits and risks of vaccination and implementation of measures for convenient access to vaccination, results in low coverage that seldomly exceeds 70%. On the other hand, mandatory vaccination has resulted in close to 100% uptake in institutions in the United States where it has been applied (44–46). However, mandatory vaccination has been difficult to implement in some countries because of acceptability issues and because the attributable benefits of health worker vaccination have been a subject of debate (32). Furthermore, it may not be feasible to implement mandatory vaccination policies in resource-constrained settings. 16 2. Establishing a policy to vaccinate health workers against seasonal influenza Voluntary vaccination One option for a vaccination policy for health workers is voluntary vaccination wherein vaccina- tion is recommended for health workers and offered but acceptance is voluntary or optional, i.e. not a requirement. Such programmes often have low vaccination coverage. Hence, with voluntary vaccination, extra efforts are required to optimize the uptake of vaccination. These could include: 1. A robust communications strategy, specifically tailored to the needs of different health worker categories, to explain the benefits and risks of vaccination, including the benefits to patients, especially those at high risk for severe disease. It needs to be emphasized that some of these patients, including the elderly and immunocompromised patients may not themselves respond to vaccination and that vaccination of health workers who come into contact with them is an important means for protecting them from infection, i.e. a professional ethics and moral argument 2. Convenient access to vaccination that is free of charge, and available to workers in every shift. Those who work during evening or night shifts might be provided access to vacci- nation either at the beginning or the end or their shifts or on designated days and times to cover their shift. 3. Other demand generation activities as outlined in the next section of this manual. A number of soft mandates may also help in increasing vaccination uptake, including: 1. Requirement of active declination of vaccination through signing of forms indicating their non-participation with or without stating the reasons for not accepting vaccination (see Annex 1 for a sample of an active declination form). 2. Reassignment of health workers who refuse vaccination to areas where they are less likely to come into contact with high risk patients, if this is feasible, or a requirement to wear masks when they do care for patients at high risk of influenza complications. 3. Use of face masks while in the health care facility. Mandatory vaccination Mandatory vaccination makes vaccination of health workers a legal or regulatory requirement while allowing some exemptions, e.g. medical contraindications. There is no WHO or other uniformly applied definition for mandatory vaccination. Infant and childhood immunization programmes described as mandatory can vary widely, especially in terms of the exemptions al- lowed and the penalties for non-compliance (47). Several experts have argued that mandatory immunization policies should be implemented against vaccine-preventable diseases that can be transmitted in the health-care setting and cause signifi- cant risk of morbidity or mortality to patients (20, 44, 48–50), as part of the professional ethics of a health care provider. It has also been argued that few ethical mandates in the practice of medicine surpass the obliga- tion to do no harm. Hence, ensuring conditions for safe patient care by minimizing transmission of communicable diseases represents a minimum ethical standard in health care practice set- tings (20). However, if mandatory vaccination policies are to be established, legal liability issues will need to be addressed and consideration given to providing compensation in the rare event of an adverse event. 17 2. Establishing a policy to vaccinate health workers against seasonal influenza Mandatory vaccination could either be part of the national policy or implemented at individual health facilities as part of institutional policies. The enactment of legislation endorsing mandatory vaccination would facilitate the implementation of such a policy. The Code of Colorado Regulations provides an example of a mandatory vaccination policy: Code of Colorado Regulations: Standards for Hospitals and Health Facilities 02 – General Licensure Standards (Part 10, Page 46) https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20CCR%20 1011-1%20Chap%2002 (Accessed 14 Mai 2019) Several countries with voluntary health worker vaccination policies for influenza do have man- datory vaccination of health workers for other infections such as measles and hepatitis B. These existing mandatory vaccination policies could be leveraged to also justify and establish mandatory vaccination policies for influenza, based on the protection afforded to the health worker as well as to vulnerable high-risk patients with whom they come into contact. Published recommendations for the ethical implementation of mandatory vaccination policies are reproduced in Toolbox 3. These recommendations may be taken into consideration in framing the national policy based on the feasibility of implementation. Toolbox 3 Recommendations for ethically implementing mandatory vaccination policies — There must be a compelling employee and patient safety problem that is clearly communicated to employees. — The least restrictive means should be used to achieve the safety objective. — There should be clear opt-out criteria for medical reasons. — Opt-out criteria based on personal views of the health worker should be allowed for current employ- ees only. These determinations must be made in a transparent and objective manner. — For those who do meet medical or other exclusion criteria, or who refuse vaccination, institutions should offer alternative means for achieving transmission control, including temporary leave during peak times, mandatory mask wearing, re-assignment to non-clinical areas (if feasible) or frequent testing during peak influenza seasons. — Prospective employees should be notified of the mandatory policy and recognize that failure to comply could be grounds for termination of employment. — The process should be transparent, with a broad range of health worker perspectives involved in policy development. — Institutions should support healthcare workers by implementing vaccination procedures that are free, easy to access, and include complete comprehensive coverage of adverse events. Particular attention should be paid to not burdening less advantaged members of the healthcare team. Source : Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 18 2. Establishing a policy to vaccinate health workers against seasonal influenza Mixed approach A mixed approach could also be adopted where a mandatory vaccination policy is applied to only certain categories of health workers likely to have direct physical contact with high-risk patients, while a voluntary vaccination policy is applied to the remaining categories. Such a policy should clearly and unambiguously define the health worker groups to whom or work areas where mandatory and voluntary vaccination policies apply. Consideration should be given to the human and financial resource implications of mandatory vaccination policies or of soft mandates. Integration with Occupational Health Policies Policies on seasonal influenza vaccination of health workers should be an integral part of the national occupational safety and health policies and regulations and the occupational safety and health management systems in health facilities. Inclusion of seasonal influenza vaccination in occupational health policies will allow access to free vaccination for all the targeted health workers as per the Occupational Safety and Health Convention, 1981, Article 215 and the recommendations in the World Health Organization and International Labour Organization (WHO-ILO) Global Framework for National Occupational Health Programmes for Health Workers.6 Such a policy would also put the responsibility for health worker vaccination on employers, rather than on the health workers alone. An integrated policy will enable greater coordination and collaboration between occupational health and immunization programmes and promote a joint approach to control of influenza in health facilities wherein vaccination is part of an infection control program that includes other in- fection measures to protect both health workers and patients. The occupational health programme at the national level and the management system at the facility level also provide an enabling environment to create a culture for infection prevention within the workplace that will stimulate the implementation of the vaccination programmes. Choice of vaccine product, schedule and timing of vaccination Choice of product WHO provides recommendations for the composition of influenza vaccines based on the infor- mation provided by the WHO Global Influenza Surveillance and Response System.7 Based on these recommendations, manufacturers formulate Northern Hemisphere (NH) and Southern Hemisphere (SH) vaccines, which are generally accessible around September (NH) and April 5 C155-Occupational Safety and Health Convention, 1981 (No. 155). https://www.ilo.org/dyn/normlex/en/f?p=NO RMLEXPUB:12100:0::NO::p12100_instrument_id:312300 (Accessed 14 Mai 2019) 6 The sectoral dimension of the ILO’s work : Review of sectoral initiatives on HIV and AIDS Appendix II – WHO- ILO WHO-ILO Global Framework for National Occupational Health Programmes for Health Workers. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/wcms_145837.pdf (Accessed 14 Mai 2019) 7 Influenza: vaccines. http://www.who.int/influenza/vaccines (Accessed 14 Mai 2019) 19 2. Establishing a policy to vaccinate health workers against seasonal influenza (SH) of each year, respectively. A list of WHO prequalified vaccines with information on their characteristics is published on the WHO website.8 Several different types of vaccines are available, including inactivated influenza vaccines (triva- lent and quadrivalent composition), live attenuated influenza vaccines, adjuvanted vaccine, and recombinant vaccine. Being a health worker per se does not lead to a preference for any vaccine type (subject to country-specific marketing authorizations).9 Health workers who care for severely immunocompromised persons should preferably receive inactivated influenza vaccine (IIV). Price and supply availability of each product are additional considerations in informing the choice of product. Timing of vaccination In countries where influenza infection is seasonal and seasonality patterns are defined, vaccina- tion should ideally be scheduled before the start of the influenza season, allowing approximately 14 days for induction of protective antibodies. Where delays in securing vaccine supply does not allow ideal timing to be met, vaccination should be initiated as soon as supplies are made available. Furthermore, individual health workers should never be refused vaccination at any time during the influenza season if they are late in seeking vaccination. In tropical and subtropical regions where several peaks may occur, vaccination should be timed before the main peak of transmission, using the most recent vaccine formulation available. Where no data on national influenza seasonality are available, countries could use data from epidemio- logically similar countries. Toolbox 4 provides published information of influenza seasonality in the tropics and subtropics. 8 WHO Prequalified Vaccines. https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 9 In some countries the quadrivalent vaccine is the product of choice. The WHO Strategic Advisory Group of Experts (SAGE) in immunization is currently reviewing the evidence and expected to make a recommendation in 2020. Toolbox 4 Guidance on choice of product and timing of seasonal influenza Seasonal influenza policy use and effectiveness in the tropics and subtropics. Geneva: World Health Organization; 2016. ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf (Accessed 14 Mai 2019) Influenza seasonality in the tropics and subtropics – when to vaccinate  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 (Accessed 14 Mai 2019) WHO list of prequalified vaccines  https://extranet.who.int/gavi/PQ_Web (Accessed 14 Mai 2019) 20 2. Establishing a policy to vaccinate health workers against seasonal influenza Defining monitoring and disease impact measurement objectives Ministries of Health would benefit from advice from the NITAG or other relevant advisory groups on the monitoring and impact measurement objectives so that they are taken into consideration during the planning and implementation of Monitoring and Evaluation (see chapter 4). NITAGs, with additional inputs from other relevant advisory groups and academia, should make recommendations on: 1. Monitoring and reporting of vaccination coverage, where possible by unit and type of care provided. 2. Measurement of vaccination impact, including: a) Target groups (health workers and or patients) for impact measurement. b) Outcomes to be monitored. e.g. influenza-like illness, laboratory-confirmed disease, severe disease, death, absenteeism, patient-related outcomes, etc. c) urveillance strategies for measuring impact; if at sentinel sites, the number and distribution of sites. d) Time periods for impact measurement, e.g. continued monitoring for an indefinite period or limited to a certain number of seasons. These measurements would be useful to the NITAG in reviewing the impact of vaccination and making recommendations for optimizing the impact and the cost-effectiveness of vaccination. Impact measurement could also generate empiric data to allow for estimation of cost-effectiveness of vaccination. It should be noted that any such measurements should include data collection for multiple seasons since the intensity of transmission, the severity of infection and vaccine effectiveness varies from one season to another. For further details, see the section on “Monitoring and evaluation” (chapter 4). 21 3. Planning and managing vaccination of health workers Planning for successful vaccine introduction Once a national vaccination policy has been established, it is necessary to convert the policy into operational plans that are fully costed, budgeted and include granular detail on the various pro- gramme components related to the introduction of a new vaccine into the national programme. The general concepts for addition of a new vaccine within the national immunization plans and the management of introduction are outlined in the WHO guide “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” (see Annex 3 for New Vaccine Introduction Plan Template). This section provides guidance on the additional elements specific to seasonal influenza vaccination of health workers. A vaccine introduction plan integrated into the annual plan for immunization along with the as- sociated checklists enable programme planners to ensure that all the necessary preparations are in place for the timely and efficient introduction of a vaccine into the national programme. For easy access the links to the relevant Annexes of the WHO guide are provided in Toolbox 5. In addition to the generic vaccine introduction checklist, the complementary checklist in Annex 2 con- tains a list of issues specific to health worker immunization. The elements of this checklist should be added (as appropriate) to the more generic checklist of activities. A sample health facility checklist is also provided (Annex 3) to guide the preparations for vaccination at the health facility level. Toolbox 5 Links to templates and checklists for a new vaccine introduction plan in “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” Generic template to guide the development of a national introduction plan Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc (Accessed 14 Mai 2019) New vaccine introduction checklist, activity list and timeline of WHO new vaccine introduction guide provides advice on planning budgeting, activities, distribution of roles and responsibilities and timelines ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_ resources/nvi_guidelines/Annex4_Instructions.pdf (Accessed 14 Mai 2019) Corresponding checklist tool Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_checklist_en.xls (Accessed 14 Mai 2019) 22 3. Planning and managing vaccination of health workers The timelines for planning and introduction should be included in the checklists and/or as a sepa- rate Gantt chart to ensure that all the activities are completed in their appropriate order to allow timely implementation of vaccination activities. Cross-reference should be made to the relevant sections of the occupational health strategies and plans at both the national and health facility level (see previous chapter on integration of health worker influenza policies into occupational health policies and requirements) to facilitate a more cohesive approach to planning and implementation. The WHO-ILO Global Framework for National Occupational Health Programme for Health Work- ers recommends that all countries identify the responsible person(s) for occupational health, both at the national and workplace levels. These focal points should be a part of the planning team at the national and health facility levels, respectively. Inclusion of the occupational health focal points would allow for an integrated approach to prevention of influenza in the work place where vaccina- tion forms part of a larger package of interventions for influenza control, including other infection control measures to protect both health workers and patients. The labour-management committees for occupational safety and health in health facilities, where they exist, can help in engaging the management and the workers’ representatives in the implementation of the vaccination programme. In addition to the national operational plans for the implementation of health worker vaccination, the national comprehensive multi-year plan (cMYP) for immunization should also be updated to include health worker immunization (Toolbox 6). Costing and financing As with the addition of any new vaccine to the national vaccination schedule, the vaccine and deliv- ery costs should be estimated and included in the annual and multi-year immunization budgets. In addition to the costs of vaccines and supplies (syringes, needles, safety boxes etc.), costs for vaccine delivery (including human resources), annual communications/education and demand generation efforts at the national and health facility level, and monitoring and reporting would need to be included in the costs. Several tools and resources are available that could be used or adapted for costing, budgeting and securing finances for health workers vaccination (see Toolbox 7). Since communications and other activities/interventions to enhance vaccination uptake will be required each year, these costs should be incorporated into the annual vaccine delivery costs and not considered only as a one-time activity. In addition to costing and budgeting for annual health worker influenza vaccination, it may also be necessary to advocate with those responsible for allocating funds for health programmes to ensure that financing for vaccination is sustained. Toolbox 8 provides links to resources for ad- vocacy for sustainable financing. Toolbox 6 WHO-UNICEF guidelines for multi-year planning WHO-UNICEF guidelines for developing a comprehensive multi-year plan (cMYP)  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. Planning and managing vaccination of health workers Toolbox 7 Resources for costing and financing cMYP Costing and Financing Tool  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (Accessed 14 Mai 2019) Immunization Costing Action Network (ICAN) Immunization Delivery Cost Catalogue This interactive website provides information on vaccine delivery costs across different low and middle- income countries through a variety of delivery strategies.  http://immunizationeconomics.org/ican-idcc (Accessed 14 Mai 2019) WHO Flu tool for planning and costing maternal influenza vaccination (new name: SIICT tool) This tool is being expanded to include all influenza risk groups, including health workers.  https://www.who.int/immunization/research/development/influenza_economics/ (Accessed 14 Mai 2019) Management Sciences for Health. Planning, costing and budgeting framework  http://www.msh.org/resources/planning-costing-and-budgeting-framework (Accessed 14 Mai 2019) Immunization financing: a resource guide for advocates, policy makers and program managers  https://immunizationeconomics.org/imfin (Accessed 14 Mai 2019) Toolbox 8 Resources for advocacy or sustainable financing Immunization advocacy library. Provides a number of tools and guides to convey the value of vaccination and the need to invest in vaccination  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/communication-and-advocacy/immunization-advocacy-library (Accessed 14 Mai 2019) Two specific documents in this library are of relevance: Workbook – advocacy for sustainable funding of immunization programmes  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/workbook-advocacy-for-sustainable-funding-of-immunization-programmes (Accessed 14 Mai 2019) How to prepare a financial profile of your immunization programme  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/how-to-prepare-a-financial-profile-of-your-immunization-programme (Accessed 14 Mai 2019) 24 3. Planning and managing vaccination of health workers Formative research to inform the planning process To prepare for the launch of influenza vaccination, several countries have used formative research to better understand the factors affecting uptake of seasonal influenza vaccination in health work- ers, including concerns, beliefs, information needs, cultural issues, and barriers to vaccination in order to develop a tailored plan to address them. Formative research can include both quantitative and qualitative research and, in some situations, might include a desk review. Quantitative research may be used to identify the main predictors for low uptake of vaccination among health workers and the main drivers for compliance with vaccina- tion recommendations. Data may be collected through surveys and questionnaires administered to health workers. The sample should ideally include sufficient representation from the different categories of health workers since the perceptions and reasons for low uptake may vary between health worker groups, e.g. between doctors and nurses (40), as well as from a sample of primary, secondary and tertiary health care facilities and from different work areas within these facilities. Qualitative research is insight research, based on understanding the audience’s point of view. It elucidates new issues and provides a more in-depth understanding of the complex issues underly- ing the uptake of vaccination. Qualitative research methods commonly include focus group dis- cussions and individual in-depth interviews. The WHO European Regional Office has published a step-by-step field guide to qualitative research for new vaccine introduction (see Toolbox 9). To be useful, formative research must be properly planned and well executed, failing which there is a risk of drawing wrong conclusions. This requires time and resources. While it is useful to conduct such research to inform the planning process, if time and resources do not permit, the lack of such research should not delay seasonal influenza vaccine introduction, unless attitudes of health workers are expected to be an issue that may significantly and adversely impact vaccine uptake. When data from formative research are not available, data from such studies conducted in other countries may be used to inform the planning process. While the reasons for low uptake of vac- cine are heterogenous, available evidence suggests that there is broad convergence on the major influencers of vaccine uptake among health workers, especially between countries within the same sub-region, which may be used in the initial planning process. The rapid appraisal of evidence (10) summarizes the key findings from the published literature and this evidence could be used, as applicable and appropriate, in the absence of locally conducted research. Data from the published literature may be complemented with information obtained through quantitative formative research using rapid surveys in a sample of health workers, ideally including different health worker categories. These surveys may be less resource intensive than qualitative formative research and could be completed without resulting in any delays to vaccine introduction. Annex 4 provides a sample questionnaire that may be used for such surveys. Toolbox 9 Field Guide for qualitative formative research A field guide to qualitative research for new vaccine introduction ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_VaccineIntro.pdf (Accessed 14 Mai 2019) 25 3. Planning and managing vaccination of health workers Further research may be conducted if vaccine uptake remains persistently low. The TIPflu tool is an important resource that may be used in such situations. Communication and vaccine acceptance Personal beliefs, cultural attitudes and perceptions about vaccination, in addition to official rec- ommendations, often guide the actions of many of those responsible for delivery of vaccines and many recipients (51, 52). This also holds true at the level of health workers. Available evidence shows that there are often misperceptions about vaccination as well as a gap between knowledge and behaviours (53, 54). Thus, simply improving knowledge about the risks and benefits of vac- cination among health workers has not proven to be sufficient to achieve optimal vaccination uptake. Achieving optimal vaccination coverage in health workers requires a multi-dimensional demand generation effort that is informed by a good understanding of the perception, motivators and barriers of vaccine acceptance among health workers, both as providers of vaccination and as recipients. Communications messages need to be tailored to address the needs of different health worker groups since available evidence suggests that perceptions about the need, risks and benefits of vaccination may vary between these groups (55). Current efforts mainly focus on preparing fact- based approaches to preparing communication messages. However, these types of messages may need to be framed according to the intended audiences based on their level of education and understanding. Taking the preferred cognitive decision-making styles of the individual groups to be targeted into account may have greater impact (54). Framing such messages will require an understanding of vaccine psychology and cognitive decision-making and may require engagement of communication specialists. A traditional approach to communications regarding immunization was through the use of mass media. However, research has shown that mass media alone and a one-way communication to health workers may not be sufficient to optimize the uptake of vaccination. Individual and group communications, in this instance at the health facility level, will be required to build trust and motivate health workers to accept vaccination. Including information on the relevance of vaccination of health workers (self-protection, responsi- bilities towards patients, pandemic preparedness in the case of influenza) in pre-service curricula for medical schools, nursing schools and other training institutions targeting health professionals may help to better establish health worker vaccination as an organizing concept and create better informed health worker generations providing immunization. Effective communications and demand generation activities are not a one-time event but need to be continuous and have the ability to quickly respond to the evolving perceptions about vac- cination and quell rumours and mis-perceptions. Front line vaccination staff responsible for health worker influenza vaccination will need to be trained to be able to deal with vaccine hesi- tant health workers as well as vocal vaccine deniers10 who may negatively impact the uptake of vaccination (56). 10 Vocal vaccine deniers are at the extreme end of the subgroup of vaccine refusers and actively advocate against vaccination, using science denialism techniques to justify their beliefs (reference 32). 26 3. Planning and managing vaccination of health workers A national vaccine communication working group that includes communications specialists will facilitate strong working relations with and collaboration among partners and allies, strengthen routine communication for immunization, and ensure well-coordinated and immediate response from all involved authorities to any safety event. Inclusion of members of the Occupational Safety and Health department and from professional societies in communicating with health workers contributes to building trust and improving acceptance of vaccination. Representation from health workers, professional associations, and unions and from the different health worker categories targeted for vaccination would ensure that the viewpoints of each health worker category is taken into consideration in developing tailored communication materials. A number of tools and guidance documents are available that can be used for developing an ef- fective communications strategy and for framing the communications messages that are specifi- cally tailored towards different health worker groups, including a template terms of reference for a vaccine communication working groups (Toolbox 10). In addition to vaccination, the information and education and communication materials should also include information on other infection control measures to reduce transmission of influenza in the work place and steps to be taken should a health worker develop an influenza like illness. Communications at the health facility level Effective communications at the health facility level will benefit from a dedicated and well-trained team to deliver the communications strategy at the health facility level. Such a team should be established and trained well in advance of the planned introduction date and should include rep- resentation from the main health worker categories in the facility and an advocacy and commu- nications specialist, if one is available. Ideally, communications for seasonal influenza vaccination should be part of a broader communications effort on control of influenza in health care settings. Communication activities at the health facility level should begin sufficiently in advance of the planned date for the onset of vaccination, especially in countries introducing vaccination for the Toolbox 10 Tools and guides for developing communications strategy and messages Vaccination and trust library  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/vaccination-and-trust (Accessed 14 Mai 2019) New vaccine introduction: checklist for planning communications and advocacy (2017)  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2017/new-vaccine-introduction-checklist-for-planning-communication-and-advo- cacy-2017 (Accessed 14 Mai 2019) Template terms of reference for a vaccine communication working group ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_Sup- portDoc_TOR_Proof7.pdf (Accessed 14 Mai 2019) 27 3. Planning and managing vaccination of health workers first time. Initial activities could include the display of information posters at all the relevant areas of the health facility. The manager of the health facility and the heads of all the relevant depart- ments and clinical areas should be sent a formal communication along with sufficient copies of all information materials about vaccination to be displayed in each clinical area. Where possible, relevant information on influenza vaccination could also be sent to all health workers using e-mail and/or local social media networks. In-person group briefings should complement the display and distribution of information materi- als. Existing staff meetings could be leveraged to conduct these briefings. The number of in-person group briefings will depend on the size of the health facility and the number of targeted health workers. Larger health facilities (e.g. secondary and tertiary level health facilities) may need to conduct several briefing sessions to cover all the targeted health workers. Since communications messages may differ between different categories of health workers, consideration should be given to holding separate briefing sessions for each health worker category using information and mate- rials relevant to them. To allow better communication and enough time for questions from health workers to be addressed, the size of each group should be designed to allow sufficient opportunity for interaction. Provision should be made to facilitate the participation of health workers working night shifts. The schedule for the briefings should be widely publicized within the health facility and reminders sent to promote high attendance. In-person meetings should: 1. Explain why vaccination is important for themselves, their patients and families and for wider society – with a particular focus on severe outcomes associated with influenza; 2. Inform health workers about national policies; 3. Provide information on the safety of seasonal influenza vaccines; 4. Provide information on the timing and venue(s) for vaccination; 5. Explain potential consequences of non-vaccination; 6. Allow sufficient time for questions. Consideration may be given to establishing a telephone hotline or web-based system to address questions from individual health workers. In addition to the display of posters and other com- munications materials, the use of visible and removable stickers that can be displayed by health workers who have been vaccinated (e.g. on their ID badges) would serve as a visible reminder to their colleagues who have not been vaccinated. In addition, text messages, generic e-mails and social media platforms could be used to provide periodic reminders on vaccination. Demand Generation at the Health Facility Level In addition to communication strategies, behavioural science-based demand generation efforts can be implemented prior to the availability of vaccines in order to prime health workers for vac- cination. These nudge-based interventions work by creating an environment that can influence behaviour in a predictable way but does not eliminate choice (57), and have proven effective in a variety of healthcare settings (58). These interventions can narrow the gap between intention and actual behaviour, which is usually caused by individuals or health workers forgetting to get 28 3. Planning and managing vaccination of health workers their vaccination or through barriers to convenient vaccination. Additionally, these interventions frequently can be implemented for relatively low cost (59). The figure below (Figure 3), adapted from the Nuffield Council on Bioethics, demonstrates the hierarchy of nudge-based interventions to improve vaccine uptake (60). Nudges lower on the ladder are less aggressive but can still have a measurable impact. By providing health-facility vaccination rate feedback, a process used in the United States to improve uptake of childhood vaccination, progress in health facilities can be monitored, and provide motivation to health workers to improve their own vaccination practices (61). Figure 3. Ladder of nudge interventions to increase vaccination rates Guide choice through default options Automatically set up appointment for vaccination unless individual opts out Enable choice Increase options to obtain vaccination such as at workplace or near home Prompt implementation intentions Ask individual to precommit to a time and location to obtain vaccination Frame information Deliver social comparsion feedback on vaccination rate among peers or healthier individuals Provide information Offer education on benefits of vaccination to self ant others Do nothing Simply monitor vaccination rates Source: Patel MS (ref. 32) Reminders to individuals to vaccinate can serve as a nudge, notifying individuals when they are due for a vaccine and prompting them to come to the vaccination site to receive the vaccine. These can be paper-based or mobile phone text message-based and have proven effective (62). In the health facility, health worker reminders through an immunization data collection tool (whether paper- or electronic-based) can help improve the delivery of vaccines by health workers (59). A successful nudge-based strategy to reduce barriers to convenient vaccination and enable choice is standing orders. Standing orders are a policy put in place in a health facility that permits non- physician health workers to administer vaccines without a prescription or explicit order from a physician and have proven one of the most effective strategies for improving vaccine uptake when applicable (63). All of these strategies can be combined with communication approaches to create demand in the community. 29 3. Planning and managing vaccination of health workers Going beyond nudges Nudges are a favoured method for influencing demand since they preserve choice and are not coercive. However, some experts have argued that when nudges fail to achieve optimal uptake of vaccination in health workers, and this failure results in harm to their patients, decision-makers should consider adopting more forceful policies (64). This is not to imply that when nudges fail one should immediately go to measures that eliminate choice. There are interventions that exist across a continuum leading up to restriction of choice. The use of “soft mandates” provide examples of actions across this continuum. Case study: The «flulapalooza» campaign to increase uptake of seasonal influenza vaccination in health workers Vanderbilt University Medical Center in Nashville, Tennessee, in the United States, employs over 24,000 health workers. Since 2011, the cornerstone of its seasonal influenza vaccination campaign for health workers has been its mass influenza vaccination event, playfully named “flulapalooza”. This event vac- cinates, on average, over 14,000 people in a single day. The closed point-of-dispensing (c-pod) design has been evaluated and refined over time to substantially increase administration efficiency and cover- age rates. The event emphasizes a festive atmosphere while practicing critical pandemic vaccination skills among hospital occupational health and administrative leadership. This event achieves high coverage among categories of health workers who are present that day; how- ever, due to the structure of nursing shifts and ward responsibilities at the institution, less than 30% of nursing staff are typically vaccinated at the event. Thus, the medical center combines flulapalooza with ward visits, mobile carts and other strategies to achieve its annual target of greater than 90% overall health worker vaccine coverage. Notably, although institutional policy gradually increased the difficulty of declination and eventually included disciplinary action in response for unexcused failure to vacci- nate, it is notable that 92% coverage had been achieved in seasons before disciplinary policies were in place. Details of event design, workflow diagrams and practical, specific lessons learned are described in a publication available online. Source: Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168–76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 Annex 5 provides a table that lists the different communications and demand creation approaches, along with an indication of the effort required to implement the approach and the expected impact. Vaccine procurement and supply chain management Vaccine procurement Accessing vaccines at optimal prices requires a good understanding of procurement mechanisms and systems, vaccine market dynamics, and the elements of vaccine pricing. Procurement starts with forecasting vaccine demand, followed by tendering, contracting and procurement processes. The tools and resources for vaccine procurement are listed in Toolbox 11. Procurement of seasonal influenza vaccination may have some unique features and may require regulatory approvals and advance purchase commitments with specific manufacturers shortly after the publication of the 30 3. Planning and managing vaccination of health workers WHO recommendations on the seasonal vaccine formulation (in February for the northern and in September for the southern hemisphere) and well in advance of the influenza season. Selection of the vaccine product and presentation As with any other vaccine, the choice of product and presentation will depend on multiple fac- tors including supply availability, price, ease of use, storage and transport requirements, vaccine wastage and missed opportunities for vaccination (e.g. postponing vaccination due to reluctance to open a 10-dose vial for only one or two individuals). The choice of vial size should be based on the number of doses to be delivered at each vaccination point and the number of sessions to be held at each point. The currently prequalified injectable seasonal influenza vaccines are available in single dose pre-filled syringes and in single and 10-dose vials. All the 10-dose vial presentations contain thiomersal as a preservative. However, it may be noted that not all the currently available prequalified products in 10-dose vials have market authorization for storage up to 28 days once opened, and not all products have a vaccine vial monitor (VVM). These aspects should be taken into consideration in selecting the product and presentation. The specifications of each product and presentation should be checked to confirm that they meet the requirements of the programme before a procurement order is placed. Information on WHO prequalified vaccines may be found on the WHO website (see Toolbox 11). Forecasting vaccine demand is an important first step in vaccine procurement. Forecasting demand requires an estimate of the number of health workers who will be targeted for vaccination, the expected vaccination coverage, and an estimate of vaccine wastage. Ideally health workers in both public and private facilities would be targeted for vaccination. This process of estimating the size of the target population for health workers vaccination is likely to be more complex than for other vaccines targeting the general populations. The data to derive such estimates may also be more difficult to find, especially in low and middle-income countries. Toolbox 12 provides resources for estimating the size of the health work force and those that need to be targeted for vaccination. Toolbox 11 Vaccine procurement tools Procurement mechanisms and systems  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_systems (Accessed 14 Mai 2019) Vaccine product, price and procurement (V3P) web platform  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (Accessed 14 Mai 2019) Vaccine market  http://www.who.int/immunization/programmes_systems/procurement/market (Accessed 14 Mai 2019) List of WHO prequalified seasonal influenza vaccines  https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 31 3. Planning and managing vaccination of health workers The global health workforce databases may not carry information on all the health workers catego- ries that may be targeted for vaccination. For example, global databases may only have estimates of the numbers of doctors, nurses and midwives, but not other health worker categories. In such instances, rough estimates could be made based on ratios of those health workers for whom data are not available to those where data are available (e.g. ratio of physicians to laboratory workers). These ratios could be quickly obtained through a survey of a small representative sample (e.g. tertiary, secondary and primary) of health facilities. Since each health facility may be required to prepare beneficiary lists with the names of those targeted for vaccination, for tracking vaccination delivery, and for maintaining records of those vaccinated; the initial demand forecasts could be refined in subsequent years using data from these beneficiary lists and vaccination records. Logistics and cold chain management The handling of influenza vaccine is similar to most other vaccines in the national immunization programmes. It needs to be stored at 2–8 degrees Celsius. Since vaccination of health workers is expected to occur annually during a relatively short window period each year before the onset of the influenza season, a plan needs to be developed to ensure storage and transport of vaccine at the different levels involved in the supply chain during the window period chosen for vaccina- tion. Tools and resources for vaccine forecasting, management and logistics are available on the WHO website (Toolbox 13). The cold chain volume requirement for each WHO prequalified product and presentation are available on the WHO website (please select the vaccine type and click on the links for each individual product and presentation to obtain this information).11 At the health facility level, the focal point responsible for health worker vaccination should ensure that the vaccine doses required in the facility are included in the demand forecast and that sufficient storage space to accommodate the required vaccine doses is available prior to the anticipated date of vaccine arrival at the health facility. 11 WHO prequalified vaccines. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 Toolbox 12 Resources for estimating target population size Global Health Observatory: Health Workforce  http://www.who.int/gho/health_workforce Global Health Workforce Statistics database. Geneva: World Health Organization.  http://www.who.int/hrh/statistics/hwfstats Counting health workers: definitions, data, methods and global results. Geneva: World Health Organization; 2007. ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf Classifying health workers: mapping occupations to the international standard classification ƥ https://www.who.int/hrh/statistics/Health_workers_classification.pdf 32 3. Planning and managing vaccination of health workers Vaccination of health workers Vaccination of health workers should ideally take place at the health facilities where the targeted health workers normally work to ensure convenient access to vaccination. Case study: Using an immunization champion to enhance uptake of influenza vaccination in health workers in Oman Oman has a universal free-of-charge, integrated health care system, which includes influenza vaccina- tion of health workers. Oman is one of the few high-income countries in the WHO Eastern Mediterranean Region (EMR) that has achieved high influenza coverage among health workers (>80%). This was made possible by immunization champions. The minister of health in Oman is passionate about protecting the health of health workers and is at the forefront in taking the first influenza seasonal vaccine. As the patron of health worker community and an influential person in the country, this action has reinforced the importance of vaccination and continually helps promote influenza immunization programs. He has also been personally involved in the communication of vaccination messages to the health worker community. Every health facility should prepare a health facility plan for implementing seasonal influenza vac- cination of health workers well ahead of the influenza season. These plans should include measures to enable convenient access to vaccination for health workers in every shift. Different options may need to be determined at the health facility level to cover health workers during night shifts with- out resorting to 24-hour vaccination services, for example insuring the availability of vaccination just before or after a shift change. A vaccination team should be established at the level of the health facility to coordinate the vac- cination activities and optimize uptake under the overall supervision of the head of the facility. One person should be designated as the team leader. This could be either the occupational safety and health focal points, or the persons responsible for immunization activities in the health facil- ity. In larger facilities the staff medical services may be tasked with this activity. Experience from some organizations and health facilities have shown that using “vaccination champions” from among the health workers may contribute to improving vaccination uptake among their peers. In Toolbox 13 Vaccine management and support resources The resources that can assist programme managers in supply chain and logistics support planning may be found at the WHO website at:  http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ index4.html (Accessed 14 Mai 2019) Overview of technologies for the treatment of infectious and sharp waste from health care facilities ƥ https://apps.who.int/iris/bitstream/handle/10665/328146/9789241516228-eng.pdf (Accessed 14 Mai 2019) 33 3. Planning and managing vaccination of health workers some countries, a mobile team that goes to each clinical area in the health facility and provides vaccination has been successfully used. Training of the vaccination team Training workshops for health facility vaccination focal points should be conducted to conduct training in developing a health facility plan and in implementing and monitoring vaccination activities. A standardized agenda, curriculum, resource documents, checklists and model forms for recording data, as required, should be created at the national level for use in these workshops so that training is uniform across all health facilities. To further ensure uniform training, the workshops could be conducted using teams of trainers who are themselves trained centrally and are assigned to each region/subregion, using a cascade training approach. Short training videos may be used to achieve uniformity in content in the training. Web-based self-learning modules may be considered for those who were unable to attend the training sessions. The health facility vaccination team should have the capacity to classify health worker groups (see chapter 2 for sample risk categorization of health workers) and establish a list of health workers eligible for vaccination, with their designations, and areas of work. Where different vaccination policies apply to different risk categories, either separate lists should be created, or mechanisms established to easily identify and monitor the vaccination status of those in each category. The beneficiary lists should be developed sufficiently in advance of the start of vaccination activities and the relevant health workers informed on the need for vaccination. In addition to health workers employed at the health facility, provision may be made to include health workers in smaller facilities within their catchment area, including private facilities, as per the national policy, should vaccination not be available at all facilities. A mechanism for defaulter tracking and for sending reminders should be established at each health facility. For health workers who come into contact with high risk patients, (e.g. those in organ transplant, oncology, intensive care or perinatal units), the supervisors of those who have not been vaccinated before the start of the influenza season may need to be informed (local confidentiality norms permitting) so that they can reinforce the written reminders or, in case of refusals, get active declination forms signed and institute infection control measures applicable to active refusals, e.g. reassignment of duties, wearing of masks etc. as per the established national of health facility policy. 34 4. Monitoring and evaluation All countries should have a mechanism in place to monitor vaccine coverage as well as adverse events following immunization (AEFI) from the health facility to the national level and conduct at least one influenza vaccine post-introduction evaluation. However, measuring vaccine accep- tance and vaccine effectiveness or impact will be necessary and feasible only in a setting where immunization targets are not reached and if funding is available. Developing and updating information systems Appropriate forms and data entry modules for recording and reporting vaccination data at the health facility level and processes for reporting the data should be established. In developing tools and guidance for data collection, the need to include both public and private health systems should be considered. This may require mapping of existing health information systems and immunization data collection instruments as well as guidance on how these systems may be used to collect data on seasonal immunization of health workers. Data collection systems may vary across health facilities depending on the size and available infra- structure of the facility. However, each health facility must be provided with a standardized data reporting form to ensure that the data required for reporting to the national level are collected, irrespective of the data recording system used. This could include the name of the health worker, the health worker category, area of work, risk category, date of vaccination, the vaccine product and lot number. In developing the data reporting form, the advice provided by the NITAG on monitoring and impact assessment should be considered. All data collection systems, whether paper-based or electronic should have the capability for defaulter tracking and a system for generating and sending out reminders to defaulters. When using such reminder systems, protecting the confidentiality of data on the health and vaccination status of health workers will be critical and access to the data should be restricted to the facility vaccination coordinator. Coverage monitoring Several approaches for estimating health worker influenza vaccine coverage are available. The timing of such coverage measurement is important and should be coordinated with the timing of vaccination in the country. Given that influenza vaccine is usually administered in seasonal campaigns, frequent reporting (e.g. monthly) is recommended. Ideally, assessments should be done at the end of the season, when complete data are available and assessed and data cleaned for any inconsistencies. 35 4. Monitoring and evaluation Health facility registries Information on influenza vaccines administered to health workers should be included in existing records maintained as part of occupational health requirements and in vaccination registers as part of institutional monitoring mechanisms. Careful assessment of data discrepancies is requi- red if reporting is done from multiple sources, and data protection issues should be judiciously considered. The minimum set of data will include the number of people receiving influenza vac- cination during each annual season, the total number of targeted health workers, and the derived vaccination coverage (%). Often both numerator and denominator data can be obtained from the departments of occupational health at health facilities. For establishing more detailed denomina- tors, nominal health worker records e.g. based on payrolls can be used as a first step. A beneficiary list of those targeted for influenza vaccination can be selected from these records by applying criteria related to the health worker’s risk of infection or of transmitting the infection to those for whom they care (see section on “Characterizing the target groups for vaccination” and table 1). Depending on the capacity of the reporting system and program, this could include tallying numbers by health worker category and risk profile to allow coverage estimates by subcategories, such as doctors, nurses, laboratory workers, or staff working in Intensive Care Units or general (e.g. medicine or paediatric) wards, etc. If a vaccination registry does not exist, a crude estimate of coverage among health workers could be calculated by using the number of vaccine doses distributed to each facility minus the number of vaccine doses returned (unused) divided by the estimated number of health workers targeted for vaccination at the facility. A similar, rather imprecise method to assess coverage at the national level would be to use the regularly compiled data on health workers (as reported to WHO) to estimate the denominator (see Toolbox 12), as used for the vaccine demand forecast, and the overall number of vaccines adminis- tered as the numerator. This approach should only be used as a last resort where none of the other methods described are feasible. Administrative data If vaccines are provided free to health workers with government, national insurance system or employers bearing the costs, there may be regular, sometimes mandatory, reporting on the number of health workers who have received vaccinations at the institutional level. Such administrative data may be available from well-documented national vaccine programmes or from health insu- rance records. Surveys Surveys to obtain data on vaccinations and other interventions should be performed every 3 to 5 years and allow the identification of heterogeneity of coverage at the subnational level, important for the necessary adaptation of immunization practices. A representative sample of health workers can be selected though a stratified random sampling approach from national registries of health workers (e.g. professional organizations). If such registries are not available, a two-stage selection of health facilities and of health workers in these facilities can be done. If contact information is available, standardized interviews could be done face-to-face, by phone or via internet-based pla- tforms. Without such information, online survey links could be provided to all health workers in the selected facilities with an invitation to access the survey platform using their mobile phones or personal computers. It should be noted that when using this approach, self-reporting of vacci- nation may lead to overreporting.12 12 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394773/ 36 4. Monitoring and evaluation In all of these approaches to estimate coverage it will be important to specify the categories of health workers, e.g. those with or without direct patient contact, the latter including students, trainees, volunteers, maintenance, information technology, food service staff etc., who have been included in the numerators and denominators. It is also important to specify if part-time personnel working during the influenza season were included in the coverage estimates. Where individuals for whom vaccination is not recommended are vaccinated, such as back office workers or staff relatives, etc., care must be taken not to count these in estimating vaccination coverage. Refusal and completion rates of surveys will need to be monitored and adjustments for possible selection biases made in the analysis. At times, influenza vaccination programs may merely set absolute number targets of health work- ers to be vaccinated, based on the number of vaccines procured and available in a specific area or location. Such an approach, while followed in some countries, will not allow the proper estimation of coverage rates, including coverage by risk category, or comparisons over time, which will be important for interpreting any data on impact. It will also not enable identification of determinants of vaccination or of refusers. If available, data as well as methods used to estimate vaccination coverage for other regular health worker vaccinations should be accessed, e.g. for hepatitis B, measles, polio, pertussis or tetanus vaccines. It must be noted, however, that these vaccines are not provided on an annual basis and will often only be checked at entry to service. Toolbox 14 lists available tools for collecting and reporting immunization data and for estimating coverage. Toolbox 14 Monitoring and evaluation tools and indicators Immunization in practice series, module 7: Monitoring and using your data. Describes how to collect and report data and how to monitor immunization performance. ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf (Accessed 14 Mai 2019) Training for mid-level managers. Module 7: The EPI coverage survey (Document WHO/IVB/08.07). Geneva: World Health Organization; 2008. Provides a step-by-step walkthrough, including relevant guidance and tools, to plan and conduct a coverage survey of a newly introduced vaccine. ƥ http://who.int/immunization/documents/MLM_module7.pdf (Accessed 14 Mai 2019) WHO reference for estimating influenza vaccination coverage among target groups. Outlines different methodologies that can be used to estimate national influenza vaccine coverage among high-risk groups targeted for vaccination. ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing-influenza- vaccination-coverage-target-groups.pdf (Accessed 14 Mai 2019) 37 4. Monitoring and evaluation AEFI monitoring As for any vaccine and target group, a functioning AEFI monitoring system is a basic requirement, since knowledge gaps and misperceptions about influenza vaccine safety among health workers are consistently identified in in the literature. The system utilized to monitor and investigate possible AEFIs when delivering influenza vaccine to health workers should ideally be integrated into existing AEFI surveillance systems in line with national regulations for the monitoring of vaccine safety. The NIP or other departments responsible for health worker influenza vaccination (e.g. occupational health) should work with the National Regulatory Authority to define roles and responsibilities in vaccine safety monitor- ing. In countries using influenza vaccines for the first time, it could be conceivable to intensify AEFI surveillance during the first year of influenza vaccine introduction in order to provide quick feedback to stakeholders to help assure them of the safety of the vaccines in use. A functioning AEFI monitoring system will detect and elucidate problems with vaccines, which could be due to the product itself, its quality, or errors in the administration of the vaccines. All vaccine recipients reported as having an event (including minor events) perceived to be related to the influenza vaccine should be reported to the AEFI surveillance system using standard report- ing forms (see Toolbox 15). Given adequate reporting, the monitoring system should be able to evaluate the observed rate of reactions to influenza vaccine and compare this to the expected rates reported in the literature. For serious AEFIs, causality will normally be assessed by a group of experts. Importantly, and as for any vaccine, such a system needs to be able to identify a previously unknown or unexpected vaccine reaction that should be investigated in more depth. Care must be taken to ensure that coincidental events are not mistaken for vaccine reactions. Toolbox 15 AEFI-related information sources AEFI core variables, including data on case, vaccine, event and reporter ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_Dec2015.pdf (Accessed 14 Mai 2019) Sample form for AEFI recording with detailed description of reporting elements ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (Accessed 14 Mai 2019) Causality assessment of an AEFI: Provides the detailed methodology in a four-step process with access to a related software tool  http://www.who.int/vaccine_safety/publications/gvs_aefi/ (Accessed 14 Mai 2019) Vaccine safety training resources providing access to vaccine and pharmacovigilance training packages  http://www.who.int/vaccine_safety/initiative/tech_support/ (Accessed 14 Mai 2019) Information sheet: observed rate of vaccine reactions – influenza vaccines ƥ https://www.who.int/vaccine_safety/initiative/tools/Influenza_Vaccine_rates_information_sheet.pdf (Accessed 14 Mai 2019) 38 4. Monitoring and evaluation By establishing and enhancing AEFI systems, influenza vaccination can also be used to further improve the awareness of overall immunization safety in the health worker community. Monitoring and evaluation of vaccine acceptance Key determinants of vaccine acceptance among health workers have been investigated and include the desire for self-protection and to protect family and patients. (see also section on communica- tion and vaccine acceptance). As part of an initial situation analysis of health worker influenza vaccination programmes, available information on policy, programmes and practices, the factors affecting acceptance and participa- tion, and the influence of media and communications can be investigated through key informant interviews, or participatory workshops. Results of such an analysis could then be used to inform additional communication strategies addressing the identified concerns in a targeted manner. Other determinants can be explored through formative research. Both qualitative and quantita- tive research methods can be used to evaluate changes in health workers’ knowledge, attitudes, practices and behaviours. Behavioural determinants that differentiate health workers who get vaccinated from those who do not should be assessed regularly. Understanding the reasons and reasoning behind health workers’ attitudes towards annual flu vaccination is useful for the de- velopment of communications messages and products. Involving health workers in behavioural research related to their perceptions, beliefs, emotions and potential conflicts also provides an opportunity for the health worker community to be engaged in the approach, which can result in greater acceptance of the vaccination program. Vaccine impact monitoring After an influenza vaccine has been introduced in a population, additional studies may help in evaluating the impact of the immunization program. However, WHO does not recommend that vaccine impact or effectiveness studies be conducted by all countries with influenza vaccination programs, given their complexity and expense. A number of research networks worldwide conduct such studies and results can be expected to be applicable in Toolbox 16 Tools to assess vaccine acceptance among health workers TIP-FLU tool. Provides an approach and tools grounded in behavior change theories and health programme planning models to tailor seasonal influenza vaccination to the needs and attitudes of frontline HWs.  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) TIP FLU case study Montenegro. Provides a practical example of the use of the TIP FLU tool. ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization-Pro- grammes-Seasonal-Influenza-TIP-FLU.pdf (Accessed 14 Mai 2019) 39 4. Monitoring and evaluation other settings with similar influenza epidemiology and vaccination programs. The decision to carry out such studies should therefore be based on the need for country-specific estimates and on the local capacity to conduct such rigorous studies. If studies are not appropriately designed with adequate sampling of different health worker categories, there is a risk of arriving at wrong conclusions. Before-after studies to demonstrate vaccine effectiveness are not advised for influenza, given that influenza vaccine effectiveness for preventing influenza symptoms in seasonal influenza epi- demics display considerable heterogeneity.13 Studies to evaluate the impact of seasonal influenza vaccination in health workers can be even more complex, given the varying risk of infection and transmission to patients among different categories of health workers. In health workers, a general reduction in absenteeism or, if available, reduction in influenza-asso- ciated absenteeism is often used as a surrogate indicator for the impact of an influenza vaccination programme. For this, health facility institutional monitoring would need to include disease rates in health workers, and a measure of sickness absence. Where possible, reporting days of absenteeism due to influenza-like illness (ILI) (or respiratory infections) should be recorded. This will include self-reported ILI with or without virological confirmation. Other non-specific outcomes include severe acute respiratory infection (SARI) and all-cause pneumonia requiring hospitalization. It is important to note that all these clinical syndromes include various other respiratory pathogens against which influenza vaccine does not protect. If such assessments are done, they should ide- ally cover multiple seasons, since impact can vary substantially by season, else such studies will be quite difficult to interpret. Laboratory-confirmed outcomes (e.g. by RT-PCR and other molecular diagnostic tests) improve the specificity of influenza disease classification. Where possible, establishment of sentinel sites with such capacity could be considered for collecting samples from health workers for laboratory confirmation. In these sites, vaccine effectiveness could be assessed using a case-control design and comparing vaccine coverage in laboratory-confirmed versus test-negative cases, if vaccine coverage is sufficiently high. Any of these approaches require sophisticated laboratory capacity which is not available everywhere. The screening method is a study design which could also be used for health worker vaccine im- pact assessment: it uses individual-level data on vaccination history from cases and data on vac- cination coverage in the health worker population from which the cases came. However, such a study requires accurate information on the vaccination status of the cases and of health worker vaccination coverage. Given the indication that annual influenza vaccination for health workers could reduce illness among the patients they care for, studies can be designed to evaluate the effect of health worker influenza vaccination on mortality, hospitalization, and influenza cases in patients of healthcare facilities. Several research approaches have been used in this context such as randomized trials or case-control approaches. Given the complexity of study designs, the conduct of such studies should be limited to research institutions that have the capacity and experience to conduct such studies. Economic assessments and cost-effectiveness evaluations may be considered once sufficient cost and impact data are available following influenza vaccine introduction. WHO provides a number of relevant resource documents, which are being further developed to specifically estimate vaccine 13 Evaluation of influenza vaccine effectiveness: A guide to the design and interpretation of observational studies, WHO 2017. 40 4. Monitoring and evaluation introduction costs for health worker vaccination (Toolbox 17; see also Toolbox 2). Relevant data are not easily available everywhere and assessments can be difficult to perform, given the limited size of the group of health workers. Post-introduction evaluation National Immunization Program Reviews routinely assess the use of specific vaccines about every 5 years following a new vaccine introduction. Such NIP Reviews should include relevant items to identify possible programmatic areas related to the new vaccine use. As needed in-between NIP Reviews, a specific influenza-related Post-Introduction Evaluation (I- PIE) tool may be performed after the first or second influenza immunization season. The I-PIE package (Toolbox 18) includes a number of tools to support the planning and conduct of the evaluation, including standard questionnaires and data collection forms in paper or electronic format as well as reporting templates together with instructions on how to perform the I-PIE in a cost-efficient manner. These tools will need to be adapted to the specific country context and to the specifics of the vaccine formulation and presentations. The I-PIE is performed at all levels of the health system and includes observation of practices at the points of vaccine administration, vaccine storage areas as well as data and record reviews. An I-PIE can thus provide a more immediate approach to assess the programmatic challenges and impact of influenza vaccine use, and to compare results across countries, enabling them to share and learn from each other’s experiences. Toolbox 17 Influenza in health workers: Study methodologies Evaluation of flu vaccine effectiveness 2017. Provides detailed information for researchers who design observational influenza vaccine effectiveness studies and for public health scientists who interpret and apply the results of these studies. An annex will address the effectiveness of influenza vaccine in health workers. ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (Accessed 14 Mai 2019) Manual for estimating disease burden associated with seasonal influenza. Provides step-by-step approach to estimate influenza disease burden in the general population as well as those with specific conditions who are vulnerable to severe disease.  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (Accessed 14 Mai 2019) Toolbox 18 Influenza post-introduction evaluation tools I-PIE tool with instructions and recording and reporting templates  https://www.who.int/immunization/research/development/ipie_influenza_post_introduction_ evaluation (Accessed 14 Mai 2019) 41 References [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination accep- tance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during preg- nancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are count- ries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evi- dence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare wor- kers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-ana- lysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13(6):e0198685. 42 [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care wor- kers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epide- miol. 2002; 23(10):615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influen- za-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kin- dergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial out- break of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a mul- ti-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 43 [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vacci- nation of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12(1):e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vac- cination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection cont- rol and hospital epidemiology. 1998; 19(7):518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward man- datory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62(1):1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 44 [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing inter- vention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccination: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36(2):196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, ado- lescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertive- ness. N Engl J Med. 2019 Jan24; 380(4):309–11. 45 Annex 1. Sample non-participation form This form is to be used in cases of voluntary vaccination where health workers in the very high or high-risk categories who decline to participate in assessment, screening and vaccination in accordance with the national policy. Completion of the form is particularly important where failure to get vaccinated will result in reassign- ment or require the use of protective measures to protect patients as specified in the national policy. Non-participation in vaccination 1. I have read and understood the policy directive regarding seasonal influenza vaccination of health workers. 2. I decline to participate in vaccination against influenza. 3. I am aware of the potential risks to myself and/or others that my non-participation in vaccination may pose. 4. I am aware that my non-participation may result in my being reassigned to a non-high-risk area or in other requirements to protect others with whom I may come in contact, as per the national policy. 5. The reason for my non-participation is: Refusal to sign In circumstances where the health worker refuses to sign this form, it should be noted on the form and the health worker should be notified of consequences, if any, as per the policy. Name of health worker: Date of birth: Health service/ facility: Work area: Signature: Date: OFFICE USE ONLY I have discussed the potential risks that non-participation in vaccination may pose and the management of unvaccinated workers in accordance with the vaccination policy. Name of vaccination team staff: Designation: Health facility /agency: Signature: Date: 46 Annex 2. Complementary checklist for planning health worker immuniza- tion: national14 level (To be adapted for local use) To account for the specifics of seasonal influenza vaccination of health workers, the following ADDITIONAL elements may be added to the generic new vaccine introduction check list, see Annex 4 of the document “Princi- ples and considerations for adding a vaccine to a national immunization programme” for the checklist structure. Health worker seasonal influenza vaccination policy 1. National policy on seasonal influenza vaccination of health workers are published and dissemi- nated to all relevant agencies and health facilities, including private health facilities and relevant professional societies. 2. The policy on seasonal influenza vaccination of health workers is reflected in the national occupational health policies. 3. The costs of seasonal influenza vaccination of health workers are included in either the immu- nization or occupational health budget, as appropriate. 4. Surveillance system is in place for influenza activity, including defining start and end of the influenza season, to inform selection of the most appropriate vaccine formulation and timing of influenza vaccination. Planning for successful vaccine introduction 5. A functional multidisciplinary coordination group is in place to discuss and promote access to a new target population of health workers, enabling the formation of partnerships which support and shape the national agenda. 6. The group includes focal points from the occupational health and immunization programs, professional organization representatives, and other relevant stakeholders. 7. A costed operational plan for health worker vaccination is developed and integrated into the na- tional immunization plans and relevant occupational health plans. Formative research (optional and to be included only if formative research is planned) 8. The need and scope of any formative research to be conducted in preparation for vaccine introduction is defined. 9. A research group to conduct formative research has been identified and terms of reference for the research has been developed. Communications 10. National communications working group established for planning communications strategy and developing communications materials for health worker vaccination against seasonal influenza. 14 In some countries, especially large countries with decentralized system, elements of this checklist may also apply at relevant subnational levels, e.g. provincial level. 47 11. Tailored communications messages and materials developed along with an overall communications strategy. 12. Training for health facility communications teams is conducted. Vaccine procurement and supply chain management 13. Target population size estimate developed and included in demand forecast. 14. Individual health facility demand estimated, and vaccine distribution plan developed. 15. Sufficient storage space for vaccines and supplies for seasonal vaccination at all levels established to accommodate vaccine during vaccination period. Vaccine Delivery 16. Health facility vaccination delivery teams are established and trained. 17. System for management of vaccination refusals and implementation of infection control mea- sures in place for prevention of nosocomial transmission, e.g. reassignment, wearing of masks, mandatory leave in case of ILI. Monitoring and evaluation 18. Data recording and reporting tools developed and distributed including for coverage monitoring (updated administrative data and health worker surveys) and AEFI monitoring. 19. Post-introduction evaluation conducted within the first 2 seasons following vaccine introduction. 20. Possibilities reviewed for operational research to assess health worker vaccine acceptance. 48 Annex 3. Health facility checklist (To be adapted for local use) Person responsible Deadline Status Communications 1. Health facilities communications working groups are established and trained 2. Health facility communications plan and schedule for group communications with health workers finalized 3. Adequate supplies of posters and information materials for health worker vac- cination are available 4. Notification of vaccination sent out to targeted health workers and supervisors 5. Telephone hotline established to address individual queries from health workers Storage capacity for vaccines and supplies 6. Adequate storage capacity for influenza vaccines and supplies during vaccination window period established 7. Adequate supplies of influenza vaccines and supplies for health worker vaccination available 8. Provision to deal with extra injection waste during period of vaccination Vaccine Delivery 9. Vaccination delivery team established and trained and vaccination sites within health facility finalized 10. Categorization of health workers completed and beneficiary list for vaccination developed 11. System for management of vaccination refusals and implementation of infection control measures in place for prevention of nosocomial transmission, e.g. reas- signment, wearing of masks, mandatory leave in case of ILI Monitoring and evaluation 12. Data recording and reporting instruments available taking into account data protection issues 13. System for defaulter tracking and reminders established 14. Health facility registries updated to include influenza vaccination 15. AEFI monitoring and reporting systems updated to identify AEFI in health workers 16. Vaccine acceptance monitoring system to address uptake issues in health workers established (if uptake issues are observed) 49 Annex 4. Sample questionnaire for conducting a survey among health workers 1 Name (optional) 2 Age (years) 3 Sex ¨ Male ¨ Female 4 Job category15 ¨ Doctor ¨ Nurse/midwife ¨ Laboratory technician ¨ Other technical staff ¨ Other (specify) 5 Patient contact ¨ Direct ¨ Face-to-face but not direct ¨ None 6 Contact with high risk patients ¨ Yes ¨ No 7 Work area (name of clinical area of work) Statements Strongly agree Agree Neutral Disagree Strongly disagree 1 Vaccination of health workers against diseases such as hepatitis B and influenza are important 2 If I was unvaccinated exposure to influenza would be a risk to my health 3 Exposure to influenza poses a risk to my patients’ health 4 Influenza vaccination poses a risk to my health 5 The benefits of vaccination are greater than the risks 6 My receiving vaccination will protect my patients 7 The best way to protect my patients is to combine seasonal influenza vaccination with other infection control measures 8 I am sufficiently informed about risks of influenza infection I am sufficiently informed about the risks and benefits of influenza vaccination The following factors that would influence my decision to accept vaccination 9 Recommendations from the national policy-making body (e.g. NITAG) 15 Adapt for local use based on local health worker classification. 50 10 Endorsement of recommendation from the professional society to which I belong 11 If it is part of occupational health regulations/ requirements 12 Recommendation from my personal physician 13 Availability of vaccination at no cost to me 14 Easy access to vaccination at my place of work 15 Colleagues having been vaccinated 16 Previous experience with vaccination 17 Protecting my patients 18 Preventing/reducing absenteeism from work 19 Contributing to pandemic preparedness Other factors that would affect my decision to accept influenza vaccination (list below) 20 21 22 51 Annex 5. Communications and demand generation: Stratification of approaches to developing the content Approach Effort Impact Developing the content for communication messages Framing information by delivering social comparison feedback on vaccination rates among peers or healthier individuals Low Medium Tailored communication based on cognitive styles and cultural behaviours Medium High Communication methods Distribution and display of Information, Education and Communication (IEC) materials Low Medium Establish a specially trained communications team at health facility level to administer communications and demand generation approaches Medium High Web-based (including FAQs and chat groups) and social media communications Medium Medium Text message and e-mail reminders to health workers Low Medium Small group in-person briefing meetings High Medium Use immunization champions at national and health facility level Medium High Demand generation approaches Provision of free vaccines Medium High Provide vaccination in the work area using mobile teams Medium High Provide incentives or stimulate competition, e.g. awards to clinical areas with highest vaccination coverage Low Medium Visible reminders and peer-pressure, e.g. badges or stickers worn by those who have been vaccinated Low Medium Ask individual to commit to a time and location to obtain vaccination Low Medium Increase options to obtain vaccination, either near home or at workplace Medium High Guide choice through default options, e.g. automatically set up appointment for vaccina- tion unless individual opts out Low High Establish standing orders to facilitate vaccination Medium High 52 ISBN 978-92-4-151559-7

1An introduction manual for national immunization programme managers and policy makers How to implement seasonal influenza vaccination of health workers Family, Womens’s and Children’s Health (FWC) DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS This document was produced by the Initiative for Vaccine Research (IVR) of the Department of Immunization, Vaccines and Biologicals How to implement seasonal influenza vaccination of health workers ISBN 978-92-4-151559-7 Published: May 2019 This publication is available on the Internet at: https://apps.who.int/iris/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: + 41 22 791 4227 • Email: vaccines@who.int © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following dis- claimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. How to implement seasonal influenza vaccination of health workers. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. IAcknowledgements This manual was developed by Thomas Cherian and Carsten Mantel, MMGH Consulting and Philipp Lambach (WHO/IVR) with review and inputs of an Independent Expert Advisory Group: Salah Al Awaidy, Silvia Bino, Joseph S. Bresee (chair), Supamit Chunsuttiwat, Daouda Coulibaly, Luzhao Feng, Rachel Hale, Shabir A. Madhi, Helena C. Maltezou, Kelly Moore, Jonathan Nguyen- Van-Tam, Saad Omer, Gregory Poland, Sabine Wicker. Kelly Moore and Chris Morgan were consultant as representatives of the WHO Immunization Practices Advisory Committee, IPAC. Consultants: Thomas Cherian, Carsten Mantel. Additional experts: Birte Bödeker, Susan Y. Chu, Sara Hamid, Kathryn Lafond, Kathleen Morales, Julia Neufeind, Susan Wang. WHO: Philipp Lambach, Onyema Ajuebor, Ms Phionah Lynn Atuhebwe, Philip Gould, Shalini De- sai, Julia Fitzner, Martin Howell Friede, Shoshanna Goldin, James Dawson Heffelfinger, Raymond Hutubessy, Ivan Dimov Ivanov, Pernille Jorgensen, Melanie Marti, Hasan Qamrul, Lisa Menning, Ann Moen, Liudmila Mosina, Andreas Alois Reis, Alba Maria Ropero Alvarez, Claudia Steulet, Nadia Teleb. Financial support for the development and pilot-testing of this manual is provided through the Centers for Disease Control and Prevention (CDC), which provides financial support to the World Health Organization Initiative for Vaccine Research (U50 CK000431). II Contents Executive summary 1 About this manual 2 Objective 2 Audience 2 Structure of the document 3 Key related documents 4 1. Background and rationale 5 Current status of influenza vaccination in health workers 5 Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers 6 Evidence for health worker risk of influenza and impact of vaccination 6 Evidence of transmission of infection from health workers to patients and the impact of vaccination 7 Evidence for interventions to increase health worker vaccination uptake 7 Global Action Plan for Influenza Vaccines 8 2. Establishing a policy to vaccinate health workers against seasonal influenza 10 The decision-making process 10 Considerations for decision-making 12 Defining the public health objectives for vaccination 12 Economic analysis for establishing national policies 13 Characterizing the target groups for vaccination 14 Framing an immunization policy for health workers 15 Integration with Occupational Health Policies 18 Choice of vaccine product, schedule and timing of vaccination 18 Defining monitoring and disease impact measurement objectives 20 III 3. Planning and managing vaccination of health workers 21 Planning for successful vaccine introduction 21 Costing and financing 22 Formative research to inform the planning process 24 Communication and vaccine acceptance 25 Communications at the health facility level 26 Demand Generation at the Health Facility Level 28 Vaccine procurement and supply chain management 30 Vaccine procurement 30 Selection of the vaccine product and presentation 30 Logistics and cold chain management 31 Vaccination of health workers 32 Training of the vaccination team 33 4. Monitoring and evaluation 34 Developing and updating information systems 34 Coverage monitoring 34 AEFI monitoring 37 Monitoring and evaluation of vaccine acceptance 38 Vaccine impact monitoring 38 Post-introduction evaluation 40 References 41 Annex 1. Sample non-participation form 45 Annex 2. Complementary checklist for planning health worker immunization: national level 46 Annex 3. Health facility checklist 48 Annex 4. Sample questionnaire for conducting a survey among health workers 49 Annex 5. Communications and demand generation: Stratification of approaches to developing the content 51 1Executive summary Health workers are at higher risk of influenza infection than the general population. In addition to morbid- ity among health workers, influenza infection may also lead to increased absenteeism, presenteeism1 and disruption of medical services. Moreover, influenza infected health workers may contribute to nosocomial transmission of infection to their patients, including those at high risk for developing severe influenza disease and complications. Hence, the World Health Organization (WHO) considers health workers to be a priority target group for seasonal influenza vaccination. In addition, influenza vaccination of health workers contributes to influenza pandemic preparedness. Finally, studies have shown that health workers who are vaccinated against influenza themselves are more likely to recommend vaccination to their patients. This manual serves as a resource to assist users in establishing a national policy for seasonal influenza vaccination of health workers. It provides guidance along with a catalogue of available tools to facilitate policy development, planning, implementation, monitoring and evaluation of influenza vaccination of health workers. The contents of the manual are meant to supplement the document titled “Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring”, published by WHO in 2014. The main target audiences for this manual include national policy makers; national health planners; the na- tional programme managers for immunization and occupational health; and those responsible for occupational health, health worker immunization and infection control in health facilities. Close collaboration between immunization managers, and occupational health and infection control programmes is essential to optimize vaccine uptake, and for a cohesive and comprehensive approach to influenza control in health facilities. This manual summarizes the evidence and rationale, provides guidance on key issues, and lists available tools for influenza vaccination of health workers, covering three main components of vaccine introduction and management: 1. Establishing an evidence-based national policy for seasonal influenza vaccination of health workers. 2. Planning and management of health worker influenza vaccination. 3. Monitoring and evaluation, including assessing vaccination coverage, monitoring for adverse events following immunization, impact assessment and post-introduction evaluation. Complementing this manual, deliberations of an Independant Expert Advisory Group developing this manual are available in form of a meeting report summarizing critical issues. These include policy con- siderations, the evidence in support of health worker vaccination; categorization and prioritization of health workers; the choice of vaccination strategy; its integration into broader health worker vaccination and occupational health policies; planning and management of vaccination, particularly the approaches for communication and demand generation; and the challenges with monitoring and evaluation of health worker vaccination, especially in low and middle-income countries.2 1 Presenteeism refers to health workers who work while ill, yet have reduced accuracy and effectiveness and pose a risk to vulnerable patients in their care. 2 Cherian T. et al. Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16–17, Berlin, Germany. Vaccine. 2019;37(43):6255–6261. 2About this manual Objective This manual serves as a resource and catalogue of available tools to assist country officials in de- ciding upon, planning, implementing and monitoring health worker influenza vaccination in order to achieve optimal vaccination coverage. It is not meant to be a prescriptive document, but rather articulates general principles and key considerations to support policy formulation; plan- ning and management of vaccination; and monitoring and evaluation of influenza vaccination of health care workers. The manual also outlines measures to ensure integration of health worker influenza vaccination into existing national occupational health policies and occupational safety and health management systems of health facilities. It also addresses the opportunity for health worker influenza vaccina- tion to promote an integrated approach for monitoring and optimizing the uptake of all interven- tions included in national occupational health policies. In addition, it refers to the relationship and contribution of health worker vaccination to pandemic influenza preparedness. Seasonal influenza vaccination in health workers differs from other vaccine-preventable diseases in that vaccination is required annually. However, elements of this manual may be of relevance for health worker vaccination in general, particularly the sections on planning and management of vaccination and on monitoring and evaluation. Audience The main target audience for the manual include: 1. National policy-making bodies and health planners. 2. Programme managers for immunization, infection control and occupational health programmes at national and subnational levels and those responsible for occupational health and infection control in health facilities. 3. Organizations of health workers and employers. While the different sections of the document may be of greater relevance to one or the other group, it is advisable that the document be read as a whole because of the information on a particular topic may be found in the different sections of the manual. The document may also be useful to other audiences with an interest in immunization or occu- pational health. 3Structure of the document The manual consists of four sections as outlined in Figure 1. However, for clarity and complete- ness there is some overlap between some of the sections, with cross-references made to the other relevant sections. Figure 1. Structure of the document Establishing a policy Planning & management of vaccination Monitoring & evaluation Introduction, background and rationale •About the manual, including objectives and target audience •WHO policy recommendations on influenza vaccination •Current status of health workers vaccination •Summary of evidence to support health worker vaccination •Global Action Plan for Influenza Vaccines •Considerations for making a decision •Defining the objectives for vaccination •Categorization and prioritization of health workers •Framing an immunization policy • Integration with Occupational Health Policies •Choice of product and timing for vaccination •Delivery options and strategies to optimize coverage •Defining monitoring and impact assessment objectives •Planning for successful vaccine introduction •Costing and financing •Formative research to inform planning process •Communication & vaccine acceptance •Demand generation at the health facility •Vaccine procurement and supply chain management •Vaccination of health workers •Training of vaccination team •Coverage monitoring •AEFI monitoring •Vaccine acceptance assessment •Vaccine impact monitoring •Post-introduction evaluation POLICY MAKERS IMPLEMENTERS 4Key related documents The following documents are important resource materials that complement the guidance in this manual. 1. The WHO policy recommendations on seasonal influenza vaccination, including health worker vaccination are published in WHO Position Papers. These position papers are peri- odically updated. Vaccines against influenza: WHO position paper – November 2012 https://www.who.int/wer/2012/wer8747.pdf (Accessed 14 Mai 2019) Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (Accessed 14 Mai 2019) 2. The following document provides detailed guidance to countries that already provide sea- sonal influenza vaccination to health workers on how to identify, analyse, and effectively target issues related to uptake: Tailoring immunization programmes for seasonal influenza (TIP FLU). A guide for increasing health care workers’ uptake of seasonal influenza vaccination (2015). Copenhagen: World Health Organization Regional Office for Europe; 2015. http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) 3. While the contents of this manual can help inform national policies, the manual does not provide an exhaustive review of the available evidence to inform decision-making. A more detailed review of such evidence in support of vaccination of health workers is found in the following document: Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. July 2019. https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (Accessed 12 July 2019) 4. This manual is part of a series of introduction manuals on seasonal influenza vaccination developed by WHO. A manual on the implementation of influenza vaccination of pregnant women has been published earlier. How to implement influenza vaccination of pregnant women: an introduction manual for national immunization programme managers and policy makers. http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (Accessed 14 Mai 2019) 51. Background and rationale Health workers are at risk of influenza virus infection and of transmitting infection to patients under their care who may be at high risk for severe disease, complications, and death (1). The increased risk in health workers compared to the general population may vary by occupation or setting (2). WHO considers health workers to be an important priority group for influenza vaccina- tion, not only to protect themselves and maintain essential health-care services during influenza epidemics, but also to reduce the spread of influenza to vulnerable patient groups with whom they come into contact (1). Furthermore, many studies have found that a strong recommendation from health workers, especially from physicians, is highly likely to increase public uptake of vaccination (3–5). Health workers who have themselves been vaccinated are more likely to be knowledgeable about vaccination and be more effective in improving public acceptance of vaccination (3–5). Fi- nally, because health workers are likely to be targets of vaccination programs during an influenza pandemic, establishing functional programs for seasonal influenza vaccination of health workers will facilitate timely and effective vaccination during a pandemic (6). Current status of influenza vaccination in health workers Global adoption of a policy for influenza vaccination of health workers has been slow. In 2017, only 119 of the 194 countries reporting having a national influenza vaccination policy. Of these, 96 report targeting health care workers as a priority group. However, the proportion of Member States that reported having a policy varies by WHO region, with the majority of countries in the WHO regions of the Americas, Europe and Eastern Mediterranean reporting a national policy for influenza vaccination, whereas a lower proportion of countries report having such a policy in the Western Pacific, African and South-East Asian regions. Information on influenza vaccination coverage in health workers is not available for most coun- tries, though it varies widely and is reported to be low in many countries where such data are available. For example, data on coverage in health workers were available from only 26 (56%) countries in the European region for the 2014–15 season. The median coverage was 29.5% with a range of 2.6% to 99.5%; only three countries, namely Albania, Armenia and Belarus, reported coverage > 75% (7). More recent data from a systematic review through compulsory reporting from all hospitals in England showed an uptake of 69% in the 2017–18 season.3 An internet survey of 2000 health workers in the United States demonstrated coverage to be 78% during the 2017–18 season, with higher coverage rates (95%) among those working in settings where they were required by their employers to be vaccinated (8). Higher vaccination coverage rates are reported when man- datory vaccination policies are implemented. In one systematic review that included eight studies, coverage rates exceeding 94% were achieved in all (9). 3 Seasonal influenza vaccine uptake in healthcare workers (HCWs) in England: winter season 2017 to 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/Sea- sonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf (Accessed 14 Mai 2019) 61. Background and rationale Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers A rapid evidence appraisal of materials available in the English language, published since 2006, and considered to be of medium or high quality, was conducted by WHO (10). The questions considered, and the main findings of this appraisal are summarized here. Readers are referred to the published report for the details and for the relevant citations. The review considered three issues, namely: 1. The evidence that health workers are at increased risk of influenza infection compared to the general population, and that vaccinating them reduces influenza or absenteeism and/or the wider economic impact of influenza in the health workforce. 2. The evidence that health workers transmit influenza to their patients in health care set- tings and, if so, whether vaccination protects the patients and the proportion of health workers who need to be protected to obtain this effect. 3. The evidence for successful practical interventions to increase vaccination uptake and the state of knowledge of social, behavioural and public health public policy research on vaccination uptake in health workers. Evidence for health worker risk of influenza and impact of vaccination Studies comparing the risk of influenza infection in health workers compared to the general population are challenging, may measure different outcomes, or are executed in different set- tings, limiting the comparability across studies or the pooling of data from these studies. Recent systematic reviews suggest that health workers are at an increased risk of influenza infection compared to the general population (Odds Ratio = 2.08, 95% CI = 1.73 to 2.51) (2), though the evidence is strongest for asymptomatic laboratory-confirmed infection (11). However, health work- ers with asymptomatic infection may still transmit influenza virus to highly vulnerable patients in a health-care setting. Respiratory illness is reported as a common cause of absenteeism among health workers. Epidem- ics or pandemics of influenza have been associated with increased rates of absenteeism among health workers (12). Vaccine efficacy in health workers has been shown to be as high at 90% for well-matched seasonal influenza vaccines (13, 14), which suggests that vaccination of health work- ers will reduce influenza-related morbidity and absenteeism. A systematic review showed a pro- tective effect against laboratory confirmed influenza and shorter absenteeism due to influenza- like illness (ILI) in vaccinated groups (15). A recent study among health workers in the United Kingdom showed that a 10% increase in vaccination uptake is associated with a 10% decrease in absence due to illness (12). However, there are observational studies that provide conflicting results – though often constrained by poor study design, non-specific outcomes, high risk of bias, and failure to adjust for confounding factors (16–19). Since the risk of illness following infection is based on the level of exposure, and absence behav- iours may vary between different categories of health workers, it is possible that the lack of suf- ficiently granular data on absenteeism, e.g. stratified by health worker categories, may account for the mixed results seen in the different studies. On the other hand, the lack of impact on 71. Background and rationale absenteeism observed in some studies, despite evidence of increased rates of infection in health workers, raises the question as to whether health workers nonetheless continue to work when infected and lead to heightened concerns about the consequent risk of nosocomial transmis- sion (20). Several studies have documented presenteeism in health workers with influenza-like illness (21–23), including one instance which was associated with nosocomial transmission in an oncology unit (24). Evidence of transmission of infection from health workers to patients and the impact of vaccination Epidemiological studies using molecular subtyping approaches demonstrate evidence of transmis- sion from health workers to patients. The use of automated collection of high-resolution contact data using wearable sensors combined with virologic data have allowed the identification of potential routes of transmission in cases of hospital-acquired influenza (25). The extent of direct transmission from health worker to patient in health care settings is difficult to capture because of the constant influx of visitors, interactions between patients, and the possibility of multiple simultaneous introductions of influenza (26–28). However, among those who may contribute to transmission of infection in the health care setting, health workers represent a sizeable vaccine- preventable portion since they are easier to target for vaccination. The direct patient benefit of health worker vaccination can be measured in several ways, as il- lustrated in the literature. Several studies evaluate the impact on laboratory confirmed influenza, while others evaluate impact on non-specific outcomes such as ILI, respiratory illness, all-cause mortality, respiratory illness associated mortality, or incidence of nosocomial influenza infection. The evidence is stronger for non-specific outcomes such as ILI, all-cause mortality (29), and inci- dence of nosocomial influenza infection (30, 31). Although some studies have attempted to mea- sure the number of health workers that need to be vaccinated for optimal protection, the evidence in support of a coverage threshold is weak, leading to disputes in the literature (32). However, it is likely that patient protection is positively associated with increasing health worker vaccination coverage but would also depend on other factors including the type of patient contact, vulnerability of the patient, use of other infection control measures, and the effectiveness of vaccination in a particular influenza season (33–35). Evidence for interventions to increase health worker vaccination uptake There is a substantial body of evidence on successful interventions to increase health worker in- fluenza vaccination uptake, much of which has been incorporated into existing toolkits aimed at increasing vaccine uptake. Although the factors that contribute to the health worker decision-making pathway are diverse, some strategies appear to be more effective than others. No single intervention has been shown to rapidly and substantially increase and sustain vaccination uptake except for mandatory vaccina- tion. However, mandatory health worker vaccination is an issue that has been extensively debated with many different perspectives for and against its use (20, 32, 36). Successful mandatory vac- cination programmes require organizational and educational efforts to secure employee support prior to implementation (37). 81. Background and rationale A combination of one or more “soft mandates” such as active declination, required surgical mask use and exclusion of non-vaccinated staff from working with highly vulnerable patients may be used as alternatives to mandatory vaccination, although there are organizational, educational, monitoring and enforcement, and human and financial resource implications for applying such soft mandates. Additional components that contribute to increased uptake include the following: • Provision of free vaccine; • Convenient access to vaccination, including on-site vaccination in health facilities; • Knowledge and behaviour modification through education, reminders, and incentives tailored towards different health worker categories; • Management and organizational approaches such as personnel assigned to oversee vac- cination activities. The reasons for low vaccination uptake are heterogenous and vary across different health worker categories and cultures. Therefore, approaches to increase uptake need to be tailored for different groups. Some studies have demonstrated that formative research, including surveys and qualitative research, can provide insights that assist in tailoring interventions to optimize uptake. Conclusion Despite the ongoing debate in the literature, influenza vaccination is important for ensuring the safety of health workers, their patients, and the general population who rely on a functioning health system, especially during epidemic/pandemic periods. Studies to conclusively establish the value of health worker vaccination will be chal- lenging though the emerging data on this issue will be closely monitored to inform any changes to existing WHO policies.4 Global Action Plan for Influenza Vaccines In an influenza pandemic, most of the world’s population will be highly susceptible to infection and it is likely that infection will spread rapidly. Vaccination is considered one of the key strategies to mitigate the potential impact of a pandemic. While it is expected that there will be a delay in the development of strain-specific pandemic vaccines, insufficient production capacity will further restrict the global access to the vaccines, at least in the early phases of the pandemic. Resource- constrained countries, especially those that lack local vaccine production capacity and those that do not have seasonal influenza vaccination policies, will face the greatest challenge in securing timely access to vaccines during a pandemic, and mitigating the substantial adverse effects of a pandemic. 4 A working group of the WHO Strategic Advisory Group of Experts (SAGE) on immunization will be reviewing the emerging data and updates to the existing WHO recommendations are expected in 2020. 91. Background and rationale To address this challenge a Global Action Plan for Pandemic Influenza vaccines was developed by WHO with short, medium and long term-strategies aimed at increasing influenza vaccine production and surge capacity before and during an influenza pandemic (38). The plan proposed three approaches to enhance access to pandemic vaccines: (i) an increase in the baseline use of seasonal influenza vaccination; (ii) an increase in global production capacity; and (iii) further research and development. The first of the above three approaches relies on countries establishing clear and effective immu- nization policies to increase the baseline use of seasonal influenza vaccines – providing industry with better demand forecasts and stimulate increased production capacity. While vaccination of health workers will only result in a modest increase in overall vaccine de- mand, it will establish a robust and functional platform for rapidly immunizing health workers and could contribute to achieving high coverage in the event of a pandemic, thereby protecting health service delivery during a pandemic. Furthermore, high uptake of vaccination by health workers is likely to build trust and increase the uptake of vaccination among other high-risk groups tar- geted for seasonal influenza vaccination in national policies. Health worker vaccination may also establish or strengthen processes that would allow rapid deployment of pandemic vaccines. Thus, seasonal influenza vaccination of health workers goes beyond the issue of immediate protection against seasonal influenza as outlined above and contributes to pandemic influenza preparedness. 10 2. Establishing a policy to vaccinate health workers against seasonal influenza The decision to establish a policy to vaccinate health workers against seasonal influenza should be evidence-based, with a clear rationale, and with the required investments for sustainable implementation. The general principles and considerations for adding a vaccine to a national im- munization programme are articulated in the 2014 WHO guidance document titled “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: From Decision to Implementation and Monitoring” (39). Health workers comprise a target population not usually included in the national immunization programmes of many low and middle-income countries. While hepatitis B vaccination pro- grammes for health workers may exist, influenza vaccines are unique since vaccination for the foreseeable future must be repeated annually. This section of the manual deals primarily with additional considerations specific to annual seasonal influenza vaccination of health workers, building on the generic framework provided by the document cited above. The decision-making process As with any other vaccine for which policies have to be established, Ministries of Health (MoH) would request National Immunization Technical Advisory Groups (NITAGs) or equivalent na- tional or regional bodies to conduct a review of the evidence and provide advice on establishing a policy for seasonal influenza vaccination of health workers, and to make recommendations on the content of the vaccination policy. Engagement of the many stakeholders affected by this policy is essential to secure their endorse- ment and facilitate high vaccination uptake, and is likely to result in a more coordinated approach to the control of influenza in health facilities. Stakeholder consultation should be broadly sought and include: 1. Professional associations and societies representing different health worker groups such as medical, nursing and allied health service associations, as well as representatives of private health care providers; 2. Medical and nursing councils and other health worker regulatory bodies; 3. Patient safety groups, where they exist, and organizations representing patients, since health worker immunization should also be regarded as a patient safety and quality of care issue; 4. Health worker unions, where they exist and when their participation is likely to be use- ful in promoting vaccination uptake. 5. Health facility managers. 11 2. Establishing a policy to vaccinate health workers against seasonal influenza The process should also include early engagement with the bodies that establish occupational health policies and regulations to ensure that the policies established for health worker vaccina- tion against influenza are also reflected in the national occupational safety and health policies. If vaccination policies for health workers exist for other vaccines, e.g. hepatitis B vaccination, a review of these policies may provide useful inputs for policy formulation for seasonal influenza vaccination and on strategies to optimize vaccination uptake. Where available, NITAGs could access the information required from data available from the national influenza surveillance, the National Influenza Centres or other institutions participating in the Global Influenza Surveillance and Response System (GISRS) (see Toolbox 1). In places where local evidence is not readily available, especially on rates of disease amongst health workers and on transmission of disease from health workers to patients, efforts to generate such evidence could be time- and resource-intensive. Policy-makers would have to consider whether it is necessary to conduct local studies or whether data from other countries with similar epide- miological profiles and health system characteristics could be used to infer the likely burden of disease and support decision-making. NITAGs would need to balance the desire to have national data against the costs and delays that would result in generating the data and the consequent health impacts of this delay. Toolbox 1 National Influenza Centers To monitor and respond to the changes in the influenza virus antigenic structure and the subsequent necessity to change vaccine compositions, many countries have established national influenza centers (NIC) to collect and characterize virus specimens in their country and perform other analyses to inform the decisions of WHO and partners on the composition of the next year’s influenza vaccine. In many countries, virologic surveillance is complemented by more systematic influenza surveillance for severe acute respiratory illness (SARI) and influenza-like illness (ILI). A NIC in a country – or in a neighbouring country – can support evidence-based recommendations by providing data on the influenza disease burden and seasonality to the NITAG or other relevant national decision-making body. Involving these and other centers in NITAG discussions is key to bringing together all relevant information that is needed for the decision-making process. A list of NICS, WHO collaborating centers and essential regulatory laboratories (ERLS) can be found at the following links:  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (Accessed 14 Mai 2019)  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (Accessed 14 Mai 2019) 12 2. Establishing a policy to vaccinate health workers against seasonal influenza Considerations for decision-making In addition to the general considerations outlined in the WHO document “Principles and Consid- erations for Adding a Vaccine to a National Immunization Programme: from decision to implemen- tation and monitoring” referred to earlier, other key issues need to be considered when framing a policy for health worker vaccination. These are listed in Figure 2. Figure 2. Key considerations in establishing a vaccination policy for health workers Defining the public health objectives for seasonal influenza vaccination of health workers Characterizing and prioritizing the target groups for vaccination Framing the vaccination policy for seasonal influenza vaccination of health workers Choice of vaccine product, schedule and timing of vaccination Defining the monitoring and impact assessment objectives Defining the public health objectives for vaccination A critical first step in establishing a policy for vaccinating health workers with seasonal influenza vaccination would be to clearly define the aims and objectives of the vaccination programme. Such objectives may vary between countries but would underlie the prioritization of the health worker groups to be targeted for vaccination, set vaccination coverage targets, and provide guidance on the outcomes and scope for measuring the impact of vaccination. Vaccination of health workers serves multiple objectives. These may include: 1. Prevention of infection in the health workers themselves, averting associated morbidity. 2. Prevention of transmission of infection from health workers to vulnerable patients, including those at high risk of severe disease, complications, and death. 3. Sustaining health services by reducing health worker absenteeism, especially during seaso- nal and pandemic influenza outbreaks, which is a period of increased health care demand. 4. Promoting uptake of seasonal influenza vaccination among other target groups and enhance public trust for influenza vaccination. 5. Contributing to influenza pandemic preparedness by: a) Establishing a mechanism for rapidly immunizing health workers during a pandem- ic of influenza or epidemics of other vaccine-preventable diseases; 13 2. Establishing a policy to vaccinate health workers against seasonal influenza b) Contributing to increasing demand for influenza vaccine and thereby enhance pro- duction capacity to improve timely access to vaccine in case of a pandemic. c) Establishing or strengthening national capacity for vaccine regulation. One or more of the above could serve in defining the national objectives for health worker vac- cination. Important considerations when defining vaccination objectives include: 1. Review of the available data on the burden of disease among health workers and health care-related infections in patients and residents of long-term care facilities. National data, where available, complemented with representative regional or global data or esti- mates developed through the use of mathematical models may be used for this purpose. 2. The cost and impact of vaccination and availability of vaccine supply. 3. Review of the national pandemic preparedness plan and consideration of how health worker vaccination could contribute to pandemic preparedness. Economic analysis for establishing national policies While economic analysis is generally recommended prior to deciding on vaccination policies, lack of data for estimating and comparing the economic benefits of the different vaccination objectives may be a limiting factor, as will be the relatively small size of the target group. Toolbox 2 lists the available tools for conducting economic analysis for influenza vaccination. The costs and economic benefits of influenza vaccination of health workers are likely to depend on several factors, including the number and categories of health workers targeted, the incidence and severity of infection in the targeted health workers, their contribution to health care-associated transmission and the consequences of such infections. These factors may vary between different health facilities and will vary from one influenza season to another. A recent systematic review of the epidemiological and economic effects of seasonal influenza vaccination of health workers found that vaccination of health workers was cost-saving, based on crude estimates of absenteeism averted through vaccination (15). However, all the studies included Toolbox 2 Tools for the economic analysis of seasonal influenza vaccination Several tools are available for conducting economic analysis of influenza vaccination: WHO Guide for Stanardization of economic evaluations of immunization programmes (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf WHO Manual for Estimating the Economic Burden of Seasonal Influenza (WHO/IVB/16.04) ƥ http://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-eng.pdf Guidance on the economic evaluation of influenza vaccination (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. Establishing a policy to vaccinate health workers against seasonal influenza in this review were from high-income countries and took an employer perspective with a strong focus on absenteeism averted. Initial decisions could take vaccination costs and the impact of these costs to the immunization and health budgets into consideration, with the option of measuring cost-effectiveness post- introduction, if required. Further guidance on costing and budgeting of health worker influenza vaccination, with links to the available costing tools and resource materials on immunization financing are covered in the next section of this manual. Characterizing the target groups for vaccination Ideally all health workers should be targeted for vaccination, including those who may not come into direct contact with patients. Even if not in direct contact, health workers could potentially transmit infection acquired in the community to colleagues and, thereby, participate in the chain of health care-associated transmission of infection. However, in situations where there are resource constraints or limited or unstable vaccine supplies, categorization and prioritization of health workers for vaccination would be required. Prioritization of health workers would depend on as- sessment of risk of infection among the health workers themselves, transmission of infection to their patients and the consequences of health care-associated transmission. Even without financial resource constraints or limitations in vaccine supply, categorization of health workers would be useful when different policies are applied to different health worker cat- egories, based on risk assessment. For example, a mandatory vaccination policy may be applied to select categories of health workers who work with patients at high risk of severe influenza and who are more likely to accept mandatory vaccination, while vaccination may be voluntary for other categories (40, 41). Table 1 provides an example of risk categorization of health workers based on risk to themselves and of those for whom they care. Table 1. Risk categorization of health workers Risk category Health worker characteristics Very High • High risk health workers (see below) who work in clinical areas that admit patients at high risk for severe disease, complications, or death following influenza virus infection. These include intensive care units; transplant or oncology wards; antenatal, peri-natal or post- natal areas; and areas with elderly individuals, especially those with chronic diseases. High • Health workers who come into direct physical contact with patients, or with infectious materials, including surfaces or equipment contaminated by infectious materials. • Health workers who have contact which is not physical but that would allow the acquisi- tion or transmission of diseases that are spread at short range (1–2 m) by respiratory means, e.g., counsellors who have prolonged fact-to-face contact (42, 43). Low • Health workers who do not have contact with patients and whose normal work is not in a clinical area as defined above. 15 2. Establishing a policy to vaccinate health workers against seasonal influenza The very high-risk category is also the one where the evidence for risk and impact of vaccination is the strongest and where there is a stronger justification for vaccination (10). Those targeted for vaccination should also include part-time personnel, students, contractors, and volunteers at the health facility who have possible exposure to patients as health workers in the above categories. Risk categorization of individual health workers may be too complex and resource intensive in many settings, especially in low- and middle-income countries. In these situations, simpler ap- proaches wherein health worker categories are classified into only two groups, i.e. at high risk group (targeted for vaccination) and low risk groups (not targeted for vaccination) may be used. To ensure targeted use of influenza vaccination of health workers and to address potential uptake issues, national policies for health worker vaccination should outline: 1. The classification of different health worker categories based on assessment of risk. 2. The policy for vaccination for each category, e.g. whether vaccination is recommended and whether the recommendation is for mandatory or voluntary vaccination. 3. Strategies for managing non-compliant health workers and vaccine refusers. The following document provides an example of a framework for the assessment, classification and prioritization of health workers: The policy directive of the New South Wales Ministry of Health on the Occupational Assessment, Screening and Vaccination Against Specified Infectious Diseases https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (Accessed 14 Mai 2019) Framing an immunization policy for health workers Recommendations for health worker vaccination could propose either mandatory vaccination, voluntary vaccination or a mixed approach depending on the risks in the specific clinical setting. Multiple studies across many countries has demonstrated that voluntary vaccination of health workers, even when accompanied by considerable efforts to educate them on the benefits and risks of vaccination and implementation of measures for convenient access to vaccination, results in low coverage that seldomly exceeds 70%. On the other hand, mandatory vaccination has resulted in close to 100% uptake in institutions in the United States where it has been applied (44–46). However, mandatory vaccination has been difficult to implement in some countries because of acceptability issues and because the attributable benefits of health worker vaccination have been a subject of debate (32). Furthermore, it may not be feasible to implement mandatory vaccination policies in resource-constrained settings. 16 2. Establishing a policy to vaccinate health workers against seasonal influenza Voluntary vaccination One option for a vaccination policy for health workers is voluntary vaccination wherein vaccina- tion is recommended for health workers and offered but acceptance is voluntary or optional, i.e. not a requirement. Such programmes often have low vaccination coverage. Hence, with voluntary vaccination, extra efforts are required to optimize the uptake of vaccination. These could include: 1. A robust communications strategy, specifically tailored to the needs of different health worker categories, to explain the benefits and risks of vaccination, including the benefits to patients, especially those at high risk for severe disease. It needs to be emphasized that some of these patients, including the elderly and immunocompromised patients may not themselves respond to vaccination and that vaccination of health workers who come into contact with them is an important means for protecting them from infection, i.e. a professional ethics and moral argument 2. Convenient access to vaccination that is free of charge, and available to workers in every shift. Those who work during evening or night shifts might be provided access to vacci- nation either at the beginning or the end or their shifts or on designated days and times to cover their shift. 3. Other demand generation activities as outlined in the next section of this manual. A number of soft mandates may also help in increasing vaccination uptake, including: 1. Requirement of active declination of vaccination through signing of forms indicating their non-participation with or without stating the reasons for not accepting vaccination (see Annex 1 for a sample of an active declination form). 2. Reassignment of health workers who refuse vaccination to areas where they are less likely to come into contact with high risk patients, if this is feasible, or a requirement to wear masks when they do care for patients at high risk of influenza complications. 3. Use of face masks while in the health care facility. Mandatory vaccination Mandatory vaccination makes vaccination of health workers a legal or regulatory requirement while allowing some exemptions, e.g. medical contraindications. There is no WHO or other uniformly applied definition for mandatory vaccination. Infant and childhood immunization programmes described as mandatory can vary widely, especially in terms of the exemptions al- lowed and the penalties for non-compliance (47). Several experts have argued that mandatory immunization policies should be implemented against vaccine-preventable diseases that can be transmitted in the health-care setting and cause signifi- cant risk of morbidity or mortality to patients (20, 44, 48–50), as part of the professional ethics of a health care provider. It has also been argued that few ethical mandates in the practice of medicine surpass the obliga- tion to do no harm. Hence, ensuring conditions for safe patient care by minimizing transmission of communicable diseases represents a minimum ethical standard in health care practice set- tings (20). However, if mandatory vaccination policies are to be established, legal liability issues will need to be addressed and consideration given to providing compensation in the rare event of an adverse event. 17 2. Establishing a policy to vaccinate health workers against seasonal influenza Mandatory vaccination could either be part of the national policy or implemented at individual health facilities as part of institutional policies. The enactment of legislation endorsing mandatory vaccination would facilitate the implementation of such a policy. The Code of Colorado Regulations provides an example of a mandatory vaccination policy: Code of Colorado Regulations: Standards for Hospitals and Health Facilities 02 – General Licensure Standards (Part 10, Page 46) https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20CCR%20 1011-1%20Chap%2002 (Accessed 14 Mai 2019) Several countries with voluntary health worker vaccination policies for influenza do have man- datory vaccination of health workers for other infections such as measles and hepatitis B. These existing mandatory vaccination policies could be leveraged to also justify and establish mandatory vaccination policies for influenza, based on the protection afforded to the health worker as well as to vulnerable high-risk patients with whom they come into contact. Published recommendations for the ethical implementation of mandatory vaccination policies are reproduced in Toolbox 3. These recommendations may be taken into consideration in framing the national policy based on the feasibility of implementation. Toolbox 3 Recommendations for ethically implementing mandatory vaccination policies — There must be a compelling employee and patient safety problem that is clearly communicated to employees. — The least restrictive means should be used to achieve the safety objective. — There should be clear opt-out criteria for medical reasons. — Opt-out criteria based on personal views of the health worker should be allowed for current employ- ees only. These determinations must be made in a transparent and objective manner. — For those who do meet medical or other exclusion criteria, or who refuse vaccination, institutions should offer alternative means for achieving transmission control, including temporary leave during peak times, mandatory mask wearing, re-assignment to non-clinical areas (if feasible) or frequent testing during peak influenza seasons. — Prospective employees should be notified of the mandatory policy and recognize that failure to comply could be grounds for termination of employment. — The process should be transparent, with a broad range of health worker perspectives involved in policy development. — Institutions should support healthcare workers by implementing vaccination procedures that are free, easy to access, and include complete comprehensive coverage of adverse events. Particular attention should be paid to not burdening less advantaged members of the healthcare team. Source : Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 18 2. Establishing a policy to vaccinate health workers against seasonal influenza Mixed approach A mixed approach could also be adopted where a mandatory vaccination policy is applied to only certain categories of health workers likely to have direct physical contact with high-risk patients, while a voluntary vaccination policy is applied to the remaining categories. Such a policy should clearly and unambiguously define the health worker groups to whom or work areas where mandatory and voluntary vaccination policies apply. Consideration should be given to the human and financial resource implications of mandatory vaccination policies or of soft mandates. Integration with Occupational Health Policies Policies on seasonal influenza vaccination of health workers should be an integral part of the national occupational safety and health policies and regulations and the occupational safety and health management systems in health facilities. Inclusion of seasonal influenza vaccination in occupational health policies will allow access to free vaccination for all the targeted health workers as per the Occupational Safety and Health Convention, 1981, Article 215 and the recommendations in the World Health Organization and International Labour Organization (WHO-ILO) Global Framework for National Occupational Health Programmes for Health Workers.6 Such a policy would also put the responsibility for health worker vaccination on employers, rather than on the health workers alone. An integrated policy will enable greater coordination and collaboration between occupational health and immunization programmes and promote a joint approach to control of influenza in health facilities wherein vaccination is part of an infection control program that includes other in- fection measures to protect both health workers and patients. The occupational health programme at the national level and the management system at the facility level also provide an enabling environment to create a culture for infection prevention within the workplace that will stimulate the implementation of the vaccination programmes. Choice of vaccine product, schedule and timing of vaccination Choice of product WHO provides recommendations for the composition of influenza vaccines based on the infor- mation provided by the WHO Global Influenza Surveillance and Response System.7 Based on these recommendations, manufacturers formulate Northern Hemisphere (NH) and Southern Hemisphere (SH) vaccines, which are generally accessible around September (NH) and April 5 C155-Occupational Safety and Health Convention, 1981 (No. 155). https://www.ilo.org/dyn/normlex/en/f?p=NO RMLEXPUB:12100:0::NO::p12100_instrument_id:312300 (Accessed 14 Mai 2019) 6 The sectoral dimension of the ILO’s work : Review of sectoral initiatives on HIV and AIDS Appendix II – WHO- ILO WHO-ILO Global Framework for National Occupational Health Programmes for Health Workers. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/wcms_145837.pdf (Accessed 14 Mai 2019) 7 Influenza: vaccines. http://www.who.int/influenza/vaccines (Accessed 14 Mai 2019) 19 2. Establishing a policy to vaccinate health workers against seasonal influenza (SH) of each year, respectively. A list of WHO prequalified vaccines with information on their characteristics is published on the WHO website.8 Several different types of vaccines are available, including inactivated influenza vaccines (triva- lent and quadrivalent composition), live attenuated influenza vaccines, adjuvanted vaccine, and recombinant vaccine. Being a health worker per se does not lead to a preference for any vaccine type (subject to country-specific marketing authorizations).9 Health workers who care for severely immunocompromised persons should preferably receive inactivated influenza vaccine (IIV). Price and supply availability of each product are additional considerations in informing the choice of product. Timing of vaccination In countries where influenza infection is seasonal and seasonality patterns are defined, vaccina- tion should ideally be scheduled before the start of the influenza season, allowing approximately 14 days for induction of protective antibodies. Where delays in securing vaccine supply does not allow ideal timing to be met, vaccination should be initiated as soon as supplies are made available. Furthermore, individual health workers should never be refused vaccination at any time during the influenza season if they are late in seeking vaccination. In tropical and subtropical regions where several peaks may occur, vaccination should be timed before the main peak of transmission, using the most recent vaccine formulation available. Where no data on national influenza seasonality are available, countries could use data from epidemio- logically similar countries. Toolbox 4 provides published information of influenza seasonality in the tropics and subtropics. 8 WHO Prequalified Vaccines. https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 9 In some countries the quadrivalent vaccine is the product of choice. The WHO Strategic Advisory Group of Experts (SAGE) in immunization is currently reviewing the evidence and expected to make a recommendation in 2020. Toolbox 4 Guidance on choice of product and timing of seasonal influenza Seasonal influenza policy use and effectiveness in the tropics and subtropics. Geneva: World Health Organization; 2016. ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf (Accessed 14 Mai 2019) Influenza seasonality in the tropics and subtropics – when to vaccinate  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 (Accessed 14 Mai 2019) WHO list of prequalified vaccines  https://extranet.who.int/gavi/PQ_Web (Accessed 14 Mai 2019) 20 2. Establishing a policy to vaccinate health workers against seasonal influenza Defining monitoring and disease impact measurement objectives Ministries of Health would benefit from advice from the NITAG or other relevant advisory groups on the monitoring and impact measurement objectives so that they are taken into consideration during the planning and implementation of Monitoring and Evaluation (see chapter 4). NITAGs, with additional inputs from other relevant advisory groups and academia, should make recommendations on: 1. Monitoring and reporting of vaccination coverage, where possible by unit and type of care provided. 2. Measurement of vaccination impact, including: a) Target groups (health workers and or patients) for impact measurement. b) Outcomes to be monitored. e.g. influenza-like illness, laboratory-confirmed disease, severe disease, death, absenteeism, patient-related outcomes, etc. c) urveillance strategies for measuring impact; if at sentinel sites, the number and distribution of sites. d) Time periods for impact measurement, e.g. continued monitoring for an indefinite period or limited to a certain number of seasons. These measurements would be useful to the NITAG in reviewing the impact of vaccination and making recommendations for optimizing the impact and the cost-effectiveness of vaccination. Impact measurement could also generate empiric data to allow for estimation of cost-effectiveness of vaccination. It should be noted that any such measurements should include data collection for multiple seasons since the intensity of transmission, the severity of infection and vaccine effectiveness varies from one season to another. For further details, see the section on “Monitoring and evaluation” (chapter 4). 21 3. Planning and managing vaccination of health workers Planning for successful vaccine introduction Once a national vaccination policy has been established, it is necessary to convert the policy into operational plans that are fully costed, budgeted and include granular detail on the various pro- gramme components related to the introduction of a new vaccine into the national programme. The general concepts for addition of a new vaccine within the national immunization plans and the management of introduction are outlined in the WHO guide “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” (see Annex 3 for New Vaccine Introduction Plan Template). This section provides guidance on the additional elements specific to seasonal influenza vaccination of health workers. A vaccine introduction plan integrated into the annual plan for immunization along with the as- sociated checklists enable programme planners to ensure that all the necessary preparations are in place for the timely and efficient introduction of a vaccine into the national programme. For easy access the links to the relevant Annexes of the WHO guide are provided in Toolbox 5. In addition to the generic vaccine introduction checklist, the complementary checklist in Annex 2 con- tains a list of issues specific to health worker immunization. The elements of this checklist should be added (as appropriate) to the more generic checklist of activities. A sample health facility checklist is also provided (Annex 3) to guide the preparations for vaccination at the health facility level. Toolbox 5 Links to templates and checklists for a new vaccine introduction plan in “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” Generic template to guide the development of a national introduction plan Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc (Accessed 14 Mai 2019) New vaccine introduction checklist, activity list and timeline of WHO new vaccine introduction guide provides advice on planning budgeting, activities, distribution of roles and responsibilities and timelines ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_ resources/nvi_guidelines/Annex4_Instructions.pdf (Accessed 14 Mai 2019) Corresponding checklist tool Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_checklist_en.xls (Accessed 14 Mai 2019) 22 3. Planning and managing vaccination of health workers The timelines for planning and introduction should be included in the checklists and/or as a sepa- rate Gantt chart to ensure that all the activities are completed in their appropriate order to allow timely implementation of vaccination activities. Cross-reference should be made to the relevant sections of the occupational health strategies and plans at both the national and health facility level (see previous chapter on integration of health worker influenza policies into occupational health policies and requirements) to facilitate a more cohesive approach to planning and implementation. The WHO-ILO Global Framework for National Occupational Health Programme for Health Work- ers recommends that all countries identify the responsible person(s) for occupational health, both at the national and workplace levels. These focal points should be a part of the planning team at the national and health facility levels, respectively. Inclusion of the occupational health focal points would allow for an integrated approach to prevention of influenza in the work place where vaccina- tion forms part of a larger package of interventions for influenza control, including other infection control measures to protect both health workers and patients. The labour-management committees for occupational safety and health in health facilities, where they exist, can help in engaging the management and the workers’ representatives in the implementation of the vaccination programme. In addition to the national operational plans for the implementation of health worker vaccination, the national comprehensive multi-year plan (cMYP) for immunization should also be updated to include health worker immunization (Toolbox 6). Costing and financing As with the addition of any new vaccine to the national vaccination schedule, the vaccine and deliv- ery costs should be estimated and included in the annual and multi-year immunization budgets. In addition to the costs of vaccines and supplies (syringes, needles, safety boxes etc.), costs for vaccine delivery (including human resources), annual communications/education and demand generation efforts at the national and health facility level, and monitoring and reporting would need to be included in the costs. Several tools and resources are available that could be used or adapted for costing, budgeting and securing finances for health workers vaccination (see Toolbox 7). Since communications and other activities/interventions to enhance vaccination uptake will be required each year, these costs should be incorporated into the annual vaccine delivery costs and not considered only as a one-time activity. In addition to costing and budgeting for annual health worker influenza vaccination, it may also be necessary to advocate with those responsible for allocating funds for health programmes to ensure that financing for vaccination is sustained. Toolbox 8 provides links to resources for ad- vocacy for sustainable financing. Toolbox 6 WHO-UNICEF guidelines for multi-year planning WHO-UNICEF guidelines for developing a comprehensive multi-year plan (cMYP)  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. Planning and managing vaccination of health workers Toolbox 7 Resources for costing and financing cMYP Costing and Financing Tool  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (Accessed 14 Mai 2019) Immunization Costing Action Network (ICAN) Immunization Delivery Cost Catalogue This interactive website provides information on vaccine delivery costs across different low and middle- income countries through a variety of delivery strategies.  http://immunizationeconomics.org/ican-idcc (Accessed 14 Mai 2019) WHO Flu tool for planning and costing maternal influenza vaccination (new name: SIICT tool) This tool is being expanded to include all influenza risk groups, including health workers.  https://www.who.int/immunization/research/development/influenza_economics/ (Accessed 14 Mai 2019) Management Sciences for Health. Planning, costing and budgeting framework  http://www.msh.org/resources/planning-costing-and-budgeting-framework (Accessed 14 Mai 2019) Immunization financing: a resource guide for advocates, policy makers and program managers  https://immunizationeconomics.org/imfin (Accessed 14 Mai 2019) Toolbox 8 Resources for advocacy or sustainable financing Immunization advocacy library. Provides a number of tools and guides to convey the value of vaccination and the need to invest in vaccination  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/communication-and-advocacy/immunization-advocacy-library (Accessed 14 Mai 2019) Two specific documents in this library are of relevance: Workbook – advocacy for sustainable funding of immunization programmes  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/workbook-advocacy-for-sustainable-funding-of-immunization-programmes (Accessed 14 Mai 2019) How to prepare a financial profile of your immunization programme  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/how-to-prepare-a-financial-profile-of-your-immunization-programme (Accessed 14 Mai 2019) 24 3. Planning and managing vaccination of health workers Formative research to inform the planning process To prepare for the launch of influenza vaccination, several countries have used formative research to better understand the factors affecting uptake of seasonal influenza vaccination in health work- ers, including concerns, beliefs, information needs, cultural issues, and barriers to vaccination in order to develop a tailored plan to address them. Formative research can include both quantitative and qualitative research and, in some situations, might include a desk review. Quantitative research may be used to identify the main predictors for low uptake of vaccination among health workers and the main drivers for compliance with vaccina- tion recommendations. Data may be collected through surveys and questionnaires administered to health workers. The sample should ideally include sufficient representation from the different categories of health workers since the perceptions and reasons for low uptake may vary between health worker groups, e.g. between doctors and nurses (40), as well as from a sample of primary, secondary and tertiary health care facilities and from different work areas within these facilities. Qualitative research is insight research, based on understanding the audience’s point of view. It elucidates new issues and provides a more in-depth understanding of the complex issues underly- ing the uptake of vaccination. Qualitative research methods commonly include focus group dis- cussions and individual in-depth interviews. The WHO European Regional Office has published a step-by-step field guide to qualitative research for new vaccine introduction (see Toolbox 9). To be useful, formative research must be properly planned and well executed, failing which there is a risk of drawing wrong conclusions. This requires time and resources. While it is useful to conduct such research to inform the planning process, if time and resources do not permit, the lack of such research should not delay seasonal influenza vaccine introduction, unless attitudes of health workers are expected to be an issue that may significantly and adversely impact vaccine uptake. When data from formative research are not available, data from such studies conducted in other countries may be used to inform the planning process. While the reasons for low uptake of vac- cine are heterogenous, available evidence suggests that there is broad convergence on the major influencers of vaccine uptake among health workers, especially between countries within the same sub-region, which may be used in the initial planning process. The rapid appraisal of evidence (10) summarizes the key findings from the published literature and this evidence could be used, as applicable and appropriate, in the absence of locally conducted research. Data from the published literature may be complemented with information obtained through quantitative formative research using rapid surveys in a sample of health workers, ideally including different health worker categories. These surveys may be less resource intensive than qualitative formative research and could be completed without resulting in any delays to vaccine introduction. Annex 4 provides a sample questionnaire that may be used for such surveys. Toolbox 9 Field Guide for qualitative formative research A field guide to qualitative research for new vaccine introduction ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_VaccineIntro.pdf (Accessed 14 Mai 2019) 25 3. Planning and managing vaccination of health workers Further research may be conducted if vaccine uptake remains persistently low. The TIPflu tool is an important resource that may be used in such situations. Communication and vaccine acceptance Personal beliefs, cultural attitudes and perceptions about vaccination, in addition to official rec- ommendations, often guide the actions of many of those responsible for delivery of vaccines and many recipients (51, 52). This also holds true at the level of health workers. Available evidence shows that there are often misperceptions about vaccination as well as a gap between knowledge and behaviours (53, 54). Thus, simply improving knowledge about the risks and benefits of vac- cination among health workers has not proven to be sufficient to achieve optimal vaccination uptake. Achieving optimal vaccination coverage in health workers requires a multi-dimensional demand generation effort that is informed by a good understanding of the perception, motivators and barriers of vaccine acceptance among health workers, both as providers of vaccination and as recipients. Communications messages need to be tailored to address the needs of different health worker groups since available evidence suggests that perceptions about the need, risks and benefits of vaccination may vary between these groups (55). Current efforts mainly focus on preparing fact- based approaches to preparing communication messages. However, these types of messages may need to be framed according to the intended audiences based on their level of education and understanding. Taking the preferred cognitive decision-making styles of the individual groups to be targeted into account may have greater impact (54). Framing such messages will require an understanding of vaccine psychology and cognitive decision-making and may require engagement of communication specialists. A traditional approach to communications regarding immunization was through the use of mass media. However, research has shown that mass media alone and a one-way communication to health workers may not be sufficient to optimize the uptake of vaccination. Individual and group communications, in this instance at the health facility level, will be required to build trust and motivate health workers to accept vaccination. Including information on the relevance of vaccination of health workers (self-protection, responsi- bilities towards patients, pandemic preparedness in the case of influenza) in pre-service curricula for medical schools, nursing schools and other training institutions targeting health professionals may help to better establish health worker vaccination as an organizing concept and create better informed health worker generations providing immunization. Effective communications and demand generation activities are not a one-time event but need to be continuous and have the ability to quickly respond to the evolving perceptions about vac- cination and quell rumours and mis-perceptions. Front line vaccination staff responsible for health worker influenza vaccination will need to be trained to be able to deal with vaccine hesi- tant health workers as well as vocal vaccine deniers10 who may negatively impact the uptake of vaccination (56). 10 Vocal vaccine deniers are at the extreme end of the subgroup of vaccine refusers and actively advocate against vaccination, using science denialism techniques to justify their beliefs (reference 32). 26 3. Planning and managing vaccination of health workers A national vaccine communication working group that includes communications specialists will facilitate strong working relations with and collaboration among partners and allies, strengthen routine communication for immunization, and ensure well-coordinated and immediate response from all involved authorities to any safety event. Inclusion of members of the Occupational Safety and Health department and from professional societies in communicating with health workers contributes to building trust and improving acceptance of vaccination. Representation from health workers, professional associations, and unions and from the different health worker categories targeted for vaccination would ensure that the viewpoints of each health worker category is taken into consideration in developing tailored communication materials. A number of tools and guidance documents are available that can be used for developing an ef- fective communications strategy and for framing the communications messages that are specifi- cally tailored towards different health worker groups, including a template terms of reference for a vaccine communication working groups (Toolbox 10). In addition to vaccination, the information and education and communication materials should also include information on other infection control measures to reduce transmission of influenza in the work place and steps to be taken should a health worker develop an influenza like illness. Communications at the health facility level Effective communications at the health facility level will benefit from a dedicated and well-trained team to deliver the communications strategy at the health facility level. Such a team should be established and trained well in advance of the planned introduction date and should include rep- resentation from the main health worker categories in the facility and an advocacy and commu- nications specialist, if one is available. Ideally, communications for seasonal influenza vaccination should be part of a broader communications effort on control of influenza in health care settings. Communication activities at the health facility level should begin sufficiently in advance of the planned date for the onset of vaccination, especially in countries introducing vaccination for the Toolbox 10 Tools and guides for developing communications strategy and messages Vaccination and trust library  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/vaccination-and-trust (Accessed 14 Mai 2019) New vaccine introduction: checklist for planning communications and advocacy (2017)  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2017/new-vaccine-introduction-checklist-for-planning-communication-and-advo- cacy-2017 (Accessed 14 Mai 2019) Template terms of reference for a vaccine communication working group ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_Sup- portDoc_TOR_Proof7.pdf (Accessed 14 Mai 2019) 27 3. Planning and managing vaccination of health workers first time. Initial activities could include the display of information posters at all the relevant areas of the health facility. The manager of the health facility and the heads of all the relevant depart- ments and clinical areas should be sent a formal communication along with sufficient copies of all information materials about vaccination to be displayed in each clinical area. Where possible, relevant information on influenza vaccination could also be sent to all health workers using e-mail and/or local social media networks. In-person group briefings should complement the display and distribution of information materi- als. Existing staff meetings could be leveraged to conduct these briefings. The number of in-person group briefings will depend on the size of the health facility and the number of targeted health workers. Larger health facilities (e.g. secondary and tertiary level health facilities) may need to conduct several briefing sessions to cover all the targeted health workers. Since communications messages may differ between different categories of health workers, consideration should be given to holding separate briefing sessions for each health worker category using information and mate- rials relevant to them. To allow better communication and enough time for questions from health workers to be addressed, the size of each group should be designed to allow sufficient opportunity for interaction. Provision should be made to facilitate the participation of health workers working night shifts. The schedule for the briefings should be widely publicized within the health facility and reminders sent to promote high attendance. In-person meetings should: 1. Explain why vaccination is important for themselves, their patients and families and for wider society – with a particular focus on severe outcomes associated with influenza; 2. Inform health workers about national policies; 3. Provide information on the safety of seasonal influenza vaccines; 4. Provide information on the timing and venue(s) for vaccination; 5. Explain potential consequences of non-vaccination; 6. Allow sufficient time for questions. Consideration may be given to establishing a telephone hotline or web-based system to address questions from individual health workers. In addition to the display of posters and other com- munications materials, the use of visible and removable stickers that can be displayed by health workers who have been vaccinated (e.g. on their ID badges) would serve as a visible reminder to their colleagues who have not been vaccinated. In addition, text messages, generic e-mails and social media platforms could be used to provide periodic reminders on vaccination. Demand Generation at the Health Facility Level In addition to communication strategies, behavioural science-based demand generation efforts can be implemented prior to the availability of vaccines in order to prime health workers for vac- cination. These nudge-based interventions work by creating an environment that can influence behaviour in a predictable way but does not eliminate choice (57), and have proven effective in a variety of healthcare settings (58). These interventions can narrow the gap between intention and actual behaviour, which is usually caused by individuals or health workers forgetting to get 28 3. Planning and managing vaccination of health workers their vaccination or through barriers to convenient vaccination. Additionally, these interventions frequently can be implemented for relatively low cost (59). The figure below (Figure 3), adapted from the Nuffield Council on Bioethics, demonstrates the hierarchy of nudge-based interventions to improve vaccine uptake (60). Nudges lower on the ladder are less aggressive but can still have a measurable impact. By providing health-facility vaccination rate feedback, a process used in the United States to improve uptake of childhood vaccination, progress in health facilities can be monitored, and provide motivation to health workers to improve their own vaccination practices (61). Figure 3. Ladder of nudge interventions to increase vaccination rates Guide choice through default options Automatically set up appointment for vaccination unless individual opts out Enable choice Increase options to obtain vaccination such as at workplace or near home Prompt implementation intentions Ask individual to precommit to a time and location to obtain vaccination Frame information Deliver social comparsion feedback on vaccination rate among peers or healthier individuals Provide information Offer education on benefits of vaccination to self ant others Do nothing Simply monitor vaccination rates Source: Patel MS (ref. 32) Reminders to individuals to vaccinate can serve as a nudge, notifying individuals when they are due for a vaccine and prompting them to come to the vaccination site to receive the vaccine. These can be paper-based or mobile phone text message-based and have proven effective (62). In the health facility, health worker reminders through an immunization data collection tool (whether paper- or electronic-based) can help improve the delivery of vaccines by health workers (59). A successful nudge-based strategy to reduce barriers to convenient vaccination and enable choice is standing orders. Standing orders are a policy put in place in a health facility that permits non- physician health workers to administer vaccines without a prescription or explicit order from a physician and have proven one of the most effective strategies for improving vaccine uptake when applicable (63). All of these strategies can be combined with communication approaches to create demand in the community. 29 3. Planning and managing vaccination of health workers Going beyond nudges Nudges are a favoured method for influencing demand since they preserve choice and are not coercive. However, some experts have argued that when nudges fail to achieve optimal uptake of vaccination in health workers, and this failure results in harm to their patients, decision-makers should consider adopting more forceful policies (64). This is not to imply that when nudges fail one should immediately go to measures that eliminate choice. There are interventions that exist across a continuum leading up to restriction of choice. The use of “soft mandates” provide examples of actions across this continuum. Case study: The «flulapalooza» campaign to increase uptake of seasonal influenza vaccination in health workers Vanderbilt University Medical Center in Nashville, Tennessee, in the United States, employs over 24,000 health workers. Since 2011, the cornerstone of its seasonal influenza vaccination campaign for health workers has been its mass influenza vaccination event, playfully named “flulapalooza”. This event vac- cinates, on average, over 14,000 people in a single day. The closed point-of-dispensing (c-pod) design has been evaluated and refined over time to substantially increase administration efficiency and cover- age rates. The event emphasizes a festive atmosphere while practicing critical pandemic vaccination skills among hospital occupational health and administrative leadership. This event achieves high coverage among categories of health workers who are present that day; how- ever, due to the structure of nursing shifts and ward responsibilities at the institution, less than 30% of nursing staff are typically vaccinated at the event. Thus, the medical center combines flulapalooza with ward visits, mobile carts and other strategies to achieve its annual target of greater than 90% overall health worker vaccine coverage. Notably, although institutional policy gradually increased the difficulty of declination and eventually included disciplinary action in response for unexcused failure to vacci- nate, it is notable that 92% coverage had been achieved in seasons before disciplinary policies were in place. Details of event design, workflow diagrams and practical, specific lessons learned are described in a publication available online. Source: Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168–76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 Annex 5 provides a table that lists the different communications and demand creation approaches, along with an indication of the effort required to implement the approach and the expected impact. Vaccine procurement and supply chain management Vaccine procurement Accessing vaccines at optimal prices requires a good understanding of procurement mechanisms and systems, vaccine market dynamics, and the elements of vaccine pricing. Procurement starts with forecasting vaccine demand, followed by tendering, contracting and procurement processes. The tools and resources for vaccine procurement are listed in Toolbox 11. Procurement of seasonal influenza vaccination may have some unique features and may require regulatory approvals and advance purchase commitments with specific manufacturers shortly after the publication of the 30 3. Planning and managing vaccination of health workers WHO recommendations on the seasonal vaccine formulation (in February for the northern and in September for the southern hemisphere) and well in advance of the influenza season. Selection of the vaccine product and presentation As with any other vaccine, the choice of product and presentation will depend on multiple fac- tors including supply availability, price, ease of use, storage and transport requirements, vaccine wastage and missed opportunities for vaccination (e.g. postponing vaccination due to reluctance to open a 10-dose vial for only one or two individuals). The choice of vial size should be based on the number of doses to be delivered at each vaccination point and the number of sessions to be held at each point. The currently prequalified injectable seasonal influenza vaccines are available in single dose pre-filled syringes and in single and 10-dose vials. All the 10-dose vial presentations contain thiomersal as a preservative. However, it may be noted that not all the currently available prequalified products in 10-dose vials have market authorization for storage up to 28 days once opened, and not all products have a vaccine vial monitor (VVM). These aspects should be taken into consideration in selecting the product and presentation. The specifications of each product and presentation should be checked to confirm that they meet the requirements of the programme before a procurement order is placed. Information on WHO prequalified vaccines may be found on the WHO website (see Toolbox 11). Forecasting vaccine demand is an important first step in vaccine procurement. Forecasting demand requires an estimate of the number of health workers who will be targeted for vaccination, the expected vaccination coverage, and an estimate of vaccine wastage. Ideally health workers in both public and private facilities would be targeted for vaccination. This process of estimating the size of the target population for health workers vaccination is likely to be more complex than for other vaccines targeting the general populations. The data to derive such estimates may also be more difficult to find, especially in low and middle-income countries. Toolbox 12 provides resources for estimating the size of the health work force and those that need to be targeted for vaccination. Toolbox 11 Vaccine procurement tools Procurement mechanisms and systems  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_systems (Accessed 14 Mai 2019) Vaccine product, price and procurement (V3P) web platform  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (Accessed 14 Mai 2019) Vaccine market  http://www.who.int/immunization/programmes_systems/procurement/market (Accessed 14 Mai 2019) List of WHO prequalified seasonal influenza vaccines  https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 31 3. Planning and managing vaccination of health workers The global health workforce databases may not carry information on all the health workers catego- ries that may be targeted for vaccination. For example, global databases may only have estimates of the numbers of doctors, nurses and midwives, but not other health worker categories. In such instances, rough estimates could be made based on ratios of those health workers for whom data are not available to those where data are available (e.g. ratio of physicians to laboratory workers). These ratios could be quickly obtained through a survey of a small representative sample (e.g. tertiary, secondary and primary) of health facilities. Since each health facility may be required to prepare beneficiary lists with the names of those targeted for vaccination, for tracking vaccination delivery, and for maintaining records of those vaccinated; the initial demand forecasts could be refined in subsequent years using data from these beneficiary lists and vaccination records. Logistics and cold chain management The handling of influenza vaccine is similar to most other vaccines in the national immunization programmes. It needs to be stored at 2–8 degrees Celsius. Since vaccination of health workers is expected to occur annually during a relatively short window period each year before the onset of the influenza season, a plan needs to be developed to ensure storage and transport of vaccine at the different levels involved in the supply chain during the window period chosen for vaccina- tion. Tools and resources for vaccine forecasting, management and logistics are available on the WHO website (Toolbox 13). The cold chain volume requirement for each WHO prequalified product and presentation are available on the WHO website (please select the vaccine type and click on the links for each individual product and presentation to obtain this information).11 At the health facility level, the focal point responsible for health worker vaccination should ensure that the vaccine doses required in the facility are included in the demand forecast and that sufficient storage space to accommodate the required vaccine doses is available prior to the anticipated date of vaccine arrival at the health facility. 11 WHO prequalified vaccines. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 Toolbox 12 Resources for estimating target population size Global Health Observatory: Health Workforce  http://www.who.int/gho/health_workforce Global Health Workforce Statistics database. Geneva: World Health Organization.  http://www.who.int/hrh/statistics/hwfstats Counting health workers: definitions, data, methods and global results. Geneva: World Health Organization; 2007. ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf Classifying health workers: mapping occupations to the international standard classification ƥ https://www.who.int/hrh/statistics/Health_workers_classification.pdf 32 3. Planning and managing vaccination of health workers Vaccination of health workers Vaccination of health workers should ideally take place at the health facilities where the targeted health workers normally work to ensure convenient access to vaccination. Case study: Using an immunization champion to enhance uptake of influenza vaccination in health workers in Oman Oman has a universal free-of-charge, integrated health care system, which includes influenza vaccina- tion of health workers. Oman is one of the few high-income countries in the WHO Eastern Mediterranean Region (EMR) that has achieved high influenza coverage among health workers (>80%). This was made possible by immunization champions. The minister of health in Oman is passionate about protecting the health of health workers and is at the forefront in taking the first influenza seasonal vaccine. As the patron of health worker community and an influential person in the country, this action has reinforced the importance of vaccination and continually helps promote influenza immunization programs. He has also been personally involved in the communication of vaccination messages to the health worker community. Every health facility should prepare a health facility plan for implementing seasonal influenza vac- cination of health workers well ahead of the influenza season. These plans should include measures to enable convenient access to vaccination for health workers in every shift. Different options may need to be determined at the health facility level to cover health workers during night shifts with- out resorting to 24-hour vaccination services, for example insuring the availability of vaccination just before or after a shift change. A vaccination team should be established at the level of the health facility to coordinate the vac- cination activities and optimize uptake under the overall supervision of the head of the facility. One person should be designated as the team leader. This could be either the occupational safety and health focal points, or the persons responsible for immunization activities in the health facil- ity. In larger facilities the staff medical services may be tasked with this activity. Experience from some organizations and health facilities have shown that using “vaccination champions” from among the health workers may contribute to improving vaccination uptake among their peers. In Toolbox 13 Vaccine management and support resources The resources that can assist programme managers in supply chain and logistics support planning may be found at the WHO website at:  http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ index4.html (Accessed 14 Mai 2019) Overview of technologies for the treatment of infectious and sharp waste from health care facilities ƥ https://apps.who.int/iris/bitstream/handle/10665/328146/9789241516228-eng.pdf (Accessed 14 Mai 2019) 33 3. Planning and managing vaccination of health workers some countries, a mobile team that goes to each clinical area in the health facility and provides vaccination has been successfully used. Training of the vaccination team Training workshops for health facility vaccination focal points should be conducted to conduct training in developing a health facility plan and in implementing and monitoring vaccination activities. A standardized agenda, curriculum, resource documents, checklists and model forms for recording data, as required, should be created at the national level for use in these workshops so that training is uniform across all health facilities. To further ensure uniform training, the workshops could be conducted using teams of trainers who are themselves trained centrally and are assigned to each region/subregion, using a cascade training approach. Short training videos may be used to achieve uniformity in content in the training. Web-based self-learning modules may be considered for those who were unable to attend the training sessions. The health facility vaccination team should have the capacity to classify health worker groups (see chapter 2 for sample risk categorization of health workers) and establish a list of health workers eligible for vaccination, with their designations, and areas of work. Where different vaccination policies apply to different risk categories, either separate lists should be created, or mechanisms established to easily identify and monitor the vaccination status of those in each category. The beneficiary lists should be developed sufficiently in advance of the start of vaccination activities and the relevant health workers informed on the need for vaccination. In addition to health workers employed at the health facility, provision may be made to include health workers in smaller facilities within their catchment area, including private facilities, as per the national policy, should vaccination not be available at all facilities. A mechanism for defaulter tracking and for sending reminders should be established at each health facility. For health workers who come into contact with high risk patients, (e.g. those in organ transplant, oncology, intensive care or perinatal units), the supervisors of those who have not been vaccinated before the start of the influenza season may need to be informed (local confidentiality norms permitting) so that they can reinforce the written reminders or, in case of refusals, get active declination forms signed and institute infection control measures applicable to active refusals, e.g. reassignment of duties, wearing of masks etc. as per the established national of health facility policy. 34 4. Monitoring and evaluation All countries should have a mechanism in place to monitor vaccine coverage as well as adverse events following immunization (AEFI) from the health facility to the national level and conduct at least one influenza vaccine post-introduction evaluation. However, measuring vaccine accep- tance and vaccine effectiveness or impact will be necessary and feasible only in a setting where immunization targets are not reached and if funding is available. Developing and updating information systems Appropriate forms and data entry modules for recording and reporting vaccination data at the health facility level and processes for reporting the data should be established. In developing tools and guidance for data collection, the need to include both public and private health systems should be considered. This may require mapping of existing health information systems and immunization data collection instruments as well as guidance on how these systems may be used to collect data on seasonal immunization of health workers. Data collection systems may vary across health facilities depending on the size and available infra- structure of the facility. However, each health facility must be provided with a standardized data reporting form to ensure that the data required for reporting to the national level are collected, irrespective of the data recording system used. This could include the name of the health worker, the health worker category, area of work, risk category, date of vaccination, the vaccine product and lot number. In developing the data reporting form, the advice provided by the NITAG on monitoring and impact assessment should be considered. All data collection systems, whether paper-based or electronic should have the capability for defaulter tracking and a system for generating and sending out reminders to defaulters. When using such reminder systems, protecting the confidentiality of data on the health and vaccination status of health workers will be critical and access to the data should be restricted to the facility vaccination coordinator. Coverage monitoring Several approaches for estimating health worker influenza vaccine coverage are available. The timing of such coverage measurement is important and should be coordinated with the timing of vaccination in the country. Given that influenza vaccine is usually administered in seasonal campaigns, frequent reporting (e.g. monthly) is recommended. Ideally, assessments should be done at the end of the season, when complete data are available and assessed and data cleaned for any inconsistencies. 35 4. Monitoring and evaluation Health facility registries Information on influenza vaccines administered to health workers should be included in existing records maintained as part of occupational health requirements and in vaccination registers as part of institutional monitoring mechanisms. Careful assessment of data discrepancies is requi- red if reporting is done from multiple sources, and data protection issues should be judiciously considered. The minimum set of data will include the number of people receiving influenza vac- cination during each annual season, the total number of targeted health workers, and the derived vaccination coverage (%). Often both numerator and denominator data can be obtained from the departments of occupational health at health facilities. For establishing more detailed denomina- tors, nominal health worker records e.g. based on payrolls can be used as a first step. A beneficiary list of those targeted for influenza vaccination can be selected from these records by applying criteria related to the health worker’s risk of infection or of transmitting the infection to those for whom they care (see section on “Characterizing the target groups for vaccination” and table 1). Depending on the capacity of the reporting system and program, this could include tallying numbers by health worker category and risk profile to allow coverage estimates by subcategories, such as doctors, nurses, laboratory workers, or staff working in Intensive Care Units or general (e.g. medicine or paediatric) wards, etc. If a vaccination registry does not exist, a crude estimate of coverage among health workers could be calculated by using the number of vaccine doses distributed to each facility minus the number of vaccine doses returned (unused) divided by the estimated number of health workers targeted for vaccination at the facility. A similar, rather imprecise method to assess coverage at the national level would be to use the regularly compiled data on health workers (as reported to WHO) to estimate the denominator (see Toolbox 12), as used for the vaccine demand forecast, and the overall number of vaccines adminis- tered as the numerator. This approach should only be used as a last resort where none of the other methods described are feasible. Administrative data If vaccines are provided free to health workers with government, national insurance system or employers bearing the costs, there may be regular, sometimes mandatory, reporting on the number of health workers who have received vaccinations at the institutional level. Such administrative data may be available from well-documented national vaccine programmes or from health insu- rance records. Surveys Surveys to obtain data on vaccinations and other interventions should be performed every 3 to 5 years and allow the identification of heterogeneity of coverage at the subnational level, important for the necessary adaptation of immunization practices. A representative sample of health workers can be selected though a stratified random sampling approach from national registries of health workers (e.g. professional organizations). If such registries are not available, a two-stage selection of health facilities and of health workers in these facilities can be done. If contact information is available, standardized interviews could be done face-to-face, by phone or via internet-based pla- tforms. Without such information, online survey links could be provided to all health workers in the selected facilities with an invitation to access the survey platform using their mobile phones or personal computers. It should be noted that when using this approach, self-reporting of vacci- nation may lead to overreporting.12 12 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394773/ 36 4. Monitoring and evaluation In all of these approaches to estimate coverage it will be important to specify the categories of health workers, e.g. those with or without direct patient contact, the latter including students, trainees, volunteers, maintenance, information technology, food service staff etc., who have been included in the numerators and denominators. It is also important to specify if part-time personnel working during the influenza season were included in the coverage estimates. Where individuals for whom vaccination is not recommended are vaccinated, such as back office workers or staff relatives, etc., care must be taken not to count these in estimating vaccination coverage. Refusal and completion rates of surveys will need to be monitored and adjustments for possible selection biases made in the analysis. At times, influenza vaccination programs may merely set absolute number targets of health work- ers to be vaccinated, based on the number of vaccines procured and available in a specific area or location. Such an approach, while followed in some countries, will not allow the proper estimation of coverage rates, including coverage by risk category, or comparisons over time, which will be important for interpreting any data on impact. It will also not enable identification of determinants of vaccination or of refusers. If available, data as well as methods used to estimate vaccination coverage for other regular health worker vaccinations should be accessed, e.g. for hepatitis B, measles, polio, pertussis or tetanus vaccines. It must be noted, however, that these vaccines are not provided on an annual basis and will often only be checked at entry to service. Toolbox 14 lists available tools for collecting and reporting immunization data and for estimating coverage. Toolbox 14 Monitoring and evaluation tools and indicators Immunization in practice series, module 7: Monitoring and using your data. Describes how to collect and report data and how to monitor immunization performance. ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf (Accessed 14 Mai 2019) Training for mid-level managers. Module 7: The EPI coverage survey (Document WHO/IVB/08.07). Geneva: World Health Organization; 2008. Provides a step-by-step walkthrough, including relevant guidance and tools, to plan and conduct a coverage survey of a newly introduced vaccine. ƥ http://who.int/immunization/documents/MLM_module7.pdf (Accessed 14 Mai 2019) WHO reference for estimating influenza vaccination coverage among target groups. Outlines different methodologies that can be used to estimate national influenza vaccine coverage among high-risk groups targeted for vaccination. ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing-influenza- vaccination-coverage-target-groups.pdf (Accessed 14 Mai 2019) 37 4. Monitoring and evaluation AEFI monitoring As for any vaccine and target group, a functioning AEFI monitoring system is a basic requirement, since knowledge gaps and misperceptions about influenza vaccine safety among health workers are consistently identified in in the literature. The system utilized to monitor and investigate possible AEFIs when delivering influenza vaccine to health workers should ideally be integrated into existing AEFI surveillance systems in line with national regulations for the monitoring of vaccine safety. The NIP or other departments responsible for health worker influenza vaccination (e.g. occupational health) should work with the National Regulatory Authority to define roles and responsibilities in vaccine safety monitor- ing. In countries using influenza vaccines for the first time, it could be conceivable to intensify AEFI surveillance during the first year of influenza vaccine introduction in order to provide quick feedback to stakeholders to help assure them of the safety of the vaccines in use. A functioning AEFI monitoring system will detect and elucidate problems with vaccines, which could be due to the product itself, its quality, or errors in the administration of the vaccines. All vaccine recipients reported as having an event (including minor events) perceived to be related to the influenza vaccine should be reported to the AEFI surveillance system using standard report- ing forms (see Toolbox 15). Given adequate reporting, the monitoring system should be able to evaluate the observed rate of reactions to influenza vaccine and compare this to the expected rates reported in the literature. For serious AEFIs, causality will normally be assessed by a group of experts. Importantly, and as for any vaccine, such a system needs to be able to identify a previously unknown or unexpected vaccine reaction that should be investigated in more depth. Care must be taken to ensure that coincidental events are not mistaken for vaccine reactions. Toolbox 15 AEFI-related information sources AEFI core variables, including data on case, vaccine, event and reporter ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_Dec2015.pdf (Accessed 14 Mai 2019) Sample form for AEFI recording with detailed description of reporting elements ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (Accessed 14 Mai 2019) Causality assessment of an AEFI: Provides the detailed methodology in a four-step process with access to a related software tool  http://www.who.int/vaccine_safety/publications/gvs_aefi/ (Accessed 14 Mai 2019) Vaccine safety training resources providing access to vaccine and pharmacovigilance training packages  http://www.who.int/vaccine_safety/initiative/tech_support/ (Accessed 14 Mai 2019) Information sheet: observed rate of vaccine reactions – influenza vaccines ƥ https://www.who.int/vaccine_safety/initiative/tools/Influenza_Vaccine_rates_information_sheet.pdf (Accessed 14 Mai 2019) 38 4. Monitoring and evaluation By establishing and enhancing AEFI systems, influenza vaccination can also be used to further improve the awareness of overall immunization safety in the health worker community. Monitoring and evaluation of vaccine acceptance Key determinants of vaccine acceptance among health workers have been investigated and include the desire for self-protection and to protect family and patients. (see also section on communica- tion and vaccine acceptance). As part of an initial situation analysis of health worker influenza vaccination programmes, available information on policy, programmes and practices, the factors affecting acceptance and participa- tion, and the influence of media and communications can be investigated through key informant interviews, or participatory workshops. Results of such an analysis could then be used to inform additional communication strategies addressing the identified concerns in a targeted manner. Other determinants can be explored through formative research. Both qualitative and quantita- tive research methods can be used to evaluate changes in health workers’ knowledge, attitudes, practices and behaviours. Behavioural determinants that differentiate health workers who get vaccinated from those who do not should be assessed regularly. Understanding the reasons and reasoning behind health workers’ attitudes towards annual flu vaccination is useful for the de- velopment of communications messages and products. Involving health workers in behavioural research related to their perceptions, beliefs, emotions and potential conflicts also provides an opportunity for the health worker community to be engaged in the approach, which can result in greater acceptance of the vaccination program. Vaccine impact monitoring After an influenza vaccine has been introduced in a population, additional studies may help in evaluating the impact of the immunization program. However, WHO does not recommend that vaccine impact or effectiveness studies be conducted by all countries with influenza vaccination programs, given their complexity and expense. A number of research networks worldwide conduct such studies and results can be expected to be applicable in Toolbox 16 Tools to assess vaccine acceptance among health workers TIP-FLU tool. Provides an approach and tools grounded in behavior change theories and health programme planning models to tailor seasonal influenza vaccination to the needs and attitudes of frontline HWs.  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) TIP FLU case study Montenegro. Provides a practical example of the use of the TIP FLU tool. ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization-Pro- grammes-Seasonal-Influenza-TIP-FLU.pdf (Accessed 14 Mai 2019) 39 4. Monitoring and evaluation other settings with similar influenza epidemiology and vaccination programs. The decision to carry out such studies should therefore be based on the need for country-specific estimates and on the local capacity to conduct such rigorous studies. If studies are not appropriately designed with adequate sampling of different health worker categories, there is a risk of arriving at wrong conclusions. Before-after studies to demonstrate vaccine effectiveness are not advised for influenza, given that influenza vaccine effectiveness for preventing influenza symptoms in seasonal influenza epi- demics display considerable heterogeneity.13 Studies to evaluate the impact of seasonal influenza vaccination in health workers can be even more complex, given the varying risk of infection and transmission to patients among different categories of health workers. In health workers, a general reduction in absenteeism or, if available, reduction in influenza-asso- ciated absenteeism is often used as a surrogate indicator for the impact of an influenza vaccination programme. For this, health facility institutional monitoring would need to include disease rates in health workers, and a measure of sickness absence. Where possible, reporting days of absenteeism due to influenza-like illness (ILI) (or respiratory infections) should be recorded. This will include self-reported ILI with or without virological confirmation. Other non-specific outcomes include severe acute respiratory infection (SARI) and all-cause pneumonia requiring hospitalization. It is important to note that all these clinical syndromes include various other respiratory pathogens against which influenza vaccine does not protect. If such assessments are done, they should ide- ally cover multiple seasons, since impact can vary substantially by season, else such studies will be quite difficult to interpret. Laboratory-confirmed outcomes (e.g. by RT-PCR and other molecular diagnostic tests) improve the specificity of influenza disease classification. Where possible, establishment of sentinel sites with such capacity could be considered for collecting samples from health workers for laboratory confirmation. In these sites, vaccine effectiveness could be assessed using a case-control design and comparing vaccine coverage in laboratory-confirmed versus test-negative cases, if vaccine coverage is sufficiently high. Any of these approaches require sophisticated laboratory capacity which is not available everywhere. The screening method is a study design which could also be used for health worker vaccine im- pact assessment: it uses individual-level data on vaccination history from cases and data on vac- cination coverage in the health worker population from which the cases came. However, such a study requires accurate information on the vaccination status of the cases and of health worker vaccination coverage. Given the indication that annual influenza vaccination for health workers could reduce illness among the patients they care for, studies can be designed to evaluate the effect of health worker influenza vaccination on mortality, hospitalization, and influenza cases in patients of healthcare facilities. Several research approaches have been used in this context such as randomized trials or case-control approaches. Given the complexity of study designs, the conduct of such studies should be limited to research institutions that have the capacity and experience to conduct such studies. Economic assessments and cost-effectiveness evaluations may be considered once sufficient cost and impact data are available following influenza vaccine introduction. WHO provides a number of relevant resource documents, which are being further developed to specifically estimate vaccine 13 Evaluation of influenza vaccine effectiveness: A guide to the design and interpretation of observational studies, WHO 2017. 40 4. Monitoring and evaluation introduction costs for health worker vaccination (Toolbox 17; see also Toolbox 2). Relevant data are not easily available everywhere and assessments can be difficult to perform, given the limited size of the group of health workers. Post-introduction evaluation National Immunization Program Reviews routinely assess the use of specific vaccines about every 5 years following a new vaccine introduction. Such NIP Reviews should include relevant items to identify possible programmatic areas related to the new vaccine use. As needed in-between NIP Reviews, a specific influenza-related Post-Introduction Evaluation (I- PIE) tool may be performed after the first or second influenza immunization season. The I-PIE package (Toolbox 18) includes a number of tools to support the planning and conduct of the evaluation, including standard questionnaires and data collection forms in paper or electronic format as well as reporting templates together with instructions on how to perform the I-PIE in a cost-efficient manner. These tools will need to be adapted to the specific country context and to the specifics of the vaccine formulation and presentations. The I-PIE is performed at all levels of the health system and includes observation of practices at the points of vaccine administration, vaccine storage areas as well as data and record reviews. An I-PIE can thus provide a more immediate approach to assess the programmatic challenges and impact of influenza vaccine use, and to compare results across countries, enabling them to share and learn from each other’s experiences. Toolbox 17 Influenza in health workers: Study methodologies Evaluation of flu vaccine effectiveness 2017. Provides detailed information for researchers who design observational influenza vaccine effectiveness studies and for public health scientists who interpret and apply the results of these studies. An annex will address the effectiveness of influenza vaccine in health workers. ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (Accessed 14 Mai 2019) Manual for estimating disease burden associated with seasonal influenza. Provides step-by-step approach to estimate influenza disease burden in the general population as well as those with specific conditions who are vulnerable to severe disease.  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (Accessed 14 Mai 2019) Toolbox 18 Influenza post-introduction evaluation tools I-PIE tool with instructions and recording and reporting templates  https://www.who.int/immunization/research/development/ipie_influenza_post_introduction_ evaluation (Accessed 14 Mai 2019) 41 References [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination accep- tance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during preg- nancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are count- ries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evi- dence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare wor- kers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-ana- lysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13(6):e0198685. 42 [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care wor- kers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epide- miol. 2002; 23(10):615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influen- za-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kin- dergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial out- break of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a mul- ti-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 43 [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vacci- nation of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12(1):e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vac- cination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection cont- rol and hospital epidemiology. 1998; 19(7):518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward man- datory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62(1):1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 44 [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing inter- vention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccination: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36(2):196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, ado- lescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertive- ness. N Engl J Med. 2019 Jan24; 380(4):309–11. 45 Annex 1. Sample non-participation form This form is to be used in cases of voluntary vaccination where health workers in the very high or high-risk categories who decline to participate in assessment, screening and vaccination in accordance with the national policy. Completion of the form is particularly important where failure to get vaccinated will result in reassign- ment or require the use of protective measures to protect patients as specified in the national policy. Non-participation in vaccination 1. I have read and understood the policy directive regarding seasonal influenza vaccination of health workers. 2. I decline to participate in vaccination against influenza. 3. I am aware of the potential risks to myself and/or others that my non-participation in vaccination may pose. 4. I am aware that my non-participation may result in my being reassigned to a non-high-risk area or in other requirements to protect others with whom I may come in contact, as per the national policy. 5. The reason for my non-participation is: Refusal to sign In circumstances where the health worker refuses to sign this form, it should be noted on the form and the health worker should be notified of consequences, if any, as per the policy. Name of health worker: Date of birth: Health service/ facility: Work area: Signature: Date: OFFICE USE ONLY I have discussed the potential risks that non-participation in vaccination may pose and the management of unvaccinated workers in accordance with the vaccination policy. Name of vaccination team staff: Designation: Health facility /agency: Signature: Date: 46 Annex 2. Complementary checklist for planning health worker immuniza- tion: national14 level (To be adapted for local use) To account for the specifics of seasonal influenza vaccination of health workers, the following ADDITIONAL elements may be added to the generic new vaccine introduction check list, see Annex 4 of the document “Princi- ples and considerations for adding a vaccine to a national immunization programme” for the checklist structure. Health worker seasonal influenza vaccination policy 1. National policy on seasonal influenza vaccination of health workers are published and dissemi- nated to all relevant agencies and health facilities, including private health facilities and relevant professional societies. 2. The policy on seasonal influenza vaccination of health workers is reflected in the national occupational health policies. 3. The costs of seasonal influenza vaccination of health workers are included in either the immu- nization or occupational health budget, as appropriate. 4. Surveillance system is in place for influenza activity, including defining start and end of the influenza season, to inform selection of the most appropriate vaccine formulation and timing of influenza vaccination. Planning for successful vaccine introduction 5. A functional multidisciplinary coordination group is in place to discuss and promote access to a new target population of health workers, enabling the formation of partnerships which support and shape the national agenda. 6. The group includes focal points from the occupational health and immunization programs, professional organization representatives, and other relevant stakeholders. 7. A costed operational plan for health worker vaccination is developed and integrated into the na- tional immunization plans and relevant occupational health plans. Formative research (optional and to be included only if formative research is planned) 8. The need and scope of any formative research to be conducted in preparation for vaccine introduction is defined. 9. A research group to conduct formative research has been identified and terms of reference for the research has been developed. Communications 10. National communications working group established for planning communications strategy and developing communications materials for health worker vaccination against seasonal influenza. 14 In some countries, especially large countries with decentralized system, elements of this checklist may also apply at relevant subnational levels, e.g. provincial level. 47 11. Tailored communications messages and materials developed along with an overall communications strategy. 12. Training for health facility communications teams is conducted. Vaccine procurement and supply chain management 13. Target population size estimate developed and included in demand forecast. 14. Individual health facility demand estimated, and vaccine distribution plan developed. 15. Sufficient storage space for vaccines and supplies for seasonal vaccination at all levels established to accommodate vaccine during vaccination period. Vaccine Delivery 16. Health facility vaccination delivery teams are established and trained. 17. System for management of vaccination refusals and implementation of infection control mea- sures in place for prevention of nosocomial transmission, e.g. reassignment, wearing of masks, mandatory leave in case of ILI. Monitoring and evaluation 18. Data recording and reporting tools developed and distributed including for coverage monitoring (updated administrative data and health worker surveys) and AEFI monitoring. 19. Post-introduction evaluation conducted within the first 2 seasons following vaccine introduction. 20. Possibilities reviewed for operational research to assess health worker vaccine acceptance. 48 Annex 3. Health facility checklist (To be adapted for local use) Person responsible Deadline Status Communications 1. Health facilities communications working groups are established and trained 2. Health facility communications plan and schedule for group communications with health workers finalized 3. Adequate supplies of posters and information materials for health worker vac- cination are available 4. Notification of vaccination sent out to targeted health workers and supervisors 5. Telephone hotline established to address individual queries from health workers Storage capacity for vaccines and supplies 6. Adequate storage capacity for influenza vaccines and supplies during vaccination window period established 7. Adequate supplies of influenza vaccines and supplies for health worker vaccination available 8. Provision to deal with extra injection waste during period of vaccination Vaccine Delivery 9. Vaccination delivery team established and trained and vaccination sites within health facility finalized 10. Categorization of health workers completed and beneficiary list for vaccination developed 11. System for management of vaccination refusals and implementation of infection control measures in place for prevention of nosocomial transmission, e.g. reas- signment, wearing of masks, mandatory leave in case of ILI Monitoring and evaluation 12. Data recording and reporting instruments available taking into account data protection issues 13. System for defaulter tracking and reminders established 14. Health facility registries updated to include influenza vaccination 15. AEFI monitoring and reporting systems updated to identify AEFI in health workers 16. Vaccine acceptance monitoring system to address uptake issues in health workers established (if uptake issues are observed) 49 Annex 4. Sample questionnaire for conducting a survey among health workers 1 Name (optional) 2 Age (years) 3 Sex ¨ Male ¨ Female 4 Job category15 ¨ Doctor ¨ Nurse/midwife ¨ Laboratory technician ¨ Other technical staff ¨ Other (specify) 5 Patient contact ¨ Direct ¨ Face-to-face but not direct ¨ None 6 Contact with high risk patients ¨ Yes ¨ No 7 Work area (name of clinical area of work) Statements Strongly agree Agree Neutral Disagree Strongly disagree 1 Vaccination of health workers against diseases such as hepatitis B and influenza are important 2 If I was unvaccinated exposure to influenza would be a risk to my health 3 Exposure to influenza poses a risk to my patients’ health 4 Influenza vaccination poses a risk to my health 5 The benefits of vaccination are greater than the risks 6 My receiving vaccination will protect my patients 7 The best way to protect my patients is to combine seasonal influenza vaccination with other infection control measures 8 I am sufficiently informed about risks of influenza infection I am sufficiently informed about the risks and benefits of influenza vaccination The following factors that would influence my decision to accept vaccination 9 Recommendations from the national policy-making body (e.g. NITAG) 15 Adapt for local use based on local health worker classification. 50 10 Endorsement of recommendation from the professional society to which I belong 11 If it is part of occupational health regulations/ requirements 12 Recommendation from my personal physician 13 Availability of vaccination at no cost to me 14 Easy access to vaccination at my place of work 15 Colleagues having been vaccinated 16 Previous experience with vaccination 17 Protecting my patients 18 Preventing/reducing absenteeism from work 19 Contributing to pandemic preparedness Other factors that would affect my decision to accept influenza vaccination (list below) 20 21 22 51 Annex 5. Communications and demand generation: Stratification of approaches to developing the content Approach Effort Impact Developing the content for communication messages Framing information by delivering social comparison feedback on vaccination rates among peers or healthier individuals Low Medium Tailored communication based on cognitive styles and cultural behaviours Medium High Communication methods Distribution and display of Information, Education and Communication (IEC) materials Low Medium Establish a specially trained communications team at health facility level to administer communications and demand generation approaches Medium High Web-based (including FAQs and chat groups) and social media communications Medium Medium Text message and e-mail reminders to health workers Low Medium Small group in-person briefing meetings High Medium Use immunization champions at national and health facility level Medium High Demand generation approaches Provision of free vaccines Medium High Provide vaccination in the work area using mobile teams Medium High Provide incentives or stimulate competition, e.g. awards to clinical areas with highest vaccination coverage Low Medium Visible reminders and peer-pressure, e.g. badges or stickers worn by those who have been vaccinated Low Medium Ask individual to commit to a time and location to obtain vaccination Low Medium Increase options to obtain vaccination, either near home or at workplace Medium High Guide choice through default options, e.g. automatically set up appointment for vaccina- tion unless individual opts out Low High Establish standing orders to facilitate vaccination Medium High 52 ISBN 978-92-4-151559-7

1An introduction manual for national immunization programme managers and policy makers How to implement seasonal influenza vaccination of health workers Family, Womens’s and Children’s Health (FWC) DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS This document was produced by the Initiative for Vaccine Research (IVR) of the Department of Immunization, Vaccines and Biologicals How to implement seasonal influenza vaccination of health workers ISBN 978-92-4-151559-7 Published: May 2019 This publication is available on the Internet at: https://apps.who.int/iris/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: + 41 22 791 4227 • Email: vaccines@who.int © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following dis- claimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. How to implement seasonal influenza vaccination of health workers. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. IAcknowledgements This manual was developed by Thomas Cherian and Carsten Mantel, MMGH Consulting and Philipp Lambach (WHO/IVR) with review and inputs of an Independent Expert Advisory Group: Salah Al Awaidy, Silvia Bino, Joseph S. Bresee (chair), Supamit Chunsuttiwat, Daouda Coulibaly, Luzhao Feng, Rachel Hale, Shabir A. Madhi, Helena C. Maltezou, Kelly Moore, Jonathan Nguyen- Van-Tam, Saad Omer, Gregory Poland, Sabine Wicker. Kelly Moore and Chris Morgan were consultant as representatives of the WHO Immunization Practices Advisory Committee, IPAC. Consultants: Thomas Cherian, Carsten Mantel. Additional experts: Birte Bödeker, Susan Y. Chu, Sara Hamid, Kathryn Lafond, Kathleen Morales, Julia Neufeind, Susan Wang. WHO: Philipp Lambach, Onyema Ajuebor, Ms Phionah Lynn Atuhebwe, Philip Gould, Shalini De- sai, Julia Fitzner, Martin Howell Friede, Shoshanna Goldin, James Dawson Heffelfinger, Raymond Hutubessy, Ivan Dimov Ivanov, Pernille Jorgensen, Melanie Marti, Hasan Qamrul, Lisa Menning, Ann Moen, Liudmila Mosina, Andreas Alois Reis, Alba Maria Ropero Alvarez, Claudia Steulet, Nadia Teleb. Financial support for the development and pilot-testing of this manual is provided through the Centers for Disease Control and Prevention (CDC), which provides financial support to the World Health Organization Initiative for Vaccine Research (U50 CK000431). II Contents Executive summary 1 About this manual 2 Objective 2 Audience 2 Structure of the document 3 Key related documents 4 1. Background and rationale 5 Current status of influenza vaccination in health workers 5 Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers 6 Evidence for health worker risk of influenza and impact of vaccination 6 Evidence of transmission of infection from health workers to patients and the impact of vaccination 7 Evidence for interventions to increase health worker vaccination uptake 7 Global Action Plan for Influenza Vaccines 8 2. Establishing a policy to vaccinate health workers against seasonal influenza 10 The decision-making process 10 Considerations for decision-making 12 Defining the public health objectives for vaccination 12 Economic analysis for establishing national policies 13 Characterizing the target groups for vaccination 14 Framing an immunization policy for health workers 15 Integration with Occupational Health Policies 18 Choice of vaccine product, schedule and timing of vaccination 18 Defining monitoring and disease impact measurement objectives 20 III 3. Planning and managing vaccination of health workers 21 Planning for successful vaccine introduction 21 Costing and financing 22 Formative research to inform the planning process 24 Communication and vaccine acceptance 25 Communications at the health facility level 26 Demand Generation at the Health Facility Level 28 Vaccine procurement and supply chain management 30 Vaccine procurement 30 Selection of the vaccine product and presentation 30 Logistics and cold chain management 31 Vaccination of health workers 32 Training of the vaccination team 33 4. Monitoring and evaluation 34 Developing and updating information systems 34 Coverage monitoring 34 AEFI monitoring 37 Monitoring and evaluation of vaccine acceptance 38 Vaccine impact monitoring 38 Post-introduction evaluation 40 References 41 Annex 1. Sample non-participation form 45 Annex 2. Complementary checklist for planning health worker immunization: national level 46 Annex 3. Health facility checklist 48 Annex 4. Sample questionnaire for conducting a survey among health workers 49 Annex 5. Communications and demand generation: Stratification of approaches to developing the content 51 1Executive summary Health workers are at higher risk of influenza infection than the general population. In addition to morbid- ity among health workers, influenza infection may also lead to increased absenteeism, presenteeism1 and disruption of medical services. Moreover, influenza infected health workers may contribute to nosocomial transmission of infection to their patients, including those at high risk for developing severe influenza disease and complications. Hence, the World Health Organization (WHO) considers health workers to be a priority target group for seasonal influenza vaccination. In addition, influenza vaccination of health workers contributes to influenza pandemic preparedness. Finally, studies have shown that health workers who are vaccinated against influenza themselves are more likely to recommend vaccination to their patients. This manual serves as a resource to assist users in establishing a national policy for seasonal influenza vaccination of health workers. It provides guidance along with a catalogue of available tools to facilitate policy development, planning, implementation, monitoring and evaluation of influenza vaccination of health workers. The contents of the manual are meant to supplement the document titled “Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring”, published by WHO in 2014. The main target audiences for this manual include national policy makers; national health planners; the na- tional programme managers for immunization and occupational health; and those responsible for occupational health, health worker immunization and infection control in health facilities. Close collaboration between immunization managers, and occupational health and infection control programmes is essential to optimize vaccine uptake, and for a cohesive and comprehensive approach to influenza control in health facilities. This manual summarizes the evidence and rationale, provides guidance on key issues, and lists available tools for influenza vaccination of health workers, covering three main components of vaccine introduction and management: 1. Establishing an evidence-based national policy for seasonal influenza vaccination of health workers. 2. Planning and management of health worker influenza vaccination. 3. Monitoring and evaluation, including assessing vaccination coverage, monitoring for adverse events following immunization, impact assessment and post-introduction evaluation. Complementing this manual, deliberations of an Independant Expert Advisory Group developing this manual are available in form of a meeting report summarizing critical issues. These include policy con- siderations, the evidence in support of health worker vaccination; categorization and prioritization of health workers; the choice of vaccination strategy; its integration into broader health worker vaccination and occupational health policies; planning and management of vaccination, particularly the approaches for communication and demand generation; and the challenges with monitoring and evaluation of health worker vaccination, especially in low and middle-income countries.2 1 Presenteeism refers to health workers who work while ill, yet have reduced accuracy and effectiveness and pose a risk to vulnerable patients in their care. 2 Cherian T. et al. Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16–17, Berlin, Germany. Vaccine. 2019;37(43):6255–6261. 2About this manual Objective This manual serves as a resource and catalogue of available tools to assist country officials in de- ciding upon, planning, implementing and monitoring health worker influenza vaccination in order to achieve optimal vaccination coverage. It is not meant to be a prescriptive document, but rather articulates general principles and key considerations to support policy formulation; plan- ning and management of vaccination; and monitoring and evaluation of influenza vaccination of health care workers. The manual also outlines measures to ensure integration of health worker influenza vaccination into existing national occupational health policies and occupational safety and health management systems of health facilities. It also addresses the opportunity for health worker influenza vaccina- tion to promote an integrated approach for monitoring and optimizing the uptake of all interven- tions included in national occupational health policies. In addition, it refers to the relationship and contribution of health worker vaccination to pandemic influenza preparedness. Seasonal influenza vaccination in health workers differs from other vaccine-preventable diseases in that vaccination is required annually. However, elements of this manual may be of relevance for health worker vaccination in general, particularly the sections on planning and management of vaccination and on monitoring and evaluation. Audience The main target audience for the manual include: 1. National policy-making bodies and health planners. 2. Programme managers for immunization, infection control and occupational health programmes at national and subnational levels and those responsible for occupational health and infection control in health facilities. 3. Organizations of health workers and employers. While the different sections of the document may be of greater relevance to one or the other group, it is advisable that the document be read as a whole because of the information on a particular topic may be found in the different sections of the manual. The document may also be useful to other audiences with an interest in immunization or occu- pational health. 3Structure of the document The manual consists of four sections as outlined in Figure 1. However, for clarity and complete- ness there is some overlap between some of the sections, with cross-references made to the other relevant sections. Figure 1. Structure of the document Establishing a policy Planning & management of vaccination Monitoring & evaluation Introduction, background and rationale •About the manual, including objectives and target audience •WHO policy recommendations on influenza vaccination •Current status of health workers vaccination •Summary of evidence to support health worker vaccination •Global Action Plan for Influenza Vaccines •Considerations for making a decision •Defining the objectives for vaccination •Categorization and prioritization of health workers •Framing an immunization policy • Integration with Occupational Health Policies •Choice of product and timing for vaccination •Delivery options and strategies to optimize coverage •Defining monitoring and impact assessment objectives •Planning for successful vaccine introduction •Costing and financing •Formative research to inform planning process •Communication & vaccine acceptance •Demand generation at the health facility •Vaccine procurement and supply chain management •Vaccination of health workers •Training of vaccination team •Coverage monitoring •AEFI monitoring •Vaccine acceptance assessment •Vaccine impact monitoring •Post-introduction evaluation POLICY MAKERS IMPLEMENTERS 4Key related documents The following documents are important resource materials that complement the guidance in this manual. 1. The WHO policy recommendations on seasonal influenza vaccination, including health worker vaccination are published in WHO Position Papers. These position papers are peri- odically updated. Vaccines against influenza: WHO position paper – November 2012 https://www.who.int/wer/2012/wer8747.pdf (Accessed 14 Mai 2019) Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (Accessed 14 Mai 2019) 2. The following document provides detailed guidance to countries that already provide sea- sonal influenza vaccination to health workers on how to identify, analyse, and effectively target issues related to uptake: Tailoring immunization programmes for seasonal influenza (TIP FLU). A guide for increasing health care workers’ uptake of seasonal influenza vaccination (2015). Copenhagen: World Health Organization Regional Office for Europe; 2015. http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) 3. While the contents of this manual can help inform national policies, the manual does not provide an exhaustive review of the available evidence to inform decision-making. A more detailed review of such evidence in support of vaccination of health workers is found in the following document: Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. July 2019. https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (Accessed 12 July 2019) 4. This manual is part of a series of introduction manuals on seasonal influenza vaccination developed by WHO. A manual on the implementation of influenza vaccination of pregnant women has been published earlier. How to implement influenza vaccination of pregnant women: an introduction manual for national immunization programme managers and policy makers. http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (Accessed 14 Mai 2019) 51. Background and rationale Health workers are at risk of influenza virus infection and of transmitting infection to patients under their care who may be at high risk for severe disease, complications, and death (1). The increased risk in health workers compared to the general population may vary by occupation or setting (2). WHO considers health workers to be an important priority group for influenza vaccina- tion, not only to protect themselves and maintain essential health-care services during influenza epidemics, but also to reduce the spread of influenza to vulnerable patient groups with whom they come into contact (1). Furthermore, many studies have found that a strong recommendation from health workers, especially from physicians, is highly likely to increase public uptake of vaccination (3–5). Health workers who have themselves been vaccinated are more likely to be knowledgeable about vaccination and be more effective in improving public acceptance of vaccination (3–5). Fi- nally, because health workers are likely to be targets of vaccination programs during an influenza pandemic, establishing functional programs for seasonal influenza vaccination of health workers will facilitate timely and effective vaccination during a pandemic (6). Current status of influenza vaccination in health workers Global adoption of a policy for influenza vaccination of health workers has been slow. In 2017, only 119 of the 194 countries reporting having a national influenza vaccination policy. Of these, 96 report targeting health care workers as a priority group. However, the proportion of Member States that reported having a policy varies by WHO region, with the majority of countries in the WHO regions of the Americas, Europe and Eastern Mediterranean reporting a national policy for influenza vaccination, whereas a lower proportion of countries report having such a policy in the Western Pacific, African and South-East Asian regions. Information on influenza vaccination coverage in health workers is not available for most coun- tries, though it varies widely and is reported to be low in many countries where such data are available. For example, data on coverage in health workers were available from only 26 (56%) countries in the European region for the 2014–15 season. The median coverage was 29.5% with a range of 2.6% to 99.5%; only three countries, namely Albania, Armenia and Belarus, reported coverage > 75% (7). More recent data from a systematic review through compulsory reporting from all hospitals in England showed an uptake of 69% in the 2017–18 season.3 An internet survey of 2000 health workers in the United States demonstrated coverage to be 78% during the 2017–18 season, with higher coverage rates (95%) among those working in settings where they were required by their employers to be vaccinated (8). Higher vaccination coverage rates are reported when man- datory vaccination policies are implemented. In one systematic review that included eight studies, coverage rates exceeding 94% were achieved in all (9). 3 Seasonal influenza vaccine uptake in healthcare workers (HCWs) in England: winter season 2017 to 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/Sea- sonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf (Accessed 14 Mai 2019) 61. Background and rationale Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers A rapid evidence appraisal of materials available in the English language, published since 2006, and considered to be of medium or high quality, was conducted by WHO (10). The questions considered, and the main findings of this appraisal are summarized here. Readers are referred to the published report for the details and for the relevant citations. The review considered three issues, namely: 1. The evidence that health workers are at increased risk of influenza infection compared to the general population, and that vaccinating them reduces influenza or absenteeism and/or the wider economic impact of influenza in the health workforce. 2. The evidence that health workers transmit influenza to their patients in health care set- tings and, if so, whether vaccination protects the patients and the proportion of health workers who need to be protected to obtain this effect. 3. The evidence for successful practical interventions to increase vaccination uptake and the state of knowledge of social, behavioural and public health public policy research on vaccination uptake in health workers. Evidence for health worker risk of influenza and impact of vaccination Studies comparing the risk of influenza infection in health workers compared to the general population are challenging, may measure different outcomes, or are executed in different set- tings, limiting the comparability across studies or the pooling of data from these studies. Recent systematic reviews suggest that health workers are at an increased risk of influenza infection compared to the general population (Odds Ratio = 2.08, 95% CI = 1.73 to 2.51) (2), though the evidence is strongest for asymptomatic laboratory-confirmed infection (11). However, health work- ers with asymptomatic infection may still transmit influenza virus to highly vulnerable patients in a health-care setting. Respiratory illness is reported as a common cause of absenteeism among health workers. Epidem- ics or pandemics of influenza have been associated with increased rates of absenteeism among health workers (12). Vaccine efficacy in health workers has been shown to be as high at 90% for well-matched seasonal influenza vaccines (13, 14), which suggests that vaccination of health work- ers will reduce influenza-related morbidity and absenteeism. A systematic review showed a pro- tective effect against laboratory confirmed influenza and shorter absenteeism due to influenza- like illness (ILI) in vaccinated groups (15). A recent study among health workers in the United Kingdom showed that a 10% increase in vaccination uptake is associated with a 10% decrease in absence due to illness (12). However, there are observational studies that provide conflicting results – though often constrained by poor study design, non-specific outcomes, high risk of bias, and failure to adjust for confounding factors (16–19). Since the risk of illness following infection is based on the level of exposure, and absence behav- iours may vary between different categories of health workers, it is possible that the lack of suf- ficiently granular data on absenteeism, e.g. stratified by health worker categories, may account for the mixed results seen in the different studies. On the other hand, the lack of impact on 71. Background and rationale absenteeism observed in some studies, despite evidence of increased rates of infection in health workers, raises the question as to whether health workers nonetheless continue to work when infected and lead to heightened concerns about the consequent risk of nosocomial transmis- sion (20). Several studies have documented presenteeism in health workers with influenza-like illness (21–23), including one instance which was associated with nosocomial transmission in an oncology unit (24). Evidence of transmission of infection from health workers to patients and the impact of vaccination Epidemiological studies using molecular subtyping approaches demonstrate evidence of transmis- sion from health workers to patients. The use of automated collection of high-resolution contact data using wearable sensors combined with virologic data have allowed the identification of potential routes of transmission in cases of hospital-acquired influenza (25). The extent of direct transmission from health worker to patient in health care settings is difficult to capture because of the constant influx of visitors, interactions between patients, and the possibility of multiple simultaneous introductions of influenza (26–28). However, among those who may contribute to transmission of infection in the health care setting, health workers represent a sizeable vaccine- preventable portion since they are easier to target for vaccination. The direct patient benefit of health worker vaccination can be measured in several ways, as il- lustrated in the literature. Several studies evaluate the impact on laboratory confirmed influenza, while others evaluate impact on non-specific outcomes such as ILI, respiratory illness, all-cause mortality, respiratory illness associated mortality, or incidence of nosocomial influenza infection. The evidence is stronger for non-specific outcomes such as ILI, all-cause mortality (29), and inci- dence of nosocomial influenza infection (30, 31). Although some studies have attempted to mea- sure the number of health workers that need to be vaccinated for optimal protection, the evidence in support of a coverage threshold is weak, leading to disputes in the literature (32). However, it is likely that patient protection is positively associated with increasing health worker vaccination coverage but would also depend on other factors including the type of patient contact, vulnerability of the patient, use of other infection control measures, and the effectiveness of vaccination in a particular influenza season (33–35). Evidence for interventions to increase health worker vaccination uptake There is a substantial body of evidence on successful interventions to increase health worker in- fluenza vaccination uptake, much of which has been incorporated into existing toolkits aimed at increasing vaccine uptake. Although the factors that contribute to the health worker decision-making pathway are diverse, some strategies appear to be more effective than others. No single intervention has been shown to rapidly and substantially increase and sustain vaccination uptake except for mandatory vaccina- tion. However, mandatory health worker vaccination is an issue that has been extensively debated with many different perspectives for and against its use (20, 32, 36). Successful mandatory vac- cination programmes require organizational and educational efforts to secure employee support prior to implementation (37). 81. Background and rationale A combination of one or more “soft mandates” such as active declination, required surgical mask use and exclusion of non-vaccinated staff from working with highly vulnerable patients may be used as alternatives to mandatory vaccination, although there are organizational, educational, monitoring and enforcement, and human and financial resource implications for applying such soft mandates. Additional components that contribute to increased uptake include the following: • Provision of free vaccine; • Convenient access to vaccination, including on-site vaccination in health facilities; • Knowledge and behaviour modification through education, reminders, and incentives tailored towards different health worker categories; • Management and organizational approaches such as personnel assigned to oversee vac- cination activities. The reasons for low vaccination uptake are heterogenous and vary across different health worker categories and cultures. Therefore, approaches to increase uptake need to be tailored for different groups. Some studies have demonstrated that formative research, including surveys and qualitative research, can provide insights that assist in tailoring interventions to optimize uptake. Conclusion Despite the ongoing debate in the literature, influenza vaccination is important for ensuring the safety of health workers, their patients, and the general population who rely on a functioning health system, especially during epidemic/pandemic periods. Studies to conclusively establish the value of health worker vaccination will be chal- lenging though the emerging data on this issue will be closely monitored to inform any changes to existing WHO policies.4 Global Action Plan for Influenza Vaccines In an influenza pandemic, most of the world’s population will be highly susceptible to infection and it is likely that infection will spread rapidly. Vaccination is considered one of the key strategies to mitigate the potential impact of a pandemic. While it is expected that there will be a delay in the development of strain-specific pandemic vaccines, insufficient production capacity will further restrict the global access to the vaccines, at least in the early phases of the pandemic. Resource- constrained countries, especially those that lack local vaccine production capacity and those that do not have seasonal influenza vaccination policies, will face the greatest challenge in securing timely access to vaccines during a pandemic, and mitigating the substantial adverse effects of a pandemic. 4 A working group of the WHO Strategic Advisory Group of Experts (SAGE) on immunization will be reviewing the emerging data and updates to the existing WHO recommendations are expected in 2020. 91. Background and rationale To address this challenge a Global Action Plan for Pandemic Influenza vaccines was developed by WHO with short, medium and long term-strategies aimed at increasing influenza vaccine production and surge capacity before and during an influenza pandemic (38). The plan proposed three approaches to enhance access to pandemic vaccines: (i) an increase in the baseline use of seasonal influenza vaccination; (ii) an increase in global production capacity; and (iii) further research and development. The first of the above three approaches relies on countries establishing clear and effective immu- nization policies to increase the baseline use of seasonal influenza vaccines – providing industry with better demand forecasts and stimulate increased production capacity. While vaccination of health workers will only result in a modest increase in overall vaccine de- mand, it will establish a robust and functional platform for rapidly immunizing health workers and could contribute to achieving high coverage in the event of a pandemic, thereby protecting health service delivery during a pandemic. Furthermore, high uptake of vaccination by health workers is likely to build trust and increase the uptake of vaccination among other high-risk groups tar- geted for seasonal influenza vaccination in national policies. Health worker vaccination may also establish or strengthen processes that would allow rapid deployment of pandemic vaccines. Thus, seasonal influenza vaccination of health workers goes beyond the issue of immediate protection against seasonal influenza as outlined above and contributes to pandemic influenza preparedness. 10 2. Establishing a policy to vaccinate health workers against seasonal influenza The decision to establish a policy to vaccinate health workers against seasonal influenza should be evidence-based, with a clear rationale, and with the required investments for sustainable implementation. The general principles and considerations for adding a vaccine to a national im- munization programme are articulated in the 2014 WHO guidance document titled “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: From Decision to Implementation and Monitoring” (39). Health workers comprise a target population not usually included in the national immunization programmes of many low and middle-income countries. While hepatitis B vaccination pro- grammes for health workers may exist, influenza vaccines are unique since vaccination for the foreseeable future must be repeated annually. This section of the manual deals primarily with additional considerations specific to annual seasonal influenza vaccination of health workers, building on the generic framework provided by the document cited above. The decision-making process As with any other vaccine for which policies have to be established, Ministries of Health (MoH) would request National Immunization Technical Advisory Groups (NITAGs) or equivalent na- tional or regional bodies to conduct a review of the evidence and provide advice on establishing a policy for seasonal influenza vaccination of health workers, and to make recommendations on the content of the vaccination policy. Engagement of the many stakeholders affected by this policy is essential to secure their endorse- ment and facilitate high vaccination uptake, and is likely to result in a more coordinated approach to the control of influenza in health facilities. Stakeholder consultation should be broadly sought and include: 1. Professional associations and societies representing different health worker groups such as medical, nursing and allied health service associations, as well as representatives of private health care providers; 2. Medical and nursing councils and other health worker regulatory bodies; 3. Patient safety groups, where they exist, and organizations representing patients, since health worker immunization should also be regarded as a patient safety and quality of care issue; 4. Health worker unions, where they exist and when their participation is likely to be use- ful in promoting vaccination uptake. 5. Health facility managers. 11 2. Establishing a policy to vaccinate health workers against seasonal influenza The process should also include early engagement with the bodies that establish occupational health policies and regulations to ensure that the policies established for health worker vaccina- tion against influenza are also reflected in the national occupational safety and health policies. If vaccination policies for health workers exist for other vaccines, e.g. hepatitis B vaccination, a review of these policies may provide useful inputs for policy formulation for seasonal influenza vaccination and on strategies to optimize vaccination uptake. Where available, NITAGs could access the information required from data available from the national influenza surveillance, the National Influenza Centres or other institutions participating in the Global Influenza Surveillance and Response System (GISRS) (see Toolbox 1). In places where local evidence is not readily available, especially on rates of disease amongst health workers and on transmission of disease from health workers to patients, efforts to generate such evidence could be time- and resource-intensive. Policy-makers would have to consider whether it is necessary to conduct local studies or whether data from other countries with similar epide- miological profiles and health system characteristics could be used to infer the likely burden of disease and support decision-making. NITAGs would need to balance the desire to have national data against the costs and delays that would result in generating the data and the consequent health impacts of this delay. Toolbox 1 National Influenza Centers To monitor and respond to the changes in the influenza virus antigenic structure and the subsequent necessity to change vaccine compositions, many countries have established national influenza centers (NIC) to collect and characterize virus specimens in their country and perform other analyses to inform the decisions of WHO and partners on the composition of the next year’s influenza vaccine. In many countries, virologic surveillance is complemented by more systematic influenza surveillance for severe acute respiratory illness (SARI) and influenza-like illness (ILI). A NIC in a country – or in a neighbouring country – can support evidence-based recommendations by providing data on the influenza disease burden and seasonality to the NITAG or other relevant national decision-making body. Involving these and other centers in NITAG discussions is key to bringing together all relevant information that is needed for the decision-making process. A list of NICS, WHO collaborating centers and essential regulatory laboratories (ERLS) can be found at the following links:  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (Accessed 14 Mai 2019)  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (Accessed 14 Mai 2019) 12 2. Establishing a policy to vaccinate health workers against seasonal influenza Considerations for decision-making In addition to the general considerations outlined in the WHO document “Principles and Consid- erations for Adding a Vaccine to a National Immunization Programme: from decision to implemen- tation and monitoring” referred to earlier, other key issues need to be considered when framing a policy for health worker vaccination. These are listed in Figure 2. Figure 2. Key considerations in establishing a vaccination policy for health workers Defining the public health objectives for seasonal influenza vaccination of health workers Characterizing and prioritizing the target groups for vaccination Framing the vaccination policy for seasonal influenza vaccination of health workers Choice of vaccine product, schedule and timing of vaccination Defining the monitoring and impact assessment objectives Defining the public health objectives for vaccination A critical first step in establishing a policy for vaccinating health workers with seasonal influenza vaccination would be to clearly define the aims and objectives of the vaccination programme. Such objectives may vary between countries but would underlie the prioritization of the health worker groups to be targeted for vaccination, set vaccination coverage targets, and provide guidance on the outcomes and scope for measuring the impact of vaccination. Vaccination of health workers serves multiple objectives. These may include: 1. Prevention of infection in the health workers themselves, averting associated morbidity. 2. Prevention of transmission of infection from health workers to vulnerable patients, including those at high risk of severe disease, complications, and death. 3. Sustaining health services by reducing health worker absenteeism, especially during seaso- nal and pandemic influenza outbreaks, which is a period of increased health care demand. 4. Promoting uptake of seasonal influenza vaccination among other target groups and enhance public trust for influenza vaccination. 5. Contributing to influenza pandemic preparedness by: a) Establishing a mechanism for rapidly immunizing health workers during a pandem- ic of influenza or epidemics of other vaccine-preventable diseases; 13 2. Establishing a policy to vaccinate health workers against seasonal influenza b) Contributing to increasing demand for influenza vaccine and thereby enhance pro- duction capacity to improve timely access to vaccine in case of a pandemic. c) Establishing or strengthening national capacity for vaccine regulation. One or more of the above could serve in defining the national objectives for health worker vac- cination. Important considerations when defining vaccination objectives include: 1. Review of the available data on the burden of disease among health workers and health care-related infections in patients and residents of long-term care facilities. National data, where available, complemented with representative regional or global data or esti- mates developed through the use of mathematical models may be used for this purpose. 2. The cost and impact of vaccination and availability of vaccine supply. 3. Review of the national pandemic preparedness plan and consideration of how health worker vaccination could contribute to pandemic preparedness. Economic analysis for establishing national policies While economic analysis is generally recommended prior to deciding on vaccination policies, lack of data for estimating and comparing the economic benefits of the different vaccination objectives may be a limiting factor, as will be the relatively small size of the target group. Toolbox 2 lists the available tools for conducting economic analysis for influenza vaccination. The costs and economic benefits of influenza vaccination of health workers are likely to depend on several factors, including the number and categories of health workers targeted, the incidence and severity of infection in the targeted health workers, their contribution to health care-associated transmission and the consequences of such infections. These factors may vary between different health facilities and will vary from one influenza season to another. A recent systematic review of the epidemiological and economic effects of seasonal influenza vaccination of health workers found that vaccination of health workers was cost-saving, based on crude estimates of absenteeism averted through vaccination (15). However, all the studies included Toolbox 2 Tools for the economic analysis of seasonal influenza vaccination Several tools are available for conducting economic analysis of influenza vaccination: WHO Guide for Stanardization of economic evaluations of immunization programmes (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf WHO Manual for Estimating the Economic Burden of Seasonal Influenza (WHO/IVB/16.04) ƥ http://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-eng.pdf Guidance on the economic evaluation of influenza vaccination (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. Establishing a policy to vaccinate health workers against seasonal influenza in this review were from high-income countries and took an employer perspective with a strong focus on absenteeism averted. Initial decisions could take vaccination costs and the impact of these costs to the immunization and health budgets into consideration, with the option of measuring cost-effectiveness post- introduction, if required. Further guidance on costing and budgeting of health worker influenza vaccination, with links to the available costing tools and resource materials on immunization financing are covered in the next section of this manual. Characterizing the target groups for vaccination Ideally all health workers should be targeted for vaccination, including those who may not come into direct contact with patients. Even if not in direct contact, health workers could potentially transmit infection acquired in the community to colleagues and, thereby, participate in the chain of health care-associated transmission of infection. However, in situations where there are resource constraints or limited or unstable vaccine supplies, categorization and prioritization of health workers for vaccination would be required. Prioritization of health workers would depend on as- sessment of risk of infection among the health workers themselves, transmission of infection to their patients and the consequences of health care-associated transmission. Even without financial resource constraints or limitations in vaccine supply, categorization of health workers would be useful when different policies are applied to different health worker cat- egories, based on risk assessment. For example, a mandatory vaccination policy may be applied to select categories of health workers who work with patients at high risk of severe influenza and who are more likely to accept mandatory vaccination, while vaccination may be voluntary for other categories (40, 41). Table 1 provides an example of risk categorization of health workers based on risk to themselves and of those for whom they care. Table 1. Risk categorization of health workers Risk category Health worker characteristics Very High • High risk health workers (see below) who work in clinical areas that admit patients at high risk for severe disease, complications, or death following influenza virus infection. These include intensive care units; transplant or oncology wards; antenatal, peri-natal or post- natal areas; and areas with elderly individuals, especially those with chronic diseases. High • Health workers who come into direct physical contact with patients, or with infectious materials, including surfaces or equipment contaminated by infectious materials. • Health workers who have contact which is not physical but that would allow the acquisi- tion or transmission of diseases that are spread at short range (1–2 m) by respiratory means, e.g., counsellors who have prolonged fact-to-face contact (42, 43). Low • Health workers who do not have contact with patients and whose normal work is not in a clinical area as defined above. 15 2. Establishing a policy to vaccinate health workers against seasonal influenza The very high-risk category is also the one where the evidence for risk and impact of vaccination is the strongest and where there is a stronger justification for vaccination (10). Those targeted for vaccination should also include part-time personnel, students, contractors, and volunteers at the health facility who have possible exposure to patients as health workers in the above categories. Risk categorization of individual health workers may be too complex and resource intensive in many settings, especially in low- and middle-income countries. In these situations, simpler ap- proaches wherein health worker categories are classified into only two groups, i.e. at high risk group (targeted for vaccination) and low risk groups (not targeted for vaccination) may be used. To ensure targeted use of influenza vaccination of health workers and to address potential uptake issues, national policies for health worker vaccination should outline: 1. The classification of different health worker categories based on assessment of risk. 2. The policy for vaccination for each category, e.g. whether vaccination is recommended and whether the recommendation is for mandatory or voluntary vaccination. 3. Strategies for managing non-compliant health workers and vaccine refusers. The following document provides an example of a framework for the assessment, classification and prioritization of health workers: The policy directive of the New South Wales Ministry of Health on the Occupational Assessment, Screening and Vaccination Against Specified Infectious Diseases https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (Accessed 14 Mai 2019) Framing an immunization policy for health workers Recommendations for health worker vaccination could propose either mandatory vaccination, voluntary vaccination or a mixed approach depending on the risks in the specific clinical setting. Multiple studies across many countries has demonstrated that voluntary vaccination of health workers, even when accompanied by considerable efforts to educate them on the benefits and risks of vaccination and implementation of measures for convenient access to vaccination, results in low coverage that seldomly exceeds 70%. On the other hand, mandatory vaccination has resulted in close to 100% uptake in institutions in the United States where it has been applied (44–46). However, mandatory vaccination has been difficult to implement in some countries because of acceptability issues and because the attributable benefits of health worker vaccination have been a subject of debate (32). Furthermore, it may not be feasible to implement mandatory vaccination policies in resource-constrained settings. 16 2. Establishing a policy to vaccinate health workers against seasonal influenza Voluntary vaccination One option for a vaccination policy for health workers is voluntary vaccination wherein vaccina- tion is recommended for health workers and offered but acceptance is voluntary or optional, i.e. not a requirement. Such programmes often have low vaccination coverage. Hence, with voluntary vaccination, extra efforts are required to optimize the uptake of vaccination. These could include: 1. A robust communications strategy, specifically tailored to the needs of different health worker categories, to explain the benefits and risks of vaccination, including the benefits to patients, especially those at high risk for severe disease. It needs to be emphasized that some of these patients, including the elderly and immunocompromised patients may not themselves respond to vaccination and that vaccination of health workers who come into contact with them is an important means for protecting them from infection, i.e. a professional ethics and moral argument 2. Convenient access to vaccination that is free of charge, and available to workers in every shift. Those who work during evening or night shifts might be provided access to vacci- nation either at the beginning or the end or their shifts or on designated days and times to cover their shift. 3. Other demand generation activities as outlined in the next section of this manual. A number of soft mandates may also help in increasing vaccination uptake, including: 1. Requirement of active declination of vaccination through signing of forms indicating their non-participation with or without stating the reasons for not accepting vaccination (see Annex 1 for a sample of an active declination form). 2. Reassignment of health workers who refuse vaccination to areas where they are less likely to come into contact with high risk patients, if this is feasible, or a requirement to wear masks when they do care for patients at high risk of influenza complications. 3. Use of face masks while in the health care facility. Mandatory vaccination Mandatory vaccination makes vaccination of health workers a legal or regulatory requirement while allowing some exemptions, e.g. medical contraindications. There is no WHO or other uniformly applied definition for mandatory vaccination. Infant and childhood immunization programmes described as mandatory can vary widely, especially in terms of the exemptions al- lowed and the penalties for non-compliance (47). Several experts have argued that mandatory immunization policies should be implemented against vaccine-preventable diseases that can be transmitted in the health-care setting and cause signifi- cant risk of morbidity or mortality to patients (20, 44, 48–50), as part of the professional ethics of a health care provider. It has also been argued that few ethical mandates in the practice of medicine surpass the obliga- tion to do no harm. Hence, ensuring conditions for safe patient care by minimizing transmission of communicable diseases represents a minimum ethical standard in health care practice set- tings (20). However, if mandatory vaccination policies are to be established, legal liability issues will need to be addressed and consideration given to providing compensation in the rare event of an adverse event. 17 2. Establishing a policy to vaccinate health workers against seasonal influenza Mandatory vaccination could either be part of the national policy or implemented at individual health facilities as part of institutional policies. The enactment of legislation endorsing mandatory vaccination would facilitate the implementation of such a policy. The Code of Colorado Regulations provides an example of a mandatory vaccination policy: Code of Colorado Regulations: Standards for Hospitals and Health Facilities 02 – General Licensure Standards (Part 10, Page 46) https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20CCR%20 1011-1%20Chap%2002 (Accessed 14 Mai 2019) Several countries with voluntary health worker vaccination policies for influenza do have man- datory vaccination of health workers for other infections such as measles and hepatitis B. These existing mandatory vaccination policies could be leveraged to also justify and establish mandatory vaccination policies for influenza, based on the protection afforded to the health worker as well as to vulnerable high-risk patients with whom they come into contact. Published recommendations for the ethical implementation of mandatory vaccination policies are reproduced in Toolbox 3. These recommendations may be taken into consideration in framing the national policy based on the feasibility of implementation. Toolbox 3 Recommendations for ethically implementing mandatory vaccination policies — There must be a compelling employee and patient safety problem that is clearly communicated to employees. — The least restrictive means should be used to achieve the safety objective. — There should be clear opt-out criteria for medical reasons. — Opt-out criteria based on personal views of the health worker should be allowed for current employ- ees only. These determinations must be made in a transparent and objective manner. — For those who do meet medical or other exclusion criteria, or who refuse vaccination, institutions should offer alternative means for achieving transmission control, including temporary leave during peak times, mandatory mask wearing, re-assignment to non-clinical areas (if feasible) or frequent testing during peak influenza seasons. — Prospective employees should be notified of the mandatory policy and recognize that failure to comply could be grounds for termination of employment. — The process should be transparent, with a broad range of health worker perspectives involved in policy development. — Institutions should support healthcare workers by implementing vaccination procedures that are free, easy to access, and include complete comprehensive coverage of adverse events. Particular attention should be paid to not burdening less advantaged members of the healthcare team. Source : Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 18 2. Establishing a policy to vaccinate health workers against seasonal influenza Mixed approach A mixed approach could also be adopted where a mandatory vaccination policy is applied to only certain categories of health workers likely to have direct physical contact with high-risk patients, while a voluntary vaccination policy is applied to the remaining categories. Such a policy should clearly and unambiguously define the health worker groups to whom or work areas where mandatory and voluntary vaccination policies apply. Consideration should be given to the human and financial resource implications of mandatory vaccination policies or of soft mandates. Integration with Occupational Health Policies Policies on seasonal influenza vaccination of health workers should be an integral part of the national occupational safety and health policies and regulations and the occupational safety and health management systems in health facilities. Inclusion of seasonal influenza vaccination in occupational health policies will allow access to free vaccination for all the targeted health workers as per the Occupational Safety and Health Convention, 1981, Article 215 and the recommendations in the World Health Organization and International Labour Organization (WHO-ILO) Global Framework for National Occupational Health Programmes for Health Workers.6 Such a policy would also put the responsibility for health worker vaccination on employers, rather than on the health workers alone. An integrated policy will enable greater coordination and collaboration between occupational health and immunization programmes and promote a joint approach to control of influenza in health facilities wherein vaccination is part of an infection control program that includes other in- fection measures to protect both health workers and patients. The occupational health programme at the national level and the management system at the facility level also provide an enabling environment to create a culture for infection prevention within the workplace that will stimulate the implementation of the vaccination programmes. Choice of vaccine product, schedule and timing of vaccination Choice of product WHO provides recommendations for the composition of influenza vaccines based on the infor- mation provided by the WHO Global Influenza Surveillance and Response System.7 Based on these recommendations, manufacturers formulate Northern Hemisphere (NH) and Southern Hemisphere (SH) vaccines, which are generally accessible around September (NH) and April 5 C155-Occupational Safety and Health Convention, 1981 (No. 155). https://www.ilo.org/dyn/normlex/en/f?p=NO RMLEXPUB:12100:0::NO::p12100_instrument_id:312300 (Accessed 14 Mai 2019) 6 The sectoral dimension of the ILO’s work : Review of sectoral initiatives on HIV and AIDS Appendix II – WHO- ILO WHO-ILO Global Framework for National Occupational Health Programmes for Health Workers. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/wcms_145837.pdf (Accessed 14 Mai 2019) 7 Influenza: vaccines. http://www.who.int/influenza/vaccines (Accessed 14 Mai 2019) 19 2. Establishing a policy to vaccinate health workers against seasonal influenza (SH) of each year, respectively. A list of WHO prequalified vaccines with information on their characteristics is published on the WHO website.8 Several different types of vaccines are available, including inactivated influenza vaccines (triva- lent and quadrivalent composition), live attenuated influenza vaccines, adjuvanted vaccine, and recombinant vaccine. Being a health worker per se does not lead to a preference for any vaccine type (subject to country-specific marketing authorizations).9 Health workers who care for severely immunocompromised persons should preferably receive inactivated influenza vaccine (IIV). Price and supply availability of each product are additional considerations in informing the choice of product. Timing of vaccination In countries where influenza infection is seasonal and seasonality patterns are defined, vaccina- tion should ideally be scheduled before the start of the influenza season, allowing approximately 14 days for induction of protective antibodies. Where delays in securing vaccine supply does not allow ideal timing to be met, vaccination should be initiated as soon as supplies are made available. Furthermore, individual health workers should never be refused vaccination at any time during the influenza season if they are late in seeking vaccination. In tropical and subtropical regions where several peaks may occur, vaccination should be timed before the main peak of transmission, using the most recent vaccine formulation available. Where no data on national influenza seasonality are available, countries could use data from epidemio- logically similar countries. Toolbox 4 provides published information of influenza seasonality in the tropics and subtropics. 8 WHO Prequalified Vaccines. https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 9 In some countries the quadrivalent vaccine is the product of choice. The WHO Strategic Advisory Group of Experts (SAGE) in immunization is currently reviewing the evidence and expected to make a recommendation in 2020. Toolbox 4 Guidance on choice of product and timing of seasonal influenza Seasonal influenza policy use and effectiveness in the tropics and subtropics. Geneva: World Health Organization; 2016. ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf (Accessed 14 Mai 2019) Influenza seasonality in the tropics and subtropics – when to vaccinate  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 (Accessed 14 Mai 2019) WHO list of prequalified vaccines  https://extranet.who.int/gavi/PQ_Web (Accessed 14 Mai 2019) 20 2. Establishing a policy to vaccinate health workers against seasonal influenza Defining monitoring and disease impact measurement objectives Ministries of Health would benefit from advice from the NITAG or other relevant advisory groups on the monitoring and impact measurement objectives so that they are taken into consideration during the planning and implementation of Monitoring and Evaluation (see chapter 4). NITAGs, with additional inputs from other relevant advisory groups and academia, should make recommendations on: 1. Monitoring and reporting of vaccination coverage, where possible by unit and type of care provided. 2. Measurement of vaccination impact, including: a) Target groups (health workers and or patients) for impact measurement. b) Outcomes to be monitored. e.g. influenza-like illness, laboratory-confirmed disease, severe disease, death, absenteeism, patient-related outcomes, etc. c) urveillance strategies for measuring impact; if at sentinel sites, the number and distribution of sites. d) Time periods for impact measurement, e.g. continued monitoring for an indefinite period or limited to a certain number of seasons. These measurements would be useful to the NITAG in reviewing the impact of vaccination and making recommendations for optimizing the impact and the cost-effectiveness of vaccination. Impact measurement could also generate empiric data to allow for estimation of cost-effectiveness of vaccination. It should be noted that any such measurements should include data collection for multiple seasons since the intensity of transmission, the severity of infection and vaccine effectiveness varies from one season to another. For further details, see the section on “Monitoring and evaluation” (chapter 4). 21 3. Planning and managing vaccination of health workers Planning for successful vaccine introduction Once a national vaccination policy has been established, it is necessary to convert the policy into operational plans that are fully costed, budgeted and include granular detail on the various pro- gramme components related to the introduction of a new vaccine into the national programme. The general concepts for addition of a new vaccine within the national immunization plans and the management of introduction are outlined in the WHO guide “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” (see Annex 3 for New Vaccine Introduction Plan Template). This section provides guidance on the additional elements specific to seasonal influenza vaccination of health workers. A vaccine introduction plan integrated into the annual plan for immunization along with the as- sociated checklists enable programme planners to ensure that all the necessary preparations are in place for the timely and efficient introduction of a vaccine into the national programme. For easy access the links to the relevant Annexes of the WHO guide are provided in Toolbox 5. In addition to the generic vaccine introduction checklist, the complementary checklist in Annex 2 con- tains a list of issues specific to health worker immunization. The elements of this checklist should be added (as appropriate) to the more generic checklist of activities. A sample health facility checklist is also provided (Annex 3) to guide the preparations for vaccination at the health facility level. Toolbox 5 Links to templates and checklists for a new vaccine introduction plan in “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” Generic template to guide the development of a national introduction plan Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc (Accessed 14 Mai 2019) New vaccine introduction checklist, activity list and timeline of WHO new vaccine introduction guide provides advice on planning budgeting, activities, distribution of roles and responsibilities and timelines ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_ resources/nvi_guidelines/Annex4_Instructions.pdf (Accessed 14 Mai 2019) Corresponding checklist tool Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_checklist_en.xls (Accessed 14 Mai 2019) 22 3. Planning and managing vaccination of health workers The timelines for planning and introduction should be included in the checklists and/or as a sepa- rate Gantt chart to ensure that all the activities are completed in their appropriate order to allow timely implementation of vaccination activities. Cross-reference should be made to the relevant sections of the occupational health strategies and plans at both the national and health facility level (see previous chapter on integration of health worker influenza policies into occupational health policies and requirements) to facilitate a more cohesive approach to planning and implementation. The WHO-ILO Global Framework for National Occupational Health Programme for Health Work- ers recommends that all countries identify the responsible person(s) for occupational health, both at the national and workplace levels. These focal points should be a part of the planning team at the national and health facility levels, respectively. Inclusion of the occupational health focal points would allow for an integrated approach to prevention of influenza in the work place where vaccina- tion forms part of a larger package of interventions for influenza control, including other infection control measures to protect both health workers and patients. The labour-management committees for occupational safety and health in health facilities, where they exist, can help in engaging the management and the workers’ representatives in the implementation of the vaccination programme. In addition to the national operational plans for the implementation of health worker vaccination, the national comprehensive multi-year plan (cMYP) for immunization should also be updated to include health worker immunization (Toolbox 6). Costing and financing As with the addition of any new vaccine to the national vaccination schedule, the vaccine and deliv- ery costs should be estimated and included in the annual and multi-year immunization budgets. In addition to the costs of vaccines and supplies (syringes, needles, safety boxes etc.), costs for vaccine delivery (including human resources), annual communications/education and demand generation efforts at the national and health facility level, and monitoring and reporting would need to be included in the costs. Several tools and resources are available that could be used or adapted for costing, budgeting and securing finances for health workers vaccination (see Toolbox 7). Since communications and other activities/interventions to enhance vaccination uptake will be required each year, these costs should be incorporated into the annual vaccine delivery costs and not considered only as a one-time activity. In addition to costing and budgeting for annual health worker influenza vaccination, it may also be necessary to advocate with those responsible for allocating funds for health programmes to ensure that financing for vaccination is sustained. Toolbox 8 provides links to resources for ad- vocacy for sustainable financing. Toolbox 6 WHO-UNICEF guidelines for multi-year planning WHO-UNICEF guidelines for developing a comprehensive multi-year plan (cMYP)  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. Planning and managing vaccination of health workers Toolbox 7 Resources for costing and financing cMYP Costing and Financing Tool  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (Accessed 14 Mai 2019) Immunization Costing Action Network (ICAN) Immunization Delivery Cost Catalogue This interactive website provides information on vaccine delivery costs across different low and middle- income countries through a variety of delivery strategies.  http://immunizationeconomics.org/ican-idcc (Accessed 14 Mai 2019) WHO Flu tool for planning and costing maternal influenza vaccination (new name: SIICT tool) This tool is being expanded to include all influenza risk groups, including health workers.  https://www.who.int/immunization/research/development/influenza_economics/ (Accessed 14 Mai 2019) Management Sciences for Health. Planning, costing and budgeting framework  http://www.msh.org/resources/planning-costing-and-budgeting-framework (Accessed 14 Mai 2019) Immunization financing: a resource guide for advocates, policy makers and program managers  https://immunizationeconomics.org/imfin (Accessed 14 Mai 2019) Toolbox 8 Resources for advocacy or sustainable financing Immunization advocacy library. Provides a number of tools and guides to convey the value of vaccination and the need to invest in vaccination  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/communication-and-advocacy/immunization-advocacy-library (Accessed 14 Mai 2019) Two specific documents in this library are of relevance: Workbook – advocacy for sustainable funding of immunization programmes  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/workbook-advocacy-for-sustainable-funding-of-immunization-programmes (Accessed 14 Mai 2019) How to prepare a financial profile of your immunization programme  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/how-to-prepare-a-financial-profile-of-your-immunization-programme (Accessed 14 Mai 2019) 24 3. Planning and managing vaccination of health workers Formative research to inform the planning process To prepare for the launch of influenza vaccination, several countries have used formative research to better understand the factors affecting uptake of seasonal influenza vaccination in health work- ers, including concerns, beliefs, information needs, cultural issues, and barriers to vaccination in order to develop a tailored plan to address them. Formative research can include both quantitative and qualitative research and, in some situations, might include a desk review. Quantitative research may be used to identify the main predictors for low uptake of vaccination among health workers and the main drivers for compliance with vaccina- tion recommendations. Data may be collected through surveys and questionnaires administered to health workers. The sample should ideally include sufficient representation from the different categories of health workers since the perceptions and reasons for low uptake may vary between health worker groups, e.g. between doctors and nurses (40), as well as from a sample of primary, secondary and tertiary health care facilities and from different work areas within these facilities. Qualitative research is insight research, based on understanding the audience’s point of view. It elucidates new issues and provides a more in-depth understanding of the complex issues underly- ing the uptake of vaccination. Qualitative research methods commonly include focus group dis- cussions and individual in-depth interviews. The WHO European Regional Office has published a step-by-step field guide to qualitative research for new vaccine introduction (see Toolbox 9). To be useful, formative research must be properly planned and well executed, failing which there is a risk of drawing wrong conclusions. This requires time and resources. While it is useful to conduct such research to inform the planning process, if time and resources do not permit, the lack of such research should not delay seasonal influenza vaccine introduction, unless attitudes of health workers are expected to be an issue that may significantly and adversely impact vaccine uptake. When data from formative research are not available, data from such studies conducted in other countries may be used to inform the planning process. While the reasons for low uptake of vac- cine are heterogenous, available evidence suggests that there is broad convergence on the major influencers of vaccine uptake among health workers, especially between countries within the same sub-region, which may be used in the initial planning process. The rapid appraisal of evidence (10) summarizes the key findings from the published literature and this evidence could be used, as applicable and appropriate, in the absence of locally conducted research. Data from the published literature may be complemented with information obtained through quantitative formative research using rapid surveys in a sample of health workers, ideally including different health worker categories. These surveys may be less resource intensive than qualitative formative research and could be completed without resulting in any delays to vaccine introduction. Annex 4 provides a sample questionnaire that may be used for such surveys. Toolbox 9 Field Guide for qualitative formative research A field guide to qualitative research for new vaccine introduction ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_VaccineIntro.pdf (Accessed 14 Mai 2019) 25 3. Planning and managing vaccination of health workers Further research may be conducted if vaccine uptake remains persistently low. The TIPflu tool is an important resource that may be used in such situations. Communication and vaccine acceptance Personal beliefs, cultural attitudes and perceptions about vaccination, in addition to official rec- ommendations, often guide the actions of many of those responsible for delivery of vaccines and many recipients (51, 52). This also holds true at the level of health workers. Available evidence shows that there are often misperceptions about vaccination as well as a gap between knowledge and behaviours (53, 54). Thus, simply improving knowledge about the risks and benefits of vac- cination among health workers has not proven to be sufficient to achieve optimal vaccination uptake. Achieving optimal vaccination coverage in health workers requires a multi-dimensional demand generation effort that is informed by a good understanding of the perception, motivators and barriers of vaccine acceptance among health workers, both as providers of vaccination and as recipients. Communications messages need to be tailored to address the needs of different health worker groups since available evidence suggests that perceptions about the need, risks and benefits of vaccination may vary between these groups (55). Current efforts mainly focus on preparing fact- based approaches to preparing communication messages. However, these types of messages may need to be framed according to the intended audiences based on their level of education and understanding. Taking the preferred cognitive decision-making styles of the individual groups to be targeted into account may have greater impact (54). Framing such messages will require an understanding of vaccine psychology and cognitive decision-making and may require engagement of communication specialists. A traditional approach to communications regarding immunization was through the use of mass media. However, research has shown that mass media alone and a one-way communication to health workers may not be sufficient to optimize the uptake of vaccination. Individual and group communications, in this instance at the health facility level, will be required to build trust and motivate health workers to accept vaccination. Including information on the relevance of vaccination of health workers (self-protection, responsi- bilities towards patients, pandemic preparedness in the case of influenza) in pre-service curricula for medical schools, nursing schools and other training institutions targeting health professionals may help to better establish health worker vaccination as an organizing concept and create better informed health worker generations providing immunization. Effective communications and demand generation activities are not a one-time event but need to be continuous and have the ability to quickly respond to the evolving perceptions about vac- cination and quell rumours and mis-perceptions. Front line vaccination staff responsible for health worker influenza vaccination will need to be trained to be able to deal with vaccine hesi- tant health workers as well as vocal vaccine deniers10 who may negatively impact the uptake of vaccination (56). 10 Vocal vaccine deniers are at the extreme end of the subgroup of vaccine refusers and actively advocate against vaccination, using science denialism techniques to justify their beliefs (reference 32). 26 3. Planning and managing vaccination of health workers A national vaccine communication working group that includes communications specialists will facilitate strong working relations with and collaboration among partners and allies, strengthen routine communication for immunization, and ensure well-coordinated and immediate response from all involved authorities to any safety event. Inclusion of members of the Occupational Safety and Health department and from professional societies in communicating with health workers contributes to building trust and improving acceptance of vaccination. Representation from health workers, professional associations, and unions and from the different health worker categories targeted for vaccination would ensure that the viewpoints of each health worker category is taken into consideration in developing tailored communication materials. A number of tools and guidance documents are available that can be used for developing an ef- fective communications strategy and for framing the communications messages that are specifi- cally tailored towards different health worker groups, including a template terms of reference for a vaccine communication working groups (Toolbox 10). In addition to vaccination, the information and education and communication materials should also include information on other infection control measures to reduce transmission of influenza in the work place and steps to be taken should a health worker develop an influenza like illness. Communications at the health facility level Effective communications at the health facility level will benefit from a dedicated and well-trained team to deliver the communications strategy at the health facility level. Such a team should be established and trained well in advance of the planned introduction date and should include rep- resentation from the main health worker categories in the facility and an advocacy and commu- nications specialist, if one is available. Ideally, communications for seasonal influenza vaccination should be part of a broader communications effort on control of influenza in health care settings. Communication activities at the health facility level should begin sufficiently in advance of the planned date for the onset of vaccination, especially in countries introducing vaccination for the Toolbox 10 Tools and guides for developing communications strategy and messages Vaccination and trust library  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/vaccination-and-trust (Accessed 14 Mai 2019) New vaccine introduction: checklist for planning communications and advocacy (2017)  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2017/new-vaccine-introduction-checklist-for-planning-communication-and-advo- cacy-2017 (Accessed 14 Mai 2019) Template terms of reference for a vaccine communication working group ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_Sup- portDoc_TOR_Proof7.pdf (Accessed 14 Mai 2019) 27 3. Planning and managing vaccination of health workers first time. Initial activities could include the display of information posters at all the relevant areas of the health facility. The manager of the health facility and the heads of all the relevant depart- ments and clinical areas should be sent a formal communication along with sufficient copies of all information materials about vaccination to be displayed in each clinical area. Where possible, relevant information on influenza vaccination could also be sent to all health workers using e-mail and/or local social media networks. In-person group briefings should complement the display and distribution of information materi- als. Existing staff meetings could be leveraged to conduct these briefings. The number of in-person group briefings will depend on the size of the health facility and the number of targeted health workers. Larger health facilities (e.g. secondary and tertiary level health facilities) may need to conduct several briefing sessions to cover all the targeted health workers. Since communications messages may differ between different categories of health workers, consideration should be given to holding separate briefing sessions for each health worker category using information and mate- rials relevant to them. To allow better communication and enough time for questions from health workers to be addressed, the size of each group should be designed to allow sufficient opportunity for interaction. Provision should be made to facilitate the participation of health workers working night shifts. The schedule for the briefings should be widely publicized within the health facility and reminders sent to promote high attendance. In-person meetings should: 1. Explain why vaccination is important for themselves, their patients and families and for wider society – with a particular focus on severe outcomes associated with influenza; 2. Inform health workers about national policies; 3. Provide information on the safety of seasonal influenza vaccines; 4. Provide information on the timing and venue(s) for vaccination; 5. Explain potential consequences of non-vaccination; 6. Allow sufficient time for questions. Consideration may be given to establishing a telephone hotline or web-based system to address questions from individual health workers. In addition to the display of posters and other com- munications materials, the use of visible and removable stickers that can be displayed by health workers who have been vaccinated (e.g. on their ID badges) would serve as a visible reminder to their colleagues who have not been vaccinated. In addition, text messages, generic e-mails and social media platforms could be used to provide periodic reminders on vaccination. Demand Generation at the Health Facility Level In addition to communication strategies, behavioural science-based demand generation efforts can be implemented prior to the availability of vaccines in order to prime health workers for vac- cination. These nudge-based interventions work by creating an environment that can influence behaviour in a predictable way but does not eliminate choice (57), and have proven effective in a variety of healthcare settings (58). These interventions can narrow the gap between intention and actual behaviour, which is usually caused by individuals or health workers forgetting to get 28 3. Planning and managing vaccination of health workers their vaccination or through barriers to convenient vaccination. Additionally, these interventions frequently can be implemented for relatively low cost (59). The figure below (Figure 3), adapted from the Nuffield Council on Bioethics, demonstrates the hierarchy of nudge-based interventions to improve vaccine uptake (60). Nudges lower on the ladder are less aggressive but can still have a measurable impact. By providing health-facility vaccination rate feedback, a process used in the United States to improve uptake of childhood vaccination, progress in health facilities can be monitored, and provide motivation to health workers to improve their own vaccination practices (61). Figure 3. Ladder of nudge interventions to increase vaccination rates Guide choice through default options Automatically set up appointment for vaccination unless individual opts out Enable choice Increase options to obtain vaccination such as at workplace or near home Prompt implementation intentions Ask individual to precommit to a time and location to obtain vaccination Frame information Deliver social comparsion feedback on vaccination rate among peers or healthier individuals Provide information Offer education on benefits of vaccination to self ant others Do nothing Simply monitor vaccination rates Source: Patel MS (ref. 32) Reminders to individuals to vaccinate can serve as a nudge, notifying individuals when they are due for a vaccine and prompting them to come to the vaccination site to receive the vaccine. These can be paper-based or mobile phone text message-based and have proven effective (62). In the health facility, health worker reminders through an immunization data collection tool (whether paper- or electronic-based) can help improve the delivery of vaccines by health workers (59). A successful nudge-based strategy to reduce barriers to convenient vaccination and enable choice is standing orders. Standing orders are a policy put in place in a health facility that permits non- physician health workers to administer vaccines without a prescription or explicit order from a physician and have proven one of the most effective strategies for improving vaccine uptake when applicable (63). All of these strategies can be combined with communication approaches to create demand in the community. 29 3. Planning and managing vaccination of health workers Going beyond nudges Nudges are a favoured method for influencing demand since they preserve choice and are not coercive. However, some experts have argued that when nudges fail to achieve optimal uptake of vaccination in health workers, and this failure results in harm to their patients, decision-makers should consider adopting more forceful policies (64). This is not to imply that when nudges fail one should immediately go to measures that eliminate choice. There are interventions that exist across a continuum leading up to restriction of choice. The use of “soft mandates” provide examples of actions across this continuum. Case study: The «flulapalooza» campaign to increase uptake of seasonal influenza vaccination in health workers Vanderbilt University Medical Center in Nashville, Tennessee, in the United States, employs over 24,000 health workers. Since 2011, the cornerstone of its seasonal influenza vaccination campaign for health workers has been its mass influenza vaccination event, playfully named “flulapalooza”. This event vac- cinates, on average, over 14,000 people in a single day. The closed point-of-dispensing (c-pod) design has been evaluated and refined over time to substantially increase administration efficiency and cover- age rates. The event emphasizes a festive atmosphere while practicing critical pandemic vaccination skills among hospital occupational health and administrative leadership. This event achieves high coverage among categories of health workers who are present that day; how- ever, due to the structure of nursing shifts and ward responsibilities at the institution, less than 30% of nursing staff are typically vaccinated at the event. Thus, the medical center combines flulapalooza with ward visits, mobile carts and other strategies to achieve its annual target of greater than 90% overall health worker vaccine coverage. Notably, although institutional policy gradually increased the difficulty of declination and eventually included disciplinary action in response for unexcused failure to vacci- nate, it is notable that 92% coverage had been achieved in seasons before disciplinary policies were in place. Details of event design, workflow diagrams and practical, specific lessons learned are described in a publication available online. Source: Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168–76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 Annex 5 provides a table that lists the different communications and demand creation approaches, along with an indication of the effort required to implement the approach and the expected impact. Vaccine procurement and supply chain management Vaccine procurement Accessing vaccines at optimal prices requires a good understanding of procurement mechanisms and systems, vaccine market dynamics, and the elements of vaccine pricing. Procurement starts with forecasting vaccine demand, followed by tendering, contracting and procurement processes. The tools and resources for vaccine procurement are listed in Toolbox 11. Procurement of seasonal influenza vaccination may have some unique features and may require regulatory approvals and advance purchase commitments with specific manufacturers shortly after the publication of the 30 3. Planning and managing vaccination of health workers WHO recommendations on the seasonal vaccine formulation (in February for the northern and in September for the southern hemisphere) and well in advance of the influenza season. Selection of the vaccine product and presentation As with any other vaccine, the choice of product and presentation will depend on multiple fac- tors including supply availability, price, ease of use, storage and transport requirements, vaccine wastage and missed opportunities for vaccination (e.g. postponing vaccination due to reluctance to open a 10-dose vial for only one or two individuals). The choice of vial size should be based on the number of doses to be delivered at each vaccination point and the number of sessions to be held at each point. The currently prequalified injectable seasonal influenza vaccines are available in single dose pre-filled syringes and in single and 10-dose vials. All the 10-dose vial presentations contain thiomersal as a preservative. However, it may be noted that not all the currently available prequalified products in 10-dose vials have market authorization for storage up to 28 days once opened, and not all products have a vaccine vial monitor (VVM). These aspects should be taken into consideration in selecting the product and presentation. The specifications of each product and presentation should be checked to confirm that they meet the requirements of the programme before a procurement order is placed. Information on WHO prequalified vaccines may be found on the WHO website (see Toolbox 11). Forecasting vaccine demand is an important first step in vaccine procurement. Forecasting demand requires an estimate of the number of health workers who will be targeted for vaccination, the expected vaccination coverage, and an estimate of vaccine wastage. Ideally health workers in both public and private facilities would be targeted for vaccination. This process of estimating the size of the target population for health workers vaccination is likely to be more complex than for other vaccines targeting the general populations. The data to derive such estimates may also be more difficult to find, especially in low and middle-income countries. Toolbox 12 provides resources for estimating the size of the health work force and those that need to be targeted for vaccination. Toolbox 11 Vaccine procurement tools Procurement mechanisms and systems  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_systems (Accessed 14 Mai 2019) Vaccine product, price and procurement (V3P) web platform  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (Accessed 14 Mai 2019) Vaccine market  http://www.who.int/immunization/programmes_systems/procurement/market (Accessed 14 Mai 2019) List of WHO prequalified seasonal influenza vaccines  https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 31 3. Planning and managing vaccination of health workers The global health workforce databases may not carry information on all the health workers catego- ries that may be targeted for vaccination. For example, global databases may only have estimates of the numbers of doctors, nurses and midwives, but not other health worker categories. In such instances, rough estimates could be made based on ratios of those health workers for whom data are not available to those where data are available (e.g. ratio of physicians to laboratory workers). These ratios could be quickly obtained through a survey of a small representative sample (e.g. tertiary, secondary and primary) of health facilities. Since each health facility may be required to prepare beneficiary lists with the names of those targeted for vaccination, for tracking vaccination delivery, and for maintaining records of those vaccinated; the initial demand forecasts could be refined in subsequent years using data from these beneficiary lists and vaccination records. Logistics and cold chain management The handling of influenza vaccine is similar to most other vaccines in the national immunization programmes. It needs to be stored at 2–8 degrees Celsius. Since vaccination of health workers is expected to occur annually during a relatively short window period each year before the onset of the influenza season, a plan needs to be developed to ensure storage and transport of vaccine at the different levels involved in the supply chain during the window period chosen for vaccina- tion. Tools and resources for vaccine forecasting, management and logistics are available on the WHO website (Toolbox 13). The cold chain volume requirement for each WHO prequalified product and presentation are available on the WHO website (please select the vaccine type and click on the links for each individual product and presentation to obtain this information).11 At the health facility level, the focal point responsible for health worker vaccination should ensure that the vaccine doses required in the facility are included in the demand forecast and that sufficient storage space to accommodate the required vaccine doses is available prior to the anticipated date of vaccine arrival at the health facility. 11 WHO prequalified vaccines. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 Toolbox 12 Resources for estimating target population size Global Health Observatory: Health Workforce  http://www.who.int/gho/health_workforce Global Health Workforce Statistics database. Geneva: World Health Organization.  http://www.who.int/hrh/statistics/hwfstats Counting health workers: definitions, data, methods and global results. Geneva: World Health Organization; 2007. ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf Classifying health workers: mapping occupations to the international standard classification ƥ https://www.who.int/hrh/statistics/Health_workers_classification.pdf 32 3. Planning and managing vaccination of health workers Vaccination of health workers Vaccination of health workers should ideally take place at the health facilities where the targeted health workers normally work to ensure convenient access to vaccination. Case study: Using an immunization champion to enhance uptake of influenza vaccination in health workers in Oman Oman has a universal free-of-charge, integrated health care system, which includes influenza vaccina- tion of health workers. Oman is one of the few high-income countries in the WHO Eastern Mediterranean Region (EMR) that has achieved high influenza coverage among health workers (>80%). This was made possible by immunization champions. The minister of health in Oman is passionate about protecting the health of health workers and is at the forefront in taking the first influenza seasonal vaccine. As the patron of health worker community and an influential person in the country, this action has reinforced the importance of vaccination and continually helps promote influenza immunization programs. He has also been personally involved in the communication of vaccination messages to the health worker community. Every health facility should prepare a health facility plan for implementing seasonal influenza vac- cination of health workers well ahead of the influenza season. These plans should include measures to enable convenient access to vaccination for health workers in every shift. Different options may need to be determined at the health facility level to cover health workers during night shifts with- out resorting to 24-hour vaccination services, for example insuring the availability of vaccination just before or after a shift change. A vaccination team should be established at the level of the health facility to coordinate the vac- cination activities and optimize uptake under the overall supervision of the head of the facility. One person should be designated as the team leader. This could be either the occupational safety and health focal points, or the persons responsible for immunization activities in the health facil- ity. In larger facilities the staff medical services may be tasked with this activity. Experience from some organizations and health facilities have shown that using “vaccination champions” from among the health workers may contribute to improving vaccination uptake among their peers. In Toolbox 13 Vaccine management and support resources The resources that can assist programme managers in supply chain and logistics support planning may be found at the WHO website at:  http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ index4.html (Accessed 14 Mai 2019) Overview of technologies for the treatment of infectious and sharp waste from health care facilities ƥ https://apps.who.int/iris/bitstream/handle/10665/328146/9789241516228-eng.pdf (Accessed 14 Mai 2019) 33 3. Planning and managing vaccination of health workers some countries, a mobile team that goes to each clinical area in the health facility and provides vaccination has been successfully used. Training of the vaccination team Training workshops for health facility vaccination focal points should be conducted to conduct training in developing a health facility plan and in implementing and monitoring vaccination activities. A standardized agenda, curriculum, resource documents, checklists and model forms for recording data, as required, should be created at the national level for use in these workshops so that training is uniform across all health facilities. To further ensure uniform training, the workshops could be conducted using teams of trainers who are themselves trained centrally and are assigned to each region/subregion, using a cascade training approach. Short training videos may be used to achieve uniformity in content in the training. Web-based self-learning modules may be considered for those who were unable to attend the training sessions. The health facility vaccination team should have the capacity to classify health worker groups (see chapter 2 for sample risk categorization of health workers) and establish a list of health workers eligible for vaccination, with their designations, and areas of work. Where different vaccination policies apply to different risk categories, either separate lists should be created, or mechanisms established to easily identify and monitor the vaccination status of those in each category. The beneficiary lists should be developed sufficiently in advance of the start of vaccination activities and the relevant health workers informed on the need for vaccination. In addition to health workers employed at the health facility, provision may be made to include health workers in smaller facilities within their catchment area, including private facilities, as per the national policy, should vaccination not be available at all facilities. A mechanism for defaulter tracking and for sending reminders should be established at each health facility. For health workers who come into contact with high risk patients, (e.g. those in organ transplant, oncology, intensive care or perinatal units), the supervisors of those who have not been vaccinated before the start of the influenza season may need to be informed (local confidentiality norms permitting) so that they can reinforce the written reminders or, in case of refusals, get active declination forms signed and institute infection control measures applicable to active refusals, e.g. reassignment of duties, wearing of masks etc. as per the established national of health facility policy. 34 4. Monitoring and evaluation All countries should have a mechanism in place to monitor vaccine coverage as well as adverse events following immunization (AEFI) from the health facility to the national level and conduct at least one influenza vaccine post-introduction evaluation. However, measuring vaccine accep- tance and vaccine effectiveness or impact will be necessary and feasible only in a setting where immunization targets are not reached and if funding is available. Developing and updating information systems Appropriate forms and data entry modules for recording and reporting vaccination data at the health facility level and processes for reporting the data should be established. In developing tools and guidance for data collection, the need to include both public and private health systems should be considered. This may require mapping of existing health information systems and immunization data collection instruments as well as guidance on how these systems may be used to collect data on seasonal immunization of health workers. Data collection systems may vary across health facilities depending on the size and available infra- structure of the facility. However, each health facility must be provided with a standardized data reporting form to ensure that the data required for reporting to the national level are collected, irrespective of the data recording system used. This could include the name of the health worker, the health worker category, area of work, risk category, date of vaccination, the vaccine product and lot number. In developing the data reporting form, the advice provided by the NITAG on monitoring and impact assessment should be considered. All data collection systems, whether paper-based or electronic should have the capability for defaulter tracking and a system for generating and sending out reminders to defaulters. When using such reminder systems, protecting the confidentiality of data on the health and vaccination status of health workers will be critical and access to the data should be restricted to the facility vaccination coordinator. Coverage monitoring Several approaches for estimating health worker influenza vaccine coverage are available. The timing of such coverage measurement is important and should be coordinated with the timing of vaccination in the country. Given that influenza vaccine is usually administered in seasonal campaigns, frequent reporting (e.g. monthly) is recommended. Ideally, assessments should be done at the end of the season, when complete data are available and assessed and data cleaned for any inconsistencies. 35 4. Monitoring and evaluation Health facility registries Information on influenza vaccines administered to health workers should be included in existing records maintained as part of occupational health requirements and in vaccination registers as part of institutional monitoring mechanisms. Careful assessment of data discrepancies is requi- red if reporting is done from multiple sources, and data protection issues should be judiciously considered. The minimum set of data will include the number of people receiving influenza vac- cination during each annual season, the total number of targeted health workers, and the derived vaccination coverage (%). Often both numerator and denominator data can be obtained from the departments of occupational health at health facilities. For establishing more detailed denomina- tors, nominal health worker records e.g. based on payrolls can be used as a first step. A beneficiary list of those targeted for influenza vaccination can be selected from these records by applying criteria related to the health worker’s risk of infection or of transmitting the infection to those for whom they care (see section on “Characterizing the target groups for vaccination” and table 1). Depending on the capacity of the reporting system and program, this could include tallying numbers by health worker category and risk profile to allow coverage estimates by subcategories, such as doctors, nurses, laboratory workers, or staff working in Intensive Care Units or general (e.g. medicine or paediatric) wards, etc. If a vaccination registry does not exist, a crude estimate of coverage among health workers could be calculated by using the number of vaccine doses distributed to each facility minus the number of vaccine doses returned (unused) divided by the estimated number of health workers targeted for vaccination at the facility. A similar, rather imprecise method to assess coverage at the national level would be to use the regularly compiled data on health workers (as reported to WHO) to estimate the denominator (see Toolbox 12), as used for the vaccine demand forecast, and the overall number of vaccines adminis- tered as the numerator. This approach should only be used as a last resort where none of the other methods described are feasible. Administrative data If vaccines are provided free to health workers with government, national insurance system or employers bearing the costs, there may be regular, sometimes mandatory, reporting on the number of health workers who have received vaccinations at the institutional level. Such administrative data may be available from well-documented national vaccine programmes or from health insu- rance records. Surveys Surveys to obtain data on vaccinations and other interventions should be performed every 3 to 5 years and allow the identification of heterogeneity of coverage at the subnational level, important for the necessary adaptation of immunization practices. A representative sample of health workers can be selected though a stratified random sampling approach from national registries of health workers (e.g. professional organizations). If such registries are not available, a two-stage selection of health facilities and of health workers in these facilities can be done. If contact information is available, standardized interviews could be done face-to-face, by phone or via internet-based pla- tforms. Without such information, online survey links could be provided to all health workers in the selected facilities with an invitation to access the survey platform using their mobile phones or personal computers. It should be noted that when using this approach, self-reporting of vacci- nation may lead to overreporting.12 12 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394773/ 36 4. Monitoring and evaluation In all of these approaches to estimate coverage it will be important to specify the categories of health workers, e.g. those with or without direct patient contact, the latter including students, trainees, volunteers, maintenance, information technology, food service staff etc., who have been included in the numerators and denominators. It is also important to specify if part-time personnel working during the influenza season were included in the coverage estimates. Where individuals for whom vaccination is not recommended are vaccinated, such as back office workers or staff relatives, etc., care must be taken not to count these in estimating vaccination coverage. Refusal and completion rates of surveys will need to be monitored and adjustments for possible selection biases made in the analysis. At times, influenza vaccination programs may merely set absolute number targets of health work- ers to be vaccinated, based on the number of vaccines procured and available in a specific area or location. Such an approach, while followed in some countries, will not allow the proper estimation of coverage rates, including coverage by risk category, or comparisons over time, which will be important for interpreting any data on impact. It will also not enable identification of determinants of vaccination or of refusers. If available, data as well as methods used to estimate vaccination coverage for other regular health worker vaccinations should be accessed, e.g. for hepatitis B, measles, polio, pertussis or tetanus vaccines. It must be noted, however, that these vaccines are not provided on an annual basis and will often only be checked at entry to service. Toolbox 14 lists available tools for collecting and reporting immunization data and for estimating coverage. Toolbox 14 Monitoring and evaluation tools and indicators Immunization in practice series, module 7: Monitoring and using your data. Describes how to collect and report data and how to monitor immunization performance. ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf (Accessed 14 Mai 2019) Training for mid-level managers. Module 7: The EPI coverage survey (Document WHO/IVB/08.07). Geneva: World Health Organization; 2008. Provides a step-by-step walkthrough, including relevant guidance and tools, to plan and conduct a coverage survey of a newly introduced vaccine. ƥ http://who.int/immunization/documents/MLM_module7.pdf (Accessed 14 Mai 2019) WHO reference for estimating influenza vaccination coverage among target groups. Outlines different methodologies that can be used to estimate national influenza vaccine coverage among high-risk groups targeted for vaccination. ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing-influenza- vaccination-coverage-target-groups.pdf (Accessed 14 Mai 2019) 37 4. Monitoring and evaluation AEFI monitoring As for any vaccine and target group, a functioning AEFI monitoring system is a basic requirement, since knowledge gaps and misperceptions about influenza vaccine safety among health workers are consistently identified in in the literature. The system utilized to monitor and investigate possible AEFIs when delivering influenza vaccine to health workers should ideally be integrated into existing AEFI surveillance systems in line with national regulations for the monitoring of vaccine safety. The NIP or other departments responsible for health worker influenza vaccination (e.g. occupational health) should work with the National Regulatory Authority to define roles and responsibilities in vaccine safety monitor- ing. In countries using influenza vaccines for the first time, it could be conceivable to intensify AEFI surveillance during the first year of influenza vaccine introduction in order to provide quick feedback to stakeholders to help assure them of the safety of the vaccines in use. A functioning AEFI monitoring system will detect and elucidate problems with vaccines, which could be due to the product itself, its quality, or errors in the administration of the vaccines. All vaccine recipients reported as having an event (including minor events) perceived to be related to the influenza vaccine should be reported to the AEFI surveillance system using standard report- ing forms (see Toolbox 15). Given adequate reporting, the monitoring system should be able to evaluate the observed rate of reactions to influenza vaccine and compare this to the expected rates reported in the literature. For serious AEFIs, causality will normally be assessed by a group of experts. Importantly, and as for any vaccine, such a system needs to be able to identify a previously unknown or unexpected vaccine reaction that should be investigated in more depth. Care must be taken to ensure that coincidental events are not mistaken for vaccine reactions. Toolbox 15 AEFI-related information sources AEFI core variables, including data on case, vaccine, event and reporter ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_Dec2015.pdf (Accessed 14 Mai 2019) Sample form for AEFI recording with detailed description of reporting elements ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (Accessed 14 Mai 2019) Causality assessment of an AEFI: Provides the detailed methodology in a four-step process with access to a related software tool  http://www.who.int/vaccine_safety/publications/gvs_aefi/ (Accessed 14 Mai 2019) Vaccine safety training resources providing access to vaccine and pharmacovigilance training packages  http://www.who.int/vaccine_safety/initiative/tech_support/ (Accessed 14 Mai 2019) Information sheet: observed rate of vaccine reactions – influenza vaccines ƥ https://www.who.int/vaccine_safety/initiative/tools/Influenza_Vaccine_rates_information_sheet.pdf (Accessed 14 Mai 2019) 38 4. Monitoring and evaluation By establishing and enhancing AEFI systems, influenza vaccination can also be used to further improve the awareness of overall immunization safety in the health worker community. Monitoring and evaluation of vaccine acceptance Key determinants of vaccine acceptance among health workers have been investigated and include the desire for self-protection and to protect family and patients. (see also section on communica- tion and vaccine acceptance). As part of an initial situation analysis of health worker influenza vaccination programmes, available information on policy, programmes and practices, the factors affecting acceptance and participa- tion, and the influence of media and communications can be investigated through key informant interviews, or participatory workshops. Results of such an analysis could then be used to inform additional communication strategies addressing the identified concerns in a targeted manner. Other determinants can be explored through formative research. Both qualitative and quantita- tive research methods can be used to evaluate changes in health workers’ knowledge, attitudes, practices and behaviours. Behavioural determinants that differentiate health workers who get vaccinated from those who do not should be assessed regularly. Understanding the reasons and reasoning behind health workers’ attitudes towards annual flu vaccination is useful for the de- velopment of communications messages and products. Involving health workers in behavioural research related to their perceptions, beliefs, emotions and potential conflicts also provides an opportunity for the health worker community to be engaged in the approach, which can result in greater acceptance of the vaccination program. Vaccine impact monitoring After an influenza vaccine has been introduced in a population, additional studies may help in evaluating the impact of the immunization program. However, WHO does not recommend that vaccine impact or effectiveness studies be conducted by all countries with influenza vaccination programs, given their complexity and expense. A number of research networks worldwide conduct such studies and results can be expected to be applicable in Toolbox 16 Tools to assess vaccine acceptance among health workers TIP-FLU tool. Provides an approach and tools grounded in behavior change theories and health programme planning models to tailor seasonal influenza vaccination to the needs and attitudes of frontline HWs.  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) TIP FLU case study Montenegro. Provides a practical example of the use of the TIP FLU tool. ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization-Pro- grammes-Seasonal-Influenza-TIP-FLU.pdf (Accessed 14 Mai 2019) 39 4. Monitoring and evaluation other settings with similar influenza epidemiology and vaccination programs. The decision to carry out such studies should therefore be based on the need for country-specific estimates and on the local capacity to conduct such rigorous studies. If studies are not appropriately designed with adequate sampling of different health worker categories, there is a risk of arriving at wrong conclusions. Before-after studies to demonstrate vaccine effectiveness are not advised for influenza, given that influenza vaccine effectiveness for preventing influenza symptoms in seasonal influenza epi- demics display considerable heterogeneity.13 Studies to evaluate the impact of seasonal influenza vaccination in health workers can be even more complex, given the varying risk of infection and transmission to patients among different categories of health workers. In health workers, a general reduction in absenteeism or, if available, reduction in influenza-asso- ciated absenteeism is often used as a surrogate indicator for the impact of an influenza vaccination programme. For this, health facility institutional monitoring would need to include disease rates in health workers, and a measure of sickness absence. Where possible, reporting days of absenteeism due to influenza-like illness (ILI) (or respiratory infections) should be recorded. This will include self-reported ILI with or without virological confirmation. Other non-specific outcomes include severe acute respiratory infection (SARI) and all-cause pneumonia requiring hospitalization. It is important to note that all these clinical syndromes include various other respiratory pathogens against which influenza vaccine does not protect. If such assessments are done, they should ide- ally cover multiple seasons, since impact can vary substantially by season, else such studies will be quite difficult to interpret. Laboratory-confirmed outcomes (e.g. by RT-PCR and other molecular diagnostic tests) improve the specificity of influenza disease classification. Where possible, establishment of sentinel sites with such capacity could be considered for collecting samples from health workers for laboratory confirmation. In these sites, vaccine effectiveness could be assessed using a case-control design and comparing vaccine coverage in laboratory-confirmed versus test-negative cases, if vaccine coverage is sufficiently high. Any of these approaches require sophisticated laboratory capacity which is not available everywhere. The screening method is a study design which could also be used for health worker vaccine im- pact assessment: it uses individual-level data on vaccination history from cases and data on vac- cination coverage in the health worker population from which the cases came. However, such a study requires accurate information on the vaccination status of the cases and of health worker vaccination coverage. Given the indication that annual influenza vaccination for health workers could reduce illness among the patients they care for, studies can be designed to evaluate the effect of health worker influenza vaccination on mortality, hospitalization, and influenza cases in patients of healthcare facilities. Several research approaches have been used in this context such as randomized trials or case-control approaches. Given the complexity of study designs, the conduct of such studies should be limited to research institutions that have the capacity and experience to conduct such studies. Economic assessments and cost-effectiveness evaluations may be considered once sufficient cost and impact data are available following influenza vaccine introduction. WHO provides a number of relevant resource documents, which are being further developed to specifically estimate vaccine 13 Evaluation of influenza vaccine effectiveness: A guide to the design and interpretation of observational studies, WHO 2017. 40 4. Monitoring and evaluation introduction costs for health worker vaccination (Toolbox 17; see also Toolbox 2). Relevant data are not easily available everywhere and assessments can be difficult to perform, given the limited size of the group of health workers. Post-introduction evaluation National Immunization Program Reviews routinely assess the use of specific vaccines about every 5 years following a new vaccine introduction. Such NIP Reviews should include relevant items to identify possible programmatic areas related to the new vaccine use. As needed in-between NIP Reviews, a specific influenza-related Post-Introduction Evaluation (I- PIE) tool may be performed after the first or second influenza immunization season. The I-PIE package (Toolbox 18) includes a number of tools to support the planning and conduct of the evaluation, including standard questionnaires and data collection forms in paper or electronic format as well as reporting templates together with instructions on how to perform the I-PIE in a cost-efficient manner. These tools will need to be adapted to the specific country context and to the specifics of the vaccine formulation and presentations. The I-PIE is performed at all levels of the health system and includes observation of practices at the points of vaccine administration, vaccine storage areas as well as data and record reviews. An I-PIE can thus provide a more immediate approach to assess the programmatic challenges and impact of influenza vaccine use, and to compare results across countries, enabling them to share and learn from each other’s experiences. Toolbox 17 Influenza in health workers: Study methodologies Evaluation of flu vaccine effectiveness 2017. Provides detailed information for researchers who design observational influenza vaccine effectiveness studies and for public health scientists who interpret and apply the results of these studies. An annex will address the effectiveness of influenza vaccine in health workers. ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (Accessed 14 Mai 2019) Manual for estimating disease burden associated with seasonal influenza. Provides step-by-step approach to estimate influenza disease burden in the general population as well as those with specific conditions who are vulnerable to severe disease.  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (Accessed 14 Mai 2019) Toolbox 18 Influenza post-introduction evaluation tools I-PIE tool with instructions and recording and reporting templates  https://www.who.int/immunization/research/development/ipie_influenza_post_introduction_ evaluation (Accessed 14 Mai 2019) 41 References [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination accep- tance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during preg- nancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are count- ries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evi- dence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare wor- kers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-ana- lysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13(6):e0198685. 42 [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care wor- kers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epide- miol. 2002; 23(10):615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influen- za-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kin- dergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial out- break of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a mul- ti-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 43 [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vacci- nation of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12(1):e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vac- cination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection cont- rol and hospital epidemiology. 1998; 19(7):518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward man- datory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62(1):1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 44 [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing inter- vention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccination: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36(2):196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, ado- lescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertive- ness. N Engl J Med. 2019 Jan24; 380(4):309–11. 45 Annex 1. Sample non-participation form This form is to be used in cases of voluntary vaccination where health workers in the very high or high-risk categories who decline to participate in assessment, screening and vaccination in accordance with the national policy. Completion of the form is particularly important where failure to get vaccinated will result in reassign- ment or require the use of protective measures to protect patients as specified in the national policy. Non-participation in vaccination 1. I have read and understood the policy directive regarding seasonal influenza vaccination of health workers. 2. I decline to participate in vaccination against influenza. 3. I am aware of the potential risks to myself and/or others that my non-participation in vaccination may pose. 4. I am aware that my non-participation may result in my being reassigned to a non-high-risk area or in other requirements to protect others with whom I may come in contact, as per the national policy. 5. The reason for my non-participation is: Refusal to sign In circumstances where the health worker refuses to sign this form, it should be noted on the form and the health worker should be notified of consequences, if any, as per the policy. Name of health worker: Date of birth: Health service/ facility: Work area: Signature: Date: OFFICE USE ONLY I have discussed the potential risks that non-participation in vaccination may pose and the management of unvaccinated workers in accordance with the vaccination policy. Name of vaccination team staff: Designation: Health facility /agency: Signature: Date: 46 Annex 2. Complementary checklist for planning health worker immuniza- tion: national14 level (To be adapted for local use) To account for the specifics of seasonal influenza vaccination of health workers, the following ADDITIONAL elements may be added to the generic new vaccine introduction check list, see Annex 4 of the document “Princi- ples and considerations for adding a vaccine to a national immunization programme” for the checklist structure. Health worker seasonal influenza vaccination policy 1. National policy on seasonal influenza vaccination of health workers are published and dissemi- nated to all relevant agencies and health facilities, including private health facilities and relevant professional societies. 2. The policy on seasonal influenza vaccination of health workers is reflected in the national occupational health policies. 3. The costs of seasonal influenza vaccination of health workers are included in either the immu- nization or occupational health budget, as appropriate. 4. Surveillance system is in place for influenza activity, including defining start and end of the influenza season, to inform selection of the most appropriate vaccine formulation and timing of influenza vaccination. Planning for successful vaccine introduction 5. A functional multidisciplinary coordination group is in place to discuss and promote access to a new target population of health workers, enabling the formation of partnerships which support and shape the national agenda. 6. The group includes focal points from the occupational health and immunization programs, professional organization representatives, and other relevant stakeholders. 7. A costed operational plan for health worker vaccination is developed and integrated into the na- tional immunization plans and relevant occupational health plans. Formative research (optional and to be included only if formative research is planned) 8. The need and scope of any formative research to be conducted in preparation for vaccine introduction is defined. 9. A research group to conduct formative research has been identified and terms of reference for the research has been developed. Communications 10. National communications working group established for planning communications strategy and developing communications materials for health worker vaccination against seasonal influenza. 14 In some countries, especially large countries with decentralized system, elements of this checklist may also apply at relevant subnational levels, e.g. provincial level. 47 11. Tailored communications messages and materials developed along with an overall communications strategy. 12. Training for health facility communications teams is conducted. Vaccine procurement and supply chain management 13. Target population size estimate developed and included in demand forecast. 14. Individual health facility demand estimated, and vaccine distribution plan developed. 15. Sufficient storage space for vaccines and supplies for seasonal vaccination at all levels established to accommodate vaccine during vaccination period. Vaccine Delivery 16. Health facility vaccination delivery teams are established and trained. 17. System for management of vaccination refusals and implementation of infection control mea- sures in place for prevention of nosocomial transmission, e.g. reassignment, wearing of masks, mandatory leave in case of ILI. Monitoring and evaluation 18. Data recording and reporting tools developed and distributed including for coverage monitoring (updated administrative data and health worker surveys) and AEFI monitoring. 19. Post-introduction evaluation conducted within the first 2 seasons following vaccine introduction. 20. Possibilities reviewed for operational research to assess health worker vaccine acceptance. 48 Annex 3. Health facility checklist (To be adapted for local use) Person responsible Deadline Status Communications 1. Health facilities communications working groups are established and trained 2. Health facility communications plan and schedule for group communications with health workers finalized 3. Adequate supplies of posters and information materials for health worker vac- cination are available 4. Notification of vaccination sent out to targeted health workers and supervisors 5. Telephone hotline established to address individual queries from health workers Storage capacity for vaccines and supplies 6. Adequate storage capacity for influenza vaccines and supplies during vaccination window period established 7. Adequate supplies of influenza vaccines and supplies for health worker vaccination available 8. Provision to deal with extra injection waste during period of vaccination Vaccine Delivery 9. Vaccination delivery team established and trained and vaccination sites within health facility finalized 10. Categorization of health workers completed and beneficiary list for vaccination developed 11. System for management of vaccination refusals and implementation of infection control measures in place for prevention of nosocomial transmission, e.g. reas- signment, wearing of masks, mandatory leave in case of ILI Monitoring and evaluation 12. Data recording and reporting instruments available taking into account data protection issues 13. System for defaulter tracking and reminders established 14. Health facility registries updated to include influenza vaccination 15. AEFI monitoring and reporting systems updated to identify AEFI in health workers 16. Vaccine acceptance monitoring system to address uptake issues in health workers established (if uptake issues are observed) 49 Annex 4. Sample questionnaire for conducting a survey among health workers 1 Name (optional) 2 Age (years) 3 Sex ¨ Male ¨ Female 4 Job category15 ¨ Doctor ¨ Nurse/midwife ¨ Laboratory technician ¨ Other technical staff ¨ Other (specify) 5 Patient contact ¨ Direct ¨ Face-to-face but not direct ¨ None 6 Contact with high risk patients ¨ Yes ¨ No 7 Work area (name of clinical area of work) Statements Strongly agree Agree Neutral Disagree Strongly disagree 1 Vaccination of health workers against diseases such as hepatitis B and influenza are important 2 If I was unvaccinated exposure to influenza would be a risk to my health 3 Exposure to influenza poses a risk to my patients’ health 4 Influenza vaccination poses a risk to my health 5 The benefits of vaccination are greater than the risks 6 My receiving vaccination will protect my patients 7 The best way to protect my patients is to combine seasonal influenza vaccination with other infection control measures 8 I am sufficiently informed about risks of influenza infection I am sufficiently informed about the risks and benefits of influenza vaccination The following factors that would influence my decision to accept vaccination 9 Recommendations from the national policy-making body (e.g. NITAG) 15 Adapt for local use based on local health worker classification. 50 10 Endorsement of recommendation from the professional society to which I belong 11 If it is part of occupational health regulations/ requirements 12 Recommendation from my personal physician 13 Availability of vaccination at no cost to me 14 Easy access to vaccination at my place of work 15 Colleagues having been vaccinated 16 Previous experience with vaccination 17 Protecting my patients 18 Preventing/reducing absenteeism from work 19 Contributing to pandemic preparedness Other factors that would affect my decision to accept influenza vaccination (list below) 20 21 22 51 Annex 5. Communications and demand generation: Stratification of approaches to developing the content Approach Effort Impact Developing the content for communication messages Framing information by delivering social comparison feedback on vaccination rates among peers or healthier individuals Low Medium Tailored communication based on cognitive styles and cultural behaviours Medium High Communication methods Distribution and display of Information, Education and Communication (IEC) materials Low Medium Establish a specially trained communications team at health facility level to administer communications and demand generation approaches Medium High Web-based (including FAQs and chat groups) and social media communications Medium Medium Text message and e-mail reminders to health workers Low Medium Small group in-person briefing meetings High Medium Use immunization champions at national and health facility level Medium High Demand generation approaches Provision of free vaccines Medium High Provide vaccination in the work area using mobile teams Medium High Provide incentives or stimulate competition, e.g. awards to clinical areas with highest vaccination coverage Low Medium Visible reminders and peer-pressure, e.g. badges or stickers worn by those who have been vaccinated Low Medium Ask individual to commit to a time and location to obtain vaccination Low Medium Increase options to obtain vaccination, either near home or at workplace Medium High Guide choice through default options, e.g. automatically set up appointment for vaccina- tion unless individual opts out Low High Establish standing orders to facilitate vaccination Medium High 52 ISBN 978-92-4-151559-7

1An introduction manual for national immunization programme managers and policy makers How to implement seasonal influenza vaccination of health workers Family, Womens’s and Children’s Health (FWC) DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS This document was produced by the Initiative for Vaccine Research (IVR) of the Department of Immunization, Vaccines and Biologicals How to implement seasonal influenza vaccination of health workers ISBN 978-92-4-151559-7 Published: May 2019 This publication is available on the Internet at: https://apps.who.int/iris/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: + 41 22 791 4227 • Email: vaccines@who.int © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following dis- claimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. How to implement seasonal influenza vaccination of health workers. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. IAcknowledgements This manual was developed by Thomas Cherian and Carsten Mantel, MMGH Consulting and Philipp Lambach (WHO/IVR) with review and inputs of an Independent Expert Advisory Group: Salah Al Awaidy, Silvia Bino, Joseph S. Bresee (chair), Supamit Chunsuttiwat, Daouda Coulibaly, Luzhao Feng, Rachel Hale, Shabir A. Madhi, Helena C. Maltezou, Kelly Moore, Jonathan Nguyen- Van-Tam, Saad Omer, Gregory Poland, Sabine Wicker. Kelly Moore and Chris Morgan were consultant as representatives of the WHO Immunization Practices Advisory Committee, IPAC. Consultants: Thomas Cherian, Carsten Mantel. Additional experts: Birte Bödeker, Susan Y. Chu, Sara Hamid, Kathryn Lafond, Kathleen Morales, Julia Neufeind, Susan Wang. WHO: Philipp Lambach, Onyema Ajuebor, Ms Phionah Lynn Atuhebwe, Philip Gould, Shalini De- sai, Julia Fitzner, Martin Howell Friede, Shoshanna Goldin, James Dawson Heffelfinger, Raymond Hutubessy, Ivan Dimov Ivanov, Pernille Jorgensen, Melanie Marti, Hasan Qamrul, Lisa Menning, Ann Moen, Liudmila Mosina, Andreas Alois Reis, Alba Maria Ropero Alvarez, Claudia Steulet, Nadia Teleb. Financial support for the development and pilot-testing of this manual is provided through the Centers for Disease Control and Prevention (CDC), which provides financial support to the World Health Organization Initiative for Vaccine Research (U50 CK000431). II Contents Executive summary 1 About this manual 2 Objective 2 Audience 2 Structure of the document 3 Key related documents 4 1. Background and rationale 5 Current status of influenza vaccination in health workers 5 Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers 6 Evidence for health worker risk of influenza and impact of vaccination 6 Evidence of transmission of infection from health workers to patients and the impact of vaccination 7 Evidence for interventions to increase health worker vaccination uptake 7 Global Action Plan for Influenza Vaccines 8 2. Establishing a policy to vaccinate health workers against seasonal influenza 10 The decision-making process 10 Considerations for decision-making 12 Defining the public health objectives for vaccination 12 Economic analysis for establishing national policies 13 Characterizing the target groups for vaccination 14 Framing an immunization policy for health workers 15 Integration with Occupational Health Policies 18 Choice of vaccine product, schedule and timing of vaccination 18 Defining monitoring and disease impact measurement objectives 20 III 3. Planning and managing vaccination of health workers 21 Planning for successful vaccine introduction 21 Costing and financing 22 Formative research to inform the planning process 24 Communication and vaccine acceptance 25 Communications at the health facility level 26 Demand Generation at the Health Facility Level 28 Vaccine procurement and supply chain management 30 Vaccine procurement 30 Selection of the vaccine product and presentation 30 Logistics and cold chain management 31 Vaccination of health workers 32 Training of the vaccination team 33 4. Monitoring and evaluation 34 Developing and updating information systems 34 Coverage monitoring 34 AEFI monitoring 37 Monitoring and evaluation of vaccine acceptance 38 Vaccine impact monitoring 38 Post-introduction evaluation 40 References 41 Annex 1. Sample non-participation form 45 Annex 2. Complementary checklist for planning health worker immunization: national level 46 Annex 3. Health facility checklist 48 Annex 4. Sample questionnaire for conducting a survey among health workers 49 Annex 5. Communications and demand generation: Stratification of approaches to developing the content 51 1Executive summary Health workers are at higher risk of influenza infection than the general population. In addition to morbid- ity among health workers, influenza infection may also lead to increased absenteeism, presenteeism1 and disruption of medical services. Moreover, influenza infected health workers may contribute to nosocomial transmission of infection to their patients, including those at high risk for developing severe influenza disease and complications. Hence, the World Health Organization (WHO) considers health workers to be a priority target group for seasonal influenza vaccination. In addition, influenza vaccination of health workers contributes to influenza pandemic preparedness. Finally, studies have shown that health workers who are vaccinated against influenza themselves are more likely to recommend vaccination to their patients. This manual serves as a resource to assist users in establishing a national policy for seasonal influenza vaccination of health workers. It provides guidance along with a catalogue of available tools to facilitate policy development, planning, implementation, monitoring and evaluation of influenza vaccination of health workers. The contents of the manual are meant to supplement the document titled “Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring”, published by WHO in 2014. The main target audiences for this manual include national policy makers; national health planners; the na- tional programme managers for immunization and occupational health; and those responsible for occupational health, health worker immunization and infection control in health facilities. Close collaboration between immunization managers, and occupational health and infection control programmes is essential to optimize vaccine uptake, and for a cohesive and comprehensive approach to influenza control in health facilities. This manual summarizes the evidence and rationale, provides guidance on key issues, and lists available tools for influenza vaccination of health workers, covering three main components of vaccine introduction and management: 1. Establishing an evidence-based national policy for seasonal influenza vaccination of health workers. 2. Planning and management of health worker influenza vaccination. 3. Monitoring and evaluation, including assessing vaccination coverage, monitoring for adverse events following immunization, impact assessment and post-introduction evaluation. Complementing this manual, deliberations of an Independant Expert Advisory Group developing this manual are available in form of a meeting report summarizing critical issues. These include policy con- siderations, the evidence in support of health worker vaccination; categorization and prioritization of health workers; the choice of vaccination strategy; its integration into broader health worker vaccination and occupational health policies; planning and management of vaccination, particularly the approaches for communication and demand generation; and the challenges with monitoring and evaluation of health worker vaccination, especially in low and middle-income countries.2 1 Presenteeism refers to health workers who work while ill, yet have reduced accuracy and effectiveness and pose a risk to vulnerable patients in their care. 2 Cherian T. et al. Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16–17, Berlin, Germany. Vaccine. 2019;37(43):6255–6261. 2About this manual Objective This manual serves as a resource and catalogue of available tools to assist country officials in de- ciding upon, planning, implementing and monitoring health worker influenza vaccination in order to achieve optimal vaccination coverage. It is not meant to be a prescriptive document, but rather articulates general principles and key considerations to support policy formulation; plan- ning and management of vaccination; and monitoring and evaluation of influenza vaccination of health care workers. The manual also outlines measures to ensure integration of health worker influenza vaccination into existing national occupational health policies and occupational safety and health management systems of health facilities. It also addresses the opportunity for health worker influenza vaccina- tion to promote an integrated approach for monitoring and optimizing the uptake of all interven- tions included in national occupational health policies. In addition, it refers to the relationship and contribution of health worker vaccination to pandemic influenza preparedness. Seasonal influenza vaccination in health workers differs from other vaccine-preventable diseases in that vaccination is required annually. However, elements of this manual may be of relevance for health worker vaccination in general, particularly the sections on planning and management of vaccination and on monitoring and evaluation. Audience The main target audience for the manual include: 1. National policy-making bodies and health planners. 2. Programme managers for immunization, infection control and occupational health programmes at national and subnational levels and those responsible for occupational health and infection control in health facilities. 3. Organizations of health workers and employers. While the different sections of the document may be of greater relevance to one or the other group, it is advisable that the document be read as a whole because of the information on a particular topic may be found in the different sections of the manual. The document may also be useful to other audiences with an interest in immunization or occu- pational health. 3Structure of the document The manual consists of four sections as outlined in Figure 1. However, for clarity and complete- ness there is some overlap between some of the sections, with cross-references made to the other relevant sections. Figure 1. Structure of the document Establishing a policy Planning & management of vaccination Monitoring & evaluation Introduction, background and rationale •About the manual, including objectives and target audience •WHO policy recommendations on influenza vaccination •Current status of health workers vaccination •Summary of evidence to support health worker vaccination •Global Action Plan for Influenza Vaccines •Considerations for making a decision •Defining the objectives for vaccination •Categorization and prioritization of health workers •Framing an immunization policy • Integration with Occupational Health Policies •Choice of product and timing for vaccination •Delivery options and strategies to optimize coverage •Defining monitoring and impact assessment objectives •Planning for successful vaccine introduction •Costing and financing •Formative research to inform planning process •Communication & vaccine acceptance •Demand generation at the health facility •Vaccine procurement and supply chain management •Vaccination of health workers •Training of vaccination team •Coverage monitoring •AEFI monitoring •Vaccine acceptance assessment •Vaccine impact monitoring •Post-introduction evaluation POLICY MAKERS IMPLEMENTERS 4Key related documents The following documents are important resource materials that complement the guidance in this manual. 1. The WHO policy recommendations on seasonal influenza vaccination, including health worker vaccination are published in WHO Position Papers. These position papers are peri- odically updated. Vaccines against influenza: WHO position paper – November 2012 https://www.who.int/wer/2012/wer8747.pdf (Accessed 14 Mai 2019) Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (Accessed 14 Mai 2019) 2. The following document provides detailed guidance to countries that already provide sea- sonal influenza vaccination to health workers on how to identify, analyse, and effectively target issues related to uptake: Tailoring immunization programmes for seasonal influenza (TIP FLU). A guide for increasing health care workers’ uptake of seasonal influenza vaccination (2015). Copenhagen: World Health Organization Regional Office for Europe; 2015. http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) 3. While the contents of this manual can help inform national policies, the manual does not provide an exhaustive review of the available evidence to inform decision-making. A more detailed review of such evidence in support of vaccination of health workers is found in the following document: Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. July 2019. https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (Accessed 12 July 2019) 4. This manual is part of a series of introduction manuals on seasonal influenza vaccination developed by WHO. A manual on the implementation of influenza vaccination of pregnant women has been published earlier. How to implement influenza vaccination of pregnant women: an introduction manual for national immunization programme managers and policy makers. http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (Accessed 14 Mai 2019) 51. Background and rationale Health workers are at risk of influenza virus infection and of transmitting infection to patients under their care who may be at high risk for severe disease, complications, and death (1). The increased risk in health workers compared to the general population may vary by occupation or setting (2). WHO considers health workers to be an important priority group for influenza vaccina- tion, not only to protect themselves and maintain essential health-care services during influenza epidemics, but also to reduce the spread of influenza to vulnerable patient groups with whom they come into contact (1). Furthermore, many studies have found that a strong recommendation from health workers, especially from physicians, is highly likely to increase public uptake of vaccination (3–5). Health workers who have themselves been vaccinated are more likely to be knowledgeable about vaccination and be more effective in improving public acceptance of vaccination (3–5). Fi- nally, because health workers are likely to be targets of vaccination programs during an influenza pandemic, establishing functional programs for seasonal influenza vaccination of health workers will facilitate timely and effective vaccination during a pandemic (6). Current status of influenza vaccination in health workers Global adoption of a policy for influenza vaccination of health workers has been slow. In 2017, only 119 of the 194 countries reporting having a national influenza vaccination policy. Of these, 96 report targeting health care workers as a priority group. However, the proportion of Member States that reported having a policy varies by WHO region, with the majority of countries in the WHO regions of the Americas, Europe and Eastern Mediterranean reporting a national policy for influenza vaccination, whereas a lower proportion of countries report having such a policy in the Western Pacific, African and South-East Asian regions. Information on influenza vaccination coverage in health workers is not available for most coun- tries, though it varies widely and is reported to be low in many countries where such data are available. For example, data on coverage in health workers were available from only 26 (56%) countries in the European region for the 2014–15 season. The median coverage was 29.5% with a range of 2.6% to 99.5%; only three countries, namely Albania, Armenia and Belarus, reported coverage > 75% (7). More recent data from a systematic review through compulsory reporting from all hospitals in England showed an uptake of 69% in the 2017–18 season.3 An internet survey of 2000 health workers in the United States demonstrated coverage to be 78% during the 2017–18 season, with higher coverage rates (95%) among those working in settings where they were required by their employers to be vaccinated (8). Higher vaccination coverage rates are reported when man- datory vaccination policies are implemented. In one systematic review that included eight studies, coverage rates exceeding 94% were achieved in all (9). 3 Seasonal influenza vaccine uptake in healthcare workers (HCWs) in England: winter season 2017 to 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/Sea- sonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf (Accessed 14 Mai 2019) 61. Background and rationale Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers A rapid evidence appraisal of materials available in the English language, published since 2006, and considered to be of medium or high quality, was conducted by WHO (10). The questions considered, and the main findings of this appraisal are summarized here. Readers are referred to the published report for the details and for the relevant citations. The review considered three issues, namely: 1. The evidence that health workers are at increased risk of influenza infection compared to the general population, and that vaccinating them reduces influenza or absenteeism and/or the wider economic impact of influenza in the health workforce. 2. The evidence that health workers transmit influenza to their patients in health care set- tings and, if so, whether vaccination protects the patients and the proportion of health workers who need to be protected to obtain this effect. 3. The evidence for successful practical interventions to increase vaccination uptake and the state of knowledge of social, behavioural and public health public policy research on vaccination uptake in health workers. Evidence for health worker risk of influenza and impact of vaccination Studies comparing the risk of influenza infection in health workers compared to the general population are challenging, may measure different outcomes, or are executed in different set- tings, limiting the comparability across studies or the pooling of data from these studies. Recent systematic reviews suggest that health workers are at an increased risk of influenza infection compared to the general population (Odds Ratio = 2.08, 95% CI = 1.73 to 2.51) (2), though the evidence is strongest for asymptomatic laboratory-confirmed infection (11). However, health work- ers with asymptomatic infection may still transmit influenza virus to highly vulnerable patients in a health-care setting. Respiratory illness is reported as a common cause of absenteeism among health workers. Epidem- ics or pandemics of influenza have been associated with increased rates of absenteeism among health workers (12). Vaccine efficacy in health workers has been shown to be as high at 90% for well-matched seasonal influenza vaccines (13, 14), which suggests that vaccination of health work- ers will reduce influenza-related morbidity and absenteeism. A systematic review showed a pro- tective effect against laboratory confirmed influenza and shorter absenteeism due to influenza- like illness (ILI) in vaccinated groups (15). A recent study among health workers in the United Kingdom showed that a 10% increase in vaccination uptake is associated with a 10% decrease in absence due to illness (12). However, there are observational studies that provide conflicting results – though often constrained by poor study design, non-specific outcomes, high risk of bias, and failure to adjust for confounding factors (16–19). Since the risk of illness following infection is based on the level of exposure, and absence behav- iours may vary between different categories of health workers, it is possible that the lack of suf- ficiently granular data on absenteeism, e.g. stratified by health worker categories, may account for the mixed results seen in the different studies. On the other hand, the lack of impact on 71. Background and rationale absenteeism observed in some studies, despite evidence of increased rates of infection in health workers, raises the question as to whether health workers nonetheless continue to work when infected and lead to heightened concerns about the consequent risk of nosocomial transmis- sion (20). Several studies have documented presenteeism in health workers with influenza-like illness (21–23), including one instance which was associated with nosocomial transmission in an oncology unit (24). Evidence of transmission of infection from health workers to patients and the impact of vaccination Epidemiological studies using molecular subtyping approaches demonstrate evidence of transmis- sion from health workers to patients. The use of automated collection of high-resolution contact data using wearable sensors combined with virologic data have allowed the identification of potential routes of transmission in cases of hospital-acquired influenza (25). The extent of direct transmission from health worker to patient in health care settings is difficult to capture because of the constant influx of visitors, interactions between patients, and the possibility of multiple simultaneous introductions of influenza (26–28). However, among those who may contribute to transmission of infection in the health care setting, health workers represent a sizeable vaccine- preventable portion since they are easier to target for vaccination. The direct patient benefit of health worker vaccination can be measured in several ways, as il- lustrated in the literature. Several studies evaluate the impact on laboratory confirmed influenza, while others evaluate impact on non-specific outcomes such as ILI, respiratory illness, all-cause mortality, respiratory illness associated mortality, or incidence of nosocomial influenza infection. The evidence is stronger for non-specific outcomes such as ILI, all-cause mortality (29), and inci- dence of nosocomial influenza infection (30, 31). Although some studies have attempted to mea- sure the number of health workers that need to be vaccinated for optimal protection, the evidence in support of a coverage threshold is weak, leading to disputes in the literature (32). However, it is likely that patient protection is positively associated with increasing health worker vaccination coverage but would also depend on other factors including the type of patient contact, vulnerability of the patient, use of other infection control measures, and the effectiveness of vaccination in a particular influenza season (33–35). Evidence for interventions to increase health worker vaccination uptake There is a substantial body of evidence on successful interventions to increase health worker in- fluenza vaccination uptake, much of which has been incorporated into existing toolkits aimed at increasing vaccine uptake. Although the factors that contribute to the health worker decision-making pathway are diverse, some strategies appear to be more effective than others. No single intervention has been shown to rapidly and substantially increase and sustain vaccination uptake except for mandatory vaccina- tion. However, mandatory health worker vaccination is an issue that has been extensively debated with many different perspectives for and against its use (20, 32, 36). Successful mandatory vac- cination programmes require organizational and educational efforts to secure employee support prior to implementation (37). 81. Background and rationale A combination of one or more “soft mandates” such as active declination, required surgical mask use and exclusion of non-vaccinated staff from working with highly vulnerable patients may be used as alternatives to mandatory vaccination, although there are organizational, educational, monitoring and enforcement, and human and financial resource implications for applying such soft mandates. Additional components that contribute to increased uptake include the following: • Provision of free vaccine; • Convenient access to vaccination, including on-site vaccination in health facilities; • Knowledge and behaviour modification through education, reminders, and incentives tailored towards different health worker categories; • Management and organizational approaches such as personnel assigned to oversee vac- cination activities. The reasons for low vaccination uptake are heterogenous and vary across different health worker categories and cultures. Therefore, approaches to increase uptake need to be tailored for different groups. Some studies have demonstrated that formative research, including surveys and qualitative research, can provide insights that assist in tailoring interventions to optimize uptake. Conclusion Despite the ongoing debate in the literature, influenza vaccination is important for ensuring the safety of health workers, their patients, and the general population who rely on a functioning health system, especially during epidemic/pandemic periods. Studies to conclusively establish the value of health worker vaccination will be chal- lenging though the emerging data on this issue will be closely monitored to inform any changes to existing WHO policies.4 Global Action Plan for Influenza Vaccines In an influenza pandemic, most of the world’s population will be highly susceptible to infection and it is likely that infection will spread rapidly. Vaccination is considered one of the key strategies to mitigate the potential impact of a pandemic. While it is expected that there will be a delay in the development of strain-specific pandemic vaccines, insufficient production capacity will further restrict the global access to the vaccines, at least in the early phases of the pandemic. Resource- constrained countries, especially those that lack local vaccine production capacity and those that do not have seasonal influenza vaccination policies, will face the greatest challenge in securing timely access to vaccines during a pandemic, and mitigating the substantial adverse effects of a pandemic. 4 A working group of the WHO Strategic Advisory Group of Experts (SAGE) on immunization will be reviewing the emerging data and updates to the existing WHO recommendations are expected in 2020. 91. Background and rationale To address this challenge a Global Action Plan for Pandemic Influenza vaccines was developed by WHO with short, medium and long term-strategies aimed at increasing influenza vaccine production and surge capacity before and during an influenza pandemic (38). The plan proposed three approaches to enhance access to pandemic vaccines: (i) an increase in the baseline use of seasonal influenza vaccination; (ii) an increase in global production capacity; and (iii) further research and development. The first of the above three approaches relies on countries establishing clear and effective immu- nization policies to increase the baseline use of seasonal influenza vaccines – providing industry with better demand forecasts and stimulate increased production capacity. While vaccination of health workers will only result in a modest increase in overall vaccine de- mand, it will establish a robust and functional platform for rapidly immunizing health workers and could contribute to achieving high coverage in the event of a pandemic, thereby protecting health service delivery during a pandemic. Furthermore, high uptake of vaccination by health workers is likely to build trust and increase the uptake of vaccination among other high-risk groups tar- geted for seasonal influenza vaccination in national policies. Health worker vaccination may also establish or strengthen processes that would allow rapid deployment of pandemic vaccines. Thus, seasonal influenza vaccination of health workers goes beyond the issue of immediate protection against seasonal influenza as outlined above and contributes to pandemic influenza preparedness. 10 2. Establishing a policy to vaccinate health workers against seasonal influenza The decision to establish a policy to vaccinate health workers against seasonal influenza should be evidence-based, with a clear rationale, and with the required investments for sustainable implementation. The general principles and considerations for adding a vaccine to a national im- munization programme are articulated in the 2014 WHO guidance document titled “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: From Decision to Implementation and Monitoring” (39). Health workers comprise a target population not usually included in the national immunization programmes of many low and middle-income countries. While hepatitis B vaccination pro- grammes for health workers may exist, influenza vaccines are unique since vaccination for the foreseeable future must be repeated annually. This section of the manual deals primarily with additional considerations specific to annual seasonal influenza vaccination of health workers, building on the generic framework provided by the document cited above. The decision-making process As with any other vaccine for which policies have to be established, Ministries of Health (MoH) would request National Immunization Technical Advisory Groups (NITAGs) or equivalent na- tional or regional bodies to conduct a review of the evidence and provide advice on establishing a policy for seasonal influenza vaccination of health workers, and to make recommendations on the content of the vaccination policy. Engagement of the many stakeholders affected by this policy is essential to secure their endorse- ment and facilitate high vaccination uptake, and is likely to result in a more coordinated approach to the control of influenza in health facilities. Stakeholder consultation should be broadly sought and include: 1. Professional associations and societies representing different health worker groups such as medical, nursing and allied health service associations, as well as representatives of private health care providers; 2. Medical and nursing councils and other health worker regulatory bodies; 3. Patient safety groups, where they exist, and organizations representing patients, since health worker immunization should also be regarded as a patient safety and quality of care issue; 4. Health worker unions, where they exist and when their participation is likely to be use- ful in promoting vaccination uptake. 5. Health facility managers. 11 2. Establishing a policy to vaccinate health workers against seasonal influenza The process should also include early engagement with the bodies that establish occupational health policies and regulations to ensure that the policies established for health worker vaccina- tion against influenza are also reflected in the national occupational safety and health policies. If vaccination policies for health workers exist for other vaccines, e.g. hepatitis B vaccination, a review of these policies may provide useful inputs for policy formulation for seasonal influenza vaccination and on strategies to optimize vaccination uptake. Where available, NITAGs could access the information required from data available from the national influenza surveillance, the National Influenza Centres or other institutions participating in the Global Influenza Surveillance and Response System (GISRS) (see Toolbox 1). In places where local evidence is not readily available, especially on rates of disease amongst health workers and on transmission of disease from health workers to patients, efforts to generate such evidence could be time- and resource-intensive. Policy-makers would have to consider whether it is necessary to conduct local studies or whether data from other countries with similar epide- miological profiles and health system characteristics could be used to infer the likely burden of disease and support decision-making. NITAGs would need to balance the desire to have national data against the costs and delays that would result in generating the data and the consequent health impacts of this delay. Toolbox 1 National Influenza Centers To monitor and respond to the changes in the influenza virus antigenic structure and the subsequent necessity to change vaccine compositions, many countries have established national influenza centers (NIC) to collect and characterize virus specimens in their country and perform other analyses to inform the decisions of WHO and partners on the composition of the next year’s influenza vaccine. In many countries, virologic surveillance is complemented by more systematic influenza surveillance for severe acute respiratory illness (SARI) and influenza-like illness (ILI). A NIC in a country – or in a neighbouring country – can support evidence-based recommendations by providing data on the influenza disease burden and seasonality to the NITAG or other relevant national decision-making body. Involving these and other centers in NITAG discussions is key to bringing together all relevant information that is needed for the decision-making process. A list of NICS, WHO collaborating centers and essential regulatory laboratories (ERLS) can be found at the following links:  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (Accessed 14 Mai 2019)  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (Accessed 14 Mai 2019) 12 2. Establishing a policy to vaccinate health workers against seasonal influenza Considerations for decision-making In addition to the general considerations outlined in the WHO document “Principles and Consid- erations for Adding a Vaccine to a National Immunization Programme: from decision to implemen- tation and monitoring” referred to earlier, other key issues need to be considered when framing a policy for health worker vaccination. These are listed in Figure 2. Figure 2. Key considerations in establishing a vaccination policy for health workers Defining the public health objectives for seasonal influenza vaccination of health workers Characterizing and prioritizing the target groups for vaccination Framing the vaccination policy for seasonal influenza vaccination of health workers Choice of vaccine product, schedule and timing of vaccination Defining the monitoring and impact assessment objectives Defining the public health objectives for vaccination A critical first step in establishing a policy for vaccinating health workers with seasonal influenza vaccination would be to clearly define the aims and objectives of the vaccination programme. Such objectives may vary between countries but would underlie the prioritization of the health worker groups to be targeted for vaccination, set vaccination coverage targets, and provide guidance on the outcomes and scope for measuring the impact of vaccination. Vaccination of health workers serves multiple objectives. These may include: 1. Prevention of infection in the health workers themselves, averting associated morbidity. 2. Prevention of transmission of infection from health workers to vulnerable patients, including those at high risk of severe disease, complications, and death. 3. Sustaining health services by reducing health worker absenteeism, especially during seaso- nal and pandemic influenza outbreaks, which is a period of increased health care demand. 4. Promoting uptake of seasonal influenza vaccination among other target groups and enhance public trust for influenza vaccination. 5. Contributing to influenza pandemic preparedness by: a) Establishing a mechanism for rapidly immunizing health workers during a pandem- ic of influenza or epidemics of other vaccine-preventable diseases; 13 2. Establishing a policy to vaccinate health workers against seasonal influenza b) Contributing to increasing demand for influenza vaccine and thereby enhance pro- duction capacity to improve timely access to vaccine in case of a pandemic. c) Establishing or strengthening national capacity for vaccine regulation. One or more of the above could serve in defining the national objectives for health worker vac- cination. Important considerations when defining vaccination objectives include: 1. Review of the available data on the burden of disease among health workers and health care-related infections in patients and residents of long-term care facilities. National data, where available, complemented with representative regional or global data or esti- mates developed through the use of mathematical models may be used for this purpose. 2. The cost and impact of vaccination and availability of vaccine supply. 3. Review of the national pandemic preparedness plan and consideration of how health worker vaccination could contribute to pandemic preparedness. Economic analysis for establishing national policies While economic analysis is generally recommended prior to deciding on vaccination policies, lack of data for estimating and comparing the economic benefits of the different vaccination objectives may be a limiting factor, as will be the relatively small size of the target group. Toolbox 2 lists the available tools for conducting economic analysis for influenza vaccination. The costs and economic benefits of influenza vaccination of health workers are likely to depend on several factors, including the number and categories of health workers targeted, the incidence and severity of infection in the targeted health workers, their contribution to health care-associated transmission and the consequences of such infections. These factors may vary between different health facilities and will vary from one influenza season to another. A recent systematic review of the epidemiological and economic effects of seasonal influenza vaccination of health workers found that vaccination of health workers was cost-saving, based on crude estimates of absenteeism averted through vaccination (15). However, all the studies included Toolbox 2 Tools for the economic analysis of seasonal influenza vaccination Several tools are available for conducting economic analysis of influenza vaccination: WHO Guide for Stanardization of economic evaluations of immunization programmes (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf WHO Manual for Estimating the Economic Burden of Seasonal Influenza (WHO/IVB/16.04) ƥ http://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-eng.pdf Guidance on the economic evaluation of influenza vaccination (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. Establishing a policy to vaccinate health workers against seasonal influenza in this review were from high-income countries and took an employer perspective with a strong focus on absenteeism averted. Initial decisions could take vaccination costs and the impact of these costs to the immunization and health budgets into consideration, with the option of measuring cost-effectiveness post- introduction, if required. Further guidance on costing and budgeting of health worker influenza vaccination, with links to the available costing tools and resource materials on immunization financing are covered in the next section of this manual. Characterizing the target groups for vaccination Ideally all health workers should be targeted for vaccination, including those who may not come into direct contact with patients. Even if not in direct contact, health workers could potentially transmit infection acquired in the community to colleagues and, thereby, participate in the chain of health care-associated transmission of infection. However, in situations where there are resource constraints or limited or unstable vaccine supplies, categorization and prioritization of health workers for vaccination would be required. Prioritization of health workers would depend on as- sessment of risk of infection among the health workers themselves, transmission of infection to their patients and the consequences of health care-associated transmission. Even without financial resource constraints or limitations in vaccine supply, categorization of health workers would be useful when different policies are applied to different health worker cat- egories, based on risk assessment. For example, a mandatory vaccination policy may be applied to select categories of health workers who work with patients at high risk of severe influenza and who are more likely to accept mandatory vaccination, while vaccination may be voluntary for other categories (40, 41). Table 1 provides an example of risk categorization of health workers based on risk to themselves and of those for whom they care. Table 1. Risk categorization of health workers Risk category Health worker characteristics Very High • High risk health workers (see below) who work in clinical areas that admit patients at high risk for severe disease, complications, or death following influenza virus infection. These include intensive care units; transplant or oncology wards; antenatal, peri-natal or post- natal areas; and areas with elderly individuals, especially those with chronic diseases. High • Health workers who come into direct physical contact with patients, or with infectious materials, including surfaces or equipment contaminated by infectious materials. • Health workers who have contact which is not physical but that would allow the acquisi- tion or transmission of diseases that are spread at short range (1–2 m) by respiratory means, e.g., counsellors who have prolonged fact-to-face contact (42, 43). Low • Health workers who do not have contact with patients and whose normal work is not in a clinical area as defined above. 15 2. Establishing a policy to vaccinate health workers against seasonal influenza The very high-risk category is also the one where the evidence for risk and impact of vaccination is the strongest and where there is a stronger justification for vaccination (10). Those targeted for vaccination should also include part-time personnel, students, contractors, and volunteers at the health facility who have possible exposure to patients as health workers in the above categories. Risk categorization of individual health workers may be too complex and resource intensive in many settings, especially in low- and middle-income countries. In these situations, simpler ap- proaches wherein health worker categories are classified into only two groups, i.e. at high risk group (targeted for vaccination) and low risk groups (not targeted for vaccination) may be used. To ensure targeted use of influenza vaccination of health workers and to address potential uptake issues, national policies for health worker vaccination should outline: 1. The classification of different health worker categories based on assessment of risk. 2. The policy for vaccination for each category, e.g. whether vaccination is recommended and whether the recommendation is for mandatory or voluntary vaccination. 3. Strategies for managing non-compliant health workers and vaccine refusers. The following document provides an example of a framework for the assessment, classification and prioritization of health workers: The policy directive of the New South Wales Ministry of Health on the Occupational Assessment, Screening and Vaccination Against Specified Infectious Diseases https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (Accessed 14 Mai 2019) Framing an immunization policy for health workers Recommendations for health worker vaccination could propose either mandatory vaccination, voluntary vaccination or a mixed approach depending on the risks in the specific clinical setting. Multiple studies across many countries has demonstrated that voluntary vaccination of health workers, even when accompanied by considerable efforts to educate them on the benefits and risks of vaccination and implementation of measures for convenient access to vaccination, results in low coverage that seldomly exceeds 70%. On the other hand, mandatory vaccination has resulted in close to 100% uptake in institutions in the United States where it has been applied (44–46). However, mandatory vaccination has been difficult to implement in some countries because of acceptability issues and because the attributable benefits of health worker vaccination have been a subject of debate (32). Furthermore, it may not be feasible to implement mandatory vaccination policies in resource-constrained settings. 16 2. Establishing a policy to vaccinate health workers against seasonal influenza Voluntary vaccination One option for a vaccination policy for health workers is voluntary vaccination wherein vaccina- tion is recommended for health workers and offered but acceptance is voluntary or optional, i.e. not a requirement. Such programmes often have low vaccination coverage. Hence, with voluntary vaccination, extra efforts are required to optimize the uptake of vaccination. These could include: 1. A robust communications strategy, specifically tailored to the needs of different health worker categories, to explain the benefits and risks of vaccination, including the benefits to patients, especially those at high risk for severe disease. It needs to be emphasized that some of these patients, including the elderly and immunocompromised patients may not themselves respond to vaccination and that vaccination of health workers who come into contact with them is an important means for protecting them from infection, i.e. a professional ethics and moral argument 2. Convenient access to vaccination that is free of charge, and available to workers in every shift. Those who work during evening or night shifts might be provided access to vacci- nation either at the beginning or the end or their shifts or on designated days and times to cover their shift. 3. Other demand generation activities as outlined in the next section of this manual. A number of soft mandates may also help in increasing vaccination uptake, including: 1. Requirement of active declination of vaccination through signing of forms indicating their non-participation with or without stating the reasons for not accepting vaccination (see Annex 1 for a sample of an active declination form). 2. Reassignment of health workers who refuse vaccination to areas where they are less likely to come into contact with high risk patients, if this is feasible, or a requirement to wear masks when they do care for patients at high risk of influenza complications. 3. Use of face masks while in the health care facility. Mandatory vaccination Mandatory vaccination makes vaccination of health workers a legal or regulatory requirement while allowing some exemptions, e.g. medical contraindications. There is no WHO or other uniformly applied definition for mandatory vaccination. Infant and childhood immunization programmes described as mandatory can vary widely, especially in terms of the exemptions al- lowed and the penalties for non-compliance (47). Several experts have argued that mandatory immunization policies should be implemented against vaccine-preventable diseases that can be transmitted in the health-care setting and cause signifi- cant risk of morbidity or mortality to patients (20, 44, 48–50), as part of the professional ethics of a health care provider. It has also been argued that few ethical mandates in the practice of medicine surpass the obliga- tion to do no harm. Hence, ensuring conditions for safe patient care by minimizing transmission of communicable diseases represents a minimum ethical standard in health care practice set- tings (20). However, if mandatory vaccination policies are to be established, legal liability issues will need to be addressed and consideration given to providing compensation in the rare event of an adverse event. 17 2. Establishing a policy to vaccinate health workers against seasonal influenza Mandatory vaccination could either be part of the national policy or implemented at individual health facilities as part of institutional policies. The enactment of legislation endorsing mandatory vaccination would facilitate the implementation of such a policy. The Code of Colorado Regulations provides an example of a mandatory vaccination policy: Code of Colorado Regulations: Standards for Hospitals and Health Facilities 02 – General Licensure Standards (Part 10, Page 46) https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20CCR%20 1011-1%20Chap%2002 (Accessed 14 Mai 2019) Several countries with voluntary health worker vaccination policies for influenza do have man- datory vaccination of health workers for other infections such as measles and hepatitis B. These existing mandatory vaccination policies could be leveraged to also justify and establish mandatory vaccination policies for influenza, based on the protection afforded to the health worker as well as to vulnerable high-risk patients with whom they come into contact. Published recommendations for the ethical implementation of mandatory vaccination policies are reproduced in Toolbox 3. These recommendations may be taken into consideration in framing the national policy based on the feasibility of implementation. Toolbox 3 Recommendations for ethically implementing mandatory vaccination policies — There must be a compelling employee and patient safety problem that is clearly communicated to employees. — The least restrictive means should be used to achieve the safety objective. — There should be clear opt-out criteria for medical reasons. — Opt-out criteria based on personal views of the health worker should be allowed for current employ- ees only. These determinations must be made in a transparent and objective manner. — For those who do meet medical or other exclusion criteria, or who refuse vaccination, institutions should offer alternative means for achieving transmission control, including temporary leave during peak times, mandatory mask wearing, re-assignment to non-clinical areas (if feasible) or frequent testing during peak influenza seasons. — Prospective employees should be notified of the mandatory policy and recognize that failure to comply could be grounds for termination of employment. — The process should be transparent, with a broad range of health worker perspectives involved in policy development. — Institutions should support healthcare workers by implementing vaccination procedures that are free, easy to access, and include complete comprehensive coverage of adverse events. Particular attention should be paid to not burdening less advantaged members of the healthcare team. Source : Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 18 2. Establishing a policy to vaccinate health workers against seasonal influenza Mixed approach A mixed approach could also be adopted where a mandatory vaccination policy is applied to only certain categories of health workers likely to have direct physical contact with high-risk patients, while a voluntary vaccination policy is applied to the remaining categories. Such a policy should clearly and unambiguously define the health worker groups to whom or work areas where mandatory and voluntary vaccination policies apply. Consideration should be given to the human and financial resource implications of mandatory vaccination policies or of soft mandates. Integration with Occupational Health Policies Policies on seasonal influenza vaccination of health workers should be an integral part of the national occupational safety and health policies and regulations and the occupational safety and health management systems in health facilities. Inclusion of seasonal influenza vaccination in occupational health policies will allow access to free vaccination for all the targeted health workers as per the Occupational Safety and Health Convention, 1981, Article 215 and the recommendations in the World Health Organization and International Labour Organization (WHO-ILO) Global Framework for National Occupational Health Programmes for Health Workers.6 Such a policy would also put the responsibility for health worker vaccination on employers, rather than on the health workers alone. An integrated policy will enable greater coordination and collaboration between occupational health and immunization programmes and promote a joint approach to control of influenza in health facilities wherein vaccination is part of an infection control program that includes other in- fection measures to protect both health workers and patients. The occupational health programme at the national level and the management system at the facility level also provide an enabling environment to create a culture for infection prevention within the workplace that will stimulate the implementation of the vaccination programmes. Choice of vaccine product, schedule and timing of vaccination Choice of product WHO provides recommendations for the composition of influenza vaccines based on the infor- mation provided by the WHO Global Influenza Surveillance and Response System.7 Based on these recommendations, manufacturers formulate Northern Hemisphere (NH) and Southern Hemisphere (SH) vaccines, which are generally accessible around September (NH) and April 5 C155-Occupational Safety and Health Convention, 1981 (No. 155). https://www.ilo.org/dyn/normlex/en/f?p=NO RMLEXPUB:12100:0::NO::p12100_instrument_id:312300 (Accessed 14 Mai 2019) 6 The sectoral dimension of the ILO’s work : Review of sectoral initiatives on HIV and AIDS Appendix II – WHO- ILO WHO-ILO Global Framework for National Occupational Health Programmes for Health Workers. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/wcms_145837.pdf (Accessed 14 Mai 2019) 7 Influenza: vaccines. http://www.who.int/influenza/vaccines (Accessed 14 Mai 2019) 19 2. Establishing a policy to vaccinate health workers against seasonal influenza (SH) of each year, respectively. A list of WHO prequalified vaccines with information on their characteristics is published on the WHO website.8 Several different types of vaccines are available, including inactivated influenza vaccines (triva- lent and quadrivalent composition), live attenuated influenza vaccines, adjuvanted vaccine, and recombinant vaccine. Being a health worker per se does not lead to a preference for any vaccine type (subject to country-specific marketing authorizations).9 Health workers who care for severely immunocompromised persons should preferably receive inactivated influenza vaccine (IIV). Price and supply availability of each product are additional considerations in informing the choice of product. Timing of vaccination In countries where influenza infection is seasonal and seasonality patterns are defined, vaccina- tion should ideally be scheduled before the start of the influenza season, allowing approximately 14 days for induction of protective antibodies. Where delays in securing vaccine supply does not allow ideal timing to be met, vaccination should be initiated as soon as supplies are made available. Furthermore, individual health workers should never be refused vaccination at any time during the influenza season if they are late in seeking vaccination. In tropical and subtropical regions where several peaks may occur, vaccination should be timed before the main peak of transmission, using the most recent vaccine formulation available. Where no data on national influenza seasonality are available, countries could use data from epidemio- logically similar countries. Toolbox 4 provides published information of influenza seasonality in the tropics and subtropics. 8 WHO Prequalified Vaccines. https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 9 In some countries the quadrivalent vaccine is the product of choice. The WHO Strategic Advisory Group of Experts (SAGE) in immunization is currently reviewing the evidence and expected to make a recommendation in 2020. Toolbox 4 Guidance on choice of product and timing of seasonal influenza Seasonal influenza policy use and effectiveness in the tropics and subtropics. Geneva: World Health Organization; 2016. ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf (Accessed 14 Mai 2019) Influenza seasonality in the tropics and subtropics – when to vaccinate  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 (Accessed 14 Mai 2019) WHO list of prequalified vaccines  https://extranet.who.int/gavi/PQ_Web (Accessed 14 Mai 2019) 20 2. Establishing a policy to vaccinate health workers against seasonal influenza Defining monitoring and disease impact measurement objectives Ministries of Health would benefit from advice from the NITAG or other relevant advisory groups on the monitoring and impact measurement objectives so that they are taken into consideration during the planning and implementation of Monitoring and Evaluation (see chapter 4). NITAGs, with additional inputs from other relevant advisory groups and academia, should make recommendations on: 1. Monitoring and reporting of vaccination coverage, where possible by unit and type of care provided. 2. Measurement of vaccination impact, including: a) Target groups (health workers and or patients) for impact measurement. b) Outcomes to be monitored. e.g. influenza-like illness, laboratory-confirmed disease, severe disease, death, absenteeism, patient-related outcomes, etc. c) urveillance strategies for measuring impact; if at sentinel sites, the number and distribution of sites. d) Time periods for impact measurement, e.g. continued monitoring for an indefinite period or limited to a certain number of seasons. These measurements would be useful to the NITAG in reviewing the impact of vaccination and making recommendations for optimizing the impact and the cost-effectiveness of vaccination. Impact measurement could also generate empiric data to allow for estimation of cost-effectiveness of vaccination. It should be noted that any such measurements should include data collection for multiple seasons since the intensity of transmission, the severity of infection and vaccine effectiveness varies from one season to another. For further details, see the section on “Monitoring and evaluation” (chapter 4). 21 3. Planning and managing vaccination of health workers Planning for successful vaccine introduction Once a national vaccination policy has been established, it is necessary to convert the policy into operational plans that are fully costed, budgeted and include granular detail on the various pro- gramme components related to the introduction of a new vaccine into the national programme. The general concepts for addition of a new vaccine within the national immunization plans and the management of introduction are outlined in the WHO guide “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” (see Annex 3 for New Vaccine Introduction Plan Template). This section provides guidance on the additional elements specific to seasonal influenza vaccination of health workers. A vaccine introduction plan integrated into the annual plan for immunization along with the as- sociated checklists enable programme planners to ensure that all the necessary preparations are in place for the timely and efficient introduction of a vaccine into the national programme. For easy access the links to the relevant Annexes of the WHO guide are provided in Toolbox 5. In addition to the generic vaccine introduction checklist, the complementary checklist in Annex 2 con- tains a list of issues specific to health worker immunization. The elements of this checklist should be added (as appropriate) to the more generic checklist of activities. A sample health facility checklist is also provided (Annex 3) to guide the preparations for vaccination at the health facility level. Toolbox 5 Links to templates and checklists for a new vaccine introduction plan in “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” Generic template to guide the development of a national introduction plan Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc (Accessed 14 Mai 2019) New vaccine introduction checklist, activity list and timeline of WHO new vaccine introduction guide provides advice on planning budgeting, activities, distribution of roles and responsibilities and timelines ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_ resources/nvi_guidelines/Annex4_Instructions.pdf (Accessed 14 Mai 2019) Corresponding checklist tool Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_checklist_en.xls (Accessed 14 Mai 2019) 22 3. Planning and managing vaccination of health workers The timelines for planning and introduction should be included in the checklists and/or as a sepa- rate Gantt chart to ensure that all the activities are completed in their appropriate order to allow timely implementation of vaccination activities. Cross-reference should be made to the relevant sections of the occupational health strategies and plans at both the national and health facility level (see previous chapter on integration of health worker influenza policies into occupational health policies and requirements) to facilitate a more cohesive approach to planning and implementation. The WHO-ILO Global Framework for National Occupational Health Programme for Health Work- ers recommends that all countries identify the responsible person(s) for occupational health, both at the national and workplace levels. These focal points should be a part of the planning team at the national and health facility levels, respectively. Inclusion of the occupational health focal points would allow for an integrated approach to prevention of influenza in the work place where vaccina- tion forms part of a larger package of interventions for influenza control, including other infection control measures to protect both health workers and patients. The labour-management committees for occupational safety and health in health facilities, where they exist, can help in engaging the management and the workers’ representatives in the implementation of the vaccination programme. In addition to the national operational plans for the implementation of health worker vaccination, the national comprehensive multi-year plan (cMYP) for immunization should also be updated to include health worker immunization (Toolbox 6). Costing and financing As with the addition of any new vaccine to the national vaccination schedule, the vaccine and deliv- ery costs should be estimated and included in the annual and multi-year immunization budgets. In addition to the costs of vaccines and supplies (syringes, needles, safety boxes etc.), costs for vaccine delivery (including human resources), annual communications/education and demand generation efforts at the national and health facility level, and monitoring and reporting would need to be included in the costs. Several tools and resources are available that could be used or adapted for costing, budgeting and securing finances for health workers vaccination (see Toolbox 7). Since communications and other activities/interventions to enhance vaccination uptake will be required each year, these costs should be incorporated into the annual vaccine delivery costs and not considered only as a one-time activity. In addition to costing and budgeting for annual health worker influenza vaccination, it may also be necessary to advocate with those responsible for allocating funds for health programmes to ensure that financing for vaccination is sustained. Toolbox 8 provides links to resources for ad- vocacy for sustainable financing. Toolbox 6 WHO-UNICEF guidelines for multi-year planning WHO-UNICEF guidelines for developing a comprehensive multi-year plan (cMYP)  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. Planning and managing vaccination of health workers Toolbox 7 Resources for costing and financing cMYP Costing and Financing Tool  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (Accessed 14 Mai 2019) Immunization Costing Action Network (ICAN) Immunization Delivery Cost Catalogue This interactive website provides information on vaccine delivery costs across different low and middle- income countries through a variety of delivery strategies.  http://immunizationeconomics.org/ican-idcc (Accessed 14 Mai 2019) WHO Flu tool for planning and costing maternal influenza vaccination (new name: SIICT tool) This tool is being expanded to include all influenza risk groups, including health workers.  https://www.who.int/immunization/research/development/influenza_economics/ (Accessed 14 Mai 2019) Management Sciences for Health. Planning, costing and budgeting framework  http://www.msh.org/resources/planning-costing-and-budgeting-framework (Accessed 14 Mai 2019) Immunization financing: a resource guide for advocates, policy makers and program managers  https://immunizationeconomics.org/imfin (Accessed 14 Mai 2019) Toolbox 8 Resources for advocacy or sustainable financing Immunization advocacy library. Provides a number of tools and guides to convey the value of vaccination and the need to invest in vaccination  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/communication-and-advocacy/immunization-advocacy-library (Accessed 14 Mai 2019) Two specific documents in this library are of relevance: Workbook – advocacy for sustainable funding of immunization programmes  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/workbook-advocacy-for-sustainable-funding-of-immunization-programmes (Accessed 14 Mai 2019) How to prepare a financial profile of your immunization programme  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/how-to-prepare-a-financial-profile-of-your-immunization-programme (Accessed 14 Mai 2019) 24 3. Planning and managing vaccination of health workers Formative research to inform the planning process To prepare for the launch of influenza vaccination, several countries have used formative research to better understand the factors affecting uptake of seasonal influenza vaccination in health work- ers, including concerns, beliefs, information needs, cultural issues, and barriers to vaccination in order to develop a tailored plan to address them. Formative research can include both quantitative and qualitative research and, in some situations, might include a desk review. Quantitative research may be used to identify the main predictors for low uptake of vaccination among health workers and the main drivers for compliance with vaccina- tion recommendations. Data may be collected through surveys and questionnaires administered to health workers. The sample should ideally include sufficient representation from the different categories of health workers since the perceptions and reasons for low uptake may vary between health worker groups, e.g. between doctors and nurses (40), as well as from a sample of primary, secondary and tertiary health care facilities and from different work areas within these facilities. Qualitative research is insight research, based on understanding the audience’s point of view. It elucidates new issues and provides a more in-depth understanding of the complex issues underly- ing the uptake of vaccination. Qualitative research methods commonly include focus group dis- cussions and individual in-depth interviews. The WHO European Regional Office has published a step-by-step field guide to qualitative research for new vaccine introduction (see Toolbox 9). To be useful, formative research must be properly planned and well executed, failing which there is a risk of drawing wrong conclusions. This requires time and resources. While it is useful to conduct such research to inform the planning process, if time and resources do not permit, the lack of such research should not delay seasonal influenza vaccine introduction, unless attitudes of health workers are expected to be an issue that may significantly and adversely impact vaccine uptake. When data from formative research are not available, data from such studies conducted in other countries may be used to inform the planning process. While the reasons for low uptake of vac- cine are heterogenous, available evidence suggests that there is broad convergence on the major influencers of vaccine uptake among health workers, especially between countries within the same sub-region, which may be used in the initial planning process. The rapid appraisal of evidence (10) summarizes the key findings from the published literature and this evidence could be used, as applicable and appropriate, in the absence of locally conducted research. Data from the published literature may be complemented with information obtained through quantitative formative research using rapid surveys in a sample of health workers, ideally including different health worker categories. These surveys may be less resource intensive than qualitative formative research and could be completed without resulting in any delays to vaccine introduction. Annex 4 provides a sample questionnaire that may be used for such surveys. Toolbox 9 Field Guide for qualitative formative research A field guide to qualitative research for new vaccine introduction ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_VaccineIntro.pdf (Accessed 14 Mai 2019) 25 3. Planning and managing vaccination of health workers Further research may be conducted if vaccine uptake remains persistently low. The TIPflu tool is an important resource that may be used in such situations. Communication and vaccine acceptance Personal beliefs, cultural attitudes and perceptions about vaccination, in addition to official rec- ommendations, often guide the actions of many of those responsible for delivery of vaccines and many recipients (51, 52). This also holds true at the level of health workers. Available evidence shows that there are often misperceptions about vaccination as well as a gap between knowledge and behaviours (53, 54). Thus, simply improving knowledge about the risks and benefits of vac- cination among health workers has not proven to be sufficient to achieve optimal vaccination uptake. Achieving optimal vaccination coverage in health workers requires a multi-dimensional demand generation effort that is informed by a good understanding of the perception, motivators and barriers of vaccine acceptance among health workers, both as providers of vaccination and as recipients. Communications messages need to be tailored to address the needs of different health worker groups since available evidence suggests that perceptions about the need, risks and benefits of vaccination may vary between these groups (55). Current efforts mainly focus on preparing fact- based approaches to preparing communication messages. However, these types of messages may need to be framed according to the intended audiences based on their level of education and understanding. Taking the preferred cognitive decision-making styles of the individual groups to be targeted into account may have greater impact (54). Framing such messages will require an understanding of vaccine psychology and cognitive decision-making and may require engagement of communication specialists. A traditional approach to communications regarding immunization was through the use of mass media. However, research has shown that mass media alone and a one-way communication to health workers may not be sufficient to optimize the uptake of vaccination. Individual and group communications, in this instance at the health facility level, will be required to build trust and motivate health workers to accept vaccination. Including information on the relevance of vaccination of health workers (self-protection, responsi- bilities towards patients, pandemic preparedness in the case of influenza) in pre-service curricula for medical schools, nursing schools and other training institutions targeting health professionals may help to better establish health worker vaccination as an organizing concept and create better informed health worker generations providing immunization. Effective communications and demand generation activities are not a one-time event but need to be continuous and have the ability to quickly respond to the evolving perceptions about vac- cination and quell rumours and mis-perceptions. Front line vaccination staff responsible for health worker influenza vaccination will need to be trained to be able to deal with vaccine hesi- tant health workers as well as vocal vaccine deniers10 who may negatively impact the uptake of vaccination (56). 10 Vocal vaccine deniers are at the extreme end of the subgroup of vaccine refusers and actively advocate against vaccination, using science denialism techniques to justify their beliefs (reference 32). 26 3. Planning and managing vaccination of health workers A national vaccine communication working group that includes communications specialists will facilitate strong working relations with and collaboration among partners and allies, strengthen routine communication for immunization, and ensure well-coordinated and immediate response from all involved authorities to any safety event. Inclusion of members of the Occupational Safety and Health department and from professional societies in communicating with health workers contributes to building trust and improving acceptance of vaccination. Representation from health workers, professional associations, and unions and from the different health worker categories targeted for vaccination would ensure that the viewpoints of each health worker category is taken into consideration in developing tailored communication materials. A number of tools and guidance documents are available that can be used for developing an ef- fective communications strategy and for framing the communications messages that are specifi- cally tailored towards different health worker groups, including a template terms of reference for a vaccine communication working groups (Toolbox 10). In addition to vaccination, the information and education and communication materials should also include information on other infection control measures to reduce transmission of influenza in the work place and steps to be taken should a health worker develop an influenza like illness. Communications at the health facility level Effective communications at the health facility level will benefit from a dedicated and well-trained team to deliver the communications strategy at the health facility level. Such a team should be established and trained well in advance of the planned introduction date and should include rep- resentation from the main health worker categories in the facility and an advocacy and commu- nications specialist, if one is available. Ideally, communications for seasonal influenza vaccination should be part of a broader communications effort on control of influenza in health care settings. Communication activities at the health facility level should begin sufficiently in advance of the planned date for the onset of vaccination, especially in countries introducing vaccination for the Toolbox 10 Tools and guides for developing communications strategy and messages Vaccination and trust library  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/vaccination-and-trust (Accessed 14 Mai 2019) New vaccine introduction: checklist for planning communications and advocacy (2017)  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2017/new-vaccine-introduction-checklist-for-planning-communication-and-advo- cacy-2017 (Accessed 14 Mai 2019) Template terms of reference for a vaccine communication working group ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_Sup- portDoc_TOR_Proof7.pdf (Accessed 14 Mai 2019) 27 3. Planning and managing vaccination of health workers first time. Initial activities could include the display of information posters at all the relevant areas of the health facility. The manager of the health facility and the heads of all the relevant depart- ments and clinical areas should be sent a formal communication along with sufficient copies of all information materials about vaccination to be displayed in each clinical area. Where possible, relevant information on influenza vaccination could also be sent to all health workers using e-mail and/or local social media networks. In-person group briefings should complement the display and distribution of information materi- als. Existing staff meetings could be leveraged to conduct these briefings. The number of in-person group briefings will depend on the size of the health facility and the number of targeted health workers. Larger health facilities (e.g. secondary and tertiary level health facilities) may need to conduct several briefing sessions to cover all the targeted health workers. Since communications messages may differ between different categories of health workers, consideration should be given to holding separate briefing sessions for each health worker category using information and mate- rials relevant to them. To allow better communication and enough time for questions from health workers to be addressed, the size of each group should be designed to allow sufficient opportunity for interaction. Provision should be made to facilitate the participation of health workers working night shifts. The schedule for the briefings should be widely publicized within the health facility and reminders sent to promote high attendance. In-person meetings should: 1. Explain why vaccination is important for themselves, their patients and families and for wider society – with a particular focus on severe outcomes associated with influenza; 2. Inform health workers about national policies; 3. Provide information on the safety of seasonal influenza vaccines; 4. Provide information on the timing and venue(s) for vaccination; 5. Explain potential consequences of non-vaccination; 6. Allow sufficient time for questions. Consideration may be given to establishing a telephone hotline or web-based system to address questions from individual health workers. In addition to the display of posters and other com- munications materials, the use of visible and removable stickers that can be displayed by health workers who have been vaccinated (e.g. on their ID badges) would serve as a visible reminder to their colleagues who have not been vaccinated. In addition, text messages, generic e-mails and social media platforms could be used to provide periodic reminders on vaccination. Demand Generation at the Health Facility Level In addition to communication strategies, behavioural science-based demand generation efforts can be implemented prior to the availability of vaccines in order to prime health workers for vac- cination. These nudge-based interventions work by creating an environment that can influence behaviour in a predictable way but does not eliminate choice (57), and have proven effective in a variety of healthcare settings (58). These interventions can narrow the gap between intention and actual behaviour, which is usually caused by individuals or health workers forgetting to get 28 3. Planning and managing vaccination of health workers their vaccination or through barriers to convenient vaccination. Additionally, these interventions frequently can be implemented for relatively low cost (59). The figure below (Figure 3), adapted from the Nuffield Council on Bioethics, demonstrates the hierarchy of nudge-based interventions to improve vaccine uptake (60). Nudges lower on the ladder are less aggressive but can still have a measurable impact. By providing health-facility vaccination rate feedback, a process used in the United States to improve uptake of childhood vaccination, progress in health facilities can be monitored, and provide motivation to health workers to improve their own vaccination practices (61). Figure 3. Ladder of nudge interventions to increase vaccination rates Guide choice through default options Automatically set up appointment for vaccination unless individual opts out Enable choice Increase options to obtain vaccination such as at workplace or near home Prompt implementation intentions Ask individual to precommit to a time and location to obtain vaccination Frame information Deliver social comparsion feedback on vaccination rate among peers or healthier individuals Provide information Offer education on benefits of vaccination to self ant others Do nothing Simply monitor vaccination rates Source: Patel MS (ref. 32) Reminders to individuals to vaccinate can serve as a nudge, notifying individuals when they are due for a vaccine and prompting them to come to the vaccination site to receive the vaccine. These can be paper-based or mobile phone text message-based and have proven effective (62). In the health facility, health worker reminders through an immunization data collection tool (whether paper- or electronic-based) can help improve the delivery of vaccines by health workers (59). A successful nudge-based strategy to reduce barriers to convenient vaccination and enable choice is standing orders. Standing orders are a policy put in place in a health facility that permits non- physician health workers to administer vaccines without a prescription or explicit order from a physician and have proven one of the most effective strategies for improving vaccine uptake when applicable (63). All of these strategies can be combined with communication approaches to create demand in the community. 29 3. Planning and managing vaccination of health workers Going beyond nudges Nudges are a favoured method for influencing demand since they preserve choice and are not coercive. However, some experts have argued that when nudges fail to achieve optimal uptake of vaccination in health workers, and this failure results in harm to their patients, decision-makers should consider adopting more forceful policies (64). This is not to imply that when nudges fail one should immediately go to measures that eliminate choice. There are interventions that exist across a continuum leading up to restriction of choice. The use of “soft mandates” provide examples of actions across this continuum. Case study: The «flulapalooza» campaign to increase uptake of seasonal influenza vaccination in health workers Vanderbilt University Medical Center in Nashville, Tennessee, in the United States, employs over 24,000 health workers. Since 2011, the cornerstone of its seasonal influenza vaccination campaign for health workers has been its mass influenza vaccination event, playfully named “flulapalooza”. This event vac- cinates, on average, over 14,000 people in a single day. The closed point-of-dispensing (c-pod) design has been evaluated and refined over time to substantially increase administration efficiency and cover- age rates. The event emphasizes a festive atmosphere while practicing critical pandemic vaccination skills among hospital occupational health and administrative leadership. This event achieves high coverage among categories of health workers who are present that day; how- ever, due to the structure of nursing shifts and ward responsibilities at the institution, less than 30% of nursing staff are typically vaccinated at the event. Thus, the medical center combines flulapalooza with ward visits, mobile carts and other strategies to achieve its annual target of greater than 90% overall health worker vaccine coverage. Notably, although institutional policy gradually increased the difficulty of declination and eventually included disciplinary action in response for unexcused failure to vacci- nate, it is notable that 92% coverage had been achieved in seasons before disciplinary policies were in place. Details of event design, workflow diagrams and practical, specific lessons learned are described in a publication available online. Source: Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168–76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 Annex 5 provides a table that lists the different communications and demand creation approaches, along with an indication of the effort required to implement the approach and the expected impact. Vaccine procurement and supply chain management Vaccine procurement Accessing vaccines at optimal prices requires a good understanding of procurement mechanisms and systems, vaccine market dynamics, and the elements of vaccine pricing. Procurement starts with forecasting vaccine demand, followed by tendering, contracting and procurement processes. The tools and resources for vaccine procurement are listed in Toolbox 11. Procurement of seasonal influenza vaccination may have some unique features and may require regulatory approvals and advance purchase commitments with specific manufacturers shortly after the publication of the 30 3. Planning and managing vaccination of health workers WHO recommendations on the seasonal vaccine formulation (in February for the northern and in September for the southern hemisphere) and well in advance of the influenza season. Selection of the vaccine product and presentation As with any other vaccine, the choice of product and presentation will depend on multiple fac- tors including supply availability, price, ease of use, storage and transport requirements, vaccine wastage and missed opportunities for vaccination (e.g. postponing vaccination due to reluctance to open a 10-dose vial for only one or two individuals). The choice of vial size should be based on the number of doses to be delivered at each vaccination point and the number of sessions to be held at each point. The currently prequalified injectable seasonal influenza vaccines are available in single dose pre-filled syringes and in single and 10-dose vials. All the 10-dose vial presentations contain thiomersal as a preservative. However, it may be noted that not all the currently available prequalified products in 10-dose vials have market authorization for storage up to 28 days once opened, and not all products have a vaccine vial monitor (VVM). These aspects should be taken into consideration in selecting the product and presentation. The specifications of each product and presentation should be checked to confirm that they meet the requirements of the programme before a procurement order is placed. Information on WHO prequalified vaccines may be found on the WHO website (see Toolbox 11). Forecasting vaccine demand is an important first step in vaccine procurement. Forecasting demand requires an estimate of the number of health workers who will be targeted for vaccination, the expected vaccination coverage, and an estimate of vaccine wastage. Ideally health workers in both public and private facilities would be targeted for vaccination. This process of estimating the size of the target population for health workers vaccination is likely to be more complex than for other vaccines targeting the general populations. The data to derive such estimates may also be more difficult to find, especially in low and middle-income countries. Toolbox 12 provides resources for estimating the size of the health work force and those that need to be targeted for vaccination. Toolbox 11 Vaccine procurement tools Procurement mechanisms and systems  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_systems (Accessed 14 Mai 2019) Vaccine product, price and procurement (V3P) web platform  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (Accessed 14 Mai 2019) Vaccine market  http://www.who.int/immunization/programmes_systems/procurement/market (Accessed 14 Mai 2019) List of WHO prequalified seasonal influenza vaccines  https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 31 3. Planning and managing vaccination of health workers The global health workforce databases may not carry information on all the health workers catego- ries that may be targeted for vaccination. For example, global databases may only have estimates of the numbers of doctors, nurses and midwives, but not other health worker categories. In such instances, rough estimates could be made based on ratios of those health workers for whom data are not available to those where data are available (e.g. ratio of physicians to laboratory workers). These ratios could be quickly obtained through a survey of a small representative sample (e.g. tertiary, secondary and primary) of health facilities. Since each health facility may be required to prepare beneficiary lists with the names of those targeted for vaccination, for tracking vaccination delivery, and for maintaining records of those vaccinated; the initial demand forecasts could be refined in subsequent years using data from these beneficiary lists and vaccination records. Logistics and cold chain management The handling of influenza vaccine is similar to most other vaccines in the national immunization programmes. It needs to be stored at 2–8 degrees Celsius. Since vaccination of health workers is expected to occur annually during a relatively short window period each year before the onset of the influenza season, a plan needs to be developed to ensure storage and transport of vaccine at the different levels involved in the supply chain during the window period chosen for vaccina- tion. Tools and resources for vaccine forecasting, management and logistics are available on the WHO website (Toolbox 13). The cold chain volume requirement for each WHO prequalified product and presentation are available on the WHO website (please select the vaccine type and click on the links for each individual product and presentation to obtain this information).11 At the health facility level, the focal point responsible for health worker vaccination should ensure that the vaccine doses required in the facility are included in the demand forecast and that sufficient storage space to accommodate the required vaccine doses is available prior to the anticipated date of vaccine arrival at the health facility. 11 WHO prequalified vaccines. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 Toolbox 12 Resources for estimating target population size Global Health Observatory: Health Workforce  http://www.who.int/gho/health_workforce Global Health Workforce Statistics database. Geneva: World Health Organization.  http://www.who.int/hrh/statistics/hwfstats Counting health workers: definitions, data, methods and global results. Geneva: World Health Organization; 2007. ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf Classifying health workers: mapping occupations to the international standard classification ƥ https://www.who.int/hrh/statistics/Health_workers_classification.pdf 32 3. Planning and managing vaccination of health workers Vaccination of health workers Vaccination of health workers should ideally take place at the health facilities where the targeted health workers normally work to ensure convenient access to vaccination. Case study: Using an immunization champion to enhance uptake of influenza vaccination in health workers in Oman Oman has a universal free-of-charge, integrated health care system, which includes influenza vaccina- tion of health workers. Oman is one of the few high-income countries in the WHO Eastern Mediterranean Region (EMR) that has achieved high influenza coverage among health workers (>80%). This was made possible by immunization champions. The minister of health in Oman is passionate about protecting the health of health workers and is at the forefront in taking the first influenza seasonal vaccine. As the patron of health worker community and an influential person in the country, this action has reinforced the importance of vaccination and continually helps promote influenza immunization programs. He has also been personally involved in the communication of vaccination messages to the health worker community. Every health facility should prepare a health facility plan for implementing seasonal influenza vac- cination of health workers well ahead of the influenza season. These plans should include measures to enable convenient access to vaccination for health workers in every shift. Different options may need to be determined at the health facility level to cover health workers during night shifts with- out resorting to 24-hour vaccination services, for example insuring the availability of vaccination just before or after a shift change. A vaccination team should be established at the level of the health facility to coordinate the vac- cination activities and optimize uptake under the overall supervision of the head of the facility. One person should be designated as the team leader. This could be either the occupational safety and health focal points, or the persons responsible for immunization activities in the health facil- ity. In larger facilities the staff medical services may be tasked with this activity. Experience from some organizations and health facilities have shown that using “vaccination champions” from among the health workers may contribute to improving vaccination uptake among their peers. In Toolbox 13 Vaccine management and support resources The resources that can assist programme managers in supply chain and logistics support planning may be found at the WHO website at:  http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ index4.html (Accessed 14 Mai 2019) Overview of technologies for the treatment of infectious and sharp waste from health care facilities ƥ https://apps.who.int/iris/bitstream/handle/10665/328146/9789241516228-eng.pdf (Accessed 14 Mai 2019) 33 3. Planning and managing vaccination of health workers some countries, a mobile team that goes to each clinical area in the health facility and provides vaccination has been successfully used. Training of the vaccination team Training workshops for health facility vaccination focal points should be conducted to conduct training in developing a health facility plan and in implementing and monitoring vaccination activities. A standardized agenda, curriculum, resource documents, checklists and model forms for recording data, as required, should be created at the national level for use in these workshops so that training is uniform across all health facilities. To further ensure uniform training, the workshops could be conducted using teams of trainers who are themselves trained centrally and are assigned to each region/subregion, using a cascade training approach. Short training videos may be used to achieve uniformity in content in the training. Web-based self-learning modules may be considered for those who were unable to attend the training sessions. The health facility vaccination team should have the capacity to classify health worker groups (see chapter 2 for sample risk categorization of health workers) and establish a list of health workers eligible for vaccination, with their designations, and areas of work. Where different vaccination policies apply to different risk categories, either separate lists should be created, or mechanisms established to easily identify and monitor the vaccination status of those in each category. The beneficiary lists should be developed sufficiently in advance of the start of vaccination activities and the relevant health workers informed on the need for vaccination. In addition to health workers employed at the health facility, provision may be made to include health workers in smaller facilities within their catchment area, including private facilities, as per the national policy, should vaccination not be available at all facilities. A mechanism for defaulter tracking and for sending reminders should be established at each health facility. For health workers who come into contact with high risk patients, (e.g. those in organ transplant, oncology, intensive care or perinatal units), the supervisors of those who have not been vaccinated before the start of the influenza season may need to be informed (local confidentiality norms permitting) so that they can reinforce the written reminders or, in case of refusals, get active declination forms signed and institute infection control measures applicable to active refusals, e.g. reassignment of duties, wearing of masks etc. as per the established national of health facility policy. 34 4. Monitoring and evaluation All countries should have a mechanism in place to monitor vaccine coverage as well as adverse events following immunization (AEFI) from the health facility to the national level and conduct at least one influenza vaccine post-introduction evaluation. However, measuring vaccine accep- tance and vaccine effectiveness or impact will be necessary and feasible only in a setting where immunization targets are not reached and if funding is available. Developing and updating information systems Appropriate forms and data entry modules for recording and reporting vaccination data at the health facility level and processes for reporting the data should be established. In developing tools and guidance for data collection, the need to include both public and private health systems should be considered. This may require mapping of existing health information systems and immunization data collection instruments as well as guidance on how these systems may be used to collect data on seasonal immunization of health workers. Data collection systems may vary across health facilities depending on the size and available infra- structure of the facility. However, each health facility must be provided with a standardized data reporting form to ensure that the data required for reporting to the national level are collected, irrespective of the data recording system used. This could include the name of the health worker, the health worker category, area of work, risk category, date of vaccination, the vaccine product and lot number. In developing the data reporting form, the advice provided by the NITAG on monitoring and impact assessment should be considered. All data collection systems, whether paper-based or electronic should have the capability for defaulter tracking and a system for generating and sending out reminders to defaulters. When using such reminder systems, protecting the confidentiality of data on the health and vaccination status of health workers will be critical and access to the data should be restricted to the facility vaccination coordinator. Coverage monitoring Several approaches for estimating health worker influenza vaccine coverage are available. The timing of such coverage measurement is important and should be coordinated with the timing of vaccination in the country. Given that influenza vaccine is usually administered in seasonal campaigns, frequent reporting (e.g. monthly) is recommended. Ideally, assessments should be done at the end of the season, when complete data are available and assessed and data cleaned for any inconsistencies. 35 4. Monitoring and evaluation Health facility registries Information on influenza vaccines administered to health workers should be included in existing records maintained as part of occupational health requirements and in vaccination registers as part of institutional monitoring mechanisms. Careful assessment of data discrepancies is requi- red if reporting is done from multiple sources, and data protection issues should be judiciously considered. The minimum set of data will include the number of people receiving influenza vac- cination during each annual season, the total number of targeted health workers, and the derived vaccination coverage (%). Often both numerator and denominator data can be obtained from the departments of occupational health at health facilities. For establishing more detailed denomina- tors, nominal health worker records e.g. based on payrolls can be used as a first step. A beneficiary list of those targeted for influenza vaccination can be selected from these records by applying criteria related to the health worker’s risk of infection or of transmitting the infection to those for whom they care (see section on “Characterizing the target groups for vaccination” and table 1). Depending on the capacity of the reporting system and program, this could include tallying numbers by health worker category and risk profile to allow coverage estimates by subcategories, such as doctors, nurses, laboratory workers, or staff working in Intensive Care Units or general (e.g. medicine or paediatric) wards, etc. If a vaccination registry does not exist, a crude estimate of coverage among health workers could be calculated by using the number of vaccine doses distributed to each facility minus the number of vaccine doses returned (unused) divided by the estimated number of health workers targeted for vaccination at the facility. A similar, rather imprecise method to assess coverage at the national level would be to use the regularly compiled data on health workers (as reported to WHO) to estimate the denominator (see Toolbox 12), as used for the vaccine demand forecast, and the overall number of vaccines adminis- tered as the numerator. This approach should only be used as a last resort where none of the other methods described are feasible. Administrative data If vaccines are provided free to health workers with government, national insurance system or employers bearing the costs, there may be regular, sometimes mandatory, reporting on the number of health workers who have received vaccinations at the institutional level. Such administrative data may be available from well-documented national vaccine programmes or from health insu- rance records. Surveys Surveys to obtain data on vaccinations and other interventions should be performed every 3 to 5 years and allow the identification of heterogeneity of coverage at the subnational level, important for the necessary adaptation of immunization practices. A representative sample of health workers can be selected though a stratified random sampling approach from national registries of health workers (e.g. professional organizations). If such registries are not available, a two-stage selection of health facilities and of health workers in these facilities can be done. If contact information is available, standardized interviews could be done face-to-face, by phone or via internet-based pla- tforms. Without such information, online survey links could be provided to all health workers in the selected facilities with an invitation to access the survey platform using their mobile phones or personal computers. It should be noted that when using this approach, self-reporting of vacci- nation may lead to overreporting.12 12 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394773/ 36 4. Monitoring and evaluation In all of these approaches to estimate coverage it will be important to specify the categories of health workers, e.g. those with or without direct patient contact, the latter including students, trainees, volunteers, maintenance, information technology, food service staff etc., who have been included in the numerators and denominators. It is also important to specify if part-time personnel working during the influenza season were included in the coverage estimates. Where individuals for whom vaccination is not recommended are vaccinated, such as back office workers or staff relatives, etc., care must be taken not to count these in estimating vaccination coverage. Refusal and completion rates of surveys will need to be monitored and adjustments for possible selection biases made in the analysis. At times, influenza vaccination programs may merely set absolute number targets of health work- ers to be vaccinated, based on the number of vaccines procured and available in a specific area or location. Such an approach, while followed in some countries, will not allow the proper estimation of coverage rates, including coverage by risk category, or comparisons over time, which will be important for interpreting any data on impact. It will also not enable identification of determinants of vaccination or of refusers. If available, data as well as methods used to estimate vaccination coverage for other regular health worker vaccinations should be accessed, e.g. for hepatitis B, measles, polio, pertussis or tetanus vaccines. It must be noted, however, that these vaccines are not provided on an annual basis and will often only be checked at entry to service. Toolbox 14 lists available tools for collecting and reporting immunization data and for estimating coverage. Toolbox 14 Monitoring and evaluation tools and indicators Immunization in practice series, module 7: Monitoring and using your data. Describes how to collect and report data and how to monitor immunization performance. ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf (Accessed 14 Mai 2019) Training for mid-level managers. Module 7: The EPI coverage survey (Document WHO/IVB/08.07). Geneva: World Health Organization; 2008. Provides a step-by-step walkthrough, including relevant guidance and tools, to plan and conduct a coverage survey of a newly introduced vaccine. ƥ http://who.int/immunization/documents/MLM_module7.pdf (Accessed 14 Mai 2019) WHO reference for estimating influenza vaccination coverage among target groups. Outlines different methodologies that can be used to estimate national influenza vaccine coverage among high-risk groups targeted for vaccination. ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing-influenza- vaccination-coverage-target-groups.pdf (Accessed 14 Mai 2019) 37 4. Monitoring and evaluation AEFI monitoring As for any vaccine and target group, a functioning AEFI monitoring system is a basic requirement, since knowledge gaps and misperceptions about influenza vaccine safety among health workers are consistently identified in in the literature. The system utilized to monitor and investigate possible AEFIs when delivering influenza vaccine to health workers should ideally be integrated into existing AEFI surveillance systems in line with national regulations for the monitoring of vaccine safety. The NIP or other departments responsible for health worker influenza vaccination (e.g. occupational health) should work with the National Regulatory Authority to define roles and responsibilities in vaccine safety monitor- ing. In countries using influenza vaccines for the first time, it could be conceivable to intensify AEFI surveillance during the first year of influenza vaccine introduction in order to provide quick feedback to stakeholders to help assure them of the safety of the vaccines in use. A functioning AEFI monitoring system will detect and elucidate problems with vaccines, which could be due to the product itself, its quality, or errors in the administration of the vaccines. All vaccine recipients reported as having an event (including minor events) perceived to be related to the influenza vaccine should be reported to the AEFI surveillance system using standard report- ing forms (see Toolbox 15). Given adequate reporting, the monitoring system should be able to evaluate the observed rate of reactions to influenza vaccine and compare this to the expected rates reported in the literature. For serious AEFIs, causality will normally be assessed by a group of experts. Importantly, and as for any vaccine, such a system needs to be able to identify a previously unknown or unexpected vaccine reaction that should be investigated in more depth. Care must be taken to ensure that coincidental events are not mistaken for vaccine reactions. Toolbox 15 AEFI-related information sources AEFI core variables, including data on case, vaccine, event and reporter ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_Dec2015.pdf (Accessed 14 Mai 2019) Sample form for AEFI recording with detailed description of reporting elements ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (Accessed 14 Mai 2019) Causality assessment of an AEFI: Provides the detailed methodology in a four-step process with access to a related software tool  http://www.who.int/vaccine_safety/publications/gvs_aefi/ (Accessed 14 Mai 2019) Vaccine safety training resources providing access to vaccine and pharmacovigilance training packages  http://www.who.int/vaccine_safety/initiative/tech_support/ (Accessed 14 Mai 2019) Information sheet: observed rate of vaccine reactions – influenza vaccines ƥ https://www.who.int/vaccine_safety/initiative/tools/Influenza_Vaccine_rates_information_sheet.pdf (Accessed 14 Mai 2019) 38 4. Monitoring and evaluation By establishing and enhancing AEFI systems, influenza vaccination can also be used to further improve the awareness of overall immunization safety in the health worker community. Monitoring and evaluation of vaccine acceptance Key determinants of vaccine acceptance among health workers have been investigated and include the desire for self-protection and to protect family and patients. (see also section on communica- tion and vaccine acceptance). As part of an initial situation analysis of health worker influenza vaccination programmes, available information on policy, programmes and practices, the factors affecting acceptance and participa- tion, and the influence of media and communications can be investigated through key informant interviews, or participatory workshops. Results of such an analysis could then be used to inform additional communication strategies addressing the identified concerns in a targeted manner. Other determinants can be explored through formative research. Both qualitative and quantita- tive research methods can be used to evaluate changes in health workers’ knowledge, attitudes, practices and behaviours. Behavioural determinants that differentiate health workers who get vaccinated from those who do not should be assessed regularly. Understanding the reasons and reasoning behind health workers’ attitudes towards annual flu vaccination is useful for the de- velopment of communications messages and products. Involving health workers in behavioural research related to their perceptions, beliefs, emotions and potential conflicts also provides an opportunity for the health worker community to be engaged in the approach, which can result in greater acceptance of the vaccination program. Vaccine impact monitoring After an influenza vaccine has been introduced in a population, additional studies may help in evaluating the impact of the immunization program. However, WHO does not recommend that vaccine impact or effectiveness studies be conducted by all countries with influenza vaccination programs, given their complexity and expense. A number of research networks worldwide conduct such studies and results can be expected to be applicable in Toolbox 16 Tools to assess vaccine acceptance among health workers TIP-FLU tool. Provides an approach and tools grounded in behavior change theories and health programme planning models to tailor seasonal influenza vaccination to the needs and attitudes of frontline HWs.  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) TIP FLU case study Montenegro. Provides a practical example of the use of the TIP FLU tool. ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization-Pro- grammes-Seasonal-Influenza-TIP-FLU.pdf (Accessed 14 Mai 2019) 39 4. Monitoring and evaluation other settings with similar influenza epidemiology and vaccination programs. The decision to carry out such studies should therefore be based on the need for country-specific estimates and on the local capacity to conduct such rigorous studies. If studies are not appropriately designed with adequate sampling of different health worker categories, there is a risk of arriving at wrong conclusions. Before-after studies to demonstrate vaccine effectiveness are not advised for influenza, given that influenza vaccine effectiveness for preventing influenza symptoms in seasonal influenza epi- demics display considerable heterogeneity.13 Studies to evaluate the impact of seasonal influenza vaccination in health workers can be even more complex, given the varying risk of infection and transmission to patients among different categories of health workers. In health workers, a general reduction in absenteeism or, if available, reduction in influenza-asso- ciated absenteeism is often used as a surrogate indicator for the impact of an influenza vaccination programme. For this, health facility institutional monitoring would need to include disease rates in health workers, and a measure of sickness absence. Where possible, reporting days of absenteeism due to influenza-like illness (ILI) (or respiratory infections) should be recorded. This will include self-reported ILI with or without virological confirmation. Other non-specific outcomes include severe acute respiratory infection (SARI) and all-cause pneumonia requiring hospitalization. It is important to note that all these clinical syndromes include various other respiratory pathogens against which influenza vaccine does not protect. If such assessments are done, they should ide- ally cover multiple seasons, since impact can vary substantially by season, else such studies will be quite difficult to interpret. Laboratory-confirmed outcomes (e.g. by RT-PCR and other molecular diagnostic tests) improve the specificity of influenza disease classification. Where possible, establishment of sentinel sites with such capacity could be considered for collecting samples from health workers for laboratory confirmation. In these sites, vaccine effectiveness could be assessed using a case-control design and comparing vaccine coverage in laboratory-confirmed versus test-negative cases, if vaccine coverage is sufficiently high. Any of these approaches require sophisticated laboratory capacity which is not available everywhere. The screening method is a study design which could also be used for health worker vaccine im- pact assessment: it uses individual-level data on vaccination history from cases and data on vac- cination coverage in the health worker population from which the cases came. However, such a study requires accurate information on the vaccination status of the cases and of health worker vaccination coverage. Given the indication that annual influenza vaccination for health workers could reduce illness among the patients they care for, studies can be designed to evaluate the effect of health worker influenza vaccination on mortality, hospitalization, and influenza cases in patients of healthcare facilities. Several research approaches have been used in this context such as randomized trials or case-control approaches. Given the complexity of study designs, the conduct of such studies should be limited to research institutions that have the capacity and experience to conduct such studies. Economic assessments and cost-effectiveness evaluations may be considered once sufficient cost and impact data are available following influenza vaccine introduction. WHO provides a number of relevant resource documents, which are being further developed to specifically estimate vaccine 13 Evaluation of influenza vaccine effectiveness: A guide to the design and interpretation of observational studies, WHO 2017. 40 4. Monitoring and evaluation introduction costs for health worker vaccination (Toolbox 17; see also Toolbox 2). Relevant data are not easily available everywhere and assessments can be difficult to perform, given the limited size of the group of health workers. Post-introduction evaluation National Immunization Program Reviews routinely assess the use of specific vaccines about every 5 years following a new vaccine introduction. Such NIP Reviews should include relevant items to identify possible programmatic areas related to the new vaccine use. As needed in-between NIP Reviews, a specific influenza-related Post-Introduction Evaluation (I- PIE) tool may be performed after the first or second influenza immunization season. The I-PIE package (Toolbox 18) includes a number of tools to support the planning and conduct of the evaluation, including standard questionnaires and data collection forms in paper or electronic format as well as reporting templates together with instructions on how to perform the I-PIE in a cost-efficient manner. These tools will need to be adapted to the specific country context and to the specifics of the vaccine formulation and presentations. The I-PIE is performed at all levels of the health system and includes observation of practices at the points of vaccine administration, vaccine storage areas as well as data and record reviews. An I-PIE can thus provide a more immediate approach to assess the programmatic challenges and impact of influenza vaccine use, and to compare results across countries, enabling them to share and learn from each other’s experiences. Toolbox 17 Influenza in health workers: Study methodologies Evaluation of flu vaccine effectiveness 2017. Provides detailed information for researchers who design observational influenza vaccine effectiveness studies and for public health scientists who interpret and apply the results of these studies. An annex will address the effectiveness of influenza vaccine in health workers. ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (Accessed 14 Mai 2019) Manual for estimating disease burden associated with seasonal influenza. Provides step-by-step approach to estimate influenza disease burden in the general population as well as those with specific conditions who are vulnerable to severe disease.  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (Accessed 14 Mai 2019) Toolbox 18 Influenza post-introduction evaluation tools I-PIE tool with instructions and recording and reporting templates  https://www.who.int/immunization/research/development/ipie_influenza_post_introduction_ evaluation (Accessed 14 Mai 2019) 41 References [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination accep- tance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during preg- nancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are count- ries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evi- dence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare wor- kers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-ana- lysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13(6):e0198685. 42 [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care wor- kers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epide- miol. 2002; 23(10):615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influen- za-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kin- dergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial out- break of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a mul- ti-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 43 [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vacci- nation of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12(1):e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vac- cination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection cont- rol and hospital epidemiology. 1998; 19(7):518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward man- datory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62(1):1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 44 [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing inter- vention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccination: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36(2):196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, ado- lescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertive- ness. N Engl J Med. 2019 Jan24; 380(4):309–11. 45 Annex 1. Sample non-participation form This form is to be used in cases of voluntary vaccination where health workers in the very high or high-risk categories who decline to participate in assessment, screening and vaccination in accordance with the national policy. Completion of the form is particularly important where failure to get vaccinated will result in reassign- ment or require the use of protective measures to protect patients as specified in the national policy. Non-participation in vaccination 1. I have read and understood the policy directive regarding seasonal influenza vaccination of health workers. 2. I decline to participate in vaccination against influenza. 3. I am aware of the potential risks to myself and/or others that my non-participation in vaccination may pose. 4. I am aware that my non-participation may result in my being reassigned to a non-high-risk area or in other requirements to protect others with whom I may come in contact, as per the national policy. 5. The reason for my non-participation is: Refusal to sign In circumstances where the health worker refuses to sign this form, it should be noted on the form and the health worker should be notified of consequences, if any, as per the policy. Name of health worker: Date of birth: Health service/ facility: Work area: Signature: Date: OFFICE USE ONLY I have discussed the potential risks that non-participation in vaccination may pose and the management of unvaccinated workers in accordance with the vaccination policy. Name of vaccination team staff: Designation: Health facility /agency: Signature: Date: 46 Annex 2. Complementary checklist for planning health worker immuniza- tion: national14 level (To be adapted for local use) To account for the specifics of seasonal influenza vaccination of health workers, the following ADDITIONAL elements may be added to the generic new vaccine introduction check list, see Annex 4 of the document “Princi- ples and considerations for adding a vaccine to a national immunization programme” for the checklist structure. Health worker seasonal influenza vaccination policy 1. National policy on seasonal influenza vaccination of health workers are published and dissemi- nated to all relevant agencies and health facilities, including private health facilities and relevant professional societies. 2. The policy on seasonal influenza vaccination of health workers is reflected in the national occupational health policies. 3. The costs of seasonal influenza vaccination of health workers are included in either the immu- nization or occupational health budget, as appropriate. 4. Surveillance system is in place for influenza activity, including defining start and end of the influenza season, to inform selection of the most appropriate vaccine formulation and timing of influenza vaccination. Planning for successful vaccine introduction 5. A functional multidisciplinary coordination group is in place to discuss and promote access to a new target population of health workers, enabling the formation of partnerships which support and shape the national agenda. 6. The group includes focal points from the occupational health and immunization programs, professional organization representatives, and other relevant stakeholders. 7. A costed operational plan for health worker vaccination is developed and integrated into the na- tional immunization plans and relevant occupational health plans. Formative research (optional and to be included only if formative research is planned) 8. The need and scope of any formative research to be conducted in preparation for vaccine introduction is defined. 9. A research group to conduct formative research has been identified and terms of reference for the research has been developed. Communications 10. National communications working group established for planning communications strategy and developing communications materials for health worker vaccination against seasonal influenza. 14 In some countries, especially large countries with decentralized system, elements of this checklist may also apply at relevant subnational levels, e.g. provincial level. 47 11. Tailored communications messages and materials developed along with an overall communications strategy. 12. Training for health facility communications teams is conducted. Vaccine procurement and supply chain management 13. Target population size estimate developed and included in demand forecast. 14. Individual health facility demand estimated, and vaccine distribution plan developed. 15. Sufficient storage space for vaccines and supplies for seasonal vaccination at all levels established to accommodate vaccine during vaccination period. Vaccine Delivery 16. Health facility vaccination delivery teams are established and trained. 17. System for management of vaccination refusals and implementation of infection control mea- sures in place for prevention of nosocomial transmission, e.g. reassignment, wearing of masks, mandatory leave in case of ILI. Monitoring and evaluation 18. Data recording and reporting tools developed and distributed including for coverage monitoring (updated administrative data and health worker surveys) and AEFI monitoring. 19. Post-introduction evaluation conducted within the first 2 seasons following vaccine introduction. 20. Possibilities reviewed for operational research to assess health worker vaccine acceptance. 48 Annex 3. Health facility checklist (To be adapted for local use) Person responsible Deadline Status Communications 1. Health facilities communications working groups are established and trained 2. Health facility communications plan and schedule for group communications with health workers finalized 3. Adequate supplies of posters and information materials for health worker vac- cination are available 4. Notification of vaccination sent out to targeted health workers and supervisors 5. Telephone hotline established to address individual queries from health workers Storage capacity for vaccines and supplies 6. Adequate storage capacity for influenza vaccines and supplies during vaccination window period established 7. Adequate supplies of influenza vaccines and supplies for health worker vaccination available 8. Provision to deal with extra injection waste during period of vaccination Vaccine Delivery 9. Vaccination delivery team established and trained and vaccination sites within health facility finalized 10. Categorization of health workers completed and beneficiary list for vaccination developed 11. System for management of vaccination refusals and implementation of infection control measures in place for prevention of nosocomial transmission, e.g. reas- signment, wearing of masks, mandatory leave in case of ILI Monitoring and evaluation 12. Data recording and reporting instruments available taking into account data protection issues 13. System for defaulter tracking and reminders established 14. Health facility registries updated to include influenza vaccination 15. AEFI monitoring and reporting systems updated to identify AEFI in health workers 16. Vaccine acceptance monitoring system to address uptake issues in health workers established (if uptake issues are observed) 49 Annex 4. Sample questionnaire for conducting a survey among health workers 1 Name (optional) 2 Age (years) 3 Sex ¨ Male ¨ Female 4 Job category15 ¨ Doctor ¨ Nurse/midwife ¨ Laboratory technician ¨ Other technical staff ¨ Other (specify) 5 Patient contact ¨ Direct ¨ Face-to-face but not direct ¨ None 6 Contact with high risk patients ¨ Yes ¨ No 7 Work area (name of clinical area of work) Statements Strongly agree Agree Neutral Disagree Strongly disagree 1 Vaccination of health workers against diseases such as hepatitis B and influenza are important 2 If I was unvaccinated exposure to influenza would be a risk to my health 3 Exposure to influenza poses a risk to my patients’ health 4 Influenza vaccination poses a risk to my health 5 The benefits of vaccination are greater than the risks 6 My receiving vaccination will protect my patients 7 The best way to protect my patients is to combine seasonal influenza vaccination with other infection control measures 8 I am sufficiently informed about risks of influenza infection I am sufficiently informed about the risks and benefits of influenza vaccination The following factors that would influence my decision to accept vaccination 9 Recommendations from the national policy-making body (e.g. NITAG) 15 Adapt for local use based on local health worker classification. 50 10 Endorsement of recommendation from the professional society to which I belong 11 If it is part of occupational health regulations/ requirements 12 Recommendation from my personal physician 13 Availability of vaccination at no cost to me 14 Easy access to vaccination at my place of work 15 Colleagues having been vaccinated 16 Previous experience with vaccination 17 Protecting my patients 18 Preventing/reducing absenteeism from work 19 Contributing to pandemic preparedness Other factors that would affect my decision to accept influenza vaccination (list below) 20 21 22 51 Annex 5. Communications and demand generation: Stratification of approaches to developing the content Approach Effort Impact Developing the content for communication messages Framing information by delivering social comparison feedback on vaccination rates among peers or healthier individuals Low Medium Tailored communication based on cognitive styles and cultural behaviours Medium High Communication methods Distribution and display of Information, Education and Communication (IEC) materials Low Medium Establish a specially trained communications team at health facility level to administer communications and demand generation approaches Medium High Web-based (including FAQs and chat groups) and social media communications Medium Medium Text message and e-mail reminders to health workers Low Medium Small group in-person briefing meetings High Medium Use immunization champions at national and health facility level Medium High Demand generation approaches Provision of free vaccines Medium High Provide vaccination in the work area using mobile teams Medium High Provide incentives or stimulate competition, e.g. awards to clinical areas with highest vaccination coverage Low Medium Visible reminders and peer-pressure, e.g. badges or stickers worn by those who have been vaccinated Low Medium Ask individual to commit to a time and location to obtain vaccination Low Medium Increase options to obtain vaccination, either near home or at workplace Medium High Guide choice through default options, e.g. automatically set up appointment for vaccina- tion unless individual opts out Low High Establish standing orders to facilitate vaccination Medium High 52 ISBN 978-92-4-151559-7

1An introduction manual for national immunization programme managers and policy makers How to implement seasonal influenza vaccination of health workers Family, Womens’s and Children’s Health (FWC) DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS This document was produced by the Initiative for Vaccine Research (IVR) of the Department of Immunization, Vaccines and Biologicals How to implement seasonal influenza vaccination of health workers ISBN 978-92-4-151559-7 Published: May 2019 This publication is available on the Internet at: https://apps.who.int/iris/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: + 41 22 791 4227 • Email: vaccines@who.int © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following dis- claimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. How to implement seasonal influenza vaccination of health workers. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. IAcknowledgements This manual was developed by Thomas Cherian and Carsten Mantel, MMGH Consulting and Philipp Lambach (WHO/IVR) with review and inputs of an Independent Expert Advisory Group: Salah Al Awaidy, Silvia Bino, Joseph S. Bresee (chair), Supamit Chunsuttiwat, Daouda Coulibaly, Luzhao Feng, Rachel Hale, Shabir A. Madhi, Helena C. Maltezou, Kelly Moore, Jonathan Nguyen- Van-Tam, Saad Omer, Gregory Poland, Sabine Wicker. Kelly Moore and Chris Morgan were consultant as representatives of the WHO Immunization Practices Advisory Committee, IPAC. Consultants: Thomas Cherian, Carsten Mantel. Additional experts: Birte Bödeker, Susan Y. Chu, Sara Hamid, Kathryn Lafond, Kathleen Morales, Julia Neufeind, Susan Wang. WHO: Philipp Lambach, Onyema Ajuebor, Ms Phionah Lynn Atuhebwe, Philip Gould, Shalini De- sai, Julia Fitzner, Martin Howell Friede, Shoshanna Goldin, James Dawson Heffelfinger, Raymond Hutubessy, Ivan Dimov Ivanov, Pernille Jorgensen, Melanie Marti, Hasan Qamrul, Lisa Menning, Ann Moen, Liudmila Mosina, Andreas Alois Reis, Alba Maria Ropero Alvarez, Claudia Steulet, Nadia Teleb. Financial support for the development and pilot-testing of this manual is provided through the Centers for Disease Control and Prevention (CDC), which provides financial support to the World Health Organization Initiative for Vaccine Research (U50 CK000431). II Contents Executive summary 1 About this manual 2 Objective 2 Audience 2 Structure of the document 3 Key related documents 4 1. Background and rationale 5 Current status of influenza vaccination in health workers 5 Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers 6 Evidence for health worker risk of influenza and impact of vaccination 6 Evidence of transmission of infection from health workers to patients and the impact of vaccination 7 Evidence for interventions to increase health worker vaccination uptake 7 Global Action Plan for Influenza Vaccines 8 2. Establishing a policy to vaccinate health workers against seasonal influenza 10 The decision-making process 10 Considerations for decision-making 12 Defining the public health objectives for vaccination 12 Economic analysis for establishing national policies 13 Characterizing the target groups for vaccination 14 Framing an immunization policy for health workers 15 Integration with Occupational Health Policies 18 Choice of vaccine product, schedule and timing of vaccination 18 Defining monitoring and disease impact measurement objectives 20 III 3. Planning and managing vaccination of health workers 21 Planning for successful vaccine introduction 21 Costing and financing 22 Formative research to inform the planning process 24 Communication and vaccine acceptance 25 Communications at the health facility level 26 Demand Generation at the Health Facility Level 28 Vaccine procurement and supply chain management 30 Vaccine procurement 30 Selection of the vaccine product and presentation 30 Logistics and cold chain management 31 Vaccination of health workers 32 Training of the vaccination team 33 4. Monitoring and evaluation 34 Developing and updating information systems 34 Coverage monitoring 34 AEFI monitoring 37 Monitoring and evaluation of vaccine acceptance 38 Vaccine impact monitoring 38 Post-introduction evaluation 40 References 41 Annex 1. Sample non-participation form 45 Annex 2. Complementary checklist for planning health worker immunization: national level 46 Annex 3. Health facility checklist 48 Annex 4. Sample questionnaire for conducting a survey among health workers 49 Annex 5. Communications and demand generation: Stratification of approaches to developing the content 51 1Executive summary Health workers are at higher risk of influenza infection than the general population. In addition to morbid- ity among health workers, influenza infection may also lead to increased absenteeism, presenteeism1 and disruption of medical services. Moreover, influenza infected health workers may contribute to nosocomial transmission of infection to their patients, including those at high risk for developing severe influenza disease and complications. Hence, the World Health Organization (WHO) considers health workers to be a priority target group for seasonal influenza vaccination. In addition, influenza vaccination of health workers contributes to influenza pandemic preparedness. Finally, studies have shown that health workers who are vaccinated against influenza themselves are more likely to recommend vaccination to their patients. This manual serves as a resource to assist users in establishing a national policy for seasonal influenza vaccination of health workers. It provides guidance along with a catalogue of available tools to facilitate policy development, planning, implementation, monitoring and evaluation of influenza vaccination of health workers. The contents of the manual are meant to supplement the document titled “Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring”, published by WHO in 2014. The main target audiences for this manual include national policy makers; national health planners; the na- tional programme managers for immunization and occupational health; and those responsible for occupational health, health worker immunization and infection control in health facilities. Close collaboration between immunization managers, and occupational health and infection control programmes is essential to optimize vaccine uptake, and for a cohesive and comprehensive approach to influenza control in health facilities. This manual summarizes the evidence and rationale, provides guidance on key issues, and lists available tools for influenza vaccination of health workers, covering three main components of vaccine introduction and management: 1. Establishing an evidence-based national policy for seasonal influenza vaccination of health workers. 2. Planning and management of health worker influenza vaccination. 3. Monitoring and evaluation, including assessing vaccination coverage, monitoring for adverse events following immunization, impact assessment and post-introduction evaluation. Complementing this manual, deliberations of an Independant Expert Advisory Group developing this manual are available in form of a meeting report summarizing critical issues. These include policy con- siderations, the evidence in support of health worker vaccination; categorization and prioritization of health workers; the choice of vaccination strategy; its integration into broader health worker vaccination and occupational health policies; planning and management of vaccination, particularly the approaches for communication and demand generation; and the challenges with monitoring and evaluation of health worker vaccination, especially in low and middle-income countries.2 1 Presenteeism refers to health workers who work while ill, yet have reduced accuracy and effectiveness and pose a risk to vulnerable patients in their care. 2 Cherian T. et al. Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16–17, Berlin, Germany. Vaccine. 2019;37(43):6255–6261. 2About this manual Objective This manual serves as a resource and catalogue of available tools to assist country officials in de- ciding upon, planning, implementing and monitoring health worker influenza vaccination in order to achieve optimal vaccination coverage. It is not meant to be a prescriptive document, but rather articulates general principles and key considerations to support policy formulation; plan- ning and management of vaccination; and monitoring and evaluation of influenza vaccination of health care workers. The manual also outlines measures to ensure integration of health worker influenza vaccination into existing national occupational health policies and occupational safety and health management systems of health facilities. It also addresses the opportunity for health worker influenza vaccina- tion to promote an integrated approach for monitoring and optimizing the uptake of all interven- tions included in national occupational health policies. In addition, it refers to the relationship and contribution of health worker vaccination to pandemic influenza preparedness. Seasonal influenza vaccination in health workers differs from other vaccine-preventable diseases in that vaccination is required annually. However, elements of this manual may be of relevance for health worker vaccination in general, particularly the sections on planning and management of vaccination and on monitoring and evaluation. Audience The main target audience for the manual include: 1. National policy-making bodies and health planners. 2. Programme managers for immunization, infection control and occupational health programmes at national and subnational levels and those responsible for occupational health and infection control in health facilities. 3. Organizations of health workers and employers. While the different sections of the document may be of greater relevance to one or the other group, it is advisable that the document be read as a whole because of the information on a particular topic may be found in the different sections of the manual. The document may also be useful to other audiences with an interest in immunization or occu- pational health. 3Structure of the document The manual consists of four sections as outlined in Figure 1. However, for clarity and complete- ness there is some overlap between some of the sections, with cross-references made to the other relevant sections. Figure 1. Structure of the document Establishing a policy Planning & management of vaccination Monitoring & evaluation Introduction, background and rationale •About the manual, including objectives and target audience •WHO policy recommendations on influenza vaccination •Current status of health workers vaccination •Summary of evidence to support health worker vaccination •Global Action Plan for Influenza Vaccines •Considerations for making a decision •Defining the objectives for vaccination •Categorization and prioritization of health workers •Framing an immunization policy • Integration with Occupational Health Policies •Choice of product and timing for vaccination •Delivery options and strategies to optimize coverage •Defining monitoring and impact assessment objectives •Planning for successful vaccine introduction •Costing and financing •Formative research to inform planning process •Communication & vaccine acceptance •Demand generation at the health facility •Vaccine procurement and supply chain management •Vaccination of health workers •Training of vaccination team •Coverage monitoring •AEFI monitoring •Vaccine acceptance assessment •Vaccine impact monitoring •Post-introduction evaluation POLICY MAKERS IMPLEMENTERS 4Key related documents The following documents are important resource materials that complement the guidance in this manual. 1. The WHO policy recommendations on seasonal influenza vaccination, including health worker vaccination are published in WHO Position Papers. These position papers are peri- odically updated. Vaccines against influenza: WHO position paper – November 2012 https://www.who.int/wer/2012/wer8747.pdf (Accessed 14 Mai 2019) Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (Accessed 14 Mai 2019) 2. The following document provides detailed guidance to countries that already provide sea- sonal influenza vaccination to health workers on how to identify, analyse, and effectively target issues related to uptake: Tailoring immunization programmes for seasonal influenza (TIP FLU). A guide for increasing health care workers’ uptake of seasonal influenza vaccination (2015). Copenhagen: World Health Organization Regional Office for Europe; 2015. http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) 3. While the contents of this manual can help inform national policies, the manual does not provide an exhaustive review of the available evidence to inform decision-making. A more detailed review of such evidence in support of vaccination of health workers is found in the following document: Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. July 2019. https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (Accessed 12 July 2019) 4. This manual is part of a series of introduction manuals on seasonal influenza vaccination developed by WHO. A manual on the implementation of influenza vaccination of pregnant women has been published earlier. How to implement influenza vaccination of pregnant women: an introduction manual for national immunization programme managers and policy makers. http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (Accessed 14 Mai 2019) 51. Background and rationale Health workers are at risk of influenza virus infection and of transmitting infection to patients under their care who may be at high risk for severe disease, complications, and death (1). The increased risk in health workers compared to the general population may vary by occupation or setting (2). WHO considers health workers to be an important priority group for influenza vaccina- tion, not only to protect themselves and maintain essential health-care services during influenza epidemics, but also to reduce the spread of influenza to vulnerable patient groups with whom they come into contact (1). Furthermore, many studies have found that a strong recommendation from health workers, especially from physicians, is highly likely to increase public uptake of vaccination (3–5). Health workers who have themselves been vaccinated are more likely to be knowledgeable about vaccination and be more effective in improving public acceptance of vaccination (3–5). Fi- nally, because health workers are likely to be targets of vaccination programs during an influenza pandemic, establishing functional programs for seasonal influenza vaccination of health workers will facilitate timely and effective vaccination during a pandemic (6). Current status of influenza vaccination in health workers Global adoption of a policy for influenza vaccination of health workers has been slow. In 2017, only 119 of the 194 countries reporting having a national influenza vaccination policy. Of these, 96 report targeting health care workers as a priority group. However, the proportion of Member States that reported having a policy varies by WHO region, with the majority of countries in the WHO regions of the Americas, Europe and Eastern Mediterranean reporting a national policy for influenza vaccination, whereas a lower proportion of countries report having such a policy in the Western Pacific, African and South-East Asian regions. Information on influenza vaccination coverage in health workers is not available for most coun- tries, though it varies widely and is reported to be low in many countries where such data are available. For example, data on coverage in health workers were available from only 26 (56%) countries in the European region for the 2014–15 season. The median coverage was 29.5% with a range of 2.6% to 99.5%; only three countries, namely Albania, Armenia and Belarus, reported coverage > 75% (7). More recent data from a systematic review through compulsory reporting from all hospitals in England showed an uptake of 69% in the 2017–18 season.3 An internet survey of 2000 health workers in the United States demonstrated coverage to be 78% during the 2017–18 season, with higher coverage rates (95%) among those working in settings where they were required by their employers to be vaccinated (8). Higher vaccination coverage rates are reported when man- datory vaccination policies are implemented. In one systematic review that included eight studies, coverage rates exceeding 94% were achieved in all (9). 3 Seasonal influenza vaccine uptake in healthcare workers (HCWs) in England: winter season 2017 to 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/Sea- sonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf (Accessed 14 Mai 2019) 61. Background and rationale Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers A rapid evidence appraisal of materials available in the English language, published since 2006, and considered to be of medium or high quality, was conducted by WHO (10). The questions considered, and the main findings of this appraisal are summarized here. Readers are referred to the published report for the details and for the relevant citations. The review considered three issues, namely: 1. The evidence that health workers are at increased risk of influenza infection compared to the general population, and that vaccinating them reduces influenza or absenteeism and/or the wider economic impact of influenza in the health workforce. 2. The evidence that health workers transmit influenza to their patients in health care set- tings and, if so, whether vaccination protects the patients and the proportion of health workers who need to be protected to obtain this effect. 3. The evidence for successful practical interventions to increase vaccination uptake and the state of knowledge of social, behavioural and public health public policy research on vaccination uptake in health workers. Evidence for health worker risk of influenza and impact of vaccination Studies comparing the risk of influenza infection in health workers compared to the general population are challenging, may measure different outcomes, or are executed in different set- tings, limiting the comparability across studies or the pooling of data from these studies. Recent systematic reviews suggest that health workers are at an increased risk of influenza infection compared to the general population (Odds Ratio = 2.08, 95% CI = 1.73 to 2.51) (2), though the evidence is strongest for asymptomatic laboratory-confirmed infection (11). However, health work- ers with asymptomatic infection may still transmit influenza virus to highly vulnerable patients in a health-care setting. Respiratory illness is reported as a common cause of absenteeism among health workers. Epidem- ics or pandemics of influenza have been associated with increased rates of absenteeism among health workers (12). Vaccine efficacy in health workers has been shown to be as high at 90% for well-matched seasonal influenza vaccines (13, 14), which suggests that vaccination of health work- ers will reduce influenza-related morbidity and absenteeism. A systematic review showed a pro- tective effect against laboratory confirmed influenza and shorter absenteeism due to influenza- like illness (ILI) in vaccinated groups (15). A recent study among health workers in the United Kingdom showed that a 10% increase in vaccination uptake is associated with a 10% decrease in absence due to illness (12). However, there are observational studies that provide conflicting results – though often constrained by poor study design, non-specific outcomes, high risk of bias, and failure to adjust for confounding factors (16–19). Since the risk of illness following infection is based on the level of exposure, and absence behav- iours may vary between different categories of health workers, it is possible that the lack of suf- ficiently granular data on absenteeism, e.g. stratified by health worker categories, may account for the mixed results seen in the different studies. On the other hand, the lack of impact on 71. Background and rationale absenteeism observed in some studies, despite evidence of increased rates of infection in health workers, raises the question as to whether health workers nonetheless continue to work when infected and lead to heightened concerns about the consequent risk of nosocomial transmis- sion (20). Several studies have documented presenteeism in health workers with influenza-like illness (21–23), including one instance which was associated with nosocomial transmission in an oncology unit (24). Evidence of transmission of infection from health workers to patients and the impact of vaccination Epidemiological studies using molecular subtyping approaches demonstrate evidence of transmis- sion from health workers to patients. The use of automated collection of high-resolution contact data using wearable sensors combined with virologic data have allowed the identification of potential routes of transmission in cases of hospital-acquired influenza (25). The extent of direct transmission from health worker to patient in health care settings is difficult to capture because of the constant influx of visitors, interactions between patients, and the possibility of multiple simultaneous introductions of influenza (26–28). However, among those who may contribute to transmission of infection in the health care setting, health workers represent a sizeable vaccine- preventable portion since they are easier to target for vaccination. The direct patient benefit of health worker vaccination can be measured in several ways, as il- lustrated in the literature. Several studies evaluate the impact on laboratory confirmed influenza, while others evaluate impact on non-specific outcomes such as ILI, respiratory illness, all-cause mortality, respiratory illness associated mortality, or incidence of nosocomial influenza infection. The evidence is stronger for non-specific outcomes such as ILI, all-cause mortality (29), and inci- dence of nosocomial influenza infection (30, 31). Although some studies have attempted to mea- sure the number of health workers that need to be vaccinated for optimal protection, the evidence in support of a coverage threshold is weak, leading to disputes in the literature (32). However, it is likely that patient protection is positively associated with increasing health worker vaccination coverage but would also depend on other factors including the type of patient contact, vulnerability of the patient, use of other infection control measures, and the effectiveness of vaccination in a particular influenza season (33–35). Evidence for interventions to increase health worker vaccination uptake There is a substantial body of evidence on successful interventions to increase health worker in- fluenza vaccination uptake, much of which has been incorporated into existing toolkits aimed at increasing vaccine uptake. Although the factors that contribute to the health worker decision-making pathway are diverse, some strategies appear to be more effective than others. No single intervention has been shown to rapidly and substantially increase and sustain vaccination uptake except for mandatory vaccina- tion. However, mandatory health worker vaccination is an issue that has been extensively debated with many different perspectives for and against its use (20, 32, 36). Successful mandatory vac- cination programmes require organizational and educational efforts to secure employee support prior to implementation (37). 81. Background and rationale A combination of one or more “soft mandates” such as active declination, required surgical mask use and exclusion of non-vaccinated staff from working with highly vulnerable patients may be used as alternatives to mandatory vaccination, although there are organizational, educational, monitoring and enforcement, and human and financial resource implications for applying such soft mandates. Additional components that contribute to increased uptake include the following: • Provision of free vaccine; • Convenient access to vaccination, including on-site vaccination in health facilities; • Knowledge and behaviour modification through education, reminders, and incentives tailored towards different health worker categories; • Management and organizational approaches such as personnel assigned to oversee vac- cination activities. The reasons for low vaccination uptake are heterogenous and vary across different health worker categories and cultures. Therefore, approaches to increase uptake need to be tailored for different groups. Some studies have demonstrated that formative research, including surveys and qualitative research, can provide insights that assist in tailoring interventions to optimize uptake. Conclusion Despite the ongoing debate in the literature, influenza vaccination is important for ensuring the safety of health workers, their patients, and the general population who rely on a functioning health system, especially during epidemic/pandemic periods. Studies to conclusively establish the value of health worker vaccination will be chal- lenging though the emerging data on this issue will be closely monitored to inform any changes to existing WHO policies.4 Global Action Plan for Influenza Vaccines In an influenza pandemic, most of the world’s population will be highly susceptible to infection and it is likely that infection will spread rapidly. Vaccination is considered one of the key strategies to mitigate the potential impact of a pandemic. While it is expected that there will be a delay in the development of strain-specific pandemic vaccines, insufficient production capacity will further restrict the global access to the vaccines, at least in the early phases of the pandemic. Resource- constrained countries, especially those that lack local vaccine production capacity and those that do not have seasonal influenza vaccination policies, will face the greatest challenge in securing timely access to vaccines during a pandemic, and mitigating the substantial adverse effects of a pandemic. 4 A working group of the WHO Strategic Advisory Group of Experts (SAGE) on immunization will be reviewing the emerging data and updates to the existing WHO recommendations are expected in 2020. 91. Background and rationale To address this challenge a Global Action Plan for Pandemic Influenza vaccines was developed by WHO with short, medium and long term-strategies aimed at increasing influenza vaccine production and surge capacity before and during an influenza pandemic (38). The plan proposed three approaches to enhance access to pandemic vaccines: (i) an increase in the baseline use of seasonal influenza vaccination; (ii) an increase in global production capacity; and (iii) further research and development. The first of the above three approaches relies on countries establishing clear and effective immu- nization policies to increase the baseline use of seasonal influenza vaccines – providing industry with better demand forecasts and stimulate increased production capacity. While vaccination of health workers will only result in a modest increase in overall vaccine de- mand, it will establish a robust and functional platform for rapidly immunizing health workers and could contribute to achieving high coverage in the event of a pandemic, thereby protecting health service delivery during a pandemic. Furthermore, high uptake of vaccination by health workers is likely to build trust and increase the uptake of vaccination among other high-risk groups tar- geted for seasonal influenza vaccination in national policies. Health worker vaccination may also establish or strengthen processes that would allow rapid deployment of pandemic vaccines. Thus, seasonal influenza vaccination of health workers goes beyond the issue of immediate protection against seasonal influenza as outlined above and contributes to pandemic influenza preparedness. 10 2. Establishing a policy to vaccinate health workers against seasonal influenza The decision to establish a policy to vaccinate health workers against seasonal influenza should be evidence-based, with a clear rationale, and with the required investments for sustainable implementation. The general principles and considerations for adding a vaccine to a national im- munization programme are articulated in the 2014 WHO guidance document titled “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: From Decision to Implementation and Monitoring” (39). Health workers comprise a target population not usually included in the national immunization programmes of many low and middle-income countries. While hepatitis B vaccination pro- grammes for health workers may exist, influenza vaccines are unique since vaccination for the foreseeable future must be repeated annually. This section of the manual deals primarily with additional considerations specific to annual seasonal influenza vaccination of health workers, building on the generic framework provided by the document cited above. The decision-making process As with any other vaccine for which policies have to be established, Ministries of Health (MoH) would request National Immunization Technical Advisory Groups (NITAGs) or equivalent na- tional or regional bodies to conduct a review of the evidence and provide advice on establishing a policy for seasonal influenza vaccination of health workers, and to make recommendations on the content of the vaccination policy. Engagement of the many stakeholders affected by this policy is essential to secure their endorse- ment and facilitate high vaccination uptake, and is likely to result in a more coordinated approach to the control of influenza in health facilities. Stakeholder consultation should be broadly sought and include: 1. Professional associations and societies representing different health worker groups such as medical, nursing and allied health service associations, as well as representatives of private health care providers; 2. Medical and nursing councils and other health worker regulatory bodies; 3. Patient safety groups, where they exist, and organizations representing patients, since health worker immunization should also be regarded as a patient safety and quality of care issue; 4. Health worker unions, where they exist and when their participation is likely to be use- ful in promoting vaccination uptake. 5. Health facility managers. 11 2. Establishing a policy to vaccinate health workers against seasonal influenza The process should also include early engagement with the bodies that establish occupational health policies and regulations to ensure that the policies established for health worker vaccina- tion against influenza are also reflected in the national occupational safety and health policies. If vaccination policies for health workers exist for other vaccines, e.g. hepatitis B vaccination, a review of these policies may provide useful inputs for policy formulation for seasonal influenza vaccination and on strategies to optimize vaccination uptake. Where available, NITAGs could access the information required from data available from the national influenza surveillance, the National Influenza Centres or other institutions participating in the Global Influenza Surveillance and Response System (GISRS) (see Toolbox 1). In places where local evidence is not readily available, especially on rates of disease amongst health workers and on transmission of disease from health workers to patients, efforts to generate such evidence could be time- and resource-intensive. Policy-makers would have to consider whether it is necessary to conduct local studies or whether data from other countries with similar epide- miological profiles and health system characteristics could be used to infer the likely burden of disease and support decision-making. NITAGs would need to balance the desire to have national data against the costs and delays that would result in generating the data and the consequent health impacts of this delay. Toolbox 1 National Influenza Centers To monitor and respond to the changes in the influenza virus antigenic structure and the subsequent necessity to change vaccine compositions, many countries have established national influenza centers (NIC) to collect and characterize virus specimens in their country and perform other analyses to inform the decisions of WHO and partners on the composition of the next year’s influenza vaccine. In many countries, virologic surveillance is complemented by more systematic influenza surveillance for severe acute respiratory illness (SARI) and influenza-like illness (ILI). A NIC in a country – or in a neighbouring country – can support evidence-based recommendations by providing data on the influenza disease burden and seasonality to the NITAG or other relevant national decision-making body. Involving these and other centers in NITAG discussions is key to bringing together all relevant information that is needed for the decision-making process. A list of NICS, WHO collaborating centers and essential regulatory laboratories (ERLS) can be found at the following links:  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (Accessed 14 Mai 2019)  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (Accessed 14 Mai 2019) 12 2. Establishing a policy to vaccinate health workers against seasonal influenza Considerations for decision-making In addition to the general considerations outlined in the WHO document “Principles and Consid- erations for Adding a Vaccine to a National Immunization Programme: from decision to implemen- tation and monitoring” referred to earlier, other key issues need to be considered when framing a policy for health worker vaccination. These are listed in Figure 2. Figure 2. Key considerations in establishing a vaccination policy for health workers Defining the public health objectives for seasonal influenza vaccination of health workers Characterizing and prioritizing the target groups for vaccination Framing the vaccination policy for seasonal influenza vaccination of health workers Choice of vaccine product, schedule and timing of vaccination Defining the monitoring and impact assessment objectives Defining the public health objectives for vaccination A critical first step in establishing a policy for vaccinating health workers with seasonal influenza vaccination would be to clearly define the aims and objectives of the vaccination programme. Such objectives may vary between countries but would underlie the prioritization of the health worker groups to be targeted for vaccination, set vaccination coverage targets, and provide guidance on the outcomes and scope for measuring the impact of vaccination. Vaccination of health workers serves multiple objectives. These may include: 1. Prevention of infection in the health workers themselves, averting associated morbidity. 2. Prevention of transmission of infection from health workers to vulnerable patients, including those at high risk of severe disease, complications, and death. 3. Sustaining health services by reducing health worker absenteeism, especially during seaso- nal and pandemic influenza outbreaks, which is a period of increased health care demand. 4. Promoting uptake of seasonal influenza vaccination among other target groups and enhance public trust for influenza vaccination. 5. Contributing to influenza pandemic preparedness by: a) Establishing a mechanism for rapidly immunizing health workers during a pandem- ic of influenza or epidemics of other vaccine-preventable diseases; 13 2. Establishing a policy to vaccinate health workers against seasonal influenza b) Contributing to increasing demand for influenza vaccine and thereby enhance pro- duction capacity to improve timely access to vaccine in case of a pandemic. c) Establishing or strengthening national capacity for vaccine regulation. One or more of the above could serve in defining the national objectives for health worker vac- cination. Important considerations when defining vaccination objectives include: 1. Review of the available data on the burden of disease among health workers and health care-related infections in patients and residents of long-term care facilities. National data, where available, complemented with representative regional or global data or esti- mates developed through the use of mathematical models may be used for this purpose. 2. The cost and impact of vaccination and availability of vaccine supply. 3. Review of the national pandemic preparedness plan and consideration of how health worker vaccination could contribute to pandemic preparedness. Economic analysis for establishing national policies While economic analysis is generally recommended prior to deciding on vaccination policies, lack of data for estimating and comparing the economic benefits of the different vaccination objectives may be a limiting factor, as will be the relatively small size of the target group. Toolbox 2 lists the available tools for conducting economic analysis for influenza vaccination. The costs and economic benefits of influenza vaccination of health workers are likely to depend on several factors, including the number and categories of health workers targeted, the incidence and severity of infection in the targeted health workers, their contribution to health care-associated transmission and the consequences of such infections. These factors may vary between different health facilities and will vary from one influenza season to another. A recent systematic review of the epidemiological and economic effects of seasonal influenza vaccination of health workers found that vaccination of health workers was cost-saving, based on crude estimates of absenteeism averted through vaccination (15). However, all the studies included Toolbox 2 Tools for the economic analysis of seasonal influenza vaccination Several tools are available for conducting economic analysis of influenza vaccination: WHO Guide for Stanardization of economic evaluations of immunization programmes (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf WHO Manual for Estimating the Economic Burden of Seasonal Influenza (WHO/IVB/16.04) ƥ http://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-eng.pdf Guidance on the economic evaluation of influenza vaccination (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. Establishing a policy to vaccinate health workers against seasonal influenza in this review were from high-income countries and took an employer perspective with a strong focus on absenteeism averted. Initial decisions could take vaccination costs and the impact of these costs to the immunization and health budgets into consideration, with the option of measuring cost-effectiveness post- introduction, if required. Further guidance on costing and budgeting of health worker influenza vaccination, with links to the available costing tools and resource materials on immunization financing are covered in the next section of this manual. Characterizing the target groups for vaccination Ideally all health workers should be targeted for vaccination, including those who may not come into direct contact with patients. Even if not in direct contact, health workers could potentially transmit infection acquired in the community to colleagues and, thereby, participate in the chain of health care-associated transmission of infection. However, in situations where there are resource constraints or limited or unstable vaccine supplies, categorization and prioritization of health workers for vaccination would be required. Prioritization of health workers would depend on as- sessment of risk of infection among the health workers themselves, transmission of infection to their patients and the consequences of health care-associated transmission. Even without financial resource constraints or limitations in vaccine supply, categorization of health workers would be useful when different policies are applied to different health worker cat- egories, based on risk assessment. For example, a mandatory vaccination policy may be applied to select categories of health workers who work with patients at high risk of severe influenza and who are more likely to accept mandatory vaccination, while vaccination may be voluntary for other categories (40, 41). Table 1 provides an example of risk categorization of health workers based on risk to themselves and of those for whom they care. Table 1. Risk categorization of health workers Risk category Health worker characteristics Very High • High risk health workers (see below) who work in clinical areas that admit patients at high risk for severe disease, complications, or death following influenza virus infection. These include intensive care units; transplant or oncology wards; antenatal, peri-natal or post- natal areas; and areas with elderly individuals, especially those with chronic diseases. High • Health workers who come into direct physical contact with patients, or with infectious materials, including surfaces or equipment contaminated by infectious materials. • Health workers who have contact which is not physical but that would allow the acquisi- tion or transmission of diseases that are spread at short range (1–2 m) by respiratory means, e.g., counsellors who have prolonged fact-to-face contact (42, 43). Low • Health workers who do not have contact with patients and whose normal work is not in a clinical area as defined above. 15 2. Establishing a policy to vaccinate health workers against seasonal influenza The very high-risk category is also the one where the evidence for risk and impact of vaccination is the strongest and where there is a stronger justification for vaccination (10). Those targeted for vaccination should also include part-time personnel, students, contractors, and volunteers at the health facility who have possible exposure to patients as health workers in the above categories. Risk categorization of individual health workers may be too complex and resource intensive in many settings, especially in low- and middle-income countries. In these situations, simpler ap- proaches wherein health worker categories are classified into only two groups, i.e. at high risk group (targeted for vaccination) and low risk groups (not targeted for vaccination) may be used. To ensure targeted use of influenza vaccination of health workers and to address potential uptake issues, national policies for health worker vaccination should outline: 1. The classification of different health worker categories based on assessment of risk. 2. The policy for vaccination for each category, e.g. whether vaccination is recommended and whether the recommendation is for mandatory or voluntary vaccination. 3. Strategies for managing non-compliant health workers and vaccine refusers. The following document provides an example of a framework for the assessment, classification and prioritization of health workers: The policy directive of the New South Wales Ministry of Health on the Occupational Assessment, Screening and Vaccination Against Specified Infectious Diseases https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (Accessed 14 Mai 2019) Framing an immunization policy for health workers Recommendations for health worker vaccination could propose either mandatory vaccination, voluntary vaccination or a mixed approach depending on the risks in the specific clinical setting. Multiple studies across many countries has demonstrated that voluntary vaccination of health workers, even when accompanied by considerable efforts to educate them on the benefits and risks of vaccination and implementation of measures for convenient access to vaccination, results in low coverage that seldomly exceeds 70%. On the other hand, mandatory vaccination has resulted in close to 100% uptake in institutions in the United States where it has been applied (44–46). However, mandatory vaccination has been difficult to implement in some countries because of acceptability issues and because the attributable benefits of health worker vaccination have been a subject of debate (32). Furthermore, it may not be feasible to implement mandatory vaccination policies in resource-constrained settings. 16 2. Establishing a policy to vaccinate health workers against seasonal influenza Voluntary vaccination One option for a vaccination policy for health workers is voluntary vaccination wherein vaccina- tion is recommended for health workers and offered but acceptance is voluntary or optional, i.e. not a requirement. Such programmes often have low vaccination coverage. Hence, with voluntary vaccination, extra efforts are required to optimize the uptake of vaccination. These could include: 1. A robust communications strategy, specifically tailored to the needs of different health worker categories, to explain the benefits and risks of vaccination, including the benefits to patients, especially those at high risk for severe disease. It needs to be emphasized that some of these patients, including the elderly and immunocompromised patients may not themselves respond to vaccination and that vaccination of health workers who come into contact with them is an important means for protecting them from infection, i.e. a professional ethics and moral argument 2. Convenient access to vaccination that is free of charge, and available to workers in every shift. Those who work during evening or night shifts might be provided access to vacci- nation either at the beginning or the end or their shifts or on designated days and times to cover their shift. 3. Other demand generation activities as outlined in the next section of this manual. A number of soft mandates may also help in increasing vaccination uptake, including: 1. Requirement of active declination of vaccination through signing of forms indicating their non-participation with or without stating the reasons for not accepting vaccination (see Annex 1 for a sample of an active declination form). 2. Reassignment of health workers who refuse vaccination to areas where they are less likely to come into contact with high risk patients, if this is feasible, or a requirement to wear masks when they do care for patients at high risk of influenza complications. 3. Use of face masks while in the health care facility. Mandatory vaccination Mandatory vaccination makes vaccination of health workers a legal or regulatory requirement while allowing some exemptions, e.g. medical contraindications. There is no WHO or other uniformly applied definition for mandatory vaccination. Infant and childhood immunization programmes described as mandatory can vary widely, especially in terms of the exemptions al- lowed and the penalties for non-compliance (47). Several experts have argued that mandatory immunization policies should be implemented against vaccine-preventable diseases that can be transmitted in the health-care setting and cause signifi- cant risk of morbidity or mortality to patients (20, 44, 48–50), as part of the professional ethics of a health care provider. It has also been argued that few ethical mandates in the practice of medicine surpass the obliga- tion to do no harm. Hence, ensuring conditions for safe patient care by minimizing transmission of communicable diseases represents a minimum ethical standard in health care practice set- tings (20). However, if mandatory vaccination policies are to be established, legal liability issues will need to be addressed and consideration given to providing compensation in the rare event of an adverse event. 17 2. Establishing a policy to vaccinate health workers against seasonal influenza Mandatory vaccination could either be part of the national policy or implemented at individual health facilities as part of institutional policies. The enactment of legislation endorsing mandatory vaccination would facilitate the implementation of such a policy. The Code of Colorado Regulations provides an example of a mandatory vaccination policy: Code of Colorado Regulations: Standards for Hospitals and Health Facilities 02 – General Licensure Standards (Part 10, Page 46) https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20CCR%20 1011-1%20Chap%2002 (Accessed 14 Mai 2019) Several countries with voluntary health worker vaccination policies for influenza do have man- datory vaccination of health workers for other infections such as measles and hepatitis B. These existing mandatory vaccination policies could be leveraged to also justify and establish mandatory vaccination policies for influenza, based on the protection afforded to the health worker as well as to vulnerable high-risk patients with whom they come into contact. Published recommendations for the ethical implementation of mandatory vaccination policies are reproduced in Toolbox 3. These recommendations may be taken into consideration in framing the national policy based on the feasibility of implementation. Toolbox 3 Recommendations for ethically implementing mandatory vaccination policies — There must be a compelling employee and patient safety problem that is clearly communicated to employees. — The least restrictive means should be used to achieve the safety objective. — There should be clear opt-out criteria for medical reasons. — Opt-out criteria based on personal views of the health worker should be allowed for current employ- ees only. These determinations must be made in a transparent and objective manner. — For those who do meet medical or other exclusion criteria, or who refuse vaccination, institutions should offer alternative means for achieving transmission control, including temporary leave during peak times, mandatory mask wearing, re-assignment to non-clinical areas (if feasible) or frequent testing during peak influenza seasons. — Prospective employees should be notified of the mandatory policy and recognize that failure to comply could be grounds for termination of employment. — The process should be transparent, with a broad range of health worker perspectives involved in policy development. — Institutions should support healthcare workers by implementing vaccination procedures that are free, easy to access, and include complete comprehensive coverage of adverse events. Particular attention should be paid to not burdening less advantaged members of the healthcare team. Source : Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 18 2. Establishing a policy to vaccinate health workers against seasonal influenza Mixed approach A mixed approach could also be adopted where a mandatory vaccination policy is applied to only certain categories of health workers likely to have direct physical contact with high-risk patients, while a voluntary vaccination policy is applied to the remaining categories. Such a policy should clearly and unambiguously define the health worker groups to whom or work areas where mandatory and voluntary vaccination policies apply. Consideration should be given to the human and financial resource implications of mandatory vaccination policies or of soft mandates. Integration with Occupational Health Policies Policies on seasonal influenza vaccination of health workers should be an integral part of the national occupational safety and health policies and regulations and the occupational safety and health management systems in health facilities. Inclusion of seasonal influenza vaccination in occupational health policies will allow access to free vaccination for all the targeted health workers as per the Occupational Safety and Health Convention, 1981, Article 215 and the recommendations in the World Health Organization and International Labour Organization (WHO-ILO) Global Framework for National Occupational Health Programmes for Health Workers.6 Such a policy would also put the responsibility for health worker vaccination on employers, rather than on the health workers alone. An integrated policy will enable greater coordination and collaboration between occupational health and immunization programmes and promote a joint approach to control of influenza in health facilities wherein vaccination is part of an infection control program that includes other in- fection measures to protect both health workers and patients. The occupational health programme at the national level and the management system at the facility level also provide an enabling environment to create a culture for infection prevention within the workplace that will stimulate the implementation of the vaccination programmes. Choice of vaccine product, schedule and timing of vaccination Choice of product WHO provides recommendations for the composition of influenza vaccines based on the infor- mation provided by the WHO Global Influenza Surveillance and Response System.7 Based on these recommendations, manufacturers formulate Northern Hemisphere (NH) and Southern Hemisphere (SH) vaccines, which are generally accessible around September (NH) and April 5 C155-Occupational Safety and Health Convention, 1981 (No. 155). https://www.ilo.org/dyn/normlex/en/f?p=NO RMLEXPUB:12100:0::NO::p12100_instrument_id:312300 (Accessed 14 Mai 2019) 6 The sectoral dimension of the ILO’s work : Review of sectoral initiatives on HIV and AIDS Appendix II – WHO- ILO WHO-ILO Global Framework for National Occupational Health Programmes for Health Workers. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/wcms_145837.pdf (Accessed 14 Mai 2019) 7 Influenza: vaccines. http://www.who.int/influenza/vaccines (Accessed 14 Mai 2019) 19 2. Establishing a policy to vaccinate health workers against seasonal influenza (SH) of each year, respectively. A list of WHO prequalified vaccines with information on their characteristics is published on the WHO website.8 Several different types of vaccines are available, including inactivated influenza vaccines (triva- lent and quadrivalent composition), live attenuated influenza vaccines, adjuvanted vaccine, and recombinant vaccine. Being a health worker per se does not lead to a preference for any vaccine type (subject to country-specific marketing authorizations).9 Health workers who care for severely immunocompromised persons should preferably receive inactivated influenza vaccine (IIV). Price and supply availability of each product are additional considerations in informing the choice of product. Timing of vaccination In countries where influenza infection is seasonal and seasonality patterns are defined, vaccina- tion should ideally be scheduled before the start of the influenza season, allowing approximately 14 days for induction of protective antibodies. Where delays in securing vaccine supply does not allow ideal timing to be met, vaccination should be initiated as soon as supplies are made available. Furthermore, individual health workers should never be refused vaccination at any time during the influenza season if they are late in seeking vaccination. In tropical and subtropical regions where several peaks may occur, vaccination should be timed before the main peak of transmission, using the most recent vaccine formulation available. Where no data on national influenza seasonality are available, countries could use data from epidemio- logically similar countries. Toolbox 4 provides published information of influenza seasonality in the tropics and subtropics. 8 WHO Prequalified Vaccines. https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 9 In some countries the quadrivalent vaccine is the product of choice. The WHO Strategic Advisory Group of Experts (SAGE) in immunization is currently reviewing the evidence and expected to make a recommendation in 2020. Toolbox 4 Guidance on choice of product and timing of seasonal influenza Seasonal influenza policy use and effectiveness in the tropics and subtropics. Geneva: World Health Organization; 2016. ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf (Accessed 14 Mai 2019) Influenza seasonality in the tropics and subtropics – when to vaccinate  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 (Accessed 14 Mai 2019) WHO list of prequalified vaccines  https://extranet.who.int/gavi/PQ_Web (Accessed 14 Mai 2019) 20 2. Establishing a policy to vaccinate health workers against seasonal influenza Defining monitoring and disease impact measurement objectives Ministries of Health would benefit from advice from the NITAG or other relevant advisory groups on the monitoring and impact measurement objectives so that they are taken into consideration during the planning and implementation of Monitoring and Evaluation (see chapter 4). NITAGs, with additional inputs from other relevant advisory groups and academia, should make recommendations on: 1. Monitoring and reporting of vaccination coverage, where possible by unit and type of care provided. 2. Measurement of vaccination impact, including: a) Target groups (health workers and or patients) for impact measurement. b) Outcomes to be monitored. e.g. influenza-like illness, laboratory-confirmed disease, severe disease, death, absenteeism, patient-related outcomes, etc. c) urveillance strategies for measuring impact; if at sentinel sites, the number and distribution of sites. d) Time periods for impact measurement, e.g. continued monitoring for an indefinite period or limited to a certain number of seasons. These measurements would be useful to the NITAG in reviewing the impact of vaccination and making recommendations for optimizing the impact and the cost-effectiveness of vaccination. Impact measurement could also generate empiric data to allow for estimation of cost-effectiveness of vaccination. It should be noted that any such measurements should include data collection for multiple seasons since the intensity of transmission, the severity of infection and vaccine effectiveness varies from one season to another. For further details, see the section on “Monitoring and evaluation” (chapter 4). 21 3. Planning and managing vaccination of health workers Planning for successful vaccine introduction Once a national vaccination policy has been established, it is necessary to convert the policy into operational plans that are fully costed, budgeted and include granular detail on the various pro- gramme components related to the introduction of a new vaccine into the national programme. The general concepts for addition of a new vaccine within the national immunization plans and the management of introduction are outlined in the WHO guide “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” (see Annex 3 for New Vaccine Introduction Plan Template). This section provides guidance on the additional elements specific to seasonal influenza vaccination of health workers. A vaccine introduction plan integrated into the annual plan for immunization along with the as- sociated checklists enable programme planners to ensure that all the necessary preparations are in place for the timely and efficient introduction of a vaccine into the national programme. For easy access the links to the relevant Annexes of the WHO guide are provided in Toolbox 5. In addition to the generic vaccine introduction checklist, the complementary checklist in Annex 2 con- tains a list of issues specific to health worker immunization. The elements of this checklist should be added (as appropriate) to the more generic checklist of activities. A sample health facility checklist is also provided (Annex 3) to guide the preparations for vaccination at the health facility level. Toolbox 5 Links to templates and checklists for a new vaccine introduction plan in “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” Generic template to guide the development of a national introduction plan Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc (Accessed 14 Mai 2019) New vaccine introduction checklist, activity list and timeline of WHO new vaccine introduction guide provides advice on planning budgeting, activities, distribution of roles and responsibilities and timelines ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_ resources/nvi_guidelines/Annex4_Instructions.pdf (Accessed 14 Mai 2019) Corresponding checklist tool Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_checklist_en.xls (Accessed 14 Mai 2019) 22 3. Planning and managing vaccination of health workers The timelines for planning and introduction should be included in the checklists and/or as a sepa- rate Gantt chart to ensure that all the activities are completed in their appropriate order to allow timely implementation of vaccination activities. Cross-reference should be made to the relevant sections of the occupational health strategies and plans at both the national and health facility level (see previous chapter on integration of health worker influenza policies into occupational health policies and requirements) to facilitate a more cohesive approach to planning and implementation. The WHO-ILO Global Framework for National Occupational Health Programme for Health Work- ers recommends that all countries identify the responsible person(s) for occupational health, both at the national and workplace levels. These focal points should be a part of the planning team at the national and health facility levels, respectively. Inclusion of the occupational health focal points would allow for an integrated approach to prevention of influenza in the work place where vaccina- tion forms part of a larger package of interventions for influenza control, including other infection control measures to protect both health workers and patients. The labour-management committees for occupational safety and health in health facilities, where they exist, can help in engaging the management and the workers’ representatives in the implementation of the vaccination programme. In addition to the national operational plans for the implementation of health worker vaccination, the national comprehensive multi-year plan (cMYP) for immunization should also be updated to include health worker immunization (Toolbox 6). Costing and financing As with the addition of any new vaccine to the national vaccination schedule, the vaccine and deliv- ery costs should be estimated and included in the annual and multi-year immunization budgets. In addition to the costs of vaccines and supplies (syringes, needles, safety boxes etc.), costs for vaccine delivery (including human resources), annual communications/education and demand generation efforts at the national and health facility level, and monitoring and reporting would need to be included in the costs. Several tools and resources are available that could be used or adapted for costing, budgeting and securing finances for health workers vaccination (see Toolbox 7). Since communications and other activities/interventions to enhance vaccination uptake will be required each year, these costs should be incorporated into the annual vaccine delivery costs and not considered only as a one-time activity. In addition to costing and budgeting for annual health worker influenza vaccination, it may also be necessary to advocate with those responsible for allocating funds for health programmes to ensure that financing for vaccination is sustained. Toolbox 8 provides links to resources for ad- vocacy for sustainable financing. Toolbox 6 WHO-UNICEF guidelines for multi-year planning WHO-UNICEF guidelines for developing a comprehensive multi-year plan (cMYP)  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. Planning and managing vaccination of health workers Toolbox 7 Resources for costing and financing cMYP Costing and Financing Tool  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (Accessed 14 Mai 2019) Immunization Costing Action Network (ICAN) Immunization Delivery Cost Catalogue This interactive website provides information on vaccine delivery costs across different low and middle- income countries through a variety of delivery strategies.  http://immunizationeconomics.org/ican-idcc (Accessed 14 Mai 2019) WHO Flu tool for planning and costing maternal influenza vaccination (new name: SIICT tool) This tool is being expanded to include all influenza risk groups, including health workers.  https://www.who.int/immunization/research/development/influenza_economics/ (Accessed 14 Mai 2019) Management Sciences for Health. Planning, costing and budgeting framework  http://www.msh.org/resources/planning-costing-and-budgeting-framework (Accessed 14 Mai 2019) Immunization financing: a resource guide for advocates, policy makers and program managers  https://immunizationeconomics.org/imfin (Accessed 14 Mai 2019) Toolbox 8 Resources for advocacy or sustainable financing Immunization advocacy library. Provides a number of tools and guides to convey the value of vaccination and the need to invest in vaccination  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/communication-and-advocacy/immunization-advocacy-library (Accessed 14 Mai 2019) Two specific documents in this library are of relevance: Workbook – advocacy for sustainable funding of immunization programmes  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/workbook-advocacy-for-sustainable-funding-of-immunization-programmes (Accessed 14 Mai 2019) How to prepare a financial profile of your immunization programme  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/how-to-prepare-a-financial-profile-of-your-immunization-programme (Accessed 14 Mai 2019) 24 3. Planning and managing vaccination of health workers Formative research to inform the planning process To prepare for the launch of influenza vaccination, several countries have used formative research to better understand the factors affecting uptake of seasonal influenza vaccination in health work- ers, including concerns, beliefs, information needs, cultural issues, and barriers to vaccination in order to develop a tailored plan to address them. Formative research can include both quantitative and qualitative research and, in some situations, might include a desk review. Quantitative research may be used to identify the main predictors for low uptake of vaccination among health workers and the main drivers for compliance with vaccina- tion recommendations. Data may be collected through surveys and questionnaires administered to health workers. The sample should ideally include sufficient representation from the different categories of health workers since the perceptions and reasons for low uptake may vary between health worker groups, e.g. between doctors and nurses (40), as well as from a sample of primary, secondary and tertiary health care facilities and from different work areas within these facilities. Qualitative research is insight research, based on understanding the audience’s point of view. It elucidates new issues and provides a more in-depth understanding of the complex issues underly- ing the uptake of vaccination. Qualitative research methods commonly include focus group dis- cussions and individual in-depth interviews. The WHO European Regional Office has published a step-by-step field guide to qualitative research for new vaccine introduction (see Toolbox 9). To be useful, formative research must be properly planned and well executed, failing which there is a risk of drawing wrong conclusions. This requires time and resources. While it is useful to conduct such research to inform the planning process, if time and resources do not permit, the lack of such research should not delay seasonal influenza vaccine introduction, unless attitudes of health workers are expected to be an issue that may significantly and adversely impact vaccine uptake. When data from formative research are not available, data from such studies conducted in other countries may be used to inform the planning process. While the reasons for low uptake of vac- cine are heterogenous, available evidence suggests that there is broad convergence on the major influencers of vaccine uptake among health workers, especially between countries within the same sub-region, which may be used in the initial planning process. The rapid appraisal of evidence (10) summarizes the key findings from the published literature and this evidence could be used, as applicable and appropriate, in the absence of locally conducted research. Data from the published literature may be complemented with information obtained through quantitative formative research using rapid surveys in a sample of health workers, ideally including different health worker categories. These surveys may be less resource intensive than qualitative formative research and could be completed without resulting in any delays to vaccine introduction. Annex 4 provides a sample questionnaire that may be used for such surveys. Toolbox 9 Field Guide for qualitative formative research A field guide to qualitative research for new vaccine introduction ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_VaccineIntro.pdf (Accessed 14 Mai 2019) 25 3. Planning and managing vaccination of health workers Further research may be conducted if vaccine uptake remains persistently low. The TIPflu tool is an important resource that may be used in such situations. Communication and vaccine acceptance Personal beliefs, cultural attitudes and perceptions about vaccination, in addition to official rec- ommendations, often guide the actions of many of those responsible for delivery of vaccines and many recipients (51, 52). This also holds true at the level of health workers. Available evidence shows that there are often misperceptions about vaccination as well as a gap between knowledge and behaviours (53, 54). Thus, simply improving knowledge about the risks and benefits of vac- cination among health workers has not proven to be sufficient to achieve optimal vaccination uptake. Achieving optimal vaccination coverage in health workers requires a multi-dimensional demand generation effort that is informed by a good understanding of the perception, motivators and barriers of vaccine acceptance among health workers, both as providers of vaccination and as recipients. Communications messages need to be tailored to address the needs of different health worker groups since available evidence suggests that perceptions about the need, risks and benefits of vaccination may vary between these groups (55). Current efforts mainly focus on preparing fact- based approaches to preparing communication messages. However, these types of messages may need to be framed according to the intended audiences based on their level of education and understanding. Taking the preferred cognitive decision-making styles of the individual groups to be targeted into account may have greater impact (54). Framing such messages will require an understanding of vaccine psychology and cognitive decision-making and may require engagement of communication specialists. A traditional approach to communications regarding immunization was through the use of mass media. However, research has shown that mass media alone and a one-way communication to health workers may not be sufficient to optimize the uptake of vaccination. Individual and group communications, in this instance at the health facility level, will be required to build trust and motivate health workers to accept vaccination. Including information on the relevance of vaccination of health workers (self-protection, responsi- bilities towards patients, pandemic preparedness in the case of influenza) in pre-service curricula for medical schools, nursing schools and other training institutions targeting health professionals may help to better establish health worker vaccination as an organizing concept and create better informed health worker generations providing immunization. Effective communications and demand generation activities are not a one-time event but need to be continuous and have the ability to quickly respond to the evolving perceptions about vac- cination and quell rumours and mis-perceptions. Front line vaccination staff responsible for health worker influenza vaccination will need to be trained to be able to deal with vaccine hesi- tant health workers as well as vocal vaccine deniers10 who may negatively impact the uptake of vaccination (56). 10 Vocal vaccine deniers are at the extreme end of the subgroup of vaccine refusers and actively advocate against vaccination, using science denialism techniques to justify their beliefs (reference 32). 26 3. Planning and managing vaccination of health workers A national vaccine communication working group that includes communications specialists will facilitate strong working relations with and collaboration among partners and allies, strengthen routine communication for immunization, and ensure well-coordinated and immediate response from all involved authorities to any safety event. Inclusion of members of the Occupational Safety and Health department and from professional societies in communicating with health workers contributes to building trust and improving acceptance of vaccination. Representation from health workers, professional associations, and unions and from the different health worker categories targeted for vaccination would ensure that the viewpoints of each health worker category is taken into consideration in developing tailored communication materials. A number of tools and guidance documents are available that can be used for developing an ef- fective communications strategy and for framing the communications messages that are specifi- cally tailored towards different health worker groups, including a template terms of reference for a vaccine communication working groups (Toolbox 10). In addition to vaccination, the information and education and communication materials should also include information on other infection control measures to reduce transmission of influenza in the work place and steps to be taken should a health worker develop an influenza like illness. Communications at the health facility level Effective communications at the health facility level will benefit from a dedicated and well-trained team to deliver the communications strategy at the health facility level. Such a team should be established and trained well in advance of the planned introduction date and should include rep- resentation from the main health worker categories in the facility and an advocacy and commu- nications specialist, if one is available. Ideally, communications for seasonal influenza vaccination should be part of a broader communications effort on control of influenza in health care settings. Communication activities at the health facility level should begin sufficiently in advance of the planned date for the onset of vaccination, especially in countries introducing vaccination for the Toolbox 10 Tools and guides for developing communications strategy and messages Vaccination and trust library  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/vaccination-and-trust (Accessed 14 Mai 2019) New vaccine introduction: checklist for planning communications and advocacy (2017)  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2017/new-vaccine-introduction-checklist-for-planning-communication-and-advo- cacy-2017 (Accessed 14 Mai 2019) Template terms of reference for a vaccine communication working group ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_Sup- portDoc_TOR_Proof7.pdf (Accessed 14 Mai 2019) 27 3. Planning and managing vaccination of health workers first time. Initial activities could include the display of information posters at all the relevant areas of the health facility. The manager of the health facility and the heads of all the relevant depart- ments and clinical areas should be sent a formal communication along with sufficient copies of all information materials about vaccination to be displayed in each clinical area. Where possible, relevant information on influenza vaccination could also be sent to all health workers using e-mail and/or local social media networks. In-person group briefings should complement the display and distribution of information materi- als. Existing staff meetings could be leveraged to conduct these briefings. The number of in-person group briefings will depend on the size of the health facility and the number of targeted health workers. Larger health facilities (e.g. secondary and tertiary level health facilities) may need to conduct several briefing sessions to cover all the targeted health workers. Since communications messages may differ between different categories of health workers, consideration should be given to holding separate briefing sessions for each health worker category using information and mate- rials relevant to them. To allow better communication and enough time for questions from health workers to be addressed, the size of each group should be designed to allow sufficient opportunity for interaction. Provision should be made to facilitate the participation of health workers working night shifts. The schedule for the briefings should be widely publicized within the health facility and reminders sent to promote high attendance. In-person meetings should: 1. Explain why vaccination is important for themselves, their patients and families and for wider society – with a particular focus on severe outcomes associated with influenza; 2. Inform health workers about national policies; 3. Provide information on the safety of seasonal influenza vaccines; 4. Provide information on the timing and venue(s) for vaccination; 5. Explain potential consequences of non-vaccination; 6. Allow sufficient time for questions. Consideration may be given to establishing a telephone hotline or web-based system to address questions from individual health workers. In addition to the display of posters and other com- munications materials, the use of visible and removable stickers that can be displayed by health workers who have been vaccinated (e.g. on their ID badges) would serve as a visible reminder to their colleagues who have not been vaccinated. In addition, text messages, generic e-mails and social media platforms could be used to provide periodic reminders on vaccination. Demand Generation at the Health Facility Level In addition to communication strategies, behavioural science-based demand generation efforts can be implemented prior to the availability of vaccines in order to prime health workers for vac- cination. These nudge-based interventions work by creating an environment that can influence behaviour in a predictable way but does not eliminate choice (57), and have proven effective in a variety of healthcare settings (58). These interventions can narrow the gap between intention and actual behaviour, which is usually caused by individuals or health workers forgetting to get 28 3. Planning and managing vaccination of health workers their vaccination or through barriers to convenient vaccination. Additionally, these interventions frequently can be implemented for relatively low cost (59). The figure below (Figure 3), adapted from the Nuffield Council on Bioethics, demonstrates the hierarchy of nudge-based interventions to improve vaccine uptake (60). Nudges lower on the ladder are less aggressive but can still have a measurable impact. By providing health-facility vaccination rate feedback, a process used in the United States to improve uptake of childhood vaccination, progress in health facilities can be monitored, and provide motivation to health workers to improve their own vaccination practices (61). Figure 3. Ladder of nudge interventions to increase vaccination rates Guide choice through default options Automatically set up appointment for vaccination unless individual opts out Enable choice Increase options to obtain vaccination such as at workplace or near home Prompt implementation intentions Ask individual to precommit to a time and location to obtain vaccination Frame information Deliver social comparsion feedback on vaccination rate among peers or healthier individuals Provide information Offer education on benefits of vaccination to self ant others Do nothing Simply monitor vaccination rates Source: Patel MS (ref. 32) Reminders to individuals to vaccinate can serve as a nudge, notifying individuals when they are due for a vaccine and prompting them to come to the vaccination site to receive the vaccine. These can be paper-based or mobile phone text message-based and have proven effective (62). In the health facility, health worker reminders through an immunization data collection tool (whether paper- or electronic-based) can help improve the delivery of vaccines by health workers (59). A successful nudge-based strategy to reduce barriers to convenient vaccination and enable choice is standing orders. Standing orders are a policy put in place in a health facility that permits non- physician health workers to administer vaccines without a prescription or explicit order from a physician and have proven one of the most effective strategies for improving vaccine uptake when applicable (63). All of these strategies can be combined with communication approaches to create demand in the community. 29 3. Planning and managing vaccination of health workers Going beyond nudges Nudges are a favoured method for influencing demand since they preserve choice and are not coercive. However, some experts have argued that when nudges fail to achieve optimal uptake of vaccination in health workers, and this failure results in harm to their patients, decision-makers should consider adopting more forceful policies (64). This is not to imply that when nudges fail one should immediately go to measures that eliminate choice. There are interventions that exist across a continuum leading up to restriction of choice. The use of “soft mandates” provide examples of actions across this continuum. Case study: The «flulapalooza» campaign to increase uptake of seasonal influenza vaccination in health workers Vanderbilt University Medical Center in Nashville, Tennessee, in the United States, employs over 24,000 health workers. Since 2011, the cornerstone of its seasonal influenza vaccination campaign for health workers has been its mass influenza vaccination event, playfully named “flulapalooza”. This event vac- cinates, on average, over 14,000 people in a single day. The closed point-of-dispensing (c-pod) design has been evaluated and refined over time to substantially increase administration efficiency and cover- age rates. The event emphasizes a festive atmosphere while practicing critical pandemic vaccination skills among hospital occupational health and administrative leadership. This event achieves high coverage among categories of health workers who are present that day; how- ever, due to the structure of nursing shifts and ward responsibilities at the institution, less than 30% of nursing staff are typically vaccinated at the event. Thus, the medical center combines flulapalooza with ward visits, mobile carts and other strategies to achieve its annual target of greater than 90% overall health worker vaccine coverage. Notably, although institutional policy gradually increased the difficulty of declination and eventually included disciplinary action in response for unexcused failure to vacci- nate, it is notable that 92% coverage had been achieved in seasons before disciplinary policies were in place. Details of event design, workflow diagrams and practical, specific lessons learned are described in a publication available online. Source: Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168–76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 Annex 5 provides a table that lists the different communications and demand creation approaches, along with an indication of the effort required to implement the approach and the expected impact. Vaccine procurement and supply chain management Vaccine procurement Accessing vaccines at optimal prices requires a good understanding of procurement mechanisms and systems, vaccine market dynamics, and the elements of vaccine pricing. Procurement starts with forecasting vaccine demand, followed by tendering, contracting and procurement processes. The tools and resources for vaccine procurement are listed in Toolbox 11. Procurement of seasonal influenza vaccination may have some unique features and may require regulatory approvals and advance purchase commitments with specific manufacturers shortly after the publication of the 30 3. Planning and managing vaccination of health workers WHO recommendations on the seasonal vaccine formulation (in February for the northern and in September for the southern hemisphere) and well in advance of the influenza season. Selection of the vaccine product and presentation As with any other vaccine, the choice of product and presentation will depend on multiple fac- tors including supply availability, price, ease of use, storage and transport requirements, vaccine wastage and missed opportunities for vaccination (e.g. postponing vaccination due to reluctance to open a 10-dose vial for only one or two individuals). The choice of vial size should be based on the number of doses to be delivered at each vaccination point and the number of sessions to be held at each point. The currently prequalified injectable seasonal influenza vaccines are available in single dose pre-filled syringes and in single and 10-dose vials. All the 10-dose vial presentations contain thiomersal as a preservative. However, it may be noted that not all the currently available prequalified products in 10-dose vials have market authorization for storage up to 28 days once opened, and not all products have a vaccine vial monitor (VVM). These aspects should be taken into consideration in selecting the product and presentation. The specifications of each product and presentation should be checked to confirm that they meet the requirements of the programme before a procurement order is placed. Information on WHO prequalified vaccines may be found on the WHO website (see Toolbox 11). Forecasting vaccine demand is an important first step in vaccine procurement. Forecasting demand requires an estimate of the number of health workers who will be targeted for vaccination, the expected vaccination coverage, and an estimate of vaccine wastage. Ideally health workers in both public and private facilities would be targeted for vaccination. This process of estimating the size of the target population for health workers vaccination is likely to be more complex than for other vaccines targeting the general populations. The data to derive such estimates may also be more difficult to find, especially in low and middle-income countries. Toolbox 12 provides resources for estimating the size of the health work force and those that need to be targeted for vaccination. Toolbox 11 Vaccine procurement tools Procurement mechanisms and systems  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_systems (Accessed 14 Mai 2019) Vaccine product, price and procurement (V3P) web platform  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (Accessed 14 Mai 2019) Vaccine market  http://www.who.int/immunization/programmes_systems/procurement/market (Accessed 14 Mai 2019) List of WHO prequalified seasonal influenza vaccines  https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 31 3. Planning and managing vaccination of health workers The global health workforce databases may not carry information on all the health workers catego- ries that may be targeted for vaccination. For example, global databases may only have estimates of the numbers of doctors, nurses and midwives, but not other health worker categories. In such instances, rough estimates could be made based on ratios of those health workers for whom data are not available to those where data are available (e.g. ratio of physicians to laboratory workers). These ratios could be quickly obtained through a survey of a small representative sample (e.g. tertiary, secondary and primary) of health facilities. Since each health facility may be required to prepare beneficiary lists with the names of those targeted for vaccination, for tracking vaccination delivery, and for maintaining records of those vaccinated; the initial demand forecasts could be refined in subsequent years using data from these beneficiary lists and vaccination records. Logistics and cold chain management The handling of influenza vaccine is similar to most other vaccines in the national immunization programmes. It needs to be stored at 2–8 degrees Celsius. Since vaccination of health workers is expected to occur annually during a relatively short window period each year before the onset of the influenza season, a plan needs to be developed to ensure storage and transport of vaccine at the different levels involved in the supply chain during the window period chosen for vaccina- tion. Tools and resources for vaccine forecasting, management and logistics are available on the WHO website (Toolbox 13). The cold chain volume requirement for each WHO prequalified product and presentation are available on the WHO website (please select the vaccine type and click on the links for each individual product and presentation to obtain this information).11 At the health facility level, the focal point responsible for health worker vaccination should ensure that the vaccine doses required in the facility are included in the demand forecast and that sufficient storage space to accommodate the required vaccine doses is available prior to the anticipated date of vaccine arrival at the health facility. 11 WHO prequalified vaccines. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 Toolbox 12 Resources for estimating target population size Global Health Observatory: Health Workforce  http://www.who.int/gho/health_workforce Global Health Workforce Statistics database. Geneva: World Health Organization.  http://www.who.int/hrh/statistics/hwfstats Counting health workers: definitions, data, methods and global results. Geneva: World Health Organization; 2007. ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf Classifying health workers: mapping occupations to the international standard classification ƥ https://www.who.int/hrh/statistics/Health_workers_classification.pdf 32 3. Planning and managing vaccination of health workers Vaccination of health workers Vaccination of health workers should ideally take place at the health facilities where the targeted health workers normally work to ensure convenient access to vaccination. Case study: Using an immunization champion to enhance uptake of influenza vaccination in health workers in Oman Oman has a universal free-of-charge, integrated health care system, which includes influenza vaccina- tion of health workers. Oman is one of the few high-income countries in the WHO Eastern Mediterranean Region (EMR) that has achieved high influenza coverage among health workers (>80%). This was made possible by immunization champions. The minister of health in Oman is passionate about protecting the health of health workers and is at the forefront in taking the first influenza seasonal vaccine. As the patron of health worker community and an influential person in the country, this action has reinforced the importance of vaccination and continually helps promote influenza immunization programs. He has also been personally involved in the communication of vaccination messages to the health worker community. Every health facility should prepare a health facility plan for implementing seasonal influenza vac- cination of health workers well ahead of the influenza season. These plans should include measures to enable convenient access to vaccination for health workers in every shift. Different options may need to be determined at the health facility level to cover health workers during night shifts with- out resorting to 24-hour vaccination services, for example insuring the availability of vaccination just before or after a shift change. A vaccination team should be established at the level of the health facility to coordinate the vac- cination activities and optimize uptake under the overall supervision of the head of the facility. One person should be designated as the team leader. This could be either the occupational safety and health focal points, or the persons responsible for immunization activities in the health facil- ity. In larger facilities the staff medical services may be tasked with this activity. Experience from some organizations and health facilities have shown that using “vaccination champions” from among the health workers may contribute to improving vaccination uptake among their peers. In Toolbox 13 Vaccine management and support resources The resources that can assist programme managers in supply chain and logistics support planning may be found at the WHO website at:  http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ index4.html (Accessed 14 Mai 2019) Overview of technologies for the treatment of infectious and sharp waste from health care facilities ƥ https://apps.who.int/iris/bitstream/handle/10665/328146/9789241516228-eng.pdf (Accessed 14 Mai 2019) 33 3. Planning and managing vaccination of health workers some countries, a mobile team that goes to each clinical area in the health facility and provides vaccination has been successfully used. Training of the vaccination team Training workshops for health facility vaccination focal points should be conducted to conduct training in developing a health facility plan and in implementing and monitoring vaccination activities. A standardized agenda, curriculum, resource documents, checklists and model forms for recording data, as required, should be created at the national level for use in these workshops so that training is uniform across all health facilities. To further ensure uniform training, the workshops could be conducted using teams of trainers who are themselves trained centrally and are assigned to each region/subregion, using a cascade training approach. Short training videos may be used to achieve uniformity in content in the training. Web-based self-learning modules may be considered for those who were unable to attend the training sessions. The health facility vaccination team should have the capacity to classify health worker groups (see chapter 2 for sample risk categorization of health workers) and establish a list of health workers eligible for vaccination, with their designations, and areas of work. Where different vaccination policies apply to different risk categories, either separate lists should be created, or mechanisms established to easily identify and monitor the vaccination status of those in each category. The beneficiary lists should be developed sufficiently in advance of the start of vaccination activities and the relevant health workers informed on the need for vaccination. In addition to health workers employed at the health facility, provision may be made to include health workers in smaller facilities within their catchment area, including private facilities, as per the national policy, should vaccination not be available at all facilities. A mechanism for defaulter tracking and for sending reminders should be established at each health facility. For health workers who come into contact with high risk patients, (e.g. those in organ transplant, oncology, intensive care or perinatal units), the supervisors of those who have not been vaccinated before the start of the influenza season may need to be informed (local confidentiality norms permitting) so that they can reinforce the written reminders or, in case of refusals, get active declination forms signed and institute infection control measures applicable to active refusals, e.g. reassignment of duties, wearing of masks etc. as per the established national of health facility policy. 34 4. Monitoring and evaluation All countries should have a mechanism in place to monitor vaccine coverage as well as adverse events following immunization (AEFI) from the health facility to the national level and conduct at least one influenza vaccine post-introduction evaluation. However, measuring vaccine accep- tance and vaccine effectiveness or impact will be necessary and feasible only in a setting where immunization targets are not reached and if funding is available. Developing and updating information systems Appropriate forms and data entry modules for recording and reporting vaccination data at the health facility level and processes for reporting the data should be established. In developing tools and guidance for data collection, the need to include both public and private health systems should be considered. This may require mapping of existing health information systems and immunization data collection instruments as well as guidance on how these systems may be used to collect data on seasonal immunization of health workers. Data collection systems may vary across health facilities depending on the size and available infra- structure of the facility. However, each health facility must be provided with a standardized data reporting form to ensure that the data required for reporting to the national level are collected, irrespective of the data recording system used. This could include the name of the health worker, the health worker category, area of work, risk category, date of vaccination, the vaccine product and lot number. In developing the data reporting form, the advice provided by the NITAG on monitoring and impact assessment should be considered. All data collection systems, whether paper-based or electronic should have the capability for defaulter tracking and a system for generating and sending out reminders to defaulters. When using such reminder systems, protecting the confidentiality of data on the health and vaccination status of health workers will be critical and access to the data should be restricted to the facility vaccination coordinator. Coverage monitoring Several approaches for estimating health worker influenza vaccine coverage are available. The timing of such coverage measurement is important and should be coordinated with the timing of vaccination in the country. Given that influenza vaccine is usually administered in seasonal campaigns, frequent reporting (e.g. monthly) is recommended. Ideally, assessments should be done at the end of the season, when complete data are available and assessed and data cleaned for any inconsistencies. 35 4. Monitoring and evaluation Health facility registries Information on influenza vaccines administered to health workers should be included in existing records maintained as part of occupational health requirements and in vaccination registers as part of institutional monitoring mechanisms. Careful assessment of data discrepancies is requi- red if reporting is done from multiple sources, and data protection issues should be judiciously considered. The minimum set of data will include the number of people receiving influenza vac- cination during each annual season, the total number of targeted health workers, and the derived vaccination coverage (%). Often both numerator and denominator data can be obtained from the departments of occupational health at health facilities. For establishing more detailed denomina- tors, nominal health worker records e.g. based on payrolls can be used as a first step. A beneficiary list of those targeted for influenza vaccination can be selected from these records by applying criteria related to the health worker’s risk of infection or of transmitting the infection to those for whom they care (see section on “Characterizing the target groups for vaccination” and table 1). Depending on the capacity of the reporting system and program, this could include tallying numbers by health worker category and risk profile to allow coverage estimates by subcategories, such as doctors, nurses, laboratory workers, or staff working in Intensive Care Units or general (e.g. medicine or paediatric) wards, etc. If a vaccination registry does not exist, a crude estimate of coverage among health workers could be calculated by using the number of vaccine doses distributed to each facility minus the number of vaccine doses returned (unused) divided by the estimated number of health workers targeted for vaccination at the facility. A similar, rather imprecise method to assess coverage at the national level would be to use the regularly compiled data on health workers (as reported to WHO) to estimate the denominator (see Toolbox 12), as used for the vaccine demand forecast, and the overall number of vaccines adminis- tered as the numerator. This approach should only be used as a last resort where none of the other methods described are feasible. Administrative data If vaccines are provided free to health workers with government, national insurance system or employers bearing the costs, there may be regular, sometimes mandatory, reporting on the number of health workers who have received vaccinations at the institutional level. Such administrative data may be available from well-documented national vaccine programmes or from health insu- rance records. Surveys Surveys to obtain data on vaccinations and other interventions should be performed every 3 to 5 years and allow the identification of heterogeneity of coverage at the subnational level, important for the necessary adaptation of immunization practices. A representative sample of health workers can be selected though a stratified random sampling approach from national registries of health workers (e.g. professional organizations). If such registries are not available, a two-stage selection of health facilities and of health workers in these facilities can be done. If contact information is available, standardized interviews could be done face-to-face, by phone or via internet-based pla- tforms. Without such information, online survey links could be provided to all health workers in the selected facilities with an invitation to access the survey platform using their mobile phones or personal computers. It should be noted that when using this approach, self-reporting of vacci- nation may lead to overreporting.12 12 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394773/ 36 4. Monitoring and evaluation In all of these approaches to estimate coverage it will be important to specify the categories of health workers, e.g. those with or without direct patient contact, the latter including students, trainees, volunteers, maintenance, information technology, food service staff etc., who have been included in the numerators and denominators. It is also important to specify if part-time personnel working during the influenza season were included in the coverage estimates. Where individuals for whom vaccination is not recommended are vaccinated, such as back office workers or staff relatives, etc., care must be taken not to count these in estimating vaccination coverage. Refusal and completion rates of surveys will need to be monitored and adjustments for possible selection biases made in the analysis. At times, influenza vaccination programs may merely set absolute number targets of health work- ers to be vaccinated, based on the number of vaccines procured and available in a specific area or location. Such an approach, while followed in some countries, will not allow the proper estimation of coverage rates, including coverage by risk category, or comparisons over time, which will be important for interpreting any data on impact. It will also not enable identification of determinants of vaccination or of refusers. If available, data as well as methods used to estimate vaccination coverage for other regular health worker vaccinations should be accessed, e.g. for hepatitis B, measles, polio, pertussis or tetanus vaccines. It must be noted, however, that these vaccines are not provided on an annual basis and will often only be checked at entry to service. Toolbox 14 lists available tools for collecting and reporting immunization data and for estimating coverage. Toolbox 14 Monitoring and evaluation tools and indicators Immunization in practice series, module 7: Monitoring and using your data. Describes how to collect and report data and how to monitor immunization performance. ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf (Accessed 14 Mai 2019) Training for mid-level managers. Module 7: The EPI coverage survey (Document WHO/IVB/08.07). Geneva: World Health Organization; 2008. Provides a step-by-step walkthrough, including relevant guidance and tools, to plan and conduct a coverage survey of a newly introduced vaccine. ƥ http://who.int/immunization/documents/MLM_module7.pdf (Accessed 14 Mai 2019) WHO reference for estimating influenza vaccination coverage among target groups. Outlines different methodologies that can be used to estimate national influenza vaccine coverage among high-risk groups targeted for vaccination. ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing-influenza- vaccination-coverage-target-groups.pdf (Accessed 14 Mai 2019) 37 4. Monitoring and evaluation AEFI monitoring As for any vaccine and target group, a functioning AEFI monitoring system is a basic requirement, since knowledge gaps and misperceptions about influenza vaccine safety among health workers are consistently identified in in the literature. The system utilized to monitor and investigate possible AEFIs when delivering influenza vaccine to health workers should ideally be integrated into existing AEFI surveillance systems in line with national regulations for the monitoring of vaccine safety. The NIP or other departments responsible for health worker influenza vaccination (e.g. occupational health) should work with the National Regulatory Authority to define roles and responsibilities in vaccine safety monitor- ing. In countries using influenza vaccines for the first time, it could be conceivable to intensify AEFI surveillance during the first year of influenza vaccine introduction in order to provide quick feedback to stakeholders to help assure them of the safety of the vaccines in use. A functioning AEFI monitoring system will detect and elucidate problems with vaccines, which could be due to the product itself, its quality, or errors in the administration of the vaccines. All vaccine recipients reported as having an event (including minor events) perceived to be related to the influenza vaccine should be reported to the AEFI surveillance system using standard report- ing forms (see Toolbox 15). Given adequate reporting, the monitoring system should be able to evaluate the observed rate of reactions to influenza vaccine and compare this to the expected rates reported in the literature. For serious AEFIs, causality will normally be assessed by a group of experts. Importantly, and as for any vaccine, such a system needs to be able to identify a previously unknown or unexpected vaccine reaction that should be investigated in more depth. Care must be taken to ensure that coincidental events are not mistaken for vaccine reactions. Toolbox 15 AEFI-related information sources AEFI core variables, including data on case, vaccine, event and reporter ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_Dec2015.pdf (Accessed 14 Mai 2019) Sample form for AEFI recording with detailed description of reporting elements ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (Accessed 14 Mai 2019) Causality assessment of an AEFI: Provides the detailed methodology in a four-step process with access to a related software tool  http://www.who.int/vaccine_safety/publications/gvs_aefi/ (Accessed 14 Mai 2019) Vaccine safety training resources providing access to vaccine and pharmacovigilance training packages  http://www.who.int/vaccine_safety/initiative/tech_support/ (Accessed 14 Mai 2019) Information sheet: observed rate of vaccine reactions – influenza vaccines ƥ https://www.who.int/vaccine_safety/initiative/tools/Influenza_Vaccine_rates_information_sheet.pdf (Accessed 14 Mai 2019) 38 4. Monitoring and evaluation By establishing and enhancing AEFI systems, influenza vaccination can also be used to further improve the awareness of overall immunization safety in the health worker community. Monitoring and evaluation of vaccine acceptance Key determinants of vaccine acceptance among health workers have been investigated and include the desire for self-protection and to protect family and patients. (see also section on communica- tion and vaccine acceptance). As part of an initial situation analysis of health worker influenza vaccination programmes, available information on policy, programmes and practices, the factors affecting acceptance and participa- tion, and the influence of media and communications can be investigated through key informant interviews, or participatory workshops. Results of such an analysis could then be used to inform additional communication strategies addressing the identified concerns in a targeted manner. Other determinants can be explored through formative research. Both qualitative and quantita- tive research methods can be used to evaluate changes in health workers’ knowledge, attitudes, practices and behaviours. Behavioural determinants that differentiate health workers who get vaccinated from those who do not should be assessed regularly. Understanding the reasons and reasoning behind health workers’ attitudes towards annual flu vaccination is useful for the de- velopment of communications messages and products. Involving health workers in behavioural research related to their perceptions, beliefs, emotions and potential conflicts also provides an opportunity for the health worker community to be engaged in the approach, which can result in greater acceptance of the vaccination program. Vaccine impact monitoring After an influenza vaccine has been introduced in a population, additional studies may help in evaluating the impact of the immunization program. However, WHO does not recommend that vaccine impact or effectiveness studies be conducted by all countries with influenza vaccination programs, given their complexity and expense. A number of research networks worldwide conduct such studies and results can be expected to be applicable in Toolbox 16 Tools to assess vaccine acceptance among health workers TIP-FLU tool. Provides an approach and tools grounded in behavior change theories and health programme planning models to tailor seasonal influenza vaccination to the needs and attitudes of frontline HWs.  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) TIP FLU case study Montenegro. Provides a practical example of the use of the TIP FLU tool. ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization-Pro- grammes-Seasonal-Influenza-TIP-FLU.pdf (Accessed 14 Mai 2019) 39 4. Monitoring and evaluation other settings with similar influenza epidemiology and vaccination programs. The decision to carry out such studies should therefore be based on the need for country-specific estimates and on the local capacity to conduct such rigorous studies. If studies are not appropriately designed with adequate sampling of different health worker categories, there is a risk of arriving at wrong conclusions. Before-after studies to demonstrate vaccine effectiveness are not advised for influenza, given that influenza vaccine effectiveness for preventing influenza symptoms in seasonal influenza epi- demics display considerable heterogeneity.13 Studies to evaluate the impact of seasonal influenza vaccination in health workers can be even more complex, given the varying risk of infection and transmission to patients among different categories of health workers. In health workers, a general reduction in absenteeism or, if available, reduction in influenza-asso- ciated absenteeism is often used as a surrogate indicator for the impact of an influenza vaccination programme. For this, health facility institutional monitoring would need to include disease rates in health workers, and a measure of sickness absence. Where possible, reporting days of absenteeism due to influenza-like illness (ILI) (or respiratory infections) should be recorded. This will include self-reported ILI with or without virological confirmation. Other non-specific outcomes include severe acute respiratory infection (SARI) and all-cause pneumonia requiring hospitalization. It is important to note that all these clinical syndromes include various other respiratory pathogens against which influenza vaccine does not protect. If such assessments are done, they should ide- ally cover multiple seasons, since impact can vary substantially by season, else such studies will be quite difficult to interpret. Laboratory-confirmed outcomes (e.g. by RT-PCR and other molecular diagnostic tests) improve the specificity of influenza disease classification. Where possible, establishment of sentinel sites with such capacity could be considered for collecting samples from health workers for laboratory confirmation. In these sites, vaccine effectiveness could be assessed using a case-control design and comparing vaccine coverage in laboratory-confirmed versus test-negative cases, if vaccine coverage is sufficiently high. Any of these approaches require sophisticated laboratory capacity which is not available everywhere. The screening method is a study design which could also be used for health worker vaccine im- pact assessment: it uses individual-level data on vaccination history from cases and data on vac- cination coverage in the health worker population from which the cases came. However, such a study requires accurate information on the vaccination status of the cases and of health worker vaccination coverage. Given the indication that annual influenza vaccination for health workers could reduce illness among the patients they care for, studies can be designed to evaluate the effect of health worker influenza vaccination on mortality, hospitalization, and influenza cases in patients of healthcare facilities. Several research approaches have been used in this context such as randomized trials or case-control approaches. Given the complexity of study designs, the conduct of such studies should be limited to research institutions that have the capacity and experience to conduct such studies. Economic assessments and cost-effectiveness evaluations may be considered once sufficient cost and impact data are available following influenza vaccine introduction. WHO provides a number of relevant resource documents, which are being further developed to specifically estimate vaccine 13 Evaluation of influenza vaccine effectiveness: A guide to the design and interpretation of observational studies, WHO 2017. 40 4. Monitoring and evaluation introduction costs for health worker vaccination (Toolbox 17; see also Toolbox 2). Relevant data are not easily available everywhere and assessments can be difficult to perform, given the limited size of the group of health workers. Post-introduction evaluation National Immunization Program Reviews routinely assess the use of specific vaccines about every 5 years following a new vaccine introduction. Such NIP Reviews should include relevant items to identify possible programmatic areas related to the new vaccine use. As needed in-between NIP Reviews, a specific influenza-related Post-Introduction Evaluation (I- PIE) tool may be performed after the first or second influenza immunization season. The I-PIE package (Toolbox 18) includes a number of tools to support the planning and conduct of the evaluation, including standard questionnaires and data collection forms in paper or electronic format as well as reporting templates together with instructions on how to perform the I-PIE in a cost-efficient manner. These tools will need to be adapted to the specific country context and to the specifics of the vaccine formulation and presentations. The I-PIE is performed at all levels of the health system and includes observation of practices at the points of vaccine administration, vaccine storage areas as well as data and record reviews. An I-PIE can thus provide a more immediate approach to assess the programmatic challenges and impact of influenza vaccine use, and to compare results across countries, enabling them to share and learn from each other’s experiences. Toolbox 17 Influenza in health workers: Study methodologies Evaluation of flu vaccine effectiveness 2017. Provides detailed information for researchers who design observational influenza vaccine effectiveness studies and for public health scientists who interpret and apply the results of these studies. An annex will address the effectiveness of influenza vaccine in health workers. ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (Accessed 14 Mai 2019) Manual for estimating disease burden associated with seasonal influenza. Provides step-by-step approach to estimate influenza disease burden in the general population as well as those with specific conditions who are vulnerable to severe disease.  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (Accessed 14 Mai 2019) Toolbox 18 Influenza post-introduction evaluation tools I-PIE tool with instructions and recording and reporting templates  https://www.who.int/immunization/research/development/ipie_influenza_post_introduction_ evaluation (Accessed 14 Mai 2019) 41 References [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination accep- tance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during preg- nancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are count- ries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evi- dence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare wor- kers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-ana- lysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13(6):e0198685. 42 [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care wor- kers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epide- miol. 2002; 23(10):615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influen- za-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kin- dergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial out- break of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a mul- ti-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 43 [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vacci- nation of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12(1):e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vac- cination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection cont- rol and hospital epidemiology. 1998; 19(7):518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward man- datory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62(1):1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 44 [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing inter- vention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccination: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36(2):196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, ado- lescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertive- ness. N Engl J Med. 2019 Jan24; 380(4):309–11. 45 Annex 1. Sample non-participation form This form is to be used in cases of voluntary vaccination where health workers in the very high or high-risk categories who decline to participate in assessment, screening and vaccination in accordance with the national policy. Completion of the form is particularly important where failure to get vaccinated will result in reassign- ment or require the use of protective measures to protect patients as specified in the national policy. Non-participation in vaccination 1. I have read and understood the policy directive regarding seasonal influenza vaccination of health workers. 2. I decline to participate in vaccination against influenza. 3. I am aware of the potential risks to myself and/or others that my non-participation in vaccination may pose. 4. I am aware that my non-participation may result in my being reassigned to a non-high-risk area or in other requirements to protect others with whom I may come in contact, as per the national policy. 5. The reason for my non-participation is: Refusal to sign In circumstances where the health worker refuses to sign this form, it should be noted on the form and the health worker should be notified of consequences, if any, as per the policy. Name of health worker: Date of birth: Health service/ facility: Work area: Signature: Date: OFFICE USE ONLY I have discussed the potential risks that non-participation in vaccination may pose and the management of unvaccinated workers in accordance with the vaccination policy. Name of vaccination team staff: Designation: Health facility /agency: Signature: Date: 46 Annex 2. Complementary checklist for planning health worker immuniza- tion: national14 level (To be adapted for local use) To account for the specifics of seasonal influenza vaccination of health workers, the following ADDITIONAL elements may be added to the generic new vaccine introduction check list, see Annex 4 of the document “Princi- ples and considerations for adding a vaccine to a national immunization programme” for the checklist structure. Health worker seasonal influenza vaccination policy 1. National policy on seasonal influenza vaccination of health workers are published and dissemi- nated to all relevant agencies and health facilities, including private health facilities and relevant professional societies. 2. The policy on seasonal influenza vaccination of health workers is reflected in the national occupational health policies. 3. The costs of seasonal influenza vaccination of health workers are included in either the immu- nization or occupational health budget, as appropriate. 4. Surveillance system is in place for influenza activity, including defining start and end of the influenza season, to inform selection of the most appropriate vaccine formulation and timing of influenza vaccination. Planning for successful vaccine introduction 5. A functional multidisciplinary coordination group is in place to discuss and promote access to a new target population of health workers, enabling the formation of partnerships which support and shape the national agenda. 6. The group includes focal points from the occupational health and immunization programs, professional organization representatives, and other relevant stakeholders. 7. A costed operational plan for health worker vaccination is developed and integrated into the na- tional immunization plans and relevant occupational health plans. Formative research (optional and to be included only if formative research is planned) 8. The need and scope of any formative research to be conducted in preparation for vaccine introduction is defined. 9. A research group to conduct formative research has been identified and terms of reference for the research has been developed. Communications 10. National communications working group established for planning communications strategy and developing communications materials for health worker vaccination against seasonal influenza. 14 In some countries, especially large countries with decentralized system, elements of this checklist may also apply at relevant subnational levels, e.g. provincial level. 47 11. Tailored communications messages and materials developed along with an overall communications strategy. 12. Training for health facility communications teams is conducted. Vaccine procurement and supply chain management 13. Target population size estimate developed and included in demand forecast. 14. Individual health facility demand estimated, and vaccine distribution plan developed. 15. Sufficient storage space for vaccines and supplies for seasonal vaccination at all levels established to accommodate vaccine during vaccination period. Vaccine Delivery 16. Health facility vaccination delivery teams are established and trained. 17. System for management of vaccination refusals and implementation of infection control mea- sures in place for prevention of nosocomial transmission, e.g. reassignment, wearing of masks, mandatory leave in case of ILI. Monitoring and evaluation 18. Data recording and reporting tools developed and distributed including for coverage monitoring (updated administrative data and health worker surveys) and AEFI monitoring. 19. Post-introduction evaluation conducted within the first 2 seasons following vaccine introduction. 20. Possibilities reviewed for operational research to assess health worker vaccine acceptance. 48 Annex 3. Health facility checklist (To be adapted for local use) Person responsible Deadline Status Communications 1. Health facilities communications working groups are established and trained 2. Health facility communications plan and schedule for group communications with health workers finalized 3. Adequate supplies of posters and information materials for health worker vac- cination are available 4. Notification of vaccination sent out to targeted health workers and supervisors 5. Telephone hotline established to address individual queries from health workers Storage capacity for vaccines and supplies 6. Adequate storage capacity for influenza vaccines and supplies during vaccination window period established 7. Adequate supplies of influenza vaccines and supplies for health worker vaccination available 8. Provision to deal with extra injection waste during period of vaccination Vaccine Delivery 9. Vaccination delivery team established and trained and vaccination sites within health facility finalized 10. Categorization of health workers completed and beneficiary list for vaccination developed 11. System for management of vaccination refusals and implementation of infection control measures in place for prevention of nosocomial transmission, e.g. reas- signment, wearing of masks, mandatory leave in case of ILI Monitoring and evaluation 12. Data recording and reporting instruments available taking into account data protection issues 13. System for defaulter tracking and reminders established 14. Health facility registries updated to include influenza vaccination 15. AEFI monitoring and reporting systems updated to identify AEFI in health workers 16. Vaccine acceptance monitoring system to address uptake issues in health workers established (if uptake issues are observed) 49 Annex 4. Sample questionnaire for conducting a survey among health workers 1 Name (optional) 2 Age (years) 3 Sex ¨ Male ¨ Female 4 Job category15 ¨ Doctor ¨ Nurse/midwife ¨ Laboratory technician ¨ Other technical staff ¨ Other (specify) 5 Patient contact ¨ Direct ¨ Face-to-face but not direct ¨ None 6 Contact with high risk patients ¨ Yes ¨ No 7 Work area (name of clinical area of work) Statements Strongly agree Agree Neutral Disagree Strongly disagree 1 Vaccination of health workers against diseases such as hepatitis B and influenza are important 2 If I was unvaccinated exposure to influenza would be a risk to my health 3 Exposure to influenza poses a risk to my patients’ health 4 Influenza vaccination poses a risk to my health 5 The benefits of vaccination are greater than the risks 6 My receiving vaccination will protect my patients 7 The best way to protect my patients is to combine seasonal influenza vaccination with other infection control measures 8 I am sufficiently informed about risks of influenza infection I am sufficiently informed about the risks and benefits of influenza vaccination The following factors that would influence my decision to accept vaccination 9 Recommendations from the national policy-making body (e.g. NITAG) 15 Adapt for local use based on local health worker classification. 50 10 Endorsement of recommendation from the professional society to which I belong 11 If it is part of occupational health regulations/ requirements 12 Recommendation from my personal physician 13 Availability of vaccination at no cost to me 14 Easy access to vaccination at my place of work 15 Colleagues having been vaccinated 16 Previous experience with vaccination 17 Protecting my patients 18 Preventing/reducing absenteeism from work 19 Contributing to pandemic preparedness Other factors that would affect my decision to accept influenza vaccination (list below) 20 21 22 51 Annex 5. Communications and demand generation: Stratification of approaches to developing the content Approach Effort Impact Developing the content for communication messages Framing information by delivering social comparison feedback on vaccination rates among peers or healthier individuals Low Medium Tailored communication based on cognitive styles and cultural behaviours Medium High Communication methods Distribution and display of Information, Education and Communication (IEC) materials Low Medium Establish a specially trained communications team at health facility level to administer communications and demand generation approaches Medium High Web-based (including FAQs and chat groups) and social media communications Medium Medium Text message and e-mail reminders to health workers Low Medium Small group in-person briefing meetings High Medium Use immunization champions at national and health facility level Medium High Demand generation approaches Provision of free vaccines Medium High Provide vaccination in the work area using mobile teams Medium High Provide incentives or stimulate competition, e.g. awards to clinical areas with highest vaccination coverage Low Medium Visible reminders and peer-pressure, e.g. badges or stickers worn by those who have been vaccinated Low Medium Ask individual to commit to a time and location to obtain vaccination Low Medium Increase options to obtain vaccination, either near home or at workplace Medium High Guide choice through default options, e.g. automatically set up appointment for vaccina- tion unless individual opts out Low High Establish standing orders to facilitate vaccination Medium High 52 ISBN 978-92-4-151559-7

1An introduction manual for national immunization programme managers and policy makers How to implement seasonal influenza vaccination of health workers Family, Womens’s and Children’s Health (FWC) DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS This document was produced by the Initiative for Vaccine Research (IVR) of the Department of Immunization, Vaccines and Biologicals How to implement seasonal influenza vaccination of health workers ISBN 978-92-4-151559-7 Published: May 2019 This publication is available on the Internet at: https://apps.who.int/iris/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: + 41 22 791 4227 • Email: vaccines@who.int © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following dis- claimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. How to implement seasonal influenza vaccination of health workers. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. IAcknowledgements This manual was developed by Thomas Cherian and Carsten Mantel, MMGH Consulting and Philipp Lambach (WHO/IVR) with review and inputs of an Independent Expert Advisory Group: Salah Al Awaidy, Silvia Bino, Joseph S. Bresee (chair), Supamit Chunsuttiwat, Daouda Coulibaly, Luzhao Feng, Rachel Hale, Shabir A. Madhi, Helena C. Maltezou, Kelly Moore, Jonathan Nguyen- Van-Tam, Saad Omer, Gregory Poland, Sabine Wicker. Kelly Moore and Chris Morgan were consultant as representatives of the WHO Immunization Practices Advisory Committee, IPAC. Consultants: Thomas Cherian, Carsten Mantel. Additional experts: Birte Bödeker, Susan Y. Chu, Sara Hamid, Kathryn Lafond, Kathleen Morales, Julia Neufeind, Susan Wang. WHO: Philipp Lambach, Onyema Ajuebor, Ms Phionah Lynn Atuhebwe, Philip Gould, Shalini De- sai, Julia Fitzner, Martin Howell Friede, Shoshanna Goldin, James Dawson Heffelfinger, Raymond Hutubessy, Ivan Dimov Ivanov, Pernille Jorgensen, Melanie Marti, Hasan Qamrul, Lisa Menning, Ann Moen, Liudmila Mosina, Andreas Alois Reis, Alba Maria Ropero Alvarez, Claudia Steulet, Nadia Teleb. Financial support for the development and pilot-testing of this manual is provided through the Centers for Disease Control and Prevention (CDC), which provides financial support to the World Health Organization Initiative for Vaccine Research (U50 CK000431). II Contents Executive summary 1 About this manual 2 Objective 2 Audience 2 Structure of the document 3 Key related documents 4 1. Background and rationale 5 Current status of influenza vaccination in health workers 5 Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers 6 Evidence for health worker risk of influenza and impact of vaccination 6 Evidence of transmission of infection from health workers to patients and the impact of vaccination 7 Evidence for interventions to increase health worker vaccination uptake 7 Global Action Plan for Influenza Vaccines 8 2. Establishing a policy to vaccinate health workers against seasonal influenza 10 The decision-making process 10 Considerations for decision-making 12 Defining the public health objectives for vaccination 12 Economic analysis for establishing national policies 13 Characterizing the target groups for vaccination 14 Framing an immunization policy for health workers 15 Integration with Occupational Health Policies 18 Choice of vaccine product, schedule and timing of vaccination 18 Defining monitoring and disease impact measurement objectives 20 III 3. Planning and managing vaccination of health workers 21 Planning for successful vaccine introduction 21 Costing and financing 22 Formative research to inform the planning process 24 Communication and vaccine acceptance 25 Communications at the health facility level 26 Demand Generation at the Health Facility Level 28 Vaccine procurement and supply chain management 30 Vaccine procurement 30 Selection of the vaccine product and presentation 30 Logistics and cold chain management 31 Vaccination of health workers 32 Training of the vaccination team 33 4. Monitoring and evaluation 34 Developing and updating information systems 34 Coverage monitoring 34 AEFI monitoring 37 Monitoring and evaluation of vaccine acceptance 38 Vaccine impact monitoring 38 Post-introduction evaluation 40 References 41 Annex 1. Sample non-participation form 45 Annex 2. Complementary checklist for planning health worker immunization: national level 46 Annex 3. Health facility checklist 48 Annex 4. Sample questionnaire for conducting a survey among health workers 49 Annex 5. Communications and demand generation: Stratification of approaches to developing the content 51 1Executive summary Health workers are at higher risk of influenza infection than the general population. In addition to morbid- ity among health workers, influenza infection may also lead to increased absenteeism, presenteeism1 and disruption of medical services. Moreover, influenza infected health workers may contribute to nosocomial transmission of infection to their patients, including those at high risk for developing severe influenza disease and complications. Hence, the World Health Organization (WHO) considers health workers to be a priority target group for seasonal influenza vaccination. In addition, influenza vaccination of health workers contributes to influenza pandemic preparedness. Finally, studies have shown that health workers who are vaccinated against influenza themselves are more likely to recommend vaccination to their patients. This manual serves as a resource to assist users in establishing a national policy for seasonal influenza vaccination of health workers. It provides guidance along with a catalogue of available tools to facilitate policy development, planning, implementation, monitoring and evaluation of influenza vaccination of health workers. The contents of the manual are meant to supplement the document titled “Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring”, published by WHO in 2014. The main target audiences for this manual include national policy makers; national health planners; the na- tional programme managers for immunization and occupational health; and those responsible for occupational health, health worker immunization and infection control in health facilities. Close collaboration between immunization managers, and occupational health and infection control programmes is essential to optimize vaccine uptake, and for a cohesive and comprehensive approach to influenza control in health facilities. This manual summarizes the evidence and rationale, provides guidance on key issues, and lists available tools for influenza vaccination of health workers, covering three main components of vaccine introduction and management: 1. Establishing an evidence-based national policy for seasonal influenza vaccination of health workers. 2. Planning and management of health worker influenza vaccination. 3. Monitoring and evaluation, including assessing vaccination coverage, monitoring for adverse events following immunization, impact assessment and post-introduction evaluation. Complementing this manual, deliberations of an Independant Expert Advisory Group developing this manual are available in form of a meeting report summarizing critical issues. These include policy con- siderations, the evidence in support of health worker vaccination; categorization and prioritization of health workers; the choice of vaccination strategy; its integration into broader health worker vaccination and occupational health policies; planning and management of vaccination, particularly the approaches for communication and demand generation; and the challenges with monitoring and evaluation of health worker vaccination, especially in low and middle-income countries.2 1 Presenteeism refers to health workers who work while ill, yet have reduced accuracy and effectiveness and pose a risk to vulnerable patients in their care. 2 Cherian T. et al. Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16–17, Berlin, Germany. Vaccine. 2019;37(43):6255–6261. 2About this manual Objective This manual serves as a resource and catalogue of available tools to assist country officials in de- ciding upon, planning, implementing and monitoring health worker influenza vaccination in order to achieve optimal vaccination coverage. It is not meant to be a prescriptive document, but rather articulates general principles and key considerations to support policy formulation; plan- ning and management of vaccination; and monitoring and evaluation of influenza vaccination of health care workers. The manual also outlines measures to ensure integration of health worker influenza vaccination into existing national occupational health policies and occupational safety and health management systems of health facilities. It also addresses the opportunity for health worker influenza vaccina- tion to promote an integrated approach for monitoring and optimizing the uptake of all interven- tions included in national occupational health policies. In addition, it refers to the relationship and contribution of health worker vaccination to pandemic influenza preparedness. Seasonal influenza vaccination in health workers differs from other vaccine-preventable diseases in that vaccination is required annually. However, elements of this manual may be of relevance for health worker vaccination in general, particularly the sections on planning and management of vaccination and on monitoring and evaluation. Audience The main target audience for the manual include: 1. National policy-making bodies and health planners. 2. Programme managers for immunization, infection control and occupational health programmes at national and subnational levels and those responsible for occupational health and infection control in health facilities. 3. Organizations of health workers and employers. While the different sections of the document may be of greater relevance to one or the other group, it is advisable that the document be read as a whole because of the information on a particular topic may be found in the different sections of the manual. The document may also be useful to other audiences with an interest in immunization or occu- pational health. 3Structure of the document The manual consists of four sections as outlined in Figure 1. However, for clarity and complete- ness there is some overlap between some of the sections, with cross-references made to the other relevant sections. Figure 1. Structure of the document Establishing a policy Planning & management of vaccination Monitoring & evaluation Introduction, background and rationale •About the manual, including objectives and target audience •WHO policy recommendations on influenza vaccination •Current status of health workers vaccination •Summary of evidence to support health worker vaccination •Global Action Plan for Influenza Vaccines •Considerations for making a decision •Defining the objectives for vaccination •Categorization and prioritization of health workers •Framing an immunization policy • Integration with Occupational Health Policies •Choice of product and timing for vaccination •Delivery options and strategies to optimize coverage •Defining monitoring and impact assessment objectives •Planning for successful vaccine introduction •Costing and financing •Formative research to inform planning process •Communication & vaccine acceptance •Demand generation at the health facility •Vaccine procurement and supply chain management •Vaccination of health workers •Training of vaccination team •Coverage monitoring •AEFI monitoring •Vaccine acceptance assessment •Vaccine impact monitoring •Post-introduction evaluation POLICY MAKERS IMPLEMENTERS 4Key related documents The following documents are important resource materials that complement the guidance in this manual. 1. The WHO policy recommendations on seasonal influenza vaccination, including health worker vaccination are published in WHO Position Papers. These position papers are peri- odically updated. Vaccines against influenza: WHO position paper – November 2012 https://www.who.int/wer/2012/wer8747.pdf (Accessed 14 Mai 2019) Principles and considerations for adding a vaccine to a national immunization program: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (Accessed 14 Mai 2019) 2. The following document provides detailed guidance to countries that already provide sea- sonal influenza vaccination to health workers on how to identify, analyse, and effectively target issues related to uptake: Tailoring immunization programmes for seasonal influenza (TIP FLU). A guide for increasing health care workers’ uptake of seasonal influenza vaccination (2015). Copenhagen: World Health Organization Regional Office for Europe; 2015. http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) 3. While the contents of this manual can help inform national policies, the manual does not provide an exhaustive review of the available evidence to inform decision-making. A more detailed review of such evidence in support of vaccination of health workers is found in the following document: Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. July 2019. https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (Accessed 12 July 2019) 4. This manual is part of a series of introduction manuals on seasonal influenza vaccination developed by WHO. A manual on the implementation of influenza vaccination of pregnant women has been published earlier. How to implement influenza vaccination of pregnant women: an introduction manual for national immunization programme managers and policy makers. http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (Accessed 14 Mai 2019) 51. Background and rationale Health workers are at risk of influenza virus infection and of transmitting infection to patients under their care who may be at high risk for severe disease, complications, and death (1). The increased risk in health workers compared to the general population may vary by occupation or setting (2). WHO considers health workers to be an important priority group for influenza vaccina- tion, not only to protect themselves and maintain essential health-care services during influenza epidemics, but also to reduce the spread of influenza to vulnerable patient groups with whom they come into contact (1). Furthermore, many studies have found that a strong recommendation from health workers, especially from physicians, is highly likely to increase public uptake of vaccination (3–5). Health workers who have themselves been vaccinated are more likely to be knowledgeable about vaccination and be more effective in improving public acceptance of vaccination (3–5). Fi- nally, because health workers are likely to be targets of vaccination programs during an influenza pandemic, establishing functional programs for seasonal influenza vaccination of health workers will facilitate timely and effective vaccination during a pandemic (6). Current status of influenza vaccination in health workers Global adoption of a policy for influenza vaccination of health workers has been slow. In 2017, only 119 of the 194 countries reporting having a national influenza vaccination policy. Of these, 96 report targeting health care workers as a priority group. However, the proportion of Member States that reported having a policy varies by WHO region, with the majority of countries in the WHO regions of the Americas, Europe and Eastern Mediterranean reporting a national policy for influenza vaccination, whereas a lower proportion of countries report having such a policy in the Western Pacific, African and South-East Asian regions. Information on influenza vaccination coverage in health workers is not available for most coun- tries, though it varies widely and is reported to be low in many countries where such data are available. For example, data on coverage in health workers were available from only 26 (56%) countries in the European region for the 2014–15 season. The median coverage was 29.5% with a range of 2.6% to 99.5%; only three countries, namely Albania, Armenia and Belarus, reported coverage > 75% (7). More recent data from a systematic review through compulsory reporting from all hospitals in England showed an uptake of 69% in the 2017–18 season.3 An internet survey of 2000 health workers in the United States demonstrated coverage to be 78% during the 2017–18 season, with higher coverage rates (95%) among those working in settings where they were required by their employers to be vaccinated (8). Higher vaccination coverage rates are reported when man- datory vaccination policies are implemented. In one systematic review that included eight studies, coverage rates exceeding 94% were achieved in all (9). 3 Seasonal influenza vaccine uptake in healthcare workers (HCWs) in England: winter season 2017 to 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/Sea- sonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf (Accessed 14 Mai 2019) 61. Background and rationale Summary of a rapid evidence appraisal on the rationale for influenza vaccination of health workers A rapid evidence appraisal of materials available in the English language, published since 2006, and considered to be of medium or high quality, was conducted by WHO (10). The questions considered, and the main findings of this appraisal are summarized here. Readers are referred to the published report for the details and for the relevant citations. The review considered three issues, namely: 1. The evidence that health workers are at increased risk of influenza infection compared to the general population, and that vaccinating them reduces influenza or absenteeism and/or the wider economic impact of influenza in the health workforce. 2. The evidence that health workers transmit influenza to their patients in health care set- tings and, if so, whether vaccination protects the patients and the proportion of health workers who need to be protected to obtain this effect. 3. The evidence for successful practical interventions to increase vaccination uptake and the state of knowledge of social, behavioural and public health public policy research on vaccination uptake in health workers. Evidence for health worker risk of influenza and impact of vaccination Studies comparing the risk of influenza infection in health workers compared to the general population are challenging, may measure different outcomes, or are executed in different set- tings, limiting the comparability across studies or the pooling of data from these studies. Recent systematic reviews suggest that health workers are at an increased risk of influenza infection compared to the general population (Odds Ratio = 2.08, 95% CI = 1.73 to 2.51) (2), though the evidence is strongest for asymptomatic laboratory-confirmed infection (11). However, health work- ers with asymptomatic infection may still transmit influenza virus to highly vulnerable patients in a health-care setting. Respiratory illness is reported as a common cause of absenteeism among health workers. Epidem- ics or pandemics of influenza have been associated with increased rates of absenteeism among health workers (12). Vaccine efficacy in health workers has been shown to be as high at 90% for well-matched seasonal influenza vaccines (13, 14), which suggests that vaccination of health work- ers will reduce influenza-related morbidity and absenteeism. A systematic review showed a pro- tective effect against laboratory confirmed influenza and shorter absenteeism due to influenza- like illness (ILI) in vaccinated groups (15). A recent study among health workers in the United Kingdom showed that a 10% increase in vaccination uptake is associated with a 10% decrease in absence due to illness (12). However, there are observational studies that provide conflicting results – though often constrained by poor study design, non-specific outcomes, high risk of bias, and failure to adjust for confounding factors (16–19). Since the risk of illness following infection is based on the level of exposure, and absence behav- iours may vary between different categories of health workers, it is possible that the lack of suf- ficiently granular data on absenteeism, e.g. stratified by health worker categories, may account for the mixed results seen in the different studies. On the other hand, the lack of impact on 71. Background and rationale absenteeism observed in some studies, despite evidence of increased rates of infection in health workers, raises the question as to whether health workers nonetheless continue to work when infected and lead to heightened concerns about the consequent risk of nosocomial transmis- sion (20). Several studies have documented presenteeism in health workers with influenza-like illness (21–23), including one instance which was associated with nosocomial transmission in an oncology unit (24). Evidence of transmission of infection from health workers to patients and the impact of vaccination Epidemiological studies using molecular subtyping approaches demonstrate evidence of transmis- sion from health workers to patients. The use of automated collection of high-resolution contact data using wearable sensors combined with virologic data have allowed the identification of potential routes of transmission in cases of hospital-acquired influenza (25). The extent of direct transmission from health worker to patient in health care settings is difficult to capture because of the constant influx of visitors, interactions between patients, and the possibility of multiple simultaneous introductions of influenza (26–28). However, among those who may contribute to transmission of infection in the health care setting, health workers represent a sizeable vaccine- preventable portion since they are easier to target for vaccination. The direct patient benefit of health worker vaccination can be measured in several ways, as il- lustrated in the literature. Several studies evaluate the impact on laboratory confirmed influenza, while others evaluate impact on non-specific outcomes such as ILI, respiratory illness, all-cause mortality, respiratory illness associated mortality, or incidence of nosocomial influenza infection. The evidence is stronger for non-specific outcomes such as ILI, all-cause mortality (29), and inci- dence of nosocomial influenza infection (30, 31). Although some studies have attempted to mea- sure the number of health workers that need to be vaccinated for optimal protection, the evidence in support of a coverage threshold is weak, leading to disputes in the literature (32). However, it is likely that patient protection is positively associated with increasing health worker vaccination coverage but would also depend on other factors including the type of patient contact, vulnerability of the patient, use of other infection control measures, and the effectiveness of vaccination in a particular influenza season (33–35). Evidence for interventions to increase health worker vaccination uptake There is a substantial body of evidence on successful interventions to increase health worker in- fluenza vaccination uptake, much of which has been incorporated into existing toolkits aimed at increasing vaccine uptake. Although the factors that contribute to the health worker decision-making pathway are diverse, some strategies appear to be more effective than others. No single intervention has been shown to rapidly and substantially increase and sustain vaccination uptake except for mandatory vaccina- tion. However, mandatory health worker vaccination is an issue that has been extensively debated with many different perspectives for and against its use (20, 32, 36). Successful mandatory vac- cination programmes require organizational and educational efforts to secure employee support prior to implementation (37). 81. Background and rationale A combination of one or more “soft mandates” such as active declination, required surgical mask use and exclusion of non-vaccinated staff from working with highly vulnerable patients may be used as alternatives to mandatory vaccination, although there are organizational, educational, monitoring and enforcement, and human and financial resource implications for applying such soft mandates. Additional components that contribute to increased uptake include the following: • Provision of free vaccine; • Convenient access to vaccination, including on-site vaccination in health facilities; • Knowledge and behaviour modification through education, reminders, and incentives tailored towards different health worker categories; • Management and organizational approaches such as personnel assigned to oversee vac- cination activities. The reasons for low vaccination uptake are heterogenous and vary across different health worker categories and cultures. Therefore, approaches to increase uptake need to be tailored for different groups. Some studies have demonstrated that formative research, including surveys and qualitative research, can provide insights that assist in tailoring interventions to optimize uptake. Conclusion Despite the ongoing debate in the literature, influenza vaccination is important for ensuring the safety of health workers, their patients, and the general population who rely on a functioning health system, especially during epidemic/pandemic periods. Studies to conclusively establish the value of health worker vaccination will be chal- lenging though the emerging data on this issue will be closely monitored to inform any changes to existing WHO policies.4 Global Action Plan for Influenza Vaccines In an influenza pandemic, most of the world’s population will be highly susceptible to infection and it is likely that infection will spread rapidly. Vaccination is considered one of the key strategies to mitigate the potential impact of a pandemic. While it is expected that there will be a delay in the development of strain-specific pandemic vaccines, insufficient production capacity will further restrict the global access to the vaccines, at least in the early phases of the pandemic. Resource- constrained countries, especially those that lack local vaccine production capacity and those that do not have seasonal influenza vaccination policies, will face the greatest challenge in securing timely access to vaccines during a pandemic, and mitigating the substantial adverse effects of a pandemic. 4 A working group of the WHO Strategic Advisory Group of Experts (SAGE) on immunization will be reviewing the emerging data and updates to the existing WHO recommendations are expected in 2020. 91. Background and rationale To address this challenge a Global Action Plan for Pandemic Influenza vaccines was developed by WHO with short, medium and long term-strategies aimed at increasing influenza vaccine production and surge capacity before and during an influenza pandemic (38). The plan proposed three approaches to enhance access to pandemic vaccines: (i) an increase in the baseline use of seasonal influenza vaccination; (ii) an increase in global production capacity; and (iii) further research and development. The first of the above three approaches relies on countries establishing clear and effective immu- nization policies to increase the baseline use of seasonal influenza vaccines – providing industry with better demand forecasts and stimulate increased production capacity. While vaccination of health workers will only result in a modest increase in overall vaccine de- mand, it will establish a robust and functional platform for rapidly immunizing health workers and could contribute to achieving high coverage in the event of a pandemic, thereby protecting health service delivery during a pandemic. Furthermore, high uptake of vaccination by health workers is likely to build trust and increase the uptake of vaccination among other high-risk groups tar- geted for seasonal influenza vaccination in national policies. Health worker vaccination may also establish or strengthen processes that would allow rapid deployment of pandemic vaccines. Thus, seasonal influenza vaccination of health workers goes beyond the issue of immediate protection against seasonal influenza as outlined above and contributes to pandemic influenza preparedness. 10 2. Establishing a policy to vaccinate health workers against seasonal influenza The decision to establish a policy to vaccinate health workers against seasonal influenza should be evidence-based, with a clear rationale, and with the required investments for sustainable implementation. The general principles and considerations for adding a vaccine to a national im- munization programme are articulated in the 2014 WHO guidance document titled “Principles and Considerations for Adding a Vaccine to a National Immunization Programme: From Decision to Implementation and Monitoring” (39). Health workers comprise a target population not usually included in the national immunization programmes of many low and middle-income countries. While hepatitis B vaccination pro- grammes for health workers may exist, influenza vaccines are unique since vaccination for the foreseeable future must be repeated annually. This section of the manual deals primarily with additional considerations specific to annual seasonal influenza vaccination of health workers, building on the generic framework provided by the document cited above. The decision-making process As with any other vaccine for which policies have to be established, Ministries of Health (MoH) would request National Immunization Technical Advisory Groups (NITAGs) or equivalent na- tional or regional bodies to conduct a review of the evidence and provide advice on establishing a policy for seasonal influenza vaccination of health workers, and to make recommendations on the content of the vaccination policy. Engagement of the many stakeholders affected by this policy is essential to secure their endorse- ment and facilitate high vaccination uptake, and is likely to result in a more coordinated approach to the control of influenza in health facilities. Stakeholder consultation should be broadly sought and include: 1. Professional associations and societies representing different health worker groups such as medical, nursing and allied health service associations, as well as representatives of private health care providers; 2. Medical and nursing councils and other health worker regulatory bodies; 3. Patient safety groups, where they exist, and organizations representing patients, since health worker immunization should also be regarded as a patient safety and quality of care issue; 4. Health worker unions, where they exist and when their participation is likely to be use- ful in promoting vaccination uptake. 5. Health facility managers. 11 2. Establishing a policy to vaccinate health workers against seasonal influenza The process should also include early engagement with the bodies that establish occupational health policies and regulations to ensure that the policies established for health worker vaccina- tion against influenza are also reflected in the national occupational safety and health policies. If vaccination policies for health workers exist for other vaccines, e.g. hepatitis B vaccination, a review of these policies may provide useful inputs for policy formulation for seasonal influenza vaccination and on strategies to optimize vaccination uptake. Where available, NITAGs could access the information required from data available from the national influenza surveillance, the National Influenza Centres or other institutions participating in the Global Influenza Surveillance and Response System (GISRS) (see Toolbox 1). In places where local evidence is not readily available, especially on rates of disease amongst health workers and on transmission of disease from health workers to patients, efforts to generate such evidence could be time- and resource-intensive. Policy-makers would have to consider whether it is necessary to conduct local studies or whether data from other countries with similar epide- miological profiles and health system characteristics could be used to infer the likely burden of disease and support decision-making. NITAGs would need to balance the desire to have national data against the costs and delays that would result in generating the data and the consequent health impacts of this delay. Toolbox 1 National Influenza Centers To monitor and respond to the changes in the influenza virus antigenic structure and the subsequent necessity to change vaccine compositions, many countries have established national influenza centers (NIC) to collect and characterize virus specimens in their country and perform other analyses to inform the decisions of WHO and partners on the composition of the next year’s influenza vaccine. In many countries, virologic surveillance is complemented by more systematic influenza surveillance for severe acute respiratory illness (SARI) and influenza-like illness (ILI). A NIC in a country – or in a neighbouring country – can support evidence-based recommendations by providing data on the influenza disease burden and seasonality to the NITAG or other relevant national decision-making body. Involving these and other centers in NITAG discussions is key to bringing together all relevant information that is needed for the decision-making process. A list of NICS, WHO collaborating centers and essential regulatory laboratories (ERLS) can be found at the following links:  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (Accessed 14 Mai 2019)  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (Accessed 14 Mai 2019) 12 2. Establishing a policy to vaccinate health workers against seasonal influenza Considerations for decision-making In addition to the general considerations outlined in the WHO document “Principles and Consid- erations for Adding a Vaccine to a National Immunization Programme: from decision to implemen- tation and monitoring” referred to earlier, other key issues need to be considered when framing a policy for health worker vaccination. These are listed in Figure 2. Figure 2. Key considerations in establishing a vaccination policy for health workers Defining the public health objectives for seasonal influenza vaccination of health workers Characterizing and prioritizing the target groups for vaccination Framing the vaccination policy for seasonal influenza vaccination of health workers Choice of vaccine product, schedule and timing of vaccination Defining the monitoring and impact assessment objectives Defining the public health objectives for vaccination A critical first step in establishing a policy for vaccinating health workers with seasonal influenza vaccination would be to clearly define the aims and objectives of the vaccination programme. Such objectives may vary between countries but would underlie the prioritization of the health worker groups to be targeted for vaccination, set vaccination coverage targets, and provide guidance on the outcomes and scope for measuring the impact of vaccination. Vaccination of health workers serves multiple objectives. These may include: 1. Prevention of infection in the health workers themselves, averting associated morbidity. 2. Prevention of transmission of infection from health workers to vulnerable patients, including those at high risk of severe disease, complications, and death. 3. Sustaining health services by reducing health worker absenteeism, especially during seaso- nal and pandemic influenza outbreaks, which is a period of increased health care demand. 4. Promoting uptake of seasonal influenza vaccination among other target groups and enhance public trust for influenza vaccination. 5. Contributing to influenza pandemic preparedness by: a) Establishing a mechanism for rapidly immunizing health workers during a pandem- ic of influenza or epidemics of other vaccine-preventable diseases; 13 2. Establishing a policy to vaccinate health workers against seasonal influenza b) Contributing to increasing demand for influenza vaccine and thereby enhance pro- duction capacity to improve timely access to vaccine in case of a pandemic. c) Establishing or strengthening national capacity for vaccine regulation. One or more of the above could serve in defining the national objectives for health worker vac- cination. Important considerations when defining vaccination objectives include: 1. Review of the available data on the burden of disease among health workers and health care-related infections in patients and residents of long-term care facilities. National data, where available, complemented with representative regional or global data or esti- mates developed through the use of mathematical models may be used for this purpose. 2. The cost and impact of vaccination and availability of vaccine supply. 3. Review of the national pandemic preparedness plan and consideration of how health worker vaccination could contribute to pandemic preparedness. Economic analysis for establishing national policies While economic analysis is generally recommended prior to deciding on vaccination policies, lack of data for estimating and comparing the economic benefits of the different vaccination objectives may be a limiting factor, as will be the relatively small size of the target group. Toolbox 2 lists the available tools for conducting economic analysis for influenza vaccination. The costs and economic benefits of influenza vaccination of health workers are likely to depend on several factors, including the number and categories of health workers targeted, the incidence and severity of infection in the targeted health workers, their contribution to health care-associated transmission and the consequences of such infections. These factors may vary between different health facilities and will vary from one influenza season to another. A recent systematic review of the epidemiological and economic effects of seasonal influenza vaccination of health workers found that vaccination of health workers was cost-saving, based on crude estimates of absenteeism averted through vaccination (15). However, all the studies included Toolbox 2 Tools for the economic analysis of seasonal influenza vaccination Several tools are available for conducting economic analysis of influenza vaccination: WHO Guide for Stanardization of economic evaluations of immunization programmes (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf WHO Manual for Estimating the Economic Burden of Seasonal Influenza (WHO/IVB/16.04) ƥ http://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-eng.pdf Guidance on the economic evaluation of influenza vaccination (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. Establishing a policy to vaccinate health workers against seasonal influenza in this review were from high-income countries and took an employer perspective with a strong focus on absenteeism averted. Initial decisions could take vaccination costs and the impact of these costs to the immunization and health budgets into consideration, with the option of measuring cost-effectiveness post- introduction, if required. Further guidance on costing and budgeting of health worker influenza vaccination, with links to the available costing tools and resource materials on immunization financing are covered in the next section of this manual. Characterizing the target groups for vaccination Ideally all health workers should be targeted for vaccination, including those who may not come into direct contact with patients. Even if not in direct contact, health workers could potentially transmit infection acquired in the community to colleagues and, thereby, participate in the chain of health care-associated transmission of infection. However, in situations where there are resource constraints or limited or unstable vaccine supplies, categorization and prioritization of health workers for vaccination would be required. Prioritization of health workers would depend on as- sessment of risk of infection among the health workers themselves, transmission of infection to their patients and the consequences of health care-associated transmission. Even without financial resource constraints or limitations in vaccine supply, categorization of health workers would be useful when different policies are applied to different health worker cat- egories, based on risk assessment. For example, a mandatory vaccination policy may be applied to select categories of health workers who work with patients at high risk of severe influenza and who are more likely to accept mandatory vaccination, while vaccination may be voluntary for other categories (40, 41). Table 1 provides an example of risk categorization of health workers based on risk to themselves and of those for whom they care. Table 1. Risk categorization of health workers Risk category Health worker characteristics Very High • High risk health workers (see below) who work in clinical areas that admit patients at high risk for severe disease, complications, or death following influenza virus infection. These include intensive care units; transplant or oncology wards; antenatal, peri-natal or post- natal areas; and areas with elderly individuals, especially those with chronic diseases. High • Health workers who come into direct physical contact with patients, or with infectious materials, including surfaces or equipment contaminated by infectious materials. • Health workers who have contact which is not physical but that would allow the acquisi- tion or transmission of diseases that are spread at short range (1–2 m) by respiratory means, e.g., counsellors who have prolonged fact-to-face contact (42, 43). Low • Health workers who do not have contact with patients and whose normal work is not in a clinical area as defined above. 15 2. Establishing a policy to vaccinate health workers against seasonal influenza The very high-risk category is also the one where the evidence for risk and impact of vaccination is the strongest and where there is a stronger justification for vaccination (10). Those targeted for vaccination should also include part-time personnel, students, contractors, and volunteers at the health facility who have possible exposure to patients as health workers in the above categories. Risk categorization of individual health workers may be too complex and resource intensive in many settings, especially in low- and middle-income countries. In these situations, simpler ap- proaches wherein health worker categories are classified into only two groups, i.e. at high risk group (targeted for vaccination) and low risk groups (not targeted for vaccination) may be used. To ensure targeted use of influenza vaccination of health workers and to address potential uptake issues, national policies for health worker vaccination should outline: 1. The classification of different health worker categories based on assessment of risk. 2. The policy for vaccination for each category, e.g. whether vaccination is recommended and whether the recommendation is for mandatory or voluntary vaccination. 3. Strategies for managing non-compliant health workers and vaccine refusers. The following document provides an example of a framework for the assessment, classification and prioritization of health workers: The policy directive of the New South Wales Ministry of Health on the Occupational Assessment, Screening and Vaccination Against Specified Infectious Diseases https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (Accessed 14 Mai 2019) Framing an immunization policy for health workers Recommendations for health worker vaccination could propose either mandatory vaccination, voluntary vaccination or a mixed approach depending on the risks in the specific clinical setting. Multiple studies across many countries has demonstrated that voluntary vaccination of health workers, even when accompanied by considerable efforts to educate them on the benefits and risks of vaccination and implementation of measures for convenient access to vaccination, results in low coverage that seldomly exceeds 70%. On the other hand, mandatory vaccination has resulted in close to 100% uptake in institutions in the United States where it has been applied (44–46). However, mandatory vaccination has been difficult to implement in some countries because of acceptability issues and because the attributable benefits of health worker vaccination have been a subject of debate (32). Furthermore, it may not be feasible to implement mandatory vaccination policies in resource-constrained settings. 16 2. Establishing a policy to vaccinate health workers against seasonal influenza Voluntary vaccination One option for a vaccination policy for health workers is voluntary vaccination wherein vaccina- tion is recommended for health workers and offered but acceptance is voluntary or optional, i.e. not a requirement. Such programmes often have low vaccination coverage. Hence, with voluntary vaccination, extra efforts are required to optimize the uptake of vaccination. These could include: 1. A robust communications strategy, specifically tailored to the needs of different health worker categories, to explain the benefits and risks of vaccination, including the benefits to patients, especially those at high risk for severe disease. It needs to be emphasized that some of these patients, including the elderly and immunocompromised patients may not themselves respond to vaccination and that vaccination of health workers who come into contact with them is an important means for protecting them from infection, i.e. a professional ethics and moral argument 2. Convenient access to vaccination that is free of charge, and available to workers in every shift. Those who work during evening or night shifts might be provided access to vacci- nation either at the beginning or the end or their shifts or on designated days and times to cover their shift. 3. Other demand generation activities as outlined in the next section of this manual. A number of soft mandates may also help in increasing vaccination uptake, including: 1. Requirement of active declination of vaccination through signing of forms indicating their non-participation with or without stating the reasons for not accepting vaccination (see Annex 1 for a sample of an active declination form). 2. Reassignment of health workers who refuse vaccination to areas where they are less likely to come into contact with high risk patients, if this is feasible, or a requirement to wear masks when they do care for patients at high risk of influenza complications. 3. Use of face masks while in the health care facility. Mandatory vaccination Mandatory vaccination makes vaccination of health workers a legal or regulatory requirement while allowing some exemptions, e.g. medical contraindications. There is no WHO or other uniformly applied definition for mandatory vaccination. Infant and childhood immunization programmes described as mandatory can vary widely, especially in terms of the exemptions al- lowed and the penalties for non-compliance (47). Several experts have argued that mandatory immunization policies should be implemented against vaccine-preventable diseases that can be transmitted in the health-care setting and cause signifi- cant risk of morbidity or mortality to patients (20, 44, 48–50), as part of the professional ethics of a health care provider. It has also been argued that few ethical mandates in the practice of medicine surpass the obliga- tion to do no harm. Hence, ensuring conditions for safe patient care by minimizing transmission of communicable diseases represents a minimum ethical standard in health care practice set- tings (20). However, if mandatory vaccination policies are to be established, legal liability issues will need to be addressed and consideration given to providing compensation in the rare event of an adverse event. 17 2. Establishing a policy to vaccinate health workers against seasonal influenza Mandatory vaccination could either be part of the national policy or implemented at individual health facilities as part of institutional policies. The enactment of legislation endorsing mandatory vaccination would facilitate the implementation of such a policy. The Code of Colorado Regulations provides an example of a mandatory vaccination policy: Code of Colorado Regulations: Standards for Hospitals and Health Facilities 02 – General Licensure Standards (Part 10, Page 46) https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20CCR%20 1011-1%20Chap%2002 (Accessed 14 Mai 2019) Several countries with voluntary health worker vaccination policies for influenza do have man- datory vaccination of health workers for other infections such as measles and hepatitis B. These existing mandatory vaccination policies could be leveraged to also justify and establish mandatory vaccination policies for influenza, based on the protection afforded to the health worker as well as to vulnerable high-risk patients with whom they come into contact. Published recommendations for the ethical implementation of mandatory vaccination policies are reproduced in Toolbox 3. These recommendations may be taken into consideration in framing the national policy based on the feasibility of implementation. Toolbox 3 Recommendations for ethically implementing mandatory vaccination policies — There must be a compelling employee and patient safety problem that is clearly communicated to employees. — The least restrictive means should be used to achieve the safety objective. — There should be clear opt-out criteria for medical reasons. — Opt-out criteria based on personal views of the health worker should be allowed for current employ- ees only. These determinations must be made in a transparent and objective manner. — For those who do meet medical or other exclusion criteria, or who refuse vaccination, institutions should offer alternative means for achieving transmission control, including temporary leave during peak times, mandatory mask wearing, re-assignment to non-clinical areas (if feasible) or frequent testing during peak influenza seasons. — Prospective employees should be notified of the mandatory policy and recognize that failure to comply could be grounds for termination of employment. — The process should be transparent, with a broad range of health worker perspectives involved in policy development. — Institutions should support healthcare workers by implementing vaccination procedures that are free, easy to access, and include complete comprehensive coverage of adverse events. Particular attention should be paid to not burdening less advantaged members of the healthcare team. Source : Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 18 2. Establishing a policy to vaccinate health workers against seasonal influenza Mixed approach A mixed approach could also be adopted where a mandatory vaccination policy is applied to only certain categories of health workers likely to have direct physical contact with high-risk patients, while a voluntary vaccination policy is applied to the remaining categories. Such a policy should clearly and unambiguously define the health worker groups to whom or work areas where mandatory and voluntary vaccination policies apply. Consideration should be given to the human and financial resource implications of mandatory vaccination policies or of soft mandates. Integration with Occupational Health Policies Policies on seasonal influenza vaccination of health workers should be an integral part of the national occupational safety and health policies and regulations and the occupational safety and health management systems in health facilities. Inclusion of seasonal influenza vaccination in occupational health policies will allow access to free vaccination for all the targeted health workers as per the Occupational Safety and Health Convention, 1981, Article 215 and the recommendations in the World Health Organization and International Labour Organization (WHO-ILO) Global Framework for National Occupational Health Programmes for Health Workers.6 Such a policy would also put the responsibility for health worker vaccination on employers, rather than on the health workers alone. An integrated policy will enable greater coordination and collaboration between occupational health and immunization programmes and promote a joint approach to control of influenza in health facilities wherein vaccination is part of an infection control program that includes other in- fection measures to protect both health workers and patients. The occupational health programme at the national level and the management system at the facility level also provide an enabling environment to create a culture for infection prevention within the workplace that will stimulate the implementation of the vaccination programmes. Choice of vaccine product, schedule and timing of vaccination Choice of product WHO provides recommendations for the composition of influenza vaccines based on the infor- mation provided by the WHO Global Influenza Surveillance and Response System.7 Based on these recommendations, manufacturers formulate Northern Hemisphere (NH) and Southern Hemisphere (SH) vaccines, which are generally accessible around September (NH) and April 5 C155-Occupational Safety and Health Convention, 1981 (No. 155). https://www.ilo.org/dyn/normlex/en/f?p=NO RMLEXPUB:12100:0::NO::p12100_instrument_id:312300 (Accessed 14 Mai 2019) 6 The sectoral dimension of the ILO’s work : Review of sectoral initiatives on HIV and AIDS Appendix II – WHO- ILO WHO-ILO Global Framework for National Occupational Health Programmes for Health Workers. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/wcms_145837.pdf (Accessed 14 Mai 2019) 7 Influenza: vaccines. http://www.who.int/influenza/vaccines (Accessed 14 Mai 2019) 19 2. Establishing a policy to vaccinate health workers against seasonal influenza (SH) of each year, respectively. A list of WHO prequalified vaccines with information on their characteristics is published on the WHO website.8 Several different types of vaccines are available, including inactivated influenza vaccines (triva- lent and quadrivalent composition), live attenuated influenza vaccines, adjuvanted vaccine, and recombinant vaccine. Being a health worker per se does not lead to a preference for any vaccine type (subject to country-specific marketing authorizations).9 Health workers who care for severely immunocompromised persons should preferably receive inactivated influenza vaccine (IIV). Price and supply availability of each product are additional considerations in informing the choice of product. Timing of vaccination In countries where influenza infection is seasonal and seasonality patterns are defined, vaccina- tion should ideally be scheduled before the start of the influenza season, allowing approximately 14 days for induction of protective antibodies. Where delays in securing vaccine supply does not allow ideal timing to be met, vaccination should be initiated as soon as supplies are made available. Furthermore, individual health workers should never be refused vaccination at any time during the influenza season if they are late in seeking vaccination. In tropical and subtropical regions where several peaks may occur, vaccination should be timed before the main peak of transmission, using the most recent vaccine formulation available. Where no data on national influenza seasonality are available, countries could use data from epidemio- logically similar countries. Toolbox 4 provides published information of influenza seasonality in the tropics and subtropics. 8 WHO Prequalified Vaccines. https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 9 In some countries the quadrivalent vaccine is the product of choice. The WHO Strategic Advisory Group of Experts (SAGE) in immunization is currently reviewing the evidence and expected to make a recommendation in 2020. Toolbox 4 Guidance on choice of product and timing of seasonal influenza Seasonal influenza policy use and effectiveness in the tropics and subtropics. Geneva: World Health Organization; 2016. ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf (Accessed 14 Mai 2019) Influenza seasonality in the tropics and subtropics – when to vaccinate  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 (Accessed 14 Mai 2019) WHO list of prequalified vaccines  https://extranet.who.int/gavi/PQ_Web (Accessed 14 Mai 2019) 20 2. Establishing a policy to vaccinate health workers against seasonal influenza Defining monitoring and disease impact measurement objectives Ministries of Health would benefit from advice from the NITAG or other relevant advisory groups on the monitoring and impact measurement objectives so that they are taken into consideration during the planning and implementation of Monitoring and Evaluation (see chapter 4). NITAGs, with additional inputs from other relevant advisory groups and academia, should make recommendations on: 1. Monitoring and reporting of vaccination coverage, where possible by unit and type of care provided. 2. Measurement of vaccination impact, including: a) Target groups (health workers and or patients) for impact measurement. b) Outcomes to be monitored. e.g. influenza-like illness, laboratory-confirmed disease, severe disease, death, absenteeism, patient-related outcomes, etc. c) urveillance strategies for measuring impact; if at sentinel sites, the number and distribution of sites. d) Time periods for impact measurement, e.g. continued monitoring for an indefinite period or limited to a certain number of seasons. These measurements would be useful to the NITAG in reviewing the impact of vaccination and making recommendations for optimizing the impact and the cost-effectiveness of vaccination. Impact measurement could also generate empiric data to allow for estimation of cost-effectiveness of vaccination. It should be noted that any such measurements should include data collection for multiple seasons since the intensity of transmission, the severity of infection and vaccine effectiveness varies from one season to another. For further details, see the section on “Monitoring and evaluation” (chapter 4). 21 3. Planning and managing vaccination of health workers Planning for successful vaccine introduction Once a national vaccination policy has been established, it is necessary to convert the policy into operational plans that are fully costed, budgeted and include granular detail on the various pro- gramme components related to the introduction of a new vaccine into the national programme. The general concepts for addition of a new vaccine within the national immunization plans and the management of introduction are outlined in the WHO guide “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” (see Annex 3 for New Vaccine Introduction Plan Template). This section provides guidance on the additional elements specific to seasonal influenza vaccination of health workers. A vaccine introduction plan integrated into the annual plan for immunization along with the as- sociated checklists enable programme planners to ensure that all the necessary preparations are in place for the timely and efficient introduction of a vaccine into the national programme. For easy access the links to the relevant Annexes of the WHO guide are provided in Toolbox 5. In addition to the generic vaccine introduction checklist, the complementary checklist in Annex 2 con- tains a list of issues specific to health worker immunization. The elements of this checklist should be added (as appropriate) to the more generic checklist of activities. A sample health facility checklist is also provided (Annex 3) to guide the preparations for vaccination at the health facility level. Toolbox 5 Links to templates and checklists for a new vaccine introduction plan in “Principles and considerations to adding a new vaccine to a national immunization programme: from decision to implementation and monitoring” Generic template to guide the development of a national introduction plan Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc (Accessed 14 Mai 2019) New vaccine introduction checklist, activity list and timeline of WHO new vaccine introduction guide provides advice on planning budgeting, activities, distribution of roles and responsibilities and timelines ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_ resources/nvi_guidelines/Annex4_Instructions.pdf (Accessed 14 Mai 2019) Corresponding checklist tool Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_checklist_en.xls (Accessed 14 Mai 2019) 22 3. Planning and managing vaccination of health workers The timelines for planning and introduction should be included in the checklists and/or as a sepa- rate Gantt chart to ensure that all the activities are completed in their appropriate order to allow timely implementation of vaccination activities. Cross-reference should be made to the relevant sections of the occupational health strategies and plans at both the national and health facility level (see previous chapter on integration of health worker influenza policies into occupational health policies and requirements) to facilitate a more cohesive approach to planning and implementation. The WHO-ILO Global Framework for National Occupational Health Programme for Health Work- ers recommends that all countries identify the responsible person(s) for occupational health, both at the national and workplace levels. These focal points should be a part of the planning team at the national and health facility levels, respectively. Inclusion of the occupational health focal points would allow for an integrated approach to prevention of influenza in the work place where vaccina- tion forms part of a larger package of interventions for influenza control, including other infection control measures to protect both health workers and patients. The labour-management committees for occupational safety and health in health facilities, where they exist, can help in engaging the management and the workers’ representatives in the implementation of the vaccination programme. In addition to the national operational plans for the implementation of health worker vaccination, the national comprehensive multi-year plan (cMYP) for immunization should also be updated to include health worker immunization (Toolbox 6). Costing and financing As with the addition of any new vaccine to the national vaccination schedule, the vaccine and deliv- ery costs should be estimated and included in the annual and multi-year immunization budgets. In addition to the costs of vaccines and supplies (syringes, needles, safety boxes etc.), costs for vaccine delivery (including human resources), annual communications/education and demand generation efforts at the national and health facility level, and monitoring and reporting would need to be included in the costs. Several tools and resources are available that could be used or adapted for costing, budgeting and securing finances for health workers vaccination (see Toolbox 7). Since communications and other activities/interventions to enhance vaccination uptake will be required each year, these costs should be incorporated into the annual vaccine delivery costs and not considered only as a one-time activity. In addition to costing and budgeting for annual health worker influenza vaccination, it may also be necessary to advocate with those responsible for allocating funds for health programmes to ensure that financing for vaccination is sustained. Toolbox 8 provides links to resources for ad- vocacy for sustainable financing. Toolbox 6 WHO-UNICEF guidelines for multi-year planning WHO-UNICEF guidelines for developing a comprehensive multi-year plan (cMYP)  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. Planning and managing vaccination of health workers Toolbox 7 Resources for costing and financing cMYP Costing and Financing Tool  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (Accessed 14 Mai 2019) Immunization Costing Action Network (ICAN) Immunization Delivery Cost Catalogue This interactive website provides information on vaccine delivery costs across different low and middle- income countries through a variety of delivery strategies.  http://immunizationeconomics.org/ican-idcc (Accessed 14 Mai 2019) WHO Flu tool for planning and costing maternal influenza vaccination (new name: SIICT tool) This tool is being expanded to include all influenza risk groups, including health workers.  https://www.who.int/immunization/research/development/influenza_economics/ (Accessed 14 Mai 2019) Management Sciences for Health. Planning, costing and budgeting framework  http://www.msh.org/resources/planning-costing-and-budgeting-framework (Accessed 14 Mai 2019) Immunization financing: a resource guide for advocates, policy makers and program managers  https://immunizationeconomics.org/imfin (Accessed 14 Mai 2019) Toolbox 8 Resources for advocacy or sustainable financing Immunization advocacy library. Provides a number of tools and guides to convey the value of vaccination and the need to invest in vaccination  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/communication-and-advocacy/immunization-advocacy-library (Accessed 14 Mai 2019) Two specific documents in this library are of relevance: Workbook – advocacy for sustainable funding of immunization programmes  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/workbook-advocacy-for-sustainable-funding-of-immunization-programmes (Accessed 14 Mai 2019) How to prepare a financial profile of your immunization programme  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/2015/how-to-prepare-a-financial-profile-of-your-immunization-programme (Accessed 14 Mai 2019) 24 3. Planning and managing vaccination of health workers Formative research to inform the planning process To prepare for the launch of influenza vaccination, several countries have used formative research to better understand the factors affecting uptake of seasonal influenza vaccination in health work- ers, including concerns, beliefs, information needs, cultural issues, and barriers to vaccination in order to develop a tailored plan to address them. Formative research can include both quantitative and qualitative research and, in some situations, might include a desk review. Quantitative research may be used to identify the main predictors for low uptake of vaccination among health workers and the main drivers for compliance with vaccina- tion recommendations. Data may be collected through surveys and questionnaires administered to health workers. The sample should ideally include sufficient representation from the different categories of health workers since the perceptions and reasons for low uptake may vary between health worker groups, e.g. between doctors and nurses (40), as well as from a sample of primary, secondary and tertiary health care facilities and from different work areas within these facilities. Qualitative research is insight research, based on understanding the audience’s point of view. It elucidates new issues and provides a more in-depth understanding of the complex issues underly- ing the uptake of vaccination. Qualitative research methods commonly include focus group dis- cussions and individual in-depth interviews. The WHO European Regional Office has published a step-by-step field guide to qualitative research for new vaccine introduction (see Toolbox 9). To be useful, formative research must be properly planned and well executed, failing which there is a risk of drawing wrong conclusions. This requires time and resources. While it is useful to conduct such research to inform the planning process, if time and resources do not permit, the lack of such research should not delay seasonal influenza vaccine introduction, unless attitudes of health workers are expected to be an issue that may significantly and adversely impact vaccine uptake. When data from formative research are not available, data from such studies conducted in other countries may be used to inform the planning process. While the reasons for low uptake of vac- cine are heterogenous, available evidence suggests that there is broad convergence on the major influencers of vaccine uptake among health workers, especially between countries within the same sub-region, which may be used in the initial planning process. The rapid appraisal of evidence (10) summarizes the key findings from the published literature and this evidence could be used, as applicable and appropriate, in the absence of locally conducted research. Data from the published literature may be complemented with information obtained through quantitative formative research using rapid surveys in a sample of health workers, ideally including different health worker categories. These surveys may be less resource intensive than qualitative formative research and could be completed without resulting in any delays to vaccine introduction. Annex 4 provides a sample questionnaire that may be used for such surveys. Toolbox 9 Field Guide for qualitative formative research A field guide to qualitative research for new vaccine introduction ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_VaccineIntro.pdf (Accessed 14 Mai 2019) 25 3. Planning and managing vaccination of health workers Further research may be conducted if vaccine uptake remains persistently low. The TIPflu tool is an important resource that may be used in such situations. Communication and vaccine acceptance Personal beliefs, cultural attitudes and perceptions about vaccination, in addition to official rec- ommendations, often guide the actions of many of those responsible for delivery of vaccines and many recipients (51, 52). This also holds true at the level of health workers. Available evidence shows that there are often misperceptions about vaccination as well as a gap between knowledge and behaviours (53, 54). Thus, simply improving knowledge about the risks and benefits of vac- cination among health workers has not proven to be sufficient to achieve optimal vaccination uptake. Achieving optimal vaccination coverage in health workers requires a multi-dimensional demand generation effort that is informed by a good understanding of the perception, motivators and barriers of vaccine acceptance among health workers, both as providers of vaccination and as recipients. Communications messages need to be tailored to address the needs of different health worker groups since available evidence suggests that perceptions about the need, risks and benefits of vaccination may vary between these groups (55). Current efforts mainly focus on preparing fact- based approaches to preparing communication messages. However, these types of messages may need to be framed according to the intended audiences based on their level of education and understanding. Taking the preferred cognitive decision-making styles of the individual groups to be targeted into account may have greater impact (54). Framing such messages will require an understanding of vaccine psychology and cognitive decision-making and may require engagement of communication specialists. A traditional approach to communications regarding immunization was through the use of mass media. However, research has shown that mass media alone and a one-way communication to health workers may not be sufficient to optimize the uptake of vaccination. Individual and group communications, in this instance at the health facility level, will be required to build trust and motivate health workers to accept vaccination. Including information on the relevance of vaccination of health workers (self-protection, responsi- bilities towards patients, pandemic preparedness in the case of influenza) in pre-service curricula for medical schools, nursing schools and other training institutions targeting health professionals may help to better establish health worker vaccination as an organizing concept and create better informed health worker generations providing immunization. Effective communications and demand generation activities are not a one-time event but need to be continuous and have the ability to quickly respond to the evolving perceptions about vac- cination and quell rumours and mis-perceptions. Front line vaccination staff responsible for health worker influenza vaccination will need to be trained to be able to deal with vaccine hesi- tant health workers as well as vocal vaccine deniers10 who may negatively impact the uptake of vaccination (56). 10 Vocal vaccine deniers are at the extreme end of the subgroup of vaccine refusers and actively advocate against vaccination, using science denialism techniques to justify their beliefs (reference 32). 26 3. Planning and managing vaccination of health workers A national vaccine communication working group that includes communications specialists will facilitate strong working relations with and collaboration among partners and allies, strengthen routine communication for immunization, and ensure well-coordinated and immediate response from all involved authorities to any safety event. Inclusion of members of the Occupational Safety and Health department and from professional societies in communicating with health workers contributes to building trust and improving acceptance of vaccination. Representation from health workers, professional associations, and unions and from the different health worker categories targeted for vaccination would ensure that the viewpoints of each health worker category is taken into consideration in developing tailored communication materials. A number of tools and guidance documents are available that can be used for developing an ef- fective communications strategy and for framing the communications messages that are specifi- cally tailored towards different health worker groups, including a template terms of reference for a vaccine communication working groups (Toolbox 10). In addition to vaccination, the information and education and communication materials should also include information on other infection control measures to reduce transmission of influenza in the work place and steps to be taken should a health worker develop an influenza like illness. Communications at the health facility level Effective communications at the health facility level will benefit from a dedicated and well-trained team to deliver the communications strategy at the health facility level. Such a team should be established and trained well in advance of the planned introduction date and should include rep- resentation from the main health worker categories in the facility and an advocacy and commu- nications specialist, if one is available. Ideally, communications for seasonal influenza vaccination should be part of a broader communications effort on control of influenza in health care settings. Communication activities at the health facility level should begin sufficiently in advance of the planned date for the onset of vaccination, especially in countries introducing vaccination for the Toolbox 10 Tools and guides for developing communications strategy and messages Vaccination and trust library  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publi- cations/vaccination-and-trust (Accessed 14 Mai 2019) New vaccine introduction: checklist for planning communications and advocacy (2017)  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2017/new-vaccine-introduction-checklist-for-planning-communication-and-advo- cacy-2017 (Accessed 14 Mai 2019) Template terms of reference for a vaccine communication working group ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_Sup- portDoc_TOR_Proof7.pdf (Accessed 14 Mai 2019) 27 3. Planning and managing vaccination of health workers first time. Initial activities could include the display of information posters at all the relevant areas of the health facility. The manager of the health facility and the heads of all the relevant depart- ments and clinical areas should be sent a formal communication along with sufficient copies of all information materials about vaccination to be displayed in each clinical area. Where possible, relevant information on influenza vaccination could also be sent to all health workers using e-mail and/or local social media networks. In-person group briefings should complement the display and distribution of information materi- als. Existing staff meetings could be leveraged to conduct these briefings. The number of in-person group briefings will depend on the size of the health facility and the number of targeted health workers. Larger health facilities (e.g. secondary and tertiary level health facilities) may need to conduct several briefing sessions to cover all the targeted health workers. Since communications messages may differ between different categories of health workers, consideration should be given to holding separate briefing sessions for each health worker category using information and mate- rials relevant to them. To allow better communication and enough time for questions from health workers to be addressed, the size of each group should be designed to allow sufficient opportunity for interaction. Provision should be made to facilitate the participation of health workers working night shifts. The schedule for the briefings should be widely publicized within the health facility and reminders sent to promote high attendance. In-person meetings should: 1. Explain why vaccination is important for themselves, their patients and families and for wider society – with a particular focus on severe outcomes associated with influenza; 2. Inform health workers about national policies; 3. Provide information on the safety of seasonal influenza vaccines; 4. Provide information on the timing and venue(s) for vaccination; 5. Explain potential consequences of non-vaccination; 6. Allow sufficient time for questions. Consideration may be given to establishing a telephone hotline or web-based system to address questions from individual health workers. In addition to the display of posters and other com- munications materials, the use of visible and removable stickers that can be displayed by health workers who have been vaccinated (e.g. on their ID badges) would serve as a visible reminder to their colleagues who have not been vaccinated. In addition, text messages, generic e-mails and social media platforms could be used to provide periodic reminders on vaccination. Demand Generation at the Health Facility Level In addition to communication strategies, behavioural science-based demand generation efforts can be implemented prior to the availability of vaccines in order to prime health workers for vac- cination. These nudge-based interventions work by creating an environment that can influence behaviour in a predictable way but does not eliminate choice (57), and have proven effective in a variety of healthcare settings (58). These interventions can narrow the gap between intention and actual behaviour, which is usually caused by individuals or health workers forgetting to get 28 3. Planning and managing vaccination of health workers their vaccination or through barriers to convenient vaccination. Additionally, these interventions frequently can be implemented for relatively low cost (59). The figure below (Figure 3), adapted from the Nuffield Council on Bioethics, demonstrates the hierarchy of nudge-based interventions to improve vaccine uptake (60). Nudges lower on the ladder are less aggressive but can still have a measurable impact. By providing health-facility vaccination rate feedback, a process used in the United States to improve uptake of childhood vaccination, progress in health facilities can be monitored, and provide motivation to health workers to improve their own vaccination practices (61). Figure 3. Ladder of nudge interventions to increase vaccination rates Guide choice through default options Automatically set up appointment for vaccination unless individual opts out Enable choice Increase options to obtain vaccination such as at workplace or near home Prompt implementation intentions Ask individual to precommit to a time and location to obtain vaccination Frame information Deliver social comparsion feedback on vaccination rate among peers or healthier individuals Provide information Offer education on benefits of vaccination to self ant others Do nothing Simply monitor vaccination rates Source: Patel MS (ref. 32) Reminders to individuals to vaccinate can serve as a nudge, notifying individuals when they are due for a vaccine and prompting them to come to the vaccination site to receive the vaccine. These can be paper-based or mobile phone text message-based and have proven effective (62). In the health facility, health worker reminders through an immunization data collection tool (whether paper- or electronic-based) can help improve the delivery of vaccines by health workers (59). A successful nudge-based strategy to reduce barriers to convenient vaccination and enable choice is standing orders. Standing orders are a policy put in place in a health facility that permits non- physician health workers to administer vaccines without a prescription or explicit order from a physician and have proven one of the most effective strategies for improving vaccine uptake when applicable (63). All of these strategies can be combined with communication approaches to create demand in the community. 29 3. Planning and managing vaccination of health workers Going beyond nudges Nudges are a favoured method for influencing demand since they preserve choice and are not coercive. However, some experts have argued that when nudges fail to achieve optimal uptake of vaccination in health workers, and this failure results in harm to their patients, decision-makers should consider adopting more forceful policies (64). This is not to imply that when nudges fail one should immediately go to measures that eliminate choice. There are interventions that exist across a continuum leading up to restriction of choice. The use of “soft mandates” provide examples of actions across this continuum. Case study: The «flulapalooza» campaign to increase uptake of seasonal influenza vaccination in health workers Vanderbilt University Medical Center in Nashville, Tennessee, in the United States, employs over 24,000 health workers. Since 2011, the cornerstone of its seasonal influenza vaccination campaign for health workers has been its mass influenza vaccination event, playfully named “flulapalooza”. This event vac- cinates, on average, over 14,000 people in a single day. The closed point-of-dispensing (c-pod) design has been evaluated and refined over time to substantially increase administration efficiency and cover- age rates. The event emphasizes a festive atmosphere while practicing critical pandemic vaccination skills among hospital occupational health and administrative leadership. This event achieves high coverage among categories of health workers who are present that day; how- ever, due to the structure of nursing shifts and ward responsibilities at the institution, less than 30% of nursing staff are typically vaccinated at the event. Thus, the medical center combines flulapalooza with ward visits, mobile carts and other strategies to achieve its annual target of greater than 90% overall health worker vaccine coverage. Notably, although institutional policy gradually increased the difficulty of declination and eventually included disciplinary action in response for unexcused failure to vacci- nate, it is notable that 92% coverage had been achieved in seasons before disciplinary policies were in place. Details of event design, workflow diagrams and practical, specific lessons learned are described in a publication available online. Source: Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168–76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 Annex 5 provides a table that lists the different communications and demand creation approaches, along with an indication of the effort required to implement the approach and the expected impact. Vaccine procurement and supply chain management Vaccine procurement Accessing vaccines at optimal prices requires a good understanding of procurement mechanisms and systems, vaccine market dynamics, and the elements of vaccine pricing. Procurement starts with forecasting vaccine demand, followed by tendering, contracting and procurement processes. The tools and resources for vaccine procurement are listed in Toolbox 11. Procurement of seasonal influenza vaccination may have some unique features and may require regulatory approvals and advance purchase commitments with specific manufacturers shortly after the publication of the 30 3. Planning and managing vaccination of health workers WHO recommendations on the seasonal vaccine formulation (in February for the northern and in September for the southern hemisphere) and well in advance of the influenza season. Selection of the vaccine product and presentation As with any other vaccine, the choice of product and presentation will depend on multiple fac- tors including supply availability, price, ease of use, storage and transport requirements, vaccine wastage and missed opportunities for vaccination (e.g. postponing vaccination due to reluctance to open a 10-dose vial for only one or two individuals). The choice of vial size should be based on the number of doses to be delivered at each vaccination point and the number of sessions to be held at each point. The currently prequalified injectable seasonal influenza vaccines are available in single dose pre-filled syringes and in single and 10-dose vials. All the 10-dose vial presentations contain thiomersal as a preservative. However, it may be noted that not all the currently available prequalified products in 10-dose vials have market authorization for storage up to 28 days once opened, and not all products have a vaccine vial monitor (VVM). These aspects should be taken into consideration in selecting the product and presentation. The specifications of each product and presentation should be checked to confirm that they meet the requirements of the programme before a procurement order is placed. Information on WHO prequalified vaccines may be found on the WHO website (see Toolbox 11). Forecasting vaccine demand is an important first step in vaccine procurement. Forecasting demand requires an estimate of the number of health workers who will be targeted for vaccination, the expected vaccination coverage, and an estimate of vaccine wastage. Ideally health workers in both public and private facilities would be targeted for vaccination. This process of estimating the size of the target population for health workers vaccination is likely to be more complex than for other vaccines targeting the general populations. The data to derive such estimates may also be more difficult to find, especially in low and middle-income countries. Toolbox 12 provides resources for estimating the size of the health work force and those that need to be targeted for vaccination. Toolbox 11 Vaccine procurement tools Procurement mechanisms and systems  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_systems (Accessed 14 Mai 2019) Vaccine product, price and procurement (V3P) web platform  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (Accessed 14 Mai 2019) Vaccine market  http://www.who.int/immunization/programmes_systems/procurement/market (Accessed 14 Mai 2019) List of WHO prequalified seasonal influenza vaccines  https://extranet.who.int/gavi/PQ_Web/ (Accessed 14 Mai 2019) 31 3. Planning and managing vaccination of health workers The global health workforce databases may not carry information on all the health workers catego- ries that may be targeted for vaccination. For example, global databases may only have estimates of the numbers of doctors, nurses and midwives, but not other health worker categories. In such instances, rough estimates could be made based on ratios of those health workers for whom data are not available to those where data are available (e.g. ratio of physicians to laboratory workers). These ratios could be quickly obtained through a survey of a small representative sample (e.g. tertiary, secondary and primary) of health facilities. Since each health facility may be required to prepare beneficiary lists with the names of those targeted for vaccination, for tracking vaccination delivery, and for maintaining records of those vaccinated; the initial demand forecasts could be refined in subsequent years using data from these beneficiary lists and vaccination records. Logistics and cold chain management The handling of influenza vaccine is similar to most other vaccines in the national immunization programmes. It needs to be stored at 2–8 degrees Celsius. Since vaccination of health workers is expected to occur annually during a relatively short window period each year before the onset of the influenza season, a plan needs to be developed to ensure storage and transport of vaccine at the different levels involved in the supply chain during the window period chosen for vaccina- tion. Tools and resources for vaccine forecasting, management and logistics are available on the WHO website (Toolbox 13). The cold chain volume requirement for each WHO prequalified product and presentation are available on the WHO website (please select the vaccine type and click on the links for each individual product and presentation to obtain this information).11 At the health facility level, the focal point responsible for health worker vaccination should ensure that the vaccine doses required in the facility are included in the demand forecast and that sufficient storage space to accommodate the required vaccine doses is available prior to the anticipated date of vaccine arrival at the health facility. 11 WHO prequalified vaccines. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 Toolbox 12 Resources for estimating target population size Global Health Observatory: Health Workforce  http://www.who.int/gho/health_workforce Global Health Workforce Statistics database. Geneva: World Health Organization.  http://www.who.int/hrh/statistics/hwfstats Counting health workers: definitions, data, methods and global results. Geneva: World Health Organization; 2007. ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf Classifying health workers: mapping occupations to the international standard classification ƥ https://www.who.int/hrh/statistics/Health_workers_classification.pdf 32 3. Planning and managing vaccination of health workers Vaccination of health workers Vaccination of health workers should ideally take place at the health facilities where the targeted health workers normally work to ensure convenient access to vaccination. Case study: Using an immunization champion to enhance uptake of influenza vaccination in health workers in Oman Oman has a universal free-of-charge, integrated health care system, which includes influenza vaccina- tion of health workers. Oman is one of the few high-income countries in the WHO Eastern Mediterranean Region (EMR) that has achieved high influenza coverage among health workers (>80%). This was made possible by immunization champions. The minister of health in Oman is passionate about protecting the health of health workers and is at the forefront in taking the first influenza seasonal vaccine. As the patron of health worker community and an influential person in the country, this action has reinforced the importance of vaccination and continually helps promote influenza immunization programs. He has also been personally involved in the communication of vaccination messages to the health worker community. Every health facility should prepare a health facility plan for implementing seasonal influenza vac- cination of health workers well ahead of the influenza season. These plans should include measures to enable convenient access to vaccination for health workers in every shift. Different options may need to be determined at the health facility level to cover health workers during night shifts with- out resorting to 24-hour vaccination services, for example insuring the availability of vaccination just before or after a shift change. A vaccination team should be established at the level of the health facility to coordinate the vac- cination activities and optimize uptake under the overall supervision of the head of the facility. One person should be designated as the team leader. This could be either the occupational safety and health focal points, or the persons responsible for immunization activities in the health facil- ity. In larger facilities the staff medical services may be tasked with this activity. Experience from some organizations and health facilities have shown that using “vaccination champions” from among the health workers may contribute to improving vaccination uptake among their peers. In Toolbox 13 Vaccine management and support resources The resources that can assist programme managers in supply chain and logistics support planning may be found at the WHO website at:  http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ index4.html (Accessed 14 Mai 2019) Overview of technologies for the treatment of infectious and sharp waste from health care facilities ƥ https://apps.who.int/iris/bitstream/handle/10665/328146/9789241516228-eng.pdf (Accessed 14 Mai 2019) 33 3. Planning and managing vaccination of health workers some countries, a mobile team that goes to each clinical area in the health facility and provides vaccination has been successfully used. Training of the vaccination team Training workshops for health facility vaccination focal points should be conducted to conduct training in developing a health facility plan and in implementing and monitoring vaccination activities. A standardized agenda, curriculum, resource documents, checklists and model forms for recording data, as required, should be created at the national level for use in these workshops so that training is uniform across all health facilities. To further ensure uniform training, the workshops could be conducted using teams of trainers who are themselves trained centrally and are assigned to each region/subregion, using a cascade training approach. Short training videos may be used to achieve uniformity in content in the training. Web-based self-learning modules may be considered for those who were unable to attend the training sessions. The health facility vaccination team should have the capacity to classify health worker groups (see chapter 2 for sample risk categorization of health workers) and establish a list of health workers eligible for vaccination, with their designations, and areas of work. Where different vaccination policies apply to different risk categories, either separate lists should be created, or mechanisms established to easily identify and monitor the vaccination status of those in each category. The beneficiary lists should be developed sufficiently in advance of the start of vaccination activities and the relevant health workers informed on the need for vaccination. In addition to health workers employed at the health facility, provision may be made to include health workers in smaller facilities within their catchment area, including private facilities, as per the national policy, should vaccination not be available at all facilities. A mechanism for defaulter tracking and for sending reminders should be established at each health facility. For health workers who come into contact with high risk patients, (e.g. those in organ transplant, oncology, intensive care or perinatal units), the supervisors of those who have not been vaccinated before the start of the influenza season may need to be informed (local confidentiality norms permitting) so that they can reinforce the written reminders or, in case of refusals, get active declination forms signed and institute infection control measures applicable to active refusals, e.g. reassignment of duties, wearing of masks etc. as per the established national of health facility policy. 34 4. Monitoring and evaluation All countries should have a mechanism in place to monitor vaccine coverage as well as adverse events following immunization (AEFI) from the health facility to the national level and conduct at least one influenza vaccine post-introduction evaluation. However, measuring vaccine accep- tance and vaccine effectiveness or impact will be necessary and feasible only in a setting where immunization targets are not reached and if funding is available. Developing and updating information systems Appropriate forms and data entry modules for recording and reporting vaccination data at the health facility level and processes for reporting the data should be established. In developing tools and guidance for data collection, the need to include both public and private health systems should be considered. This may require mapping of existing health information systems and immunization data collection instruments as well as guidance on how these systems may be used to collect data on seasonal immunization of health workers. Data collection systems may vary across health facilities depending on the size and available infra- structure of the facility. However, each health facility must be provided with a standardized data reporting form to ensure that the data required for reporting to the national level are collected, irrespective of the data recording system used. This could include the name of the health worker, the health worker category, area of work, risk category, date of vaccination, the vaccine product and lot number. In developing the data reporting form, the advice provided by the NITAG on monitoring and impact assessment should be considered. All data collection systems, whether paper-based or electronic should have the capability for defaulter tracking and a system for generating and sending out reminders to defaulters. When using such reminder systems, protecting the confidentiality of data on the health and vaccination status of health workers will be critical and access to the data should be restricted to the facility vaccination coordinator. Coverage monitoring Several approaches for estimating health worker influenza vaccine coverage are available. The timing of such coverage measurement is important and should be coordinated with the timing of vaccination in the country. Given that influenza vaccine is usually administered in seasonal campaigns, frequent reporting (e.g. monthly) is recommended. Ideally, assessments should be done at the end of the season, when complete data are available and assessed and data cleaned for any inconsistencies. 35 4. Monitoring and evaluation Health facility registries Information on influenza vaccines administered to health workers should be included in existing records maintained as part of occupational health requirements and in vaccination registers as part of institutional monitoring mechanisms. Careful assessment of data discrepancies is requi- red if reporting is done from multiple sources, and data protection issues should be judiciously considered. The minimum set of data will include the number of people receiving influenza vac- cination during each annual season, the total number of targeted health workers, and the derived vaccination coverage (%). Often both numerator and denominator data can be obtained from the departments of occupational health at health facilities. For establishing more detailed denomina- tors, nominal health worker records e.g. based on payrolls can be used as a first step. A beneficiary list of those targeted for influenza vaccination can be selected from these records by applying criteria related to the health worker’s risk of infection or of transmitting the infection to those for whom they care (see section on “Characterizing the target groups for vaccination” and table 1). Depending on the capacity of the reporting system and program, this could include tallying numbers by health worker category and risk profile to allow coverage estimates by subcategories, such as doctors, nurses, laboratory workers, or staff working in Intensive Care Units or general (e.g. medicine or paediatric) wards, etc. If a vaccination registry does not exist, a crude estimate of coverage among health workers could be calculated by using the number of vaccine doses distributed to each facility minus the number of vaccine doses returned (unused) divided by the estimated number of health workers targeted for vaccination at the facility. A similar, rather imprecise method to assess coverage at the national level would be to use the regularly compiled data on health workers (as reported to WHO) to estimate the denominator (see Toolbox 12), as used for the vaccine demand forecast, and the overall number of vaccines adminis- tered as the numerator. This approach should only be used as a last resort where none of the other methods described are feasible. Administrative data If vaccines are provided free to health workers with government, national insurance system or employers bearing the costs, there may be regular, sometimes mandatory, reporting on the number of health workers who have received vaccinations at the institutional level. Such administrative data may be available from well-documented national vaccine programmes or from health insu- rance records. Surveys Surveys to obtain data on vaccinations and other interventions should be performed every 3 to 5 years and allow the identification of heterogeneity of coverage at the subnational level, important for the necessary adaptation of immunization practices. A representative sample of health workers can be selected though a stratified random sampling approach from national registries of health workers (e.g. professional organizations). If such registries are not available, a two-stage selection of health facilities and of health workers in these facilities can be done. If contact information is available, standardized interviews could be done face-to-face, by phone or via internet-based pla- tforms. Without such information, online survey links could be provided to all health workers in the selected facilities with an invitation to access the survey platform using their mobile phones or personal computers. It should be noted that when using this approach, self-reporting of vacci- nation may lead to overreporting.12 12 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394773/ 36 4. Monitoring and evaluation In all of these approaches to estimate coverage it will be important to specify the categories of health workers, e.g. those with or without direct patient contact, the latter including students, trainees, volunteers, maintenance, information technology, food service staff etc., who have been included in the numerators and denominators. It is also important to specify if part-time personnel working during the influenza season were included in the coverage estimates. Where individuals for whom vaccination is not recommended are vaccinated, such as back office workers or staff relatives, etc., care must be taken not to count these in estimating vaccination coverage. Refusal and completion rates of surveys will need to be monitored and adjustments for possible selection biases made in the analysis. At times, influenza vaccination programs may merely set absolute number targets of health work- ers to be vaccinated, based on the number of vaccines procured and available in a specific area or location. Such an approach, while followed in some countries, will not allow the proper estimation of coverage rates, including coverage by risk category, or comparisons over time, which will be important for interpreting any data on impact. It will also not enable identification of determinants of vaccination or of refusers. If available, data as well as methods used to estimate vaccination coverage for other regular health worker vaccinations should be accessed, e.g. for hepatitis B, measles, polio, pertussis or tetanus vaccines. It must be noted, however, that these vaccines are not provided on an annual basis and will often only be checked at entry to service. Toolbox 14 lists available tools for collecting and reporting immunization data and for estimating coverage. Toolbox 14 Monitoring and evaluation tools and indicators Immunization in practice series, module 7: Monitoring and using your data. Describes how to collect and report data and how to monitor immunization performance. ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf (Accessed 14 Mai 2019) Training for mid-level managers. Module 7: The EPI coverage survey (Document WHO/IVB/08.07). Geneva: World Health Organization; 2008. Provides a step-by-step walkthrough, including relevant guidance and tools, to plan and conduct a coverage survey of a newly introduced vaccine. ƥ http://who.int/immunization/documents/MLM_module7.pdf (Accessed 14 Mai 2019) WHO reference for estimating influenza vaccination coverage among target groups. Outlines different methodologies that can be used to estimate national influenza vaccine coverage among high-risk groups targeted for vaccination. ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing-influenza- vaccination-coverage-target-groups.pdf (Accessed 14 Mai 2019) 37 4. Monitoring and evaluation AEFI monitoring As for any vaccine and target group, a functioning AEFI monitoring system is a basic requirement, since knowledge gaps and misperceptions about influenza vaccine safety among health workers are consistently identified in in the literature. The system utilized to monitor and investigate possible AEFIs when delivering influenza vaccine to health workers should ideally be integrated into existing AEFI surveillance systems in line with national regulations for the monitoring of vaccine safety. The NIP or other departments responsible for health worker influenza vaccination (e.g. occupational health) should work with the National Regulatory Authority to define roles and responsibilities in vaccine safety monitor- ing. In countries using influenza vaccines for the first time, it could be conceivable to intensify AEFI surveillance during the first year of influenza vaccine introduction in order to provide quick feedback to stakeholders to help assure them of the safety of the vaccines in use. A functioning AEFI monitoring system will detect and elucidate problems with vaccines, which could be due to the product itself, its quality, or errors in the administration of the vaccines. All vaccine recipients reported as having an event (including minor events) perceived to be related to the influenza vaccine should be reported to the AEFI surveillance system using standard report- ing forms (see Toolbox 15). Given adequate reporting, the monitoring system should be able to evaluate the observed rate of reactions to influenza vaccine and compare this to the expected rates reported in the literature. For serious AEFIs, causality will normally be assessed by a group of experts. Importantly, and as for any vaccine, such a system needs to be able to identify a previously unknown or unexpected vaccine reaction that should be investigated in more depth. Care must be taken to ensure that coincidental events are not mistaken for vaccine reactions. Toolbox 15 AEFI-related information sources AEFI core variables, including data on case, vaccine, event and reporter ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_Dec2015.pdf (Accessed 14 Mai 2019) Sample form for AEFI recording with detailed description of reporting elements ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (Accessed 14 Mai 2019) Causality assessment of an AEFI: Provides the detailed methodology in a four-step process with access to a related software tool  http://www.who.int/vaccine_safety/publications/gvs_aefi/ (Accessed 14 Mai 2019) Vaccine safety training resources providing access to vaccine and pharmacovigilance training packages  http://www.who.int/vaccine_safety/initiative/tech_support/ (Accessed 14 Mai 2019) Information sheet: observed rate of vaccine reactions – influenza vaccines ƥ https://www.who.int/vaccine_safety/initiative/tools/Influenza_Vaccine_rates_information_sheet.pdf (Accessed 14 Mai 2019) 38 4. Monitoring and evaluation By establishing and enhancing AEFI systems, influenza vaccination can also be used to further improve the awareness of overall immunization safety in the health worker community. Monitoring and evaluation of vaccine acceptance Key determinants of vaccine acceptance among health workers have been investigated and include the desire for self-protection and to protect family and patients. (see also section on communica- tion and vaccine acceptance). As part of an initial situation analysis of health worker influenza vaccination programmes, available information on policy, programmes and practices, the factors affecting acceptance and participa- tion, and the influence of media and communications can be investigated through key informant interviews, or participatory workshops. Results of such an analysis could then be used to inform additional communication strategies addressing the identified concerns in a targeted manner. Other determinants can be explored through formative research. Both qualitative and quantita- tive research methods can be used to evaluate changes in health workers’ knowledge, attitudes, practices and behaviours. Behavioural determinants that differentiate health workers who get vaccinated from those who do not should be assessed regularly. Understanding the reasons and reasoning behind health workers’ attitudes towards annual flu vaccination is useful for the de- velopment of communications messages and products. Involving health workers in behavioural research related to their perceptions, beliefs, emotions and potential conflicts also provides an opportunity for the health worker community to be engaged in the approach, which can result in greater acceptance of the vaccination program. Vaccine impact monitoring After an influenza vaccine has been introduced in a population, additional studies may help in evaluating the impact of the immunization program. However, WHO does not recommend that vaccine impact or effectiveness studies be conducted by all countries with influenza vaccination programs, given their complexity and expense. A number of research networks worldwide conduct such studies and results can be expected to be applicable in Toolbox 16 Tools to assess vaccine acceptance among health workers TIP-FLU tool. Provides an approach and tools grounded in behavior change theories and health programme planning models to tailor seasonal influenza vaccination to the needs and attitudes of frontline HWs.  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/publications/2015/ tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a-guide-for-increasing-health- care-workers-uptake-of-seasonal-influenza-vaccination-2015 (Accessed 14 Mai 2019) TIP FLU case study Montenegro. Provides a practical example of the use of the TIP FLU tool. ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization-Pro- grammes-Seasonal-Influenza-TIP-FLU.pdf (Accessed 14 Mai 2019) 39 4. Monitoring and evaluation other settings with similar influenza epidemiology and vaccination programs. The decision to carry out such studies should therefore be based on the need for country-specific estimates and on the local capacity to conduct such rigorous studies. If studies are not appropriately designed with adequate sampling of different health worker categories, there is a risk of arriving at wrong conclusions. Before-after studies to demonstrate vaccine effectiveness are not advised for influenza, given that influenza vaccine effectiveness for preventing influenza symptoms in seasonal influenza epi- demics display considerable heterogeneity.13 Studies to evaluate the impact of seasonal influenza vaccination in health workers can be even more complex, given the varying risk of infection and transmission to patients among different categories of health workers. In health workers, a general reduction in absenteeism or, if available, reduction in influenza-asso- ciated absenteeism is often used as a surrogate indicator for the impact of an influenza vaccination programme. For this, health facility institutional monitoring would need to include disease rates in health workers, and a measure of sickness absence. Where possible, reporting days of absenteeism due to influenza-like illness (ILI) (or respiratory infections) should be recorded. This will include self-reported ILI with or without virological confirmation. Other non-specific outcomes include severe acute respiratory infection (SARI) and all-cause pneumonia requiring hospitalization. It is important to note that all these clinical syndromes include various other respiratory pathogens against which influenza vaccine does not protect. If such assessments are done, they should ide- ally cover multiple seasons, since impact can vary substantially by season, else such studies will be quite difficult to interpret. Laboratory-confirmed outcomes (e.g. by RT-PCR and other molecular diagnostic tests) improve the specificity of influenza disease classification. Where possible, establishment of sentinel sites with such capacity could be considered for collecting samples from health workers for laboratory confirmation. In these sites, vaccine effectiveness could be assessed using a case-control design and comparing vaccine coverage in laboratory-confirmed versus test-negative cases, if vaccine coverage is sufficiently high. Any of these approaches require sophisticated laboratory capacity which is not available everywhere. The screening method is a study design which could also be used for health worker vaccine im- pact assessment: it uses individual-level data on vaccination history from cases and data on vac- cination coverage in the health worker population from which the cases came. However, such a study requires accurate information on the vaccination status of the cases and of health worker vaccination coverage. Given the indication that annual influenza vaccination for health workers could reduce illness among the patients they care for, studies can be designed to evaluate the effect of health worker influenza vaccination on mortality, hospitalization, and influenza cases in patients of healthcare facilities. Several research approaches have been used in this context such as randomized trials or case-control approaches. Given the complexity of study designs, the conduct of such studies should be limited to research institutions that have the capacity and experience to conduct such studies. Economic assessments and cost-effectiveness evaluations may be considered once sufficient cost and impact data are available following influenza vaccine introduction. WHO provides a number of relevant resource documents, which are being further developed to specifically estimate vaccine 13 Evaluation of influenza vaccine effectiveness: A guide to the design and interpretation of observational studies, WHO 2017. 40 4. Monitoring and evaluation introduction costs for health worker vaccination (Toolbox 17; see also Toolbox 2). Relevant data are not easily available everywhere and assessments can be difficult to perform, given the limited size of the group of health workers. Post-introduction evaluation National Immunization Program Reviews routinely assess the use of specific vaccines about every 5 years following a new vaccine introduction. Such NIP Reviews should include relevant items to identify possible programmatic areas related to the new vaccine use. As needed in-between NIP Reviews, a specific influenza-related Post-Introduction Evaluation (I- PIE) tool may be performed after the first or second influenza immunization season. The I-PIE package (Toolbox 18) includes a number of tools to support the planning and conduct of the evaluation, including standard questionnaires and data collection forms in paper or electronic format as well as reporting templates together with instructions on how to perform the I-PIE in a cost-efficient manner. These tools will need to be adapted to the specific country context and to the specifics of the vaccine formulation and presentations. The I-PIE is performed at all levels of the health system and includes observation of practices at the points of vaccine administration, vaccine storage areas as well as data and record reviews. An I-PIE can thus provide a more immediate approach to assess the programmatic challenges and impact of influenza vaccine use, and to compare results across countries, enabling them to share and learn from each other’s experiences. Toolbox 17 Influenza in health workers: Study methodologies Evaluation of flu vaccine effectiveness 2017. Provides detailed information for researchers who design observational influenza vaccine effectiveness studies and for public health scientists who interpret and apply the results of these studies. An annex will address the effectiveness of influenza vaccine in health workers. ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (Accessed 14 Mai 2019) Manual for estimating disease burden associated with seasonal influenza. Provides step-by-step approach to estimate influenza disease burden in the general population as well as those with specific conditions who are vulnerable to severe disease.  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (Accessed 14 Mai 2019) Toolbox 18 Influenza post-introduction evaluation tools I-PIE tool with instructions and recording and reporting templates  https://www.who.int/immunization/research/development/ipie_influenza_post_introduction_ evaluation (Accessed 14 Mai 2019) 41 References [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination accep- tance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during preg- nancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are count- ries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evi- dence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare wor- kers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-ana- lysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13(6):e0198685. 42 [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care wor- kers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epide- miol. 2002; 23(10):615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influen- za-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kin- dergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial out- break of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a mul- ti-faceted programme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 43 [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vacci- nation of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12(1):e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vac- cination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection cont- rol and hospital epidemiology. 1998; 19(7):518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward man- datory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62(1):1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 44 [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing inter- vention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccination: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36(2):196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, ado- lescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertive- ness. N Engl J Med. 2019 Jan24; 380(4):309–11. 45 Annex 1. Sample non-participation form This form is to be used in cases of voluntary vaccination where health workers in the very high or high-risk categories who decline to participate in assessment, screening and vaccination in accordance with the national policy. Completion of the form is particularly important where failure to get vaccinated will result in reassign- ment or require the use of protective measures to protect patients as specified in the national policy. Non-participation in vaccination 1. I have read and understood the policy directive regarding seasonal influenza vaccination of health workers. 2. I decline to participate in vaccination against influenza. 3. I am aware of the potential risks to myself and/or others that my non-participation in vaccination may pose. 4. I am aware that my non-participation may result in my being reassigned to a non-high-risk area or in other requirements to protect others with whom I may come in contact, as per the national policy. 5. The reason for my non-participation is: Refusal to sign In circumstances where the health worker refuses to sign this form, it should be noted on the form and the health worker should be notified of consequences, if any, as per the policy. Name of health worker: Date of birth: Health service/ facility: Work area: Signature: Date: OFFICE USE ONLY I have discussed the potential risks that non-participation in vaccination may pose and the management of unvaccinated workers in accordance with the vaccination policy. Name of vaccination team staff: Designation: Health facility /agency: Signature: Date: 46 Annex 2. Complementary checklist for planning health worker immuniza- tion: national14 level (To be adapted for local use) To account for the specifics of seasonal influenza vaccination of health workers, the following ADDITIONAL elements may be added to the generic new vaccine introduction check list, see Annex 4 of the document “Princi- ples and considerations for adding a vaccine to a national immunization programme” for the checklist structure. Health worker seasonal influenza vaccination policy 1. National policy on seasonal influenza vaccination of health workers are published and dissemi- nated to all relevant agencies and health facilities, including private health facilities and relevant professional societies. 2. The policy on seasonal influenza vaccination of health workers is reflected in the national occupational health policies. 3. The costs of seasonal influenza vaccination of health workers are included in either the immu- nization or occupational health budget, as appropriate. 4. Surveillance system is in place for influenza activity, including defining start and end of the influenza season, to inform selection of the most appropriate vaccine formulation and timing of influenza vaccination. Planning for successful vaccine introduction 5. A functional multidisciplinary coordination group is in place to discuss and promote access to a new target population of health workers, enabling the formation of partnerships which support and shape the national agenda. 6. The group includes focal points from the occupational health and immunization programs, professional organization representatives, and other relevant stakeholders. 7. A costed operational plan for health worker vaccination is developed and integrated into the na- tional immunization plans and relevant occupational health plans. Formative research (optional and to be included only if formative research is planned) 8. The need and scope of any formative research to be conducted in preparation for vaccine introduction is defined. 9. A research group to conduct formative research has been identified and terms of reference for the research has been developed. Communications 10. National communications working group established for planning communications strategy and developing communications materials for health worker vaccination against seasonal influenza. 14 In some countries, especially large countries with decentralized system, elements of this checklist may also apply at relevant subnational levels, e.g. provincial level. 47 11. Tailored communications messages and materials developed along with an overall communications strategy. 12. Training for health facility communications teams is conducted. Vaccine procurement and supply chain management 13. Target population size estimate developed and included in demand forecast. 14. Individual health facility demand estimated, and vaccine distribution plan developed. 15. Sufficient storage space for vaccines and supplies for seasonal vaccination at all levels established to accommodate vaccine during vaccination period. Vaccine Delivery 16. Health facility vaccination delivery teams are established and trained. 17. System for management of vaccination refusals and implementation of infection control mea- sures in place for prevention of nosocomial transmission, e.g. reassignment, wearing of masks, mandatory leave in case of ILI. Monitoring and evaluation 18. Data recording and reporting tools developed and distributed including for coverage monitoring (updated administrative data and health worker surveys) and AEFI monitoring. 19. Post-introduction evaluation conducted within the first 2 seasons following vaccine introduction. 20. Possibilities reviewed for operational research to assess health worker vaccine acceptance. 48 Annex 3. Health facility checklist (To be adapted for local use) Person responsible Deadline Status Communications 1. Health facilities communications working groups are established and trained 2. Health facility communications plan and schedule for group communications with health workers finalized 3. Adequate supplies of posters and information materials for health worker vac- cination are available 4. Notification of vaccination sent out to targeted health workers and supervisors 5. Telephone hotline established to address individual queries from health workers Storage capacity for vaccines and supplies 6. Adequate storage capacity for influenza vaccines and supplies during vaccination window period established 7. Adequate supplies of influenza vaccines and supplies for health worker vaccination available 8. Provision to deal with extra injection waste during period of vaccination Vaccine Delivery 9. Vaccination delivery team established and trained and vaccination sites within health facility finalized 10. Categorization of health workers completed and beneficiary list for vaccination developed 11. System for management of vaccination refusals and implementation of infection control measures in place for prevention of nosocomial transmission, e.g. reas- signment, wearing of masks, mandatory leave in case of ILI Monitoring and evaluation 12. Data recording and reporting instruments available taking into account data protection issues 13. System for defaulter tracking and reminders established 14. Health facility registries updated to include influenza vaccination 15. AEFI monitoring and reporting systems updated to identify AEFI in health workers 16. Vaccine acceptance monitoring system to address uptake issues in health workers established (if uptake issues are observed) 49 Annex 4. Sample questionnaire for conducting a survey among health workers 1 Name (optional) 2 Age (years) 3 Sex ¨ Male ¨ Female 4 Job category15 ¨ Doctor ¨ Nurse/midwife ¨ Laboratory technician ¨ Other technical staff ¨ Other (specify) 5 Patient contact ¨ Direct ¨ Face-to-face but not direct ¨ None 6 Contact with high risk patients ¨ Yes ¨ No 7 Work area (name of clinical area of work) Statements Strongly agree Agree Neutral Disagree Strongly disagree 1 Vaccination of health workers against diseases such as hepatitis B and influenza are important 2 If I was unvaccinated exposure to influenza would be a risk to my health 3 Exposure to influenza poses a risk to my patients’ health 4 Influenza vaccination poses a risk to my health 5 The benefits of vaccination are greater than the risks 6 My receiving vaccination will protect my patients 7 The best way to protect my patients is to combine seasonal influenza vaccination with other infection control measures 8 I am sufficiently informed about risks of influenza infection I am sufficiently informed about the risks and benefits of influenza vaccination The following factors that would influence my decision to accept vaccination 9 Recommendations from the national policy-making body (e.g. NITAG) 15 Adapt for local use based on local health worker classification. 50 10 Endorsement of recommendation from the professional society to which I belong 11 If it is part of occupational health regulations/ requirements 12 Recommendation from my personal physician 13 Availability of vaccination at no cost to me 14 Easy access to vaccination at my place of work 15 Colleagues having been vaccinated 16 Previous experience with vaccination 17 Protecting my patients 18 Preventing/reducing absenteeism from work 19 Contributing to pandemic preparedness Other factors that would affect my decision to accept influenza vaccination (list below) 20 21 22 51 Annex 5. Communications and demand generation: Stratification of approaches to developing the content Approach Effort Impact Developing the content for communication messages Framing information by delivering social comparison feedback on vaccination rates among peers or healthier individuals Low Medium Tailored communication based on cognitive styles and cultural behaviours Medium High Communication methods Distribution and display of Information, Education and Communication (IEC) materials Low Medium Establish a specially trained communications team at health facility level to administer communications and demand generation approaches Medium High Web-based (including FAQs and chat groups) and social media communications Medium Medium Text message and e-mail reminders to health workers Low Medium Small group in-person briefing meetings High Medium Use immunization champions at national and health facility level Medium High Demand generation approaches Provision of free vaccines Medium High Provide vaccination in the work area using mobile teams Medium High Provide incentives or stimulate competition, e.g. awards to clinical areas with highest vaccination coverage Low Medium Visible reminders and peer-pressure, e.g. badges or stickers worn by those who have been vaccinated Low Medium Ask individual to commit to a time and location to obtain vaccination Low Medium Increase options to obtain vaccination, either near home or at workplace Medium High Guide choice through default options, e.g. automatically set up appointment for vaccina- tion unless individual opts out Low High Establish standing orders to facilitate vaccination Medium High 52 ISBN 978-92-4-151559-7

1دليل مقدمة لمديري برامج التمنيع الوطنية وواضعي السياسات ُسبل تنفيذ التطعيم المضاد للأنفلونزا الموسمية في صفوف العاملين الصحيين دائرة صحة الأسرة، والمرأة، والطفل )CWF( قسم التمنيع واللقاحات والمواد البيولوجية أُِعدت هذه الوثيقة من قَِبل مبادرة بحوث اللقاحات التابعة لإدارة التمنيع واللقاحات والمستحضرات البيولوجية ُسبل تنفيذ التطعيم المضاد للأنفلونزا الموسمية في صفوف العاملين الصحيين ]srekrow htlaeh fo noitaniccav azneuflni lanosaes tnemelpmi ot woH[ 2-955156-4-29-879 NBSI تاريخ النشر: يوليو9102 هذه المطبوعة متاحة على شبكة الإنترنت على العنوان التالي: /siri/tni.ohw.sppa//:sptth يمكن الحصول على نسخ من هذه الوثيقة علاوًة على مواد إضافية بشأن التمنيع واللقاحات والمستحضرات البيولوجية من: منظمة الصحة العالمية إدارة التمنيع واللقاحات والمستحضرات البيولوجية 1121-HC جنيف 72، سويسرا فاكس: +7224 197 22 14 - بريد إلكتروني: tni.ohw@seniccav © منظمة الصحة العالمية 6102 بعض الحقوق محفوظة. هذا المصنف متاح بمقتضى ترخيص المشاع الإبداعي «نسب المصنف – غير تجاري – المشاركة بالمثل 3.0 لفائدة المنظمات الحكومية الدولية» (/ogi/0.3/as-cn-yb/sesnecil/gro.snommocevitaerc//:sptth ;OGI 0.3 AS-CN-YB CC). وبمقتضى هذا الترخيص يجوز أن تنسخوا المصنف وتعيدوا توزيعه وتحوروه للأغراض غير التجارية، وذلك شريطة أن يتم اقتباس المصنف على النحو الملائم كما هو مبين أدناه. ولا ينبغي في أي استخدام لهذا المصنف الإيحاء بأن المنظمة (OHW) تعتمد أي منظمة أو منتجات أو خدمات محددة. ولا ُيسمح باستخدام شعار المنظمة (OHW). وإذا قمتم بتعديل المصنف فيجب عندئٍذ أن تحصلوا على ترخيص لمصنفكم بمقتضى نفس ترخيص المشاع الإبداعي ((snommoC evitaerC ecnecil أو ترخيص يعادله. وإذا قمتم بترجمة المصنف فينبغي أن تدرجوا بيان إخلاء المسؤولية التالي مع الاقتباس المقترح: «هذه الترجمة ليست من إعداد منظمة الصحة العالمية (المنظمة (OHW)). والمنظمة (OHW) غير مسؤولة عن محتوى هذه الترجمة أو دقتها. ويجب أن يكون إصدار الأصل الإنكليزي هو الإصدار الملزم وذو الحجية.» ويجب أن تتم أي ــة وسـاطـة فيما يتعلق بالمنازعات التي تنشأ فـي إط ــار هــذا الترخيص وفـقـا ً لقواعد الوساطة للمنظمة العالمية للملكية الفكرية (/selur/noitaidem/ne/cma/tni.opiw.www//:ptth). الاقتباس المقترح. ُسبل تنفيذ التطعيم المضاد للأنفلونزا الموسمية في صفوف العاملين الصحيين ]srekrow htlaeh fo noitaniccav azneuflni lanosaes tnemelpmi ot woH] جنيف: منظمة الصحة العالمية: 9102. الترخيص OGI 0.3 AS-CN-YB CC. بيانات الفهرسة أثناء النشر. بيانات الفهرسة أثناء النشر متاحة في الرابط /siri/tni.ohw.sppa//:ptth. المبيعات والحقوق والترخيص. لشراء مطبوعات المنظمة (OHW) انظر الرابط sredrokoob/tni.ohw.sppa//:ptth. ولتقديم طلبات الاستخدام التجاري والاستفسارات الخاصة بالحقوق والترخيص انظر الرابط gnisnecil/tuoba/tni.ohw.www//:ptth. مواد الطرف الثالث. إذا كنتم ترغبون في إعادة استخدام مواد واردة في هذا المصنف ومنسوبة إلى طرف ثالث، مثل الجداول أو الأشكال أو الصور فإنكم تتحملون مسؤولية تحديد ما إذا كان يلزم الحصول على إذن لإعادة الاستخدام هذه أم لا، وعن الحصول على الإذن من صاحب حقوق المؤلف. ويتحمل المستخدم وحده أية مخاطر لحدوث مطالبات نتيجة انتهاك أي عنصر يملكه طرف ثالث في المصنف. بيانات عامة لإخلاء المسؤولية. التسميات المستعملة في هذا المطبوع، وطريقة عرض المواد الواردة فيه، لا تعبر ضمنا ًعن أي رأي كان من جانب المنظمة (OHW) بشأن الوضع القانوني لأي بلد أو أرض أو مدينة أو منطقة أو لسلطات أي منها أو بشأن تحديد حدودها أو تخومها. وتشكل الخطوط المنقوطة على الخرائط خطوطا ًحدودية تقريبية قد لا يوجد بعد اتفاق كامل بشأنها. كما أن ذكر شركات محددة أو منتجات جهات صانعة معينة لا يعني أن هذه الشركات والمنتجات معتمدة أو موصى بها من جانب المنظمة (OHW)، تفضيلا ًلها على سواها مما يماثلها في الطابع ولم يرد ذكره. وفيما عدا الخطأ والسهو، تميز أسماء المنتجات المسجلة الملكية بالأحرف الاستهلالية (في النص الإنكليزي). وقد اتخذت المنظمة (OHW) كل الاحتياطات المعقولة للتحقق من المعلومات الواردة في هذا المطبوع. ومع ذلك فإن المواد المنشورة ُتوزع دون أي ضمان من أي نوع، سواء أكان بشكل صريح أم بشكل ضمني. والقارئ هو المسؤول عن تفسير واستعمال المواد. والمنظمة (OHW) ليست مسؤولة بأي حال عن الأضرار التي قد تترتب على استعمالها. Iريدقتو ركش Philippو MMGH Consulting ،Carsten Mantel ،Thomas Cherian لبِق نم ليلدلا اذه ريوطت مت Awaidy Salah Al :لقتسملا يراشتسلاا ءاربخلا قيرف هتعجارمو )WHO/IVR( Lambach Daouda Coulibalyو Supamit Chunsuttiwatو )سيئرلا( Joseph S. Breseeو Silvia Binoو Kelly Mooreو Helena C. Maltezouو Shabir A. Mahdiو Luzhao Fengو Rachel Haleو .Sabine Wickerو Gregory Polandو Saad Omerو Jonathan Nguyen-Van-Tamو ةيراشتسلاا ةنجللا نع نيلثمم امهتفصب ةروشملا ريفوتب Chris Morganو Kelly Moore نم لك ماق .)IPAC( ةيملاعلا ةحصلا ةمظنمل ةعباتلا عينمتلا تاسراممب ةينعملا .Carsten Mantelو Thomas Cherian :نايراشتسلاا ناريبخلا Kathryn Lafondو Sara Hamidو Susan Y. Chuو Birte Bödeker :نويفاضلإا ءاربخلا .Susan Wangو Julia Neufeindو Kathleen Moralesو Ms Phionah Lynn Atuhebweو Onyema Ajueborو Philipp Lambach :ةيملاعلا ةحصلا ةمظنم Shoshanna Goldinو Martin Howell Friedeو Julia Fitznerو Shalini Desaiو Philip Gouldو Pernilleو Ivan Dimov Ivanovو Raymond Hutubessyو James Dawson Heffelfingerو و Liudmila Mosinaو AnnMoenو Lisa Menningو Hasan Qamrulو Melanie Martiو Jorgensen .Nadia Telebو Claudia Steuletوو Alba Maria Ropero Alvarezو Andreas Alois Reisو ضارملأا ةحفاكم زكارم ربع يبيرجتلا رابتخلال هعاضخإو بيتكلا اذه دادعلإ يلاملا معدلا رَّفويو .)U50 CK000431( تاحاقللا ثوحب نأشب ةيملاعلا ةحصلا ةمظنم ةردابم ًايلام دناست يتلا اهنم ةياقولاو II جدول المحتويات موجز تنفيذي 1 حول هذا الكتيب 2 الغرض 2 الجمهور 2 هيكل الوثيقة 3 الوثائق المعنية الأساسية 3 1 - المعلومات الأساسية والأسس المنطقية 5 الوضع الراهن للتطعيم المضاد للأنفلونزا في صفوف العاملين الصحيين 5 موجز تقدير سريع للبيِّ نات بشأن الأسس المنطقية لتطعيم العاملين الصحيين المضاد للأنفلونزا 6 البيِّنات المتعلقة بخطر إصابة العاملين الصحيين بالأنفلونزا وأثر التطعيم 6 بيِّنات سراية العدوى من العاملين الصحيين إلى المرضى وأثر التطعيم 7 بيِّنات التدخلات لزيادة إقبال العاملين الصحيين على التطعيم 8 خطة العمل العالمية الخاصة بلقاحات الأنفلونزا 9 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية 01 عملية صنع القرار 01 الاعتبارات المتعلقة باتخاذ القرار 21 تحديد الأغراض الصحية العمومية للتطعيم 21 التحليل الاقتصادي لإرساء السياسات الوطنية 31 توصيف المجموعات المستهدفة بالتطعيم 41 تأطير سياسة تمنيع العاملين الصحيين 61 الإدماج بسياسات الصحة المهنية 91 اختيار الُمنَتج اللقاحي، والجدول الزمني للتطعيم وتوقيته 91 تحديد أغراض الرصد وقياس أثر المرض 02 III 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين 22 تخطيط الإدخال الناجح للتطعيم 22 تحديد التكاليف والتمويل 42 البحوث التكوينية لتنوير عملية التخطيط 52 التواصل وقبول اللقاحات 72 الاتصالات على مستوى المرفق الصحي 82 توليد الطلب على مستوى المرفق الصحي 03 شراء اللقاحات وإدارة سلسلة الإمداد 23 شراء اللقاحات 23 اختيار منتج اللقاح ونموذج التعبئة 33 اللوجستيات وسلسلة التبريد 43 تطعيم العاملين الصحيين 53 تدريب فريق التطعيم 63 4 - الرصد والتقييم 73 استحداث نظم المعلومات وتحديثها 73 رصد التغطية 73 رصد الأحداث الضارة بعد التمنيع 93 رصد وتقييم قبول اللقاح 14 رصد أثر اللقاحات 24 تقييم مرحلة ما بعد إدخال اللقاحات 44 المراجع 54 الملحق 1: نموذج استمارة عدم المشاركة 84 الملحق 2: قائمة مرجعية تكميلية لتخطيط تطعيم العاملين الصحيين: المستوى الوطني 94 الملحق 3: القائمة المرجعية للمرافق الصحية 15 الملحق 4: نموذج استبيان لإجراء مسح في صفوف العاملين الصحيين 25 الملحق 5: الاتصالات وتوليد الطلب: الترتيب الطبقي لُنهج إعداد المحتوى 45 1موجز تنفيذي يواجه العاملون الصحيون قدرا ً أكبر من مخاطر الإصابة بعدوى الأنفلونزا بالمقارنة مع عموم السكان. وإلى جانب المراضة في صفوف هؤلاء العاملين فإن العدوى قد تؤدي إلى تصاعد معدلات التغيب عن العمل، والدوام الشكلي1، وتعطل الخدمات الصحية. وفضلا ًعن ذلك فإن العدوى التي تصيب العاملين الصحيين قد تسهم في السراية المستشفوية للعدوى إلى مرضاهم، بما في ذلك المعرضون بشدة لخطر الإصابة بالأنفلونزا الوخيمة وبالمضاعفات. وعلى هذا فإن منظمة الصحة العالمية ُتدرج العاملين الصحيين ضمن المجموعات المستهدفة ذات الأولية بتدابير التطعيم المضادة للأنفلونزا الموسمية. وفضلا ًعن ذلك فإن تطعيم العاملين الصحيين المضاد للأنفلونزا يساهم في التأهب لجوائح الأنفلونزا. وأخيرا ً فإن الدراسات تشير إلى أن العاملين الصحيين الحاصلين أنفسهم على التطعيم المضاد للأنفلونزا ُيظهرون ميلا ًأشد لدعوة المرضى الخاضعين لرعايتهم إلى تلقي هذا التطعيم. ويشكل الكتيب الحالي مرجعا ًلمساعدة المستخدمين على إرساء سياسة لتوفير التطعيم المضاد للأنفلونزا الموسمية للعاملين الصحيين. ويوفر الكتيب الإرشاد إلى جانب فهرس بالأدوات المتاحة لتيسير تدابير إعداد السياسات، والتخطيط، والتنفيذ، والرصد، والتقييم، بشأن تطعيم العاملين الصحيين المضاد للأنفلونزا. ويهدف محتوى الكتيب إلى استكمال الوثيقة المعنونة “مبادئ واعتبارات إضافة اللقاحات إلى البرنامج الوطني للتمنيع: من اتخاذ القرار إلى التنفيذ والرصد” الذي أصدرته منظمة الصحة العالمية عام 4102. ويضم الجمهور المستهدف الرئيسي لهذا الكتيب صنَّاع السياسات؛ ومخططي الصحة الوطنية؛ ومدراء البرامج الوطنية للتمنيع والصحة المهنية؛ والمسؤولين عن الصحة المهنية، وتمنيع العاملين الصحيين، ومكافحة العدوى في المرافق الصحية. ويعد التعاون الوثيق بين مدراء التمنيع، وبرامج الصحة المهنية ومكافحة العدوى، ضروريا ًلتعظيم الإقبال على تلقي اللقاحات، ولاعتماد نهج متماسك وشامل إزاء مكافحة الأنفلونزا في المرافق الصحية. ويوجز الكتيب البيِّنات والأسس المنطقية، ويوفر الإرشاد بشأن القضايا الأساسية، وُيعدد الأدوات المتاحة لتطعيم العاملين الصحيين المضاد للأنفلونزا، ويغطي ثلاثة مكوِّ نات رئيسية لإدخال اللقاحات وإدارتها: إرساء سياسة وطنية مسَندة بالبيِّنات بشأن تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية.1 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية.2 - الرصد والتقييم، بما في ذلك تقدير تغطية التطعيم، ورصد الأحداث الضارة في أعقاب التمنيع، وتقدير الأثر، 3 - وتقييم مرحلة ما بعد إدخال اللقاحات. واستكمالا ًلهذا الدليل ، تتوفر مداولات مجموعة استشارية مستقلة مكونة من خبراء على شكل تقريرعن اجتماع يلخص القضايا المهمة . تشمل هذه القضايا الامور التالية : اعتبارات سياسية عامة , الدليل الداعم لتلقيح الموظفين الذين يعملون في مجال الصحة )عاملين صحيين( اولوية و تصنيف هؤلاء الموظفين; خيار استراتجية التلقيح و دمج هذه الاستراتجية في السياسات و الخطط العامة التي تشمل صحة و تلقيح الموظفين الذين يعملون في مجال الصحة , تخطيط و ادارة التلقيح و بالاخص طرق التواصل و الطلب ; والتحديات المتعلقة برصد وتقييم لقاح العاملين الصحيين خاصة في البلدان المنخفضة و المتوسطة الدخل.2 1 يشير الدوام الشكلي إلى العاملين الصحيين الذين يعملون رغم اعتلالهم ولكن بمستوى أدنى من الدقة والفعالية، وهو ما يشكل خطرا ًعلى المرضى الضعفاء الخاضعين لرعايتهم. 2 htlaeh fo noitaniccav azneulfni lanosaes gnivorpmi dna gnihsilbatse rof snoitaredisnoc dna srotcaF .la te .T nairehC .1626–5526:(34)73;9102 .eniccaV .ynamreG ,nilreB ,71–61 yraunaJ ,gniteem OHW a morf tropeR :srekrow 2حول هذا الكتيب الغرض يشكل هذا الكتيب مرجعا ً وفهرسا ً للأدوات المتاحة لمساعدة المسؤولين القُطريين على البت بأمر تطعيم العاملين الصحيين، والتخطيط له، وتنفيذه، ورصده ُبْغية إنجاز التغطية اللقاحية الشاملة. وليس الغرض من الكتيب أن يكون وثيقة ذات طابع إلزامي، بل أن يوضح فحسب المبادئ العامة والاعتبارات الأساسية لدعم صياغة السياسات؛ وتخطيط التطعيم وإدارته؛ ورصد وتقييم توفير التطعيم المضاد للأنفلونزا للعاملين في ميدان الرعاية الصحية. كما يحدد الكتيب معالم الإجراءات اللازمة لإدماج تطعيم العاملين الصحيين المضاد للأنفلونزا في السياسات الوطنية للصحة المهنية ونظم إدارة السلامة والصحة المهنيتين في المرافق الصحية. كما يتناول الفرصة المتاحة لتطعيم العاملين الصحيين المضاد للأنفلونزا لترويج نهج متكامل لرصد كل التدخلات المدرجة في السياسات الوطنية للصحة المهنية وتعظيم الإقبال عليها. وفضلا ًعن ذلك فإن الكتيب يشير إلى علاقة تطعيم العاملين الصحيين بالتأهب للأنفلونزا الجائحة ومساهمته فيه. ويختلف تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية عن تدابير التطعيم المضادة للأمراض الأخرى التي يمكن توقيها باللقاحات من حيث أن من الواجب إجراؤه كل سنة. على أن بعض عناصر هذا الكتيب قد تكون مفيدة لتطعيم العاملين الصحيين عموما،ً ولاسّيما تلك الأقسام المتصلة بتخطيط التطعيم وإدارته وبشأن الرصد والتقييم. الجمهور يشمل الجمهور الرئيسي المستهدف بهذا الكتيب ما يلي: الهيئات الوطنية لصنع السياسات والمخططون الصحيون؛1 - مدراء برامج التمنيع، ومكافحة العدوى، والصحة المهنية على المستويات الوطنية ودون الوطنية، 2 - والمسؤولون عن الصحة المهنية ومكافحة العدوى في المرافق الصحية؛ منظمات العاملين الصحيين وأرباب العمل.3 - وفي حين أن الأقسام المختلفة من الوثيقة تتباين من حيث أهميتها بالنسبة لمجموعة ما أو أخرى، فإن من المستصوب قراءة الوثيقة ككل لأن المعلومات الخاصة بموضوع معين قد تكون موزعة على أقسام مختلفة من الكتيب. كما قد تكون الوثيقة مفيدة لجماهير أخرى من القراء مهتمة بالتمنيع أو الصحة المهنية. 3هيكل الوثيقة يتألف الكتيب من أربعة أقسام على النحو المعروض في الشكل 1. على أنه توخيا ًللوضوح والكمال فإن هناك قدرا ًمن التداخل بين بعض الأقسام، مع إيراد إحالات مرجعية إلى أقسام معنية أخرى. هيكل الوثيقةالشكل 1لا الرصد والتقییمتخطیط التطعیم وإدارتھإرساء السیاسة المقدمة، والمعلومات الأساسیة والأسس المنطقیة • حول الكتیب، بما في ذلك الأغراض والجمھور المستھدف • توصیات سیاسة منظمة الصحة العالمیة بشأن التطعیم المضاد للأنفلونزا • الوضع الراھن لتطعیم العاملین الصحیین • موجز البیِّنات المساندة لتطعیم العاملین الصحیین • خطة العمل العالمیة الخاصة بلقاحات الأنفلونزا • الاعتبارات المتعلقة باتخاذ القرار • تحدید أغراض التطعیم • تصنیف العاملین الصحیین وترتیبھم من حیث الأولویة • تأطیر سیاسة التمنیع • الإدماج بالسیاسات الصحیة المھنیة • اختیار المنتج وتوقیت • خیارات التسلیم واسترالتطعیم اتیجیات تعظیم التغطیة • تحدید أغراض الرصد وتقدیر الأثر • تخطیط الإدخال الناجح للقاحات • التكلفة والجوانب المالیة • البحوث التكوینیة لتنویر عملیة التخطیط • التواصل وقبول اللقاح • تولید الطلب في المر فق الصحي • تورید اللقاحات وإدارة سلسلة الإمداد • تطعیم العاملین الصحیین • تدریب فریق التطعیم • رصد التغطیة • رصد الأحداث الضارة بعد التطعیم • تقدیر قبول اللقاحات • رصد أثر اللقاحات • تقییم مرحلة ما بعد إدخال اللقاحات المنفذونصنَّاع السیاسات الوثائق المعنية الأساسية تعد الوثائق التالية مراجع مهمة لاستكمال الإرشادات الواردة في هذا الكتيب: إن التوصيات الخاصة بسياسة منظمة الصحة العالمية بشأن التطعيم المضاد للأنفلونزا الموسمية، 1 - بما في ذلك تطعيم العاملين الصحيين، منشورة ضمن أوراق مواقف المنظمة. ويجري تحديث هذه الأوراق بانتظام. اللقاحات المضادة للأنفلونزال ورقة موقف منظمة الصحة العالمية – تشرين الثاني/ نوفمبر 2102 fdp.7478rew/2102/rew/tni.ohw.www//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102) مبادئ واعتبارات إضافة اللقاحات إلى البرنامج الوطني للتمنيعل من اتخاذ القرار إلى التنفيذ والرصد. جنيف، منظمة الصحة العالمية، 4102. 29_86051_4_29_879_NBSI/lareneg/stnemucod/noitazinummi/tni.ohw.www//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102) 4وتوفر الوثيقة التالية إرشادات مفصلة للبلدان التي تقوم بالفعل بتوفير التطعيم المضاد للأنفلونزا 2 - الموسمية للعاملين الصحيين فيما يتعلق بسبل تحديد المسائل المتصلة بالإقبال على التطعيم، وتحليلها، واستهدافها بفعالية: مواءمة برامج التمنيع لتتناسب مع الأنفلونزا الموسمية )ULF PIT(. دليل لزيادة إقبال العاملين في ميدان الرعاية الصحية على تلقي التطعيم المضاد للأنفلونزا الموسمية )5102(. كوبنهاغن، المكتب الإقليمي لأوروبا التابع لمنظمة الصحة العالمية، 5102. /5102/snoitacilbup/azneuflni/sesaesid-elbacinummoc/scipot-htlaeh/ne/tni.ohw.orue.www//:ptth -htlaeh-gnisaercni-rof-ediug-a-.ufl-pit-azneuflni-lanosaes-rof-semmargorp-noitazinummi-gniroliat 5102-noitaniccav-azneuflni-lanosaes-fo-ekatpu-srekrow-erac (تم الاطلاع في 41 شباط/ فبراير 9102) وفي حين أن محتوى هذا الكتيب يمكن أن يساعد في تنوير السياسات الوطنية فإن الكتيب لا يوفر 3 - استعراضا ًشاملا ًللبيِّنات المتاحة لإرشاد عملية صنع القرار. ويمكن الاطلاع على استعراض مستفيض لمثل هذه البيِّنات دعما ًلتطعيم العاملين الصحيين في الوثيقة التالية: التقدير السريع للبيِّ ناتل التطعيم المضاد للأنفلونزا للعاملين في ميدان الرعاية الصحية – استعراض عالمي للبيِّ نات. يوليو 9102. buhiD3%aiv?3730039126310952S/iip/elcitra/ecneics/moc.tceridecneics.www//:sptth (تم الوصول إليه في 21 يوليو 9102) ويشكل هذا الكتيب جزءا ًمن سلسلة من الكتيبات التمهيدية التي وضعتها منظمة الصحة العالمية عن 4 - التطعيم المضاد للأنفلونزا الموسمية. وكان قد تم قبلا ًنشر كتيب عن تنفيذ التطعيم المضاد للأنفلونزا في صفوف الحوامل. سبل تنفيذ التطعيم المضاد للأنفلونزا في صفوف الحواملل كتيب تمهيدي لمدراء برامج التمنيع الوطنية وصنَّ اع السياسات. fdp.gne-60.61-BVI-OHW/480052/56601/eldnah/maertstib/siri/tni.ohw.sppa//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102) 5المعلومات الأساسية والأسس المنطقية1 - يواجه العمال الصحيون خطر الإصابة بعدوى فيروس الأنفلونزا ونقل هذه العدوى إلى المرضى الخاضعين لرعايتهم الذين قد يكونون معرضين بشدة لمخاطر المرض الوخيم، والمضاعفات، والوفاة )1(. ويمكن أن يتباين مستوى الخطر الأعلى بين العمال الصحيين بالمقارنة مع عموم السكان تبعا ً للمهنة والسياق )2(. وترى منظمة الصحة العالمية أن العمال الصحيين هم مجموعة ذات أولوية مهمة في تلقي التطعيم المضاد للأنفلونزا، لا لحماية أنفسهم والحفاظ على خدمات الرعاية الصحية الضرورية أثناء جائحات الأنفلونزا فحسب، بل وللحد من انتشار الأنفلونزا في صفوف مجموعات المرضى الضعفاء التي يحتكون بها )1(. وفضلا ًعن ذلك فقد تبين للعديد من الدراسات إن من المرجح أن يؤدي صدور توصية قوية من جانب العاملين الصحيين، ولاسّيما الأطباء، إلى زيادة كبيرة على الأغلب في إقبال الجمهور العام على تلقي التطعيم )3–5(. وسيكون العاملون الصحيون ممن تلقوا التطعيم أنفسهم أعمق معرفة على الأرجح بالتطعيم وأشد فعالية في النهوض بتقبل الجمهور له )3–5(. وأخيرا،ً وبالنظر إلى أن من المحتمل أن يكون العاملون الصحيون هدفا ً لبرامج التطعيم أثناء جائحات الأنفلونزا، فإن إرساء برامج وظيفية لتطعيمهم المضاد للأنفلونزا الموسمية سييسر التطعيم الفعال وذي التوقيت الحسن خلال الجائحات )6(. الوضع الراهن للتطعيم المضاد للأنفلونزا في صفوف العاملين الصحيين اتسم الاعتماد العالمي لسياسة تطعيم العاملين الصحيين المضاد للأنفلونزا بالبطء. وفي عام 7102 أبلغ 911 بلدا ًفقط من أصل 481 بلدا ًعن أن لديها سياسة وطنية بشأن التطعيم المضاد للأنفلونزا. ومن أصل تلك البلدان الُمبلغة أشار 69 بلدا ًإلى أنه يستهدف العاملين في مجال الرعاية الصحية كمجموعة ذات أولوية. على أن نسبة الدول الأعضاء الُمبلغة عن امتلاكها لمثل هذه السياسة تتباين بين أقاليم المنظمة، فبينما أفادت غالبية البلدان في أقاليم منظمة الصحة العالمية في الأمريكيتين، وأوروبا، وشرقي المتوسط عن وجود سياسات وطنية للتطعيم المضاد للأنفلونزا، فإن هذه النسبة كانت أدنى في صفوف بلدان أقاليم غرب المحيط الهادئ، وأفريقيا، وجنوب شرق آسيا. ولا تتوافر معلومات عن تغطية التطعيم المضاد للأنفلونزا في صفوف العاملين الصحيين في معظم البلدان، ولو أن هناك تفاوتا ًشاسعا ًفي ذلك، علما ًبأنه جرى الإبلاغ عن أن معدل هذا التطعيم منخفض في العديد من البلدان التي تتوافر عنها مثل تلك البيانات. وعلى سبيل المثال فقد توافرت بيانات عن تغطية العاملين الصحيين من 62 بلدا ً فحسب (65 بالمائة) في الإقليم الأوروبي في موسم 4102–5102. وكان المعدل الوسطي للتغطية هو 5.92 بالمائة مع نطاق يتراوح بين 6.2 و5.99 بالمائة؛ وأبلغ ثلاثة بلدان فقط، هي ألبانيا، وأرمينيا، وبيلاروس، عن تغطية تزيد على 57 بالمائة )7(. وأوضحت بيانات أحدث ُمستخلصة من استعراض منهجي من خلال التبليغ الإلزامي من كل المستشفيات في إنكلترا عن نسبة إقبال قدرها 96 بالمائة في موسم 7102–8102.3 وأوضح مسح عبر شبكة الإنترنت لألفين من العاملين الصحيين في الولايات 3 .8102 ot 7102 nosaes retniw :dnalgnE ni (sWCH) srekrow erachtlaeh ni ekatpu eniccav azneulfni lanosaeS _lanosaeS/135017/elif/atad_tnemhcatta/sdaolpu/metsys/sdaolpu/tnemnrevog/ku.vog.ecivres.gnihsilbup.stessa//:sptth fdp.8102_ot_7102_nosaes_retniw_sWCH_ekatpu_eniccav_azneulfni (تم الاطلاع في 41 شباط/ فبراير 9102) 61 - المعلومات الأساسية والأسس المنطقية المتحدة أن نسبة التغطية وصلت إلى 87 بالمائة في موسم 7102–8102، مع ارتفاع هذه النسبة (59 بالمائة) بين العاملين في سياقات ُيلزمهم فيها أرباب العمل بالتطعيم )8(. ويجري الإبلاغ عن معدلات تغطية أعلى للتطعيم عند تطبيق سياسات التطعيم الإلزامي. وفي استعراض منهجي واحد شمل ثماني دراسات فإن معدلات التغطية تجاوزت نسبة 49 بالمائة فيها جميعا )9(. موجز تقدير سريع للبيِّ نات بشأن الأسس المنطقية لتطعيم العاملين الصحيين المضاد للأنفلونزا أجرت منظمة الصحة العالمية تقديرا ًسريعا ًللبيِّنات الواردة في مؤلفات متاحة باللغة الإنكليزية، ومنشورة منذ عام 6002، ومصنَّفة على أنها ذات جودة متوسطة أو عالية )01(. ونوجز هنا الأسئلة المدروسة، والاستنتاجات الرئيسية لهذا التقدير. وبإمكان القراء الرجوع إلى التقرير المنشور للاطلاع على التفاصيل وعلى الاقتباسات المعنية. ودرس الاستعراض ثلاث مسائل هي: البيِّنات القائلة بأن العاملين الصحيين عرضة لخطر أعلى من الإصابة بعدوى الأنفلونزا بالمقارنة مع 1 - عموم السكان، وأن تطعيمهم سيؤدي إلى خفض معدلات الأنفلونزا و/أو التغيب عن العمل و/أو الأثر الاقتصادي الواسع للأنفلونزا في صفوف القوة العاملة الصحية. البيِّنات القائلة بأن العمال الصحيين ينقلون عدوى الأنفلونزا إلى مرضاهم في سياقات الرعاية 2 - الصحية، وإذا كان الأمر كذلك، فهل يحمي التطعيم المرضى، وما هي نسبة العاملين الصحيين التي تتطلب الحماية للحصول على هذا الأثر. البيِّنات بشأن التدخلات العملية الناجحة لزيادة الإقبال على التطعيم ودرجة معرفة البحوث المتعلقة 3 - بالجوانب الاجتماعية، والسلوكية، وسياسات الصحة العمومية بمدى إقبال العاملين الصحيين على التطعيم. البيِّ نات المتعلقة بخطر إصابة العاملين الصحيين بالأنفلونزا وأثر التطعيم ُتعد الدراسات التي تقارن خطر إصابة العاملين الصحيين بعدوى الأنفلونزا بما هو عليه الحال في صفوف عموم السكان عسيرة، وقد تقيس حصائل مختلفة، أو أنها ُتنفذ في سياقات متباينة، مما يحد من قابلية المقارنة عبر الدراسات أو من تجميع بياناتها. وتشير عمليات الاستعراض المنهجي الحديثة إلى أن العاملين الصحيين يتعرضون لخطر أعلى من الإصابة بعدوى الأنفلونزا بالمقارنة مع عموم السكان (نسبة الأرجحية: 80.2، نطاق الثقة 59%: 37,1 إلى 15,2) )2(، علما ًبأن البيِّنات هي أقوى ما تكون فيما يتعلق بالعدوى عديمة الأعراض المؤكدة مختبريا)11( على أنه يمكن للعاملين الصحيين عديمي الأعراض نقل فيروس الأنفلونزا مع ذلك إلى المرضى الضعفاء للغاية في سياق الرعاية الصحية. وتشير التقارير إلى أن المرض التنفسي هو سبب شائع من أسباب تغيب العاملين الصحيين عن العمل. وترتبط الأوبئة أو الجائحات بزيادة معدلات التغيب في صفوف العاملين الصحيين )21(. وثُبت أن نجاعة اللقاحات بين العاملين الصحيين تبلغ درجة عالية تصل إلى 09 بالمائة للقاحات الأنفلونزا الموسمية المناسبة جيدا )31، 41( ، وهو ما يشير إلى أن تطعيم العاملين الصحيين سيخفِّض معدلات المراضة والتغيب 71 - المعلومات الأساسية والأسس المنطقية المرتبطة بالأنفلونزا. وأظهر استعراض منهجي حدوث تأثير وقائي إزاء الأنفلونزا المؤكدة مختبريا ًوِقصر في فترات التغيب الناجمة عن العلة الشبيهة بالأنفلونزا (ILI) لدى المجموعات المطعَّ مة )51(. وأوضحت دراسة حديثة للعاملين الصحيين في المملكة المتحدة ارتباط زيادة بنسبة 01 بالمائة في تلقي التطعيم بانخفاض بنسبة مماثلة في التغيب الناجم عن الاعتلال )21(. على أن هناك دراسات رصدية توفر نتائج متعارضة، ولو أن هذه الدراسات مقيدة في الغالب بفعل رداءة تصميمها، وحصائلها غير النوعية، والخطر العالي للتحيز، وعدم مراعاة عوامل الالتباس )61–91(. وبما أن خطر المرض في أعقاب العدوى يستند إلى مستوى التعرض، وأن سلوكيات التغيب قد تتفاوت بين الفئات المختلفة للعاملين الصحيين، فإن من المحتمل أن يكون الافتقار إلى بيانات مفصَّ لة بشكل كاف عن ظاهرة التغيب عن العمل، أي مقسمة حسب فئات العاملين الصحيين، هو السبب في النتائج المتفاوتة للدراسات المختلفة. ومن جهة أخرى فإن انعدام الأثر على التغيب الذي يلاَحظ في بعض الدراسات، على الرغم من البيِّنات على المعدلات المتزايدة للعدوى بين العاملين الصحيين، يطرح التساؤل عمَّ ا إذا كان العاملون الصحيون يواصلون العمل رغم إصابتهم بالعدوى، وهو ما يؤدي إلى تصاعد القلق بشأن الخطر اللاحق للسراية المستشفوية )02(. وتوثِّق العديد من الدراسات تغيب العاملين الصحيين المصابين بالعلة الشبيهة بالأنفلونزا عن العمل )12–32(، بما في ذلك حادثة واحدة جرى ربطها بالسراية المستشفوية في وحدة للأورام )42(. بيِّ نات سراية العدوى من العاملين الصحيين إلى المرضى وأثر التطعيم توفر الدراسات الوبائية التي تعتمد ُنهج الأنماط الفرعية الجزيئية بيِّنات للسراية من العاملين الصحيين إلى المرضى. وبفضل استخدام الجمع المؤتمت لبيانات المخالطين العالية الاستبانة المعتمد على المجسَّ ات الملبوسة بالترافق مع البيانات الفيرولوجية فقد أمكن تحديد المسالك المحتملة للسراية في حالات الأنفلونزا التي تتم الإصابة بها في المستشفيات )52(. ومن الصعب استخلاص مدى السراية المباشرة من العاملين الصحيين إلى المرضى في سياقات الرعاية الطبية بالنظر إلى التدفق المتواصل للزوار، والتفاعلات بين المرضى، وإمكانية الإدخالات المتزامنة المتعددة للأنفلونزا )62–82(. على أنه من بين أولئك الذين قد يساهمون في سراية العدوى في سياقات الرعاية الطبية، فإن العاملين الصحيين يشكلون جزءا ًضخما ًقابلا ً للوقاية باللقاحات حيث أنه من الأيسر استهدافهم بالتطعيم. ويمكن قياس المنفعة المباشرة للمرضى الناجمة عن تطعيم العاملين الصحيين بطرق عديدة، على نحو ما هو موضح في المؤلفات. وتقيِّم العديد من الدراسات أثر الأنفلونزا المؤكدة مختبريا،ً في حين تعمل دراسات أخرى على تقييم الحصائل غير النوعية مثل العلة الشبيهة بالأنفلونزا، والعلة التنفسية، والوفيات الناجمة عن كل الأسباب، والوفيات المرتبطة بالعلة التنفسية، أو حالات الإصابة بعدوى الأنفلونزا المستشفوية. والبيِّنات المتوافرة أقوى بالنسبة للحصائل غير النوعية، مثل العلة الشبيهة بالأنفلونزا، والوفيات الناجمة عن كل الأسباب )92(، والإصابة بعدوى الأنفلونزا المستشفوية )03، 13( . ومع أن بعض الدراسات سعت إلى قياس عدد العاملين الصحيين الواجب تطعيمهم لضمان الحماية المثلى، فإن البيانات المساندة لعتبة التغطية ضعيفة، مما يقود إلى خلافات في المؤلفات المعنية )23(. غير أن من المحتمل أن حماية المرضى ترتبط ارتباطا ًإيجابيا ًبتوسيع تغطية تطعيم العاملين الصحيين ولكنها تعتمد أيضا ًعلى عوامل أخرى تشمل نوع مخالطي المريض، ومدى ضعفه، واستخدام إجراءات أخرى لمكافحة العدوى، وفعالية التطعيم في موسم معين من مواسم الأنفلونزا )33–53(. 81 - المعلومات الأساسية والأسس المنطقية بيِّ نات التدخلات لزيادة إقبال العاملين الصحيين على التطعيم ثمة قدر ضخم من البيِّنات على التدخلات الناجحة لزيادة إقبال العاملين الصحيين على التطعيم المضاد للأنفلونزا، وقد أُدرج قسم كبير منه في مجموعات الأدوات القائمة الهادفة إلى زيادة الإقبال على اللقاحات. ومع أن العوامل التي تسهم في مسار اتخاذ قرارات العاملين الصحيين متنوعة، فإنه يبدو أن بعض الاستراتيجيات أشد فعالية من غيرها. ولم يثبت أن بمقدور تدخل بمفرده أن يزيد بسرعة وبشكل كبير من الإقبال على التطعيم ومواصلته باستثناء التطعيم الإلزامي. على أن مسألة التطعيم الإلزامي للعاملين الصحيين كانت مدار مناقشات مستفيضة وهناك العديد من وجهات النظر المختلفة المؤيدة والمعارضة لها )02، 23، 63(. وتتطلب البرامج الناجحة للتطعيم الإلزامي جهودا ًتنظيمية وتثقيفية لضمان مساندة الموظفين قبل بدء التنفيذ )73(. وبالمستطاع استخدام توليفة من «الأحكام اللينة» التي تشترط إبداء الامتناع الصريح عن تلقي اللقاحات، واستخدام أقنعة الوجه الجراحية، واستبعاد الموظفين غير المطعَّ مين عن العمل مع المرضى الضعفاء للغاية، وذلك كبديل عن التطعيم الإلزامي، علما ًبأن لمثل هذه الأحكام تبعات تتعلق بالتنظيم، والتثقيف، والرصد، والإنفاذ، والموارد البشرية والمالية. وتشمل المكوِّ نات الإضافية التي تسهم في زيادة الإقبال على التطعيم ما يلي: توفير اللقاح المجاني؛ الحصول الميسور على التطعيم، بما في ذلك إجراء التطعيم في موقع العمل ذاته في المرافق الصحية؛ تعديل المعرفة والسلوك عبر التثقيف، والتذكيرات، والحوافز المصممة لتتناسب مع الفئات المختلفة للعاملين الصحيين؛ النهج الإدارية والتنظيمية مثل تعيين موظفين للإشراف على أنشطة التطعيم. وتتنوع أسباب الإقبال الضعيف على التطعيم وتتفاوت على امتداد الفئات والثقافات المختلفة للعاملين الصحيين. ولذلك فإنه لا بد من أن ُتصمم نهج زيادة الإقبال لتلائم المجموعات المتباينة. وقد برهنت بعض الدراسات على أن البحوث التكوينية، بما في ذلك المسوح والبحوث النوعية، يمكن أن توفر آراء ثاقبة تساعد على تصميم التدخلات على نحو يكفل تعظيم الإقبال. الخلاصة على الرغم من النقاش الدائر في المؤلفات فإن التطعيم المضاد للأنفلونزا مهم لضمان سلامة العاملين الصحيين، ومرضاهم، وعموم السكان الذين يعتمدون على نظام صحي قيد العمل، ولاسّيما خلال فترات الأوبئة/الجوائح. وستتسم الدراسات القادرة على أن تحدد بصورة قاطعة قيمة تطعيم العاملين الصحيين بالصعوبة البالغة ولو أن البيانات الناشئة عن هذه المسألة ستخضع لرصد دقيق ُبْغية تنوير أية تعديلات على السياسات الحالية لمنظمة الصحة العالمية.4 4 سيقوم فريق عامل تابع لفريق الخبراء الاستشاري الاستراتيجي المعني بالتمنيع لمنظمة الصحة العالمية باستعراض البيانات الناشئة، ومن المنتظر صدور تحديثات لتوصيات المنظمة الراهنة عام 0202. 91 - المعلومات الأساسية والأسس المنطقية خطة العمل العالمية الخاصة بلقاحات الأنفلونزا سيكون معظم سكان العالم خلال جائحة للأنفلونزا عرضة بشدة للعدوى، ومن الممكن أن تنتشر هذه العدوى بسرعة. ويندرج التطعيم في عداد الاستراتيجيات الرئيسية للتخفيف من الأثر المحتمل للجائحة. وفي حين أن من المنتظر أن يكون هناك تأخير في تطوير لقاحات جائحية خاصة بالسلالة المعنية، فإن قدرة الإنتاج غير الكافية ستسهم بدورها في الحد من الحصول العالمي على اللقاحات، وذلك في المراحل الأولى للجائحة على الأقل. وستواجه البلدان الشحيحة الموارد، ولاسّيما ما يفتقر منها إلى قدرة محلية على إنتاج اللقاحات وتلك التي لا تمتلك سياسات بشأن التطعيم المضاد للأنفلونزا الموسمية، التحدي الأعظم في ضمان الحصول في الوقت المناسب على اللقاحات أثناء الجائحة، والتخفيف من وطأة التأثيرات الضارة الضخمة لها. ولمجابهة هذا التحدي فقد وضعت منظمة الصحة العالمية خطة العمل العالمية الخاصة بلقاحات الأنفلونزا التي تتضمن استراتيجيات للآجال القصيرة، والمتوسطة، والطويلة تهدف إلى زيادة إنتاج لقاحات الأنفلونزا والسلالات اللقاحية قبل جائحة الأنفلونزا وخلالها )83(. واقترحت الخطة ثلاثة نهج لتعزيز الحصول على اللقاحات الجائحية وهي: (1) زيادة الاستخدام القاعدي للتطعيم المضاد للأنفلونزا الموسمية؛ (2) زيادة قدرة الإنتاج العالمية؛ (3) مواصلة البحث والتطوير. ويعتمد أول هذه الُنهج الثلاثة على إرساء البلدان لسياسات تطعيم واضحة وفعالة لزيادة الاستخدام القاعدي للقاحات الأنفلونزا الموسمية، بما يزوِّ د دوائر الصناعة بتوقعات أفضل للطلب ويحفِّز زيادة قدرة الإنتاج. وفي حين أن تطعيم العاملين الصحيين سيؤدي فحسب إلى زيادة متواضعة في الطلب الكلي على اللقاحات؛ فإنه سيرسي منصة متينة وعاملة لتمنيع العاملين الصحيين بسرعة، كما يمكن أن يسهم في تحقيق تغطية أوسع في حال حدوث جائحة، ومن َثّم حماية تقديم الخدمات الصحية خلال الجائحة. وفضلا ًعن ذلك فإن إقبال العاملين الصحيين العالي على التطعيم يمكن أن يبني الثقة وأن يزيد من إقبال المجموعات الأخرى ذات المخاطر الشديدة والمستهدفة بالتطعيم المضاد للأنفلونزا الموسمية في السياسات الوطنية. كما أن تطعيم العاملين الصحيين قد ينشئ أو يعزز عمليات تتيح النشر السريع للقاحات الجائحية. وهكذا فإن تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية يتجاوز نطاق مسألة الحماية الفورية من الأنفلونزا الموسمية على النحو المعروض أعلاه، ويسهم في التأهب للأنفلونزا الجائحية. 01 إرساء سياسة لتطعيم العاملين الصحيين المضاد 2 - للأنفلونزا الموسمية ينبغي أن يكون القرار الخاص بإرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية مسندا ً بالبيِّنات، وأن يرتكز إلى أساس منطقي واضح، وأن تتوافر له الاستثمارات اللازمة للتنفيذ المستدام. والمبادئ والاعتبارات العامة لإضافة لقاح إلى برنامج وطني للتمنيع موضحة في الوثيقة الإرشادية الصادرة عن منظمة الصحة العالمية والمعنونة «مبادئ واعتبارات إضافة اللقاحات إلى البرنامج الوطني للتمنيع: من اتخاذ القرار إلى التنفيذ والرصد» )93(. ويشكل العاملون الصحيون مجموعة سكانية مستهدفة لا ُتدرج عادة ضمن برامج التمنيع الوطنية في البلدان المنخفضة والمتوسطة الدخل. وفي حين أنه قد تكون هناك برامج لتطعيم العاملين الصحيين المضاد لالتهاب الكبد B؛ فإن لقاحات الأنفلونزا ذات طابع فريد من حيث أن من الواجب تكرار التطعيم في المستقبل المنظور كل سنة. ويتناول هذا القسم من الكتيب في المقام الأول الاعتبارات الإضافية المخصوصة للتطعيم السنوي للعاملين الصحيين المضاد للأنفلونزا الموسمية، بالاستناد إلى الإطار العام الذي توفره الوثيقة المشار إليها أعلاه. عملية صنع القرار على غرار ما هو عليه الحال بالنسبة لأي لقاح آخر يتطلب إرساء سياسات بشأنه، فإن وزارات الصحة ستكلف الأفرقة الاستشارية التقنية الوطنية للتمنيع (sGATIN) أو هيئات وطنية أو إقليمية مكافئة بإجراء استعراض للبيِّنات وتوفير المشورة بشأن إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية، والتقدم بتوصيات عن محتوى سياسة التطعيم هذه. ومن الضروري إشراك العديد من أصحاب المصلحة المتأثرين بالسياسة المذكورة لضمان تأييدهم وتيسير الإقبال العالي على التطعيم، وهو ما يمكن أن يسفر عن نهج أكثر اتساقا ً لمكافحة الأنفلونزا في المرافق الصحية. وينبغي التماس مشورة أصحاب المصلحة على نطاق واسع، وأن يشمل ذلك: الرابطات والجمعيات المهنية التي تمثل مختلف مجموعات العاملين الصحيين، مثل رابطات الأطباء، 1 - والممرضين، والخدمات الصحية ذات الصلة، إلى جانب ممثلي مقدمي خدمات الرعاية الصحية في القطاع الخاص. مجالس الأطباء والممرضين والهيئات التنظيمية الأخرى للعاملين الصحيين؛2 - مجموعات سلامة المرضى، إن وِجدت، والمنظمات الممثلة للمرضى، حيث أنه ينبغي النظر إلى 3 - تمنيع العاملين الصحيين على أنه أيضا ًمسألة تتعلق بسلامة المرضى وجودة رعايتهم؛ اتحادات العاملين الصحيين، إن كانت قائمة وحيث ُيحتمل أن تكون مشاركتها مفيدة في ترويج الإقبال 4 - على التطعيم. مدراء المرافق الصحية. - 11 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية وينبغي كذلك أن تتضمن العملية الانخراط المبكر في الهيئات التي تضع السياسات واللوائح المتعلقة بالصحة المهنية لضمان إدراج السياسات الموضوعة لتطعيم العاملين الصحيين المضاد للأنفلونزا في السياسات الوطنية للسلامة والصحة المهنيتين. وفي حال وجود سياسات لتطعيم العاملين الصحيين بلقاحات أخرى، مثل التطعيم المضاد لالتهاب الكبد B، فإن استعراض هذه السياسات قد يوفر مدخلات مفيدة لصياغة سياسة التطعيم المضاد للأنفلونزا الموسمية وبشأن استراتيجيات تعظيم الإقبال على التطعيم. وعند توافر المعلومات اللازمة فإن بمقدور الأفرقة الاستشارية التقنية الوطنية للتمنيع استخلاصها من البيانات المتاحة من المراكز الوطنية لترصد الأنفلونزا، أو المراكز الوطنية لمكافحة الأنفلونزا، أو من مؤسسات أخرى مشاركة في شبكة المنظمة العالمية لترصد الأنفلونزا والتصدي لها (SRSIG) (انظر صندوق الأدوات 1). صندوق الأدوات 1 المراكز الوطنية لمكافحة الأنفلونزا ُبْغية توفير الرصد والاستجابة للتحولات في البنية المستضدية لفيروسات الأنفلونزا والحاجة اللاحقة إلى تغيير تركيبات اللقاحات فقد أنشأت العديد من البلدان مراكز وطنية لمكافحة الأنفلونزا (CIN) لجمع وتوصيف عينات الفيروسات في بلدانها وإجراء تحليلات أخرى لتنوير قرارات منظمة الصحة العالمية والشركاء بشأن تركيب لقاح العام التالي للأنفلونزا. وفي كثير من البلدان ُيستكمل الرصد الفيرولوجي بترصد منهجي أشد للأنفلونزا يتعلق بالعلة التنفسية الحادة الوخيمة (IRAS) والعلة الشبيهة بالأنفلونزا. وبمقدور مركز وطني لمكافحة الأنفلونزا في البلد المعني، أو في بلد مجاور، أن يدعم التوصيات المسندة بالبيِّنات من خلال تقديم البيانات المتعلقة بعبء مرض الأنفلونزا وسماته الموسمية إلى الفريق الاستشاري التقني الوطني للتمنيع أو إلى هيئة وطنية معنية أخرى تضطلع باتخاذ القرارات. ويعد إشراك هذه المراكز وغيرها في مداولات الفريق الاستشاري التقني الوطني للتمنيع عاملا ً أساسيا ًفي الجمع بين كل المعلومات ذات الصلة اللازمة لعملية اتخاذ القرار. ويمكن الاطلاع على قائمة بأسماء المراكز الوطنية لمكافحة الأنفلونزا، والمراكز المتعاونة مع منظمة الصحة العالمية والمختبرات التنظيمية الأساسية التابعة لها (SLRE) من خلال الرابطين التاليين: tsil/sertnec_azneuflni_lanoitan/yrotarobal_srsig/azneuflni/tni.ohw.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) tsil/sertnec_gnitaroballoc/yrotarobal_srsig/azneuflni/tni.ohw.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) 21 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية وفي المناطق التي لا تتوافر فيها البيِّنات المحلية بسهولة، ولاسّيما بشأن معدلات المرض بين العاملين الصحيين وسراية المرض منهم إلى المرضى، فإن الجهود اللازمة لتوليد هذه البيِّنات قد تتطلب الكثير من الوقت والموارد. وعلى صنَّاع السياسات النظر فيما إذا كان من الضروري إجراء دراسات محلية أو إذا كان بالمستطاع استخدام بيانات من بلدان أخرى ذات مرتسمات وبائية وخصائص أنظمة صحية مماثلة لاستقراء العبء المحتمل للمرض ودعم عملية اتخاذ القرار. وينبغي على الأفرقة الاستشارية التقنية الوطنية للتمنيع أن توازن بين الرغبة في امتلاك بيانات وطنية من جهة والتكاليف والتأخيرات التي ستنجم عن توليد البيانات والآثار الصحية اللاحقة لهذه التأخيرات. الاعتبارات المتعلقة باتخاذ القرار إلى جانب الاعتبارات العامة المحددة في وثيقة منظمة الصحة العالمية «مبادئ واعتبارات إضافة اللقاحات إلى البرنامج الوطني للتمنيع: من اتخاذ القرار إلى التنفيذ والرصد» التي سبقت الإشارة إليها، فإن من الضروري دراسة مسائل رئيسية أخرى عند تأطير سياسة لتطعيم العاملين الصحيين. ويعرض الشكل 2 هذه المسائل. الاعتبارات الرئيسية عند إرساء سياسة لتطعيم العاملين الصحيينلالشكل 2لا تحدید الأغراض الصحیة العمومیة لتطعیم العاملین الصحیین المضاد للأنفلونزا الموسمیة توصیف المجموعات المستھدفة بالتطعیم وترتیبھا من حیث الأولویة تأطیر سیاسة تطعیم العاملین الصحیین المضاد للأنفلونزا اختیار المُنتَج اللقاحي، والجدول الزمني للتطعیم وتوقیتھ تحدید أغراض الرصد وتقدیر الأثر تحديد الأغراض الصحية العمومية للتطعيم ينبغي أن تتمثل إحدى الخطوات الأولى الحاسمة في وضع سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية في التحديد الواضح لأهداف برنامج التطعيم وأغراضه. وقد تتباين هذه الأغراض بين البلدان ولكنها ستشكل المرتكز لترتيب مجموعات العاملين الصحيين المزمع استهدافها من حيث الأولوية، وتحديد أهداف تغطية التطعيم، وتوفير الإرشادات بشأن الحصائل ونطاق قياس أثر التطعيم. 31 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية ويخدم تطعيم العاملين الصحيين أهدافا ًمتعددة. ويشمل ذلك ما يلي: وقاية العمال الصحيين أنفسهم من العدوى، وتفادي المراضة المصاحبة.1 - الحيلولة دون سراية العدوى من العاملين الصحيين إلى المرضى الضعفاء، بما في ذلك المعرضون 2 - منهم بشدة لمخاطر المرض الوخيم، والمضاعفات، والوفاة. دعم الخدمات الصحية من خلال الحد من ظاهرة تغيب العاملين الصحيين عن العمل، ولاسّيما خلال 3 - فاشيات الأنفلونزا الموسمية والجائحة، وهي فترات تتسم بتزايد الطلب على خدمات الرعاية الصحية. ترويج الإقبال على التطعيم المضاد للأنفلونزا الموسمية في صفوف المجموعات المستهدفة الأخرى 4 - وتعزيز ثقة الجمهور بالتطعيم إزاء الأنفلونزا. الإسهام في التأهب لجوائح الأنفلونزا من خلال ما يلي: - إرساء آلية لتمنيع العاملين الصحيين بسرعة أثناء جائحة الأنفلونزا أو أوبئة الأمراض الأخرى – التي يمكن توقيها باللقاحات؛ المساهمة في زيادة الطلب على لقاح الأنفلونزا ومن َثّم تعزيز قدرة الإنتاج للنهوض بالحصول – على اللقاح في الوقت المناسب في حال اندلاع الجوائح. إرساء أو تعزيز قدرة وطنية على تنظيم اللقاحات. – ويمكن أن يخدم بند واحد أو أكثر من البنود الآنفة الذكر في تحديد الأغراض الوطنية لتطعيم العاملين الصحيين. وتتضمن الاعتبارات المهمة عند تحديد أغراض التطعيم ما يلي: استعراض البيانات المتاحة عن عبء المرض في صفوف العاملين الصحيين والعداوى المرتبطة 1 - بالرعاية الصحية لدى المرضى والمقيمين في مرافق الرعاية الطويلة الأجل. ويمكن أن ُتستخدم لهذه الغاية البيانات الوطنية، في حال توافرها، ُمستكملة ببيانات إقليمية أو عالمية تمثيلية أو بتقديرات مستخلصة عبر استخدام النماذج الحسابية. تكلفة التطعيم وأثره وتوافر إمدادات اللقاح.2 - استعراض الخطة الوطنية للتأهب الجائحي ودراسة السبل التي يمكن أن يسهم فيها تطعيم العاملين 3 - الصحيين في هذا التأهب. التحليل الاقتصادي لإرساء السياسات الوطنية في حين أن من المستصوب عموما ًإجراء تحليل اقتصادي قبل البت في أمر سياسات التطعيم فإن الافتقار إلى البيانات اللازمة لتقدير ومقارنة المنافع الاقتصادية لأغراض التطعيم المختلفة قد يكون عاملا ًمقيِّدا،ً بالإضافة إلى الحجم الصغير نسبيا ً للمجموعة المستهدفة. ويعرض صندوق الأدوات 2 الأدوات المتاحة لإجراء تحليل اقتصادي للتطعيم المضاد للأنفلونزا. 41 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية ومن المحتمل أن تعتمد التكاليف والمنافع الاقتصادية لتطعيم العاملين الصحيين المضاد للأنفلونزا على العديد من العوامل، بما في ذلك أعداد العاملين الصحيين المستهدفين وفئاتهم، ومعدلات حدوث العدوى وشدتها في صفوفهم، ومساهمتهم في السراية المرتبطة بالرعاية الصحية وعواقب مثل هذه العداوى. وقد تتباين هذه العوامل طبقا ًللمرافق الصحية المختلفة وهي ستتفاوت من موسم للأنفلونزا إلى آخر. وتبين لاستعراض منهجي حديث عن التأثيرات الوبائية والاقتصادية لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية بأن هذه التطعيم يكفل توفير التكاليف، وذلك بالاستناد إلى التقديرات التقريبية لحالات التغيب عن العمل التي أمكن تفاديها بفضل التطعيم )51(. على أن كل الدراسات المدرجة في هذا الاستعراض كانت من بلدان ذات دخل مرتفع واعتمدت منظور أرباب العمل مع تركيز قوي على حالات التغيب المتفاداة. ويمكن للقرارات الأولية أن تأخذ في الحسبان تكاليف التطعيم وأثر هذه التكاليف على ميزانيات التمنيع والصحة، مع خيار قياس المردودية في مرحلة ما بعد إدخال اللقاحات، عند الاقتضاء. ويغطي القسم التالي من هذا الكتيب المزيد من الإرشادات بشأن جوانب تحديد التكاليف والميزنة المتعلقة بتطعيم العاملين الصحيين المضاد للأنفلونزا مع إيراد روابط بما هو متاح من أدوات لتحديد التكاليف ومواد مرجعية عن تمويل التمنيع. توصيف المجموعات المستهدفة بالتطعيم ينبغي في الوضع المثالي استهداف كل العاملين الصحيين بالتطعيم، بما في ذلك أولئك الذين قد لا يكون لهم احتكاك مباشر مع المرضى. إذ إن العاملين الصحيين، حتى لو لم يكن لهم مثل هذا الاحتكاك، يمكن أن ينقلوا العدوى المكتسبة في المجتمع المحلي إلى زملائهم، ومن َثّم المشاركة في سلسة سراية العدوى المرتبطة بالرعاية الصحية. على أنه في حالات قيود الموارد أو قلة إمدادات اللقاحات أو عدم استقرارها، صندوق الأدوات 2 أدوات التحليل الاقتصادي للتطعيم المضاد للأنفلونزا الموسمية تتوافر عدة أدوات لإجراء التحليل الاقتصادي لتحليل التطعيم المضاد للأنفلونزا: دليل منظمة الصحة العالمية لتنميط التقييمات الاقتصادية لبرامج التمنيع (41.80/BVI/OHW) fdp.gne_41.80_BVI_OHW/18996/56601/eldnah/maertstib/siri/tni.ohw.sppa//:ptth دليل منظمة الصحة العالمية لتقدير العبء الاقتصادي للأنفلونزا الموسمية (40.61/BVI/OHW) fdp.ara-40.61-BVI-OHW/580052/56601/eldnah/maertstib/siri/tni.ohw.sppa//:ptth إرشادات بشأن التقييم الاقتصادي للتطعيم المضاد للأنفلونزا (50.61/BVI/OHW) fdp.gne-50.61-BVI-OHW/680052/56601/eldnah/maertstib/siri/tni.ohw.sppa//:ptth 51 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية فإن الحاجة ستتطلب تصنيف العاملين الصحيين وترتيبهم من حيث أولوية التطعيم. وسيعتمد ترتيب الأولوية بين العاملين الصحيين على تقدير خطر العدوى في صفوفهم ذاتهم، وسراية العدوى إلى مرضاهم، وعواقب السراية المرتبطة بالرعاية الصحية. وحتى لو لم تكن هناك قيود على الموارد المالية أو أوجه قصور في إمدادات اللقاحات، فإن ترتيب الأولوية بين العاملين الصحيين سيكون مفيدا ًعند تطبيق سياسات مختلفة على الفئات المتباينة للعاملين الصحيين استنادا ً إلى تقدير المخاطر. وعلى سبيل المثال فقد ُتطبق سياسة التطعيم الإلزامي على فئات مختارة من العاملين الصحيين ممن يتعاملون مع المرضى المعرضين لخطر شديد للإصابة بالأنفلونزا الوخيمة، وممن ترتفع احتمالات تقبلهم للتطعيم الإلزامي، في حين قد يكون التطعيم طوعيا ًبالنسبة للفئات الأخرى )04، 14(. ويوفر الجدول 1 مثالا ً على تصنيف العاملين الصحيين من حيث المخاطر استنادا ً إلى الأخطار التي يتعرضون لها هم أنفسهم أو من يخضعون لرعايتهم. تصنيف العاملين الصحيين من حيث المخاطرالجدول 1لا فئة المخاطر خصائص العاملين الصحيين العاملون الصحيون ذوو المخاطر العالية (انظر أدناه) الذين يعملون في المناطق – السريرية التي تستقبل مرضى معرضين بشدة لمخاطر المرض الوخيم، أو المضاعفات، أو الوفاة في أعقاب عدوى بفيروس الأنفلونزا. ويشمل ذلك وحدات العناية المركزة؛ وأقسام الأورام أو زرع الأعضاء؛ ومناطق خدمات ما قبل الولادة، والفترة المحيطة بالولادة، وما بعد الولادة؛ والمناطق التي تضم مسنين، ولاسّيما من المصابين بأمراض مزمنة. عالية جداً العاملون الصحيون ممن لهم احتكاك بدني مباشر مع المرضى، أو مع المواد الُمعدية، – بما في ذلك السطوح أو المعدات الملوَّ ثة بمواد ُمعدية. العاملون الصحيون ممن لهم احتكاك غير بدني ولكنه يسمح باكتساب أو سراية – الأمراض التي تنتشر على مسافة قصيرة (1–2 م) عبر سبل تنفسية، مثل المستشارين الذين لهم احتكاك مطوَّ ل وجها ًلوجه )24، 34(. عالية العاملون الصحيون من غير ذوي الاحتكاك بالمرضى والذين لا يجري عملهم العادي – في مناطق سريرية حسبما هي محددة أعلاه. منخفضة والفئة ذات المخاطر العالية جدا ًهي أيضا ًالفئة التي تكون فيها البيِّنات بشأن المخاطر والأثر في ذروة قوتها وحيث تتوافر مبررات أشد للتطعيم )01(. كما ينبغي أن يشمل المستهدفون بالتطعيم العاملين بدوام جزئي، والطلاب، والمتعهدين، والمتطوعين في المرفق الصحي ممن ُيحتمل تعرضهم للمرضى بالإضافة إلى العاملين الصحيين من الفئات الآنفة الذكر. وقد يكون تصنيف المخاطر لفرادى العاملين الصحيين مسألة مفرطة التعقيد وكثيفة الموارد في العديد 61 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية من السياقات، ولاسّيما في البلدان المنخفضة والمتوسطة الدخل. وفي هذه الحالات، يمكن استخدام ُنهج أبسط تتمثل في تصنيف فئات العاملين الصحيين ضمن مجموعتين فحْسب، أي المجموعة العالية المخاطر (المستهدفة بالتطعيم) والمجموعة المنخفضة المخاطر (غير المستهدفة بالتطعيم). وضمانا ًللاستخدام الموجه لتطعيم العاملين الصحيين المضاد للأنفلونزا ومعالجة المسائل المحتملة للإقبال على التطعيم، فإن على السياسات الوطنية لتطعيم العاملين الصحيين أن توضح ما يلي: تصنيف الفئات المختلفة للعاملين الصحيين بالاستناد إلى تقدير للمخاطر.1 - سياسة تطعيم كل فئة، مثل ما إذا كان يوَصى بالتطعيم وما إذا كانت التوصية تنص على تطعيم 2 - إلزامي أو طوعي. استراتيجيات إدارة العاملين الصحيين غير الممتثلين والرافضين لتلقي التطعيم.3 - وتوفر الوثيقة التالية مثالا ًعلى إطار لتقدير العاملين الصحيين، وتصنيفهم، وترتيبهم من حيث الأولوية. توجيه السياسات الصادر عن وزارة الصحة في نيو ساوث ويلز بشأن التقدير المهني، والتحري، والتطعيم المضاد لأمراض ُمعدية معينة. fdp.900_8102DP/stnemucoDSDPevitcA/sdp/ua.vog.wsn.htlaeh.1www//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102) تأطير سياسة تمنيع العاملين الصحيين يمكن أن تقترح التوصيات المتعلقة بتطعيم العاملين الصحيين التطعيم الإلزامي، أو الطوعي، أو نهجا ًخليطا،ً تبعا ًللمخاطر في السياق السريري المحدد. وأثبتت الدراسات المتعددة على امتداد بلدان كثيرة أن التطعيم الطوعي للعاملين الصحيين، حتى لو ترافق مع جهود واسعة لتوعيتهم بشأن منافع التطعيم ومخاطره وتنفيذ إجراءات للحصول الميسور على التطعيم، يؤدي إلى تغطية منخفضة قلما تتجاوز نسبة 07 بالمائة. ومن جهة أخرى فإن التطعيم الإلزامي أسفر عن نسبة لتلقي التطعيم تقارب 001 بالمائة حينما تم تطبيقه في بعض المؤسسات في الولايات المتحدة )64–44(. غير أنه كان من العسير تطبيق التطعيم الإلزامي في بعض البلدان بسبب مسائل التقبل ولأن المنافع المنسوبة إلى تطعيم العاملين الصحيين كانت مدارا ًللنقاش )23(. وفضلا ًعن ذلك فقد لا يكون من المجدي تنفيذ سياسات التطعيم الإلزامي في السياقات الشحيحة الموارد. التطعيم الطوعي ومن بين الخيارات المطروحة لسياسة تطعيم العاملين الصحيين اعتماد التطعيم الطوعي حيث يوَصى بتطعيم العاملين الصحيين ويتم عرضه عليهم، غير أن قبولهم به هو مسألة طوعية أو اختيارية أي أنها ليست في عداد المتطلبات. وفي العادة فإن تغطية التطعيم في مثل هذه البرامج منخفضة. وعلى هذا فإن الأمر يقتضي في حالة التطعيم الطوعي بذل جهود أشد لتعظيم الإقبال على التطعيم. وتشمل مثل هذه الجهود ما يلي: 71 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية استراتيجية متينة للاتصالات مصممة لتتناسب مع احتياجات الفئات المختلفة للعاملين الصحيين، بهدف 1 - إيضاح منافع التطعيم ومخاطره، بما في ذلك المنافع بالنسبة للمرضى، ولاسّيما المعرضون منهم لمخاطر عالية للإصابة بمرض وخيم. وتدعو الحاجة إلى تأكيد أن بعض هؤلاء المرضى، وبينهم المسنون وناقصو المناعة قد لا يستجيبون أنفسهم للتطعيم، وأن تطعيم العاملين الصحيين الذين يحتكون بهم هو وسيلة مهمة لحماية المرضى المذكورين من العدوى، أي أن ذلك يشكل حجة معنوية وأخلاقية مهنية. الحصول الميسور على التطعيم على أن يكون مجانيا،ً ومتاحا ًللعاملين في كل نوبة. ويمكن إتاحة 2 - التطعيم للعاملين في النوبات المسائية أو الليلية في بداية نوبتهم أو عند نهايتها أو في أيام أو أوقات محددة لتغطية نوباتهم. أنشطة أخرى لتوليد الطلب على النحو المحدد في القسم التالي من هذا الكتيب.3 - كما قد يساعد عدد من الأحكام اللينة في زيادة الإقبال على التطعيم، بما في ذلك ما يلي: اشتراط الرفض الصريح للتطعيم من خلال توقيع استمارات تشير إلى عدم المشاركة مع أو بدون إبداء 1 - أسباب الامتناع عن قبول التطعيم (انظر الملحق 1 للاطلاع على استمارة نموذج الرفض الصريح). نقل العاملين الصحيين الذين يرفضون تلقي التطعيم إلى مناطق تقل فيها احتمالات احتكاكهم 2 - بالمرضى ذوي المخاطر العالية، إن أمكن، أو اشتراط ارتداء الأقنعة إن كانوا يتولون بالفعل رعاية المرضي المعرضين لخطر شديد من مضاعفات الأنفلونزا. استخدام أقنعة الوجه ضمن مرفق الرعاية الصحية.3 - التطعيم الإلزامي يجعل التطعيم الإلزامي من تطعيم العاملين الصحيين متطلبا ًقانونيا ًأو تنظيميا ًمع السماح ببعض الاستثناءات بسبب موانع الاستعمال الطبية مثلا. وليس هناك من تعريف لمنظمة الصحة العالمية أو تعريف آخر مطبق بشكل موحد لمصطلح التطعيم الإلزامي. وقد تتباين برامج تمنيع الرضع والأطفال الموصوفة بأنها إلزامية تباينا ًشاسعا،ً ولاسّيما من حيث الإعفاءات المسموحة أو جزاءات عدم الامتثال )74(. ويحاجج العديد من الخبراء بأنه ينبغي تنفيذ سياسات التمنيع الإلزامية إزاء الأمراض القابلة للوقاية باللقاحات والتي يمكن أن تسري في سياق الرعاية الطبية وأن ُتعرِّ ض المرضى لمخاطر جسيمة للمراضة والوفاة )02، 44، 84–05(، كجزء من الأخلاقيات المهنية لمقدمي الرعاية الصحية. كما أن هناك حججا ًتقول بأن بضعة مسؤوليات أخلاقية في ممارسة الطب تتجاوز الالتزام بعدم الإضرار. ومن ثم فإن ضمان شروط الرعاية المأمونة للمرضى من خلال تقليل سراية الأمراض السارية إلى الحد الأدنى يشكل معيارا ًأخلاقيا ًأدنى في سياق ممارسة الرعاية الصحية )02(. على أنه في حال العزم على إرساء سياسات للتطعيم الإلزامي، فإن الأمر سيتطلب العناية بقضايا المسؤولية القانونية ودراسة تقديم التعويضات في الحالات النادرة لوقوع أحداث ضارة. ويمكن أن يكون التطعيم الإلزامي جزءا ًمن السياسة الوطنية أو أن ُينفذ على مستوى المرافق الصحية الفردية كجزء من السياسات المؤسسية. وسيسهل إنفاذ تشريعات مؤيدة للتطعيم الإلزامي من تنفيذ مثل هذه السياسة. وتوفر مدونة لوائح كولورادو مثالا ًعلى سياسة للتطعيم الإلزامي. 81 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية مدونة لوائح كولورادو – معايير للمستشفيات والمرافق الصحية 2 – معايير الترخيص العامة (الجزء 01، الصفحة 64). 02%6=emaNelfi&0206=dInoisreVelur?od.fdPeluRetareneG/RCC/su.oc.etats.sos.www//:sptth 2002%pahC02%1-110102%RCC (تم الاطلاع في 41 شباط/ فبراير 9102) وهناك بلدان عديدة تعتمد سياسات لتطعيم العاملين الصحيين المضاد للأنفلونزا بصورة طوعية وتفرض في الوقت ذاته التطعيم الإلزامي عليهم بشأن عداوى أخرى مثل الحصبة والتهاب الكبد B. ويمكن الاستفادة من سياسات التطعيم الإلزامي القائمة هذه في تبرير وإرساء سياسات للتطعيم الإلزامي المضاد للأنفلونزا، بالاستناد إلى الحماية الموفَّرة للعاملين الصحيين وكذلك للمرضى الضعفاء ذوي المخاطر العالية الذين يحتكون بهم. وقد تم استنساخ التوصيات المنشورة بشأن التنفيذ الأخلاقي لسياسات التطعيم الإلزامي في صندوق الأدوات 3. ويمكن أن تؤخذ هذه التوصيات في الحسبان لدى تأطير السياسة الوطنية بالاستناد إلى جدوى التنفيذ. صندوق الأدوات 3 توصيات بشأن التنفيذ الأخلاقي لسياسات التطعيم الإلزامي يجب أن تكون ه1ناك مشكلة قاهرة بشأن سلامة الموظفين والمرضى يتم توضيحها بجلاء للعاملين. — ينبغي استخدام الوسائل الأقل صرامة لتحقيق غرض السلامة. — يتعين أن تكون هناك معايير واضحة لعدم التقيد لأسباب طبية. — ينبغي أن يقتصر السماح بمعايير عدم التقيد المستندة إلى الآراء الشخصية للعاملين الصحيين على — الموظفين الحاليين منهم فحْسب. ومن الواجب أن ُتتخذ القرارات بهذه الشأن بصورة شفافة وموضوعية. وبالنسبة لمن يلبي المعايير الطبية أو غير الطبية للاستبعاد، أو الذين يرفضون التطعيم، فإن — على المؤسسات أن توفر وسائل بديلة لمكافحة السراية، بما في ذلك الإجازة المؤقتة من العمل خلال فترات الذروة، أو الارتداء الإلزامي للأقنعة، أو النقل إلى مناطق غير سريرية (إن أمكن)، أو الإخضاع لاختبارات متكررة أثناء مواسم ذروة الأنفلونزا. يتعين إخطار الموظفين المرشحين بالسياسة الإلزامية وأن يدركوا أن عدم الامتثال يمكن أن — يكون سببا ًلإنهاء الخدمة. ينبغي أن تكون العملية شفافة، مع الاستعانة بطائفة واسعة من آراء العاملين الصحيين عند — وضع السياسة. على المؤسسات أن تساند العاملين في الرعاية الصحية من خلال تنفيذ إجراءات تطعيم مجانية، — وميسورة المنال، وتشتمل على تغطية شاملة كاملة للأحداث الضارة. المصدر : (1) 03D-72D (8002) S62 eniccaV .la te CJ trubliT 91 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية النهج المختلط يمكن أيضا ً اعتماد نهج مختلط يقتصر فيه تطبيق سياسة التطعيم الإلزامي على فئات معنية فحْسب من العاملين الصحيين الذين يحتمل أن يكون لهم احتكاك بدني مباشر بالمرضى ذوي المخاطر العالية، مع تطبيق سياسة التطعيم الطوعي على بقية الفئات. وينبغي أن تحدِّ د مثل هذه السياسة بوضوح ودون أي لبس مجموعات العاملين الصحيين أو أماكن العمل التي ُتطبق فيها سياسات التطعيم الإلزامية والطوعية. ويتعين مراعاة تبعات الموارد البشرية والمالية لسياسات التطعيم الإلزامي أو الأحكام اللينة. الإدماج بسياسات الصحة المهنية ينبغي أن تكون سياسات تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية جزءا ًأصيلا ًمن السياسات واللوائح الوطنية المعنية بالسلامة والصحة المهنيتين ونظم إدارة السلامة والصحة المهنيتين في المرافق الصحية. وسيتيح إدماج التطعيم المضاد للأنفلونزا الموسمية ضمن سياسات الصحة المهنية حصول كل العاملين الصحيين المستهدفين على التطعيم المجاني وفقا ً للمادة 12 من اتفاقية السلامة والصحة المهنيتين لعام 18915 وتوصيات الإطار العالمي المشترك بين منظمة الصحة العالمية ومنظمة العمل الدولية المعني بالبرامج الوطنية للسلامة المهنية للعاملين الصحيين.6 وستلقي مثل هذه السياسة بمسؤولية تطعيم العاملين الصحيين على عاتق أرباب العمل، لا على كاهل العاملين الصحيين وحدهم. وستتيح السياسة المتكاملة قدرا ًأعظم من التنسيق والتعاون بين برامج السلامة المهنية والتمنيع وستروج نهجا ًمشتركا ًلمكافحة الأنفلونزا في المرافق الصحية يشكل التطعيم فيه جزءا ًمن برنامج لمكافحة العدوى يشمل إجراءات أخرى تتعلق بالعدوى لحماية العاملين الصحيين والمرضى على حد سواء. كما أن برنامج الصحة المهنية على المستوى الوطني ونظام الإدارة على صعيد المرافق سيوفر بيئة تمكينية لتكوين ثقافة للوقاية من العدوى ضمن مكان العمل تحفز تنفيذ برامج التطعيم. اختيار الُمنَتج اللقاحي، والجدول الزمني للتطعيم وتوقيته اختيار الُمنتج توفر منظمة الصحة العالمية توصيات بشأن تركيب لقاحات الأنفلونزا استنادا ًإلى المعلومات التي تزودها بها شبكة المنظمة العالمية لترصُّ د الأنفلونزا والتصّدي لها.7 وبالارتكاز على هذه التوصيات تقوم جهات التصنيع بصياغة لقاحات نصف الكرة الشمالي (HN) ونصف الكرة الجنوبي (HS)، التي ُتتاح عادة بحلول 5 ELMRON=p?f/ne/xelmron/nyd/gro.oli.www//:sptth .(551 .oN) 1891 ,noitnevnoC htlaeH dna ytefaS lanoitapuccO-551C (9102 yraurbeF 41 desseccA) 003213:di_tnemurtsni_00121p::ON::0:00121:BUPX 6 OLI-OHW – II xidneppA SDIA dna VIH no sevitaitini larotces fo weiveR : krow s’OLI eht fo noisnemid larotces ehT .srekroW htlaeH rof semmargorP htlaeH lanoitapuccO lanoitaN rof krowemarF labolG OLI-OHW fdp.738541_smcw/tnemucodgniteem/stnemucod/fnocler---/mron_de---/cilbup/spuorg/5psmcw/gro.oli.www//:ptth (9102 yraurbeF 41 desseccA) 7 (9102 yraurbeF 41 desseccA) seniccav/azneulfni/tni.ohw.www//:ptth .seniccav :azneulfnI 02 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية شهر أيلول/سبتمبر (HN) وشهر نيسان/أبريل (HS) من كل عام، على التوالي. وتنشر منظمة الصحة العالمية في موقعها الإلكتروني قائمة باللقاحات الُمختبرة الصلاحية مع معلومات تتعلق بخصائصها.8 ويتوافر العديد من الأنماط المختلفة للقاحات، بما في ذلك لقاحات الأنفلونزا الموهَّ نة (تركيب ثلاثي التكافؤ ورباعي التكافؤ)، ولقاحات الأنفلونزا الموهنة الحية، واللقاحات المتقارنة، واللقاحات المأشوبة. ولا تقود وظيفة العامل الصحي بحد ذاتها إلى تفضيل أي نمط من اللقاحات (رهنا ًبتراخيص التسويق الخاصة بكل بلد).9 ومن الأفضل أن يتلقى العاملون الصحيون القائمون على رعاية المعانين من نقص وخيم في المناعة لقاح الأنفلونزا الموهَّ ن (VII). وتندرج أسعار كل ُمنتج وتوافر إمداداته في عداد الاعتبارات الإضافية التي تنير عملية اختيار الُمنتجات. توقيت التطعيم في البلدان التي تكون فيها عدوى الأنفلونزا موسمية وأنماط الطابع الموسمي محددة، ينبغي تحديد موعد التطعيم، مثاليا،ً قبل بدء موسم الأنفلونزا، بما يتيح نحو 41 يوما ًلتحريض الأضداد الوقائية. وحين لا يتيح التأخير في ضمان إمدادات اللقاحات الوفاء بالتوقيت المثالي فإنه يتعين البدء بالتطعيم حال إتاحة الإمدادات. وفضلا ًعن ذلك فإن على العاملين الصحيين الأفراد عدم رفض التطعيم أبدا ًفي أي وقت من أوقات موسم الأنفلونزا إذا كانوا قد تأخروا في التماس التطعيم. وفي الأقاليم المدارية وشبه المدارية التي قد تقع فيها العديد من فترات الذروة فإنه ينبغي توقيت التطعيم قبل الذروة الرئيسية للسراية، باستخدام المستحضر الأحدث للقاح. وعند عدم توافر بيانات عن الطابع الموسمي الوطني للأنفلونزا فإن بمقدور البلدان استخدام البيانات الواردة من بلدان تماثلها من الناحية الوبائية. ويوفر صندوق الأدوات 4 معلومات منشورة عن الطابع الموسمي للأنفلونزا في الأقاليم المدارية وشبه المدارية. تحديد أغراض الرصد وقياس أثر المرض ستستفيد وزارات الصحة من مشورة الأفرقة الاستشارية التقنية الوطنية للتمنيع أو الأفرقة الاستشارية المعنية الأخرى بشأن أغراض الرصد وقياس الأثر بحيث ُيراعى ذلك عند تخطيط وتنفيذ تدابير الرصد والتقييم (انظر الفصل 4). وعلى الأفرقة الاستشارية التقنية الوطنية للتمنيع أن تتقدم، وبمدخلات إضافية من الأفرقة الاستشارية المعنية الأخرى والهيئات الأكاديمية، بتوصيات بشأن ما يلي: رصد تغطية التطعيم والتبليغ عنها، وذلك بحسب الوحدة ونمط الرعاية المقدَّ م إن أمكن.1 - قياس أثر التطعيم، بما في ذلك الآتي:2 - 8 (9102 yraurbeF 41 desseccA) /beW_QP/ivag/tni.ohw.tenartxe//:sptth .seniccaV deifilauqerP OHW 9 في بعض البلدان فإن اللقاح الرباعي التكافؤ هو الُمنتج المفضل. ويقوم فريق الخبراء الاستشاري الاستراتيجي المعني بالتمنيع التابع لمنظمة الصحة العالمية حاليا ًباستعراض البيِّنات، ومن المنتظر أن ُيصدر توصية في عام 0202. 12 2 - إرساء سياسة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية المجموعات المستهدفة (العاملون الصحيون أو المرضى) لقياس الأثر. – الحصائل المزمع رصدها، مثل العلة الشبيهة بالأنفلونزا، والمرض المؤكد مختبريا،ً والمرض – الوخيم، والوفاة، والتغيب عن العمل، والحصائل المتعلقة بالمرضى، وما إلى ذلك. استراتيجيات ترصد قياس الأثر؛ وإذا تم ذلك في المواقع الخافرة، فعدد هذه المواقع وتوزيعها. – فترات قياس الأثر، مثل الرصد المتواصل لفترة غير محدودة أو محددة بعدد معين من المواسم. – وستفيد هذه القياسات الأفرقة الاستشارية التقنية الوطنية للتمنيع في استعراض أثر التطعيم وتقديم التوصيات لتعظيم أثر التطعيم ومردوديته. كما أن قياس الأثر يمكن أن يولِّد بيانات تجريبية تتيح تقدير مردودية التطعيم. وتجدر الإشارة إلى أن مثل هذه القياسات ينبغي أن تشتمل على جمع البيانات من مواسم متعددة بالنظر إلى تباين شدة السراية، ووخامة العدوى، وفعالية اللقاحات من موسم إلى آخر. وللاطلاع على مزيد من التفاصيل انظر الجزء المتعلق بالرصد والتقييم (الفصل 4). صندوق الأدوات 4 إرشادات بشأن اختيار الُمنتج وتوقيت التطعيم المضاد للأنفلونزا الموسمية استخدام السياسة المتعلقة بالأنفلونزا الموسمية وفعاليتها في الأقاليم المدارية وشبه المدارية. جنيف: منظمة الصحة العالمية; 6102. fdp.452-01-VRI/fdp/3710194CMP/selcitra/cmp/vog.hin.mln.ibcn.www//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102) الطابع الموسمي للأنفلونزا في الأقاليم المدارية وشبه المدارية – متى ينبغي التطعيم 3003510.enop.lanruoj/1731.01=di?elcitra/enosolp/gro.solp.slanruoj//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) قائمة منظمة الصحة العالمية باللقاحات الُمختبرة الصلاحية beW_QP/ivag/tni.ohw.tenartxe//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102)  22 تخطيط وإدارة تدابير تطعيم العاملين الصحيين3 - تخطيط الإدخال الناجح للتطعيم من الضروري، فور إرساء سياسة وطنية للتطعيم، تحويل هذه السياسة إلى خطط تشغيلية محسوبة التكاليف بالكامل، ومميزنة، ومشتملة على تفاصيل دقيقة عن مختلف المكوِّ نات البرامجية المتعلقة بإدخال لقاح جديد إلى البرنامج الوطني. ويعرض دليل المنظمة المعنون «مبادئ واعتبارات إضافة اللقاحات إلى البرنامج الوطني للتمنيع: من اتخاذ القرار إلى التنفيذ والرصد» المفاهيم العامة لإضافة لقاح جديد ضمن خطط التمنيع الوطنية وإدارة هذا الإدخال (انظرالملحق 3 للاطلاع على قالب خطة إدخال اللقاحات الجديدة). ويوفر هذا القسم الإرشاد بشأن العناصر الإضافية الخاصة تحديدا ًبتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية. وبفضل خطة إدخال اللقاحات الُمدمجة ضمن الخطة السنوية للتمنيع إلى جانب القوائم المرجعية المصاحبة يتمكن مخططو البرامج من ضمان اتخاذ كل التحضيرات الضرورية لإدخال اللقاح بصورة كفوءة وحسنة التوقيت في البرنامج الوطني. وقد أُدرجت روابط الملاحق المعنية لدليل منظمة الصحة العالمية في صندوق الأدوات تسهيلا ًللرجوع إليها. صندوق الأدوات الروابط بالقوالب والقوائم المرجعية الخاصة بخطة إدخال اللقاحات الجديدة في وثيقة «مبادئ واعتبارات إضافة اللقاحات إلى البرنامج الوطني للتمنيعل من اتخاذ القرار إلى التنفيذ والرصد» قالب عام لإرشاد وضع خطة إدخال وطنية. _eniccav/seigetarts_seicilop/smetsys_semmargorp/noitazinummi/ytitne/tni.ohw.www//:ptth cod.NE_etalpmeT_IVN_3xennA/senilediug_ivn/secruoser_ortni (تم الاطلاع في 41 شباط/ فبراير 9102) قائمة مرجعية، وقائمة أنشطة، وإطار زمني لإدخال اللقاحات الجديدة وفقا ًلمنظمة الصحة العالمية. ويوفر الدليل المشورة عن تخطيط الميزنة، والأنشطة، وتوزيع الأدوار والمسؤوليات، والأطر الزمنية. _ortni_eniccav/seigetarts_seicilop/smetsys_semmargorp/noitazinummi/tni.ohw.www//:ptth fdp.snoitcurtsnI_4xennA/senilediug_ivn/secruoser (تم الاطلاع في 41 شباط/ فبراير 9102) أداة القائمة المرجعية المناظرة _eniccav/seigetarts_seicilop/smetsys_semmargorp/noitazinummi/ytitne/tni.ohw.www//:ptth slx.ne_tsilkcehc_4xennA/senilediug_ivn/secruoser_ortni (تم الاطلاع في 41 شباط/ فبراير 9102) 32 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين وإلى جانب القائمة المرجعية العامة لإدخال اللقاحات فإن القائمة المرجعية التكميلية في الملحق 2 تحتوي على قائمة بالمسائل الخاصة بتمنيع العاملين الصحيين. وينبغي إضافة عناصر هذه القائمة (حسب الاقتضاء) إلى القائمة المرجعية ذات الطابع الأعم للأنشطة. كما تم توفير نموذج لقائمة مرجعية للمرافق الصحية (الملحق 3) لإرشاد التحضيرات للتطعيم على مستوى المرافق الصحية. ويتعين إدراج الأطر الزمنية للتخطيط والإدخال في القوائم المرجعية و/ أو رسم منفصل من رسوم غانت البيانية لضمان إنجاز كل الأنشطة بترتيبها الملائم لإتاحة تنفيذ أنشطة التطعيم في الوقت المناسب. وينبغي إيراد إحالات مرجعية إلى الأقسام ذات الصلة من استراتيجيات وخطط الصحة المهنية سواء على المستوى الوطني أو على مستوى المرافق الصحية (انظر الفصل السابق بشأن إدماج السياسات المتعلقة بالأنفلونزا والخاصة بالعاملين الصحيين ضمن سياسات ومتطلبات الصحة المهنية) لتيسير نهج أكثر اتساقا ً إزاء التخطيط والتنفيذ. ويوصي الإطار العالمي المشترك بين منظمة الصحة العالمية ومنظمة العمل الدولية المعني بالبرامج الوطنية للسلامة المهنية للعاملين الصحيين بأن تحدد كل البلدان الشخص المسؤول (الأشخاص المسؤولين) عن الصحة المهنية، على المستوى الوطني ومستوى أماكن العمل على حد سواء. وينبغي أن يكون هؤلاء المنسقون جزءا ًمن فريق التخطيط على المستوى الوطني ومستوى المرافق الصحية على التوالي. وسيتيح إشراك منسقي الصحة المهنية اعتماد نهج متكامل للوقاية من الأنفلونزا في مكان العمل حيث يشكل التطعيم جانبا ًمن حزمة أكبر للتدخلات الرامية إلى مكافحة الأنفلونزا، بما في ذلك الإجراءات الأخرى لمكافحة العدوى لحماية العاملين الصحيين والمرضى سواء بسواء. ويمكن أن تساعد اللجان المشتركة بين العاملين والإدارة والمعنية بالسلامة والصحة المهنيتين في المرافق الصحية، إن وِجدت، على إشراك الإدارة وممثلي العاملين في تنفيذ برنامج التطعيم. وبالإضافة إلى الخطط التشغيلية الوطنية لتنفيذ تدابير تطعيم العاملين الصحيين فإنه ينبغي أيضا ً تحديث الخطة الوطنية الشاملة المتعددة السنوات (cMYP) للتمنيع بحيث تشمل تمنيع العاملين الصحيين (صندوق الأدوات 6). صندوق الأدوات 6 المبادئ التوجيهية المشتركة بين منظمة الصحة العالمية وصندوق الأمم المتحدة للطفولة (يونيسف) بشأن التخطيط المتعدد السنوات المبادئ التوجيهية المشتركة بين منظمة الصحة العالمية واليونيسف بشأن وضع خطة شاملة متعددة السنوات. pymc/sloot/gnicnanfi/smetsys_semmargorp/noitazinummi/tni.ohw.www//:ptth  42 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين تحديد التكاليف والتمويل على غرار إضافة أي لقاح جديد إلى الجدول الزمني الوطني للتلقيح فإنه ينبغي تقدير تكاليف اللقاح وتسليمه وإدراجها في ميزانيات التمنيع السنوية والمتعددة السنوات. وبالإضافة إلى تكاليف اللقاحات والإمدادات (محاقن، إبر، صناديق آمنة، وما إلى ذلك)، فإن الأمر يقتضي إدراج تكلفة تسليم اللقاح (بما في ذلك الموارد البشرية)، والجهود السنوية للاتصالات/التوعية وتوليد الطلب على المستوى الوطني ومستوى المرافق الصحية، والرصد والتبليغ، ضمن التكاليف. ويتوافر العديد من الأدوات والموارد التي يمكن استخدامها أو مواءمتها لتحديد التكاليف، والميزنة، وضمان الموارد المالية اللازمة لتطعيم العاملين الصحيين. (انظر صندوق الأدوات 7). وبما أن الحاجة ستدعو إلى القيام باتصالات وأنشطة/تدخلات أخرى لتعزيز الإقبال على التطعيم كل سنة، فإن هذه التكاليف ينبغي أن ُتدرج ضمن التكاليف السنوية لتسليم اللقاحات وألا ُتعتبر مجرد نشاط غير متكرر. صندوق الأدوات 7 موارد تحديد التكاليف والتمويل أداة تحديد تكاليف الخطة الوطنية الشاملة المتعددة السنوات وتمويلها pymc/sloot/gnicnanfi/smetsys_semmargorp/noitazinummi/tni.ohw.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) فهرس تكاليف تسليم التمنيع الصادر عن شبكة العمل المعنية بتحديد تكاليف التمنيع )NACI(. يوفر هذا الموقع الإلكتروني التفاعلي معلومات عن تكاليف تسليم اللقاحات عبر مختلف البلدان المنخفضة والمتوسطة الدخل ومن خلال طائفة متنوعة من استراتيجيات التسليم. ccdi-naci/gro.scimonocenoitazinummi//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102)  أداة منظمة الصحة العالمية الخاصة بالأنفلونزا لتخطيط وتحديد تكاليف تطعيم الأمهات المضاد للأنفلونزا – يجري توسيع هذه الأداة لتشمل كل المجموعات المعرضة لمخاطر الأنفلونزا، بما في ذلك العاملون الصحيون (الاسم الجديد: أداة TCIIS) /scimonoce_azneuflni/tnempoleved/hcraeser/noitazinummi/tni.ohw.www//:sptth  (تم الاطلاع في 41 شباط/ فبراير 9102) علوم الإدارة الخاصة بإطار الصحة، والتخطيط، وتحديد التكاليف، والميزنة krowemarf-gnitegdub-dna-gnitsoc-gninnalp/secruoser/gro.hsm.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) تمويل التمنيعل دليل موارد للمناصرين، وصنَّ اع السياسات، ومدراء البرامج. nfimi/gro.scimonocenoitazinummi//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102)  52 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين وبالإضافة إلى تحديد التكاليف والميزنة للتطعيم السنوي للعاملين الصحيين المضاد للأنفلونزا، فقد يكون من الضروري بذل جهود مناصرة في صفوف المسؤولين عن تخصيص الأموال للبرامج الصحية لضمان مواصلة تمويل التطعيم. ويوفر صندوق الأدوات 8 روابط بالموارد اللازمة لمناصرة التمويل المستدام. البحوث التكوينية لتنوير عملية التخطيط استعدادا ًلإطلاق عملية التطعيم المضاد للأنفلونزا فقد استخدمت العديد من البلدان البحوث التكوينية لتحسين فهم العوامل المؤثرة على الإقبال على التطعيم المضاد للأنفلونزا الموسمية في صفوف العاملين الصحيين، بما في ذلك الهواجس، والمعتقدات، والاحتياجات الإعلامية، والمسائل الثقافية، والحواجز القائمة في وجه التطعيم ُبْغية وضع خطة مخصوصة للعناية بكل ذلك. ويمكن أن تتضمن البحوث التكوينية بحوثا ًكمية ونوعية على حد سواء، كما قد تتضمن، في بعض الأحيان، استعراضا ً مكتبيا. وقد ُتستخدم البحوث الكمية لتحديد ُمنبئات الإقبال الضعيف على التطعيم في صفوف العاملين الصحيين والعوامل المحركة الرئيسية للامتثال إلى توصيات التطعيم. ويمكن جمع البيانات عبر المسوح والاستبيانات المنفَّذة في صفوف العاملين الصحيين. وبصورة مثالية فإن العينة ينبغي أن تحتوي على تمثيل كاف لمختلف فئات العاملين الصحيين نظرا ًلأن الانطباعات والأسباب الكامنة وراء ضعف الإقبال قد تتباين فيما بين هذه الفئات، كالأطباء والممرضين مثلا ً)04(، وكذلك لعينة من مرافق الرعاية الصحية الأولية، والثانوية، والثالثية، ولمختلف مناطق العمل ضمن تلك المرافق. صندوق الأدوات 8 موارد للمناصرة أو التمويل المستدام مكتبة مناصرة التمنيع. توفر عددا ًمن الأدوات والكتيبات الإرشادية لإيضاح قيمة التطعيم والحاجة إلى الاستثمار فيه /noitazinummi-dna-seniccav/noitneverp-esaesid/scipot-htlaeh/ne/tni.ohw.orue.www//:ptth  yrarbil-ycacovda-noitazinummi/ycacovda-dna-noitacinummoc/snoitacilbup (تم الاطلاع في 41 شباط/ فبراير 9102) هناك وثيقتان معينتان في هذه المكتبة تتسمان بالأهمية وهما: كتيب عمل – مناصرة التمويل المستدام لبرامج التمنيع. /noitazinummi-dna-seniccav/noitneverp-esaesid/scipot-htlaeh/ne/tni.ohw.orue.www//:ptth  semmargorp-noitazinummi-fo-gnidnuf-elbaniatsus-rof-ycacovda-koobkrow/5102/snoitacilbup (تم الاطلاع في 41 شباط/ فبراير 9102) كيف ُتعد المرتسم المالي لبرنامجك للتمنيع /noitazinummi-dna-seniccav/noitneverp-esaesid/scipot-htlaeh/ne/tni.ohw.orue.www//:ptth  emmargorp-noitazinummi-ruoy-fo-elfiorp-laicnanfi-a-eraperp-ot-woh/5102/snoitacilbup (تم الاطلاع في 41 شباط/ فبراير 9102) 62 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين والبحوث النوعية هي بحوث مستبصرة تستند إلى فهم وجهة نظر الجمهور. وهي توضح المسائل الجديدة وتوفر فهما ًأعمق للمسائل العميقة التي يرتكز عليها الإقبال على التطعيم. وبشكل عام فإن طرق البحوث النوعية تتضمن مناقشات مجموعات التركيز ومقابلات معمقة فردية. وقد نشر المكتب الإقليمي الأوروبي لمنظمة الصحة العالمية دليلا ً ميدانيا ً متدرجا ً للبحوث النوعية الخاصة بإدخال اللقاحات الجديدة (انظر صندوق الأدوات 9). ولكي تكون البحوث النوعية مفيدة فإن من الواجب أن تحظى بتخطيط مناسب وتنفيذ جديد، وإذا لم يتحقق ذلك فإن هناك خطرا ًمن استخلاص استنتاجات خاطئة. ويتطلب هذا الوقت والموارد. وفي حين أن من المفيد إجراء مثل هذه البحوث لتنوير عملية التخطيط فإن الافتقار إليها، بسبب ضيق الوقت وقلة الموارد، ينبغي ألا يؤدي إلى تأخير إدخال لقاحات الأنفلونزا الموسمية، ما لم يكن من المنتظر أن تشكل مواقف العاملين الصحيين مسألة تؤثر بشدة وبشكل ضار على الإقبال على اللقاحات. وحينما لا تتوافر البيانات من البحوث التكوينية فإن بالإمكان استخدام البيانات الواردة من دراسات من هذا النوع ُنفذت في بلدان أخرى لتنوير عملية التخطيط. وفي حين أن أسباب ضعف الإقبال على اللقاحات ليست متجانسة فإن البيِّنات المتاحة تشير إلى أن هناك تقارب عريض بشأن العوامل المؤثرة البارزة على الإقبال على اللقاحات في صفوف العاملين الصحيين، ولاسّيما في البلدان التي تقع ضمن الإقليم الفرعي ذاته، وهو ما يمكن استخدامه في عملية التخطيط الأولي. ويوجز التقدير السريع للبيِّنات (01) الاستنتاجات الرئيسية المستخلصة من المؤلفات المنشورة وبالمستطاع استخدام هذه البيِّنات، حسب الانطباق والاقتضاء، عند الافتقار إلى بحوث منّفًذة على المستوى المحلي. ويمكن استكمال بيانات المؤلفات المنشورة بالمعلومات المستخلصة من البحوث التكوينية الكمية باستعمال المسوح السريعة في صفوف عينة من العاملين الصحيين التي تغطي، بصورة مثالية، فئاتهم المختلفة. وقد تكون هذه المسوح أقل كثافة في الموارد من البحوث التكوينية النوعية ويمكن استكمالها دون أن يسفر ذلك عن أي تأخير في إدخال اللقاحات. ويوفر الملحق 4 نموذج استبيان يمكن استخدامه لمثل هذه المسوح. ويجوز إجراء المزيد من البحوث إذا ما ظل الإقبال على اللقاحات ضعيفا ًبإصرار. وتعد أداة uflPIT موردا ً هاما ًيمكن استخدامه في هذه الحالات. صندوق الأدوات 9 دليل ميداني للبحوث التكوينية النوعية دليل ميداني للبحوث التكوينية النوعية بشأن إدخال اللقاحات الجديدة _ediuGdleiF_8102WIE/878953/4000/elif_fdp/stessa/atad__/tni.ohw.orue.www//:ptth fdp.ortnIeniccaV (تم الاطلاع في 41 شباط/ فبراير 9102) 72 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين التواصل وقبول اللقاحات توجِّ ه المعتقدات الشخصية، والمواقف الثقافية، والانطباعات المتعلقة باللقاحات، إلى جانب التوصيات الرسمية، في كثير من الأحيان الأفعال التي يتخذها المسؤولون عن تسليم اللقاحات والعديد من المتلقين )15، 25(. ويصح ذلك أيضا ًعلى مستوى العاملين الصحيين. وتظهر البيِّنات المتاحة أن هناك في الغالب انطباعات خاطئة عن اللقاحات إلى جانب فجوة في المعارف والسلوكيات )45، 35(. وهكذا فقد تبين أن الاقتصار على تحسين المعرفة بمخاطر التطعيم ومنافعه لدى العاملين الصحيين ليس كافيا ًلتحقيق الإقبال الأمثل على التطعيم. ويتطلب بلوغ تغطية التطعيم المثلى في صفوف العاملين الصحيين جهودا ً متعددة الأبعاد لتوليد الطلب تستنير بالفهم الجيد للانطباعات، والعوامل المحفزة، والحواجز القائمة في وجه قبول اللقاحات عند العاملين الصحيين كمقدمين للتطعيم أو كمتلقين له على حد سواء. وينبغي تصميم رسائل الاتصالات على نحو ُيعنى باحتياجات المجموعات المختلفة للعاملين الصحيين حيث أن البيِّنات المتاحة تشير إلى أن الانطباعات بشأن الحاجة إلى التطعيم، ومخاطره، ومنافعه قد تتفاوت بين هذه المجموعات )55(. وتركز الجهود الراهنة أساسا ًعلى تحضير ُنهج مسندة بالوقائع لإعداد رسائل الاتصالات. غير أن هذه الأنواع من الرسائل قد تحتاج إلى تأطير وفقا ًللجمهور المستهدف بالارتكاز على مستوى ثقافته وفهمه. وقد ُيخلِّف اعتماد الأساليب المفضلة للعملية المعرفية لاتخاذ القرار للمجموعات الفردية المزمع استهدافها أثرا ًأعظم )45(. وسيتطلب تأطير مثل تلك الرسائل فهما ًلسيكولوجيا اللقاحات والعملية المعرفية لاتخاذ القرار وقد يحتاج إلى أشراك خبراء بالاتصالات. وَتمثَّل نهج تقليدي للاتصالات المتعلقة بالتمنيع في استخدام وسائل الإعلام. على أن البحوث أظهرت أن وسائل الإعلام بمفردها والاتصالات وحيدة الاتجاه الموجهة إلى العاملين الصحيين قد لا تكون كافية لتحقيق المستوى الأمثل من التطعيم. ويتطلب الأمر اتصالات فردية وجماعية، وفي هذه الحالة على مستوى المرفق الصحي، لبناء الثقة وتحفيز العاملين على قبول التطعيم. ويمكن أن يسهم إدراج معلومات عن أهمية تطعيم العاملين الصحيين (الحماية الذاتية، والمسؤولية إزاء المرضى، والتأهب الجائحي في حالة الأنفلونزا) ضمن مناهج ما قبل الخدمة في المدارس الطبية، ومدارس التمريض، ومؤسسات التدريب الأخرى الخاصة بالمهنيين الطبيين، في تحسين إرساء تطعيم العاملين الصحيين كمفهوم تنظيمي وتكوين أجيال أفضل معرفة من العاملين الصحيين الذين يقدمون خدمات التمنيع. وليست الأنشطة الفعالة للاتصالات وتوليد الطلب حدثا ًيقع لمرة واحدة فحْسب بل ينبغي أن يكون متواصلا،ً وقادرا ً على الاستجابة بسرعة للانطباعات المتطورة عن التطعيم، ومبددا ً للانطباعات الخاطئة. وتدعو الحاجة إلى تدريب موظفي التطعيم الميدانيين المسؤولين عن تطعيم العاملين الصحيين المضاد للأنفلونزا ليتمكنوا من التعامل مع العاملين الصحيين المترددين إزاء تلقي اللقاحات وكذلك مع منكري اللقاحات المجادلين الذين قد يخلِّفون01 أثرا ًسلبيا ًعلى الإقبال على التطعيم )65(. وسييسر توافر فريق عامل وطني معني بالتواصل ومشتمل على خبراء بالاتصالات إرساء علاقات عمل 01 يشكل منكرو اللقاحات المجادلون الطرف الأقصى من المجموعة الفرعية لرافضي اللقاحات ويدعون بنشاط ضد التطعيم مستخدمين تقنيات الإنكار العلمي لتبرير معتقداتهم (انظر المرجع 23). 82 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين متينة مع الشركاء والحلفاء والتعاون فيما بينهم، وسيعزز التواصل الروتيني من أجل التمنيع، وسيكفل الاستجابة الفورية والمنسقة بشكل جيد من جانب كل السلطات المنخرطة في أي حدث للسلامة. ويسهم إشراك أعضاء من إدارة السلامة والصحة المهنيتين ومن الجمعيات المهنية في عملية التواصل مع العاملين الصحيين، في بناء الثقة وتحسين القبول بالتطعيم. وسيضمن تمثيل العاملين الصحيين، والرابطات المهنية، والاتحادات من مختلف فئات العاملين الصحيين المستهدفة بالتطعيم مراعاة وجهات نظر كل فئة من فئاتهم عند إعداد مواد التواصل المصممة خصيصا ًلهم. ويتوافر عدد من الأدوات والوثائق الإرشادية التي يمكن استخدامها في وضع استراتيجية فعالة للتواصل ولتأطير رسائل الاتصالات المصممة خصيصا ًلتتناسب مع الفئات المختلفة للعاملين الصحيين، بما في ذلك قالب لاختصاصات الأفرقة العاملة للتواصل بشأن اللقاحات (صندوق الأدوات 10). وبالإضافة إلى التطعيم فإن على مواد التوعية والتواصل أن تتضمن أيضا ًمعلومات عن الإجراءات الأخرى لمكافحة العدوى للحد من سراية الأنفلونزا في مكان العمل والخطوات الواجب اتخاذها في حال إصابة أحد العاملين الصحيين بعلة شبيهة بالأنفلونزا. الاتصالات على مستوى المرفق الصحي ستستفيد الاتصالات الفعالة على مستوى المرفق الصحي من فريق مخصص وحسن التدريب لتنفيذ استراتيجية الاتصالات على هذا المستوى. وينبغي إنشاء مثل هذا الفريق وتدريبه قبل فترة طويلة من موعد الإدخال المزمع للقاحات وأن يشمل ممثلين عن الفئات الرئيسية للعاملين الصحيين في المرفق، إلى جانب خبير للمناصرة والاتصالات، إن توافر. وبصورة مثالية فإن الاتصالات المتعلقة بالتطعيم المضاد صندوق الأدوات 01 الأدوات والأدلة لوضع استراتيجية ورسائل الاتصالات مكتبة التطعيم والثقة /noitazinummi-dna-seniccav/noitneverp-esaesid/scipot-htlaeh/ne/tni.ohw.orue.www//:ptth  tsurt-dna-noitaniccav/snoitacilbup (تم الاطلاع في 41 شباط/ فبراير 9102) إدخال اللقاحات الجديدةل قائمة مرجعية لتخطيط الاتصالات والمناصرة (7102) /noitazinummi-dna-seniccav/noitneverp-esaesid/scipot-htlaeh/ne/tni.ohw.orue.www//:ptth  -dna-noitacinummoc-gninnalp-rof-tsilkcehc-noitcudortni-eniccav-wen/7102/snoitacilbup 7102-ycacovda (تم الاطلاع في 41 شباط/ فبراير9102 ) قالب اختصاصات الفريق العامل للتواصل بشأن اللقاحات _ytefaSeniccaV_OHW_20/694733/5000/elif_fdp/stessa/atad__/tni.ohw.orue.www//:ptth fdp.7foorP_ROT_coDtroppuS (تم الاطلاع في 41 شباط/ فبراير 9102) 92 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين للأنفلونزا الموسمية يجب أن تكون جزءا ًمن جهد أوسع للاتصالات بشأن مكافحة الأنفلونزا في سياقات الرعاية الصحية. وينبغي أن تبدأ أنشطة التواصل على مستوى المرفق الصحي قبل وقت كاف من الموعد المزمع لانطلاق التطعيم، ولاسّيما في البلدان التي ُتدخل التطعيم للمرة الأولى. ويتعين أن تتضمن الأنشطة الأولية عرض الملصقات الإعلامية في كل المناطق ذات الصلة في المرفق الصحي. كما ينبغي إرسال خطاب رسمي إلى مدير المرفق الصحي ورؤساء كل الإدارات والمناطق السريرية المعنية مع نسخ كافية من جميع المواد الإعلامية عن التطعيم لعرضها في كل منطقة سريرية. وحيثما أمكن فإن بالمستطاع أيضا ًإرسال المعلومات ذات الصلة عن التطعيم المضاد للأنفلونزا إلى كل العاملين الصحيين باستخدام البريد الإلكتروني و/أو الشبكات المحلية للتواصل الاجتماعي. ويتعين استكمال عرض وتوزيع المواد الإعلامية بجلسات إحاطة للمجموعات الشخصية. ويمكن الاستفادة من اجتماعات الموظفين الحالية لعقد هذه الجلسات. وسيعتمد عدد الجلسات المذكورة على حجم المرفق الصحي وعدد العاملين الصحيين المستهدفين. وقد تحتاج المرافق الصحية الضخمة (مثل المرافق الصحية من المستويين الثانوي والثالثي) إلى عقد عدة جلسات للإحاطة لتغطية كل العاملين الصحيين المستهدفين. وبالنظر إلى أن رسائل الاتصالات قد تتفاوت بين الفئات المختلفة للعاملين الصحيين فإنه ينبغي النظر في عقد جلسات منفصلة لكل فئة من هذه الفئات باستخدام المعلومات والمواد ذات الصلة بها. ولإتاحة التواصل على نحو أفضل وتوفير وقت كاف للرد على أسئلة العاملين الصحيين فإنه يتعين تصميم حجم كل مجموعة بما يتيح فرصة للتفاعل. وينبغي اتخاذ الترتيبات اللازمة لتيسير مشاركة العاملين الصحيين الذين يعملون في النوبات الليلية. كما ينبغي الإعلان على نطاق واسع عن الجدول الزمني لجلسات الإحاطة ضمن المرفق الصحي وإرسال التذكيرات لترويج الحضور الواسع. وينبغي للاجتماعات الشخصية أن تقوم بما يلي: شرح أسباب أهمية التطعيم بالنسبة للعاملين الصحيين، ولمرضاهم، وأسرهم، والمجتمع الواسع، مع 1 - تركيز خاص على الحصائل الوخيمة المرتبطة بالأنفلونزا؛ تنوير العاملين الصحيين بشأن السياسات الوطنية؛2 - توفير المعلومات عن سلامة اللقاحات المضادة للأنفلونزا الموسمية؛3 - توفير المعلومات عن توقيت وموقع (مواقع) التطعيم؛4 - إيضاح العواقب المحتملة لعدم التطعيم؛ - إتاحة الوقت الكافي للأسئلة.6 - ويمكن النظر في إنشاء خط هاتفي ساخن أو نظام مستند إلى شبكة الإنترنت للرد على أسئلة العاملين الصحيين الأفراد. وبالإضافة إلى عرض الملصقات ومواد الاتصالات الأخرى فإن استخدام العاملين الصحيين الذين تم تطعيمهم للصاقات بارزة وقابلة للنزع (على شارات الهوية الشخصية مثلا)ً يمكن أن يشكل تذكرة مرئية لزملائهم الذين لم يتلقوا التطعيم. وفضلا ًعن ذلك فإن الرسائل النصية، والرسائل العامة للبريد الإلكتروني، ومنصات التواصل الاجتماعي يمكن أن ُتستعمل لتوفير تذكيرات دورية بشأن التطعيم. 03 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين توليد الطلب على مستوى المرفق الصحي إلى جانب استراتيجيات التواصل فإن بالإمكان تنفيذ جهود لتوليد الطلب قائمة على علم السلوك قبل إتاحة اللقاحات لتهيئة العاملين الصحيين للتطعيم. وتعمل هذه التدخلات المستندة إلى الإيماءات عبر خلق بيئة يمكن أن تؤثر على السلوك بطريقة متوقعة دون أن تلغي فرصة الاختيار )75(، وقد أثبتت فعاليتها في طائفة متنوعة من سياقات الرعاية الصحية )85(. ويمكن لهذه التدخلات أن تضيِّق الفجوة بين النية والسلوك الفعلي، والناجمة عادة عن نسيان الأفراد أو العاملين الصحيين لتلقي تطعيمهم أو بسبب الحواجز التي تعترض سبيل التطعيم المريح. وبالإضافة إلى ذلك فكثيرا ً ما يمكن تنفيذ هذه التدخلات بتكلفة منخفضة نسبيا ً)95(. ويعرض الشكل الُمدرج أدناه (الشكل 3)، المقتبس من مجلس الأخلاقيات البيولوجية في نفيليد، تراتبية التدخلات لتحسين الإقبال على اللقاحات )06(. وتتسم الإيماءات الواردة في الدرجات الدنيا من السلم بقدر أقل من الإقدام ولكنها تظل ذات أثر ملموس. وعبر توفير معلومات عن معدل التطعيم في المرافق الصحية، وهو عملية مستخدمة في الولايات المتحدة لتحسين الإقبال على تطعيم الأطفال، فإن بالمستطاع رصد التقدم في هذه المرافق، وتوفير الحوافز للعاملين الصحيين للنهوض بممارساتهم الذاتية بشأن التطعيم )16(. سلم التدخلات لزيادة معدلات التطعيمالشكل 3لا توجیھ الاختیار عبر الخیارات التلقائیة تحدید موعد لتطعیم الشخص تلقائیاً ما لم یقرر الامتناع عن ذلك إتاحة الاختیار زیادة الخیارات المتاحة لتلقي التطعیم مثل تلقیھ في مكان العمل أو بالقرب من المنزل حفز نوایا التنفیذ الطلب إلى الأفراد الالتزام المسبق بموعد ومكان لتلقي التطعیم تأطیر المعلومات توفیر معلومات مقارنة اجتماعیة بشأن معدلات التطعیم بین الأقران أو الأفراد الأصحاء تقدیم المعلومات عرض توفیر التوعیة بشأن منافع التطعیم للمتلقین ذاتھم وللآخرین الإحجام عن القیام بأي عمل الاكتفاء ببساطة برصد معدلات التطعیم )المصدر : SM letaP المرجع 23( ويمكن أن تشكل التذكيرات الموجهة إلى الأفراد إيماءة لإخطارهم بموعد استحقاق تطعيمهم ودفعهم إلى القدوم إلى موقع التطعيم لتلقيه. وقد تكون هذه التذكيرات على شكل رسائل ورقية أو رسائل نصية عبر الهواتف المحمولة، وقد أثبتت فعاليتها )26(. وفي المرفق الصحي فإن باستطاعة التذكيرات الموجهة إلى 13 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين العاملين الصحيين من خلال أداة جمع بيانات التمنيع (سواء الورقية منها أو الإلكترونية) أن تساعد على النهوض بتسليم العاملين الصحيين للقاحات التطعيم. ومن بين الاستراتيجيات الناجحة المستندة إلى الإيماءات والرامية إلى الحد من الحواجز القائمة في وجه التطعيم وإتاحة الاختيار اعتماد الأوامر الدائمة. وهذه الأوامر هي سياسة ُترسى في مرفق صحي وتتيح للعاملين الصحيين من غير الأطباء إعطاء اللقاحات دون حاجة إلى وصفة أو أمر صريح من طبيب، وقد برهنت هذه السياسة على أنها من بين أكثر الاستراتيجيات فعالية في النهوض بالإقبال على التطعيم حينما تكون ملائمة )36(. ويمكن ضم كل هذه الاستراتيجيات إلى ُنهج الاتصالات لخلق الطلب في المجتمع المحلي. حملة «azoolapalufl» لزيادة الإقبال على التطعيم المضاد دراسة حالةلا للأنفلونزا الموسمية في صفوف العاملين الصحيين يستخدم المركز الطبي لجامعة فاندربيلت في ناشفيل في تنيسي بالولايات المتحدة أكثر من 42 000 من العاملين الصحيين. ومنذ عام 1102 كان حجر الزاوية في حملته للتطعيم المضاد للأنفلونزا الموسمية هو حدث التطعيم الجموعي المضاد للأنفلونزا، الذي أطلق عليه على سبيل الدعابة اسم مهرجان الأنفلونزا «azoolapalufl». ويتم في هذا الحدث تطعيم أكثر من 41 000 شخص في يوم واحد وسطيا. وقد خضع تصميم نقاط التوزيع الحصرية (dop-c) للتقييم والصقل على مر الزمن لزيادة معدلات إعطاء اللقاحات من حيث الكفاءة والتغطية بشكل ضخم. ويؤكد الحدث على الطابع الاحتفالي عند ممارسة المهارات المهمة للتطعيم الجائحي في صفوف القيادة الصحية التشغيلية والإدارية للمستشفى. ويحقق هذا الحدث تغطية عالية بين فئات العاملين الصحيين من الحاضرين في ذلك اليوم؛ غير أنه بفعل تركيب نوبات التمريض ومسؤوليات الأجنحة في المؤسسة فإن التطعيم يغطي في العادة أقل من 03 بالمائة من موظفي التمريض أثناء الحدث. وهكذا فإن المركز الطبي يعتمد بالإضافة إلى المهرجان أساليب الزيارات إلى الأجنحة، والعربات المتنقلة، واستراتيجيات أخرى لتحقيق المعدل السنوي المستهدف للتغطية الكلية للعاملين الصحيين بالتطعيم والذي يزيد عن 09 بالمائة. وتجدر الإشارة إلى أنه على الرغم من أن السياسة المؤسسية زادت تدريجيا ًمن الصعوبات القائمة في وجه الامتناع عن التطعيم وأدرجت في نهاية المطاف تدابير انضباطية لعدم التطعيم بدون مبرر، فإن نسبة التغطية وصلت إلى 29 بالمائة في المواسم التي سبقت تطبيق السياسات الانضباطية. وثمة مطبوع متاح على شبكة الإنترنت يعرض تفاصيل تصميم الحدث، والرسوم البيانية لتدفق العمل، والدروس النوعية العملية المستفادة. المصدر: azoolapalufl eht :ecalpkrow eht ni ssenderaperp ycnegremE .la te ,WD enryB ,HM uyilA ,DM tfiwS .67–861s:(2s)701;pes 7102 .htlaeH cilbuP fo lanruoJ naciremA .noitaniccav ssam rof ledom 359303.7102.HPJA/5012.01/sba/iod/gro.snoitacilbupahpa.hpja//:ptth 23 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين تجاوز الإيماءات إن الإيماءات هي الطريقة المفضلة للتأثير على الطلب لأنها تحفظ حق الاختيار ولأنها غير قسرية. على أن بعض الخبراء يحاجون بأنه عندما تفشل الإيماءات في تحقيق الإقبال الأمثل على التطعيم في صفوف العاملين الصحيين، وتؤدي إلى الإضرار بمرضاهم، فإن على صنَّاع السياسات أن ينظروا في اعتماد سياسات أشد )46(. ولا يعني ذلك أنه عند فشل الإيماءات فإنه ينبغي المبادرة على الفور لاعتماد إجراءات تلغي الاختيار. فهناك تدخلات قائمة عبر متسلسلة تصل حتى تقييد الاختيار. وتوفر «الأحكام اللينة» أمثلة على التدابير عبر هذه المتسلسلة. ويعرض الملحق جدولا ً يعدد الُنهج المختلفة للاتصالات وخلق الطلب، إلى جانب الإشارة إلى الجهد اللازم لتنفيذ النهج والأثر المنتظر. شراء اللقاحات وإدارة سلسلة الإمداد شراء اللقاحات يتطلب الحصول على اللقاحات بأسعار ُمثلى فهما ًجيدا ًلآليات الشراء ونظمه، وديناميات أسواق اللقاحات، وعناصر تسعير اللقاحات. ويبدأ الشراء بتوقع الطلب على اللقاحات، وتعقب ذلك عمليات طرح المناقصات، والتعاقد، والمشتريات. ويعرض صندوق الأدوات 11 الأدوات والموارد اللازمة لشراء اللقاحات. وقد تكون هناك سمات فريدة لعملية شراء لقاحات الأنفلونزا الموسمية وربما تتطلب موافقات تنظيمية والتزامات شراء مسبقة مع جهات تصنيع محددة ُبعيد نشر توصيات منظمة الصحة العالمية بشأن تركيب اللقاحات الموسمية (في فبراير/ شباط في نصف الكرة الشمالي وفي سبتمبر/ أيلول في النصف الجنوبي) وقبل فترة طويلة من موسم الأنفلونزا. صندوق الأدوات 11 أدوات شراء اللقاحات آليات الشراء وُنظمه smetsys_smsinahcem/tnemerucorp/smetsys_semmargorp/noitazinummi/tni.ohw.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) المنصة الإلكترونية لمنتجات اللقاحات، وأسعارها، وشرائها (P3V) mroftalp/p3v/tnemerucorp/smetsys_semmargorp/noitazinummi/tni.ohw.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) سوق اللقاحات tekram/tnemerucorp/smetsys_semmargorp/noitazinummi/tni.ohw.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) قائمة منظمة الصحة العالمية للقاحات الأنفلونزا الموسمية المختبرة الصلاحية /beW_QP/ivag/tni.ohw.tenartxe//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102)  33 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين اختيار منتج اللقاح ونموذج التعبئة على غرار كل اللقاحات الأخرى فإن اختيار اللقاح ونموذج التعبئة يعتمد على عوامل متعددة بما في ذلك توافر الإمدادات، والسعر، وسهولة الاستخدام، ومتطلبات التخزين والنقل، ومخلفات اللقاحات، وفرص التطعيم الضائعة (مثل تأخير التطعيم نتيجة التردد في فتح قارورة تحتوي على 01 جرعات من أجل شخص واحد أو شخصين). وينبغي أن يعتمد اختيار حجم القارورة على عدد الجرعات التي سُتعطى في كل نقطة تطعيم وعدد الجلسات التي سُتعقد في كل نقطة. وتتوافر اللقاحات الحالية الحقنية المختبرة الصلاحية المضادة للأنفلونزا الموسمية على شكل محاقن مسبقة التعبئة تحتوي جرعة واحدة وفي قوارير محتوية على جرعة واحدة أو 01 جرعات. وتتضمن كل نماذج القوارير عشرية الجرعات الثيوميرسال كمادة حافظة. على أنه تجدر الإشارة إلى أن المنتجات المختبرة الصلاحية المتاحة حاليا ًفي قوارير عشرية الجرعات لا تتمتع جميعها بترخيص سوقي للتخزين مدة تزيد على 82 يوما ًبعد فتحها، كما أنها ليست جميعا ًمجهزة براصد لقوارير اللقاحات (MVV). وينبغي مراعاة كل هذه الجوانب عند اختيار المنتج ونموذج تعبئته. ويتعين التدقيق في مواصفات المنتج ونموذج التعبئة للتأكد من أنها تلبي متطلبات البرنامج قبل تقديم طلب الشراء. ويمكن الاطلاع على المعلومات المتصلة بلقاحات منظمة الصحة العالمية المختبرة الصلاحية في الموقع الإلكتروني للمنظمة (انظر صندوق الأدوات 11). ويعتبر توقع الطلب على اللقاحات خطوة أولى مهمة في عملية شرائها. ويتطلب توقع الطلب تقدير عدد العاملين الصحيين المزمع استهدافهم بالتطعيم، وتغطية التطعيم المنتظرة، وتقدير مخلفات اللقاحات. وبصورة مثالية فسيتم استهداف العاملين الصحيين في المرافق العامة والخاصة على حد سواء. ومن المحتمل أن تكون عملية تقدير حجم الجمهرة المستهدفة في تطعيم العاملين الصحيين أكثر تعقيدا ًمن أنشطة استهداف المجموعات السكانية العامة باللقاحات الأخرى. كما قد يكون من الأصعب تحديد تاريخ استخلاص مثل هذه التقديرات، ولاسّيما في البلدان المنخفضة والمتوسطة الدخل. ويوفر صندوق الأدوات 12 موارد لتقدير حجم قوة العمل الصحية وأولئك الذين يجب استهدافهم بالتطعيم. صندوق الأدوات 21 موارد تقدير حجم الجمهرة المستهدفة المرصد الصحي العالمي ecrofkrow_htlaeh/ohg/tni.ohw.www//:ptth  قاعدة بيانات الإحصاءات العالمية للقوة العاملة الصحية statsfwh/scitsitats/hrh/tni.ohw.www//:ptth  تعداد العاملين الصحيينل التعاريف، والبيانات، والمنهجية، والنتائج العالمية fdp.srekrow_htlaeh_gnitnuoc/stnemucod/hrh/tni.ohw.www//:ptth نموذج تصنيف العامل الصحي – بالإنجليزية fdp.noitacifissalc_srekrow_htlaeH/scitsitats/hrh/tni.ohw.www//:sptth 43 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين وقد لا تتضمن قواعد بيانات القوة العاملة الصحية العالمية معلومات عن كل فئات العاملين الصحيين التي قد ُتستهدف بالتطعيم. وعلى سبيل المثال فإن قواعد البيانات العالمية قد تتضمن فحسب تقديرات عن عدد الأطباء، والممرضين، والقابلات، وأن ُتغفل الفئات الأخرى للعاملين الصحيين. وفي هذه الحالات فإن بالمستطاع وضع تقديرات تقريبية استنادا ًإلى نسب أولئك العاملين الصحيين الذين لا تتوافر البيانات عنهم إلى من تتوافر عنهم البيانات (مثل نسبة الأطباء إلى العاملين في المختبرات). ويمكن استخلاص مثل هذه النسب بسرعة عبر مسح عينية تمثيلية صغيرة (مثل الثالثية، والثانوية، والأولية) للمرافق الصحية. وبما أنه قد ُيطلب إلى كل مرفق صحي إعداد قائمة بالمستفيدين مع أسماء المستهدفين بالتطعيم، لتتبع تسليم التطعيم، ولحفظ سجلات المطعَّ مين، فإن بالمستطاع صقل توقعات الطلب الأولية في السنوات التالية باستخدام بيانات قوائم المستفيدين وسجلات التطعيم تلك. اللوجستيات وسلسلة التبريد ُتماثل مناولة لقاح الأنفلونزا ما هو مطبق على معظم اللقاحات الأخرى في برنامج التمنيع الوطني. ومن الواجب تخزين هذا اللقاح عند درجة حرارة مئوية قدرها 2–8 درجات. وبما أن من المنتظر أن يجري تطعيم العاملين الصحيين سنويا ًخلال فترة سانحة قصيرة كل عام قبل بدء موسم الأنفلونزا فلا بد من وضع خطة لضمان تخزين ونقل اللقاحات على مختلف الأصعدة المنخرطة في سلسلة الإمداد خلال الفترة السانحة المختارة للتطعيم. وتتوافر الأدوات والموارد اللازمة للتوقعات، والإدارة، واللوجستيات في الموقع الإلكتروني لمنظمة الصحة العالمية (صندوق الأدوات 13). كما تتوافر المتطلبات الحجمية لسلسلة التبريد ونماذج التعبئة لكل منتج مختبر الصلاحية لمنظمة الصحة العالمية في الموقع المذكور (يرجى اختيار نوع اللقاح والضغط على الروابط الخاصة بكل منتج ونموذج تعبئة منفرد للحصول على هذه المعلومات).11 وعلى مستوى المرفق الصحي فإن على المنسِّ ق المسؤول عن تطعيم العاملين الصحيين أن يكفل إدراج جرعات اللقاح اللازمة في المرفق ضمن توقعات الطلب وإتاحة حيز تخزين كاف قبل التاريخ المتوقع لوصول اللقاح إلى المرفق الصحي. 11 3=van?xpsa.esworB/beW_QP/ivag/tni.ohw.tenartxe//:sptth .seniccav deifilauqerp OHW صندوق الأدوات 31 إدارة اللقاحات وموارد الدعم هناك موارد يمكن أن تساعد مدراء البرامج في تخطيط سلسلة الإمداد والدعم اللوجستي في الموقع الإلكتروني لمنظمة الصحة العالمية: /ne/sloot/secruoser/niahc_ylppus/smetsys_semmargorp/noitazinummi/tni.ohw.www//:ptth  lmth.4xedni (تم الاطلاع في 41 شباط/ فبراير 9102) نظرة عامة على تقنيات حديثة لمعالجة النفايات المعدية والحادة من مراكزالرعاية الصحية fdp.gne-8226151429879/641823/56601/eldnah/maertstib/siri/tni.ohw.sppa//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102) 53 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين تطعيم العاملين الصحيين ينبغي أن يتم تطعيم العاملين الصحيين في الوضع المثالي في المرافق الصحية التي يعمل فيها هؤلاء العاملون الصحيون المستهدفون عادًة لضمان حصولهم المريح على التطعيم. وعلى كل مرفق صحي أن يعد خطة له لتنفيذ تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية قبل فترة طويلة من موسم الأنفلونزا. وعلى هذه الخطط أن تتضمن إجراءات لتمكين الحصول المريح على التطعيم للعاملين الصحيين في كل نوبة. وقد تدعو الحاجة إلى تقرير خيارات مختلفة على مستوى المرفق الصحي لتغطية العاملين الصحيين خلال النوبات الليلية دون اللجوء إلى خدمات للتطعيم على مدار 42 ساعة، وذلك مثلا ًبضمان توافر التطعيم قبل عملية تبديل النوبة أو بعدها. الاستعانة بمناصري التمنيع في تعزيز الإقبال على التطعيم دراسة حالةلا المضاد للأنفلونزا في صفوف العاملين الصحيين في ُعمان تمتلك ُعمان نظاما ًشاملا ًمجانيا ًللرعاية الصحية المتكاملة يتضمن تطعيم العاملين الصحيين المضاد للأنفلونزا. وتعد ُعمان من بين البلدان القليلة ذات الدخل المرتفع في إقليم شرق المتوسط التابع لمنظمة الصحة العالمية التي تمكنت من تحقيق تغطية عالية للتطعيم المضاد للأنفلونزا في صفوف العاملين الصحيين (>80 بالمائة). وأمكن تحقيق ذلك بفضل مناصري التمنيع. ويبدي وزير الصحة العماني حماسا ً شديدا ً لحماية صحة العاملين الصحيين ويتصدر الصفوف عند تلقي اللقاح الأول المضاد للأنفلونزا الموسمية. وباعتباره حامي مجتمع العاملين الصحيين ومن بين ذوي النفوذ في البلاد فإن عمله هذا يعزز أهمية التطعيم ويساعد باستمرار على ترويج برامج التمنيع الخاصة بالأنفلونزا. كما أنه ينخرط شخصيا ًفي نقل رسائل التطعيم إلى مجتمع العاملين الصحيين. وينبغي إنشاء فريق للتطعيم على مستوى المرفق الصحي لتنسيق أنشطة التطعيم والنهوض بالإقبال عليه إلى المستوى الأمثل تحت الإشراف الشامل لرئيس المرفق. ويتعين تسمية شخص واحد كقائد للفريق. ويمكن أن يضطلع بهذه المهمة منسِّ ق السلامة والصحة المهنيتين، أو المسؤول عن أنشطة التمنيع في المرفق الصحي. وفي المرافق الضخمة يمكن تكليف الخدمات الصحية للموظفين بهذا النشاط. وأظهرت الخبرة المكتسبة من بعض المنظمات والمرافق الصحية أن استخدام «مناصري التطعيم» من بين العاملين الصحيين قد يسهم في تحسين الإقبال على التطعيم في صفوف أقرانهم. وفي بعض البلدان تم بنجاح اللجوء إلى استخدام فريق متنقل يتوجه إلى كل منطقة سريرية ويوفر التطعيم. 63 3 - تخطيط وإدارة تدابير تطعيم العاملين الصحيين تدريب فريق التطعيم ينبغي إقامة حلقات عملية تدريبية لمنسقي التطعيم في المرافق الصحية لتوفير التدريب على وضع خطط للمرافق وتنفيذ أنشطة التطعيم ورصدها. ويتعين وضع جدول أعمال منمَّط، ومنهاج دراسي، ووثائق للموارد، وقوائم مرجعية، واستمارات نموذجية لتسجيل البيانات، حسب الاقتضاء، على المستوى الوطني لاستخدامها في تلك الحلقات العملية بحيث يكون التدريب متسقا ًعبر كل المرافق الصحية. وتعزيزا ًلضمان التدريب المتسق فإن بالإمكان إجراء الحلقات العملية بالاستعانة بأفرقة من المدربين الذين تم تأهيلهم مركزيا ً والمعينين لكل منطقة رئيسية/فرعية باستخدام نهج التدريب المتسلسل. وبالمستطاع استعمال أشرطة فيديو تدريبية قصيرة لتحقيق الاتساق في محتوى التدريب. ويمكن النظر في اعتماد وحدات نموذجية للتدريب الذاتي على شبكة الإنترنت لأولئك الذين يعجزون عن حضور الدورات التدريبية. ويتعين أن يمتلك فريق التطعيم على مستوى المرفق الصحي القدرة على تصنيف مجموعات العاملين الصحيين (انظر الفصل 2 للاطلاع على نموذج لتصنيف العاملين الصحيين من حيث المخاطر) ووضع قائمة بأسماء العاملين الصحيين المؤهلين للتطعيم، مع تسميات وظائفهم، ومناطق عملهم. وعند انطباق سياسات تطعيم مختلفة على فئات المخاطر المتفاوتة فإنه يتعين وضع قوائم منفصلة، أو إرساء آليات لتحديد ورصد وضع المندرجين في كل فئة بسهولة. وينبغي إعداد قوائم المستفيدين قبل فترة كافية من بدء أنشطة التطعيم وإخطار العاملين الصحيين المعنيين بالحاجة إلى تلقي التطعيم. وبالإضافة إلى العاملين الصحيين المستخدمين في المرفق الصحي، فإنه يمكن وضع ترتيبات لإدراج العاملين الصحيين في المرافق الصحية الأصغر الواقعة ضمن نطاق تغطيته، وفقا ً للسياسة الوطنية، في حال عدم توافر التطعيم في كل المرافق. وينبغي إنشاء آلية لتتبع المتخلفين وإرسال التذكيرات في كل مرفق صحي. وبالنسبة للعاملين الصحيين الذين يحتكون بالمرضى ذوي المخاطر العالية (مثل العاملين في وحدات زرع الأعضاء، والأورام، والعناية المركزة، أو الوحدات المعنية بالفترة المحيطة بالولادة) فإن الأمر قد يقتضي إخطار المشرفين على أولئك الذين لم يتلقوا التطعيم قبل بداية موسم الأنفلونزا بحيث يمكن لهم تعزيز التذكيرات الخطية، أو إلزام الرافضين بتوقيع استمارات بالامتناع الصريح عن التطعيم، وتطبيق إجراءات لمكافحة العدوى على الرافضين الصريحين، مثل النقل من الوظائف، وارتداء الأقنعة، وما إلى ذلك طبقا ًللسياسة المعتمدة على المستوى الوطني أو مستوى المرفق الصحي. 73 الرصد والتقييم4 - ينبغي أن تمتلك كل البلدان آلية قائمة لرصد تغطية اللقاحات وكذلك الأحداث الضارة بعد التمنيع (AEFI) من المرفق الصحي وحتى المستوى الوطني وأن تجري تقييما ًواحدا ًعلى الأقل لمرحلة ما بعد إدخال لقاح الأنفلونزا. غير أن قياس قبول اللقاح وفعاليته أو أثره سيكون ضروريا ًومجديا ًفحسب في سياق لم يتم فيه تحقيق الأرقام المستهدفة وإذا كان التمويل متوافرا. استحداث نظم المعلومات وتحديثها يتعين إرساء استمارات ونماذج تدوين مناسبة لتسجيل بيانات التطعيم والتبليغ عنها على مستوى المرفق الصحي وعمليات للتبليغ عن البيانات. وعند استحداث الأدوات والإرشادات لجمع البيانات ينبغي النظر في مدى الحاجة إلى إدراج النظم الصحية العامة والخاصة على حد سواء. وقد يتطلب ذلك وضع خريطة بما هو قائم من نظم للمعلومات الصحية وأدوات لجمع بيانات التمنيع وكذلك إرشادات بشأن كيفية استخدام هذه النظم في جمع البيانات المتعلقة بالتمنيع السنوي للعاملين الصحيين. وقد تتباين نظم جمع البيانات عبر المرافق الصحية تبعا ًلحجم المرفق وبنيته التحتية المتوافرة. على أن من الواجب تزويد كل مرفق باستمارة منمَّطة لجمع البيانات لضمان أن ُتجمع البيانات اللازمة لتبليغ المستوى الوطني، بغض النظر عن النظام المستعمل لتسجيل البيانات. وقد يشمل ذلك أسماء العاملين الصحيين، ومناطق عملهم، وفئة مخاطرهم، وبيانات تطعيمهم، والمنتج اللقاحي، ورقم الدفعة. وعند إعداد استمارة التبليغ عن البيانات ينبغي مراعاة مشورة الفريق الاستشاري التقني الوطني للتمنيع بشأن الرصد وتقدير الأثر. ويتعين أن تتمتع كل نظم جمع البيانات، سواء أكانت ورقية أم إلكترونية، بالقدرة على تتبع المتخلفين، وأن تكون مجهزة بنظام لتوليد وإرسال التذكيرات إليهم. ولدى استخدام نظم التذكيرات هذه فإن الحفاظ على سرية البيانات عن الوضع الصحي والتطعيمي للعاملين الصحيين يتسم بأهمية بالغة، كما ينبغي حصر الاطلاع على البيانات بمنسق التطعيم في المرفق. رصد التغطية يتوافر العديد من الُنهج لتقدير تغطية لقاحات الأنفلونزا في صفوف العاملين الصحيين. وُيَعد توقيت قياس مثل هذه التغطية مهما ًوينبغي أن ُينسَّ ق مع توقيت التطعيم في البلاد. وبما أن لقاح الأنفلونزا ُيعطى عادة خلال حملات موسمية فإنه يوصى باعتماد التبليغ المتكرر (شهريا ًمثلا). وبصورة مثالية يتعين إجراء التقديرات في نهاية الموسم عند توافر البيانات الكاملة وخضوعها للتقدير وبعد تصفية هذه البيانات من أوجه التضارب. 83 4 - الرصد والتقييم سجلات المرافق الصحية ينبغي إدراج المعلومات المتعلقة بلقاحات الأنفلونزا المعطاة للعاملين الصحيين في السجلات القائمة المحفوظة كجزء من متطلبات الصحة المهنية وفي سجلات التطعيم كجزء من آليات الرصد المؤسسية. ويتطلب الأمر تقديرا ًدقيقا ًلأوجه تضارب البيانات في حال التبليغ من مصادر متعددة، وينبغي دراسة مسائل حماية البيانات بحصافة. وتشمل المجموعة الدنيا من البيانات عدد متلقي التطعيم المضاد للأنفلونزا خلال كل موسم سنوي، والعدد الإجمالي للعاملين الصحيين المستهدفين، وتغطية التطعيم المستخلصة (كنسبة مئوية). وفي غالب الأحيان فإن بالإمكان الحصول على بيانات البسط والمقام على حد سواء من إدارات الصحة المهنية في المرافق الصحية. ولإرساء بيانات بسط أكثر تفصيلا ًيمكن استخدام السجلات الاسمية للعاملين الصحيين مثل تلك المستندة إلى كشوف المرتبات كخطوة أولى. ويمكن اختيار قائمة مستفيدين من أولئك المستهدفين بالتطعيم المضاد للأنفلونزا بتطبيق معايير ترتبط بخطر تعرض العامل الصحي للعدوى أو نقله العدوى إلى من هم في رعايته (انظر القسم المعنون ’توصيف المجموعات المستهدفة بالتطعيم’ والجدول 1). ورهنا ًبقدرة البرنامج ونظام التبليغ، فإن ذلك قد يشمل حساب الأعداد وفقا ًلفئة ومرتسم مخاطر العاملين الصحيين بما يتيح وضع تقديرات للتغطية حسب الفئات الفرعية، مثل الأطباء، والممرضين، والعمال المختبريين، أو الموظفين العاملين في وحدات العناية المركزة أو الأجنحة العامة (مثل أجنحة الأطفال أو المعالجة الدوائية)، وما إلى ذلك. وفي حال عدم وجود سجل للتطعيم فإن بالمستطاع حساب تقدير تقريبي للتغطية في صفوف العاملين الصحيين باستخدام عدد جرعات اللقاح الموزعة على كل مرفق مع خصم عدد الجرعات المرتجعة (غير المستخدمة) والتقسيم على العدد التقديري للعاملين الصحيين المستهدفين بالتطعيم في المرفق. وثمة طريقة مماثلة، علما ًبأنها غير دقيقة، لتقدير التغطية على المستوى الوطني وهي استخدام البيانات المجموعة بانتظام عن العاملين الصحيين (حسبما ُتبلَّغ إلى منظمة الصحة العالمية) لتقدير المقام (انظر صندوق الأدوات 12)، على نحو ما هو مستخدم لتوقع الطلب اللقاحي، واستخدام العدد الكلي للقاحات المعطاة على أنه البسط. ولا يجوز استخدام هذا النهج إلا كملاذ أخير حينما لا تكون أي من الطرق الموصوفة الأخرى مجدية. البيانات الإدارية في حال توفير اللقاحات مجانا ًللعاملين الصحيين وتحمُّ ل الحكومة، أو نظام التأمين الوطني، أو أرباب العمل للتكاليف فقد يكون هناك تبليغ منتظم، وإلزامي أحيانا،ً عن عدد العاملين الصحيين المتلقين للتطعيم على المستوى المؤسسي. وربما تتوافر هذه البيانات من برامج اللقاحات الوطنية الحسنة التوثيق أو من سجلات التأمين الصحي. لمسوح ينبغي إجراء المسوح لاستخلاص البيانات عن عمليات التطعيم والتدخلات الأخرى كل 3 إلى 5 سنوات، وأن تتيح تحديد عدم تجانس التغطية على المستوى دون الوطني، وهو أمر مهم للمواءمة الضرورية لممارسات التمنيع. ويمكن اختيار عينة تمثيلية للعاملين الصحيين من خلال نهج الاعتيان العشوائي الطبقي من السجلات الوطنية للعاملين الصحيين (مثل المنظمات المهنية). وفي حال عدم توافر مثل هذه السجلات فإنه يمكن القيام باختيار ذي مرحلتين للمرافق الصحية وللعاملين الصحيين في هذه المرافق. 93 4 - الرصد والتقييم وعند توافر معلومات الاتصال فإن بالمستطاع إجراء مقابلات منمَّطة وجها ًلوجه، أو عن طريق الهاتف أو منصات الإنترنت. وبدون مثل هذه المعلومات يمكن توفير روابط خاصة بالمسج على الإنترنت لكل العاملين الصحيين في المرافق الصحية ودعوتهم إلى الدخول إلى منصة المسح باستعمال هواتفهم المحمولة أو حواسيبهم الشخصية. وتجدر الإشارة إلى أن استخدام هذه النهج من التبليغ الذاتي قد يؤدي إلى فرط في التبليغ.21 وفي كل ُنهج تقدير التغطية هذه سيكون من المهم تحديد فئات العاملين الصحيين، مثل من لهم احتكاك مباشر بالمرضى، ومن ليس لهم مثل هذا الاحتكاك كالطلاب، والمتدربين، والمتطوعين، وموظفي الصيانة، وتكنولوجيا المعلومات، والخدمات الغذائية، وغيرهم، الذين أُدرجوا في بيانات البسط والمقام. كما أن من المهم تحديد ما إذا كان الموظفون ذوو الدوام الجزئي الذين يعملون أثناء موسم الأنفلونزا قد أُدرجوا في تقديرات التغطية. وعند تطعيم أشخاص لا يوصى بتطعيمهم، مثل العاملين في المكاتب الخلفية أو أقارب الموظفين وما إليهم، فإنه ينبغي توخي الحذر كي لا ُيدرج هؤلاء في تقدير تغطية التطعيم. وتدعو الحاجة إلى رصد معدلات الامتناع والاستكمال الخاصة بالمسوح وإدخال التعديلات اللازمة لمعالجة تحيزات الاختيار المحتملة التي حدثت في التحليل. وفي بعض الأحيان فإن برامج التطعيم المضاد للأنفلونزا قد تحدد فحسب أهدافا ً بأرقام مطلقة للعاملين الصحيين المزمع تطعيمهم استنادا ًإلى عدد اللقاحات التي تم شراؤها والمتوافرة في منطقة معينة أو موقع محدد. ولن يتيح مثل هذا النهج، المتبع في بعض البلدان، التقدير المناسب لمعدلات التغطية، بما في ذلك التقدير بحسب فئة المخاطر، أو المقارنات عبر الزمن، وهو ما يتسم بالأهمية لتفسير أي بيانات عن الأثر. كما أن ذلك لن يتيح تحديد العوامل المحدِّ دة للتطعيم أو للامتناع عنه. وفي حال التوافر ينبغي الاطلاع على البيانات وكذلك الطرق المستخدمة لتقدير تغطية التطعيم المتعلقة بعمليات التطعيم المنهجية الأخرى للعاملين الصحيين، مثل التطعيم باللقاحات المضادة للالتهاب الرئوي B، أو شلل الأطفال، أو الشاهوق، أو الكزاز. على أنه تجدر الإشارة إلى أن هذه اللقاحات لا ُتعطى على أساس سنوي ولن يتم التحقق منها في الغالب عند الدخول إلى الخدمة. ويعرض صندوق الأدوات 14 الأدوات المتاحة لجمع بيانات التمنيع والتبليغ عنها ولتقدير التغطية. رصد الأحداث الضارة بعد التمنيع يعد إرساء نظام عامل لرصد الأحداث الضارة بعد التمنيع متطلبا ًأساسيا ًلأي مجموعة لقاحية ومستهدفة، حيث إن المؤلفات تحدد باستمرار فجوات معرفية وتفسيرات خاطئة لمأمونية لقاحات الأنفلونزا في صفوف العاملين الصحيين. 21 ydutS lanoitceS-ssorC A :sutatS noitaniccaV azneulfnI fo tropeR-fleS secneulfnI ruoivaheB noitaniccaV .la te A aipulL /3774933CMP/selcitra/cmp/vog.hin.mln.ibcn.www//:sptth .69493e:(7)7 ;2102 enO SoLP .srekroW eraC htlaeH gnoma 04 4 - الرصد والتقييم وبصورة مثالية يتعين إدماج النظام المستخدم لتدابير الرصد والتحقيق المتعلقة بالأحداث الضارة المحتملة للتمنيع عند إعطاء لقاح الأنفلونزا ضمن نظم الترصد القائمة للأحداث الضارة بعد التمنيع بما يتماشى مع اللوائح الوطنية لرصد مأمونية اللقاحات. وعلى برنامج التمنيع الوطني أو الإدارات الأخرى المسؤولة عن تطعيم العاملين الصحيين المضاد للأنفلونزا (مثل إدارة الصحة المهنية) العمل مع السلطة التنظيمية الوطنية لتحديد الأدوار والمسؤوليات المتعلقة برصد مأمونية اللقاحات. وفي البلدان التي تستخدم لقاحات الأنفلونزا للمرة الأولى فإنه يمكن تصور تكثيف ترصُّ د الأحداث الضارة بعد التمنيع في السنة الأولى من إدخال لقاحات الأنفلونزا ُبْغية توفير معلومات مرتدة سريعة لأصحاب المصلحة للمساعدة على طمأنتهم بشأن مأمونية اللقاح المستخدم. ويكفل نظام عامل لرصد الأحداث الضارة بعد التمنيع كشف وتوضيح المشكلات المتعلقة باللقاحات، والتي قد تكون عائدة إلى المنتج ذاته، أو إلى جودته، أو إلى أخطاء في إعطاء اللقاحات. وينبغي القيام بتبليغ نظام رصد الأحداث الضارة بعد التمنيع بكل متلقي اللقاحات الذين تعرضوا لأحداث (بما في ذلك الطفيفة منها) التي ُيعتقد أن لها علاقة بلقاح الأنفلونزا، وذلك باستخدام استمارات التبليغ الموحدة (انظر صندوق الأدوات 1 ). وفي حال توافر التبليغ الكافي فإن من المفروض أن يكون نظام الرصد قادرا ًعلى تقييم المعدل الُمشاهد من التفاعلات إزاء لقاح الأنفلونزا ومقارنة ذلك بالمعدلات المنتظرة الُمبلغ عنها في المؤلفات. وبالنسبة للأحداث الضارة الخطيرة بعد التمنيع فإن فريقا ًمن الخبراء يتولى في العادة أمر تقدير السببية. ومن المهم، وعلى غرار ما هو عليه الحال بالنسبة لأي لقاح آخر، فإن مثل هذا النظام يجب أن يكون قادرا ًعلى تحديد تفاعل لقاحي مفاجئ أو غير معروف سابقا ًوالذي يمكن التحقيق فيه بمزيد من التعمق. وينبغي توخي الحذر كي لا ُيظن خطأ بأن الأحداث العرضية هي تفاعلات لقاحية. صندوق الأدوات 41 أدوات ومؤشرات الرصد والتقييم التمنيع في سلسلة الممارسة، الوحدة النموذجية 7ل رصد واستخدام بياناتك. تصف كيفية جمع البيانات والتبليغ عنها وسبل رصد أداء التمنيع. fdp.7eludoM_PII/secruoser/ecnallievrus_gnirotinom/noitazinummi/tni.ohw.www//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102) تدريب المدراء على المستوى المتوسط، الوحدة النموذجية 7ل مسح تغطية البرنامج الموسع للتمنيع (الوثيقة 70.80/BVI/OHW). جنيف. منظمة الصحة العالمية؛ 8002. توفر مسيرة خطوة فخطوة، بما في ذلك الإرشادات والأدوات المعنية لتخطيط وإجراء مسوح التغطية المتعلقة بلقاح ُمدخل حديثا. fdp.7eludom_MLM/stnemucod/noitazinummi/tni.ohw//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102) مرجع منظمة الصحة العالمية لتقدير تغطية التطعيم المضاد للأنفلونزا في صفوف المجموعات المستهدفةل يعرض مختلف المنهجيات التي يمكن استخدامها لتقدير التغطية الوطنية بلقاح الأنفلونزا في صفوف المجموعات العالية المخاطر المستهدفة بالتطعيم. -azneulfni-gnissessa-sdohteM/443713/4000/elif_fdp/stessa/atad__/tni.ohw.orue.www//:ptth fdp.spuorg-tegrat-egarevoc-noitaniccav (تم الاطلاع في 41 شباط/ فبراير 9102) 14 4 - الرصد والتقييم ومن خلال إرساء وتعزيز ُنظم رصد الأحداث الضارة بعد التمنيع فإن بالإمكان أيضا ً استخدام التطعيم المضاد للأنفلونزا لمواصلة تحسين الوعي بالمأمونية الكلية للتمنيع لدى مجتمع العاملين الصحيين. رصد وتقييم قبول اللقاح تم التحقيق في الُمحدِّ دات الأساسية لقبول اللقاحات في صفوف العاملين الصحيين وهي تشمل الرغبة في الحماية الذاتية وحماية الأِسرَّ ة والمرضى. (انظر أيضا ًالقسم المتعلق بالتواصل وقبول اللقاح). وكجزء من تحليل الحالة الأولى لبرامج تطعيم العاملين الصحيين المضاد للأنفلونزا فإن بالإمكان التحقيق في المعلومات المتاحة عن السياسات، والبرامج، والممارسات، والعوامل المؤثرة على القبول والمشاركة، وتأثير وسائل الإعلام والاتصالات عبر مقابلات مع الُمبلغين الرئيسيين، أو الحلقات العملية التشاركية. ويمكن بعد ذلك استخدام نتائج مثل هذا التحليل في تنوير استراتيجيات التواصل الإضافية التي ُتعنى بأمر الهواجس المحددة بطريقة موجهة. ويمكن استطلاع الُمحددات الأخرى عبر البحوث التكوينية. وبالمستطاع استخدام طرق البحوث النوعية والكمية لتقييم التغييرات في معارف العاملين الصحيين، ومواقفهم، وممارساتهم، وسلوكياتهم. وينبغي القيام صندوق الأدوات 51 مصادر المعلومات المرتبطة بالأحداث الضارة بعد التمنيع المتغيِّ رات الأساسية للأحداث الضارة بعد التمنيع، بما في ذلك بيانات عن الحالة، واللقاح، والحدث، والُمبلِغ. fdp.5102ceD_NE_scisab_selbairav_eroc_IFEA/sloot/evitaitini/ytefas_eniccav/tni.ohw.www//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102) استمارة نموذجية لتسجيل الأحداث الضارة بعد التمنيع مع وصف مفصل لعناصر التبليغ fdp.6102naJ_NE_mrof_gnitroper_IFEA/sloot/evitaitini/ytefas_eniccav/tni.ohw.www//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102) تقدير السببية في الأحداث الضارة بعد التمنيعل يوفر منهجية مفصلة في عملية رباعية الخطوات مع القدرة على النفاذ إلى أداة برمجيات ذات صلة /fiea_svg/snoitacilbup/ytefas_eniccav/tni.ohw.www//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102)  موارد تدريبية بشأن مأمونية اللقاحات توفر النفاذ إلى حزم تدريبية تتعلق باللقاحات والتيقظ الدوائي /troppus_hcet/evitaitini/ytefas_eniccav/tni.ohw.www//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102)  بيان حقائق عن لقاح الانفلونزا fdp.teehs_noitamrofni_setar_eniccaV_azneulfnI/sloot/evitaitini/ytefas_eniccav/tni.ohw.www//:sptth (تم الاطلاع في 41 شباط/ فبراير 9102) 24 4 - الرصد والتقييم بانتظام بتقدير الُمحددات السلوكية التي تميز العاملين الصحيين الذين يتلقون التطعيم عن أولئك الذين لا يتلقونه. ومن المفيد فهم الأسباب والحجج الكامنة وراء مواقف العاملين الصحيين إزاء التطعيم السنوي المضاد للأنفلونزا لإعداد رسائل ومنتجات الاتصالات. كما أن إشراك العاملين الصحيين في البحوث السلوكية المرتبطة بانطباعاتهم، ومعتقداتهم، ومشاعرهم، وتناقضاتهم المحتملة يتيح أيضا ًالفرصة لمجتمع هؤلاء العاملين للانخراط في النهج، وهو ما يمكن أن يسفر عن زيادة القبول ببرنامج التطعيم. رصد أثر اللقاحات بعد إدخال لقاح الأنفلونزا على مجموعة سكانية فإن إجراء المزيد من الدراسات يمكن أن يساعد على تقييم أثر برنامج التمنيع. على أن منظمة الصحة العالمية لا توصي بأن تجري كل البلدان التي تنفذ برامج للتطعيم المضاد للأنفلونزا دراسات لأثر اللقاحات أو فعاليتها بالنظر إلى تعقيد هذه الدراسات وتكاليفها. ويقوم عدد من شبكات البحوث على المستوى العالمي بهذه الدراسات، ومن المتوقع أن تكون منطبقة على سياقات أخرى مماثلة من حيث وبائية الأنفلونزا وبرامج التطعيم. وعلى هذا فإن القرار بإجراء مثل هذه الدراسات يجب أن يستند إلى الحاجة إلى تقديرات قطرية مخصوصة وإلى القدرة المحلية على إجراء هذه الدراسات الدقيقة. وإذا لم ُتصمم الدراسات على النحو السليم ولم تتوافر لها عينات كافية من الفئات المختلفة للعاملين الصحيين فإن هناك خطرا ًمن التوصل إلى استنتاجات خاطئة. ولا ُينصح بإجراء دراسات سابقة – لاحقة لإيضاح فعالية اللقاح فيما يتعلق بالأنفلونزا، نظرا ًإلى أن فعالية هذا اللقاح في توّقي أعراض الأنفلونزا خلال أوبئة الأنفلونزا الموسمية تتسم بعدم تجانس شاسع.31 بل إن 31 .7102 OHW ,seiduts lanoitavresbo fo noitaterpretni dna ngised eht ot ediug A :ssenevitceffe eniccav azneulfni fo noitaulavE صندوق الأدوات 61 أدوات تقدير قبول اللقاح لدى العاملين الصحيين أداة ULF-PIT. توفر نهجا ًوأدوات ترتكز على نظريات التغيير السلوكي ونماذج تخطيط البرامج الصحية لمواءمة التطعيم المضاد للأنفلونزا مع احتياجات ومواقف العاملين الصحيين الميدانيين. /5102/snoitacilbup/azneuflni/sesaesid-elbacinummoc/scipot-htlaeh/ne/tni.ohw.orue.www//:ptth  -gnisaercni-rof-ediug-a-.ufl-pit-azneuflni-lanosaes-rof-semmargorp-noitazinummi-gniroliat 5102-noitaniccav-azneuflni-lanosaes-fo-ekatpu-srekrow-erac-htlaeh (تم الاطلاع في 41 شباط/ فبراير 9102) دراسة حالة لاستخدام أداة ULF-PIT – الجبل الأسود. توفر مثالا ًعمليا ًعلى استخدام أداة ULF-PIT -noitazinummI-gniroliaT/068182/7000/elif_fdp/stessa/atad__/tni.ohw.orue.www//:ptth fdp.ULF-PIT-azneulfnI-lanosaeS-semmargorP (تم الاطلاع في 41 شباط/ فبراير 9102) 34 4 - الرصد والتقييم الدراسات لتقييم أثر التطعيم المضاد للأنفلونزا في صفوف العاملين الصحيين قد تكون أكثر تعقيدا،ً نظرا ً إلى تباين خطر العدوى والسراية إلى المرضى بين الفئات المختلفة لهؤلاء العاملين. وبالنسبة للعاملين الصحيين فغالبا ًما ُيستخدم الانخفاض العام في التغيب عن العمل أو، في حال التوافر، الانخفاض في التغيب عن العمل المرتبط بالأنفلونزا، كمؤشر بديل لأثر برنامج التطعيم المضاد للأنفلونزا. ولهذا فإن الرصد المؤسسي للمرافق الصحية يجب أن يشمل معدلات المرض في صفوف العاملين الصحيين، وقياس الغياب المرضي. وحيثما أمكن يتعين أن يتضمن ذلك التبليغ عن أيام التغيب عن العمل بسبب العلة الشبيهة بالأنفلونزا (أو العداوى التنفسية). ويشمل ذلك العلة الشبيهة بالأنفلونزا الُمبلغ عنها ذاتيا ًمع تأكيد فيرولوجي أو بدونه. ومن بين الحصائل الأخرى غير النوعية العلة التنفسية الحادة الوخيمة والالتهاب الرئوي الناجم عن كل الأسباب الذي يتطلب الإدخال إلى المستشفى. ومن المهم الإشارة إلى أن كل هذه المتلازمات السريرية تشتمل على شتى الُممرضات التنفسية الأخرى التي لا يكفل لقاح الأنفلونزا الحماية منها. وفي حال القيام بمثل هذه التقديرات فإنها ينبغي أن تغطي، في الوضع المثالي، مواسم متعددة، حيث إن الأثر يمكن أن يتباين بشكل واسع من موسم إلى آخر، وإلا فسيكون من العسير للغاية تفسير هذه الدراسات. وتكفل الحصائل المؤكدة مختبريا ً(مثل تفاعل النسخ المعكوس لسلسلة البوليميراز(RCP-TR) والاختبارات التشخيصية الجزيئية الأخرى) تحسين نوعية تصنيف مرض الأنفلونزا. وحيثما أمكن فإنه يجوز النظر في إنشاء مواقع خافرة تتمتع بهذه القدرة لجمع العينات من العاملين الصحيين من أجل التأكيد المختبري. وفي هذه المواقع يمكن تقدير فعالية اللقاح باستخدام تصميم الحالات والشواهد ومقارنة التغطية اللقاحية في الحالات المؤكدة مختبريا ًمع الحالات السالبة مختبريا،ً إذا ما كان معدل التغطية عاليا ًبدرجة كافية. ويتطلب أي من هذه النهج قدرات مختبرية متطورة لا تتوافر في كل مكان. وطريقة التحري هي تصميم للدراسات يمكن استخدامه أيضا ًلتقدير أثر اللقاح في صفوف العاملين الصحيين: وتستخدم هذه الطريقة بيانات الأفراد المتعلقة بسيرة التطعيم المستخلصة من الحالات والبيانات المتصلة بتغطية التطعيم في جمهرة العاملين الصحيين التي أتت منها هذه الحالات. صندوق الأدوات 71 الأنفلونزا لدى العاملين الصحيينل منهجيات الدراسة تقييم فعالية لقاح الأنفلونزا 7102. يوفر معلومات مفصلة للباحثين الذين يصممون الدراسات الرصدية لفعالية لقاحات الأنفلونزا ولعلماء الصحة العمومية القائمين على تفسير وتطبيق نتائج هذه الدراسات. وسيتناول ملحق لهذا التقييم فعالية لقاح الأنفلونزا في صفوف العاملين الصحيين. fdp.gne-1212151429879/302552/56601/eldnah/maertstib/siri/tni.ohw.sppa//:ptth (تم الاطلاع في 41 شباط/ فبراير 9102) دليل تقدير عبء المرض المرتبط بالأنفلونزا الموسمية. يوفر نهجا ًمتدرجا ًلتقدير عبء مرض الأنفلونزا لدى الجمهور العام وفي صفوف أولئك المعانين من حالات محددة معرضة للإصابة بالأمراض الوخيمة. /esaesid_fo_nedrub_launam/snoitacilbup/secruoser/azneuflni/tni.ohw.www//:ptth  (تم الاطلاع في 41 شباط/ فبراير 9102) 44 4 - الرصد والتقييم وفي ضوء الدلائل القائلة إن التطعيم السنوي للعاملين الصحيين المضاد للأنفلونزا يمكن أن يقلل من معدل العلل في صفوف المرضى الخاضعين لرعايتهم، فإن بالمستطاع تصميم دراسات لتقييم أثر هذا التطعيم على معدلات الوفاة، والإدخال إلى المستشفيات، وحالات الأنفلونزا بين مرضى مرافق الرعاية الصحية. وقد تم استخدام العديد من الُنهج البحثية في هذا السياق مثل الاختبارات المعشَّ اة والحالات والشواهد. ونظرا ًإلى تعقيد تصاميم الدراسات فإن إجراء مثل هذه الدراسات يجب أن يقتصر على مؤسسات البحوث التي تمتلك القدرة والخبرة اللازمة لذلك. ويمكن النظر في إجراء تقديرات اقتصادية وتقييمات للمردودية حال توافر بيانات كافية عن التكلفة والأثر في أعقاب إدخال لقاح الأنفلونزا. وتوفر منظمة الصحة العالمية عددا ً من الوثائق المرجعية ذات الصلة التي تخضع لمزيد من التطوير كي ٌتقدِّ ر على وجه التحديد تكاليف إدخال اللقاح لتطعيم العاملين الصحيين (صندوق الأدوات 17؛ انظر أيضا ًصندوق الأدوات 2). ولا تتوافر البيانات المعنية بسهولة في كل مكان وقد يكون من الصعب إجراء التقديرات نظرا ًإلى الحجم المحدود لمجموعة العاملين الصحيين. تقييم مرحلة ما بعد إدخال اللقاحات تقوم عمليات استعراض برامج التمنيع الوطنية اعتياديا ًبتقدير استخدام اللقاحات المحددة مرة كل 5 سنوات تقريبا ً بعد إدخال اللقاح الجديد. وينبغي أن تتضمن مثل هذه العمليات بنودا ً ذات صلة لتحديد المجالات البرنامجية المرتبطة باستخدام اللقاح الجديد. وفي الفترة الفاصلة بين عمليات استعراض برامج التمنيع الوطنية فإنه يمكن، حسب الاقتضاء، استعمال أداة لتقييم مرحلة ما بعد الإدخال خاصة بالأنفلونزا (EIP-I) بعد الموسم الأول أو الثاني للتمنيع المضاد للأنفلونزا. وتشمل حزمة EIP-I (صندوق الأدوات 18) عددا ًمن الأدوات لمساندة تخطيط التقييم وإجرائه، بما في ذلك استبيانات واستمارات موحدة لجمع البيانات بصيغة ورقية أو إلكترونية، وكذلك قوالب للتبليغ إلى جانب تعليمات بشأن كيفية استخدام أداة EIP-I بمردودية. ويقتضي الأمر مواءمة هذه الأدوات وفقا ًللسياق القطري المخصوص وتبعا ًللسمات المحددة لتركيبة اللقاح ونماذج تعبئته. وُتستخدم أداة I-PIE على مختلف أصعدة النظام الصحي وتشمل ملاحظة الممارسات عند نقاط إعطاء اللقاحات، ومناطق تخزين هذه اللقاحات، وكذلك استعراض البيانات والسجلات. وهكذا فإن الأداة المذكورة يمكن أن توفر نهجا ًأسرع لتقدير التحديات البرنامجية وأثر استخدام لقاح الأنفلونزا، وأن تقارن النتائج على امتداد البلدان، بحيث يمكن لهذه البلدان أن تتبادل خبراتها وأن تتعلم منها. صندوق الأدوات 81 أدوات تقييم مرحلة ما بعد الإدخال الخاصة بالأنفلونزا أداة EIP-I مع التعليمات وقوالب التسجيل والتبليغ _noitcudortni_tsop_azneuflni_eipi/tnempoleved/hcraeser/noitazinummi/tni.ohw.www//:sptth  /noitaulave (تم الاطلاع في 41 شباط/ فبراير 9102) 45 عجارملا [1] Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87)47(:461–76. [2] Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A )H1N1( Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11)8(:e0162061. [3] Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination acceptance during pregnancy globally: A literature review. Vaccine. 2015; 33)47(:6420–9. [4] Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during pregnancy. J Perinat Neonatal Nurs. 2014; 28)4(:261–70. [5] Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198)7(:373–5. [6] Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35)6(:851–2. [7] Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are countries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36)4(:442–52. [8] Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67)38(:1050–4. [9] Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccination in healthcare personnel. Am J Prev Med. 2014; 47)3(:330–40. [10] Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. 2017 )https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019(. [11] Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6)10(:e26239. [12] Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med )Lond(. 2017; 17)6(:484–9. [13] Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare workers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6)9(:e012149. [14] Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79)4(:279–86. [15] Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-analysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare workers. PLoS One. 2018; 13)6(:e0198685. [16] Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care workers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4)2(:61–72. [17] Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care workers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. [18] Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epidemiol. 2002; 23)10(:615–9. [19] Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11)4(:399–402. [20] Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2)1(. 46 [21] Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presen- teeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45)11(:1254–8. [22] Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influenza-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38)8(:966–9. [23] Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kindergarten to Twelfth Grade )K-12( School Nurses. J Sch Nurs. 2016; 32)6(:407–15. [24] Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial outbreak of influ- enza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553)18(31069–1. [25] Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epide- miol. 2015; 36)3(:254–60. [26] Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of multiple clus- ters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63)4(:739–44. [27] Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Transmission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10)11(:e0141744. [28] Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a pro- spective study. Arch Intern Med. 2011; 171)2(:151–7. [29] Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58)1(:50–7. [30] Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a multi-faceted programme on influ- enza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18)26(:20512. [31] Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ knowledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42)1(:69–70. [32] De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vaccination of Health- care Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enforcement. PLoS One. 2017; 12)1(:e0163586. [33] Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vaccination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32)10(:990–7. [34] Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37)7(:840–4. [35] van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care wor- kers in hospital departments. Vaccine. 2009; 27)44(:6261–7. [36] Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Person- nel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccination Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39)4(:452–61. [37] Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection control and hospital epidemiology. 1998; 19)7(:518–20. [38] Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/IVB/06.13. [39] Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. [40] Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards manda- tory vaccination and vaccination coverage against vaccine-preventable diseases among health-care workers in tertiary-care hospitals. J Infect. 2012; 64)3(:319–24. 47 [41] Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward mandatory occupa- tional vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41)1(:66–70. [42] Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011; 62)1(:1–13. [43] Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85)12(:2151–9. [44] Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Health- care )Basel(. 2016; 4)3(. [45] Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32)38(:4813. [46] Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32)38(:4876–80. [47] MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36)39(:5811–8. [48] Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101)2(:212–6. [49] Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vacci- nes. 2009; 8)11(:1469–74. [50] Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pande- mics. Vaccine. 2008; 26 Suppl 4:D27–30. [51] Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisions. Vaccine. 2014; 32)35(:4478–84. [52] Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing intervention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7)2(:111–20. [53] Leask J. Target the fence-sitters. Nature. 2011; 473)7348(:443–5. [54] Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psychological and cognitive models into vaccine education. Vaccine. 2011; 29)37(:6145–8. [55] Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vaccina- tion: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31)10(:1066–9. [56] Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deniers in public. Vaccine. 2018; 36)2(:196–8. [57] Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. [58] Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378)3(:214–6. [59] Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. [60] Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. [61] Prevention CfDCa. The AFIX Program. AFIX )Assessment, Feedback, Incentives, and eXchange( 2017. 2018 )https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019(. [62] Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2)10(:743–9. [63] Recommendations regarding interventions to improve vaccination coverage in children, adolescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18)1 Suppl(:92–6. [64] Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertiveness. N Engl J Med. 2019 Jan24; 380)4(:309–11. 84 نموذج استمارة عدم المشاركة الملحق 1لا ُتستخدم هذه الاستمارة في حالات التطعيم الطوعي حيث يمتنع العاملون الصحيون المنتمون إلى فئات ذات مخاطر عالية جدا ًأو عالية عن المشاركة في عمليات التقدير، والتحّري، والتطعيم، وفقا ًللسياسة الوطنية. ويتسم استكمال الاستمارة بالأهمية حينما يؤدي عدم التطعيم إلى نقل الموظف أو إلى اشتراط استخدام إجراءات وقائية لحماية المرضى على النحو المحدد في السياسة الوطنية. عدم المشاركة في التطعيم لقد قرأت وفهمت توجيه السياسات المتعلق بتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية.1 -  أمتنع عن المشاركة في التطعيم المضاد للأنفلونزا.2 -  أُدرك المخاطر المحتملة التي أتعرض لها أنا شخصيا ًو/أو الآخرون التي قد تنشأ عن عدم مشاركتي.3 -  أدرك أن عدم مشاركتي قد يؤدي إلى نقلي إلى منطقة ليست عالية المخاطر أو إلى متطلبات أخرى 4 -  لحماية الآخرين الذين قد أحتك بهم، وفقا ًللسياسة الوطنية. والسبب في عدم مشاركتي هو التالي:5 -  رفض التوقيع في الحالات التي يرفض فيها العامل الصحي توقيع هذه الاستمارة فإنه ينبغي الإشارة إلى ذلك على الاستمارة وأن ُيخطر هذا العامل بعواقب ذلك، إن وجدت، وفقا ًللسياسة. اسم العامل الصحيل تاريخ الولادةل الخدمة الصحية/المرفق الصحيل منطقة العملل التوقيعل التاريخل للاستخدام الرسمي فقط لقد ناقشت المخاطر المحتملة التي قد تنشأ عن عدم التطعيم وإدارة العاملين غير المطعَّ مين وفقا ًلسياسة التطعيم. اسم موظف فريق التطعيم: الوظيفة: المرفق الصحي/ الوكالة الصحية: التوقيع: التاريخ: 94 قائمة مرجعية تكميلية لتخطيط تطعيم العاملين الصحيينل الملحق 2لا المستوى الوطني41 (للمواءمة بما يتناسب مع الاستخدام المحلي) مراعاة للسمات المخصوصة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية فإنه يمكن أن ُتزاد العناصر الإضافية التالية إلى القائمة المرجعية العاملة لإدخال اللقاحات الجديدة. للاطلاع على هيكل القائمة المرجعية انظر الملحق 4 من وثيقة “مبادئ واعتبارات إضافة اللقاحات إلى البرنامج الوطني للتمنيع: من اتخاذ القرار إلى التنفيذ والرصد”. سياسة تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية إن السياسة الوطنية بشأن تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية منشورة 1 -  ومعمَّ مة على كل الوكالات والمرافق الصحية المعنية، بما في ذلك المرافق الصحية الخاصة والجمعيات المهنية ذات الصلة. إن السياسة الوطنية بشأن تطعيم العاملين الصحيين المضاد للأنفلونزا مرعية في السياسات 2 -  الوطنية للصحة المهنية. إن تكاليف تطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية مدرجة في ميزانيات التمنيع 3 -  أو الصحة المهنية، حسب الاقتضاء. هناك نظام لترصُّ د أنشطة الأنفلونزا، بما في ذلك تحديد بداية ونهاية موسم الأنفلونزا، لتنوير 4 -  اختيار التركيب المناسب الأفضل للقاح وتوقيت التطعيم المضاد للأنفلونزا. تخطيط الإدخال الناجح للقاحات هناك فريق تنسيق عامل متعدد الاختصاصات لمناقشة وترويج النفاذ إلى الجمهرة الجديدة 5 -  المستهدفة من العاملين الصحيين، بما يتيح تكوين الشراكات التي تدعم البرنامج الوطني وصياغته. تشمل المجموعة منسقين من برامج الصحة المهنية والتمنيع، وممثلين عن المنظمات المهنية، 6 -  والجهات الأخرى صاحبة المصلحة. تم إعداد خطة تشغيلية ذات تكاليف محسوبة لتطعيم العاملين الصحيين وإدماجها في خطط 7 -  التمنيع الوطنية والخطط الصحية التشغيلية ذات الصلة. البحوث التكوينية (اختيارية وُتدرج فحْسب إذا كان من المزمع إجراؤها) تحديد مدى الحاجة إلى أية بحوث تكوينية مزمعة، إعدادا ًلإدخال اللقاح ونطاقها.8 -  تم تحديد فريق بحوث لإجراء البحوث التكوينية واختصاصات هذه البحوث.9 -  41 في بعض البلدان، ولاسّيما البلدان الضخمة ذات النظام اللامركزي، فإن عناصر هذه القائمة المرجعية قد تنطبق على المستويات المعنية دون الوطنية، مثل مستوى المقاطعات. 05 الاتصالات أنشئ الفريق العامل الوطني للاتصالات لتخطيط استراتيجية الاتصالات وإعداد مواد 01 -  الاتصالات اللازمة لتطعيم العاملين الصحيين المضاد للأنفلونزا الموسمية. طوِّ رت رسائل ومواد اتصالات مخصوصة إلى جانب استراتيجية كلية للاتصالات.11 -  خضعت أفرقة اتصالات المرافق الصحية للتدريب.21 -  شراء اللقاحات وإدارة سلسلة الإمداد تم وضع تقدير لحجم الجمهرة المستهدفة وأُدرج في توقعات الطلب.31 -  قُدِّ ر طلب المرفق الصحي الفردي ووضعت خطة لتوزيع اللقاحات.41 -  أُنشئ حيز كاف لتخزين اللقاحات والإمدادات للتطعيم الموسمي على كل الأصعدة لاستيعاب 51 -  اللقاحات خلال فترة التطعيم. تسليم اللقاحات ُشكلت أفرقة تسليم اللقاحات في المرافق الصحية وخضعت للتدريب.61 -  تم إنشاء نظام لإدارة حالات رفض التطعيم وتنفيذ إجراءات مكافحة العدوى للوقاية من 71 -  السراية المستشفوية، مثل النقل، وارتداء الأقنعة، والإجازات الإجبارية في حالة الإصابة بعلة شبيهة بالأنفلونزا. الرصد والتقييم اسُتحدثت أدوات تسجيل البيانات والتبليغ وجرى توزيعها بما في ذلك رصد التغطية (بيانات 81 -  إدارية محدَّ ثة ومسوح للعاملين الصحيين) ورصد الأحداث الضارة بعد التمنيع تم إجراء تقييم مرحلة ما بعد الإدخال ضمن الموسمين الأولين في أعقاب إدخال اللقاح.91 -  تم استعراض إمكانيات القيام ببحوث تشغيلية لتقدير قبول العاملين الصحيين. 02 -  15 القائمة المرجعية للمرافق الصحية الملحق 3لا (للمواءمة بما يتناسب مع الاستخدام المحلي) الوضع الــمــوعــد المسؤول النهائي الاتصالات إنشاء الأفرقة العاملة لاتصالات المرافق الصحية وخضوعها للتدريب1 -  إنجاز خطة اتصالات المرافق الصحية والجدول الزمني للاتصالات 2 -  الجماعية مع العاملين الصحيين توافر إمدادات كافية من الملصقات والمواد الإعلامية المتعلقة بتطعيم 3 -  العاملين الصحيين إرسال إخطار التطعيم إلى العاملين الصحيين المستهدفين والمشرفين4 -  إنشاء خط هاتفي ساخن للرد على الاستفسارات الصحية الفردية الواردة 5 -  من العاملين الصحيين قدرة تخزين الإمدادات واللقاحات إرساء قدرة كافية لتخزين الإمدادات واللقاحات المضادة للأنفلونزا أثناء 6 -  الفترة السانحة للتطعيم توافر كميات كافية من الإمدادات واللقاحات المضادة للأنفلونزا لتطعيم 7 -  العاملين الصحيين تدابير للتعامل مع مخلفات الحقن الفائضة خلال فترة التطعيم8 -  تسليم اللقاحات إنشاء فريق تسليم اللقاح وتدريبه وإنجاز مواقع التطعيم ضمن المرفق 9 -  الصحي إنجاز تصنيف العاملين الصحيين وإعداد قائمة المستفيدين للتطعيم01 -  إرساء نظام لإدارة حالات رفض التطعيم وتنفيذ إجراءات مكافحة 11 -  العدوى للوقاية من السراية المستشفوية، مثل النقل، وارتداء الأقنعة، والإجازات الإجبارية في حالة الإصابة بعلة شبيهة بالأنفلونزا. الرصد والتقييم توافر أدوات تسجيل البيانات والتبليغ بما يراعي مسائل حماية البيانات21 -  إرساء نظام تتبع المتخلفين وإرسال التذكيرات31 -  تحديث سجلات المرافق الصحية لتشمل التطعيم المضاد للأنفلونزا41 -  تحديث نظم رصد الأحداث الضارة بعد التمنيع لتحديد هذه الأحداث في 51 -  صفوف العاملين الصحيين إرساء نظام رصد قبول اللقاحات للعناية بأمر مسائل الإقبال لدى 61 -  العاملين الصحيين (في حال ملاحظة وجود مثل هذه المسائل) 25 نموذج استبيان لإجراء مسح في صفوف العاملين الصحيين الملحق 4لا 1 الاسم (اختياري) 2 العمر (بالسنوات) 3 نوع الجنس  ¨أنثى  ¨ذكر  ¨طبيب  ¨ممرض/ قابلة  ¨تقني مختبر  ¨موظفون تقنيون آخرون  ¨موظفون آخرون (يرجي التحديد) 4 فئة العمل51 5 الاحتكاك بالمريض  ¨مباشر  ¨وجها ًلوجه ولكن غير مباشر  ¨لا احتكاك 6 الاحتكاك بالمرضى ذوي المخاطر العالية  ¨نعم  ¨لا 7 منطقة العمل (اسم منطقة العمل السريرية) غير موافق بقوة غير موافق محايد موافق موافق بقوة البيانات تطعيم العاملين الصحيين المضاد للأمراض مثل التهاب الكبد B والأنفلونزا هو أمر مهم 1 لو لم أخضع للتطعيم فإن التعرض للأنفلونزا سيمثل خطرا ًعلى صحتي 2 إن التعرض للأنفلونزا يخلق خطرا ًعلى صحة المرضى القائم على رعايتهم 3 4 يشكل التطعيم المضاد للأنفلونزا خطرا ًعلى صحتي 5 منافع التطعيم أعظم من المخاطر خضوعي للتطعيم سيحمي المرضى القائم على رعايتهم 6 الطريقة الفضلى لحماية المرضى القائم على رعايتهم هي الجمع بين التطعيم المضاد للأنفلونزا والإجراءات الأخرى للوقاية من العدوى 7 51 للمواءمة بما يتناسب مع الاستخدام المحلي استنادا ًإلى التصنيف المحلي للعاملين الصحيين.. 35 8 لدي معلومات كافية عن مخاطر عدوى الأنفلونزا لدي معلومات كافية عن مخاطر ومنافع التطعيم المضاد للأنفلونزا العوامل التي ستؤثر على قراري بشأن قبول التطعيم هي التالية توصيات الهيئة الوطنية لصنع القرار(مثل الفريق الاستشاري التقني الوطني للتمنيع) 9 01 إقرار التوصية من الجمعية المهنية التي انتمي إليها إذا كان ذلك جزءا ًمن لوائح/متطلبات الصحة المهنية 11 21 توصية من طبيبي الشخصي 31 توافر التطعيم مجانا ًلي 41 سهولة الحصول على التطعيم في مكان عملي 51 تلقي الزملاء للتطعيم 61 تجربة سابقة مع التطعيم 71 حماية المرضى القائم على رعايتهم 81 الوقاية/الحد من التغيب عن العمل 91 المساهمة في التأهب الجائحي العوامل الأخرى التي ستؤثر على قراري بشأن قبول التطعيم المضاد للأنفلونزا (أدرجها أدناه) 02 12 22 45 الاتصالات وتوليد الطلبل الترتيب الطبقي لُنهج إعداد الملحق لا المحتوى النهج الجهد الأثر إعداد محتوى رسائل الاتصالات منخفض متوسط تأطير المعلومات من خلال تقديم معلومات مقارنة اجتماعية مرتدة عن معدلات التطعيم بين الأقران أو الأشخاص الأوفر صحة اتصالات مصممة خصيصا ًاستنادا ًإلى الأساليب المعرفية والسلوكيات الثقافية متوسط مرتفع طرق التواصل توزيع وعرض مواد الإعلام، والتوعية، والتواصل (CEI) منخفض متوسط متوسط مرتفع إرساء فريق اتصالات مدرَّ ب خصيصا ً على مستوى المرفق الصحي لإدارة ُنهج الاتصالات وتوليد الطلب متوسط متوسط الاتصالات المستندة إلى شبكة الإنترنت (بما في ذلك الأسئلة المتكررة ومجموعات الدردشة) واتصالات وسائل التواصل الاجتماعي الرسائل النصية وتذكيرات البريد الإلكتروني إلى العاملين الصحيين منخفض متوسط اجتماعات إحاطة شخصية لمجموعات صغيرة مرتفع متوسط استخدام مناصري التمنيع على المستوى الوطني ومستوى المرافق الصحية متوسط مرتفع ُنهج توليد الطلب توفير اللقاحات المجانية متوسط مرتفع توفير التطعيم في منطقة العمل باستخدام الأفرقة المتنقلة متوسط مرتفع منخفض متوسط توفير الحوافز أو تحفيز المنافسة، مثل منح الجوائز للمناطق السريرية ذات المعدلات العليا لتغطية التطعيم منخفض متوسط تذكيرات بصرية وضغط الأقران، مثل الشارات أو الملصقات التي يضعها من تلقوا التطعيم الطلب إلى الشخص الالتزام بموعد ومكان للحصول على التطعيم منخفض متوسط زيادة الخيارات المتاحة للحصول على التطعيم، بالقرب من المنزل أو في مكان العمل متوسط مرتفع منخفض مرتفع توجيه الاختيار عبر الخيارات التلقائية، مثل تحديد موعد للتطعيم آليا ً ما لم يقرر الشخص عدم التقيد إرساء تعليمات ثابتة لتيسير التطعيم متوسط مرتفع 55 ISBN 978-92-4-651559-2

1国家免疫规划管理者和决策者 介绍手册 如何对医务人员实施季节性 流感疫苗接种 家庭、妇女和儿童卫生部门（FWC） 免疫、疫苗和生物制品部 本文件由免疫、疫苗和生物制品部的疫苗研究行动小组编写 如何对医务人员实施季节性 流感疫苗接种 [How to implement seasonal influenza vaccination of health workers] ISBN 978-92-4-551559-3 出版日期：2019年5月 此出版物可从以下网址获得：https://apps.who.int/iris/ 本文件的副本以及关于免疫、疫苗和生物制品的 补充材料可向以下地址获取： 世界卫生组织免疫、疫苗和生物制品部 World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland 传真：+ 41 22 791 4227； 电子邮件：vaccines@who.int © 世界卫生组织2019年 保留部分版权。本作品可在知识共享署名——非商业性使用——相同方式共享3.0政府间组织（CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo/deed.zh) 许可协议下使用。 根据该许可协议条款，可为非商业目的复制、重新分发和改写本作品，但须按以下说明妥善引用。在对本作品进行任何使用时，均不 得暗示世卫组织认可任何特定组织、产品或服务。不允许使用世卫组织的标识。如果改写本作品，则必须根据相同或同等的知识共享 许可协议对改写后的作品发放许可。如果对本作品进行翻译，则应与建议的引用格式一道添加下述免责声明：“本译文不由世界卫生 组织（世卫组织）翻译，世卫组织不对此译文的内容或准确性负责。原始英文版本为应遵守的正本。” 与许可协议下出现的争端有关的任何调解应根据世界知识产权组织调解规则进行。 建议的引用格式。如何对医务人员实施季节性 流感疫苗接种 [How to implement seasonal influenza vaccination of health workers]。日内 瓦：世界卫生组织；2019年。许可协议： CC BY-NC-SA 3.0 IGO. 在版编目（CIP）数据。在版编目数据可查阅 http://apps.who.int/iris。 销售、版权和许可。购买世卫组织出版物，参见http://apps.who.int/bookorders。提交商业使用请求和查询版权及许可情况，参见 http://www.who.int/about/licensing。 第三方材料。如果希望重新使用本作品中属于第三方的材料，如表格、图形或图像等，应自行决定这种重新使用是否需要获得许可， 并相应从版权所有方获取这一许可。因侵犯本作品中任何属于第三方所有的内容而导致的索赔风险完全由使用者承担。 一般免责声明。本出版物采用的名称和陈述的材料并不代表世卫组织对任何国家、领地、城市或地区或其当局的合法地位，或关于边 界或分界线的规定有任何意见。地图上的虚线表示可能尚未完全达成一致的大致边界线。 凡提及某些公司或某些制造商的产品时，并不意味着它们已为世卫组织所认可或推荐，或比其它未提及的同类公司或产品更好。 除差错和疏忽外，凡专利产品名称均冠以大写字母，以示区别。 凡提及某些公司或某些制造商的产品时，并不意味着它们已为世卫组织所认可或推荐，或比其它未提及的同类公司或产品更好。除差 错和疏忽外，凡专利产品名称均冠以大写字母，以示区别。 I致谢 本手册由Thomas Cherian、 Carsten Mantel、 MMGH咨询公司 以及Philipp Lambach（世界卫生组织 / 免疫、疫苗和生物制品）共同编写，并经由独立专家咨询小 组审阅和完善：Salah Al Awaidy、Silvia Bino、Joseph S. Bresee (chair)、Supamit Chunsutt iwat、Daouda Coul ibaly、Luzhao Feng、Rachel Hale、Shabir A. Mahdi、Helena C. Maltezou、Kelly Moore、Jonathan Nguyen-Van-Tam、Saad Omer、Gregory Poland、Sabine Wicker。Kelly Moore和 Chris Morgan都是WHO免疫 实践咨询委员会的顾问代表。顾问：Thomas Cherian、Carsten Mantel。其他专 家：Birte Bödeker、Susan Y. Chu、Sara Hamid、Kathryn Lafond、Kathleen Morales、Julia Neufeind、Susan Wang。 世界卫生组织：Philipp Lambach、Onyema Ajuebor、Ms Phionah Lynn Atuhebwe、 Philip Gould、Shalini Desai、Julia Fitzner、Martin Howell Friede、Shoshanna Goldin、James Dawson Heffelfinger、Raymond Hutubessy、Ivan Dimov Ivanov、 Pernille Jorgensen、Melanie Marti、Hasan Qamrul、Lisa Menning、Ann Moen、 Liudmila Mosina、Andreas Alois Reis、Alba Maria Ropero Alvarez、Claudia Steulet、 Nadia Teleb。 该手册的编写和试发行的资金支持由疾病控制预防和中心（Centers for Disease Control and Prevention，CDC）提供，该中心向世界卫生组织的疫苗行动计划提供资金 支持（U50 CK000431）。 II 目录 摘要 1 关于本手册 2 目标 2 受众 2 全文结构 3 主要相关文件 4 1. 背景和原理 5 医务人员的流感疫苗接种现状 5 关于医务人员接种流感疫苗原理的证据快速评估概要 6 医务人员感染流感的风险和疫苗接种影响的证据 6 医务人员向患者传播感染的证据和疫苗接种的影响 7 增加医务人员疫苗接种的干预措施证据 7 流感疫苗的全球行动计划 8 2. 制定一项为医务人员接种季节性流感疫苗的政策 10 决策过程 10 决策考虑因素 12 明确疫苗接种的公共卫生目标 12 制定国家政策的经济学分析 13 特征化接种目标群体 14 为医务人员制定免疫接种政策 15 与职业卫生政策相结合 17 疫苗产品的选择、接种计划和时间 19 明确衡量监测和定义监测和疾病影响的指标 19 III 3. 规划和管理医务人员的疫苗接种 21 规划疫苗的成功引入 21 成本核算和筹资 22 为计划过程提供信息的形成性研究 24 宣传和疫苗接受度 25 医疗卫生机构层面的宣传 27 医疗卫生机构层面的需求生成 28 疫苗采购和供应链管理 30 疫苗采购 30 疫苗产品的选择和介绍 31 物流和冷链管理 32 医务人员的接种 33 培训疫苗接种小组 34 4. 监测和评估 35 开发和更新信息系统 35 覆盖率监测 35 AEFI监测 38 监测和评估疫苗接受度 39 疫苗影响监测 39 引入后评价 41 参考文献 42 附录1. 不参加表格的样表 46 附录2. 规划医务人员免疫接种的补充清单：国家 层面适合当地使用 47 附录3. 卫生机构清单 49 附录4. 对医务人员进行调查的调查问卷样卷 50 附录5. 宣传和需求生成：开发内容的方法分层 52 1摘要 医务人员感染流感的风险高于一般人群。在医务人员中，除了发病率之外，流感感染也可 能导致缺勤率增加、带病出勤1 和医疗服务的中断。此外，感染流感的医务人员可能会造成院 内传播导致患者感染，其中包括那些会发生重症流感疾病和并发症的高危人群。因此，世界 卫生组织（World Health Organization, WHO）认为医务人员是季节性流感疫苗接种的优先 目标群体。此外，对医务人员接种流感疫苗有助于防范流感大流行。最后，研究表明接种过 流感疫苗的医务人员更有可能向患者推荐接种疫苗。 该手册可为那些针对医务人员的季节性流感疫苗接种的国家政策制定者充当一项资源。它 提供了指导和现有工具的目录，用以促进医务人员流感疫苗接种的政策制定、规划、执行、 监测和评价。该手册的内容旨在补充WHO在2014年发布的《在国家免疫规划中添加新疫苗的 原则和考虑：从决策到实施和监测》文件。 该手册的主要目标受众包括国家决策者、国家卫生规划人员、免疫和职业卫生的国家规划 的管理人员，以及负责职业卫生、医务人员免疫接种和医院内感控制的人员。免疫管理人员 与职业卫生和感染控制项目之间的密切合作对于优化疫苗的接种，和对卫生机构的流感控制 采取协调一致的综合方案至关重要。 该手册总结相关证据和理由，提供关键问题的指导，并列出了医务人员流感疫苗接种的可 用工具，涵盖疫苗引进和管理的三个主要组成部分： 1. 为医务人员的季节性流感疫苗接种制定循证的国家政策。 2. 医务人员流感疫苗接种的计划和管理。 3. 监测和评价，包括评估疫苗接种的覆盖率、免疫接种后不良事件的监测、影响评价和 引入后 评价。 作为本手册的补充，我们还以会议报告的形式提供了负责撰写本手册的独立专家咨询小组 的讨论和解读。该报告总结了关键的问题，包括政策考虑因素，支持卫生工作者接种疫苗的 证据；卫生工作者的分类和优先次序；疫苗接种策略的选择；将其整合入更广泛的卫生工作 者疫苗接种和职业卫生政策； 疫苗接种的计划和管理，特别是沟通和需求产生的方式方法； 以及监测和评估卫生工作者疫苗接种的挑战，特别是在中低收入国家。2 1 带病出勤是指处于生病期间的医务人员照常工作，但工作的准确性和有效性下降，并对其护理的易感患者构成风险。 2 Cherian T. et al. Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16–17, Berlin, Germany. Vaccine. 2019;37(43):6255–6261. 2关于本手册 目标 该手册作为资源和可用工具目录，帮助国家官员决策、规划、实施和监测医务人员的 流感疫苗接种，从而达到最佳的疫苗接种率。它并不是一份规范性文件，而是阐明了支持 政策制定、疫苗接种规划和管理、医务人员流感疫苗接种的监测和评估的一般原则和关键 考虑。 该手册也概述了可确保将医务人员的流感疫苗接种纳入现有国家职业卫生政策和卫生 机构职业安全和健康管理体系的措施。手册还讨论了医务人员接种流感疫苗的机会，从而 进一步推广监测和优化国家职业卫生政策中所有干预措施的使用情况的综合办法。此外， 手册还涉及到了医务人员接种疫苗与流感大流行防范的关系和作用。 医务人员的季节性流感疫苗接种不同于其他可通过疫苗预防的疾病，因为流感疫苗需 要每年接种。然而，该手册的内容可能与医务人员的常规疫苗接种有一定关系，尤其是关 于疫苗接种规划和管理、监测和评价的章节。 受众 该手册的主要目标受众包括： 1. 国家决策机构和卫生规划人员； 2. 国家和地方各级免疫、感染控制和职业卫生规划的管理人员以及在卫生机构负责职 业卫生和感染控制的人员； 3. 医务人员和雇主所在的组织机构。 虽然本文件的不同章节可能与某些群体的相关性更大，但是由于某一专题的信息可能会 在手册中其他章节中找到，所以建议将本文件视为一个整体进行阅读。 该文件也可能对其他对免疫接种和职业卫生感兴趣的受众有所帮助。 3全文结构 该手册由图1中概述的四个部分组成。但为了全文的清晰和完整，有些章节之间存在一 些重叠，并对其他相关章节作了交叉引用。 图1：文件结构 制定政策 疫苗接种的规划和管理 监测和评价 前⾔， 背景和 理由 • 关于该⼿册，包括 ⽬的和⽬标受众 • WHO对于流感疫 苗接种的政策推荐 • 医务⼈员疫苗接种 现状 • ⽀持医务⼈员疫苗 接种证据的总结 • 流感疫苗的全球 ⾏动计划 • 决策的考虑 • 定义疫苗接种的 ⽬的 • 医务⼈员分类和 优先权 • 制定疫苗政策框架 • 结合职业卫⽣政策 • 产品选择和疫苗 接种时机 • 递送选项和优化 覆盖率策略 • 定义监测和影响 评估⽬的 • 成功引⼊疫苗的 计划 • 成本和筹资 • 为规划过程提供 信息的形成性研究 • 交流和疫苗接受度 • 卫⽣机构的需求 产⽣ • 疫苗⽣产和供应链 管理 • 医务⼈员的疫苗 接种 • 疫苗接种团队训练 • 覆盖率监测 • 预防接种不良反应 监测 • 疫苗接受度评估 • 疫苗影响监测 • 引⼊后评估 决策者 实施者 4主要相关文件 以下文件是补充本手册中指导意见的重要资料： 1. 关于季节性流感疫苗接种（包括医务人员疫苗接种）的WHO政策建议发表在WHO立场 文件中。这些立场文件会定期更新。 针对流感的疫苗：WHO立场文件——2012年11月 https://www.who.int/wer/2012/wer8747.pdf（2019年5月14日访问） 在国家免疫规划中添加新疫苗的原则和考虑：从决策到实施和监测。日内瓦，世界卫 生组织，2014。 http://www.who.int/immunization/documents/general/ISBN_978_92_4_15068_92 (2019年5月14日访问） 2. 对于已为医务人员提供季节性流感疫苗接种的国家，以下文件提供了应如何确定、分 析和有效地针对与接种有关的问题的详细指导： 针对季节性流感的免疫规划（Tailoring immunization programmes for seasonal influenza，TIP FLU）。提升卫生保健工作者接种季节性流感疫苗的指导（2015）。哥 本哈根，世界卫生组织欧洲区域办事处，2015。 http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/ publications/2015/tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.-a- guide-for-increasing-health-care-workers-uptake-of-seasonal-influenza-vaccination- 2015（2019年5月14日访问） 3. 虽然该手册中的内容有助于国家政策的制定，但手册没有对可支撑决策的现有证据进 行详尽审查。以下文件对支撑医务人员接种疫苗的此类证据提供了更详尽的审查： 证据快速评估：卫生保健工作者流感疫苗接种——全球证据综述。2019年7月。 https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub (2019 年7月12日访问) 4. 该手册是WHO编写的一系列季节性流感疫苗接种入门手册中的一部分。对孕妇实施流 感疫苗接种的手册已在早期出版。 如何实施孕妇流感疫苗接种：对国家免疫规划管理者和政策制定者的介绍手册。 http://apps.who.int/iris/bitstream/handle/10665/250084/WHO-IVB-16.06-eng.pdf (2019年5月14日访问） 51. 背景和原理 医务人员面临感染流感病毒和将感染传播给受其护理的患者的风险，而这些患者可能 面临患重症疾病、并发症甚至死亡的高风险(1)。与一般人群相比，医务人员的高风险可能 因职业或环境而异(2)。WHO认为医务人员是流感疫苗接种的重要优先群体，因为他们不 仅要在流感流行期间保护自身并保障基本的卫生服务，同时还要减少向他们接触的易感患 者传播流感(1)。此外，许多研究发现，医务人员尤其是医生的有力建议可大大增加公众的 疫苗接种(3-5)。自身接种过疫苗的医务人员对接种情况更为了解，并且能更有效地提高 公众对疫苗接种的接受度(3-5)。最后，医务人员在流感大流行期间很可能成为疫苗接种 规划的目标，因此建立对医务人员接种季节性流感疫苗的计划将有助于在流感大流行期间 及时且有效地开展疫苗接种(6)。 医务人员的流感疫苗接种现状 全球医务人员流感疫苗接种政策的通过进程是缓慢的。2017年，在194个国家中，只有 119个国家报告制定了国家流感疫苗接种政策。其中，96个报告将医务人员视为优先群 体。然而，报告有政策的成员国比例因WHO地区的不同而不同，WHO美洲、欧洲和地中 海东部区域的大多数国家都报告了流感疫苗接种的国家政策，而西太平洋、非洲和东南亚 地区的国家仅有小部分报告了此类政策。 大多数国家都缺乏医务人员流感疫苗接种覆盖率的资料，但在有此类数据的许多国家 中，流感疫苗接种覆盖率的差别很大，且覆盖率很低。例如，在2014-2015年流行季节 中，欧洲地区只有26个国家（56%）提供了医务人员的接种覆盖率数据。医务人员的接种 覆盖率范围从2.6%至99.5%不等，覆盖率的中位数为29.5%；只有阿尔巴尼亚、亚美尼 亚和白俄罗斯这三个国家报告的覆盖率超过75%(7)。一份系统综述通过来自英格兰所有医 院的义务报告，获得的最新数据显示在2017-2018流行季医务人员的接种覆盖率为69%3 。对美国2000名医务人员开展的互联网调查结果显示，在2017-2018流行季医务人员的接 种覆盖率为78%，而在雇主强制要求接种疫苗的场所中接种覆盖率更高（95%）(8)。当 3 英国卫生保健工作者季节性流感疫苗接种情况：2017年到2018年冬季. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/710531/ Seasonal_influenza_vaccine_uptake_HCWs_winter_season_2017_to_2018.pdf（2019年5月14日访问） 61. 背景和原理 实施强制性疫苗接种政策时，疫苗接种覆盖率就更高。在一项纳入8项研究在内的系统综 述中，所有研究的总覆盖率超过了94%(9)。 关于医务人员接种流感疫苗原理的证据快速评估概要 WHO对2006年以来出版的、并且被认为具有中高质量的英文材料进行了证据快速评估 (10)。此处汇总了所需考虑的问题和本评价的主要结果。如需了解详情和相关引文，读者 请参考已发表的报告。 审查考虑了三个议题，即： 1. 与一般人群相比医务人员感染流感的风险增加，而为他们接种疫苗可降低流感疫情 和缺勤情况并可减少流感对卫生人力资源造成更为广泛的经济影响的证据。 2. 医务人员在医疗卫生保健机构中可将流感传染给患者，如果是这样的话，疫苗接种 是否能保护患者，以及需要为多大比例的医务人员提供疫苗保护才能获得这种效果 的证据。 3. 成功采取实际干预措施可增加疫苗接种利用率、改善对医务人员接种疫苗的社会、 行为和公共卫生政策研究的知识状况的证据。 医务人员感染流感的风险和疫苗接种影响的证据 将医务人员与一般人群感染流感的风险进行比较研究具有一定挑战性，可能会得到不 同的结果，或是由于在不同环境下开展从而限制了研究之间的可比性或数据合并。最近的 系统综述表明，与一般人群相比，医务人员感染流感的风险增加（OR=2.08, 95% CI: 1.73-2.51）(2)，且对于无症状的实验室确诊的感染病例其证据是最强的(11)。然而在医疗 卫生机构中，无症状感染的医务人员仍可能将流感病毒传染给高度易感的患者。 呼吸道疾病被报道为医务人员缺勤的常见原因。流感的流行或大流行与医务人员缺勤 率的上升有关(12)。对于匹配良好的季节性流感疫苗，医务人员中的疫苗效力可高达 90%(13, 14)，这表明医务人员接种疫苗能减少与流感相关的发病率和缺勤率。系统综述 显示，在流感疫苗接种组中，疫苗对实验室确诊的流感具有保护作用，并且能缩短因流感 样疾病（influenza-like illness, ILI）导致的缺勤时间(15)。英国最近针对医务人员开展的 一项研究表明，疫苗接种率提高10%与因病缺勤率降低10%有关(12)。然而，也有一些观 察性研究的结果不一致——这通常受到不佳的研究设计、非特异性结果、高偏倚风险以及 未能有效调整混杂因素的制约(16-19)。 71. 背景和原理 由于感染后患病的风险取决于接触程度，且不同类别医务人员的缺勤行为可能不同， 关于缺勤的精细数据（如按医务人员类别分层）也很可能是缺乏的，因此在不同研究中会 看到不一致的结果。另一方面，尽管有证据表明医务人员的感染率会上升，但一些研究并 未发现对缺勤有影响，这就引出了医务人员在感染流感后是否继续工作的问题，由此产生 的院内传播风险也受到高度关注(20)。一些研究记录了患有流感样疾病的医务人员的带病 出勤情况(21-23)，其中一项研究与肿瘤科的院内传播有关(24)。 医务人员向患者传播感染的证据和疫苗接种的影响 采用分子分型方法开展的流行病学研究证实了医务人员可向患者传播的证据。将可穿 戴传感器与病毒学数据结合，可自动收集高分辨率的接触数据，从而确定医院获得性流感 的潜在传播途径(25)。由于就诊者的不断涌入、患者之间的互动以及同时引入多次流感的 可能性，因此在医疗卫生机构很难捕捉到医务人员直接传播给患者的程度(26-28)。然 而，在可能导致医疗卫生机构内感染传播的人群中，医务人员代表着相当大的疫苗可预防 的部分，因为他们更容易接种疫苗。 如文献所示，医务人员接种疫苗对患者产生的直接效益可通过多种方式来衡量。几项 研究评估了对实验室确诊流感产生的影响，而另一些研究则评估了对非特定结局的影响， 如ILI、呼吸道疾病、全因死亡率、呼吸道疾病相关的死亡率或院内流感感染的发病率。对 于ILI、全因死亡率(29)和医院内流感感染的发病率等非特异性结果，证据强度更高(30, 31) 。虽然一些研究为获得最佳保护试图测量需要接种疫苗的医务人员数量，但支持覆盖率阈 值的证据很少，从而导致文献出现争议(32)。然而，患者获保护可能与医务人员的疫苗接 种覆盖率上升呈正相关，但也取决于其他因素，包括患者接触的类型、患者的脆弱性、其 他感染控制措施的使用情况，以及特定流感季节疫苗接种的效果(33-35)。 增加医务人员疫苗接种的干预措施证据 有大量证据表明成功的干预措施可增加医务人员的流感疫苗接种率，其中大部分已被 纳入旨在提高疫苗接种率的现有工具包中。 虽然促成医务人员做决定的途径的因素是多种多样的，但有些特定策略似乎比其他策 略更有效。除强制性免疫接种外，没有任何单一干预措施能够快速大幅增加并维持疫苗接 种。然而，强制医务人员接种疫苗是一个受广泛争论的问题，有许多不同的观点支持或反 对使用这一措施(20, 32，36)。成功的强制性接种方案需要组织和教育工作，以确保在实 施之前获得员工支持(37)。 81. 背景和原理 使用一个或多个“软命令”的组合，如主动拒绝、规定使用医用口罩和将未接种疫苗的 工作者排除在会接触高度易感患者的工作之外，可作为强制接种的替代办法，尽管应用此 类软命令会涉及到组织、教育、监测和执行以及人力财政资源等问题。 有助于增加接种率的其他方案包括： • 提供免费疫苗； • 使疫苗接种更方便获得，包括在医疗卫生机构进行现场接种； • 通过针对不同类别医务人员的教育、提醒和激励措施，从而改变知识和行为； • 管理和组织方法，例如指派疫苗接种活动的监督人员。 疫苗接种率低的原因具有异质性，在不同的医务人员类别和文化中都会有所不同。因 此，需要针对不同群体定制不同的提高接种率的方法。一些研究表明，形成性研究（包括 调查和定性研究）可以提供有助于定制干预措施的见解，从而改善接种率。 结论 尽管文献中存在持续的争议，但对于确保医务人员、患者和依赖正常运转的卫生 系统的一般人群的安全而言，流感疫苗接种至关重要，尤其是在流行或大流行期 间。尽管关于该议题的新数据将会被密切监测，为WHO现有政策提供任何变化的信 息， 4但最终确定医务人员疫苗接种价值的研究仍将具有一定的挑战性。 流感疫苗的全球行动计划 在流感大流行中，世界上大多数人口将极易受到感染，并且感染可能会迅速蔓延。疫 苗接种被认为是减轻大流行潜在影响的关键策略之一。据估计开发针对特定毒株的大流行 疫苗将会出现延期，而不足的生产能力将会进一步限制全球对疫苗的获得，至少在大流行 的早期阶段会是这样。资源有限的国家，特别是那些缺乏当地疫苗生产能力的国家和那些 没有季节性流感疫苗接种政策的国家，在大流行期间将会面临最大挑战，即能否及时获得 疫苗并减轻疾病大流行的重大不利影响。 为应对这一挑战，WHO制定了一项针对大流行流感疫苗的全球行动计划，其中包括短 期、中期和长期战略，旨在提高流感大流行之前和期间流感疫苗生产和产能激增(38)。 4 WHO免疫策略咨询专家组（Strategic Advisory Group of Experts, SAGE）的一个工作组将会审查新出现的数据， 并预计在2020年对WHO现有建议进行更新。 91. 背景和原理 该计划提出了三种方法来增加大流行疫苗的获取途径：(i)增加季节性流感疫苗的基线使 用；(ii)提升全球产能；(iii)进一步研究和开发。 上述三种方法中的第一种依赖于各国制定明确有效的免疫政策，以增加季节性流感疫 苗的基线使用——为工业提供更好的需求预测并刺激产能增加。 虽然医务人员接种疫苗只会导致疫苗的整体需求略有增加，但它将为快速免疫医务人 员建立一个强有力且有功能的平台，并有助于在大流行事件中实现高疫苗覆盖率，从而确 保了大流行期间卫生服务的提供。此外，医务人员大量接种疫苗很可能可以建立信任，并 增加国家政策中季节性流感疫苗接种的其他目标高风险群体的接种情况。医务人员接种疫 苗还可以建立或强化大流行性疫苗快速部署的过程。因此，医务人员的季节性流感疫苗接 种不仅涵盖如上所述的针对季节性流感的即时防护问题，还有助于流感大流行的防范。 10 2. 制定一项为医务人员接种季节性流感疫苗 的政策 在决定制定一项为医务人员接种季节性流感疫苗的政策之前，应当基于证据并有明确 的原理，并有实施政策所需的足够资金。2014年WHO指导性文件《在国家免疫规划中添 加新疫苗的原则和考虑：从决策到实施和监测》(39)中阐述了在国家免疫规划中增加疫苗 的一般原则和考虑。 许多低收入和中等收入国家的免疫规划中的目标人群通常不包括医务人员。虽然可能 存在针对医务人员的乙肝疫苗接种计划，但流感疫苗不同，可以预见必须每年重复接种。 本手册在这一节主要以上述文件提供的通用框架为基础，讨论对医务人员每年接种季节性 流感疫苗的其他考虑因素。 决策过程 与其他疫苗必须制定的政策一样，卫生部（Ministries of Health，MoH）会要求国家 免疫技术咨询小组（National Immunization Technical Advisory Groups，NITAGs）或同 等效力的国家及地区机构对证据进行审查，并就制定医务人员季节性流感疫苗接种政策及 其具体内容提出建议。 受政策影响的众多利益相关者的参与对于确保该政策获得认可和促进疫苗接种率的提 高至关重要，而且这样可能使卫生机构更加方便地采取措施控制流感。因此应广泛征求利 益相关者的意见，其中包括： 1. 代表医疗、护理和相关卫生服务等不同医务人员团体的专业协会和学会，以及私营 卫生保健提供者的代表； 2. 医疗和护理委员会及其他医务人员管理机构； 3. 患者安全团体（如果存在）和代表患者的组织，因为可以认为医务人员的免疫接种 与患者安全和护理质量有关； 4. 如果存在医务人员工会，他们的参与可能有助于促进疫苗接种。 5. 卫生机构管理人员。 11 2. 制定一项为医务人员接种季节性流感疫苗的政策 该过程还应尽早接触制定职业卫生政策和条例的机构，以确保为医务人员接种流感疫 苗的政策可以反映在国家职业安全和卫生政策中。 如果存在为医务人员接种其他类型疫苗的政策，例如乙肝疫苗，那么对这些政策的研 究可以为季节性流感疫苗接种政策的制定和优化提供帮助。 如有可行，NITAGs可以从国家流感监测、国家流感中心或其他参与全球流感监测和反 应系统（GISRS）的机构获得数据（见工具箱1）。 在当地数据不容易获得的地方，特别是在医务人员中疾病的发病率数据和医务人员向 患者传播疾病方面的数据，想要获取这些数据可能需要大量时间和精力。政策制定者必须 考虑是否有必要进行地方研究，或是否可以使用具有相似流行病学和卫生系统特征的其他 国家的数据来推断可能的疾病负担并支持决策。NITAGs需要衡量获得其他国家数据和当 地数据各自的成本，以及收集当地数据导致的延误对健康的影响。 工具箱1 国家流感中心 为了监测和应对流感病毒抗原结构的变化以及随后导致的疫苗成分的必要改变， 许多国家建立了国家流感中心（national influenza centers，NIC），以便于收集 和鉴定本国的病毒标本，并进行其他分析以告知WHO及其合作伙伴关于接下来一 年流感疫苗的组成成分。在许多国家，对严重急性呼吸道疾病（severe acute respiratory illness，SARI）和流感样疾病（influenza-like illnessI，ILI）进行的更 系统的流感监测可以对病毒学监测进行补充。 通过向NITAG或其他的国家相关决策机构提供有关流感疾病负担和季节性的数据， 本国或邻国的NIC支持基于这些数据而提出建议。汇集决策过程所需的所有相关信 息的关键是让所有相关机构参与NITAG的讨论。 可在以下链接中找到NICS、WHO合作中心和基础规范实验室（essential regulatory laboratories，ERLS）的清单：  http://www.who.int/influenza/gisrs_laboratory/national_influenza_centres/list (2019年5月14日访问）  http://www.who.int/influenza/gisrs_laboratory/collaborating_centres/list (2019年5月14日访问） 12 2. 制定一项为医务人员接种季节性流感疫苗的政策 决策考虑因素 除了前面提到的WHO文件《在国家免疫规划中添加新疫苗的原则和考虑：从决策到实 施和监测》中概述的一般考虑因素之外，在制定医务人员疫苗接种政策时还需要考虑其他 关键问题。这些在图2中列出。 图2：制定医务人员疫苗接种政策的关键考虑 明确医务⼈员季节性流感疫苗接种的公共卫⽣⺫标 特征化疫苗接种者和优先顺序 制定针对医务⼈员的季节性流感疫苗接种政策 疫苗产品的选择，接种的时间表和安排 确定监测和影响评估的指标 明确疫苗接种的公共卫生目标 在为医务人员制定接种季节性流感疫苗的政策时，关键的第一步是明确疫苗接种规划的 目的和目标。这些目标可能因国家不同而不同，但其将作为医务人员优先接种疫苗的依 据，并且可以据此设定疫苗接种覆盖率目标，为衡量疫苗接种的结果和影响提供指导。 对医务人员进行疫苗接种可实现多个目标。可能包括： 1. 预防医务人员自身感染，避免相关发病。 2. 预防医务人员把疾病传播给易感患者，包括患有严重疾病、并发症和具有高死亡风 险的 人群。 3. 通过减少医务人员的缺勤来保障卫生服务，特别是在卫生保健需求增加的季节性流 感和流感大流行暴发期间。 4. 促进其他目标群体接种季节性流感疫苗，提升大众对流感疫苗接种的信任。 5. 通过以下方式促进对流感大流行的准备： a) 在流感大流行或其他疫苗可预防疾病流行期间，建立医务人员快速免疫机制； 13 2. 制定一项为医务人员接种季节性流感疫苗的政策 b) 促进对流感疫苗的需求增加，从而提高生产疫苗的能力，以便在大流行期间及 时获得疫苗。 c) 建立或加强国家疫苗监管力度。 上述几项可用于确定医务人员接种疫苗的国家目标。确定疫苗接种目标时的重要考虑 因素包括： 1. 审查长期护理机构中的医务人员疾病负担以及患者和居民获得卫生保健相关感染负 担的现有数据。可使用国家数据（如果有的话）辅以数学模型得出的代表性区域或 全球数据或估计值来完成这一目的。 2. 疫苗接种的成本和影响以及疫苗供应的可获得性。 3. 审查国家大流行防制计划并考虑医务人员接种疫苗是如何有助于预防大流行的。 制定国家政策的经济学分析 尽管通常建议在决定接种政策之前进行经济学分析，但因为目标群体的规模相对较小， 故缺乏用于估计和比较不同接种目标的经济效益的数据可能是一个限制因素。工具箱2列 出了进行流感疫苗接种经济学分析的可用工具。 医务人员接种流感疫苗的成本和经济效益可能取决于若干因素，其中包括目标医务人 员的数量和类别、目标医务人员的感染率和严重程度、其对卫生保健相关传播的贡献以及 工具箱2 季节性流感疫苗接种的经济分析工具 有以下几种工具可用于流感疫苗接种的经济学分析： 世界卫生组织免疫规划经济学评价估指南 (WHO/IVB/08.14) ƥ http://apps.who.int/iris/bitstream/handle/10665/69981/WHO_IVB_08.14_eng.pdf 世界卫生组织季节性流感经济负担评估手册 (WHO/IVB/16.04) ƥ https://apps.who.int/iris/bitstream/handle/10665/250085/WHO-IVB-16.04-chi.pdf 流感疫苗接种经济评估指导 (WHO/IVB/16.05) ƥ http://apps.who.int/iris/bitstream/handle/10665/250086/WHO-IVB-16.05-eng.pdf 14 2. 制定一项为医务人员接种季节性流感疫苗的政策 此类感染的后果。这些因素在不同的医疗机构之间可能有所不同，并且在不同的流感季节 也会不同。 近期一项对医务人员接种季节性流感疫苗的流行病学和经济学影响的系统综述中发 现，基于接种疫苗所避免的缺勤的粗略估计，医务人员接种疫苗是可以节省成本的(15)。 然而，该综述中所有的研究数据均来自高收入国家，并且均从雇主的角度出发，关注重点 放在了避免缺勤。 初步决策可以考虑疫苗接种成本以及这些成本对免疫接种和卫生预算的影响，如有需 要，可选择衡量引入后的成本效益。 有关医务人员接种流感疫苗的成本计算和预算编制的进一步指导，以及可用的成本计 算工具和免疫筹资的资源材料，将在本手册的下一节中进行介绍。 特征化接种目标群体 理想情况下，所有的医务人员都应该成为目标接种对象，包括那些可能不直接接触患 者的人。即使没有直接接触，医务人员也可能把从社区获得的感染传播给同事，由此参与 卫生保健相关的感染传播链。然而，在资源有限或疫苗供应有限或不稳定的情况下，需要 对医务人员进行分类并确定优先顺序。医务人员的优先次序将取决于对医务人员本身感染 风险、将感染传播给患者以及卫生保健相关传播后果的评估。 即使没有财政资源约束或疫苗供应限制，当根据风险评估将不同的政策应用于不同类 别的医务人员时，对医务人员进行分类也是有用的。例如，强制接种政策可能适用于接触 重症流感高危患者且更愿意接受强制接种的医务人员，而对于其他类别的医务人员则是自 愿接种(40, 41)。 表1提供了根据医务人员自身风险情况和所护理病人情况来进行风险分类的例子。 极高危类别的风险和接种后的影响表现得最明显，并且拥有更有力的接种依据(10)。 疫苗接种对象还应包括卫生机构中可能如上述各类医务人员一样与患者有可能接触的 兼职人员、学生、承包商和志愿者。 在许多情况下，特别是在低收入和中等收入国家，对医务人员个体进行风险分类可能 过于复杂且耗费资源。在这种情况下，可以使用简化的方法把医务人员类别分为两组，即 高风险组（接种目标人群）和低风险组（非接种目标人群）。 15 2. 制定一项为医务人员接种季节性流感疫苗的政策 表1. 医务人员的风险分类 风险分类 医务人员特征 极高 – 在临床领域工作的高风险医务人员（见下文），收治的患者感染流感病 毒后有很高风险患重症疾病和并发症或有高死亡风险。其中包括重症监 护病房；移植或肿瘤病房；产前、围产期或产后病区；有老年人的病 区，特别是慢性病患者。 高 – 与患者或传染性物质（包括被传染性物质污染的表面或设备）直接接触 的医务人员。 – 与一些不通过身体接触而是通过短距离（1-2米）呼吸方式传播的疾病有 接触的医务人员，例如有长期面对面接触的咨询师(42, 43)。 低 – 不与患者接触，正常工作不在上述定义的临床领域内的医务人员。 为确保有针对性地对医务人员使用流感疫苗，并解决潜在的接种问题，国家医务人员 疫苗接种政策应概述为： 1. 基于风险评估对不同医务人员进行分类。 2. 每个类别的疫苗接种政策应包括以下内容，例如是否建议接种，以及建议强制接种 还是自愿接种。 3. 处理违反政策的医务人员和拒绝疫苗者的措施。 以下文件提供了一个对医务人员进行评估、分类和确定优先次序的示例。 新南威尔士州卫生部关于特定传染病职业评估、筛查和疫苗接种的政策指令 https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_009.pdf (2019年5月14日访问） 为医务人员制定免疫接种政策 根据特定临床环境中的风险，对医务人员接种疫苗的建议可以是强制接种、自愿接种 或混合接种。 许多国家的多项研究表明，虽然非常努力地去告知医务人员接种疫苗的好处和风险， 并采取措施使疫苗更方便获取，但是他们自愿接种疫苗的人数依然很少，覆盖率很少超过 70%。相反的，强制接种已使美国实行相应政策的机构的接种率接近100%(44-46)。然 16 2. 制定一项为医务人员接种季节性流感疫苗的政策 而，由于可接受性问题和医务人员接种疫苗的归因效益一直是个有争议的话题，因此在一 些国家很难实施强制接种疫苗(32)。此外，在资源有限的情况下实施强制疫苗接种政策也 是不可行的。 自愿接种 医务人员接种疫苗政策的一个选择是自愿接种，在这种政策下会建议医务人员接种疫 苗并向其提供疫苗，但接种是自愿或可选的，即不是强制的。这类规划的疫苗接种覆盖率 往往较低。因此，对于自愿接种，需要额外的努力来提高接种的覆盖率。可能包括： 1. 建立专门针对医务人员不同需求的强有力的宣传策略，解释疫苗接种的益处和风 险，其中包括给患者带来的益处（特别是那些重症疾病的高危人群）。需要强调的 是，其中一些患者，包括老年人和免疫功能低下的患者可能自身对疫苗接种无应 答，但给接触他们的医务人员接种疫苗是保护他们免受感染的重要手段，这属于职 业伦理道德。 2. 无论白班还是夜班都可以很方便地获取免费的接种疫苗。夜班工作人员可在轮班开 始或结束时或在指定的日期和时间获取接种疫苗。 3. 本手册下一节概述的其他需求生成活动。 若干软命令措施也可能有助于增加疫苗接种，包括： 1. 主动拒绝接种疫苗者，无论是否说明不接种的原因，都要求签署不接种表格。 （参见附录1主动拒绝接种的表格）。 2. 如果可行，将拒绝接种疫苗的医务人员重新分配到他们不太可能接触到高风险患者 的区域，或要求他们在护理有高风险患流感并发症的患者时佩戴口罩。 3. 在医疗保健机构中佩戴口罩。 强制接种 强制接种使医务人员接种疫苗变成法律或法规要求，但同时也允许某些例外存在，比 如医学禁忌症。WHO或其他机构对强制接种没有一致定义。婴幼儿和儿童免疫规划可能 与强制接种有很大的差异，特别是在容许例外存在和对不依从进行处罚等方面(47)。 一些专家认为，作为卫生保健人员职业道德的一部分，应针对可在卫生保健场所传播 并有较高风险引发患者得重症疾病或死亡的疫苗可预防疾病(20, 44, 48-50)执行强制免疫 接种政策。 17 2. 制定一项为医务人员接种季节性流感疫苗的政策 也有人认为，在医学实践中，很少有职业道德标准会凌驾在无伤害义务之上。所以， 通过将传染性疾病的传播风险最小化来确保患者获得安全的护理条件，代表了卫生保健实 践环境中的最低道德标准(20)。但是，如果要制定强制性疫苗接种政策，将需要解决法律 责任问题，并考虑在罕见的不良事件中提供赔偿。 强制接种疫苗可以是国家政策的一部分，也可以作为机构政策的一部分在个体医疗机 构中实施。颁布批准强制接种疫苗的法律将有助于执行这一政策。 科罗拉多州法规提供了强制接种疫苗政策的示例： 科罗拉多州法规——医院和卫生设施标准02−一般许可标准 （第10部分，第46页）。 https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=6020&fileName=6%20 CCR%201011-1%20Chap%2002 （2019年5月14日访问） 几个有医务人员自愿接种流感疫苗政策的国家，也明确对医务人员强制接种麻疹和乙 型肝炎等其他传染病的疫苗。基于对医务人员以及与之接触的易感高危患者的保护，可以 利用这些现有的政策来证明和建立流感的强制接种政策。 已出台的关于疫苗强制性接种政策在伦理上的建议可参见工具箱3。在根据实施的可行 性制定国家政策时，可以考虑这些建议。 混合方法接种 如果强制性疫苗接种政策仅适用于可能与高风险患者发生直接身体接触的某些类别的 医务人员，同时自愿接种疫苗政策适用于其余类别，那么也可采用混合方法接种。 此类政策应明确无误地界定强制和自愿疫苗接种政策适用的医务人员群体或工作领 域。应考虑到强制或自愿疫苗接种政策对人力和财力的影响。 与职业卫生政策相结合 医务人员季节性流感疫苗接种政策应成为国家职业安全与卫生政策法规和卫生机构职 业安全及卫生管理体系的组成部分。 根据1981年《职业安全卫生公约》第21条5以及世界卫生组织和国际劳工组织（World Health Organization and International Labour Organization，WHO-ILO）在国家医务人 5 C155-职业安全与卫生Occupational Safety and Health 大会，1981（第155号）。https://www.ilo.org/dyn/ normlex/en/f?p=NORMLEXPUB:12100:0::NO::p12100_instrument_id:312300（2019年5月14日访问） 18 2. 制定一项为医务人员接种季节性流感疫苗的政策 员职业健康方案全球框架中的建议6，把季节性流感疫苗纳入职业卫生政策将使所有应接 种的医务人员免费接种疫苗。这项政策还将把医务人员接种疫苗的责任交给雇主，而不仅 仅是靠医务人员自己。 综合政策将促进职业卫生和免疫规划之间更好地协调和合作，并促进在卫生设施中采 取联合方法控制流感：将疫苗接种作为感染控制规划的一部分，其中包括保护医务人员和 患者等措施。国家级的职业保健方案和设施管理制度也提供了一个有利的环境，以便在工 作场所营造一种预防感染的氛围，从而促进疫苗接种方案的实施。 6 劳工组织工作的部门层面：审查部门倡议关于人类免疫缺陷病毒和艾滋病附录二-世界卫生组织-国际劳工组织-世 界卫生组织-国际劳工组织为医务人员制定的国家职业卫生规划全球框架. http://www.ilo.org/wcmsp5/groups/public/---ed_norm/---relconf/documents/meetingdocument/ wcms_145837.pdf（2019年5月14日访问） 工具箱3 关于实施强制疫苗接种政策在伦理上的建议 — 必须向医务人员和患者清楚传达令人信服的相关安全问题。 — 应使用限制最少的方法来实现安全目标。 — 出于医疗原因，应当有明确的选择排除标准。 — 应仅根据当前在职医务人员的个人意见来决定选择退出标准。必须以透明和客 观的方式做出这些决定。 — 对于符合医学或其他排除标准或拒绝接种疫苗的患者，相关机构应提供可实现 控制传播的其他方法，包括高峰期间临时休假、强制戴口罩、重新分配至非临 床区域（如可行）或在流感高峰季节频繁检测等。 — 应将强制性政策告知准备做卫生工作的人，并指出未遵守规定可能会终止雇佣。 — 这一过程应该是透明的，在政策制定方面应广泛征求医务人员的意见。 — 研究机构应通过实施免费、易于获取、全面覆盖不良事件的疫苗接种流程来支 持医务人员接种。应特别注意不要让医疗团队中没有优势的成员负担过重。 资料来源：Tilburt JC et al. Vaccine 26S (2008) D27-D30 (1) 19 2. 制定一项为医务人员接种季节性流感疫苗的政策 疫苗产品的选择、接种计划和时间 产品的选择 WHO根据全球流感监测和响应系统7提供的信息，对流感疫苗的组成提出建议。根据这 些建议，生产商生产了北半球（Northern Hemisphere，NH）和南半球（Southern Hemisphere，SH）疫苗，一般分别在每年的9月（NH）和4月（SH）左右可接种。WHO 网站上公布了世界卫生组织预审合格疫苗的清单及其特征信息8 有几种不同类型的疫苗可供选择，包括灭活流感疫苗（三价和四价组成）、减毒活疫 苗、佐剂疫苗和重组疫苗。医务人员本身不会对任何疫苗类型有所偏好（取决于国家特定 的上市许可）。9接触免疫功能严重低下患者的医务人员应优先接种灭活流感疫苗 （inactivated influenza vaccineI，IV）。 每种产品的价格和供应量是疫苗产品选择的额外考虑因素。 接种时间 在流感感染具有季节性且季节模式明确的国家，理想情况下应在流感季节开始前安排 疫苗接种，因为疫苗大约需要14天才能诱导产生保护性抗体。如果疫苗供应不足，无法在 理想的时机接种，则应在有供应时立即开始接种。 此外，在流感季节，如果医务人员未及时接种疫苗，则应允许其在之后任何时间接种 疫苗。 在可能出现几个高峰的热带和亚热带地区，应在传播主峰之前使用最新的疫苗配方进 行接种。在没有自己国家流感季节性数据的情况下，各国可以使用流行病学相似国家的数 据。工具箱4提供了热带和亚热带流感季节性的公开信息。 明确衡量监测和定义监测和疾病影响的指标 卫生部将从NITAG或相关咨询小组就衡量监测和影响指标提供的咨询意见中获益，并 在规划和实施监测及评价时将意见纳入考虑（见第4章）。 7 流感：疫苗. http://www.who.int/influenza/vaccines （2019年5月14日访问） 8 WHO预审合格疫苗. https://extranet.who.int/gavi/PQ_Web/ （2019年5月14日访问） 9 在一些国家，四价疫苗是选择的产品. WHO免疫策略咨询专家组（SAGE）正在审查证据并预计在2020年提出建议。 20 2. 制定一项为医务人员接种季节性流感疫苗的政策 NITAGs应在其他相关咨询小组和学术界的补充意见上，就下列问题提出建议： 1. 尽可能按提供的卫生保健单位类型来监测和报告疫苗接种率。 2. 衡量疫苗接种的影响，包括： a) 衡量疫苗接种对目标群体（医务人员和/或患者）的影响。 b) 所需监测的结局。如流感样疾病、实验室确诊流感、重症流感、死亡、因患流 感缺勤、患者相关结局等。 c) 衡量监督策略的影响；如果是哨点监测，则需说明哨点的数量和分布。 d) 衡量影响的时间范围，例如，无限期持续监测或限于特定季节的监测。 这些结果将有助于NITAG审查疫苗接种的影响，并为优化疫苗接种的影响和成本效益 提出建议。衡量疫苗接种影响还可产生经验数据，以估算疫苗接种的成本效益。 应当指出，此类测量应收集多个季节的数据，因为传播的强度、感染的严重程度和疫苗 的有效性在不同季节各不相同。更多详细信息见“监测和评价”一节（第4章）。 工具箱4 季节性流感疫苗接种的产品选择和时机指导 热带和亚热带季节性流感政策的使用和有效性。日内瓦：世界卫生组织，2016年。 ƥ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910173/pdf/IRV-10-254.pdf （2019年5月14日访问） 热带和亚热带的流感季节性——何时接种  http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153003 （2019年5月14日访问） WHO预审合格疫苗清单。  https://extranet.who.int/gavi/PQ_Web（2019年5月14日访问） 21 3. 规划和管理医务人员的疫苗接种 规划疫苗的成功引入 一旦制定了国家疫苗接种政策，就有必要将该政策转变为具有完整成本核算、预算编制 的业务计划，并包括与在国家免疫规划中引入新疫苗有关的各种计划组成部分的详细细节。 关于“在国家免疫规划中增加新疫苗并对引入进行管理”的一般概念在WHO的指南：《在 国家免疫规划中添加新疫苗的原则和考虑：从决策到实施和监测》中有概述（见附录3中新 疫苗引入计划模版）。本节提供了针对医务人员接种季节性流感疫苗其它要素的指导。 将疫苗引入计划纳入年度免疫计划以及相关检查清单，使得该计划的规划人员能够确 保所有必要的准备工作完成到位，以便及时有效地将疫苗引入国家规划。为了方便查阅， 工具箱5中提供了此WHO指南中相关附录的链接。 工具箱5 《为国家免疫规划添加新疫苗的原则和考虑因素：从决策到实施和监测》 中关于“新疫苗引入计划”的模版和检查清单的链接 用于指导制定国家引入计划的通用模版。 Ʀ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex3_NVI_Template_EN.doc（2019年5月14日访问) WHO新疫苗引入指南的新疫苗引入清单、活动清单和时间表提供的关于规划预 算、活动、角色和职责分配以及时间表的建议。 ƥ http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_ intro_resources/nvi_guidelines/Annex4_Instructions.pdf（2019年5月14日访问） 相应的清单工具。 Ƨ http://www.who.int/entity/immunization/programmes_systems/policies_strategies/ vaccine_intro_resources/nvi_guidelines/Annex4_checklist_en.xls（2019年5月14日访问） 22 3. 规划和管理医务人员的疫苗接种 除了通用的疫苗引入清单之外，附录2的补充清单中还列出了医务人员免疫接种的具体问 题清单。应该将此清单中的元素添加到（视情况而定）通用的活动清单中。附录3中提供了 一个医疗机构清单的样本用来指导医疗机构一级的疫苗接种准备工作。 计划及引入疫苗的时间表应该包含在清单中并且（或者）制作一张单独的甘特图，以 确保所有的活动按照合适的顺序来完成，从而及时实施疫苗接种活动。 应当在国家及医疗机构层面交叉参考职业卫生策略和计划的相关部分（见前一节将医 务人员流感政策纳入职业卫生政策和要求的部分），从而应用一个更有凝聚力的方法来计 划和实现。 世界卫生组织——国际劳工组织（WHO-ILO）医务人员国家职业卫生全球框架建议所 有的国家都需要在国家和工作场所层面确定职业卫生负责人。这些焦点人员应该分别成为 国家和卫生机构一级规划小组的组成部分。职业卫生焦点人员的纳入将考虑在工作场所采 取综合办法来预防流感，其中疫苗接种是流感控制的干预措施中的一部分，还包含了很多 其他保护医务人员和病人的感染控制措施。卫生机构中的职业安全和健康的劳工管理委员 会（如果存在的话），可以帮助管理层以及工人代表参与实施疫苗接种计划。 除了实施医务人员疫苗接种的国家运营计划外，还应该更新国家的免疫接种综合性多年 计划（comprehensive multi-year plan, cMYP）,以纳入医务人员免疫接种（工具箱6）。 成本核算和筹资 与在国家疫苗接种计划中添加任何新疫苗一样，应该估算疫苗及其接种成本，并将其纳 入年度和多年免疫预算。除了疫苗及其用品（注射器、针头、安全盒等）的费用，疫苗接 种的费用（包括人力资源），国家和医疗机构层面的年度通信、教育和为产生需求所做的 努力，以及监测和报告所产生的费用都包含在内。有几种工具或适用于成本核算、预算制 定和确保医务人员接种疫苗的资金。（见工具箱7）。 工具箱6 世界卫生组织（WHO）-联合国儿童基金会（United Nations International Children’s Emergency Fund, UNICEF）多年计划指南多年规划准则 WHOUNICEF制定综合性多年计划指南（cMYP）。  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp 23 3. 规划和管理医务人员的疫苗接种 由于每年都需要通过通信以及其它的一些活动/干预措施来增加疫苗的接种，所以应当 将这些费用纳入年度疫苗接种费用，而不仅仅是视为一次性行为。 除了每年对医务人员流接种感疫苗进行成本核算和预算编制外，还可能有必要倡导那 些负责为卫生规划分配资金的人员，以确保为接种提供持续的资金支持。工具箱8提供了 一些用于倡导可持续筹资的资源链接。 工具箱7 成本核算和筹资的资源 cMYP成本核算和筹资工具。  http://www.who.int/immunization/programmes_systems/financing/tools/cmyp (2019年5月14日访问） 免疫成本计算行动网络（Immunization Costing Action Network，ICAN）免疫接 种成本目录。该互动网站通过各种不同的接种策略提供了不同低收入国家和中等 收入国家疫苗接种成本的信息。  http://immunizationeconomics.org/ican-idcc（2019年5月14日访问） WHO规划和计算孕产妇流感疫苗接种工具——该工具正在进行扩充从而纳入所有 流感风险群体，包括医务人员（新名称：SIICT工具）。  https://www.who.int/immunization/research/development/influenza_economics/ （2019年5月14日访问） 卫生管理科学。规划，成本核算和预算框架。  http://www.msh.org/resources/planning-costing-and-budgeting-framework （2019年5月14日访问） 免疫筹资：倡导者、决策者和计划管理者资源指南。  https://immunizationeconomics.org/imfin（2019年5月14日访问） 24 3. 规划和管理医务人员的疫苗接种 为计划过程提供信息的形成性研究 为了推出流感疫苗做准备，一些国家利用形成性研究来更好地了解影响医务人员接种 季节性流感疫苗的因素，包括担忧、信仰、信息需求、文化问题和疫苗接种障碍，以便开 发量身定制的解决方案。 形成性研究包括定量研究和定性研究，在某些情况下，也包含书面材料审查。定量研 究可用于确定医务人员疫苗接种率低的主要预测因素以及遵守疫苗接种建议的主要驱动因 素。可通过对医务人员进行调查及填写问卷来收集数据。理想情况下，样本应该包含具有 充分代表性的不同类别的医务人员，因为不同的医务人员群体疫苗接种率低的观念和原因 可能不同，比如，医生和护士之间不同(40)；一、二、三级医疗保健机构以及机构内的不 同工作区域所抽取的样本也不同。 定性研究是以了解受众观点为基础的洞察研究。它阐明了新问题，并且对接种疫苗的复杂 问题提供了更加深入的理解。定性研究的方法通常包括焦点小组讨论和个人深入访谈。WHO 欧洲区域办事处已经发布了关于新疫苗引入的定性研究分步现场操作指南（见工具箱9）。 为了使研究有效有效，形成性研究必须妥善规划和良好执行，否则就有可能得出错误的结 工具箱8 倡议或可持续筹资的资源 免疫倡议文库。提供工具和指导以传达疫苗接种的价值和投资疫苗的必要性。  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and- immunization/publications/communication-and-advocacy/immunization-advocacy-library (2019年5月14日访问） 该库的两个特定文档具有相关性： 工作手册——倡导为免疫规划进行可持续筹资。  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2015/workbook-advocacy-for-sustainable-funding-of-immunization- programmes（2019年5月14日访问） 如何准备免疫规划的财务状况。  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/ publications/2015/how-to-prepare-a-financial-profile-of-your-immunization- programme（2019年5月14日访问） 25 3. 规划和管理医务人员的疫苗接种 论。这就需要时间和资源。尽管进行此类研究为规划过程提供信息很有用，但如果时间和资 源不允许，缺乏此类研究时，也不应该推迟季节性流感疫苗的引入；除非在预判中医务人员 的态度会对疫苗的接种产生不利影响。 如果没有来自形成性研究的数据，则可以使用在其他国家进行的此类研究的数据来为 计划过程提供信息。尽管疫苗接种率低的原因具有异质性，但现有证据表明，医务人员疫 苗接种的主要影响因素存在广泛趋同，特别是在同一亚区域的国家之间，故这些数据可用 于初始规划过程。证据快速评估法(10)总结了已发表文献的主要结论，如果缺乏在本地开 展的研究，可以在适用和适当的情况下使用这些证据。 已发表文献中的数据可能会补充一些用快速调查定量形成性研究所获得的信息，这些调 查抽取医务人员样本，理想情况下应该包含不同类别的医务人员。这些调查可能比定性的 形成性研究所消耗的资源更低，并且可以在不导致疫苗引入出现延迟的情况下完成。附录4 提供了可用于此类调查的问卷样本。 如果疫苗接种率一直保持在较低水平，则可进行进一步的研究。TIPflu工具作为一种重 要资源可以在这种情况下使用。 宣传和疫苗接受度 除了官方建议之外，个人信仰、文化态度和对疫苗接种的看法常常会引导许多疫苗接 种负责人员和接种者的行为(51, 52)。在医务人员的层面也是如此。现有证据表明，人们 对疫苗接种经常存在误解，知识和行为之间存在差距(53, 54)。因此，仅仅增加医务人员 关于接种疫苗的风险和益处相关的知识并未被证明足以达到最佳的疫苗接种量。实现医务 人员最佳疫苗接种量需要多方面的产生需求努力，如充分了解医务人员（无论是疫苗提供 者还是接受者）的看法、动机和接受疫苗的障碍等。 工具箱9 形成性定性研究的现场指南 新疫苗引入的定性研究现场指南。 ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/359878/EIW2018_FieldGuide_ VaccineIntro.pdf （2019年5月14日访问） 26 3. 规划和管理医务人员的疫苗接种 需要调整宣传信息以满足不同医务人员群体的需求，因为现有证据表明，对疫苗接种的 需求、风险和益处的看法可能因为不同的群体而异(55)。目前的努力主要集中在准备基于 事实的方法来准备宣传信息。然而，这些类型的信息可能需要根据目标受众的教育和理解 水平来制定框架。考虑到各个群体偏好的认知决策风格可能会产生更大的影响(54)。构建 此类信息需要了解疫苗心理学和认知决策，并可能需要宣传专家的参与。 免疫接种的传统宣传方式是使用大众媒体。然而，研究表明，仅仅用大众媒体以及与 医务人员的单向宣传可能不足以优化疫苗接种量。在这种情况下，将会需要个人宣传和小 组宣传（如在医疗机构层面）来建立信任并激励医务人员接受疫苗接种。 在医学院、护理学校和其它针对卫生专业人员的培训机构的入职前课程中，纳入有关 医务人员疫苗接种的相关信息（自我保护、对患者的责任、关于流感大流行的防范），可 能有助于更好地将“医务人员疫苗接种”建立为一个组织概念，并且培养出更多更好的有相 应意识的提供免疫接种的医务人员。 有效的宣传和需求生成活动并不是一次性事件，而是需要持续不断并且有能力迅速响 应不断变化的疫苗接种观念、平息谣言和误解。负责医务人员流感疫苗接种的前线疫苗接 种人员需要接受培训，以便应对有疫苗犹豫的医务人员以及可能对疫苗接种产生负面影响 的疫苗否定者10。 包含宣传专家在内的国家疫苗宣传工作组将促进合作伙伴和盟友之间的密切合作，加 强免疫接种的日常宣传，并确保所有相关机构对任何安全事件做出良好协调和即时的反 应。将职业安全和健康部门的成员以及专业协会的成员纳入面向医务人员的宣传有助于建 立信任，并提高疫苗接种的接受度。医务人员、职业协会和工会以及针对接种的不同类别 医务人员的代表们将确保在制定有针对性的宣传材料时考虑到每个类别医务人员的观点。 目前有许多可用的工具和指导文件可用于制定有效的宣传战略和专门针对不同医务人 员群体的宣传信息，包含了可供疫苗宣传工作组参考的模版条目。（工具箱10） 除疫苗接种外，信息、教育和宣传材料还应包括其他感染控制措施的信息以减少工作 场所的流感传播，以及医务人员如何患上流感样疾病。 10 疫苗否认者是疫苗拒绝者亚群的极端，并积极倡导反对疫苗接种，使用科学否认主义技术来证明他们的信仰是正当 的。（见参考文献32） 27 3. 规划和管理医务人员的疫苗接种 医疗卫生机构层面的宣传 医疗机构层面的有效宣传将得益于拥有一支专业且训练有素的团队，以便在医疗机构 层面提供有效的宣传战略。应当在计划的引入日期之前建立和培训这样的一个团队，并且 其中应该包含医疗机构中主要类别的医务人员代表以及一个宣传和交流专家（如果有的 话）。理想情况下，季节性流感疫苗接种的相关宣传应成为医疗机构中为控制流感而开展 的更广泛的宣传工作的一部分。 医疗卫生机构层面的宣传互动应当在尽早在疫苗接种之前开始，特别是在首次进行疫苗 接种的国家。最初的活动可在医疗机构的所有相关领域展示信息海报。应发给医疗卫生机 构管理者和所有相关部门及临床区域的负责人正式的宣传信息，并为他们提供足够的有关 疫苗接种的所有信息材料的副本，以便在每个临床区域展示。在可能的情况下，还可以使 用电子邮件和/或当地社交媒体网络向所有医务人员发送有关流感疫苗接种的相关信息。 面对面小组简报会应补充展示和分发的信息材料。可利用现有的工作人员会议来进行 简报会。面对面小组简报会的次数将取决于医疗机构的规模和目标医务人员的数量。较大 的医疗卫生机构（如二级和三级医疗卫生机构）可能需要举办数次简报会，以涵盖所有目 标医务人员。由于不同类别的医务人员的宣传信息可能不同，因此应该考虑使用与其相关 工具箱10 用于制定宣传策略和信息的工具和指导 疫苗接种和信任文库。  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and- immunization/publications/vaccination-and-trust （2019年5月14日访问） 新疫苗引入：计划宣传和倡议清单  http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and- immunization/publications/2017/ new-vaccine-introduction-checklist-for-planning-communication-and-advocacy-2017 （2019年5月14日访问） 供疫苗宣传工作组参考的模版条目。 ƥ http://www.euro.who.int/__data/assets/pdf_file/0005/337496/02_WHO_VaccineSafety_ SupportDoc_TOR_Proof7.pdf（2019年5月14日访问） 28 3. 规划和管理医务人员的疫苗接种 的信息和材料为每个类别的医务人员举行单独的简报会。为了更好宣传并有足够的时间来 解决医务人员的问题，每个小组的规模应该合理设计，以便有足够的互动机会。应当作出 规定，以促进夜间工作的医务人员参与其中。应当在医疗机构内广泛宣传简报的时间表， 并发送提醒信息，以提高出勤率。 面对面会议应当： 1. 解释为什么接种疫苗对自己、患者和家庭以及社会都很重要，重点在于与流感相关 的严重后果； 2. 告知医务人员国家政策； 3. 提供有关季节性流感疫苗安全性的信息； 4. 提供有关疫苗接种时间和地点的信息； 5. 解释不接种的潜在后果； 6. 提供足够的时间来答疑。 可考虑建立电话热线或网页式系统来解决个别医务人员的问题。除了展示海报和其他 宣传材料外，在已经接种疫苗的医务人员（例如他们的身份证上）使用可视和可移动的标 签等，可以提示他们的同事接种疫苗。此外，可以使用文本信息、通过电子邮件和社交媒 体平台来定期提供疫苗接种提醒。 医疗卫生机构层面的需求生成 除了宣传策略之外，可以在获得疫苗之前实施基于行为科学的需求生成工作，以便使 医务人员做好接种准备。这些基于助推（nudge-based interventions）的干预措施营造 了一种环境，可以通过能够预见的方式影响行为，但不会消灭选择(57)，且在各种卫生保 健环境中证明有效(58)。由于个人或医务人员忘记接种疫苗或无法方便接种疫苗造成了意 向和行为之间的差距，这些干预措施可以此类差距。此外，这些干预措施实施的成本通常 较低(59)。下图（图3）改编自纳菲尔德生物伦理委员会，展示了基于助推的提高疫苗接 种率的干预措施等级(60)。 较低阶梯上的干预措施推动力较小，但仍然可以产生可测量的影响。美国使用了一项 提高儿童疫苗接种率的干预过程，通过提供医疗卫生机构疫苗接种率的反馈，可以监测医 疗机构的进展，为医务人员提供改善疫苗接种状况的动力(61)。 29 3. 规划和管理医务人员的疫苗接种 图3：为提高疫苗接种率的助推干预措施阶梯 通过默认选项来指导选择 除⾮个⼈选择退出，否则⾃ 动设置疫苗接种预约 促成选择 增加接种疫苗的选择，例如在 ⼯作场所或者家附近接种 促进实施意愿 要求个⼈预先提交时间和地点 以进⾏疫苗接种 框架信息 提供有关同龄⼈或者更加健康的个体 的疫苗接种率的社会⽐较反馈 提供信息 为⾃⼰和他⼈提供疫苗接种福利⽅⾯的信息 什么也不做 只监测疫苗接种率 来源：Patel MS （参考⽂献32） 向个人提供接种疫苗的提醒可以作为助推，在他们应该接种疫苗的日期通知他们，并 且提示他们到达疫苗接种点接种疫苗。这些通知可采用纸张或者手机短信的形式，已经被 证明有效(62)。在卫生机构中，卫生工作提醒者通过免疫数据收集工具（无论是纸质还是 电子）提醒，可以帮助改善医务人员的疫苗注射工作(59)。 一项成功的助推战略旨在减少便利接种的障碍并促成选择，这是一个长期适用的规 程。长期适用的规程是医疗机构中实施的一项方针，允许非医师的医务人员在没有处方或 医生的明确命令的情况下接种疫苗，并且已经证明这种策略如果适用，将是改善疫苗接种 的最有效策略之一(63)。所有的策略都可以与宣传方法相结合，以创造社区需求。 超越助推 助推是影响需求的一种有利方法，因为他们保留了选择权而不是强制性的。然而，一 些专家认为，当助推措施未能够在医务人员中实现最佳的疫苗接种率时，这种失败会对他 们的患者造成伤害，决策者应该采取更有力的政策(64)。但这并不意味着当助推失败时， 应该立即采取取消选择的措施。在限制选择之前，存在着贯穿整个策略的干预措施。“软 命令”的使用提供了在这个连续过程中的行动示范。 30 3. 规划和管理医务人员的疫苗接种 案例研究：《 flulapalooza》运动增加了医务人员对季节性流感疫苗的接种 位于美国田纳西州纳什维尔的范德比尔特大学医疗中心拥有超过24 000名医务人员。自2011年以 来，医务人员季节性流感疫苗接种运动的基石一直是大规模的流感疫苗接种活动，人们戏称这一活动 为“flulapalooza”。这项活动平均每天接种超过14 000人。封闭式点胶（The closed point-of- dispensing，c-pod）设计已经经过评估和改进，可以显著地提高管理效率和疫苗接种率。该活动在医 院职业卫生和行政领导中演习大流行疫苗的关键接种时，着重突出节日气氛。 该活动实现了当天在场的医务人员的高接种率；然而由于护理班次的结构和院内的病房责任，通常 只有不到30%的护理人员在活动中接种疫苗。因此，医疗中心将flulapalooza与病房探访、移动推车和 其它策略相结合，以实现其年度目标，即整体医务人员的疫苗接种率超过90%。机构内的政策逐渐增加 了拒绝接种的难度，并最终通过纪律处分来处理无故不接种疫苗，但值得注意的是，在纪律处分实行之 前的流感季已经达到了92%的接种率。有关活动设计、工作流程图和实用的具体经验教训的详细信息， 请参见在线出版物。 资料来源：Swift MD, Aliyu MH, Byrne DW, et al. Emergency preparedness in the workplace: the flulapalooza model for mass vaccination. American Journal of Public Health. 2017 sep;107(s2):s168-76. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303953 附录5 提供了一个表格，列出了不同的宣传和创造需求的方法，并说明了实施该方法所 需的努力和预期影响。 疫苗采购和供应链管理 疫苗采购 以最优价格购进疫苗需要充分了解采购机制和系统，疫苗市场动态以及疫苗定价要 素。采购从预测疫苗需求开始，然后招标、签署合同和进入采购流程。工具箱11中列出了 疫苗采购的工具和资源。季节性流感疫苗接种的采购可能具有一些独特的特点，可能需要 在WHO关于季节性疫苗配方的建议公布后不久获得监管批准，并且在流感季节之前与特 定厂商预先达成购买承诺（2月为北部，9月为南半球）。 31 3. 规划和管理医务人员的疫苗接种 疫苗产品的选择和介绍 与其它任何疫苗一样，产品和展示的选择将取决于多种因素，包括供应的可得性、价 格、易用性、储存和运输要求、疫苗的浪费和错过接种机会等（例如，由于不愿意仅仅为了 一两个人打开一个十剂量的小瓶而推迟了疫苗接种）。疫苗瓶尺寸的选择应该基于每个疫苗 接种点应注射的剂量和接种数。目前预审合格的可注射季节性流感疫苗有单剂量预填充注射 器以及单剂量和10剂量小瓶。所有的10剂量小瓶均含有硫柳汞作为防腐剂。然而，可以注意 到，并非所有目前可用的预审合格的10剂量小瓶产品都有开封后可存储28天的市场许可， 并且并非所有产品都具有疫苗瓶监测器（vaccine vial monitor，VVM）。在选择产品和介绍 时需要考虑这些方面。在检查采购订单之前，应当检查每种产品的规格和介绍，以确认它们 符合项目的要求。有关WHO预审合格疫苗的信息可以在WHO网站上找到（见工具箱11）。 预测疫苗需求将是疫苗采购中最重要的第一步。预测需求需要评估将成为接种目标的 医务人员人数，预期的疫苗覆盖率以及疫苗浪费估计数。理想情况下，公立医院和私立医 院的医务人员都应该是疫苗接种的目标人群。估算医务人员接种疫苗的目标人群数的过程 可能比针对一般人群的其他疫苗更加复杂。来自这些评估的数据也更难找到，特别是在低 收入和中等收入国家。工具箱12提供了用于评估医务人员数量以及疫苗目标人群的资源。 工具箱11 疫苗采购工具 采购机制和系统。  http://www.who.int/immunization/programmes_systems/procurement/mechanisms_ systems（2019年5月14日访问） 疫苗产品、价格和采购（Vaccine product, price and procurement，V3P）网络 平台。  http://www.who.int/immunization/programmes_systems/procurement/v3p/platform (2019年5月14日访问） 疫苗市场。  http://www.who.int/immunization/programmes_systems/procurement/market (2019年5月14日访问） 世界卫生组织（WHO）预审合格的季节性流感疫苗清单。  https://extranet.who.int/gavi/PQ_Web/（2019年5月14日访问） 32 3. 规划和管理医务人员的疫苗接种 全球卫生人力数据库可能没有包含所有可能成为接种目标的医务人员类别的信息。例 如，全球数据库可能只评估了医生、护士和助产士的人数，而没有包含其它医务人员的类 别。在这种情况下，粗略估计可以基于那些没有数据的医务人员与可获得数据的医务人员 的比例（例如，医生与实验室工作人员的比例）。通过对医疗机构的较小的具有代表性的 样本（例如，一级、二级、三级）的调查，可以快速获得这些比例。 由于每个医疗机构都需要准备包含了接种目标人群姓名的受益人清单，用以追踪疫苗 注射和保留疫苗接种记录；随后几年可以使用这些受益人名单和疫苗接种记录的数据对初 始需求预测进行改进。 物流和冷链管理 流感疫苗的储存与国家免疫规划中的其它大多数疫苗相似，需要储存在2-8摄氏度条件下。 由于医务人员预计将在每年流感季节开始前相对较短的窗口期内接种疫苗，因此需要 制定一项计划，以保证窗口期内供应链中不同层面的疫苗的储存和运输。用于疫苗预测、 管理和物流的工具和资源可在WHO网站上获得（工具箱13). ）。每一个WHO预审合格的 产品和介绍的冷链数量要求都可以在WHO网站上查阅（请选择疫苗类型，然后单击每个 产品和介绍的链接来获取此信息）11。在医疗机构层面，负责医务人员疫苗接种的协调中 11 世界卫生组织（WHO）预审合格疫苗：https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3 工具箱12 Resources for estimating target population size 全球卫生观察站：卫生人力资源。  http://www.who.int/gho/health_workforce 全球卫生人力统计数据库，世界卫生组织，日内瓦  http://www.who.int/hrh/statistics/hwfstats 计算医务人员：定义，数据，方法和全球结果。日内瓦，世界卫生组织。2007年 ƥ http://www.who.int/hrh/documents/counting_health_workers.pdf 卫生保健机构来源的传染性和尖锐废物的处理技术概述 ƥ https://www.who.int/hrh/statistics/Health_workers_classification.pdf 33 3. 规划和管理医务人员的疫苗接种 心应当确保该机构所需的疫苗剂量纳入需求预测，并且在疫苗运输至医疗机构的日期之前 确保有足够的储存空间以容纳所需的疫苗剂量。 医务人员的接种 理想情况下，应当在目标医务人员日常工作的医疗机构中对他们进行疫苗接种，以确 保方便地接种疫苗。 每个医疗机构都应该制定一项机构计划，以便在流感季节之前对医务人员实施季节性 流感疫苗接种。这些计划中应当包括在每个班次中为医务人员提供方便疫苗接种的措施。 医疗机构需要在机构层面上进行不同的选择，以便在夜班期间覆盖医务人员的接种而无需 进行24小时的服务，比如说在交班前后进行疫苗接种（班次变化前后）。 案例研究：利用免疫冠军（immunization champion）来加强阿曼医务人员的流感疫 苗接种 阿曼拥有一个普及的免费综合医疗保健体系，其中包括了医务人员的流感疫苗接种。阿曼是WHO东 地中海区域（Eastern Mediterranean Region，EMR）为数不多的高收入国家之一，已经实现了医务人员 流感疫苗高覆盖率（>80%）。免疫冠军使这一点成为可能。阿曼的卫生部长非常重视保护医务人员的健 康，并且率先接种了第一批季节性流感疫苗。作为医务人员团体的保护人以及在该国具有影响力的人，他 的行为加强了疫苗接种的重要性，并不断推动着流感免疫项目的实施。他还亲自参与向医务人员团体传 播疫苗接种信息。 工具箱13 疫苗管理和支持的资源 能帮助规划管理人员管理供应链和物流支持计划的资源请见WHO网站：  http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/ en/index4.html（2019年5月14日访问） 卫生保健机构来源的传染性和尖锐废物的处理技术概述 ƥ https://apps.who.int/iris/bitstream/handle/10665/328146/9789241516228-eng.pdf (2019年5月14日访问） 34 3. 规划和管理医务人员的疫苗接种 应当在医疗机构层面建立疫苗接种小组，在机构负责人的全面监督下协调疫苗接种活 动并且优化疫苗的接种。应该指定一个人为该小组的领导。他可以是职业卫生和卫生协调 中心也可以是负责卫生机构免疫活动的人员。在较大的医疗机构中，医疗服务工作人员可 能会负责此项活动。一些组织和医疗卫生机构的经验表明，医务人员中的“疫苗拥护者”的 使用可能有助于改善医务人员的疫苗接种率。一些国家成功使用了移动团队方法，团队前 往医疗机构的每个临床区域并提供疫苗接种。 培训疫苗接种小组 应当开展卫生机构疫苗接种联络点培训讲习班，以制定医疗机构计划并且实施和监测 疫苗接种活动。应当在国家层面创建标准化的日程表、课程、资源文件、清单和记录数据 的样版表格，可以在研讨会上使用以便所有的医疗机构可以统一的培训。为了进一步确保 同一培训，可以使用培训师小组开展讲习班，他们自己统一培训，随后使用极联培训方法 被分配到每个区域/亚区域。可以使用较短的培训视频来实现培训的统一性，对于那些无 法参加培训课程的人员，可以考虑使用基于网络的自学模块培训。 医疗卫生机构的疫苗接种小组应该有能力对医务人员群体进行分类（详见第二章医务 人员风险分类样本），并建立一份符合疫苗接种的医务人员名单，包括他们的职称和工作 领域。不同的疫苗接种政策适用于不同的风险类别，应该创建单独的清单或者建立机制以 便轻松识别和监测每个类别的疫苗接种状况。应当在疫苗接种活动之前充分完善受益人名 单，并向相关的医务人员通报疫苗接种的必要性。 除了医疗机构雇佣的医务人员之外，如果不是所有机构都可以进行疫苗接种，可以根 据国家政策向大型机构下游的小型机构内的医务人员供应疫苗，包括私人医疗机构中的医 务人员。 应当在每个医疗机构建立违约者跟踪及发送提醒的机制。对于接触高风险患者的医务 人员（例如器官移植、肿瘤科、重症监护室或围产期病房的工作者），可能需要在流感季 节之前通知未接种疫苗人员的主管（若当地保密规范允许）以使他们加强书面提醒，或者 在拒收取拒绝接种人员签署的主动拒绝表格，并制定适用于主动拒绝人员的感染控制措 施，如根据已建立的国家医疗机构政策，重新分配职责、戴口罩等。 35 4. 监测和评估 所有国家都应建立适当的机制，从卫生机构层面到国家层面去监测疫苗覆盖率以及免 疫接种后的不良事件（adverse events fol低ing immunization，AEFI），并在流感疫苗引 入后至少进行一次评估。但是，只有在没有达到免疫目标且资金可用的情况下，才能测量 疫苗接受度和疫苗有效性或影响。 开发和更新信息系统 应建立适当的表格和数据输入模块，用于记录和报告卫生机构层面的疫苗接种数据， 并建立报告数据的流程。 在开发数据收集工具和指南时，应考虑包括公共和私人卫生系统的需要。这可能需要 绘制现有卫生信息系统和免疫数据收集工具的图谱，以及指导如何使用这些系统收集医务 人员季节性免疫数据。 数据收集系统可能因卫生机构而异，具体取决于机构的规模和可用的基础设施。但 是，不论所使用的数据记录系统如何，每个卫生机构必须提供标准的数据报告表，以确保 收集了向国家层面报告所需的数据。这可能包括医务人员的姓名、医务人员类别、工作领 域、风险类别、疫苗接种日期、疫苗产品和批号。在编制数据报告表时，应考虑NITAG提 供的关于监测和影响评估的建议。 无论纸质的还是电子的数据收集系统，都应具有对不履行接种者的追踪能力，以及用 于生成和向未接种者发送提醒的系统。使用此类提醒系统时，保护医务人员健康状态和疫 苗接种状态数据的机密性至关重要，数据的访问应仅限于机构的疫苗接种协调员。 覆盖率监测 有几种估算医务人员流感疫苗覆盖率的方法。覆盖率测量时间的选择很重要，应该与 该国的疫苗接种时间相协调。鉴于流感疫苗通常在季节性活动中使用，建议频繁报告（例 如每月）。理想情况下，应在季节结束时评估，此时可获得完整的数据然后进行评估，并 对任何不一致的数据进行清洗。 36 4. 监测和评估 卫生机构登记 医务人员的流感疫苗接种信息应包括在已有记录中作为职业卫生要求的一部分并包括在疫苗 接种登记册中作为机构监测机制的一部分。如果从多个来源进行报告，则需要仔细评估数据差异， 并应明智地考虑数据保护问题。最低限度的数据包括每个季节接种流感疫苗的人数，目标医务人 员的总数以及得出的疫苗接种覆盖率（%）。通常，分子和分母数据都可以从卫生机构的职业卫生 部门获得。为了建立更详细的分母，第一步可以使用名义医务人员记录（例如基于工资单）。通过应 用与医务人员感染风险或将感染传播给他们所护理的病人的相关标准，可以从这些记录中选择流 感疫苗接种目标人群的收益者名单（参见”特征化接种目标群体”部分和表1）。取决于报告系统和计 划的能力，这可以包括按医务人员类别和风险概况统计数字，以按子类别进行覆盖率估计，例如医 生，护士，实验室工作人员或重症监护病房或一般工作人员，例如药房或儿科病房等。 如果疫苗接种注册表不存在，医务人员疫苗覆盖率可以通过计算粗略估计出来，用分配给每个 机构的疫苗剂量数目减去未使用的疫苗剂量数目，除以估计的该机构医务人员目标接种人群数目。 评估国家层面覆盖率的一种类似的、相当不精确的方法是使用定期汇编的医务人员数据（如向 WHO报告的）来估算分母（见工具箱12），用于疫苗需求预测，以总的疫苗接种数目作为分子。这种 方法只能作为当其他描述的方法都不可行时的最后方法。 管理性数据 如果由政府、国家保险系统或雇主承担费用，免费向医务人员提供疫苗，则可以定期（有时是强 制性地）报告机构层面中接种疫苗的医务人员人数。这些管理性数据可以从记录完备的国家疫苗 计划或健康保险记录中获得。 调查 应每隔3至5年进行一次关于疫苗接种和其他干预措施的调查，并确定亚国家层面覆盖率的异质 性，这对于必须适应免疫接种实践至关重要。可以通过国家医务人员登记处（例如专业组织）采用 分层随机抽样方法选择代表性的医务人员样本。如果没有此类登记处，可以在这些机构中分两阶段 选择卫生机构和医务人员。如果有联系信息，可以通过面对面，电话或基于互联网的平台进行标准 化访谈。如果没有此类信息，可以向所选机构中的所有医务人员提供在线调查链接，邀请他们用移 动电话或个人计算机访问调查平台。应该注意的是，当使用这种方法时，接种疫苗的自我报告可能 导致过度报告12。 12 Llupia A et al. Vaccination Behaviour Influences Self-Report of Influenza Vaccination Status: A Cross-Sectional Study among Health Care Workers. PLoS One 2012; 7(7):e39496. https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC3394773/ 37 4. 监测和评估 在所有这些估算覆盖率的方法中，重要的是详细说明医务人员的类别，例如，那些有 或没有直接接触病人的人，后者包括学生、实习生、志愿者、维护人员、信息技术人员、 食品服务人员等，他们已被列入分子和分母。同样重要的是要指明在流感季节期间工作的 兼职人员是包括在覆盖面估计中的。如果不建议接种疫苗的个体接种了疫苗，例如后勤办 公室工作人员或工作人员亲属等，则必须注意在估计疫苗接种覆盖率时不要计算这些数 目。需要监测调查的拒绝率和完成率，并对分析中可能出现的选择偏倚进行调整。 有时，流感疫苗接种计划可能仅根据在特定区域或地点采购和获得的疫苗数量，设定 接种疫苗的医务人员的绝对数量目标。这种方法虽然在一些国家得到应用，但不能正确估 计覆盖率，包括按风险类别的覆盖率，或随时间的比较，这对于解释任何影响数据都很重 要。它也无法识别疫苗接种或拒绝的决定因素。 如果可以的话，应参照其他预估常规医务人员疫苗接种覆盖率的数据和方法，例如， 乙型肝炎、麻疹、脊髓灰质炎、百日咳或破伤风疫苗。但必须注意的是，这些疫苗不是每 年提供的，通常只能在投入服务时进行核对。 工具箱14列出了用收集和报告免疫数据以及估算覆盖率的可用工具列表。 工具箱14 监测和评估工具及指标 实践系列中的免疫。模块7：监测和使用您的数据。描述如何收集和报告数据以及 如何监控免疫性能。 ƥ http://www.who.int/immunization/monitoring_surveillance/resources/IIP_Module7.pdf （2019年5月14日访问） 中层管理人员培训。模块7：EPI覆盖率调查。(Document WHO/IVB/08.07）。日 内瓦：世界卫生组织；2008。提供逐步的演练，包括相关的指导和工具，来计划 和进行新引入的疫苗的覆盖率调查。 ƥ http://who.int/immunization/documents/MLM_module7.pdf（2019年5月14日访问） WHO关于估算目标群体中流感疫苗接种覆盖率的参考概述了用于估计接种疫苗的 高风险人群中国家流感疫苗覆盖率的不同方法。 ƥ http://www.euro.who.int/__data/assets/pdf_file/0004/317344/Methods-assessing- influenza-vaccination-coverage-target-groups.pdf（2019年5月14日访问） 38 4. 监测和评估 AEFI监测 对于任何疫苗和目标人群，功能性AEFI监测系统是一项基本要求，因为文献持续指出 医务人员对流感疫苗安全性存在知识差距和误解。 在向医务人员提供流感疫苗时，用于监测和调查可能的AEFI的系统应与现有的AEFI监 测系统理想地结合，以符合国家疫苗安全监测规定。NIP或其他负责医务人员流感疫苗接 种的部门（如职业健康）应与国家监管机构合作，确定疫苗安全监测的作用和责任。在首 次使用流感疫苗的国家，可能可以在引入流感疫苗的第一年期间加强AEFI监测，以便向利 益相关者提供快速反馈，以帮助确保他们使用疫苗的安全性。 功能性AEFI监测系统将检测并阐明疫苗问题，这可能是由于产品本身，质量或疫苗管理 错误所致。所有疫苗接种者报告的被认为与流感疫苗有关的事件（包括次要事件）应使用标 准报告表格报告给AEFI监测系统（参见工具箱15）。如果报告充分，监测系统应能够评估观 察到的流感疫苗反应率，并将其与文献报道的期望率进行比较。对于严重的AEFI，通常由一 组专家评估因果关系。重要的是，对于任何疫苗，这样的系统需要能够识别先前未知的或意 外的疫苗反应，这应当更深入研究的调查。必须注意确保巧合事件不会被误诊为疫苗反应。 通过建立和加强AEFI系统，流感疫苗接种也可用于进一步提高卫生工作界对整体免疫 安全性的认识。 工具箱15 AEFI相关的信息来源 AEFI核心变量，包括病例、疫苗、事件和报告者的数据。 ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_core_variables_basics_EN_ Dec2015.pdf（2019年5月14日访问） AEFI记录的样表，包含报告要素的详细说明。 ƥ http://www.who.int/vaccine_safety/initiative/tools/AEFI_reporting_form_EN_Jan2016.pdf (2019年5月14日访问） AEFI的因果关系评估：通过访问相关软件工具，分为四个步骤提供详细的方法。  http://www.who.int/vaccine_safety/publications/gvs_aefi/（2019年5月14日访问） 疫苗安全培训资源，提供疫苗和药物安全培训包。  http://www.who.int/vaccine_safety/initiative/tech_support/（2019年5月14日访问） 信息表：观察到的疫苗反应率-流感疫苗 ƥ https://www.who.int/vaccine_safety/initiative/tools/Influenza_Vaccine_rates_information_ sheet.pdf（2019年5月14日访问） 39 4. 监测和评估 监测和评估疫苗接受度 已经调查了医务人员疫苗接受度的关键决定因素，包括自我保护和保护家庭和患者的 愿望。（另参见关于宣传和疫苗接受度的部分）。 作为医务人员流感疫苗接种计划初步情况分析的一部分，可通过关键的知情人访谈或 参与性研讨会调查有关政策、计划和实践的现有信息，接受度和参与度的影响因素以及媒 体和通信的影响。然后，这种分析的结果可以用来为其他通信策略提供信息，有针对性地 解决已确定的问题。 其他决定因素可以通过形成性研究来探索。定性和定量研究方法都可用于评估医务人员 的知识、态度，实践和行为的变化。应定期评估区分接种疫苗的医务人员与不接种疫苗的 医务人员的行为决定因素。了解医务人员对每年流感疫苗接种态度背后的原因对开发宣传 信息和产品很有用。让医务人员参与到与他们的观念，信仰，情绪和潜在冲突相关的行为 研究中也为医务人员界提供了参与该方法的机会，这可以使得更多人接受疫苗接种计划。 疫苗影响监测 在人群中引入流感疫苗后，其他研究可能有助于评估免疫计划的影响。 但是，鉴于其复杂性和费用，WHO不建议在所有有流感疫苗接种计划的国家进行疫苗 影响或效果研究。世界上许多研究网络进行此类研究，预计结果可用于具有类似流感流行 病学和疫苗接种计划的其他环境。因此，决定开展此类研究应基于对特定国家估计的需求 工具箱16 评估医务人员中疫苗接受度的工具 TIP-FLU工具。提供基于行为改变理论和健康计划规划模型的方法和工具，以根 据前线HWs的需求和态度定制季节性流感疫苗接种。  http://www.euro.who.int/en/health-topics/communicable-diseases/influenza/ publications/2015/tailoring-immunization-programmes-for-seasonal-influenza-tip-flu.- a-guide-for-increasing-health-care-workers-uptake-of-seasonal-influenza-vaccina- tion-2015（2019年5月14日访问） TIP-FLU黑山案例研究。提供使用TIP-FLU工具的实际示例。 ƥ http://www.euro.who.int/__data/assets/pdf_file/0007/281860/Tailoring-Immunization- Programmes-Seasonal-Influenza-TIP-FLU.pdf（2019年5月14日访问） 40 4. 监测和评估 以及当地进行此类严格研究的能力。如果没有对不同医务人员类别的适当抽样进行合适的 设计研究，则存在得出错误结论的风险。 鉴于流感疫苗在季节性流感疫情中预防流感症状的效果显示出相当大的异质性，13 因 此不建议对流感进行前后研究以证明疫苗有效性。鉴于不同类别的医务人员感染和传播给 患者的风险各不相同，评估季节性流感疫苗接种对医务人员的影响的研究可能更为复杂。 在医务人员中，缺勤率的普遍减少或（如果有的话）流感相关缺勤的减少通常被用作 流感疫苗接种规划影响的替代指标。为此，卫生机构的制度监测需要包括医务人员的疾病 率和疾病缺勤的测量。在可能的情况下，应记录流感样疾病（influenza-like illness，ILI） （或呼吸道感染）引起的缺勤天数。这将包括自我报告的ILI，无论有没有病毒学确诊。其 他非特异性结果包括严重急性呼吸道感染（severe acute respiratory infection，SARI） 和需要住院的全因肺炎。重要的是要注意所有这些临床综合症包含了流感疫苗不能保护的 各种其他呼吸道病原体。如果进行此类评估，理想情况下应涵盖多个季节，因为影响因季 节而有很大差异，否则此类研究将很难解释。 实验室确认的结果（例如通过RT-PCR和其他分子诊断测试）改善了流感疾病分类的特 异性。在可能的情况下，可以考虑建立具有这种能力的哨点，以便从医务人员那里收集样 本进行实验室确认。在这些地点，如果疫苗覆盖率足够高，可以使用病例对照设计评估疫 苗有效性，并比较实验室确诊与试验阴性病例的疫苗覆盖率。任何这些方法都需要复杂的 实验室能力，而这不是任何地方都有的。 筛选方法是一种研究设计，也可用于医务人员疫苗影响评估：它使用病例个体水平的 疫苗接种历史数据和来自医务人员群体的病例的疫苗接种覆盖率数据。然而，这项研究需 要有关病例的疫苗接种状况和医务人员疫苗接种覆盖率的准确信息。 鉴于每年为医务人员接种流感疫苗可以减少他们所照顾的患者的疾病，可以设计研究 来评估医务人员流感疫苗接种对医疗机构患者的死亡率，住院治疗和流感病例的影响。在 这种情况下已经使用了几种研究方法，例如随机试验或病例对照方法。鉴于研究设计的复 杂性，此类研究的开展应限于具有开展此类研究的能力和经验的研究机构。 一旦引入流感疫苗后可获得足够的成本和影响数据，可考虑进行经济学评价和成本效益 评价。WHO提供了一些相关的资源文件，这些文件正在进一步发展，以专门估算医务人员 接种疫的疫苗引入成本（工具箱17；另参见工具箱2）。鉴于医务人员群体的规模有限， 相关数据并不容易在任何地方获得，评估可能难以进行。 13 评价流感疫苗效果：设计和解释观察性研究的指南, 世界卫生组织2017 41 4. 监测和评估 引入后评价 国家免疫规划审查（National Immunization Program Reviews）定期在新疫苗引入后 每5年评估一次特定疫苗的使用情况。此类NIP评审应包括相关项目，以确定与新疫苗使用 相关的可能的计划领域。 根据NIP审查之间的需要，可以在第一次或第二次流感免疫季节后进行特定的流感相关 引入后评估（Post-Introduction Evaluation，I-PIE）工具。 I-PIE包（工具箱18）包括许多支持评估计划和实施的工具，包括纸质或电子格式的标 准问卷和数据收集表格以及报告模板以及如何以具有成本效益的方式执行I-PIE的说明。 这些工具需要根据具体的国家背景以及疫苗制剂和表现的具体情况进行调整。 I-PIE在卫生系统的各个层面进行，包括疫苗接种点，疫苗储存区以及数据和记录审查 的观察实践。因此，I-PIE可以提供更直接的方法来评估流感疫苗使用的规划性挑战和影 响，并比较各国的结果，使他们能够分享和学习彼此的经验。 工具箱17 医务人员中的流感：研究方法学 评价流感疫苗效果2017。为设计观察性流感疫苗效果研究的研究人员和解释并应 用这些研究结果的公共卫生学家提供详细信息。附录将讨论流感疫苗在医务人员 中的有效性。 ƥ http://apps.who.int/iris/bitstream/handle/10665/255203/9789241512121-eng.pdf (2019年5月14日访问） 估算与季节性流感相关的疾病负担手册。提供评估一般人群以及易患严重疾病的 特定疾病患者的流感疾病负担的逐步方法。  http://www.who.int/influenza/resources/publications/manual_burden_of_disease/ (2019年5月14日访问） 工具箱18 流感疫苗引入后评估工具 I-PIE工具，带有说明、记录、报告模板。  https://www.who.int/immunization/research/development/ipie_influenza_post_ introduction_evaluation/（2019年5月14日访问 42 参考文献 1. Vaccines against influenza. WHO position paper – November 2012. Weekly Epidemiological Report. 2012; 87(47):461–76. 2. Lietz J, Westermann C, Nienhaus A, Schablon A. The Occupational Risk of Influenza A (H1N1) Infection among Healthcare Personnel during the 2009 Pandemic: A Systematic Review and Meta-Analysis of Observational Studies. PLoS One. 2016; 11(8):e0162061. 3. Wilson RJ, Paterson P, Jarrett C, Larson HJ. Understanding factors influencing vaccination acceptance during pregnancy globally: A literature review. Vaccine. 2015; 33(47):6420–9. 4. Yuen CY, Tarrant M. A comprehensive review of influenza and influenza vaccination during pregnancy. J Perinat Neonatal Nurs. 2014; 28(4):261–70. 5. Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by preg- nant women: a cross-sectional survey. The Medical journal of Australia. 2013; 198(7):373–5. 6. Zhang W, Hirve S, Kieny MP. Seasonal vaccines – Critical path to pandemic influenza response. Vaccine. 2017; 35(6):851–2. 7. Jorgensen P, Mereckiene J, Cotter S, Johansen K, Tsolova S, Brown C. How close are countries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015. Vaccine. 2018; 36(4):442–52. 8. Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, et al. Influenza Vaccination Coverage Among Health Care Personnel – United States, 2017–18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67(38):1050–4. 9. Pitts SI, Maruthur NM, Millar KR, Perl TM, Segal J. A systematic review of mandatory influenza vaccina- tion in healthcare personnel. Am J Prev Med. 2014; 47(3):330–40. 10. Rapid Evidence Appraisal: Healthcare Worker Influenza Vaccination – A global review of the evidence. 2017 (https://www.sciencedirect.com/science/article/pii/S2590136219300373?via%3Dihub, accessed 12 July 2019). 11. Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, et al. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011; 6(10):e26239. 12. Pereira M, Williams S, Restrick L, Cullinan P, Hopkinson NS, London Respiratory N. Healthcare worker influenza vaccination and sickness absence – an ecological study. Clin Med (Lond). 2017; 17(6):484–9. 13. Kliner M, Keenan A, Sinclair D, Ghebrehewet S, Garner P. Influenza vaccination for healthcare workers in the UK: appraisal of systematic reviews and policy options. BMJ Open. 2016; 6(9):e012149. 14. Ng AN, Lai CK. Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review. J Hosp Infect. 2011; 79(4):279–86. 15. Imai C, Toizumi M, Hall L, Lambert S, Halton K, Merollini K. A systematic review and meta-analysis of the direct epidemiological and economic effects of seasonal influenza vaccination on healthcare wor- kers. PLoS One. 2018; 13(6):e0198685. 43 16. Cooley P, Lee BY, Brown S, Cajka J, Chasteen B, Ganapathi L, et al. Protecting health care workers: a pandemic simulation based on Allegheny County. Influenza Other Respir Viruses. 2010; 4(2):61–72. 17. Ip DK, Lau EH, Tam YH, So HC, Cowling BJ, Kwok HK. Increases in absenteeism among health care wor- kers in Hong Kong during influenza epidemics, 2004–2009. BMC Infect Dis. 2015; 15:586. 18. Sartor C, Zandotti C, Romain F, Jacomo V, Simon S, Atlan-Gepner C, et al. Disruption of services in an internal medicine unit due to a nosocomial influenza outbreak. Infect Control Hosp Epidemiol. 2002; 23(10):615–9. 19. Bellei N, Carraro E, Perosa A, Granato C. Patterns of influenza infections among different risk groups in Brazil. Braz J Infect Dis. 2007; 11(4):399–402. 20. Poland GA, Jacobson, R.M., Wicker, S. Mandating influenza vaccination of health care workers: a patient safety, quality of care, and public trust issue. Annals of Respiratory Medicine. 2011; 2(1). 21. Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, et al. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014–2015 influenza season. Am J Infect Control. 2017; 45(11):1254–8. 22. Mossad SB, Deshpande A, Schramm S, Liu X, Rothberg MB. Working Despite Having Influenza-Like Illness: Results of An Anonymous Survey of Healthcare Providers Who Care for Transplant Recipients. Infect Control Hosp Epidemiol. 2017; 38(8):966–9. 23. Rebmann T, Turner JA, Kunerth AK. Presenteeism Attitudes and Behavior Among Missouri Kindergarten to Twelfth Grade (K-12) School Nurses. J Sch Nurs. 2016; 32(6):407–15. 24. Wilson KE, Wood SM, Schaecher KE, Cromwell KB, Godich J, Knapp MH, et al. Nosocomial outbreak of influenza A H3N2 in an inpatient oncology unit related to health care workers presenting to work while ill. Am J Infect Control. 2019; pii: S0196-6553(18)31069–1. 25. Voirin N, Payet C, Barrat A, Cattuto C, Khanafer N, Regis C, et al. Combining Высокое-resolution contact data with virological data to investigate influenza transmission in a tertiary care hospital. Infect Control Hosp Epidemiol. 2015; 36(3):254–60. 26. Pagani L, Thomas Y, Huttner B, Sauvan V, Notaridis G, Kaiser L, et al. Transmission and effect of mul- tiple clusters of seasonal influenza in a Swiss geriatric hospital. J Am Geriatr Soc. 2015; 63(4):739–44. 27. Valley-Omar Z, Nindo F, Mudau M, Hsiao M, Martin DP. Phylogenetic Exploration of Nosocomial Trans- mission Chains of 2009 Influenza A/H1N1 among Children Admitted at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa in 2011. PLoS One. 2015; 10(11):e0141744. 28. Vanhems P, Voirin N, Roche S, Escuret V, Regis C, Gorain C, et al. Risk of influenza-like illness in an acute health care setting during community influenza epidemics in 2004–2005, 2005–2006, and 2006–2007: a prospective study. Arch Intern Med. 2011; 171(2):151–7. 29. Ahmed F, Lindley MC, Allred N, Weinbaum CM, Grohskopf L. Effect of influenza vaccination of healthcare personnel on morbidity and mortality among patients: systematic review and grading of evidence. Clin Infect Dis. 2014; 58(1):50–7. 30. Riphagen-Dalhuisen J, Burgerhof JG, Frijstein G, van der Geest-Blankert AD, Danhof-Pont MB, de Jager HJ, et al. Hospital-based cluster randomised controlled trial to assess effects of a multi-faceted pro- gramme on influenza vaccine coverage among hospital healthcare workers and nosocomial influenza in the Netherlands, 2009 to 2011. Euro Surveill. 2013; 18(26):20512. 31. Jaiyeoba O, Villers M, Soper DE, Korte J, Salgado CD. Association between health care workers’ know- ledge of influenza vaccine and vaccine uptake. Am J Infect Control. 2014; 42(1):69–70. 44 32. De Serres G, Skowronski DM, Ward BJ, Gardam M, Lemieux C, Yassi A, et al. Influenza Vaccination of Healthcare Workers: Critical Analysis of the Evidence for Patient Benefit Underpinning Policies of Enfor- cement. PLoS One. 2017; 12(1):e0163586. 33. Wendelboe AM, Avery C, Andrade B, Baumbach J, Landen MG. Importance of employee vaccination against influenza in preventing cases in long-term care facilities. Infect Control Hosp Epidemiol. 2011; 32(10):990–7. 34. Dionne B, Brett M, Culbreath K, Mercier RC. Potential Ceiling Effect of Healthcare Worker Influenza Vaccination on the Incidence of Nosocomial Influenza Infection. Infect Control Hosp Epidemiol. 2016; 37(7):840–4. 35. van den Dool C, Bonten MJ, Hak E, Wallinga J. Modeling the effects of influenza vaccination of health care workers in hospital departments. Vaccine. 2009; 27(44):6261–7. 36. Frederick J, Brown AC, Cummings DA, Gaydos CA, Gibert CL, Gorse GJ, et al. Protecting Healthcare Personnel in Outpatient Settings: The Influence of Mandatory Versus Nonmandatory Influenza Vaccina- tion Policies on Workplace Absenteeism During Multiple Respiratory Virus Seasons. Infect Control Hosp Epidemiol. 2018; 39(4):452–61. 37. Begue RE, Gee SQ. Improving influenza immunization among healthcare workers. Infection control and hospital epidemiology. 1998; 19(7):518–20. 38. Global pandemic influenza action plan to increase vaccine supply. Geneva; 2006. Contract No.: WHO/ IVB/06.13. 39. Principles and considerations for adding a vaccine to a national immunization programme: from decision to implementation and monitoring. Geneva: World Health Organization; 2014. 40. Maltezou HC, Gargalianos P, Nikolaidis P, Katerelos P, Tedoma N, Maltezos E, et al. Attitudes towards mandatory vaccination and vaccination coverage against vaccine-preventable diseases among health- care workers in tertiary-care hospitals. J Infect. 2012; 64(3):319–24. 41. Maltezou HC, Katerelos P, Poufta S, Pavli A, Maragos A, Theodoridou M. Attitudes toward mandatory occupational vaccinations and vaccination coverage against vaccine-preventable diseases of health care workers in primary health care centers. Am J Infect Control. 2013; 41(1):66–70. 42. Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen trans- mission: a review. J Infect. 2011; 62(1):1–13. 43. Gralton J, Tovey ER, McLaws ML, Rawlinson WD. Respiratory virus RNA is detectable in airborne and droplet particles. J Med Virol. 2013; 85(12):2151–9. 44. Maltezou HC, Poland GA. Immunization of Health-Care Providers: Necessity and Public Health Policies. Healthcare (Basel). 2016; 4(3). 45. Maltezou HC, Poland GA. Immunization of healthcare providers: a critical step toward patient safety. Vaccine. 2014; 32(38):4813. 46. Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014; 32(38):4876–80. 47. MacDonald NE, Harmon S, Dube E, Steenbeek A, Crowcroft N, Opel DJ, et al. Mandatory infant & child- hood immunization: Rationales, issues and knowledge gaps. Vaccine. 2018; 36(39):5811–8. 48. Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC. Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate. Am J Public Health. 2011; 101(2):212–6. 49. Sullivan SJ, Jacobson R, Poland GA. Mandating influenza vaccination for healthcare workers. Expert Rev Vaccines. 2009; 8(11):1469–74. 45 50. Tilburt JC, Mueller PS, Ottenberg AL, Poland GA, Koenig BA. Facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implicati- ons for future pandemics. Vaccine. 2008; 26 Suppl 4:D27–30. 51. Betsch C, Wicker S. Personal attitudes and misconceptions, not official recommendations guide occu- pational physicians’ vaccination decisions. Vaccine. 2014; 32(35):4478–84. 52. Rhudy LM, Tucker SJ, Ofstead CL, Poland GA. Personal choice or evidence-based nursing intervention: nurses’ decision-making about influenza vaccination. Worldviews Evid Based Nurs. 2010; 7(2):111–20. 53. Leask J. Target the fence-sitters. Nature. 2011; 473(7348):443–5. 54. Poland CM, Poland GA. Vaccine education spectrum disorder: the importance of incorporating psycho- logical and cognitive models into vaccine education. Vaccine. 2011; 29(37):6145–8. 55. Wicker S, Marckmann G, Poland GA, Rabenau HF. Healthcare workers’ perceptions of mandatory vacci- nation: results of an anonymous survey in a German University Hospital. Infect Control Hosp Epidemiol. 2010; 31(10):1066–9. 56. Schmid P, MacDonald NE, Habersaat K, Butler R. Commentary to: How to respond to vocal vaccine deni- ers in public. Vaccine. 2018; 36(2):196–8. 57. Thaler RH, Sunstein, C.R. Nudge: Improving Decisions About Health, Wealth and Happiness. New York: Penguin Books; 2009. 58. Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018; 378(3):214–6. 59. Patel MS. Nudges for influenza vaccination. Nature Human Behaviour. 2018; 2:720–1. 60. Bioethics NCo. Public Health: ethical issues. Cambridge, United Kingdom; 2007. 61. Prevention CfDCa. The AFIX Program. AFIX (Assessment, Feedback, Incentives, and eXchange) 2017. 2018 (https://www.cdc.gov/vaccines/programs/afix, accessed 14 Mai 2019). 62. Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nature Human Behaviour. 2018; 2(10):743–9. 63. Recommendations regarding interventions to improve vaccination coverage in children, adolescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan; 18(1 Suppl):92–6. 64. Ubel PA, Rosenthal MB. Beyond Nudges – When Improving Health Calls for Greater Assertiveness. N Engl J Med. 2019 Jan24; 380(4):309–11. 46 附录1. 不参加表格的样表 本表格是在自愿接种的情况下，属于极高风险或高风险的医务人员拒绝依据国家政策参加 评估、筛检与预防接种时所要填写的表格。完成这个表格尤为重要，因为按照国家特定政 策，未成功接种流感疫苗会导致医务人员被重分配岗位或者被要求采取一些保护措施来保护 病人。 不参与接种 1. 本人已阅读并理解有关医务人员注射季节性流感疫苗的政策指引。 2. 我拒绝参加流感疫苗预防接种。 3. 我知道由于我不参与流感疫苗注射可能对自己或他人会造成潜在风险。 4. 我知道依据国家政策，由于没有进行免疫接种，可能导致我被重新分配到一个非 高危领域，或者为了保护其他与我接触的人而对我有其它要求。 5. 我不参与流感疫苗注射的原因是： 拒绝签署 如果医务人员拒绝填写本表，则应在表格上注明，并依政策告知其可能后果。 医务人员姓名： 出生日期： 卫生服务/医疗机构： 工作地点： 签名： 日期： 办公人员专用： 我已经根据预防接种政策告知不参加疫苗预防接种可能带来的潜在危险以及对未接种 者的管理。 预防接种组员工姓名： 职务： 卫生机构： 签名： 日期： 47 附录2. 规划医务人员免疫接种的补充清单：国家 14  层面适合当地使用 （适合当地使用） 为了说明医务人员季节性流感疫苗接种的具体情况，可在通用新疫苗引入的核对清单中加 入以下附加要素，参见附录4“将疫苗纳入国家免疫规划的原则和考虑”清单的结构。 医务人员季节性流感疫苗预防接种政策 1. 医务人员季节性流感预防接种的国家政策已颁布并向所有相关机构以及卫生机构 发布，包括私人卫生机构和相关专业团体。 2. 医务人员季节性流感预防接种的政策体现在国家职业卫生政策中。 3. 医务人员季节性流感疫苗预防接种的花费酌情纳入免疫或职业卫生预算。 4. 已建立监测流感活动的系统，包括确定流感季节的开始和结束时间，以便选择最 合适的疫苗配方和流感疫苗接种时间。 为成功引进疫苗做计划 5. 已成立了功能性多学科协调小组，为了讨论和促进医务人员成为新的目标人群， 使之能够建立伙伴关系，支持、形成国家议程。 6. 该小组包括职业卫生和免疫规划、专业组织代表和其他利益相关方的联络人。 7. 制定了医务人员接种疫苗的成本核算工作计划并将其纳入国家免疫计划和有关的 职业卫生计划。 形成性研究（可选，只有计划进行形成性研究时才纳入） 8. 为准备疫苗引进而实施任何形成性研究的必要性和范围已经明确。 9. 已经建立了一个实施形成性研究的研究小组，并制定了研究的职权范围。 宣传 10. 为规划宣传策略以及为医务人员接种季节性流感疫苗制定宣传材料而设立了国家 宣传工作组。 11. 有针对性的宣传信息和材料以及总体宣传策略已制定。 12. 对卫生机构宣传小组进行了培训。 14 在一些国家，特别是具有分权制度的大国，本清单的要素也可适用于相关的国家以下一级，例如：省级。 48 疫苗采购和供应链管理 13. 已估计目标人群规模并将其纳入需求预测。 14. 估计单个卫生机构的需求，制定疫苗分配计划。 15. 在各个层面建立了充足的疫苗存储空间和供应条件从而在疫苗接种期间容纳疫苗。 疫苗接种 16. 已建立并培训卫生机构疫苗接种小组。 17. 为预防院内传播，用于管理拒绝疫苗接种和实施感染控制措施的系统已就位，例 如：重新分配、戴口罩、诊断为流感样病例时强制休假。 监测与评估 18. 已开发并分发数据记录和报告的工具，包括疫苗接种率的监测（更新接种数据和 医务人员的调查报告）和预防接种不良反应（AFEI）的监测。 19. 在疫苗引进后的前两个季节做引入后评估。 20. 审查运营研究的可能性，以评估医务人员对疫苗的接受度。 49 附录3. 卫生机构清单 （适合当地使用） 负责人 截止日期 情况 宣传 1. 已建立并培训了卫生机构宣传工作组 2. 卫生机构宣传计划和与对医务人员做集体宣传的时间表最终 确定 3. 为医务人员疫苗接种提供充足的海报以及信息材料 4. 向目标医务人员和监督员发出接种通知 5. 建立电话热线以解答医务人员的个人咨询问题 疫苗及用品的储存量 6. 确定疫苗接种窗口期流感疫苗和供应品的充足储存能力 7. 为医务人员接种疫苗提供充足的流感疫苗和用品 8. 有在疫苗接种期间产生的额外注射废物的处理规定 疫苗接种 9. 已建立和培训了疫苗接种组，最终确定了卫生机构内的疫苗 接种点 10. 对医务人员做好了分类并完成预防接种受益者名单 11. 为预防院内传播，用于管理拒绝疫苗接种和实施感染控制措 施的系统已就位。例如：重新分配、戴口罩、诊断为流感样 病例时的强制休假 监测与评估 12. 考虑到数据保护问题，有可用的数据记录和报告工具 13. 建立违约者追踪和提醒系统 14. 卫生机构登记册更新，包括流感疫苗接种 15. 更新了预防接种疑似不良反应（AEFI）监测和报告系统，以 识别医务人员的AEFI 16. 建立了疫苗接受度监测系统以解决医务人员的接种问题（如 果观察到问题） 50 附录4. 对医务人员进行调查的调查问卷样卷 1 姓名（选填） 2 年龄（岁） 3 Sex ¨ 男 ¨ 女 4 工作类别15 ¨ 医生 ¨ 护士/助产士 ¨ 实验室技术员 ¨ 其他技术人员 ¨ 其他（请注明） 5 与患者接触 ¨ 直接 ¨ 面对面但非直接接触 ¨ 不接 触 6 与高危病患接触 ¨ 是 ¨ 否 7 工作区域（临床工作区域的名称） 陈述 非常 同意 同意 中立 不同 意 非常 不同意 1 医务人员接种疫苗（如乙型肝炎和流感）非常重要 2 如果我未接种疫苗并暴露于流感，我的健康可能 会有风险 3 暴露于流感会对患者的健康构成风险 4 接种流感疫苗会对我的健康构成风险 5 预防接种利大于弊 6 我接受疫苗接种会保护我的病人 7 保护患者的最佳方法是将接种季节性流感疫苗与 其他感染控制措施结合起来 15 根据当地医务人员分类，适应当地使用 51 8 我充分了解感染流感的风险 我充分了解接种流感疫苗的风险与益处。 以下因素会影响我接种疫苗的决定 9 国家决策机构的建议（例如NITAG） 10 认同我隶属的专业协会的推荐 11 如果它是职业卫生规章制度/要求的一部分 12 我的私人医生的建议 13 我可以获得免费接种 14 在我工作区域内可以很容易得到接种 15 同事接种了疫苗 16 有预防接种史 17 保护患者 18 防止/减少缺勤 19 有助于防备流感大流行 影响我决定接种流感疫苗的其他因素（列在下方） 20 21 22 52 附录5. 宣传和需求生成：开发内容的方法分层 方法 投入 影响 建立宣传信息的内容 通过提供在同龄人或更健康个体中的接种率的社会比较反馈来构建信息 低 中 基于认知类型和文化行为的针对性宣传 中 高 宣传方法 信息、教育与宣传（Information, Education and Communication，IEC）材料的分发和展示 低 中 在卫生机构层面建立一支专业的训练有素的宣传团队，以管理宣传和需求 生成方法 中 高 基于网络（包括常见问题解答和聊天组）和社交媒体宣传 中 中 向医务人员发送短信和电子邮件提醒 低 中 小组面对面简报会 高 中 在国家和卫生机构层面使用免疫拥护者 中 高 需求生成方法 提供免费疫苗 中 高 使用移动团队在工作区域提供疫苗接种 中 高 提供奖励或者刺激竞争，例如：奖励疫苗接种率最高的临床区域 低 中 可视提醒和同伴压力，例如：接种疫苗后的个体佩戴徽章或贴纸 低 中 要求个体提交预计预防接种的时间和地点 低 中 增加获得接种的选择，接种场所离住所近或者在工作地点附近 中 高 通过默认选项引导选择，例如：除非个人选择退出，否则自动设置疫苗接 种预约 低 高 建立长期适用的规程以促进疫苗接种 中 高 53 ISBN 978-92-4-551559-3