Mass drug administration for falciparum malaria: a practical field manual

Mass drug administration for falciparum malaria A practical field manual

Mass drug administration for falciparum malaria A practical field manual ii Mass drug administration for falciparum malaria: a practical field manual ISBN 978-92-4-151310-4 (electronic version) ISBN 978-92-4-000773-4 (print version) © World Health Organization 2017 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. 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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. Contents Acknowledgements vii Abbreviations and acronyms viii Executive summary ix 1. INTRODUCTION 1 1.1 Background 1 1.2 Definitions 1 1.3 Objective 1 1.4 WHO recommendations 2 2. ORGANIZATION AND IMPLEMENTATION OF MASS DRUG ADMINISTRATION 3 2.1 Design phase (macroplanning) 3 2.1.1 Identify agencies to support the ministry of health 3 2.1.2 Establish a task force or coordinating committee 4 2.1.3 Conduct a context analysis 6 2.1.4 Determine the target population and geographical areas 7 2.1.5 Choose the antimalarial medicine 10 2.1.6 Estimate the requirement for antimalarial medicine, and order it 13 2.1.7 Determine the delivery strategy 13 2.1.8 Determine the period of intervention 14 2.1.9 Determine the number of rounds 15 2.1.10 Establish a chronogram 17 2.1.11 Draw up a budget 17 2.2 Planning and preparation 18 2.2.1 Micro-planning 18 2.2.2 Logistics 20 2.2.3 Human resources 22 2.2.4 Community engagement, social mobilization and communication 26 2.3 Implementation 32 2.3.1 Stock management 32 2.3.2 Distribution of antimalarial medicine 34 2.3.3 Supervision 37 2.3.4 Data collection 39 iii 2.3.5 Coordination 42 2.3.6 Treatment of malaria cases after mass drug administration 43 3. MONITORING AND EVALUATION 44 3.1 Monitoring system 44 3.2 Estimate of coverage 44 3.2.1 Distribution coverage 44 3.2.2 Post-MDA campaign survey 46 3.3 Monitoring consumption 46 3.4 Pharmacovigilance 47 3.4.1 Definitions 48 3.4.2 Safety communication 49 3.4.3 Surveillance of adverse drug reactions 49 3.5 Monitoring drug resistance 50 3.6 Evaluating impact 51 4. REPORTING 53 5. KEY STEPS IN A MASS DRUG ADMINISTRATION CAMPAIGN FOR MALARIA 55 REFERENCES 56 ANNEXES 59 Annex 1 - Standard distribution of populations in a developing country 59 Annex 2 - Available artemisinin-based combination therapy: dosing, formulation and presentation 60 Annex 3 - Example of calculation of orders for antimalarial medicine 66 Annex 4 - Example of a chronogram for mass drug administration for malaria (distribution at 8 weeks) 69 Annex 5 - Example of micro-planning in urban Western Area, Sierra Leone 72 Annex 6 - Step-by-step procedure for prepositioning supplies 75 Annex 7 - Example of radio spot on MDA for malaria (used in Sierra Leone in 2014–2015) 76 Annex 8 - Examples of discussion points on MDA for use at community meetings (adapted from those used in Sierra Leone in 2014–2015) 77 iv Annex 9 - Household visit for MDA, step by step 78 Annex 10 - Algorithm to assist community health workers in applying exclusion criteria 79 Annex 11 - Algorithm for determining the pregnancy status of women of reproductive age (15–49 years) (based on and adapted from algorithms used in malaria MDA in Mozambique by the Centro de Investigação em Saúde de Manhiça) 80 Annex 12 - Example of laminated leaflet used by community health workers in Sierra Leone in 2014-2015 to explain treatment dosage 81 Annex 13 - Example of tally sheet (adapted from that used in Sierra Leone in 2014–2015) 82 Annex 14 - Example of a household registration form (adapted from the Zambia MDA programme delivery handbook) 83 Annex 15 - Example of supervisors’ checklist used in Sierra Leone in 2014-2015 84 Annex 16 - Example of MDA Card 85 Annex 17 - Example of daily summary sheet to be completed by distribution team supervisors (adapted from that used in Sierra Leone in 2014–2015) 86 Annex 18 - Example of database for data compilation (used in Sierra Leone in 2014–2015) 87 Annex 19 - Example of standard template for reporting a suspected adverse drug reaction 89 Annex 20 - Example of questionnaire for post-MDA survey 92 Annex 21 - Example of pharmacovigilance preparedness checklist (used in Sierra Leone in 2014–2015) 96 Annex 22 - Example of an MDA pharmacovigilance training module 97 v

M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL vii Acknowledgements This operational manual on mass drug administration (MDA) for malaria is based on practical field experience in the great majority of MDA operations that have been completed over the past 10 years in malaria-endemic countries. The main author was Dr Carolina Nanclares (Médecins Sans Frontières, Spain), who prepared an excellent first draft and finalized it after careful consideration of the suggestions of multiple reviewers. Dr Nanclares based the first draft on experience and lessons learnt during widescale MDA in Sierra Leone during the epidemic of Ebola virus disease, completed in 2014–2015. The following colleagues from MSF Spain who participated in that campaign provided input on the first draft: Jonathan Caplan, Fernanda Falero, Adriana Ferracin Kleivan, Segimon Garcia, Maria Green, Yves Houedakor, Cristina Imaz, Nines Lima and Charlotte Oliveira. The WHO Global Malaria Programme then convened a drafting committee consisting of technical resource officers who contributed to control of malaria by MDA and research in: Cambodia, Comoros, Mozambique, Myanmar, Sierra Leone, Thailand, Viet Nam and Zambia. The first draft was sent by email to all the invited participants one month before the meeting, and all input received before the meeting was included in the second version, which was used as the basis of the work of the drafting committee. The meeting was held on 22–23 November 2016 in Geneva, where the members of the committee (listed below) were divided into four working groups to review and finalize the practical aspects of the different sections of the manual. During the last session of the meeting, the groups presented their conclusions in plenary, bringing to resolution the points that required consensus. Dr Nanclares, as rapporteur of the meeting, then compiled a third version that included all the input from the four working groups, which was circulated to all participants by email for final review. The text of the manual is the result of a fourth round of reviews by members of the drafting committee and the WHO Secretariat. We are very grateful to the following members of the drafting committee, who graciously reviewed all the sections of the report in several rounds, providing substantive comments that were instrumental for its finalization and improvement: Gilles Delmas (Mahidol-Oxford Tropical Medicine Research unit, Thailand), Stephan Duparc (Medicines for Malaria Venture, Switzerland), Busiku Hamainza (National Malaria Control Centre, Zambia), James Heaton (Mahidol-Oxford Tropical Medicine Research unit, Myanmar), Umu Jalloh (Pharmacy Board, Sierra Leone), Anitta Renitta Yokoe Kamara (National Malaria Control Programme, Ministry of Health and Sanitation, Sierra Leone), Calveston Machila (District Medical Office, Zambia), Joseph Mberikunashe (National Malaria Programme Control, Zimbabwe), Thuy-Nhien Thanh Nguyen (Centre for Tropical Medicine, Viet Nam), Francisco Saute (Manhiça Health Research Center, Mozambique), Jianping Song (Guangzhou University of Chinese Medicine, China) and Khieu Virak (National Centre for Parasitology, Entomoloy and Malaria Control, Cambodia). The draft manual also received input from the WHO Malaria Policy Advisory Committee at its session on 22–24 March 2017, which, with additional suggestions from the WHO Secretariat at the Global Malaria Programme, were taken into account in the final version of the document. At WHO, Andrea Bosman, Global Malaria Programme, coordinated preparation of the manual and represented the WHO Secretariat in the the drafting committee. Precious contributions were also made by Dr Maru Aregawi, Peter Olumese and Silvia Schwarte, Global Malaria Programme, and by Prabhjot Singh, WHO Regional Office for the Americas. Funding for the production of this report was provided the Bill & Melinda Gates Foundation. viii Abbreviations and acronyms ACT artemisinin-based combination therapy ADR adverse drug reaction CHW community health workers DOT directly observed treatment EVD Ebola virus disease G6PD glucose-6-phosphate dehydrogenase MDA mass drug administration M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL ix Executive summary Mass drug administration (MDA) consists of administering a full therapeutic course of antimalarial medicine (irrespective of the presence of symptoms or infection) to a defined population living in a defined geographical area (except for those for whom the medicine is contraindicated) at approximately the same time and often repeated at intervals. Recent progress in malaria control, including the use of others forms of preventive chemotherapy such as intermittent prevent treatment of malaria in pregnancy and seasonal malaria chemoprevention, the drive towards elimination of malaria in some settings and the availability of new antimalarial medicines, has renewed interest in the role that MDA can play in some settings. MDA should be viewed as a time-limited intervention with specific targets for when it should be discontinued, defined before implementation. Currently, on the basis of the evidence, WHO recommends MDA: • for interruption of transmission of falciparum malaria in areas approaching elimination, • to reduce the risk for spread of multi-drug resistance in the Greater Mekong subregion, • during malaria epidemics and • in exceptional complex emergencies. WHO recommends use of MDA for falciparum malaria, with two distinct, complementary objectives. The first is to reduce transmission of malaria, which is the primary aim of elimination and reduction of multi-drug resistance and is also relevant in malaria epidemics and complex emergencies. The objective is to quickly reduce the parasite biomass in a community and to prevent new infections for a certain period. Repeated rounds of MDA are given to remove parasites and prevent new infections in persons who were not reached in previous rounds. The expected result is a large reduction in transmission intensity. Synchronization of the intervention with high coverage of the entire population at risk is essential. In order quickly to reduce and potentially entirely interrupt transmission and avoid resurgence, several rounds are required, in combination with other malaria control tools and strategies such as effective vector control, access to prompt diagnosis and treatment and intensified surveillance. The second objective of MDA for falciparum malaria is rapid reduction of morbidity and mortality. This is a primary aim when falciparum transmission results in high mortality rates, as in epidemics and complex emergencies when health systems are overwhelmed and unable to provide core malaria preventive and curative services. In these settings, MDA is used as an initial emergency measure; several rounds are implemented while access to case management and vector control are being put in place. It is important to identify the population at risk for severe malaria and death in order to define the target groups for MDA. These may be either an entire population or specific vulnerable groups who are at high risk for mortality because of lack of vector control and access to effective case management. High coverage of such target populations is more important than synchronization, as the primary aim is to reduce morbidity and mortality in the target population and not to reduce malaria transmission. For MDA to be successful, high coverage and adherence of the target population (i.e. > 80%) must be ensured, which require a high level of community engagement and participation. Implementation strategies should therefore guarantee the highest level of participation possible. Door-to-door distribution is generally preferred to centralized distribution at a fixed site, and directly observed treatment (DOT), where feasible, is the best way to ensure adherence to treatment. xImplementing MDA for malaria is a complex, logistically challenging operation, which requires significant investments of resources (human, financial and logistic) as well as careful planning and organization. The intent of this manual is to provide technical and operational guidance on the practical aspects of organizing a successful MDA campaign for malaria. The main steps for efficient management are listed below. Design phase In this phase, the main strategies for MDA are established at national level: • Obtain commitment from policy-makers, and identify agencies to support the ministry of health. • Establish a task force or coordinating committee. • Conduct a context analysis. • Decide to implement MDA for falciparum malaria. • Define target areas and target population. • Choose the antimalarial medicine. • Estimate the requirements for the medicine, and procure it. • Determine the MDA strategy. • Estimate the budget. Planning and preparation phase This phase involves planning the operational aspects of the framework defined at national level: • Conduct micro-planning at province or district level according to the strategies defined by the national task force to guarantee an effective campaign by ensuring adequate distribution of supplies, training of staff, engagement of the community and proper management of resources. The micro-plan should include: - demographic information on the province or districts eligible for MDA; - information on the area (e.g. maps, infrastructure, location of health facilities, hard-to-reach areas); - timing of MDA in the district; - delivery strategies; - human resources (number required, number available) and training plan; - logistical information; - social mobilization and communications plan; and - pharmacovigilance plan. • Ensure effective logistics, taking into consideration: - procurement, storage and distribution of antimalarial medication; - procurement, storage and distribution of other supplies necessary for MDA; - transport; - accessibility to the entire target population, including those in hard-to-reach areas; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL xi - identification and preparation of distribution sites; and - waste management. • Plan human and financial resources: - number of teams required and composition, - training and - adequate payment of salaries and per diem. • Plan community engagement and social mobilization by - defining the roles and responsibilities of all partners; - assessing communities to understand the characteristics and social dynamics of the target population in order to orient the social mobilization plan; - preparing clear, simple, precise, consistent messages about MDA for malaria; - engaging the mass media by building relationships with local media representatives and diseminating information through the different media; - preparing to address negative rumours that may arise during the campaign, which could affect participation; and - Involving community leaders and other influential people in planning, so they will feel ownership of the campaign and its success. Implementation phase The implementation phase involves the actual distribution of antimalarial treatment and includes: • stock management: preparation of distribution kits with all the necessary materials ahead of time at the distribution point or peripheral health facility at which supplies are prepositioned; • distribution of the antimalarial medicine itself, either door to door or at a centralized, fixed site; • supervision, an essential component to ensure the quality of the campaign: at peripheral, district, regional and national levels; • data collection: collection and reporting of information on the number of people who receive treatment at community level, adverse drug reactions (ADRs) and analysis and compilation of data at higher levels through a well-established pathway of information flow; and • coordination of all actors to monitor activities, detect any difficulties or constraints, address them and react to unforeseen events. Monitoring and evaluation • intra-campaign monitoring system: a high-quality system for monitoring the campaign allows identification of constraints that require immediate action; can be done by monitors identified within the team or by independent monitors; • estimate of distribution coverage: the proportion of the target population that has been reached by distribution; • post-MDA survey: recommended, if feasible, after each round or at least at the end of the entire campaign to obtain more reliable information on coverage and to evaluate adherence to treatment, determine reasons for non-participation or non-adherence and evaluate the presentation of ADRs; xii • monitoring consumption: daily monitoring of the number of treatments distributed and the number taken; • pharmacovigilance: a vital component of an MDA, which should be planned to ensure training, detection, reporting, management of follow-up of adverse events and to promote and monitor adherence by both passive and active surveillance. This component is also essential to obtain and maintain good understanding and compliance of the population; • monitoring drug resistance: one of the main concerns with regard to MDA is the emergence and spread of drug resistance; although there is no evidence that MDA of artemisinin-based combined therapy (ACT) at therapeutic doses is related to the emergence of resistance, monitoring of resistance should be an essential component of an MDA campaign; • evaluation of impact: through routine surveillance and parasitological surveys to support a decision to stop; and • reporting: after each round and at the end of the intervention, of the coverage achieved, challenges and difficulties faced and solutions found, lessons learnt, practices with good results, effective social mobilization activities, useful tools and the costs of the intervention. In epidemics and complex emergencies, a minimum set of MDA monitoring and evaluation activities should be defined in order to document impact and for reporting. Although these steps are common to all settings, MDA for the purposes of reducing transmission of malaria or its elimination, for containing resistance, in response to an epidemic or in the event of a complex emergency may differ in ways outlined below in the corresponding sections. This manual is intended to provide general guidance. Some sections may not be relevant in all contexts and should be adapted to local circumstances (for instance, urban or rural settings). The manual also provides templates and examples from previous experience with MDA for malaria in various contexts that may be useful for developing training material or data collection. The majority of the tools are included in the annexes to this manual. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 1 1. INTRODUCTION 1.1 BACKGROUND Mass drug administration (MDA) has played a crucial role in the control and elimination of a number of prevalent neglected tropical diseases. The aim of the programmes has been to treat prevalent infection and to reduce transmission in the population simultaneously, hence decreasing the burden of the disease (1,2). Since the 1970s, MDA was not recommended as an anti-malaria intervention because of concern about its efficacy, especially the sustainability of the results, the logistical feasibility and the risk for accelerating drug resistance (3–5). Recent progress in malaria control, including the use of others forms of preventive chemotherapy, such as intermittent preventive treatment of malaria in pregnancy and seasonal malaria chemoprevention, together with the drive towards elimination of malaria in some settings and the availability of new antimalarial medicines, have renewed interest in the role that MDA can play in some settings (3,4,6,7), for example as part of work to contain multi- drug resistance and eliminate malaria transmission in the Greater Mekong subregion (8,9) and in certain complex emergencies, such as the 2013-2016 outbreak of Ebola virus disease (EVD) in West Africa (9–12). 1.2 DEFINITIONS Mass drug administration consists of the administration of a full therapeutic course of antimalarial medicine (irrespective of the presence of symptoms or infection) to every member of a defined population or person living in a defined geographical area (except for those for which the medicine is contraindicated) at approximately the same time and often at repeated intervals. (3,9). In order for MDA to be successful, a very high proportion, generally more than 80% of the targeted population must be reached during the campaign, depending on the intensity of transmission and the exact objective of the campaign (4,6,9,13,14). This requires a high level of community participation and engagement. It is not enough to reach the majority of the population with distribution: coverage will be effective only if the number of people in the community who correctly complete the full course of antimalarial treatment is adequate. To achieve this, the population must accept the intervention and be willing to take the medicine as prescribed. 1.3 OBJECTIVE The objective of malaria MDA is to provide therapeutic doses of antimalarial medicine to as large a proportion of the population as possible in order to cure all symptomatic and asymptomatic malaria infections at the time of the intervention and to prevent reinfection during the period of post-treatment prophylaxis. MDA at high coverage rapidly reduces the prevalence and incidence of malaria in the short term. Once MDA is stopped, however, malaria endemicity will return to its original level if importation of malaria is not prevented, in the absence of high coverage with other interventions such as vector control, case management, surveillance and response. The risk of such a return and the rapidity with which it occurs depend on the size of the residual parasite reservoir in humans, the rate of importation of new infections and the capacity of the vectors to transmit malaria in the target area. 21.4 WHO RECOMMENDATIONS On the basis of a recent review of the evidence (9) and the advice of the WHO Malaria Policy Advisory Committee, the current WHO recommendations for use of MDA, mass screening and treatment and focal screening and treatment for malaria (15) are listed below. 1. Use of MDA for the elimination of P. falciparum malaria can be considered in areas approaching interruption of transmission where there is good access to treatment, effective implementation of vector control and surveillance, and a minimal risk of re-introduction of infection. 2. Given the threat of multidrug resistance and the WHO call for malaria elimination in the Greater Mekong subregion (GMS), MDA may be considered as a component of accelerated malaria elimination efforts in areas of the GMS with good access to treatment, vector control and surveillance. 3. Use of Time-limited MDA to rapidly reduce malaria morbidity and mortality may be considered for epidemic control as part of the initial response, along with the urgent introduction of other interventions. 4. Use of Time-limited MDA to reduce malaria morbidity and mortality may be considered in complex emergencies, during exceptional circumstances when the health system is overwhelmed and unable to serve the affected communities. 5. In the absence of sufficient evidence, WHO does not recommend the use of MDA in situations other than for areas approaching elimination, epidemics, and complex emergencies, as specified above (see 1-4). 6. Mass primaquine prophylactic treatment, requiring pre-seasonal MDA with daily administration of primaquine for two weeks without G6PD testing, is not recommended for the interruption of vivax transmission. 7. Mass screening and treatment and focal screening and treatment for malaria are not recommended as interventions to interrupt malaria transmission. 8. Medicines used for MDA must be of proven efficacy in the implementation area and preferably have a long half-life. WHO recommends that a medicine different from that used for first-line treatment be used for MDA. Programmes should include monitoring of efficacy, safety and the potential emergence of resistance to the antimalarial medicines deployed for MDA. 9. WHO supports the need for mowre research on the optimum methods of implementing MDA programmes, promoting community participation and compliance with treatment, and evaluating their effectiveness. Modelling can help guide the optimum method of administering MDA in different epidemiological circumstances and predict its likely impact. In line with the above recommendations, this manual addresses use of MDA only for the control and elimination of falciparum malaria. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 3 2. ORGANIZATION AND IMPLEMENTATION OF MASS DRUG ADMINISTRATION 2.1 DESIGN PHASE (MACROPLANNING) Once it has been decided that MDA will be conducted, macroplanning should be started. This initial design phase, done at national level, is important to ensure a successful campaign and should involve the ministry of health and other key stakeholders. When MDA for malaria is done to impact on malaria transmission, the administration of antimalarial medicine must be done in such a way that all targeted individuals are treated in a synchronized manner and each round is completed in a very short time, generally not more than one week. In complex emergencies, when the main objective is rapid reduction of malaria morbidity and mortality, synchronous administration is less critical. Steps of the design phase: • Obtain commitment from policy-makers, and identify agencies to support the ministry of health. • Establish a task force or coordinating committee. • Conduct a context analysis. • Decide to implement MDA for falciparum malaria. • Define the target areas and target population. • Choose the medicine. • Estimate the requirements for the medicine and procure it. • Determine the delivery strategy (including period of intervention and number of rounds). • Estimate the budget. • Define the criteria for stopping MDA. As MDA targets every individual in a given population (except those with contraindications to the medicines used), it may be combined with other public health interventions, such as health education, deworming and distribution of long-lasting insecticide-treated nets; however, experience in combining multiple medicines or programmes is limited, and careful consideration should be given in advance. 2.1.1 Identify agencies to support the ministry of health MDA for malaria is a logistically challenging intervention, which will require careful planning and significant resources in order to be successful. Therefore, partners that can provide technical, financial and operational support should be identified and included in planning from the initial stages. The partners may be national (national and local government, the private sector, nongovernmental organizations, other civil society organizations, the media, community leaders, religious leaders) or international (funding agencies, procurement agencies and international nongovernmental organizations). Mapping donors and implementing partners is critical to the success of MDA. All should be encouraged to work within the framework of the “three ones” – one plan, one coordination and one monitoring and evaluation – under the oversight of the task force or coordinating committee. 4As MDA usually comprises multiple rounds for high coverage and, if the purpose is to interrupt transmission or elimination, may be repeated in subsequent years, it is therefore important to secure sustained support to ensure satisfactory completion of the intervention. Malaria services should be in place and supported in monitoring communities in the long term after the MDA has been completed. 2.1.2 Establish a task force or coordinating committee A task force or coordinating committee, under the stewardship of the Ministry of Health, must be created with representation from national, regional and target district level to serve as an oversight body in charge of implementation of the MDA campaign and ensure adequate allocation of resources. Composition The committee may include representatives from: • the national malaria control programme; • other relevant entities of the ministry of health, for example medicines, community health, neglected tropical diseases or other programmes with experience in MDA; • national research institutions; • the national medicines regulatory authority; • the national pharmacovigilance centre; • national, regional and relevant district health authorities; • technical personnel from relevant hospitals; • administrative authorities; • support agencies (the United Nation Children’s Fund, WHO, other United Nations agencies, nongovernmental organizations); • other concerned ministries; • local representatives of civil society; and • the private sector. A campaign will be successful only with close collaboration and coordination among partners. All of them should agree and, if possible, sign a formal agreement that describes the tasks and responsibilities of each. If MDA is used in an emergency, decisions will have to be made quickly. In order to avoid delay in trying to reach consensus among different agencies on any conflicting issues, a defined decision-making authority (normally the ministry of health) should be identified that will be responsible for taking rapid decisions if necessary. Responsibilities of the committee The committee will be responsible for: • agree whether MDA is appropriate to reduce transmission and / or morbidity and mortality • preparing strategic guidance for MDA implementation and preparing a plan of action; • mobilizing the necessary human and financial resources; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 5 • coordinating partners and sharing information; • identifying the target population and target geographical areas (section 2.1.4); • establishing the chronogram (section 2.1.10); • preparing, reviewing, adapting and updating guidelines and training materials; • developing data collection and monitoring tools (section 2.3.4); • drawing up the social mobilization and community engagement plan (section 2.2.4); • ensuring a functioning drug safety monitoring system (strengthening any existing pharmacovigilance body or establishing one) to guarantee effective detection, management and reporting of adverse events related to administration of the antimalarial medicine and access to consultation and hospitalization, including any necessary rescue medication, free of cost (section 3.4); • establishing monitoring and evaluation, determining objectives and methods and defining indicators (section 3); • ensuring comprehensive malaria control activities are implemented in the context of elimination: diagnosis and treatment, vector control and detection and investigation of all cases; • planning additional malaria control activities in the context of complex emergencies, such as diagnosis and treatment, vector control and surveillance; • establishing the criteria for termination of MDA; and • ensuring an effective surveillance system to compile and analyse changes in malaria burden; Responsibilities of the regional or district task force • micro-planning (section 2.2) in the framework of the strategy defined by the national task force and • coordinating and monitoring the operational aspects of the campaign. Subcommittees could be set up within the task force at both national and district levels, including, for example: • a technical committee; • a committee for information, education, communication, social mobilization and community engagement; • a human resources committee; • a training committee; • a logistics committee; • and a monitoring and evaluation committee. 62.1.3 Conduct a context analysis Planning an MDA requires a systematic context analysis and information on a number of aspects that may have major practical implications for execution of the campaign: • malaria situation in the country and neighbouring countries: - major human malaria species present; - malaria endemicity or transmission intensity (high, moderate, low or epidemic prone); - peak malaria transmission season; - malaria prevalence, incidence of uncomplicated and severe malaria and mortality; - high-risk groups: by age, gender and occupation; - other malaria control activities that are being (or have been) used, in particular distribution of long lasting insecticidal nets, indoor residual spraying, larval source management; - availability and type of diagnostic tests available and used; - national treatment guidelines; - other chemoprevention activities, in particular seasonal malaria chemoprevention, intermittent preventive treatment of infants or pregnant women; - resistance to antimalarial medicines; - main sources of financing of malaria control activities and implementation; and - mapping of malaria partners; • administrative information: - country borders and administrative divisions and - grey areas or undefined boundaries that might challenge implementation; • mapping of administrative boundaries, cities, villages, location of health structures, main roads; • demographic data, including age distribution of the population and identified marginalized groups; • health care organization: - available health infrastructure: hospitals, health centres, health posts; - available health care staff (number and level of training); and - traditional health care providers; • environmental factors: climate and seasons (rainy, dry), extreme events linked to climate change (floods, droughts); • geography of the target areas and nature of the terrain; • security - existence of armed conflict, ethnic, religious or social tension or clashes; and - civil unrest, demonstrations, corruption; • challenges to the health system: public health emergencies and disease outbreaks; • experience and lessons learnt from previous MDA campaigns for neglected tropical diseases or malaria; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 7 • previous crises in communication and rumours about the safety of MDA for neglected tropical disease or vaccination campaigns and lessons learnt; • important local events: national and religious holidays, market days, elections, planned demonstrations, food distribution, MDA for neglected tropical diseases or vaccination campaigns, which may result in poor participation; • local perceptions and beliefs (see section 2.2.4); • supply: national and local purchase and storage possibilities, formalities for importing medicines, registration status of antimalarial medicine eligible for MDA (section 2.2.2); • communications system: e.g. existing networks (providers of mobile communications), availability of Internet; and • population displacement due to security problems, seasonal migration or nomadic populations. 2.1.4 Determine the target population and geographical areas A thorough analysis of the epidemiology of malaria and of the aim of MDA – for epidemic control, malaria elimination or in a complex emergency – should guide decisions on the target population and the geographical areas that will benefit from the campaign. The larger the target population, the more challenging is implementation and the more resources (human, financial, logistic) will be required, as MDA coverage in the target areas is the major determinant of impact. The demographic data used to calculate the target population should be as accurate as possible. This may be difficult to obtain in certain developing countries. If feasible, data should be provided by official sources. Estimates of population numbers can be acquired from (Fig. 1): • head counts (census) or household registration before MDA (unlikely to be feasible in the context of emergencies); • a recent population census (if available); • household surveys; • administrative registration (if available); • data from other recent mass distributions (such as of long-lasting insecticidal nets), mass vaccination campaigns or previous MDA in the same area; or • household mapping done by indoor residual spraying teams in areas where there are strong malaria programmes. If no recent data are available to establish a realistic estimate, the annual population growth rate may be applied to the latest available population estimate. Population displacement into or out of the targeted geographical area should also be considered. If several estimates are available, it is advisable to use the highest figures. Underestimation of the target population may result in errors in calculating orders and consequently a shortage of medicines, an inadequate number of distribution teams or inadequate time required to reach the entire target population. Such errors will ultimately compromise coverage and could also have a negative impact on the perception of the population that is excluded. 8FIG. 1. Sources of demographic information for calculating target population SOURCES OF POPULATION NUMBERS Recent population census Household surveys Head count or household registration Recent distribution of long-lasting insectidal nets / indoor residual spraying Administrative registration After the first round of distribution is completed, the results may be used to recalculate the target population for subsequent rounds. The target population should be calculated by age group. If specific data on the age distribution in the country are not available, the standard age distribution for developing countries can be used (see Annex 1). Certain population groups might have to be excluded from the campaign, depending on the medicine chosen for MDA: • pregnant women in the first trimester: a decision to use pregnancy tests or self-reported pregnancy to exclude pregnant women should be guided by the health authorities and local context; • infants < 6 months of age or weighing < 5 kg; • people recently treated with the same medicine; • people with known allergy to the medicine; • severely ill people; • people taking medication known to interact with the MDA medicine; and • people with specific contraindications to the medicine used. At the design phase, inclusion and exclusion criteria for participation in the MDA campaign should be clearly established. Estimation of the expected number of individuals who will be excluded from participation in the MDA may be useful for calculating orders, for planning purposes and for analysis of coverage. The geographical area to be targeted must be defined on the basis of the size of the population in each zone or area, the population density and whether it is an urban or a rural setting. Table 1 indicates differences in implementation between urban and rural settings. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 9 TABLE 1. Main differences in MDA in urban and rural settings ELEMENT URBAN SETTING RURAL SETTING Demographic data More difficult to estimate: mobile population, slum areas Difficult to determine administrative boundaries of neighbourhoods and other areas within cities Household census before MDA difficult Estimates may be more reliable or more easily obtained Boundaries of villages are easily defined Easier to perform household census before MDA Logistic resources Fewer resources required, as population is densely distributed More resources requires, as population is scattered, and more teams and time are required Accessibility More readily accessible Access may be difficult when there is insecurity Access may be limited by distances, poor road conditions and effects of climate (rain) Human resources Easier to find qualified human resources Community health workers (CHW) and volunteers may be less well known to the population Less qualified HR available CHW and volunteers are well known to and trusted by the population Community leaders More difficult to identify Important role in micro-planning and social mobilization Door-to-door strategy Easier to miss households People less willing to allow access to their house, especially in higher socioeconomic strata People refuse to participate or are absent when they are in their workplace 15–20 households can be visited per team per day (75–100 people) Difficult to miss households People less suspicious and more welcoming of distribution teams People absent usually because of farming activities 10–15 households can be visited per team per day (50–75 people) DOT strategy More difficult to achieve as people are less likely to be at home May be easier to achieve Coverage More difficult to obtain high coverage Higher coverage is easier to obtain Adherence to treatment Lower Higher Rumours More quickly generated and disseminated More difficult to control May be generated but easier to control and limit their dissemination 10 2.1.5 Choose the antimalarial medicine A number of elements should be considered when choosing which medicine to use. • Efficacy: the 28-day cure rate for uncomplicated malaria patients should be > 90%. • Safety profile: low frequency of medicine-related adverse effects, contraindications and consequences of inadvertent exposure of excluded individuals, such as pregnant women or HIV-positive patients on antiretroviral therapy. Even rare adverse events could occur in a considerable number of healthy recipients when the medicine is administered to a large population. • Ease of administration: few tablets per dose and short duration of treatment. • Reputation and acceptability: tolerance of the population to frequent even minor side-effects (e.g. nausea, weakness) and perception of risks and benefits, sometimes affected by rumours, may influence the acceptability of the medicines used in MDA. • How to identify and exclude special populations groups for which at present there are no available options for malaria MDA: pregnant women in the 1st trimester and children weighing < 5 kg. • Interactions: with other medicines used in the population, including other MDA interventions to the same population and antiretroviral agents used by HIV-positive patients. • First-line ACT used in the country should preferably be avoided to limit the emergence of resistance and the impact on the supply for regular programmes and to avoid creating confusion and misconceptions in the population regarding the use of the medicine (prophylactic versus treatment) (9,10). Under certain circumstances, however, such as complex emergencies, the first-line treatment may be considered, as it will be well known by the population and the supply may be easier to guarantee. • Availability of required quantities from suppliers at relatively short notice. • Cost (available budget). The best treatment is one that results in the greatest reduction in parasitaemia and transmissibility and the longest period of post-treatment prophylaxis, hence preventing reinfection. Long-acting ACT is the most suitable treatment in most contexts. The artemisinin component, which quickly clears asexual parasitaemia and also has gametocytocidal activity, has a short half-life, while the partner drugs provide different durations of post-treatment prophylaxis (see elimination half-life of partner drugs in Annex 2). The post-treatment prophylactic effect prevents acquisition of infection while the medicine remains in the bloodstream, protecting the individual as well as reducing transmission. A complete (three-day) course of ACT should be administered; it is important to ensure adherence to the full regimen. Only co-formulated, fixed-dose combination tablets should be used in order to facilitate adherence and avoid resistance due to errors in administration of the medication. The five formulations of ACT currently recommended by WHO for the treatment of P. falciparum malaria are: • artemether + lumefantrine • artesunate + amodiaquine • artesunate + mefloquine • artesunate + sulfadoxine–pyrimethamine • dihydroartemisinin + piperaquine M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 11 The ACTs listed above are recommended on the basis of their therapeutic efficacy, safety, impact on transmissibility and availability. Annex 2 gives the treatment doses and presentations of the ACT currently recommended by WHO. Research is currently under way on new compounds, and the above list may be updated in the near future. Table 2 (on page 12) presents the characteristics of ACTs, which may assist in choosing a suitable antimalarial medicine for MDA. The above comparisons indicate that dihydroartemisinin–piperaquine might be a suitable option for MDA, in view of to its good efficacy, long post-treatment prophylaxis and good tolerability. It is not the first-line treatment for malaria in many countries, and resistance has been reported only in a few areas. Special population groups that might have to be excluded from MDA Pregnant women. No adverse effects on mothers or fetuses in the second and third trimesters of pregnancy have been reported, and ACT is considered safe for use in this population. As there are insufficient data on the safety of ACT in the first trimester of pregnancy, they should be avoided in women at this stage of pregnancy (16). Identification of women in the first trimester of pregnancy who are not yet visibly pregnant may be difficult in mass campaigns. The method for assessing pregnancy, through interview and / or testing, should be decided by the health authorities and based on the local context. Use of screening tests for pregnancy may be problematic, as many women or younger girls may not wish to disclose their pregnancy status, particularly in certain cultural settings. Before MDA, it is crucial to explain to the community the purpose of performing pregnancy tests and to assure them that they will be done confidentially. It is strongly recommended that interviews and pregnancy tests be performed by trained female community health workers in order to ensure privacy and discretion. A culturally sensitive approach is essential taking into consideration the values and perceptions of the communities. Infants < 6 months of age or weighing < 5 kg. Although ACT is considered to be well tolerated by young infants, the operational difficulty of ensuring accurate dosing, because of the lack of infant formulations, the proper administration and retention of the treatment leads to the exclusion of young infants in MDA programmes. Primaquine (8-aminoquinolines) WHO recommends addition of a single low dose (0.25 mg / kg body weight) of primaquine (administered on the first day of the treatment with ACT) as a P. falciparum gametocytocide if the objective of MDA is to eliminate falciparum malaria or reduce the transmission of drug-resistant P. falciparum strains. Primaquine should, however, not be administered to infants < 6 months of age, pregnant women or women breastfeeding infants < 6 months of age. Administration of the single low dose is safe and effective, even in G6PD-deficient individuals. In a recent review, WHO concluded that individuals with G6PD deficiency given a single low dose of primaquine are at very low risk of clinically significant haemolysis (17–19); therefore, it can be given without G6PD testing. The haemolytic effect of primaquine is dose-dependent and is observed mainly in individuals with G6PD deficiency given the 14-day regimen recommended for radical cure of P. vivax malaria. 12 CH AR AC TE RI ST IC A ND SE LE CT IO N CR IT ER IA AR TE M ET HE R– LU M EF AN TR IN E (A L) AR TE SU NA TE – AM O DI AQ UI NE (A S- AQ ) AR TE SU NA TE –M EF LO Q UI NE (A S- M Q ) AR TE SU NA TE -S UL FA DO XI NE PY RI M ET HA M IN E (A S- SP ) DI HY DR O AR TE M IS IN IN – PI PE RA Q UI NE (D HA -P PQ ) Effi ca cy H ig h in m os t s et tin gs Va ria bl e, d ue to e m er gi ng re si st an ce H ig h in m os t s et tin gs W id es pr ea d re si st an ce to S P H ig h in m os t s et tin gs Ha lf- lif e (d ay s) (a ct iv e dr ug ) 1.4 –1 1.4 (lu m ef an tr in e) 3. 7– 10 (d es et hy la m od ia qu in e) 8. 1– 15 .2 (m efl oq ui ne ) 2. 5– 18 .8 (S P) 13 .5 –2 8 (p ip er aq ui ne ) Sa fe ty Sa fe a nd g en er al ly w el l to le ra te d G en er al ly w el l t ol er at ed b ut as so ci at ed w ith a h ig he r in ci de nc e of g as tro in te st in al di st ur ba nc es th an o th er A CT s. AQ m ay p ro lo ng th e Q T in te rv al a nd sh ou ld n ot b e gi ve n to p eo pl e ta kin g Q T- pr ol on gi ng m ed ic in es or w ho h av e co ng en ita l Q T pr ol on ga tio n.* AQ is a ss oc ia te d w ith n eu tro pe ni a an d he pa to to xic ity a nd sh ou ld n ot be u se d in H IV -p os iti ve p at ie nt s ta kin g zid ov ud in e, e fa vi re nz an d / o r c ot rim ox az ol e. M efl oq ui ne in du ce s na us ea , v om iti ng a nd ne ur op sy ch ia tr ic s ym pt om s. M on th ly tr ea tm en t o f h ea lth y pe op le is p oo rly to le ra te d. SP is g en er al ly w el l t ol er at ed bu t m us t n ot b e us ed in pa tie nt s w ith a h is to ry o f hy pe rs en si tiv ity to s ul fa d ru gs or in H IV -p os iti ve p at ie nt s re ce iv in g co tr im ox az ol e, be ca us e of in cr ea se d ris k fo r ad ve rs e ev en ts . Pi pe ra qu in e pr ol on gs th e Q T in te rv al a nd s ho ul d no t be g iv en to p eo pl e ta ki ng Q T- pr ol on gi ng m ed ic in es or w ho h av e co ng en ita l Q T pr ol on ga tio n. * Pr eg na nc y Th e ris k– be ne fit ra tio o f a dm in is tr at io n of a nt im al ar ia l m ed ic in es g iv en to p re gn an t w om en a s pa rt o f a n M D A is d iff er en t f ro m th at fo r m al ar ia p at ie nt s. A s th er e ar e in su ffi ci en t d at a on th e sa fe ty o f A C Ts g iv en d ur in g th e fir st tr im es te r o f p re gn an cy , w om en in e ar ly p re gn an cy s ho ul d be e xc lu de d w he n AC Ts a re gi ve n fo r m al ar ia M D A. Ad m in is tr at io n Tw ic e da ily fo r 3 d ay s, pr ef er ab ly w ith fa tty fo od s (a dh er en ce is m or e di ffi cu lt co m pa re d to tr ea tm en ts w ith sin gl e da ily d os es a nd n o fo od in ta ke re qu ire m en ts ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s o n an em pt y st om ac h (id ea lly 3 h be fo re o r a fte r m ea ls, w hi ch is un lik el y to b e fe as ib le in M D A) Pr es en ta tio n Fi xe d- do se c om bi na tio n; di sp er sib le ta bl et s an d hi gh er -d os e ta bl et s av ai la bl e fo r d iff er en t a ge a nd w ei gh t gr ou ps Fi xe d- do se c om bi na tio n Fi xe d- do se c om bi na tio n N o fix ed -d os e co m bi na tio n av ai la bl e. U se o f b lis te r p ac ks m ay re su lt in d is tr ib ut io n of lo os e AS ta bl et s as m on ot he ra py . Fi xe d- do se c om bi na tio n C om m er ci al a va ila bi lit y of p re qu al ifi ed p ro du ct W id e av ai la bi lit y of pr eq ua lifi ed o rig in al a nd ge ne ric p ro du ct s by m an y co m pa ni es W id e av ai la bi lit y of pr eq ua lifi ed o rig in al a nd ge ne ric p ro du ct s by m an y co m pa ni es Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty * Ex cl us io n of p at ie nt s w ith c on ge ni ta l Q T pr ol on ga tio n w ou ld n ot b e fe as ib le in M D A, b ut p eo pl e ta ki ng s pe ci fic m ed ic in es m ig ht b e id en tifi ed b ef or e M D A. TA BL E 2. Ch ar ac te ris tic s of W H O -r ec om m en de d AC Ts fo r c ho os in g su ita bl e an tim al ar ia l m ed ic in es fo r M DA M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 13 2.1.6 Estimate the requirement for antimalarial medicine, and order it Registration and authorization to import As part of the drug selection criteria, especially for rapid deployment in emergency, it is necessary to consider the availability and requirements for registering the medicine, or obtaining a waiver, for its importation. Authorization to import the medicine and customs clearance should be agreed with the authorities beforehand to allow smooth, quick handling. These processes can take some time, especially if the medication is not licensed in the country. Depending on the country’s regulations, a post-shipment quality control test may be required for each batch of the medicine after it arrives in the country, and the necessary time should be included in planning. Procurement It is essential to ensure that the selected medicine meets international quality standards. The use of substandard, ineffective or unsafe medicines could be harmful for the population treated, affect the credibility of the campaign, increase the burden on the health care system and promote the spread of resistant strains if parasites are exposed to sub-therapeutic blood levels. Only prequalified medicines approved by WHO or by a stringent regulatory authority should be selected for MDA (20). The two main sources of relevant information are the WHO prequalification programme (21) and the Global Fund list (22). Consideration should be given to whether the supplier will be able to deliver the full required quantity at short notice, as not all suppliers have sufficiently large production capacity to deliver large quantities in a short time. Moreover, some manufacturers start production only once a purchase order has been received. These possible delays should be taken into consideration in planning procurement and in setting the dates of distribution. Calculating the required quantity of medicine for different age groups • Determine the size of the target population which will equal the total number of treatment courses needed, often in course-of-therapy packs, for each round. • Calculate number of treatments per age group per round (according to the age- categories for which the selected ACT has specific presentations). • Multiply the needs per round by the number of rounds that will be performed. • Add a buffer stock of approximately 25% (depending on the reliability of demographic data) to cover wastage or underestimation of population. See Annex 3 for examples of estimated orders of different presentations of artesunate–amodiaquine and dihydroartemisinin–piperaquine. The calculation should also take into consideration the number of individuals expected to be excluded from coverage with MDA (e.g. pregnant women, infants, HIV patients, depending on the medicine selected for use). 2.1.7 Determine the delivery strategy There are three possible distribution strategies: • door-to-door distribution: the preferred strategy for high coverage, if logistically possible; • centralized distribution at a fixed site; and 14 • a combination of door-to-door and centralized, fixed-site distribution: - centralized with door-to-door distribution for hard-to-reach groups or - door-to-door distribution followed by centralized distribution to follow up missed participants. With combined strategies, care must be taken not to dose individuals repeatedly. The choice of strategy will depend on logistic capacity, the objective of MDA and analysis of the local context, including security and any outbreak or other special circumstance. DOT is the preferred delivery strategy for ensuring adherence and reducing the potential for mistakes in taking the medicine. Although DOT is more challenging operationally, it has been used successfully in very large-scale campaigns, including with multi-day drug regimens (4). As it may not be feasible to give all three doses of ACT by DOT, a health worker may administer the first dose and give the remaining tablets to the person or carer for days 2 and 3 of the intervention, with instructions on their administration. Because of the high risk of non-adherence to treatment on the two days following the administration of the first dose by DOT and consequent misuse of the medicine, adherence must be strongly emphasized both by the distributor and in the social mobilization campaign. An alternative that promotes and allows assessment of adherence to treatment and safety is giving the first and third doses by DOT. These different delivery options – full DOT, DOT on days 1 and 3 and DOT only on day 1 – have resource implications, which should be considered in planning the intervention. If DOT for all three doses is not feasible, a strategy should be devised to encourage and monitor adherence. For example, CHWs could revisit the houses to which they have already distributed the medicine after finishing the distribution on days 2 and 3, or teams responsible for monitoring adherence could be appointed. Guaranteeing DOT in door-to-door strategies, when there is little likelihood that every member will be at home at the time of the health worker’s visit, is laborious and complicated. When MDA is planned as part of an elimination strategy and there is less time pressure than in an emergency intervention, a small-scale pilot MDA project is strongly encouraged to optimize the delivery strategy. 2.1.8 Determine the period of intervention The best time for MDA depends on the setting and the aim of MDA (see Table 3). MDA to reduce transmission and eliminate malaria In an area with seasonal transmission, a campaign should be executed during the low-transmission season when the number of parasites is lowest, immediately before the start of the malaria transmission season (6,9,13,23). If MDA is conducted at the peak or during the main transmission season, there is less probability of influencing malaria transmission and the parasite prevalence will increase rapidly (13). Timing should also take into consideration seasonal movements of the population in and out of the target area. Untreated people returning to an area after MDA constitute potential reservoirs and sources of re-infection. The access of teams to certain rural and remote settings may also determine the period of MDA, as some areas may not be accessible during the rainy season. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 15 MDA to help contain a malaria epidemic MDA should be performed as soon as possible in order rapidly to reduce morbidity and mortality while outbreak containment measures are put in place. MDA in complex emergencies The period of the intervention will correspond to that of the highest risk for morbidity and mortality – the high malaria transmission season. If the burden of malaria is high all year round, MDA can be considered at any time of the year. Certain complex public health emergencies, such as the 2014–2015 outbreak of Ebola virus disease (EVD), have major impacts on existing health care systems. During that epidemic, health care structures were overwhelmed, and access to regular health care was reduced, due to fewer functioning health facilities, loss of health care staff and fear among the population attending health structures and treatment centres of becoming contaminated with the Ebola virus. Laboratory testing was generally unavailable, and blood testing for malaria diagnosis was suspended. All these factors affected malaria case management, resulting in increased morbidity and mortality due to malaria. In addition, as the clinical presentation of malaria and EVD are similar, patients with malaria were suspected of having EVD, increasing the burden on EVD treatment units and also exposing non-EVD patients to nosocomial infection. Antimalarial MDA was provided in this context in an attempt to reduce malaria morbidity and mortality rapidly and thus to reduce the number of non-EVD patients presenting with fever to EVD treatment centres. Reduction of malaria transmission was not the objective of MDA in the context of the EVD epidemic. 2.1.9 Determine the number of rounds Multiple rounds of MDA at regular intervals are recommended, although there is insufficient evidence at present to establish the optimal number and timing (3). Most MDA campaigns for falciparum malaria have consisted of two or three rounds at monthly intervals, and further research should be conducted to determine whether one or two rounds would be sufficient in certain situations (9). Special situations are listed in Table 3. In MDA to reduce transmission or eliminate malaria, repeated rounds are necessary to clear parasites in the population. If some people remain untreated during a single round, with no additional intervention, the coverage will be partial and the impact in term of malaria transmission and burden will be lower. The aim of successive rounds is total coverage, reaching people who were initially missed and people who were treated in the previous rounds but may have been reinfected after MDA, reducing the probability of reinfecting mosquitoes. Multiple rounds may be required to obtain a major decrease in prevalence (6,8). In MDA as part of an epidemic response, the number of rounds may depend on the epidemic curve (incidence rate and attack rate) and the expected duration of transmission. In MDA in complex emergencies, the rounds should be repeated to cover the duration of the period of highest morbidity and mortality. 16 TABLE 3. Main strategic differences between planning MDA for malaria elimination and for emergency response (epidemic or other complex emergencies) ELIMINATION SETTING (ELIMINATION AND CONTAINMENT OF MULTI-DRUG RESISTANCE) EMERGENCY SETTING (EPIDEMIC, COMPLEX EMERGENCY) Source of demographic data Ideally, head count (census) or household registration before MDA Head count or household registration less feasible Recent census (if available) Household surveys (if available) Other past mass distributions or MDA Timetable for implementation Usually allows sufficient time for planning and preparation Short time for planning and preparation (≤ 1 month) Urgency + +++ Coordination of partners and institutions Required for successful campaign and easy to achieve More challenging, as many actors may be involved, but essential to guarantee an effective campaign in a short time Choice of medicines First-line antimalarial agent should be avoided First-line antimalarial agent may be considered Timing in relation to malaria transmission for intervention During the low transmission season, immediately before the start of the transmission season During the peak of transmission (highest morbidity and mortality), depending on emergency context Number of rounds per year 3 3 (but could be fewer) Administration of antimalarial medicine Must be synchronized in the target population in order to have an impact on transmission Synchronous administration is important in epidemics in order to reduce transmission In other complex emergencies, the requirement for simultaneous medicine intake is less critical Concomitant malaria control activities Preconditions for using MDA for elimination are the availability of active case finding and surveillance, rapid testing and treatment of all cases of suspected malaria and intensified vector control As the objective is to reduce malaria morbidity and mortality, MDA is deployed as an immediate response while other malaria control interventions, notably case management and vector control, are being put in place Criteria for stopping MDA Documentation of 0 indigenous cases (cases contracted locally with no evidence of importation or direct link to transmission from imported cases) Reduction of malaria burden to a level that can be maintained with case management, vector control and routine surveillance, implemented in the same area M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 17 2.1.10 Establish a chronogram A chronogram of activities (see Annex 4) will limit unexpected events, avoid forgetting things in the different planning phases and contribute to a successful intervention. Once distribution has begun, it might be difficult to correct a planning error. Poor planning, such as underestimating amounts or timelines for delivery of medicines, may lead to stock ruptures and will not only compromise the results of the campaign but also have a detrimental effect on the perception of the population. The chronogram should show the evolution of all the tasks to be carried out during the phases of design, preparation, implementation and evaluation of the campaign. It will help to coordinate the many activities to be conducted at the same time and will indicate the role of each person. The chronogram should contain: • a list of tasks to be performed, including quantification and ordering of medicines and other supplies, training, distribution of materials, community mobilization and deployment of teams; • a timeframe for the completion of each activity; and • the name of the person responsible for each activity. When deciding the actual dates on which distribution will take place, the activities and work schedules of the population and religious festivities and holidays should be considered to ensure high coverage. 2.1.11 Draw up a budget The following items should be included in the estimated budget: • MDA medicine; • logistics: - registration fees; - international transport of medicine (e.g. international freight, insurance, customs clearance, importation fees or taxes, options for waivers); - pre- or post-shipment quality control testing (as applicable); - storage of antimalarial medicine and other logistics supplies; - transport: vehicles (cars, trucks, motorcycles, boats, bicycles), fuel; • additional equipment and supplies for distribution: large-scale maps for overall planning and detailed maps to guide teams during the intervention, ropes, fencing, plastic sheeting, megaphones, chalk or other material for marking houses, rainwear (if MDA is conducted in the rainy season), backpacks, cups, other context-specific material (for biosafety for example) (See the comprehensive list of additional materials required for door-to-door and centralized fixed-site distribution in section 2.3.1); • administrative material: e.g. cards, date stamp, daily tally sheets, summary sheets, supervisor sheets, attendance sheets, registration books, stationery; • material for social mobilization and communication campaigns; • staff salaries, per diem, food or transport allowances, identification material; 18 • materials for training and supervision; • communication means: telephone, credit top-up for staff, radio; • material for monitoring and evaluation: e.g. monitors, surveys, resistance monitoring; and • material for drug safety monitoring. It is important not only to estimate the cost of each budget line but also to identify the sources of funding. All partners and task forces should have the opportunity to review and provide suggestions to the budget plan, and the final version should be made available. The exercise should estimate the total cost of the activity and a final analysis of the cost per person treated. 2.2 PLANNING AND PREPARATION 2.2.1 Micro-planning Once the overall design of the campaign has been completed at national level, the next phase is to outline a micro-plan at local (regional, district or community) level for the strategies selected and according to national guidelines. The micro-plan should guarantee that the correct treatment and other materials are available in the right amounts, in the right places and at the right time to cover the entire targeted population. This will require distribution of supplies, training of staff, engagement of the community, well-coordinated distribution and proper management of resources. Micro-planning is used to manage these details by calculating requirements on the basis of local needs, identifying what is available and requesting what is missing. Relevant partners should be involved in micro-planning, including: • health centre staff, • CHWs and community volunteers, • local councils, • community leaders or village representatives, • religious leaders, • the media, • civil society organizations, • women’s groups, • youth organizations, • nongovernmental organizations, • community organizations and • schools and colleges. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 19 The micro-plan should cover the following elements: • demographic information: - total target population of the MDA-eligible district; - the numbers of communities, villages and neighbourhoods in the district; - the target population in each community, village and neighbourhood, with a breakdown by age group; - familiarity of the population with MDA for neglected tropical diseases; - proportions of people in urban and rural areas, in order to adapt logistic requirements (see Table 1 for details of differences in implementation of MDA in urban and rural contexts); - population movement; - depending on the size of the target population and context (emergency setting or elimination), household registration or census books of the target population that list all the households in a community, with an identification number and include the name, age and sex, village, head of household, contact details (if available) and resident status (permanent, temporary or visitor). This list can later be used during distribution to monitor coverage and to keep track of households that have been visited, missing people in a household and other details. • information on the area: - maps showing main roads, villages, towns and neighbourhoods; - infrastructure in the area (e.g. availability of electricity, water, fuel); - location of health facilities and catchment areas; - areas or population that are difficult to reach because of geography, climate, lack of security or cultural reasons and suggested solutions for reaching them; - location at which medicines and other materials will be stored and then prepositioned for distribution; and - distances and travel times from the central area to each community, village or neighbourhood, health structures, storage sites and distribution sites (for centralized, fixed-site strategy) and road conditions; • calendar timing of MDA in the district: ideally specifying days and times for certain streets or neighbourhoods, so that people can arrange to be at home; • delivery strategies (centralized, fixed-site or door-to-door); • human resources and training: - number of people expected to be covered by each team of distributors (whether door-to-door or centralized, fixed-site distribution); - number of teams required to cover all communities in the district; - number of teams per supervisor; - number of supervisors required per district; - human resources available in the district; - number of teams and supervisors that can be brought together per training session; and - number of days required to train staff. 20 • logistics information: - if centralized, fixed-site distribution is decided, the number and location of distribution sites, population per site, teams per site, etc.; - areas where staff may spend the night; - number of vehicles required to transport teams and supervisors and number of vehicles available locally; - amount of fuel required for transport; - amount of material required per team; and - material required for training; • a social mobilization and communications plan; and • a pharmacovigilance plan: - training of CHWs and community volunteers; - timing of active follow-up visits (days 3–7), depending on the safety profile of the medicine; - number and location of health facilities that will provide rescue treatment for any side-effects; - referral health facilities to manage severe adverse events; - distribution and completion of ADR report forms and narratives in health facilities; and - reporting and communication with stakeholders. See Annex 5 for an example of a micro-plan used in Sierra Leone in 2014–2015 for antimalarial MDA during the outbreak of EVD. 2.2.2 Logistics Supply and stock management When the antimalarial medicine ordered for the MDA campaign is received in the country, it should be stored in a central warehouse or storage facility, which should be in an accessible location, with proper temperature and humidity conditions and well secured. Other essential material for the campaign (such as cups, sugar, mortars or pill crushers, stationery, soap, megaphones, rope, fencing) should be kept in the same location. It is vital to estimate the volume of medicine (see Annex 3) and other logistics supplies beforehand to ensure enough storage capacity. The antimalarial medicine should be stocked by presentation (age-specific blisters), batch number and expiration date. A stock card should be prepared for each item in the store in order to monitor quantities and ensure traceability. The stock cards of the antimalarial medicine should include the international non-proprietary name (not brand names) and the dosage. Antimalarial medicines and other logistic material will be distributed from central to district level, where intermediate centralized storage may be necessary, which should conform to the same indications. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 21 Prepositioning of supplies Antimalarial medicines and other logistic elements for distribution should be prepositioned in distribution points according to the micro-plan (e.g. peripheral health facilities) before MDA is launched. Therefore, the stock of each distribution point should be prepared in the central warehouse before delivery. Pre-printed order and delivery forms should be available. All movement of medication between individuals or organizations should be documented, and signed copies should be saved for future reference. See Annex 6 for a step-by-step procedure for prepositioning supplies. Transport Reliable transport is essential for all activities. The number and type of vehicles depend on: • the strategy chosen (door-to-door or centralized, fixed-site distribution), • the duration of the campaign, • the number of distribution teams or distribution points (if centralized, fixed-site), • the number of supervisors, • whether the area is urban or rural, • the social mobilization plan and • the supply system. Motorcycles, bicycles or boats may be required in some contexts. During transport, medicines should be protected from weather such as rain and sunlight. It is essential to check the local availability of vehicles and fuel. If cars are available, they should be evaluated for: • type, size and condition; • type of fuel and consumption; and • the conditions of loan or rent (with or without driver, cost, insurance, etc.). One person should be responsible for following up all issues related to transport, which is a potential target for fraud and / or theft. Accessibility The means for reaching all the eligible population should be assessed thoroughly, covering: • the road network and the condition of roads, • distances and travel times to the different locations and • roads with limited or interrupted access during the rainy season and alternatives for reaching the populations. 22 “Difficult-to-reach” populations include not only those in remote areas with poor road access but also those isolated due to lack of security or social constraints. To ensure that these populations are covered, approaches such as assigning teams specifically to those areas or extending the duration of the campaign might be considered. Distribution sites for centralized, fixed-site distribution Sites should be chosen and prepared in advance. They should be selected in collaboration with local authorities and ideally have the following characteristics: • easy access; • be well-known to the population; • possibility for creating a one-way flow of people (entry and exit points) to facilitate movement; • large enough to work comfortably but not too vast that it is difficult to manage; and • a large, shaded waiting area. Possible locations could be schools, religious centres (churches, mosques, temples) or administrative buildings in urban areas; and, if there are no suitable buildings, open public spaces or temporary shelters, including tents, in rural areas. If pregnancy testing of women of reproductive age is required before administration of the MDA medicine, the distribution site should also have bathrooms and private spaces where the test can be performed and the results communicated privately. Sites should not be set up in health structures, so as to not disrupt normal activities. Waste management Waste will be generated during an MDA campaign, and waste collection and disposal should be considered in the planning phase. The waste will consist almost entirely of soft waste, including packaging, disposable cups (if used) and pregnancy tests, if performed. For door-to door distribution campaigns, waste may be handled at household or community level if adequate waste disposal systems exist. Otherwise, distributors should collect the waste and bring it back to the distribution point, where it should be incinerated. A decision to handle waste at community level or to centralize it at health facilities should be guided by the local context. For centralized, fixed-site distribution campaigns, waste can be disposed of at the distribution site or be transported to a central location (e.g. health facility). 2.2.3 Human resources An MDA will require a significant number of dedicated staff. The number of teams required and their composition will depend on: • the intended duration of the campaign, • the distribution system (door-to-door or centralized, fixed-site), • the target population, • the target area and its accessibility, • the expected performance of each team (number of people treated per day), M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 23 • data forms to be completed and • addition of other interventions. Team composition As the antimalarial medicine is given orally, a large number of skilled health personnel will not be required. The number of qualified health workers taken from health structures should be minimized in order to disrupt the regular health activities as little as possible. A census of all locally available human resources should be carried out during micro-planning. If a network of CHWs or volunteers is already present, they should ideally be engaged in delivering the medicine, as they understand the local environment, speak the local language and are familiar with and trusted by the population. If this is not the case or there are not enough staff according to the estimate, volunteers may be selected from e.g. civil society organizations, nongovernmental organizations, Red Cross or Red Crescent societies, youth associations, schools and nursing schools. If possible, the volunteers who serve as distributors should represent the demographics of the community. When selecting volunteers to distribute treatment or conduct social mobilization, local community leaders should be consulted, as they may help to identify people who are well known, recognized and respected by the community. Each member of the team should have a job description, so that each clearly understands their role and responsibilities and those of the other members. Distribution team Door-to-door strategy. Teams should ideally be composed of two CHWs or volunteer distributors, if possible from the same village: one to provide information and administer the treatment and the other to record the necessary information on appropriate data collection tools. If pregnancy testing is planned, at least one of the two CHWs should be female. Centralized, fixed-site distribution. Teams will consist of: • 1 triage agent to check eligibility, • 1 female worker to conduct pregnancy testing (if planned in the campaign), • 2–3 registrars (if an MDA card is issued to each beneficiary or another registration system is used), • 2–3 drug dispensers, • 2–3 recorders to fill in a tally sheet (paired with drug dispenser), • 1 health care worker to assess and manage adverse events, • 1 sensitization or information officer, • 1 cleaner and • several crowd controllers and security personnel. 24 Supervision team The supervisors should be health personnel, ideally from the same catchment area. Door-to door-strategy: • Direct supervision of teams is difficult, and a large number of supervisors may be necessary to ensure quality. • Each supervisor should be responsible for supervising no more than five teams in an area. Centralized, fixed site distribution • The number of supervisors will depend on the possibility of managing several sites. • In urban areas, one supervisor might be able to visit up to three sites per day. • In rural settings, one supervisor is likely to be able to visit only one or, at a maximum, two sites per day. There should also be one logistics supervisor to manage the organization of sites, transport, supply, etc. Estimated numbers of people treated per team per day (to be adapted to each setting): Door-to-door strategy: The daily output of the teams will depend on the population density. In urban areas, one team should be able to distribute medicine to a maximum of 75–100 people per day (average of 15–20 households of five people, visits lasting 15–20 min per household). In rural areas, where the population is more dispersed, one team should be able to distribute medicine to a maximum of 50–75 people (10–15 households) per day, in view of the time for transfer and communication to individual households. An approach used in several campaigns targeting large numbers of people has been to divide the population into small units and assign each to a distribution team (4). Centralized, fixed-site strategy: One team should be able to distribute medicine to an estimated 400–500 people per day. As this strategy is likely to miss a higher proportion of the population than door-to door distribution, special activities are required to mobilize and ensure the participation of the population. The daily output of the teams will also depend on whether MDA cards are issued to participants or a registration book is completed, which is more time-consuming. It will also depend on the local context and previous experience in similar activities. Specific teams might be considered for distribution in schools, prisons, military camps and orphanages and perhaps for the main local companies, such as factories, mines and plantations. Training Training of staff is an essential component of the preparation phase. Everyone participating in MDA should take part in training sessions, including coordinators, supervisors, distributors, community mobilizers, logistics officers and any other staff. Training should be provided at national, regional, district and sub-district levels. The plan should cover the objectives, which should be defined for each aspect; the length of training; the number of participants; the contents and methods; training materials and an evaluation (e.g. a pre- and post-test). Training should provide each team member and supervisor with the minimum information required to carry out their task properly. Training should be scheduled as close as possible to the date of implementation, ensuring, however, that all teams will have been trained by the time distribution begins. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 25 All teams should be trained in a standardized way. If many partners are involved, they should all provide the same training to avoid any variations that could confuse trainees and lead to mistakes in drug delivery. Training should include: • explaining MDA; • goal of this MDA; • where and when MDA will take place; • the distribution strategy: door-to-door or centralized, fixed-site; • treatment protocol and administration, including possible side-effects and contraindications; • inclusion and exclusion criteria; • performance of pregnancy tests and confidential communication of results (if applicable); • DOT; • team composition; • roles and responsibilities of all team members; • expected daily targets and overall coverage to be achieved; • access to the medicine and other supplies; • practicalities of distribution; • reporting and management of side-effects and severe adverse events; • information, education and communication and community engagement; • dealing with rumours and any concerns or doubts in the target population; • data collection tools: tally sheets, summary sheets, registration books, referral forms, ADR report forms; • procedures for reporting; • contingency plans for unforeseen events; • management of stocks of medicines and other items; • waste management; • logistics; • administrative issues (e.g. incentives and salaries); • supervision and troubleshooting (for supervisors); and • special measures (e.g. “no touch policy” or accidental exposure as in the outbreak of EVD). Training plans should be adapted to the delivery strategy (door-to-door or centralized, fixed-site) to ensure that teams are well prepared. Job descriptions and any other reference documents or guidelines can be distributed during training after they have been discussed with the participants. 26 The methods used during training may include role-play, practical demonstrations, case studies and simulations, ideally with the material and equipment to be used, in order to cover all the details and correct any misunderstanding. Anticipating difficulties and responses in these scenarios is a fundamental part of training. An efficient way to train many people quickly is cascade training, in which certain people are trained as trainers, and each in turn provides the same training course to others. More than one level of cascade should be avoided. Supervision of this training system is important to ensure that the information being passed down is accurate and the messages are not being changed as they are passed down. Providing adequate training material, cooperative supervision and meticulous evaluation will guarantee that the skills in which distributors have been trained are applied appropriately. Salaries and per diem Large-scale MDA involves a significant number of people who are widely distributed geographically; they should be compensated accurately and in an opportune manner. Payment of salaries and / or incentives, per diem and food or transport allowances must be clearly discussed with all staff involved in distribution to avoid confusion and demotivation. CHWs and volunteers who are unhappy with their position and reward can jeopardize a campaign. It is essential to determine how the money will be transported and managed at various levels to ensure that each person receives the correct pay, while guaranteeing transparency and avoiding opportunities for theft or corruption. The options for payment are decentralization to district authorities, through banks or “outsourcing” payments. Malaria control programmes may already have relevant experience during distribution of long-lasting insecticidal nets and indoor residual spraying campaigns. When many partners are involved, harmonization of payment to the teams is crucial. An innovative method is use of mobile phones, as used in Sierra Leone. Although some technical difficulties were faced because of the size of the transaction and the fact that it was the first time the phone company had handled such an operation, more than 6000 people were paid with this method in a timely, transparent manner, without having to gather for payment and removing the inherent security risks entailed in the movement of large sums of money (10). 2.2.4 Community engagement, social mobilization and communication One of the main determinants of the success of MDA for malaria is ensuring high coverage of the target population and good adherence to the treatment, both of which depend on people’s willingness to take the medicine (3,4,24). Many asymptomatic, healthy people will be asked to take a medication, potentially exposing them to adverse reactions. Ensuring compliance requires building mutual understanding and trust in the institutions implementing the campaign. Community engagement is a key factor in the success of MDA, in order to obtain the desired participation and uptake of medication. Misconceptions within the eligible population about the treatment being administered, their risk for the disease, side-effects and the need for intervention even in people who are not ill contribute to non-participation (24,25). Effective communication and social mobilization are therefore critical to a successful MDA campaign (26). A communications plan should be developed and agreed upon by the ministry of health and other actors on strategies to reach target audiences. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 27 The steps in preparing a communications plan are: • Define the roles and responsibilities of each partner. • Conduct a community assessment. • Prepare clear, simple, precise, consistent messages about MDA for malaria. • Engage the mass media. • Engage the community. Roles and responsibilities At national level: • Plan advocacy, communication, social mobilization and community engagement. • Develop a tool for community assessment. • Elaborate key messages. • Coordinate activities. • Hold advocacy meetings with stakeholders, including the private sector, at national level. • Hold briefing with media houses, with an official launching, and identify role models who are willing to take the first dose publicly. • Participate in panel discussions on national radio and television. • Produce and air campaign spots in the main languages spoken in the target areas. • Produce information, education and communication material, such as banners, flyers and fact sheets. • Monitor the media during the campaign. At district level: • Carry out community assessment. • Diffuse messages as widely as possible. • Hold advocacy meetings with main stakeholders in the community, such as community leaders, administrative authorities, religious leaders, civil society groups and other associations or groups (women, young people) and traditional healers. • Organize sessions to sensitize the private sector, schools, etc. about potential absenteeism of workers and students during the campaign. • Identify potential participants in the community. • Air jingles spots on local radio stations. • Participate in panel discussions on local radio stations. • Send vehicles with loudspeakers to make announcements about the MDA campaign to each village. 28 At community level: • Hold discussions with chiefs and religious leaders in each village about the campaign. • Disseminate messages through appropriate channels. • Identify and train CHWs to carry out sensitization street to street and house to house in the days before distribution. • Organize group sensitization sessions in communities with the participation of key people. • Organize announcements by a town crier or a vehicle with a loudspeaker during the days before and during distribution. Community assessment Ideally, before planning MDA, a quick assessment and mapping of community groups in the targeted areas should be conducted to obtain qualitative information such as: • social structures in the community; • cultural specificities and customs; • decisional power about health in families; • role of traditional leaders, including community and religious leaders; • behaviour considered acceptable for men and for women; • health-seeking behaviour, including general knowledge about malaria; • role of traditional medicine and traditional healers; • acceptance of allopathic medicine; • use of media; • familiarity and understanding of posters, brochures and banners; • literacy; • languages spoken; • perception of and willingness to participate in this type of intervention; and • any concerns, which will be addressed during the sensitization campaign, This assessment may avoid cultural misunderstandings that could threaten the success of the campaign. Useful lessons can be drawn from previous experience in MDA and similar activities. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 29 Key messages about MDA for malaria The messages to be prepared include: • What: general information about malaria and about the campaign, emphasizing that malaria may be asymptomatic and that people can be infected without realizing it and highlighting the role of asymptomatic carriers in malaria transmission • Why: purpose and benefits of treatment of people who do not feel sick and the importance of not saving the medicine for later use • When: dates of the distribution and number of rounds • Where: door-to-door or centralized, fixed sites • Who: geographical area and eligibility criteria, with special emphasis on the need to exclude women in the first trimester of pregnancy and explaining the screening method which will be used (interview and / or pregnancy test) and assuring that it will be done confidentially. • How: dosage and duration of treatment, adherence to treatment • Potential side-effects: to avoid misconceptions and fear, possible side-effects should be described, with assurance of proper management of any that appear • Importance of continuation and reinforcement of other malaria preventive measures (e.g. use of long-lasting insecticide-treated nets) • Context-specific messages: might have to be prepared for each WHO recommendation for MDA during a malaria epidemic or a complex emergency such as an outbreak of EVD. Engaging the mass media Generally, spokespeople should be identified at the ministry of health and other credible, respected partners that are able to handle challenging interviews where awkward, inopportune questions are asked. Talking points should be prepared for speaking to and engaging with the media, avoiding the use of acronyms or scientific vocabulary that the public will not understand. Relationships should be built with local media representatives to ensure that they provide good news coverage; they should be contacted regularly, not only in response to a critical situation. The campaign should be inaugurated with an opening ceremony covered by the media, in which influential people such as high-ranking administrative authorities and celebrities participate and take a dose of the medicine as an example to the rest of the community. The methods that can be used to disseminate information and promote an MDA campaign include radio, television, newspapers, billboards, online news sites, social media, mobile phones and games. Radio is widely available and very popular in rural areas in malaria-endemic countries and should be a priority for circulating information through radio spots, radio group discussions in which community members engage with campaign health officials and role-play of community members talking about the distribution in order to spread information about the purpose, location and timing of MDA and to discuss the benefits of participating and potential side-effects. Radio also allows listeners to call in and ask questions live. Radio spots (see Annex 7) can also be used. Radio can also be a powerful method, if the micro-planning is good, to disseminate information on the days and estimated times of visits of the distribution teams per street or neighbourhood or, in the case of centralized, fixed-site distribution, location and days. Television spots and phone-in programmes with key stakeholders can be influential. 30 Media messages should address any local concerns and doubts identified either in previous campaigns or during the evaluation phase. Personal testimony of people who have previously taken the medication is valuable. Progress reports should be sent to the media throughout the campaign. Countering negative rumours Unfounded rumours or negative news may circulate, dissuading communities from participating in MDA. Random cases of unrelated severe illness or deaths in the community may be attributed to the antimalarial treatment and reduce the public’s confidence in the campaign. A plan should be prepared in advance to suppress such rumours quickly in a prudent, neutral manner to reassure the population. Distribution teams and supervisors should systematically collect information on rumours and on questions that are frequently asked at meetings with stakeholders and community groups and on radio and television programmes. Media reporting should be closely monitored to detect any negative coverage rapidly and react accordingly. If a relationship of trust is established with the media, they will be more likely to listen to all sides before reporting false information. Community engagement Community engagement at the early stages of planning is a key element of a successful MDA, so that they take ownership of the implementation and success of the campaign. The people to involve are: • community leaders and other influential members, • political leaders, • local councillors and authorities, • religious leaders (priests, imams, monks), • schoolteachers, • celebrities, • other local groups (youth, women), • village health workers or volunteers, • health care staff (to respond to questions and concerns), • traditional healers and • private pharmacy owners and drug sellers (who could potentially interfere with the activity). Cooperation with leaders and other influential members of the community is vital for good results, as their status as decision-makers makes them efficient promoters of the benefits of participating in the campaign; however, they must be well informed. Any negative opinion of the intervention will have a significant impact on the outcome. They can provide organizers with useful information on the best timing for the campaign, suggest people who should be included in sensitization sessions and how the sessions should be organized and identify potential distributors who are well known and respected by the community. See Annex 8 for a list of discussion points that could be used in community meetings. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 31 Social mobilization Group social mobilization sessions in the community can be used to provide information, allow members of the community to ask questions and establish trust between the population and campaign staff. Priority should be given to hard-to-reach and underprivileged populations, and the programme should be adapted or intensified for those groups if necessary. Other effective approaches are street theatre, music, art and other cultural activities. Communication materials should be printed in the local languages and adapted to the literacy level of the community. They could include leaflets, posters, calendars, banners, armbands, t-shirts and caps. Megaphones or town criers could also be used. Social mobilization activities should be held in religious centres, schools, cinemas and other recreational areas and places where people gather for other purposes, such as bus stops and hairdressers. The activities in the different phases of social mobilization and communication are listed below. Before the campaign: • Ideally at least one month before administration of the medicine (depending on the setting and context): information about MDA, the benefits of the campaign, the importance of participation, etc. • In the week before distribution: intensification of the sensitization campaign, with a focus on the practical aspects of starting the campaign and reminders to the population of days and location. Before distribution is begun, several households should be visited to verify that people are aware of the dates and are willing to participate, so that last-minute adjustments can be made to sensitization activities. During distribution: • Social mobilization should focus on encouraging participation and promoting treatment adherence. • Community mobilization messages should be adapted according to inputs from continuous observation by nonparticipants of people’s reactions during MDA. If MDA is conducted during the rainy season, villagers in rural areas might prefer not to participate in the campaign because of farming activities, either because they have to travel out of the eligible area to access their fields or because they fear that adverse effects might limit their capacity to work and thus provide for their families. This issue should be tackled in the communication plan to prevent or minimize refusal. During distribution, the general perception and comments of the population towards the MDA campaign should be monitored to detect any problems, which should be addressed quickly. Community leaders could signal negative perceptions to the distribution teams or identify areas or neighbourhoods that have not been adequately covered. 32 After MDA is completed: • Communities should be informed of the results by appropriate local platforms, such as radio, posters and CHWs. • Teams or MDA representatives should remain in the target communities for some time after completion of MDA to identify and address rumours, concerns or other issues that could affect future rounds of MDA or other health interventions. 2.3 IMPLEMENTATION The distribution of antimalarial medication should be started only if: • the medicines and all other material (as outlined below) are in place; • supervisory material is available (see section 2.3.3); • teams are trained (see section 2.2.3); • the logistics is ready (see section 2.2.2); • the population has been informed of the details of the campaign (see section 2.2.4) and • pharmacovigilance, including management of ADRs, is planned (see section 3.4). 2.3.1 Stock management Distribution kits should be prepared ahead of time at the distribution point or at the peripheral health facility where supplies are prepositioned. Different kits should be prepared for distributors and supervisors. The quantities in the kits should be adequate for the number of people estimated to be reached per day. Material required per distribution team For door-to-door strategy (with DOT): Each team of distributors should be provided with the following materials at initiation of the campaign: • backpacks (1 per CHW) • mortar or pill crusher (for crushing tablets for infants) • clipboards • pens • staff identification badge, t-shirt or armband • hygiene material (soap) • chalk to mark houses • pad to note any concern • printed information, education and communication material (drawings of age-specific dosages, adherence to treatment, expected adverse events, use of long-lasting insecticidal nets) M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 33 • umbrellas or clothing to protect against the rain The rest of the material should be provided daily according to consumption and remaining stocks: • the required number of treatment blisters to meet the daily target (including buffer stock) • pregnancy test kits and urine containers if pregnancy tests are to be performed • sugary solution for children if medicines with a bitter taste are used • material for documentation: MDA cards, registration book, tally sheets, referral forms • bags for waste collection For centralized, fixed-site distribution: In addition to the above, the following should be considered: • tables and chairs • ropes or fence and poles • shade net and / or plastic sheeting • waste buckets • drinking-water containers • weighing scales • disposable or reusable cups (if strict hygiene measures are in place) • hygiene material (soap and other cleaning material) • date stamp and ink • identification panels for distribution site. Material required for supervisors´ kits • clipboards and pens • identification material, e.g. shirts, arm bands • supervisory checklist, daily summary sheet, ADR report forms, referral forms • pad to note any concerns. For door-to-door distribution, the distribution teams should pick up the material at the distribution point or health facility at which it is prepositioned every morning, making sure that all the necessary supplies have been packed. At the end of the distribution day, the remaining stock should be brought back to the distribution point, where an inventory is made and recorded. All movement of antimalarial medicine and other supplies should be recorded by the person responsible for stock management. The kits should then be refilled in preparation for the following day. If a team or a site requires further supplies because of shortages, the person responsible for logistics should be contacted to arrange transport, and the movement should be clearly documented to ensure accurate accountability. At the end of each round of distribution, the remaining stock of medicines and other items must be counted and reported at district, regional and national levels. 34 The supplies must be stored correctly for the next round, and antimalarial medicine and other supplies should be ordered for the next round. After the last round is finalized, the remaining doses should be returned to district or national level, where appropriate storage should be ensured. Expiry dates should be checked. All other logistical material should be counted and also sent back to central level. 2.3.2 Distribution of antimalarial medicine Actual distribution of medicine will depend on the distribution strategy chosen. Door-to-door strategy In urban areas, it may be difficult to ensure that all members of a household are present, waiting for the distribution team throughout the campaign. It is therefore advisable that each household be informed of the date and approximate time at which the distribution team will visit them. The schedule of visits should be flexible in order to increase the chances of finding people at home. According to the context, visits should be made either early in the morning or in the evening for rural farmers or at midday for workers. The distributors should follow the steps below when visiting each household (see also Annex 9): • Greet the residents politely in their language, and introduce themselves. • Ask for the head of the household, and verify whether all members of the household are present. • Explain the objectives and provide information about the campaign. Distribution teams should have visual aids to transmit key messages translated into local languages. • Obtain oral consent to participate. • Check eligibility criteria. Anyone meeting any of the exclusion criteria (first trimester of pregnancy, infant < 6 months of age, known allergy to medicines, critically ill or presenting contraindications to the medication) should be told why they will not be given the treatment. Annex 10 presents an algorithm that could be used by CHWs to apply exclusion criteria. • Individuals who are seriously ill, e.g. children with danger signs, should be excluded from MDA and be referred to the nearest health facility. All other ill patients should first receive the antimalarial treatment as part of the MDA and then be referred to a health facility for full assessment. • A female health worker should speak to all women of reproductive age (15–49 years) alone, in a private setting to explain that ACT are not recommended in the first trimester of pregnancy and ahould also determine pregnancy status on the basis of personal history or a pregnancy test (see Annex 11 for an algorithm for determining pregnancy in women of reproductive age). Women who are visibly pregnant (assumed second or third trimester) may receive the medicine. If pregnancy is not apparent, the CHW may ask the following questions to help exclude a first trimester pregnancy: - Are you currently pregnant? - Do you think you could be pregnant? - Are you using any family planning method? M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 35 If the woman is unsure of her pregnancy status, a pregnancy test should be offered. If the test is positive, the woman is considered to be in the first trimester of pregnancy and should be excluded from the MDA. Women who do not agree to have a pregnancy test should be warned of the risks and benefits of receiving ACT in the first trimester and given the choice to take it or refuse it. Interviewing adolescent girls about pregnancy may pose an ethical issue, as parental consent might be required and is a subject of strong cultural sensitivity. Appropriate procedures should be defined in collaboration with the national reproductive health programme. • Distribute a blister appropriate for the age category. The first dose should be administered under DOT. If a child is unable to swallow a tablet, the dispenser should teach the carer how to crush it and dissolve it in water and give the first dose to the child. If the medicine has a bitter taste, it may be given with a small amount of sugary solution to encourage the child to take it. If the dose is vomited (or rejected) within 30 min, the same dose should be repeated. The parent or guardian should request another dose from the CHW to complete the treatment. • Teach the participants to take the remaining doses (on days 2 and 3), unless DOT is used for all doses. A laminated card with treatment doses should be used as a visual aid to support the explanations, and printed leaflets may be distributed (see Annex 12 for the leaflet used in MDA in Sierra Leone in 2014–2015). • Clearly explain the importance of adherence to the full treatment course. Participants may be advised to keep the empty blister packs for assessment during post-distribution monitoring. • Provide information on possible side-effects and what to do if they occur, including clear instructions for contacting the relevant services for assistance or queries. • Ask the members of the household whether they have any questions, and allay any doubts they may have. • Mark the tally sheet (see section 2.3.4 and Annex 13) after the person has taken the first dose, or fill in the registration book (see section 2.3.4 and Annex 14) and record the necessary information (e.g. name, age, gender, address, residency status, medication and dose given), including whether the entire household was covered or whether some members were missing, and specify the number missing. • When the distribution team leaves the house, they may mark it with chalk as “complete” or “incomplete” according to the household members present; if no one was at home at the time of the visit, it should not be marked. If distribution in a household was incomplete or no one was at home, the team should revisit the house later in the day or the following day. To simplify operations, the antimalarial medicine should also be given to people present in the community at the time of MDA who are not resident in the area (visitors), as long as they have no contraindication. In certain settings, such as in the context of elimination, they should be recorded separately, as they were not included in the calculation of coverage. On days 2 and 3, once CHWs have finished dispensing daily treatment, they should return to households in their area in order to reinforce sensitization, promote treatment adherence and monitor ADRs. 36 Centralized, fixed-site distribution All distribution sites must have been identified in the planning stage and should be prepared the day before distribution begins. The site should be set up as follows (Fig. 2): • Delimitation of the site with a rope or fence is recommended, and the site should be clearly identified. • Waiting lines should be organized with rope or barrier tape and should be narrow enough for only one person to pass at a time. Crowd controllers may be necessary to ensure a smooth flow. • Sensitization should be conducted in the waiting area. • People should pass through an initial triage area, where their eligibility is verified. If they are considered eligible, they will continue through the circuit. If not, they will leave the area after the reasons for non-inclusion and registration have been explained. • A private area should be identified for pregnancy screening of women of reproductive age as previously described. • If it is decided that MDA cards will be handed to participants or a registration book completed (see section 2.3.4 and Annex 14), the next step will be registration. As this may be time-consuming, enough staff should be assigned to avoid bottlenecks and long waiting times. • People will then proceed to the point where they will receive an appropriate blister for their weight or age category. The treatment distributors will administer the first dose under direct observation, and inform the recipients on how to take the medication on days 2 and 3 (unless DOT for all three doses is done). • The tally sheet is completed for each participant after the medicine has been dispensed. • An observation area may be set aside where people spend 30 min to ensure that they do not vomit and no severe adverse events or adverse events of special interest (see section 3.4.1) appear and where they will be sensitized about possible side-effects, what to do if they occur, administration of the remaining doses and the importance of adherence. • All ill people attending the distribution should be referred to the nearest health facility. FIG. 2. Example of layout of a distribution site Drug distribution station DOT Drug distribution station DOT W ai tin g ar ea , w ith in fo rm at io n, ed uc at io n an d co m m un ic at io n Registration Registration O bs er va tio n an d se ns iti za tio n ar ea Triage Tally sheet Tally sheet M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 37 2.3.3 Supervision Supervision is important to ensure an effective, efficient, successful MDA campaign. Supervision should be conducted at various levels, with clearly defined communication lines between them. Supervisors should be appointed for the distribution teams and at the levels of districts, region or province (where applicable). National supervisors and coordinators should also be available. Distribution team supervisor The roles and responsibilities of the distribution team supervisor are: Before distribution: • Ensure proper reception and management of antimalarial medicine and other supplies at the peripheral health facility. • Verify that all distributors are identified and trained and that local activities are organized and coordinated. • Prepare the daily schedules of the distribution teams. During distribution: Morning - Present the micro-plan and daily work plan for each distribution team. - Check attendance, and find replacements in case of absence. - Ensure that each team has the necessary medicine and material. - Fill in part of the supervisory checklist. - Deliver the daily data collection tools. During distribution hours - Visit distribution teams in their area of supervision, and provide technical support when needed. - Randomly visit households, and interview members of communities that have already received the distribution team’s visit to verify that they did receive the medicine and what they understood about taking the remaining doses. End of the day - Meet the distribution teams. - Collect the remaining medicine and material (guarantee stock follow-up, and confirm consumption). - Collect daily tally sheets and analyses. - Compile data, fill in daily summary forms, and report to the district supervisor. - Ask about any problem encountered during MDA or stock out, and report. - Provide feedback to the teams, correct any mistakes, inform them of the progress of the campaign, and address any concerns. - Prepare the medicines and material for the next day. - Complete the supervisory checklist. - Report to the district supervisor any difficulties or problems to be dealt with, rumours and refusal on the part of the population. 38 End of the campaign: • Report the stock level. • Return the remaining medicine and materials (to be arranged in collaboration with logistics department). • Conduct debriefing with district supervisors and task force. Supervisors should have the proper tools for their tasks, such as a supervisory checklist (see Annex 15). District supervisor The roles and responsibilities of the district team supervisor are to: • supervise and support the distribution team supervisors; • ensure that there is a team supervisor for all eligible geographical areas; • visit peripheral health structures daily and react rapidly to questions and problems; • ensure the daily presence of all teams; • brief and debrief the team supervisors before and after each day’s work, with particular attention to: - stock ruptures, - problems in data collection, - rumours circulating in the community, - insufficient information by distributors on correct administration of the medicine, - lack of motivation of health workers, - insufficient response to ADRs and - coverage of hard-to-reach populations; • inform the district task force of any problem requiring immediate action that cannot be resolved locally; • collect and compile the information on the daily summary sheets for the district; • collect and review the team supervisors‘ checklists (may be done at the end of the campaign if there is not enough time during distribution) to identify any issues and lessons to be applied in subsequent rounds; • present daily summaries to the district task force during evening debriefings and • submit a written report to national supervisor. Regional or provincial supervisor (if applicable) The regional or provincial supervisor is responsible for supervising the district supervisors. He or she must follow up daily on the progress of the campaign and on any difficulties or problems, such as rumours. He or she must collect and analyse district summary findings and present a report to the national supervisor or coordinator. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 39 National supervisor or coordinator He or she oversees the regional or provincial supervisors, follows up the overall progress of the campaign and major difficulties, such as rumours, and analyses the summaries from regions or provinces before reporting to the national task force. 2.3.4 Data collection Data collection is a vital component of an MDA in order to guarantee adequate follow-up of operations. The person responsible for collecting each type of data at each level and the mechanism of transfer from one level to another should be clearly defined (Table 4 and Fig. 3). This is particularly important when several partners are involved in order to avoid duplication of data collection, missing data or mistakes in the destination of tallies or summary sheets. FIG. 3. Recommended information flow among levels CHWs and distribution teams • daily tally sheet • daily household registration Distribution team supervisor • daily summary sheet District supervisor • district summary Regional or provincial supervisor • regional summary National supervisor • national summary Community Health facility District Region or province National level 40 TABLE 4. Data to be recorded at each level during door-to-door and centralized distribution LEVEL DISTRIBUTION STRATEGY DOOR-TO-DOOR CENTRALIZED, FIXED-SITE Community Census of people in each household or family (obtained before MDA, when feasible) List of people in community, ideally with age and sex by family; otherwise, number of people per family Daily tally sheet with stock management (medicines, pregnancy tests and other consumables) per distribution team Daily tally sheet with stock management (medicines, pregnancy tests and other consumables) per distribution site Record of each person, family treated, excluded, refused or not found (see household registration) ADRs (name, age, sex, village, head of household, contact details, treatment taken, type of ADR, day of ADR) during days 2–7 ADR reporting (observations for 30 min while still at treatment centre) Referral form (in case of severe illness, ADR, pregnant woman who inadvertently received the treatment, other reasons) Health facility Daily summary sheet and analysis of coverage by community in the health facility catchment area ADR reporting (standard form) Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables in health facility stock Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables (stock may not always be prepositioned in health facility) District District summary sheet and analysis of coverage by health facility in the district Compilation of ADR report forms from health facilities in the district Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables if district storage is used and when stock is returned from health facility Region or province Regional or provincial summary sheet and analysis of coverage by districts in region or province Compilation of ADR report forms from districts Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables if regional storage is used and / or when stock is returned from district level National National total and analysis of coverage by region or province Compilation of ADR report forms from regions or provinces Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables in national stock and when stock is returned from lower levels M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 41 MDA cards Provision of MDA cards (see Annex 16) to participants as proof that they received the treatment is optional and should be decided by the national task force during the design phase. If the task force decides that an MDA card will be provided, it should contain: • last and first names of the drug recipient, • age and sex, • address, • name and dose of the antimalarial medicine given and • date of administration of the first dose if given by DOT or of each dose if all three doses are given by DOT. Daily tally sheet Tally sheets (see Annex 13) should be completed by each team on each day of distribution and handed to the supervisor at the end of the day. The following information should be recorded: • date and place of distribution; • distribution team identification; • number of households visited; • number of people who received the medicine, by age group (defined by age categories for the medicine) and by sex if considered relevant; • individuals excluded and reason; • residence status: resident or visitor (especially useful in elimination contexts, as all may not be included in the coverage calculation) and • number of treatment blisters for each age category received at the start of the day and that remaining at the end of the day. The quantities of medicine consumed should correspond to the number of people treated, as recorded on the tally sheet. Discrepancies should be investigated to determine the cause, such as a mistake in distribution or theft. Household or line list registration Depending on the context (emergency or elimination), a household or line list registration (see Annex 14) may be used, with the following information collected: • household identification; • head of household; • name of recipient; • age; • sex; • village; • contact details (if available); 42 • residency status (permanent resident, temporary resident, visitor); • treatment taken; • refusal, excluded (reason) or not found and • observations. Daily summary sheet The distribution team supervisor should collect the completed tally sheets and compile the data corresponding to a certain geographical area (health centre catchment area, neighbourhood or village) on a daily summary form (see Annex 17). The tally sheets should be reviewed to ensure that they were properly completed and that the team is meeting the daily target. If not, the reason should be investigated (e.g. lack of sensitization, shortage of medicine, problems in recording). Feedback should be given to the teams on their performance and adjustments made, such as increasing the number of teams, changing the distribution site (in centralized distribution) or adapting mobilization. Database The data on the summary forms should be entered by a trained data manager into a centralized database at district, regional or national level (see Annex 18 for the database used in MDA in Sierra Leone), which will allow, at a later stage, a thorough analysis of the number of people treated, the number excluded, distribution coverage by age group and location and other information. Referral form A CHW who identifies a person who is ill, a pregnant woman in the first trimester who inadvertently took the antimalarial medicine or anyone presenting a potentially drug-related adverse reaction must fill in a referral form and refer the person to a health facility for proper management. ADR form If an individual presents symptoms that could be attributed to the antimalarial medication, an ADR form (see Annex 19) must be completed at a health facility or by a pharmacovigilance team. See section 3.4 for more details of pharmacovigilance and reporting of ADRs. 2.3.5 Coordination During the days of distribution, daily meetings should be held at district and national levels, with the participation of all involved in the campaign in order to: • monitor daily coverage; take action in problematic or challenging areas by targeting social mobilization or planning “catch up” distribution, ensure that hard-to-reach areas have been visited and guarantee that supplies have not run out; • monitor stocks, and ensure an uninterrupted supply of the medicine; • address any identified rumours or generalized refusal of the population; • manage enquiries from the press; • identify and correct any programme errors that could lead to failure of the campaign; • share any pertinent information, and coordinate the activities of all partners; and • mobilize the necessary resources in a coordinated way to respond to unforeseen events. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 43 2.3.6 Treatment of malaria cases after mass drug administration An individual treated during MDA who presents to a health facility with suspected malaria within 4–6 weeks should be assessed for possible malaria treatment failure or new infection. A positive result in a HRP2-based rapid diagnostic test cannot be relied upon, as a positive result may be obtained weeks after successful treatment due to persistent antigenaemia. Thus, microscopy should be used to confirm malaria. Ideally, health facilities should have antimalarial medicines in stock that are different from those used in the MDA. If microscopy confirms malaria, the health worker should enquire whether the patient adhered to the full course of treatment and if he or she vomited within the first 30 min of drug intake. If adherence was poor or the patient vomited, the same treatment used for MDA can be repeated. If adherence to treatment was good, a different antimalarial should be given, as possible treatment failure cannot be differentiated from a new infection in routine health care settings. 44 3. MONITORING AND EVALUATION 3.1 MONITORING SYSTEM Given the complexity of the intervention, the limited number of times MDA can be done and the importance of the coverage of the intervention, monitoring is essential for success. The monitoring should be of high quality and not considered routine. Use of a monitoring system during a campaign allows full allocation of resources to operations and efficient implementation of activities while dedicating resources and capacity for a separate set of activities that allow identification in real time of constraints that require immediate action and will provide lessons for subsequent rounds of MDA. The monitoring system should assess all phases of the campaign, by: • interviewing distribution teams to determine the effectiveness of training; • evaluating the logistics; • interviewing community members to appraise the effectiveness of the social mobilization campaign; • randomly visiting distribution teams to observe administration of the medication and counselling for adherence; • assessing the quality of data collection; • estimating actual coverage; • evaluating adherence to treatment and rational drug use; • monitoring drug safety and reporting adverse events; • and monitoring impact. Deployment of monitoring teams (internal or independent monitors) should be planned during the design phase in order to ensure adequate training in use of the monitoring tools. 3.2 ESTIMATE OF COVERAGE After each round is completed, coverage is estimated to determine the proportion of people reached. Areas of low coverage might be identified to improve planning for the following round. 3.2.1 Distribution coverage Distribution coverage can be defined as the proportion of the population who received the first dose of the treatment in that round, with the number of people who received the first dose as the numerator and the number of people in the target area as the denominator: Distribution coverage = number of people who received the first dose x 100 number of people targeted for treatment M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 45 The distribution coverage for each round and then the total MDA distribution coverage can be calculated. Additionally, distribution coverage should be estimated for each demographic group (age and sex) and geographical area, as applicable for campaign management. Although analysis by gender is not essential, it may be useful in settings where certain groups are likely to be underserved (e.g. girls). Such calculations do not, however, necessarily reflect the reality, because of difficulties in obtaining reliable demographic information, errors in data collection or inclusion of people from outside the target area in distribution. The estimate of coverage will be more accurate if a household census was conducted before distribution, providing the denominator. In emergencies or other situations in which performing a census is not feasible, the recommended approach is to perform a coverage survey. As stated previously, the desirable coverage is > 80%. Coverage of < 80% may be due to poor participation, a shortage of supplies or an inadequate strategy for the campaign. The reasons for not participating may be (12,26,27): • population mobility (seasonal or routine movements of people out of the area targeted for MDA); • unavailability or inability to participate at the time of MDA; • difficulty in reaching the distribution site or a long waiting time (in case of centralized distribution); • refusal to take the treatment because not sick; • fear of ADRs; • treatment considered to involve too many tablets and too long; • rumours about the medicine; • lack of engagement with community leaders and civil society in general; • lack of trust in the campaign; • misunderstanding and lack of adequate information about MDA; • interference with other community events; and • confusion between MDA for malaria and for other neglected tropical diseases, such as administration of praziquantel, which has side-effects that some people find difficult to tolerate. Although MDA in rural settings is logistically more demanding, it may be more difficult to obtain high coverage in urban than in rural settings because of differences in the characteristics and dynamics of the population, including socioeconomic status, educational level, occupation and work schedules (28,29). Some studies have shown that populations with higher social status are more reluctant to participate in MDA (28). Young people and adults who drink alcohol regularly are unwilling to participate in MDA unless they are sick. 46 The reasons for non-adherence to full treatment include (12,27): • not feeling sick, • wanting to save the medicine for when they are sick, • sharing the treatment with someone else, • forgetting to take the tablets, • fear of or appearance of side-effects, • rumours about the side-effects of the medicine and • inadequate health promotion or information on how to take the treatment correctly or on the importance of completing the full course. 3.2.2 Post-MDA campaign survey A post-campaign survey is recommended when feasible, ideally within the week after distribution. The survey comprises visiting a representative sample of the population and systematically administering a questionnaire (see sample in Annex 20) to selected household members. The results can be used to estimate the coverage of the larger population with confidence intervals. Additional information about the campaign can also be collected during the survey. Cluster sampling may be used. For information on performing a cluster survey of coverage, see Annex 4 of Monitoring and epidemiological assessment of mass drug administration in the global programme to eliminate lymphatic filariasis: a manual for national elimination programmes (30). A post-distribution survey is useful to: • estimate the coverage of the MDA, • evaluate adherence to treatment (the number of people who completed the full course of antimalarial medicine), • determine the reasons for non-participation, • determine the reasons for non-adherence, • estimate the proportion of people who experienced adverse events and • evaluate the main adverse events reported. 3.3 MONITORING CONSUMPTION The consumption of antimalarial medicine (number of treatments used) must be monitored daily and compared with the number of people reported to have been given the medication. Discrepancies between the two numbers should be investigated. They may be due to problems in recording the doses administered, errors in counting stocks, mistakes in administering the medicine or theft. Any of these problems must be suitably addressed with the teams. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 47 A major problem that could arise as a consequence of lack of reliable demographic data is that the true population at a given site largely exceeds that expected. By monitoring consumption, an eventual stock rupture can be determined. A shortage of stock linked to reports from distribution teams or from community leaders that parts of the population have not yet received MDA may alert supervisors to this possibility. Under such circumstances, the buffer stock in central storage should be used. A more logistically demanding alternative would be to shift medication from over-stocked locations to under-stocked ones. 3.4 PHARMACOVIGILANCE Even when medicines that have good safety and tolerability profiles are used, exposure of a large population may result in the appearance of rare side-effects in a number of cases. “Pharmacovigilance” is defined by WHO as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems (31). Pharmacovigilance in the context of MDA should be planned and implemented in collaboration with the national pharmacovigilance centre, which might be part of the national medicines regulatory authority or a research or academic institution. Pharmacovigilance systems depend on the performance and motivation of general health services staff, require centralized reporting lines and methods and skills for review, analysis and assessment of the causality of spontaneous reports of suspected drug reactions. The pharmacovigilance system should be organized at national, regional, district, state and municipal levels and also at health facilities and at community level in targeted populations. The objectives of pharmacovigilance during MDA are to: • detect unusually high rates of adverse events; • ensure that coincidental events are not falsely associated with MDA; • support timely detection and management of all adverse events (even those not attributed to MDA) to ensure the safety of the population; • maintain confidence in the campaign by proper responses to community concerns about the safety of the medicine while increasing awareness about its benefits and risks; • generate data about adverse events in certain populations such as asymptomatic carriers and healthy people for whom there may be no safety data, as these populations are not included in testing during development of medicines; • promote and monitor adherence to the medicine by the targeted population, and detect reasons for non-compliance and the underlying causes, if possible; • assess health systems preparedness to ensure drug safety monitoring at district and national levels by identifying appropriate responses in terms of knowledge of drug use (safety), training, knowledge and practice of pharmacovigilance; and • evaluate the expected severity, frequency, distribution and outcome of ADRs in the targeted population in order to: - identify adverse event that are not listed in the product information leaflet or are not described in populations that were not tested during development of the medicine, such as asymptomatic carriers and healthy people; - assess the association between the ADR and the antimalarial; - provide a spectrum of the ADRs associated with use of the antimalarial in large populations; and - inform health care workers about patient counselling and monitoring in health facilities. 48 The expected ADRs and the toxicity of the medicine to be used in MDA should be well known to the organizing committee. Groups at all levels should be sensitized about potential ADRs, including the general public, CHWs (treatment distributors), supervisors and health care staff. Communities should be informed about expected mild reactions, with the information that they are usually transient and self- limiting or manageable by simple treatment; they should be encouraged to seek medical care for any rare or severe symptoms. Special attention should be paid to side-effects that may reduce tolerability and lead to poor adherence, such as nausea, vomiting, diarrhoea and abdominal discomfort. This could be done via television and radio, print media, social media, press conferences, community outreach and meetings. 3.4.1 Definitions Adverse event: any untoward medical occurrence that may occur during treatment with a pharmaceutical product that is not necessarily causally associated with the treatment (32) Adverse drug reaction (ADR): a response to a drug that is noxious and unintended and that occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease or for modifying physiological function (32) Serious adverse event or reaction: any untoward medical occurrence that, at any dose: • results in death, • is life threatening, • requires hospitalization or prolongation of hospitalization, • results in persistent significant disability or incapacity or • results in congenital abnormality or birth defect (33,34). The detection of congenital abnormalities would require creation of a pregnancy registry, with enrolment and surveillance of all new pregnancies detected at antenatal care and in communities during the three months after MDA, and an evaluation to determine whether the women were pregnant at the time of exposure to the medicine. These women should be followed up to delivery to assess the outcome of the pregnancy, in terms of the health of both the foetus and infant and the mother (31). The cohort of pregnant women should be interviewed about any treatment with ACT or other medicines, with precise information on time of exposure and type of medicine and possible miscarriage, stillbirth or malformations. Analysis of data at the time of birth will allow a comparison of the frequency of miscarriage, stillbirth and congenital malformations among pregnant women who have inadvertently received various types of medicines during the first trimester. Adverse event of special interest: refers to adverse events (serious or non-serious) of significant scientific, medical and public interest, for which monitoring and rapid communication to the provider and regulators could be appropriate (35). The event should be defined and reported if some safety signals were detected during the development of a drug that required additional monitoring. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 49 3.4.2 Safety communication Reports of ADRs and rumours about the safety of the drug can damage an MDA campaign and can also influence future MDAs or even use of the medicine in the country. A communication strategy should be prepared with the national pharmacovigilance centre before the MDA campaign, in line with internationally accepted best practices (36). Relations with the media and selected spokespeople should be defined well in advance, as timeliness and efficiency in crisis communication are essential to contain serious damage by circulating rumours. Reported or perceived ADRs should be communicated appropriately to the media, with responses to any enquiries. Every serious adverse event must be properly recognized, reported and investigated. Once the assessment has been completed, the results of the investigation should be communicated to the community through appropriate media. 3.4.3 Surveillance of adverse drug reactions Routine ADR surveillance must be enhanced during an MDA campaign to identify any potentially severe cases and to manage them adequately, to detect any programmatic errors and to reassure the general public. Rescue medicine and emergency medical material required for managing potential adverse reactions should be available in health facilities. Medication errors, such as in dose administration by distributors or in taking the medicine because of inadequate sensitization, could be at the origin of adverse events and should be duly reported. In order to establish a functioning safety surveillance system, all personnel involved in an MDA campaign, especially health care staff, should be trained before the campaign on their roles and responsibilities, emphasizing prevention, early detection and management of adverse events and severe adverse events linked to the campaign as well as on the use of standard forms for reporting and the procedure to follow in case of a suspected severe ADR (notification system). Most countries have standard forms for documenting ADRs (see example in Annex 19). Forms for reporting suspected ADRs should be widely distributed, and clear guidance should be provided to health care staff and local health structures on completing the form. Any reported severe ADR must be investigated to determine its relation with the antimalarial medicine, and all responses should be documented, including treatment. The reporting form adopted by the national pharmacovigilance centre should be used for spontaneous reporting. The forms may be adapted for active monitoring of a sample of the exposed population to include days of follow-up and findings of home visits. All reporting forms should record data on the patient, the suspected drug(s), concomitant medication, medical history, detailed description of the clinical course of the event(s), diagnosis, outcome, relevant laboratory or other diagnostic procedures and treatment received and any other information that supports causality (37). Two pharmacovigilance methods may be used during MDAs. • Passive monitoring or spontaneous reporting: reporting of a suspected adverse reaction by a health practitioner who becomes aware of a safety concern or by a patient. Thus, reporting is not solicited systematically. Nevertheless, both health workers and people receiving MDA should be advised (with clear contact details) to report any untoward event they may observe during or after MDA. • Active monitoring and reporting: follow-up home visits by pharmacovigilance mobile teams or health workers trained in detecting adverse events after exposure to medicines for detection of short-term ADRs (during the week after administration) in every village, town or city in which the medicine was given. This is particularly important in settings where pharmacovigilance systems are weak and underreporting is significant. It involves active case finding and follow-up (“search, find, identify, refer and manage”). Any ADR detected should be reported to a health facility, and serious ADRs should be referred for further investigation and management. 50 To ensure effective communication and reporting of ADRs, a dedicated round-the-clock pharmacovigilance call centre or hotline could be set up to address queries from recipients of the medicine during the campaign. In countries where the national pharmacovigilance centre has an online electronic reporting system for ADRs, this can be used to enhance reporting if there is nationwide sensitization of consumers and health care professionals to the availability of the system. All ADR reports collected during or after the campaign should be forwarded to the national pharmacovigilance centre for assessment and onward submission to the WHO global ADR database. A health facility pharmacovigilance preparedness checklist (see example in Annex 21) could be used by pharmacovigilance monitors in communities to assess whether: • there are adequate quantities of rescue medications to treat ADRs; • staff are aware of the need for pharmacovigilance monitoring during the MDA; • all staff have been apprised of and trained in pharmacovigilance monitoring and the adverse reactions to the antimalarial medicine that will be used in the campaign; • staff were involved in advocacy and social mobilization before the campaign about the importance of adherence to the medicine; and • ADR reporting forms are readily available at MDA sites, with clear forwarding instructions and contact details. All health workers involved in the mass drug administration should be trained in pharmacovigilance (see example of training curriculum for drug dispensers in Annex 22). 3.5 MONITORING DRUG RESISTANCE One of the main concerns about MDA is the emergence and spread of resistance to the drug, which spreads because resistant parasites develop greater transmission potential in the presence of the antimalarial medicine. In the past, indirect MDA (in which antimalarial drugs were added to salt distributed to the population) resulted in the development of resistance because of the use of sub-therapeutic doses of antimalarial medication (5,38). MDA is likely to increase selection pressure on parasites. As antimalarial medicines with a long half-life are eliminated slowly from the body, during MDA, a large proportion of the population will have variable concentrations of the medicine in the blood over time. This increases the chances that malaria parasites will be exposed to sub-therapeutic concentrations of long-acting drugs (13,40,41). Thus, the post-treatment prophylactic effect, which is an important component of the protective and transmission-blocking effect of MDA, may also lead to selection pressure. Low adherence to treatment by a proportion of the population is expected to be higher in people with asymptomatic parasitaemia, which will also contribute to the exposure of malaria parasites to sub-therapeutic doses. Until now, there has been no evidence that MDA of antimalarial medicines given at therapeutic doses results in the emergence of resistance (39). While the use of combination treatment reduces the possibility of selecting drug-resistant parasites (23), limited evidence on the impact of MDA on drug resistance indicates that resistance to antimalarial medicines should be monitored in areas where MDA is implemented on a large scale. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 51 Several means for monitoring parasite (P. falciparum) resistance are relevant to MDA (42). • In vivo trials of therapeutic efficacy: treatment of symptomatic patients with a standard dose of antimalarial medicine and measurement of the clinical (signs and symptoms) and parasitological (parasitaemia) efficacy of medicines and treatment outcome over a defined period. Although trials of therapeutic efficacy are considered the “gold standard” and are used in national malaria control programs to guide treatment policy, they are relatively complex to perform and not always easy to implement after MDA. • Detection of molecular drug resistance markers: confirmation of genetic changes associated with resistance by molecular techniques. Serial detection of molecular markers is an accurate way of monitoring drug resistance and probably the preferred option. It has the advantage that samples can be easily obtained, transported and stored on filter paper, but it also requires expensive equipment. It can provide early evidence of resistance, particularly if pre-intervention data are available. Molecular markers of drug resistance are available for only a limited number of antimalarial medicines, notably chloroquine, amodiaquine, sulfadoxine + pyrimethamine, mefloquine, piperaquine and artemisinin. The correlation between molecular markers and the therapeutic efficacy of many antimalarials is imperfect and should be interpreted with caution. In any scenario, at least one of the two methods should be available. Monitoring drug resistance will require collaboration with reference laboratories and with research entities at national or international level. 3.6 EVALUATING IMPACT The ideal way of determining impact, especially when the objective is to reduce malaria transmission, is to monitor malaria prevalence by serial measurements of parasitaemia. The method used in pre- and post-MDA surveys should be the same in order to identify an effect. A more practical way of evaluating the impact of MDA for malaria is monitoring routine surveillance data. The following indicators should be measured, ideally weekly, but at least at monthly: • total number of consultations (outpatients), • total number of suspected cases tested for malaria, • total number of cases of confirmed malaria, • total number of admissions of severe cases of malaria, • number of deaths due to malaria, • test positivity rate and • total number of locally transmitted and imported malaria cases. For epidemics and complex emergencies, a minimum set of MDA monitoring and evaluation activities should be defined in order to document impact and for reporting. Facilities that record confirmed malaria cases continuously can be identified in most settings, in order monitor over time the numbers of consultations and of cases of confirmed malaria in the target groups exposed to MDA and, if possible, in unexposed population groups. 52 These data should be compared before and after MDA in the targeted area; in a district covered by MDA and one that was not targeted, with a similar prevalence of malaria; and in the same district in a year in which MDA was carried out and one in which it was not. More detailed analyses could indicate the contributions of aspects such as environmental or demographic factors and concomitant interventions that also influence malaria trends. When MDA is used as an emergency measure to reduce the burden of malaria and febrile illness rapidly, as was the case in the outbreak of EVD, the effectiveness in reducing both malaria morbidity and the number of febrile cases presenting to health services should be monitored (11,12). In an epidemic, the effect of MDA is difficult to document, as the temporal change may be reflected simply as a plateau, or a reduction in the rate of increasing incidence in the epidemic curve. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 53 4. REPORTING After each round and at the end of the intervention, all partners at different levels (community, health facility, district, region, province, national) should gather for a debriefing and review to assess how the campaign went, share their experiences and impressions and make recommendations for the following rounds or future MDA. A report should be written in order to capitalize on the experience and identify lessons that could improve subsequent rounds or similar experiences. It should provide: • the coverage achieved; • the main findings, challenges and difficulties faced and successful or unsuccessful solutions; • any practices that gave good results, including effective social mobilization activities; • any useful tools that were developed ad hoc in response to unpredicted events, which could be incorporated into reference documents and included in training material; • the final cost of the intervention (analysis per line item) and the cost per person treated; • transparency and accountability for all resources used, including final inventories, destination of remaining treatment, return of logistic equipment, any donations made; and • an evaluation of the whole operation. The following is a proposed outline of the essential topics that should be covered in the report to be prepared at district level at the end of each MDA round: • Introduction and background • Objectives • Duration of campaign • Geographical area of intervention and target population • Treatment regimen • Details of methods used during the campaign - Preparation and planning o Recruitment and training of human resources o Social mobilization and community engagement o Logistics and supply - Distribution o Strategy o Practical aspects o Supervision o Data collection o Results - Total number of people reached - Coverage - Excluded individuals and reasons for non-inclusion 54 • Monitoring: adverse events reported • Other relevant aspects of monitoring • Finance and administration, including breakdown per cost • Strong points, difficulties, lessons learnt and recommendations • Annexes Another important component of reporting is feedback to the communities on the outcomes of the campaign and its impact. This will improve people’s perception of the activity and build trust in the health authorities for future campaigns. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 55 5. K EY S TE PS IN A M AS S DR UG A DM IN IS TR AT IO N CA M PA IG N FO R M AL AR IA Pl an ni ng an d pr ep ar at io n Im pl em en ta tio n M on ito rin g an d ev al ua tio n Re po rt in g D es ig n ph as e (m ac ro -p la nn in g) • O bt ai n co m m itm en t f ro m po lic y- m ak er s, an d id en tif y ag en ci es to su pp or t t he m in ist ry o f h ea lth • E st ab lis h a ta sk fo rc e or co or di na tin g co m m itt ee • C on du ct a c on te xt a na lys is • D et er m in e ta rg et p op ul at io n an d ge og ra ph ica l a re as • D et er m in e an tim al ar ia l m ed ic in e to b e us ed • E st im at e re qu ire m en ts , a nd or de r m ed ic in e • D et er m in e de liv er y st ra te gy : - D oo r t o do or - C en tra liz ed - M ix ed • D et er m in e pe rio d of in te rv en tio n • E st ab lis h nu m be r o f r ou nd s • E st ab lis h a ch ro no gr am • E st im at e a bu dg et • D o m ic ro -p la nn in g • E ns ur e eff ec tiv e lo gi st ic s - Pr oc ur em en t, st or ag e an d di st rib ut io n - Tr an sp or t - Ac ce ss ib ili ty - D ist rib ut io n sit es - W as te m an ag em en t • H um an re so ur ce s - Id en tif y re qu ire m en ts - Tr ai ni ng - Sa la rie s a nd p er d ie m • C om m un ity e ng ag em en t an d so ci al m ob iliz at io n - D efi ne ro le s a nd re sp on sib ilit ie s - Co m m un ity as se ss m en t - Ke y m es sa ge s - En ga ge m as s m ed ia - A dd re ss ru m ou rs - En ga ge c om m un ity • S to ck m an ag em en t • D ist rib ut io n of a nt im al ar ia l m ed ic in e • S up er vi sio n • D at a co lle ct io n • C oo rd in at io n • R ea l-t im e m on ito rin g • E st im at io n of c ov er ag e • P os t- ca m pa ig n su rv ey • M on ito rin g of c on su m pt io n • P ha rm ac ov ig ila nc e • M on ito rin g of d ru g re sis ta nc e • E va lu at io n of im pa ct • D eb rie f a nd re vi ew in te rv en tio n • W rit e a fin al re po rt 56 REFERENCES 1. 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M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 59 Annex 1 STANDARD DISTRIBUTION OF POPULATIONS IN A DEVELOPING COUNTRY CHILDREN < 5 YEARS AGE RANGE (MONTHS) PERCENTAGE OF TOTAL POPULATION 0–11 4% 12–23 3% 24–35 3% 36–47 3% 48–59 3% Total 16% TOTAL POPULATION AGE RANGE (YEARS) PERCENTAGE OF TOTAL POPULATION 0–4 16% 5–14 27% 15–29 27% 30–44 16% ≥ 45 14% Total 100% 60 Annex 2 AVAILABLE ARTEMISININ-BASED COMBINATION THERAPY: DOSING, FORMULATION AND PRESENTATION DIHYDROARTEMISININ–PIPERAQUINE WHO recommended doses BODY WEIGHT (KG) DOSES (MG) OF DIHYDROARTEMISININ AND PIPERAQUINE GIVEN DAILY FOR 3 DAYS 5 to < 8 20 + 160 8 to < 11 30 + 240 11 to < 17 40 + 320 17 to < 25 60 + 480 25 to < 36 80 + 640 36 to < 60 120 + 960 60 to < 80 160 + 1280 ≥ 80 200 + 1600 Formulations available Fixed-dose combination in: • Paediatric tablets containing 20 mg dihydroartemisinin and 160 mg piperaquine • Tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine Presentations • Blister containing 3 tablets of 20 mg dihydroartemisinin and 160 mg piperaquine • Blister containing 3 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 6 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 9 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 12 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 61 Remarks • Dihydroartemisinin–piperaquine is an ideal candidate because of its efficacy and long post- treatment prophylactic effect. The elimination half-life of piperaquine is 13.5–28 days (1). • Piperaquine prolongs the QT interval and should not be used with medication that prolongs the QT interval or in patients with congenital QT prolongation (1). Excluding patients with congenital QT prolongation would not be feasible in MDA. A single report of a sudden unexplained death considered potentially related to lethal cardiotoxicity has been reported among approximately 200 000 individuals closely followed up after treatment with this medicine (2-4). • Dihydroartemisinin–piperaquine should ideally be administered to a person with an empty stomach, as high-fat meals accelerate the absorption of piperaquine, increasing the risk for a prolonged QT interval. Each dose should be taken at least 3 h after the last food intake; no food should be taken within 3 h of each dose. 62 ARTESUNATE–AMODIAQUINE Recommended doses BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTESUNATE + AMODIAQUINE DAILY FOR 3 DAYS 4.5 to < 9 2–11 months 25 + 67.5 9 to < 18 1–5 years 50 + 135 18 to < 36 6–13 years 100 + 270 ≥ 36 ≥ 14 years 200 + 540 Formulations available Fixed-dose combination in tablets containing • 25 mg artesunate and 67.5 mg amodiaquine • 50 mg artesunate and 135 mg amodiaquine • 100 mg artesunate and 270 mg amodiaquine Presentations • Blister containing 4.5 to < 9 kg (infant): 3 tablets of 25 mg artesunate and 67.5 mg amodiaquine • Blister containing 9 to < 18 kg (toddler): 3 tablets of 50 mg artesunate and 135 mg amodiaquine • Blister containing 18 to < 36 kg (child): 3 tablets of 100 mg artesunate and 270 mg amodiaquine • Blister containing ≥ 36 kg (adult): 6 tablets of 100 mg artesunate and 270 mg amodiaquine Remarks • Artesunate–amodiaquine is associated with neutropenia, especially in HIV-positive patients on zidovudine and / or co-trimoxazole. Concomitant use of efavirenz may also increase the hepatotoxicity of amodiaquine (1). • Although limited data is available, artesunate-amodiaquine is associated with QT interval prolongation similar to other antimalarial medicine such as quinine, chloroquine and dihydroartemisinin-piperaquine. No sudden unexplained death suggestive of cardiac arrhythmia at the doses used for malaria treatment have been reported despite widespread use suggesting that while cardiotoxicity may occur it is rare (4). • Elimination half-life: 4–10 days (1). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 63 ARTESUNATE–MEFLOQUINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTESUNATE + MEFLOQUINE GIVEN DAILY FOR 3 DAYS 5 to < 9 6 to 12 months 25 + 55 9 to < 18 1 to 6 years 50 + 110 18 to < 30 7 to 12 years 100 + 220 ≥ 30 ≥ 13 years 200 + 440 Formulations available Fixed-dose combination in: • Paediatric tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Adult tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) Presentations • Strip of 3 tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Strip of 6 tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Strip of 3 tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) • Strip of 6 tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) Remarks • Artesunate–mefloquine has a long post-treatment prophylactic effect (elimination half-life, ≤ 3 weeks) (1) but is associated with nausea, vomiting and neuropsychiatric symptoms, which may reduce its tolerability in MDA operations. 64 ARTEMETHER–LUMEFANTRINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTEMETHER + LUMEFANTRINE GIVEN TWICE DAILY FOR 3 DAYS 5 to < 15 2 to 59 months 20 + 120 15 to < 25 5 to 7 years 40 + 240 25 to < 35 8 to 12 years 60 + 360 ≥ 35 ≥ 13 years 80 + 480 Formulations available • Dispersible or standard tablets containing 20 mg artemether and 120 mg lumefantrine • Standard tablets containing 40 mg artemether and 120 mg lumefantrine Presentation • Blister containing 5 to < 15 kg: 6 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing 15 to < 25 kg: 12 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing 25 to < 35 kg: 18 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing ≥ 35 kg: 24 tablets of 20 mg artemether and 120 mg lumefantrine Remarks Artemether–lumefantrine is probably not a suitable choice for MDA. • It is currently used as first-line treatment in many countries. • The complexity of the treatment regimen of two daily doses would probably compromise adherence. • It has a short post-treatment prophylactic effect (elimination half-life, 3–6 days) (1). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 65 ARTESUNATE + SULFADOXINE–PYRIMETHAMINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSE (MG) OF ARTESUNATE GIVEN DAILY FOR 3 DAYS DOSES (MG) OF SULFADOXINE + PYRIMETHAMINE GIVEN AS A SINGLE DOSE ON DAY 1 5 to < 10 6–11 months 25 250 +12.5 10 to < 25 1–7 years 50 500 + 25 25 to < 50 8–14 years 100 1000 + 50 ≥ 50 ≥ 15 years 200 1500 + 75 Formulations available Co-blister pack (there is no fixed-dose combination): • Tablets containing 50 mg artesunate and fixed dose combination tablets containing 500 mg sulfadoxine and 25 mg pyrimethamine Presentations • Blister containing 3 tablets of 50 mg artesunate and 1 tablet of 500 mg sulfadoxine and 25 mg pyrimethamine • Blister containing 6 tablets of 50 mg artesunate and 2 tablets of 500 mg sulfadoxine and 25 mg pyrimethamine Remarks • Artesunate–sulfadoxine + pyrimethamine does not exist as a fixed-dose combination, which would result in massive distribution of loose artesunate tablets, potentially leading to the emergence of resistance. • Elimination half-life is 4.1–10.9 days for sulfadoxine and 2.5–18.8 days for pyrimethamine (1). • The combination of sulfadoxine + pyrimethamine–amodiaquine, currently used in the Sahel as seasonal malaria chemoprevention, provides protection from reinfection for 28 days; however, it is available in a co-blister formulation and currently not recommended for individuals over 5 years of age. The efficacy of both sulfadoxine–pyrimethamine and amodiaquine is limited geographically due to increasing drug resistance to both medicines. • Sulfadoxine + pyrimethamine should not be administered to people on co-trimoxazole (1). References 1. Guidelines for the treatment of malaria. 3rd edition. Geneva: World Health Organization; 2015 (http://www.who.int/malaria/publications/atoz/9789241549127/en/, accessed 17 August 2017). 2. Myint HY, Ashley EA, Daya NPJ, Nosten F, White NJ. Efficacy and safety of dihydroartemisinin- piperaquine. Trans R Soc Trop Med Hyg. 2007;101:858–66. 3. Kabanywanyi AM, Baiden R, Ali AM, Mahende MK, Ogutu BR, Oduro A et al. Multi-country evaluation of safety of dihydroartemisinin / piperaquine post-licensure in African public hospitals with electrocardiograms. PLoS One. 2016;11:e0164851. 4. The cardiotoxicity of antimalarials. Report of the WHO Evidence Review Group Meeting, 13–14 October 2016, Geneva: World Health Organization; 2017 (http://www.who.int/malaria/mpac/ mpac-mar2017-erg-cardiotoxicity-report-session2.pdf?ua=1, accessed 17 August 2017). 66 Annex 3 EXAMPLE OF CALCULATION OF ORDERS FOR ANTIMALARIAL MEDICINE EXAMPLE OF CALCULATION FOR ARTESUNATE–AMODIAQUINE Artesunate–amodiaquine comes in fixed-dose combination tablets, packed in age-appropriate blisters, in four presentations: Dosage based on body weight or age BODY WEIGHT (KG) APPROXIMATE AGE GROUP BLISTER PRESENTATION DOSAGE 4.5 to < 9 kg 2–11 months 25 mg / 67.5 mg tablets in blisters of 3 tablets 1 per day for 3 days 9 to < 18 kg 1–5 years 50 mg / 135 mg tablets in blisters of 3 tablets 1 per day for 3 days 18 to < 36 6–13 years 100 mg artesunate + 270 mg amodiaquine in blisters of 3 tablets 1 per day for 3 days ≥ 36 ≥14 years 100 mg artesunate + 270 mg amodiaquine in blisters of 6 tablets 2 per day for 3 days Total population: 100 000 Age distribution (from standard age distribution for developing countries in Annex 1): • 2–11 months ≈ 4% (0–11 months = 4%) • 1–5 years = 12% • 6–13 years ≈ 27% (5–14 years = 27%) • ≥ 14 years ≈ 57% (≥ 15 years = 57%) Target population by age group BREAKDOWN BY AGE GROUP (ACCORDING TO BLISTER PRESENTATION) 2–11 MONTHS 12–59 MONTHS 5–13 YEARS ≥ 14 YEARS Percentage of total population 100 000 x 0.04 100 000 x 0.12 100 000 x 0.27 100 000 x 0.57 Total population per age group 4000 12 000 27 000 57 000 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 67 Estimate of number of treatments (= number of blisters) per presentation and volume requirement 6–11 MONTHS 12–59 MONTHS 5–13 YEARS ≥ 14 YEARS TOTAL For one round 4 000 12 000 27 000 57 000 100 000 For three rounds 12 000 36 000 81 000 171 000 300 000 25% buffer stock 3 000 9 000 20 250 42 750 75 000 Total number of treatments 15 000 45 000 101 250 213 750 375 000 Estimated volume per treatment (in dm³) 0.02 0.03 0.04 0.04 Total estimated volume (in dm³) 300 1 350 4 050 8 550 14 250 68 EXAMPLE OF CALCULATION FOR DIHYDROARTEMISININ–PIPERAQUINE Dihydroartemisinin–piperaquine is available as fixed-dose combinations in tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine and in paediatric tablets containing 20 mg dihydroartemisinin and 160 mg piperaquine. WHO dose recommendations based on weight BODY WEIGHT (ESTIMATED AGE) DAILY DOSE FOR 3 DAYS TABLET STRENGTH AND NUMBER OF TABLETS PER DOSE 5 to < 8 kg (2–11 months) 20 + 160 1 x 20 mg / 160 mg tablet 8 to < 11 kg (12–23 months) 30 + 240 1½ x 20 mg / 160 mg tablet 11 to < 17 kg (2–4 years) 40 + 320 1 x 40 mg / 320 mg tablet 17 to < 25 kg (5–7 years) 60 + 480 1½ x 40 mg / 320 mg tablet 25 to < 36 kg (8–13 years) 80 + 640 2 x 40 mg / 320 mg tablet 36 to < 60 kg (≥ 14 years) 120 + 960 3 x 40 mg / 320 mg tablet 60 to < 80 kg (adults) 160 + 1280 4 x 40 mg / 320 mg tablet ≥ 80 kg (adults) 200 + 1600 5 x 40 mg / 320 mg tablet Total population: 100 000 Age distribution (based on standard age distribution for developing countries, Annex 1): • 2–11 months ≈ 4% (0–11 months = 4%) • 12–23 months = 3% • 2–4 years ≈ 9% (2–5 years) • 5–7 years ≈ 9% (5–14 years = 27%) • 8–13 years ≈ 18% (5–14 years = 27%) • ≥ 14 years ≈ 57% (≥ 15 years = 57%) Target population by age group AGE GROUP 2–11 MONTHS 12–23 MONTHS 2–4 YEARS 5–7 YEARS 8–13 YEARS ≥ 14 YEARS Percentage of total population 100 000 x 0.04 100 000 x 0.03 100 000 x 0.09 100 000 x 0.09 100 000 x 0.18 100 000 x 0.57 Total population per age group 4 000 3 000 9 000 9 000 18 000 57 000 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 69 Estimation of number of treatments (= number of blisters) per presentation REQUIREMENT DIHYDROARTEMISININ / PIPERAQUINE 20 mg / 160mg 3-tablet blister 40 mg / 320mg 3-tablet blister 40 mg / 320mg 6-tablet blister 40 mg / 320mg 9-tablet blister 40 mg / 320mg 12-tablet blister 1 round 10 000 9 000 27 000 28 500 28 500 3 rounds 30 000 27 000 81 000 85 500 85 500 25% buffer stock 7 500 6 750 20 250 21 375 21 375 Total number of treatments 37 500 33 750 101 250 106 875 106 875 The total number ordered should be adjusted according to existing stocks, back orders and other sources. 70 Annex 4 EXAMPLE OF A CHRONOGRAM FOR MASS DRUG ADMINISTRATION FOR MALARIA (DISTRIBUTION AT 8 WEEKS) DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Coordination Creation of task force and define composition Definition of roles, tasks Creation of subcommittees Task force meeting Sub-committees Meeting (National & District Levels) Written proposal of MDA Development of tools Conduct micro planning at district level Final report Antimalarial medicines Estimation of medicine needs Check existing stocks / backorders Make medicine order Reception of medicine order Stock management (cards, batch number) Distribution of medicines to district level Pre-positioning of medicines in peripheral health structures Other equipment (team supplies, data collection tools, stationary, etc.) Estimation of needs Evaluation of available resources Order necessary supplies Reception of supplies Preparation of kits M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 71 DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Distribution of supplies to district level Pre-positioning of logistic kits in peripheral health structures Logistics and transport Evaluation of needs Evaluation of available resources Order or rental of vehicles Verification and maintenance Vehicle movement plan and follow up Human resources Estimation of needs Evaluation of available personnel Selection and recruitment of missing personnel Identification of allocation of staff and supervisors Create training materials Training of trainers Training of supervisors Training of distribution teams Training of monitors Training of drug safety monitoring teams Supervision Salaries / perdiem Social mobilisation Develop communication plan Develop key messages Produce and distribute IEC material Advocacy meetings with Key actors at national level Advocacy meetings with Key actors at district level 72 DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Sensitization of specific groups at community level (traditional leaders, authorities, religious leaders, women's groups, etc.) House to house and street to street sensitization Town criers / megaphones Press briefing Monitoring of press Planning of radio and TV programming / ads Participation in radio / TV panel discussions Elaboration of radio jingles Airing of radio jingles Distribution sites (for centralised strategies only) Define number of sites needed Identification of sites Visit sites Organisation of sites for distribution (tables, chairs, etc.) Antimalarial medicine distribution Preparation of materials Checking of materials Supply during campaign Implementation of round one Implementation of round 2 Implementation of round 3 Supervision activities Monitoring and evaluation Data analysis Evaluation of distribution coverage Monitoring activities Post distribution survey M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 73 UR BA N W ES TE RN A RE A PO PU LA TI O N PE R AG E G RO UP (+ 5 % BU FF ER S TO CK ) BO X VO LU M E (M 3 ) TOTAL VOLUME No . Na m e of fa ci lit y Ty pe o f f ac ili ty O w ne r Lo ca lit y Ch ie fd om /z on e Po pu la tio n DH M T Po pu la tio n DH M T + 5% b uff er st oc k 6– 11 m (2 %) 12 –5 9 m (1 3. 7% ) 5– 13 y (2 8% ) > 14 y (5 4. 5% ) 6– 11 m (2 %) 12 –5 9 m (1 3. 7% ) 5– 13 y (2 8% ) > 14 y (5 4. 5% ) 12 W el lin gt on C H C G ov t W el lin gt on 1 34 4 60 36 18 3 72 4 49 57 10 13 1 19 7 20 0. 09 0. 60 1.2 2 3. 16 5. 05 14 Ko ya T ow n C H C G ov t U pp er W el lin gt on 1 10 0 93 10 5 98 21 2 14 52 29 67 57 76 0. 03 0. 18 0. 36 0. 93 1.4 8 16 Al le n To w n C H C G ov t Al le n To w n 1 40 16 1 42 16 9 84 3 57 77 11 8 07 22 9 82 0. 10 0. 69 1.4 2 3. 68 5. 89 19 Al -K ha ta b C lin ic C H C M is si on C al ab a To w n 1 10 5 99 11 12 9 22 3 15 25 31 16 60 65 0. 03 0. 18 0. 37 0. 97 1.5 6 20 C al ab a To w n C H C G ov t C al ab a To w n 1 20 3 30 21 3 47 42 7 29 24 59 77 11 6 34 0. 05 0. 35 0. 72 1.8 6 2. 98 22 St L uk e' s C lin ic C lin ic M is si on C on go W at er 1 17 9 51 18 8 49 37 7 25 82 52 78 10 2 72 0. 05 0. 31 0. 63 1.6 4 2. 63 34 AW AK E C lin ic Pr iv at e Al le n To w n 1 42 30 44 42 89 60 8 12 44 24 21 0. 01 0. 07 0. 15 0. 39 0. 62 41 Fa m ily H om e M ov em en t C H P M is si on U pp er C al ab a To w n 1 86 03 90 33 18 1 12 38 25 29 49 23 0. 02 0. 15 0. 30 0. 79 1.2 6 44 Ad -B an gs Q ua rr y M C H P G ov t Bl ac kh al l R oa d 1 10 0 39 10 5 41 21 1 14 44 29 51 57 45 0. 03 0. 17 0. 36 0. 92 1.4 8 48 M ay em ie M C H P G ov t M ay em ie 1 12 6 02 13 2 32 26 5 18 13 37 05 72 11 0. 03 0. 22 0. 45 1.1 5 1.8 5 54 Ph ili p St re et M C H P Pr iv at e Ph ili p St re et 1 10 6 15 11 14 6 22 3 15 27 31 21 60 74 0. 03 0. 18 0. 38 0. 97 1.5 6 63 O ld D om in io n (E PI ) H os pi ta l Pr iv at e U pp er M el lo n W el lin gt on 1 10 3 00 10 8 15 21 6 14 82 30 28 58 94 0. 03 0. 18 0. 36 0. 94 1.5 1 To ta l W es te rn A re a 1 1 41 7 38 1 1 98 8 25 23 9 76 16 4 23 9 33 5 67 16 53 3 60 13 0 67 89 5 10 18 2 94 1 35 6 08 1 7 12 2 D H M T, d ist ric t h ea lth m an ag em en t t ea m ; m = m on th s; y = ye ar s; C H C , c om m un ity h ea lth c en tre ; C H P, c om m un ity h ea lth p os t; M C H P, m at er na l a nd c hi ld he al th p os t; EP I, Ex pa nd ed P ro gr am m e on Im m un iz at io n An ne x 5 EX AM PL E O F M IC RO -P LA NN IN G IN U RB AN W ES TE RN A RE A, S IE RR A LE O NE D es cr ip tio n of e ac h he al th fa ci lit y, ta rg et p op ul at io n pe r f ac ili ty , a ge d is tr ib ut io n an d vo lu m e of m at er ia l 74 Zo ne Na m e of fa ci lit y No . To ta l p op ul at io n pe r f ac ili ty Fa m ili es p er fa ci lit y Fa m ili es /d ay Fa m ili es /d ay / te am No . o f t ea m s re qu ire d No . o f t ea m s pr op os ed No . o f t ea m su pe rv iso rs No . o f C HW s pr op os ed 1 W el lin gt on 12 34 4 60 68 92 17 23 30 57 .4 57 11 114 Ko ya To w n 14 10 0 93 20 19 50 5 30 16 .8 17 3 34 Al le n To w n/ UP AL 16 40 16 1 80 32 20 08 30 66 .9 67 13 13 4 Al -K ha ta b Cl in ic 19 10 5 99 21 20 53 0 30 17 .7 18 3 36 Ca la ba To w n CH C 20 20 3 30 40 66 10 17 30 33 .9 34 7 68 St L uk e' s C lin ic 22 17 9 51 35 90 89 8 30 29 .9 30 6 60 AW AK E Cl in ic 34 4 23 0 84 6 21 2 30 7.1 7 1 14 Fa m ily H om e M ov em en t 41 8 60 3 17 21 43 0 30 14 .3 14 3 28 Ad -B an gs Q ua rr y 44 10 0 39 20 08 50 2 30 16 .7 17 8 34 M ay em ie 48 12 6 02 25 20 63 0 30 21 .0 21 42 Ph ilip S tre et 54 10 6 15 21 23 53 1 30 17 .7 18 7 36 O ld D om in io n (E PI ) 63 10 3 00 20 60 51 5 30 17 .2 17 34 H ol y M ar y Cl in ic 64 5 80 0 116 0 29 0 30 9. 7 10 2 20 To ta l Z on e 1 30 32 7 64 65 4 Nu m be rs o f t ea m s an d hu m an re so ur ce s re qu ire d pe r c at ch m en t a re a M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 75 Re qu ire m en ts fo r m at er ia l p er te am p er c at ch m en t a re a PH U, p er ip he ra l h ea lth u ni t; AS –A Q , a rte su na te + a m od ia qu in e No. OF PHUs Number of teams proposed Clipboard (1  /  team) Pen (4  /  team) Backpack (2  /  team) Badge holder (2  /  team) Badge for CHW (2  /  team) Daily tally sheet (2  /  team and day) Daily summary form (1  /  day   /  20 teams) Supervision check-list (1  /  day   /  20 teams) CHW briefing note (2  /  supervisor) Leaflet on AS–AQ, 2 faces, laminated Stock card (20  /  PHU) Badge for supervisor (1  /  supervisor) Badge holder for supervisor Folder with clip (2 per supervisor) A5 notebook (2  /  supervisor) Blue pen (2  /  supervisor) A5 thin notebook (2  /  team) Permanent marker (1  /  5 teams) Plastic pocket for SC (1  /  supervisor) Dosage chart (1  /  family) Plastic folder for documents (1  /  team) Plastic bag (1  /  team) 12 57 57 22 8 114 114 114 45 6 12 12 4 114 20 11 11 22 22 22 114 12 11 30 57 57 14 17 17 68 34 34 34 13 6 4 4 2 34 20 3 3 6 6 6 34 4 3 30 17 17 16 67 67 26 8 13 4 13 4 13 4 53 6 14 14 4 13 4 20 13 13 26 26 26 13 4 14 13 30 67 67 19 18 18 72 36 36 36 14 4 4 4 2 36 20 3 3 6 6 6 36 4 3 30 18 18 20 34 34 13 6 68 68 68 27 2 7 7 4 68 20 7 7 14 14 14 68 7 7 30 34 34 22 30 30 80 40 40 40 16 0 4 4 2 40 20 6 6 12 12 12 40 4 6 30 20 20 34 7 7 28 14 14 14 56 2 2 2 14 20 1 1 2 2 2 14 2 1 30 7 7 41 14 14 56 28 28 28 112 4 4 2 28 20 3 3 6 6 6 28 3 3 30 14 14 44 17 17 68 34 34 34 13 6 4 4 2 34 20 8 8 16 16 16 34 4 8 30 17 17 48 21 21 84 42 42 42 16 8 5 5 2 42 42 5 30 21 21 54 18 18 72 36 36 36 14 4 4 4 2 36 20 7 7 14 14 14 36 4 7 30 18 18 63 17 17 68 34 34 34 13 6 4 4 0 34 34 4 30 17 17 64 10 10 40 20 20 20 80 2 2 0 20 20 2 2 4 4 4 20 2 2 30 10 10 … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … 68 1 8 29 1 8 29 7 31 6 3 65 8 3 65 8 3 65 8 14 6 32 38 6 38 6 14 60 36 58 13 60 73 0 73 0 14 60 14 60 14 60 3 65 8 1 8 29 73 0 2 04 0 1 8 29 1 8 29 76 Annex 6 STEP-BY-STEP PROCEDURE FOR PREPOSITIONING SUPPLIES Identify and train the person who will be responsible for following up and managing stocks at each distribution point. Deliver the material. Calculate the quantity of medicines to be dispatched to each distribution point according to the estimated target population of the catchment area by age group. Include a buffer stock. It may be advisable to keep part of the buffer stock (about half) in a central or district storage place to ensure capacity to react to unpredicted shortages. Organize all other necessary logistic material into kits to simplify distribution. The amounts per kit should be calculated according to the numbers of teams and supervisors. Calculate the volume and weight of the supplies in order to organize adequate transport. Use tracking tools, such as waybills, for transport of supplies, with details of quantities and batch numbers to ensure traceability. Upon reception of the order, the person responsible in each peripheral health facility should verify that the delivered goods correspond to those listed on the waybill before signing the receipt form. CC: Icons created by Gan Khoon Lay, BomSymbols, Symbolon, Jose Morbán, Sribala, David, BomSymbols Maxim David, ProSymbols for the Noun Project 1 4 7 2 5 3 6 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 77 Annex 7 EXAMPLE OF RADIO SPOT ON MDA FOR MALARIA (USED IN SIERRA LEONE IN 2014–2015) V1. Good morning, friend!! V2. Good morning. How are you? V1. Fine. Yesterday, I received the blister for the malaria treatment. Did you? V2. Yes. All my family and I took the first dose yesterday in the afternoon. And you? V1. No, we didn’t take it. V2. Why didn’t you take it? V1. Because nobody in the family has fever. V2. In our family nobody had fever, but we took it to prevent malaria fever because we don’t want to get sick. V1. But before we never took it when we were not sick. Why should we do it now? V2. Because now there is an EVD outbreak ongoing, so if you have fever you can become a suspect of EVD. A lot of EVD symptoms can be mistaken with malaria symptoms. (*) In any case, you and your family will be protected against malaria for 1 month and it is for free. V1: Ok, you are right. I’m going home now to start the treatment with my family. V2: Do you remember how to take it? V1: Yes. The community health worker explained to me that we have to take it during three consecutive days to finish the treatment properly. V2: Do you have any other doubt? V1: No, we are going to take the tablets according to the age category like the CHW told me. But if I have any doubt I will ask the CHW. V2: Good!!!! Have a nice day V1: You too and thank you. Now we will be malaria free!!!! *This section should be adapted to each MDA situation 78 Annex 8 EXAMPLES OF DISCUSSION POINTS ON MDA FOR USE AT COMMUNITY MEETINGS (ADAPTED FROM THOSE USED IN SIERRA LEONE IN 2014–2015) 1. What is MDA? 2. Goal of the campaign 3. The medication, how to take it and exclusion criteria The medication: How to take it Exclusion criteria (people who must NOT take it) Stick to the medicine and dosage for the age group. Wrong doses can cause: • Incomplete treatment = incomplete protection • Overdose = increase in possible side-effects 4. Possible side-effects and what to do 5. Explanation of the process 6. Roles of community leaders • ensure community awareness and acceptance of the campaign • sensitize importance of adherence (taking full treatment) • ensure awareness of correct dosage 7. Role of distributors and CHWs • sensitize community before and during MDA • distribute antimalarial tablets to target beneficiaries • tally all medicines distributed with the data collection tools 8.Team members: Two CHWs per team will be assigned by area and community. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 79 Annex 9 HOUSEHOLD VISIT FOR MDA, STEP BY STEP MASS DRUG ADMINISTRATION, VISIT STEP BY STEP Obtain oral consent to participate. Greet the people politely in local language and introduce yourselves. Ask for the head of the household and verify whether all members of the household are present.Explain the objectives and provide information about the MDA using visual aids. Check eligibility criteria - Exclusion criteria: » First trimester of pregnancy » Infants under 6 months old » Known allergy to any of the medication » Critically ill patients » Contraindications to the medicines Explain to excluded people why they don’t receive the treatment. Distribution of an appropriate blister according to age category. Administer the first dose under DOT. For small children, crush the tablet and dissolve it with water. Repeat dose if vomiting occurs within 30 minutes of administration. Educate the participants on how to take the remaining doses for day 2 and day 3 using a visual aid to support the explanations and / or printed leaflets. Provide clear messages on the need to ensure adherence to full treatment course. Provide information concerning possible side effects and what to do in case they occur. For women of reproductive age (15-49 years old): » If visibility pregnant (assume second or third trimester): she may receive the medicine » If pregnancy not apparent: first trimester pregnancy should be excluded either based on personal history or on pregnancy test. Ask the members of the household if they have any specific questions and clarify any doubts they may have. Mark the tally sheet after the person has taken the first dose and / or fill in the registration book. Thank the household members and move to the next household. Where applicable, upon departure, mark the house with chalk as either “complete”, “incomplete” and if no one is home at the time of the visit, do not mark it. Revisit the house at a later time in the day or the following day in the case that the distribution was incomplete or no one was home. 1 4 7 8 9 10 5 6 2 3 CC: Icons created by Wilson Joseph, Gregor Cresnar, Dinosoft Labs, 23 icons, Yorlmar Campos, To Uyen, Loudoun Design Co., Arthur Shlain, from the Noun Project 80 Annex 10 ALGORITHM TO ASSIST COMMUNITY HEALTH WORKERS IN APPLYING EXCLUSION CRITERIA * A list of medicines that prolong the QT interval that are available and are the most frequently used in the country should be given to the CHW. DHA-PPQ, dihydroartemisinin–piperaquine; AS-AQ, artesunate–amodiaquine Ask and observe whether the person is severely ill. Do not administer antimalarial medicine, and refer to nearest health facility. Do not administer antimalarial medicine. The person is not taking other medicine. Administer the antimalarial medicine, and advise the patient where to seek care if adverse events occur. Do not administer DHA-PPQ or AS-AQ. Do not administer AS-AQ. The person is taking medication with no known interactions. The person is taking medicine that prolongs the QT interval.* The person is taking zidovudine, efavirenz or co-trimoxazole. Follow algorithm to exclude pregnancy. Is the individual a woman of reproductive age (15–49 years old)? Ask about known allergy to the antimalarial medicine or other ACT. Ask if the person is taking any medicine and, if so, to show it to you. Yes No No No Yes Yes M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 81 Annex 11 ALGORITHM FOR DETERMINING THE PREGNANCY STATUS OF WOMEN OF REPRODUCTIVE AGE (15–49 YEARS) (BASED ON AND ADAPTED FROM ALGORITHMS USED IN MALARIA MDA IN MOZAMBIQUE BY THE CENTRO DE INVESTIGAÇÃO EM SAÚDE DE MANHIÇA) Ensure privacy and explain risk and benefits of ACT in pregnancy. AdultAdolescent Assume not pregnant trimester Report pregnancy Visibly pregnant Assume in second or third trimester. Administer ACT. Do not administer ACT. Pregnancy not apparent Positive Consider that the woman may be in the first trimester. Refuses pregnancy test Report not pregnant or does not know. Ask if menstrual periods have started Ask about pregnancy status. Negative Offer options according to risk and benefits. Offer a pregnancy test. No Yes Yes 82 Annex 12 EXAMPLE OF LAMINATED LEAFLET USED BY COMMUNITY HEALTH WORKERS IN SIERRA LEONE IN 2014-2015 TO EXPLAIN TREATMENT DOSAGE • Take the tablets ONLY according to age. • Take tablets each day for 3 consecutive days (at the same time). DAY 1 DAY 2 DAY 3 6-11 months 1 crushed baby tablet 1 crushed baby tablet 1 crushed baby tablet 1-5 years 1 young child tablet 1 young child tablet 1 young child tablet 6-13 years 1 child tablet 1 child tablet 1 child tablet Adult 2 adult tablets 2 adult tablets 2 adult tablets • For children, crush the tablet in a clean eating spoon and mix with water. • This treatment may cause temporary side effects (vomiting, headache, dizziness, skin itch) which may last for 1 or 2 hours. • This treatment protects against malaria for ONE month M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 83 An ne x 13 DA IL Y TA LL Y SH EE T – AN TI M AL AR IA M DA To ta l H ou se ho ld s vi si te d O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O T ot al : RE SI DE NC Y ST AT US RE SI DE NT VI SI TO R O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Te am N um be r . ... ... ... ... ... ... ... ... ... ... ... ... ... ... 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D ist ric t: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. 6- 11 M O NT HS 1- 5 YE AR S 6- 13 Y EA RS 14 Y EA RS A ND A BO VE Total distributed Tr ea tm en ts d is tr ib ut ed O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Total excluded C as es e xc lu de d du e to re fu sa l t o pa rt ic ip at e O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: C as es e xc lu de d du e to pr eg na nc y (1 st tr im es te r) O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: C as es e xc lu de d du e to ot he r e xc lu si on c ri te ri a O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Zo ne / Ar ea : . ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. H ea lth fa ci lit y ca tc hm en t a re a: ... ... ... Vi lla ge /n ei gh bo ur ho od : . ... ... ... ... ... ... ... . EX AM PL E O F TA LL Y SH EE T (A DA PT ED F RO M T H AT U SE D IN S IE RR A LE O NE IN 2 01 4– 20 15 ) D ai ly m on ito rin g of a nt im al ar ia l co ns um pt io n N ot e: a ge g ro up s sh ou ld b e ad ap te d to b lis te r p re se nt at io n of a nt im al ar ia l m ed ic in e us ed N am e of T ea m L ea de r . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . N am e of S up er vi so r: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. BL IS TE R PA CK NU M BE R O F BL IS TE RS R EC EI VE D NU M BE R O F BL IS TE RS R EM AI NI NG A T TH E EN D O F TH E DA Y NU M BE R O F BL IS TE RS U SE D Bl is te rs 2 -1 1 m on th s (4 .5 k g- 9 k g) Bl is te rs 1- 5 ye ar s (9 -1 8 kg ) Bl is te rs 6 -1 3 (1 8- 35 k g) Bl is te rs ≥ 14 y ea rs (> 3 5 kg ) 84 An ne x 14 EX AM PL E O F A H O US EH O LD R EG IS TR AT IO N FO RM (A DA PT ED F RO M T H E ZA M BI A M DA P RO G RA M M E D EL IV ER Y H AN D BO O K) H O US EH O LD R EG IS TR AT IO N FO RM Household Number/ID Head of household Date Name of participant Age (years) Sex (M/F) Relation to head of household Occupation (C: child, S: student, H: housewife, F: farmer U: unemployed, O: other) Residency status (P: permanent resident, T: Temporary resident, V: visitor) Resent at the time of visit (Y/N) Received treatment (Y/N) If treatment not received, state reason (R. refusal E: exclusion criteria) State reason for refusal to participate DO T Comments D1 D2 D3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15D ist ric t ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . Zo ne .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... N am e of C H W .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... H ea lth fa ci lit y ca tc hm en t a re a ... ... ... ... ... ... ... ... ... ... ... . Vi lla ge N am e .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 85 Annex 15 EXAMPLE OF SUPERVISORS’ CHECKLIST USED IN SIERRA LEONE IN 2014-2015 SIERRA LEONE HOUSE TO HOUSE MDA OF ASAQ-DECEMBER 2014 Supervisor Checklist for House to House Teams 1. Are all team members present? Y or N 2. Is any of the team members a CHW in the area? Y or N 3. How many team members were trained? Write number 4. Does the team carry a movement map / plan with them? Y or N 5. Does the team have sufficient chalk for house marking? Y or N 6. Does the team have sufficient ASAQ doses for all categories? Y or N 7. Does the team have all the recording tools? Y or N 8. Does the team record information on the correct form? Y or N 9. Does the team mark the houses before leaving? Y or N 10. Was the team supervised at least once a day by the team supervisor (in the field)? Y or N 11. Did the supervisor sign and indicate time of visit on the daily tally sheet? Y or N 13. Does the team have any problems that require immediate intervention? Y or N If Yes, explain in comments field Comments: 12. Are the teams meeting their daily target? Y or N If No, provide reason(s) and action intended: A. .......................................................................................................................... B. .......................................................................................................................... C. ......................................................................................................................... TEAM NUMBER 1 2 3 4 5 District ............................................................................... Chiefdom / Zone ............................................................. Urban: Rural: Supervisor Name ........................................................... Function ............................................................................ Date ................................................................................... INSTRUCTIONS Use this form to supervise distribution of ASAQ teams during Mass drug administration implementation. Take corrective actions as needed. Give feedback to team after supervision. Thank and encourage the teams. Household Number/ID Head of household Date Name of participant Age (years) Sex (M/F) Relation to head of household Occupation (C: child, S: student, H: housewife, F: farmer U: unemployed, O: other) Residency status (P: permanent resident, T: Temporary resident, V: visitor) Resent at the time of visit (Y/N) Received treatment (Y/N) If treatment not received, state reason (R. refusal E: exclusion criteria) State reason for refusal to participate DO T Comments D1 D2 D3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 86 Annex 16 EXAMPLE OF MDA CARD MALARIA MDA CARD FOR PARTICIPANT DATE TREATMENT PROVIDED NUMBER OF TABLETS DOT (Y / N) OBSERVATIONS ROUND 1 D1 D2 D3 ROUND 2 D1 D2 D3 ROUND 3 D1 D2 D3 District ............................................................................... Name ................................................................................. Adress ................................................................................ Health Center .................................................................. Age ..................................................................................... Weight ............................................................................... M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 87 Annex 17 EXAMPLE OF DAILY SUMMARY SHEET TO BE COMPLETED BY DISTRIBUTION TEAM SUPERVISORS (ADAPTED FROM THAT USED IN SIERRA LEONE IN 2014–2015) DAILY SUMMARY SHEET - MALARIA MDA Note: age groups should be adapted to blister presentation of antimalarial medicine used Supervisor ........................................................................ Date ................................................................................... Day of campaign .......................................................... District ............................................................................... Zone/area ........................................................................ Health facility catchment area .................................. Resident status 6 to 11 months 1 to 5 years 6 to 13 years 14 years and above TE AM N UM BE R NU M BE R O F HO US EH O LD S VI SI TE D RE SI DE NT S VI SI TO RS TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O P RE G NA NC Y 1S T TR IM ES TE R EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O P RE G NA NC Y 1S T TR IM ES TE R EX CL UD ED D UE T O O TH ER E XC LU SI O NC RI TE RI A TOTAL 88 An ne x 18 EX AM PL E O F DA TA BA SE F O R DA TA C O M PI LA TI O N (U SE D IN S IE RR A LE O NE IN 2 01 4– 20 15 ) DA IL Y SU M M AR Y RE PO RT IN G F O RM D ist ric t… …… …… …… …. . W AR NI NG ! O NL Y CO M PL ET E BL AN K CE LL S! !! D at e: … …… …… …… …. . IN FA NT 6 -1 1 M O NT HS TO DD LE R 1- 4 YE AR S PHU NUMBER NAME OF CHIEFDOM/ZONE NAME OF PHU CATCHMENT AREA TOTAL NUMBER OF HOUSEHOLDS TO BE VISITED FOR THE ENTIRE CAMPAIGN (TARGET) NUMBER OF HOUSEHOLDS (ACTUAL RESULT) % HOUSEHOLD COVERED % HOUSEHOLD COVERED TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! To ta l 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 89 AD O LE SC EN T 5- 14 Y EA RS AD UL TS 14 Y EA RS A ND A BO VE G RA ND T O TA L TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TOTAL TARGET POPULATION TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL % ASAQ DISTRIBUTED (COVERAGE) 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 90 Annex 19 EXAMPLE OF STANDARD TEMPLATE FOR REPORTING A SUSPECTED ADVERSE DRUG REACTION PATIENT DETAILS Name .......................................................................... Date of report: .......................................................... Age ................................ Sex ................................. Weight (kg) ................................................................. Address: ................................................................................................................................................................................. Pregnant: Yes No If yes, trimester of pregnancy .......................................................................................................................................... Hospital or treatment centre ........................................................................................................................................... Relevant medical history .................................................................................................................................................. ................................................................................................................................................................................................... SUSPECTED DRUG OR PRODUCT Brand name ................................ Strength ....................................... Generic name ............................. Name of manufacturer ............................................. Daily dose .................................................................. Date of manufacture ................. Expiry date .................................. Batch number ............................. Starting date of medication ..................................... Route of administration ............................................ Drug discontinued because of event: Yes No Date .............................................. DRUGS OR PRODUCTS TAKEN CONCOMITANTLY (INCLUDING HERBAL MEDICATION) Specify brand and generic name, dosage, route, day started, day stopped ................................................................................................................................................................................................... ................................................................................................................................................................................................... M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 91 ADVERSE REACTION Details of the reaction experienced by the patient: ................................................................................................................................................................................................... ................................................................................................................................................................................................... ................................................................................................................................................................................................... Date and time the reaction started ........................ Date and time the reaction ended ......................... Did patient require hospital admission? Yes No Duration of hospitalization ............................... Reason for reporting Requires or prolongs hospitalization Permanently disabling or incapacitating Other (please specify) .................................................................................................................................................. CONDITION OR OUTCOME AT TIME OF LATEST OBSERVATION Full recovery Ongoing illness Persistent, significant disability, incapacity Other (please specify) .................................................................................................................................................. DETAILS OF HEALTH CARE PROFESSIONAL OR REPORTER Life threatening Congenital anomaly Death Overdose Name ................................................................................. Adress ................................................................................ Signature .......................................................................... Function. ........................................................................... Telephone number ........................................................ Institution .......................................................................... 92 GUIDELINES FOR FILLING IN THE FORM An adverse event is “serious” if it • is life threatening • results in hospitalization • prolongs hospitalization • causes malignancy • is an overdose resulting in clinically relevant signs and symptoms • results in permanent disability • is fatal • causes a birth defect • causes relevant organ toxicity An adverse drug may be a manifestation of: • complications of an underlying disease • coincidental accident • concomitant medication • intercurrent disease • drug-associated effect M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 93 Annex 20 EXAMPLE OF QUESTIONNAIRE FOR POST-MDA SURVEY The following questions should be asked of each person over 6 months of age (parent or guardian of children). A. SOCIODEMOGRAPHICS 1) Age (years) ........................................................................................................................................................................ 2) Sex: Male Female 3) Status of residence in the household: Permanent Temporary visitor 4) Marital status: Single Married Widower or widow Divorced or separated Uncertain or no response 5) Level of education completed: None Primary level Secondary level Tertiary level (college or university degree) Uncertain or no response 6) Occupation: Student Farmer Herdsman Merchant or trader Village ............................................................................... Household no. ................................................................. Interviewer’s name ....................................................... Cluster no. ........................................................................ Survey date ..................................................................... Supervisors’ names ....................................................... 94 Constructor Driver Professional or civil servant Labourer (daily, seasonal or long-term) Retired or too old to work None or unemployed Uncertain or no response Other. Specify: ................................................................................................................................................................ B. INFORMATION ON MDA CAMPAIGN 1) Were you informed about the malaria MDA campaign? Yes No Uncertain or no response 2) Did you receive the malaria medication during the campaign? Yes No Uncertain or no response If yes, go to question 4. 3) Why didn’t you receive the medicines? I was travelling or I was not in town I was too busy to wait for the distributors or to go to the distribution site I do not trust the organizers of the campaign or the ministry of health Malaria is not a problem for me I never take any medicine I only take traditional medicine I did not know what the medicine was for I was pregnant I was taking other medicine at the time I was too sick I am allergic to the medicine Other. Specify ................................................................................................................................................................. Uncertain or no response Questionnaire ends here. 4) Did the person who gave you the medicine watch you take the first dose? Yes No Uncertain or no response M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 95 5) Did the person who gave you the medicine explain to you how to take the next doses? Yes No Uncertain or no response If no, go to question 7. 6) Tell us how she or he explained how to take the medicine. Correctly Incorrectly Uncertain or no response The interviewer should mark “correctly” or “incorrectly” according to the interviewee’s explanation. 7) How many doses of the medicine given by the distributor did you take? None 1 dose 2 doses 3 doses Uncertain or no answer 8) Can you show us evidence that you completed the treatment (empty blister or pill count)? Yes No 9) Did you take the complete treatment as recommended? Yes No Uncertain or no response If yes, go to question 11. 10) Why didn’t you take the treatment as recommended by the distributor? I forgot to take the medicine. I did not want to take it. Reason: I was too sick I saved the tablets for when I get sick I gave the treatment to or shared the treatment with someone else I was afraid of side-effects of the medicine I was told by a family member or friend not to take it I was told by a health professional not to take it Other people became sick after taking the medicine The medicine tastes disgusting Other, specify ................................................................................................................................................................. Uncertain or no answer 11) Did you experience any side-effects after taking the medicine? Yes No Uncertain or no response If no, end of questionnaire. 96 12) Which side-effects did you have? (More than one answer possible) : 13) How long after taking the tablets did you experience the side-effect? Less than 30 min Between 30 min and 1 h Between 1 h and 24 h Other. Specify ................................................................................................................................................................ 14) How did you manage the side-effect? I did nothing I took some medicine I visited a health professional or health facility Uncertain or no answer 15) Did you know of any emergency centre or hotline to call in case of side-effects? Yes No Uncertain or no response If no, end of questionnaire. 16) Did you call the emergency centre or hotline for help? Yes No Uncertain or no answer Loss of appetite Headache Weakness Other, specify ............................................................. Skin reaction Abdominal pain Nausea and / or vomiting Diarrhoea Dizziness Difficulty in sleeping Drowsiness Heart palpitations M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 97 Annex 21 EXAMPLE OF PHARMACOVIGILANCE PREPAREDNESS CHECKLIST (USED IN SIERRA LEONE IN 2014–2015) Instructions This is a working document. Start using it now by ticking (√ ) those items that have been accomplished. District: .................................................................................................................................................................................... Chiefdom ............................................................................................................................................................................... Facility .................................................................................................................................................................................... SUBJECT COMPLETED COMMENTS Staff 1. Is at least one person aware of pharmacovigilance monitoring during the artesunate–amodiaquine campaign? 2. Have all staff been apprised of the basics of pharmacovigilance monitoring? 3. Have all staff been trained in recognizing ADRs? 4. Do all staff know the correct dose of artesunate–amodiaquine 5. Is a plan in place to cover hard-to-reach areas? 5. Is there a map of the catchment area? 5. Are there adequate quantities of the following (Assess quantities supplied against target population) artesunate–amodiaquine oral rehydration salts paracetamol chlorphenamine Advocacy and social mobilization 1. Has there been a health talk in the community about compliance and adherence to artesunate–amodiaquine? 2. Is information available at the public health unit about ADR monitoring? Name of person completing the checklist ................................................................................................................... Signature ......................................................................... Date .................................................................................. 98 Annex 22 EXAMPLE OF AN MDA PHARMACOVIGILANCE TRAINING MODULE CURRICULUM FOR DRUG DISPENSERS The curriculum is divided into four modules, based on the chronology and structure of the WHO–ISOP curriculum (1). The content should be adapted to the pharmacovigilance requirements in the country and opportunities taken to integrate it with other training sessions for drug dispensers. Introduction The curriculum is based on several packages of topics and concepts of PV teaching used by WHO and WHO collaborating centres (2). It was designed for programmes of seasonal malaria chemoprevention and adapted for use in malaria MDA. Purpose of the course The aim of the course is to enable health workers and drug dispensers to detect, report and follow-up on suspected adverse drug reactions during malaria MDA. Target group The course is designed for drug dispensers involved in MDA, who may have very have limited medical knowledge but are present in the community at the time of the operation. They interact directly with all household members when administering the first dose, dispense and counsel carers on administering the remaining doses and provide advice on possible adverse drug reactions and where to report them. They should be able to refer people with serious adverse events and report them. Course duration The material is designed to be covered in 1 day. Sections can be reduced and prioritized if training time is limited. Course content Module one: What are adverse drug reactions and why should we monitor them? • Importance of adverse drug reactions in the context of MDA Module two: Adverse drug reactions and medication errors • Serious adverse drug reactions • Adverse events associated with medicines and concomitant medication • Administration of medicines in MDA, medication errors and their consequences, particularly over-dosing M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 99 Module three: Reporting suspected adverse reactions • Completion and use of reports and referral notes Module four: Communication • Effective communication with patients and health professionals • Managing rumours at community level References 1. Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ et al. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf. 2014;37:743–59. 2. §ISoP – PV curriculum – search. London: International Society of Pharmacovigilance; 2017 (http://isoponline.org/pv-links/, accessed 17 August 2017).

For further information please contact: Global Malaria Programme World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Email: infogmp@who.int ISBN 978-92-4-151310-4

Mass drug administration for falciparum malaria A practical field manual

Mass drug administration for falciparum malaria A practical field manual ii Mass drug administration for falciparum malaria: a practical field manual ISBN 978-92-4-151310-4 (electronic version) ISBN 978-92-4-000773-4 (print version) © World Health Organization 2017 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 disclaimer 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. Mass drug administration for falciparum malaria: a practical field manual. Geneva: World Health Organization; 2017. 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. Contents Acknowledgements vii Abbreviations and acronyms viii Executive summary ix 1. INTRODUCTION 1 1.1 Background 1 1.2 Definitions 1 1.3 Objective 1 1.4 WHO recommendations 2 2. ORGANIZATION AND IMPLEMENTATION OF MASS DRUG ADMINISTRATION 3 2.1 Design phase (macroplanning) 3 2.1.1 Identify agencies to support the ministry of health 3 2.1.2 Establish a task force or coordinating committee 4 2.1.3 Conduct a context analysis 6 2.1.4 Determine the target population and geographical areas 7 2.1.5 Choose the antimalarial medicine 10 2.1.6 Estimate the requirement for antimalarial medicine, and order it 13 2.1.7 Determine the delivery strategy 13 2.1.8 Determine the period of intervention 14 2.1.9 Determine the number of rounds 15 2.1.10 Establish a chronogram 17 2.1.11 Draw up a budget 17 2.2 Planning and preparation 18 2.2.1 Micro-planning 18 2.2.2 Logistics 20 2.2.3 Human resources 22 2.2.4 Community engagement, social mobilization and communication 26 2.3 Implementation 32 2.3.1 Stock management 32 2.3.2 Distribution of antimalarial medicine 34 2.3.3 Supervision 37 2.3.4 Data collection 39 iii 2.3.5 Coordination 42 2.3.6 Treatment of malaria cases after mass drug administration 43 3. MONITORING AND EVALUATION 44 3.1 Monitoring system 44 3.2 Estimate of coverage 44 3.2.1 Distribution coverage 44 3.2.2 Post-MDA campaign survey 46 3.3 Monitoring consumption 46 3.4 Pharmacovigilance 47 3.4.1 Definitions 48 3.4.2 Safety communication 49 3.4.3 Surveillance of adverse drug reactions 49 3.5 Monitoring drug resistance 50 3.6 Evaluating impact 51 4. REPORTING 53 5. KEY STEPS IN A MASS DRUG ADMINISTRATION CAMPAIGN FOR MALARIA 55 REFERENCES 56 ANNEXES 59 Annex 1 - Standard distribution of populations in a developing country 59 Annex 2 - Available artemisinin-based combination therapy: dosing, formulation and presentation 60 Annex 3 - Example of calculation of orders for antimalarial medicine 66 Annex 4 - Example of a chronogram for mass drug administration for malaria (distribution at 8 weeks) 69 Annex 5 - Example of micro-planning in urban Western Area, Sierra Leone 72 Annex 6 - Step-by-step procedure for prepositioning supplies 75 Annex 7 - Example of radio spot on MDA for malaria (used in Sierra Leone in 2014–2015) 76 Annex 8 - Examples of discussion points on MDA for use at community meetings (adapted from those used in Sierra Leone in 2014–2015) 77 iv Annex 9 - Household visit for MDA, step by step 78 Annex 10 - Algorithm to assist community health workers in applying exclusion criteria 79 Annex 11 - Algorithm for determining the pregnancy status of women of reproductive age (15–49 years) (based on and adapted from algorithms used in malaria MDA in Mozambique by the Centro de Investigação em Saúde de Manhiça) 80 Annex 12 - Example of laminated leaflet used by community health workers in Sierra Leone in 2014-2015 to explain treatment dosage 81 Annex 13 - Example of tally sheet (adapted from that used in Sierra Leone in 2014–2015) 82 Annex 14 - Example of a household registration form (adapted from the Zambia MDA programme delivery handbook) 83 Annex 15 - Example of supervisors’ checklist used in Sierra Leone in 2014-2015 84 Annex 16 - Example of MDA Card 85 Annex 17 - Example of daily summary sheet to be completed by distribution team supervisors (adapted from that used in Sierra Leone in 2014–2015) 86 Annex 18 - Example of database for data compilation (used in Sierra Leone in 2014–2015) 87 Annex 19 - Example of standard template for reporting a suspected adverse drug reaction 89 Annex 20 - Example of questionnaire for post-MDA survey 92 Annex 21 - Example of pharmacovigilance preparedness checklist (used in Sierra Leone in 2014–2015) 96 Annex 22 - Example of an MDA pharmacovigilance training module 97 v

M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL vii Acknowledgements This operational manual on mass drug administration (MDA) for malaria is based on practical field experience in the great majority of MDA operations that have been completed over the past 10 years in malaria-endemic countries. The main author was Dr Carolina Nanclares (Médecins Sans Frontières, Spain), who prepared an excellent first draft and finalized it after careful consideration of the suggestions of multiple reviewers. Dr Nanclares based the first draft on experience and lessons learnt during widescale MDA in Sierra Leone during the epidemic of Ebola virus disease, completed in 2014–2015. The following colleagues from MSF Spain who participated in that campaign provided input on the first draft: Jonathan Caplan, Fernanda Falero, Adriana Ferracin Kleivan, Segimon Garcia, Maria Green, Yves Houedakor, Cristina Imaz, Nines Lima and Charlotte Oliveira. The WHO Global Malaria Programme then convened a drafting committee consisting of technical resource officers who contributed to control of malaria by MDA and research in: Cambodia, Comoros, Mozambique, Myanmar, Sierra Leone, Thailand, Viet Nam and Zambia. The first draft was sent by email to all the invited participants one month before the meeting, and all input received before the meeting was included in the second version, which was used as the basis of the work of the drafting committee. The meeting was held on 22–23 November 2016 in Geneva, where the members of the committee (listed below) were divided into four working groups to review and finalize the practical aspects of the different sections of the manual. During the last session of the meeting, the groups presented their conclusions in plenary, bringing to resolution the points that required consensus. Dr Nanclares, as rapporteur of the meeting, then compiled a third version that included all the input from the four working groups, which was circulated to all participants by email for final review. The text of the manual is the result of a fourth round of reviews by members of the drafting committee and the WHO Secretariat. We are very grateful to the following members of the drafting committee, who graciously reviewed all the sections of the report in several rounds, providing substantive comments that were instrumental for its finalization and improvement: Gilles Delmas (Mahidol-Oxford Tropical Medicine Research unit, Thailand), Stephan Duparc (Medicines for Malaria Venture, Switzerland), Busiku Hamainza (National Malaria Control Centre, Zambia), James Heaton (Mahidol-Oxford Tropical Medicine Research unit, Myanmar), Umu Jalloh (Pharmacy Board, Sierra Leone), Anitta Renitta Yokoe Kamara (National Malaria Control Programme, Ministry of Health and Sanitation, Sierra Leone), Calveston Machila (District Medical Office, Zambia), Joseph Mberikunashe (National Malaria Programme Control, Zimbabwe), Thuy-Nhien Thanh Nguyen (Centre for Tropical Medicine, Viet Nam), Francisco Saute (Manhiça Health Research Center, Mozambique), Jianping Song (Guangzhou University of Chinese Medicine, China) and Khieu Virak (National Centre for Parasitology, Entomoloy and Malaria Control, Cambodia). The draft manual also received input from the WHO Malaria Policy Advisory Committee at its session on 22–24 March 2017, which, with additional suggestions from the WHO Secretariat at the Global Malaria Programme, were taken into account in the final version of the document. At WHO, Andrea Bosman, Global Malaria Programme, coordinated preparation of the manual and represented the WHO Secretariat in the the drafting committee. Precious contributions were also made by Dr Maru Aregawi, Peter Olumese and Silvia Schwarte, Global Malaria Programme, and by Prabhjot Singh, WHO Regional Office for the Americas. Funding for the production of this report was provided the Bill & Melinda Gates Foundation. viii Abbreviations and acronyms ACT artemisinin-based combination therapy ADR adverse drug reaction CHW community health workers DOT directly observed treatment EVD Ebola virus disease G6PD glucose-6-phosphate dehydrogenase MDA mass drug administration M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL ix Executive summary Mass drug administration (MDA) consists of administering a full therapeutic course of antimalarial medicine (irrespective of the presence of symptoms or infection) to a defined population living in a defined geographical area (except for those for whom the medicine is contraindicated) at approximately the same time and often repeated at intervals. Recent progress in malaria control, including the use of others forms of preventive chemotherapy such as intermittent prevent treatment of malaria in pregnancy and seasonal malaria chemoprevention, the drive towards elimination of malaria in some settings and the availability of new antimalarial medicines, has renewed interest in the role that MDA can play in some settings. MDA should be viewed as a time-limited intervention with specific targets for when it should be discontinued, defined before implementation. Currently, on the basis of the evidence, WHO recommends MDA: • for interruption of transmission of falciparum malaria in areas approaching elimination, • to reduce the risk for spread of multi-drug resistance in the Greater Mekong subregion, • during malaria epidemics and • in exceptional complex emergencies. WHO recommends use of MDA for falciparum malaria, with two distinct, complementary objectives. The first is to reduce transmission of malaria, which is the primary aim of elimination and reduction of multi-drug resistance and is also relevant in malaria epidemics and complex emergencies. The objective is to quickly reduce the parasite biomass in a community and to prevent new infections for a certain period. Repeated rounds of MDA are given to remove parasites and prevent new infections in persons who were not reached in previous rounds. The expected result is a large reduction in transmission intensity. Synchronization of the intervention with high coverage of the entire population at risk is essential. In order quickly to reduce and potentially entirely interrupt transmission and avoid resurgence, several rounds are required, in combination with other malaria control tools and strategies such as effective vector control, access to prompt diagnosis and treatment and intensified surveillance. The second objective of MDA for falciparum malaria is rapid reduction of morbidity and mortality. This is a primary aim when falciparum transmission results in high mortality rates, as in epidemics and complex emergencies when health systems are overwhelmed and unable to provide core malaria preventive and curative services. In these settings, MDA is used as an initial emergency measure; several rounds are implemented while access to case management and vector control are being put in place. It is important to identify the population at risk for severe malaria and death in order to define the target groups for MDA. These may be either an entire population or specific vulnerable groups who are at high risk for mortality because of lack of vector control and access to effective case management. High coverage of such target populations is more important than synchronization, as the primary aim is to reduce morbidity and mortality in the target population and not to reduce malaria transmission. For MDA to be successful, high coverage and adherence of the target population (i.e. > 80%) must be ensured, which require a high level of community engagement and participation. Implementation strategies should therefore guarantee the highest level of participation possible. Door-to-door distribution is generally preferred to centralized distribution at a fixed site, and directly observed treatment (DOT), where feasible, is the best way to ensure adherence to treatment. xImplementing MDA for malaria is a complex, logistically challenging operation, which requires significant investments of resources (human, financial and logistic) as well as careful planning and organization. The intent of this manual is to provide technical and operational guidance on the practical aspects of organizing a successful MDA campaign for malaria. The main steps for efficient management are listed below. Design phase In this phase, the main strategies for MDA are established at national level: • Obtain commitment from policy-makers, and identify agencies to support the ministry of health. • Establish a task force or coordinating committee. • Conduct a context analysis. • Decide to implement MDA for falciparum malaria. • Define target areas and target population. • Choose the antimalarial medicine. • Estimate the requirements for the medicine, and procure it. • Determine the MDA strategy. • Estimate the budget. Planning and preparation phase This phase involves planning the operational aspects of the framework defined at national level: • Conduct micro-planning at province or district level according to the strategies defined by the national task force to guarantee an effective campaign by ensuring adequate distribution of supplies, training of staff, engagement of the community and proper management of resources. The micro-plan should include: - demographic information on the province or districts eligible for MDA; - information on the area (e.g. maps, infrastructure, location of health facilities, hard-to-reach areas); - timing of MDA in the district; - delivery strategies; - human resources (number required, number available) and training plan; - logistical information; - social mobilization and communications plan; and - pharmacovigilance plan. • Ensure effective logistics, taking into consideration: - procurement, storage and distribution of antimalarial medication; - procurement, storage and distribution of other supplies necessary for MDA; - transport; - accessibility to the entire target population, including those in hard-to-reach areas; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL xi - identification and preparation of distribution sites; and - waste management. • Plan human and financial resources: - number of teams required and composition, - training and - adequate payment of salaries and per diem. • Plan community engagement and social mobilization by - defining the roles and responsibilities of all partners; - assessing communities to understand the characteristics and social dynamics of the target population in order to orient the social mobilization plan; - preparing clear, simple, precise, consistent messages about MDA for malaria; - engaging the mass media by building relationships with local media representatives and diseminating information through the different media; - preparing to address negative rumours that may arise during the campaign, which could affect participation; and - Involving community leaders and other influential people in planning, so they will feel ownership of the campaign and its success. Implementation phase The implementation phase involves the actual distribution of antimalarial treatment and includes: • stock management: preparation of distribution kits with all the necessary materials ahead of time at the distribution point or peripheral health facility at which supplies are prepositioned; • distribution of the antimalarial medicine itself, either door to door or at a centralized, fixed site; • supervision, an essential component to ensure the quality of the campaign: at peripheral, district, regional and national levels; • data collection: collection and reporting of information on the number of people who receive treatment at community level, adverse drug reactions (ADRs) and analysis and compilation of data at higher levels through a well-established pathway of information flow; and • coordination of all actors to monitor activities, detect any difficulties or constraints, address them and react to unforeseen events. Monitoring and evaluation • intra-campaign monitoring system: a high-quality system for monitoring the campaign allows identification of constraints that require immediate action; can be done by monitors identified within the team or by independent monitors; • estimate of distribution coverage: the proportion of the target population that has been reached by distribution; • post-MDA survey: recommended, if feasible, after each round or at least at the end of the entire campaign to obtain more reliable information on coverage and to evaluate adherence to treatment, determine reasons for non-participation or non-adherence and evaluate the presentation of ADRs; xii • monitoring consumption: daily monitoring of the number of treatments distributed and the number taken; • pharmacovigilance: a vital component of an MDA, which should be planned to ensure training, detection, reporting, management of follow-up of adverse events and to promote and monitor adherence by both passive and active surveillance. This component is also essential to obtain and maintain good understanding and compliance of the population; • monitoring drug resistance: one of the main concerns with regard to MDA is the emergence and spread of drug resistance; although there is no evidence that MDA of artemisinin-based combined therapy (ACT) at therapeutic doses is related to the emergence of resistance, monitoring of resistance should be an essential component of an MDA campaign; • evaluation of impact: through routine surveillance and parasitological surveys to support a decision to stop; and • reporting: after each round and at the end of the intervention, of the coverage achieved, challenges and difficulties faced and solutions found, lessons learnt, practices with good results, effective social mobilization activities, useful tools and the costs of the intervention. In epidemics and complex emergencies, a minimum set of MDA monitoring and evaluation activities should be defined in order to document impact and for reporting. Although these steps are common to all settings, MDA for the purposes of reducing transmission of malaria or its elimination, for containing resistance, in response to an epidemic or in the event of a complex emergency may differ in ways outlined below in the corresponding sections. This manual is intended to provide general guidance. Some sections may not be relevant in all contexts and should be adapted to local circumstances (for instance, urban or rural settings). The manual also provides templates and examples from previous experience with MDA for malaria in various contexts that may be useful for developing training material or data collection. The majority of the tools are included in the annexes to this manual. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 1 1. INTRODUCTION 1.1 BACKGROUND Mass drug administration (MDA) has played a crucial role in the control and elimination of a number of prevalent neglected tropical diseases. The aim of the programmes has been to treat prevalent infection and to reduce transmission in the population simultaneously, hence decreasing the burden of the disease (1,2). Since the 1970s, MDA was not recommended as an anti-malaria intervention because of concern about its efficacy, especially the sustainability of the results, the logistical feasibility and the risk for accelerating drug resistance (3–5). Recent progress in malaria control, including the use of others forms of preventive chemotherapy, such as intermittent preventive treatment of malaria in pregnancy and seasonal malaria chemoprevention, together with the drive towards elimination of malaria in some settings and the availability of new antimalarial medicines, have renewed interest in the role that MDA can play in some settings (3,4,6,7), for example as part of work to contain multi- drug resistance and eliminate malaria transmission in the Greater Mekong subregion (8,9) and in certain complex emergencies, such as the 2013-2016 outbreak of Ebola virus disease (EVD) in West Africa (9–12). 1.2 DEFINITIONS Mass drug administration consists of the administration of a full therapeutic course of antimalarial medicine (irrespective of the presence of symptoms or infection) to every member of a defined population or person living in a defined geographical area (except for those for which the medicine is contraindicated) at approximately the same time and often at repeated intervals. (3,9). In order for MDA to be successful, a very high proportion, generally more than 80% of the targeted population must be reached during the campaign, depending on the intensity of transmission and the exact objective of the campaign (4,6,9,13,14). This requires a high level of community participation and engagement. It is not enough to reach the majority of the population with distribution: coverage will be effective only if the number of people in the community who correctly complete the full course of antimalarial treatment is adequate. To achieve this, the population must accept the intervention and be willing to take the medicine as prescribed. 1.3 OBJECTIVE The objective of malaria MDA is to provide therapeutic doses of antimalarial medicine to as large a proportion of the population as possible in order to cure all symptomatic and asymptomatic malaria infections at the time of the intervention and to prevent reinfection during the period of post-treatment prophylaxis. MDA at high coverage rapidly reduces the prevalence and incidence of malaria in the short term. Once MDA is stopped, however, malaria endemicity will return to its original level if importation of malaria is not prevented, in the absence of high coverage with other interventions such as vector control, case management, surveillance and response. The risk of such a return and the rapidity with which it occurs depend on the size of the residual parasite reservoir in humans, the rate of importation of new infections and the capacity of the vectors to transmit malaria in the target area. 21.4 WHO RECOMMENDATIONS On the basis of a recent review of the evidence (9) and the advice of the WHO Malaria Policy Advisory Committee, the current WHO recommendations for use of MDA, mass screening and treatment and focal screening and treatment for malaria (15) are listed below. 1. Use of MDA for the elimination of P. falciparum malaria can be considered in areas approaching interruption of transmission where there is good access to treatment, effective implementation of vector control and surveillance, and a minimal risk of re-introduction of infection. 2. Given the threat of multidrug resistance and the WHO call for malaria elimination in the Greater Mekong subregion (GMS), MDA may be considered as a component of accelerated malaria elimination efforts in areas of the GMS with good access to treatment, vector control and surveillance. 3. Use of Time-limited MDA to rapidly reduce malaria morbidity and mortality may be considered for epidemic control as part of the initial response, along with the urgent introduction of other interventions. 4. Use of Time-limited MDA to reduce malaria morbidity and mortality may be considered in complex emergencies, during exceptional circumstances when the health system is overwhelmed and unable to serve the affected communities. 5. In the absence of sufficient evidence, WHO does not recommend the use of MDA in situations other than for areas approaching elimination, epidemics, and complex emergencies, as specified above (see 1-4). 6. Mass primaquine prophylactic treatment, requiring pre-seasonal MDA with daily administration of primaquine for two weeks without G6PD testing, is not recommended for the interruption of vivax transmission. 7. Mass screening and treatment and focal screening and treatment for malaria are not recommended as interventions to interrupt malaria transmission. 8. Medicines used for MDA must be of proven efficacy in the implementation area and preferably have a long half-life. WHO recommends that a medicine different from that used for first-line treatment be used for MDA. Programmes should include monitoring of efficacy, safety and the potential emergence of resistance to the antimalarial medicines deployed for MDA. 9. WHO supports the need for mowre research on the optimum methods of implementing MDA programmes, promoting community participation and compliance with treatment, and evaluating their effectiveness. Modelling can help guide the optimum method of administering MDA in different epidemiological circumstances and predict its likely impact. In line with the above recommendations, this manual addresses use of MDA only for the control and elimination of falciparum malaria. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 3 2. ORGANIZATION AND IMPLEMENTATION OF MASS DRUG ADMINISTRATION 2.1 DESIGN PHASE (MACROPLANNING) Once it has been decided that MDA will be conducted, macroplanning should be started. This initial design phase, done at national level, is important to ensure a successful campaign and should involve the ministry of health and other key stakeholders. When MDA for malaria is done to impact on malaria transmission, the administration of antimalarial medicine must be done in such a way that all targeted individuals are treated in a synchronized manner and each round is completed in a very short time, generally not more than one week. In complex emergencies, when the main objective is rapid reduction of malaria morbidity and mortality, synchronous administration is less critical. Steps of the design phase: • Obtain commitment from policy-makers, and identify agencies to support the ministry of health. • Establish a task force or coordinating committee. • Conduct a context analysis. • Decide to implement MDA for falciparum malaria. • Define the target areas and target population. • Choose the medicine. • Estimate the requirements for the medicine and procure it. • Determine the delivery strategy (including period of intervention and number of rounds). • Estimate the budget. • Define the criteria for stopping MDA. As MDA targets every individual in a given population (except those with contraindications to the medicines used), it may be combined with other public health interventions, such as health education, deworming and distribution of long-lasting insecticide-treated nets; however, experience in combining multiple medicines or programmes is limited, and careful consideration should be given in advance. 2.1.1 Identify agencies to support the ministry of health MDA for malaria is a logistically challenging intervention, which will require careful planning and significant resources in order to be successful. Therefore, partners that can provide technical, financial and operational support should be identified and included in planning from the initial stages. The partners may be national (national and local government, the private sector, nongovernmental organizations, other civil society organizations, the media, community leaders, religious leaders) or international (funding agencies, procurement agencies and international nongovernmental organizations). Mapping donors and implementing partners is critical to the success of MDA. All should be encouraged to work within the framework of the “three ones” – one plan, one coordination and one monitoring and evaluation – under the oversight of the task force or coordinating committee. 4As MDA usually comprises multiple rounds for high coverage and, if the purpose is to interrupt transmission or elimination, may be repeated in subsequent years, it is therefore important to secure sustained support to ensure satisfactory completion of the intervention. Malaria services should be in place and supported in monitoring communities in the long term after the MDA has been completed. 2.1.2 Establish a task force or coordinating committee A task force or coordinating committee, under the stewardship of the Ministry of Health, must be created with representation from national, regional and target district level to serve as an oversight body in charge of implementation of the MDA campaign and ensure adequate allocation of resources. Composition The committee may include representatives from: • the national malaria control programme; • other relevant entities of the ministry of health, for example medicines, community health, neglected tropical diseases or other programmes with experience in MDA; • national research institutions; • the national medicines regulatory authority; • the national pharmacovigilance centre; • national, regional and relevant district health authorities; • technical personnel from relevant hospitals; • administrative authorities; • support agencies (the United Nation Children’s Fund, WHO, other United Nations agencies, nongovernmental organizations); • other concerned ministries; • local representatives of civil society; and • the private sector. A campaign will be successful only with close collaboration and coordination among partners. All of them should agree and, if possible, sign a formal agreement that describes the tasks and responsibilities of each. If MDA is used in an emergency, decisions will have to be made quickly. In order to avoid delay in trying to reach consensus among different agencies on any conflicting issues, a defined decision-making authority (normally the ministry of health) should be identified that will be responsible for taking rapid decisions if necessary. Responsibilities of the committee The committee will be responsible for: • agree whether MDA is appropriate to reduce transmission and / or morbidity and mortality • preparing strategic guidance for MDA implementation and preparing a plan of action; • mobilizing the necessary human and financial resources; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 5 • coordinating partners and sharing information; • identifying the target population and target geographical areas (section 2.1.4); • establishing the chronogram (section 2.1.10); • preparing, reviewing, adapting and updating guidelines and training materials; • developing data collection and monitoring tools (section 2.3.4); • drawing up the social mobilization and community engagement plan (section 2.2.4); • ensuring a functioning drug safety monitoring system (strengthening any existing pharmacovigilance body or establishing one) to guarantee effective detection, management and reporting of adverse events related to administration of the antimalarial medicine and access to consultation and hospitalization, including any necessary rescue medication, free of cost (section 3.4); • establishing monitoring and evaluation, determining objectives and methods and defining indicators (section 3); • ensuring comprehensive malaria control activities are implemented in the context of elimination: diagnosis and treatment, vector control and detection and investigation of all cases; • planning additional malaria control activities in the context of complex emergencies, such as diagnosis and treatment, vector control and surveillance; • establishing the criteria for termination of MDA; and • ensuring an effective surveillance system to compile and analyse changes in malaria burden; Responsibilities of the regional or district task force • micro-planning (section 2.2) in the framework of the strategy defined by the national task force and • coordinating and monitoring the operational aspects of the campaign. Subcommittees could be set up within the task force at both national and district levels, including, for example: • a technical committee; • a committee for information, education, communication, social mobilization and community engagement; • a human resources committee; • a training committee; • a logistics committee; • and a monitoring and evaluation committee. 62.1.3 Conduct a context analysis Planning an MDA requires a systematic context analysis and information on a number of aspects that may have major practical implications for execution of the campaign: • malaria situation in the country and neighbouring countries: - major human malaria species present; - malaria endemicity or transmission intensity (high, moderate, low or epidemic prone); - peak malaria transmission season; - malaria prevalence, incidence of uncomplicated and severe malaria and mortality; - high-risk groups: by age, gender and occupation; - other malaria control activities that are being (or have been) used, in particular distribution of long lasting insecticidal nets, indoor residual spraying, larval source management; - availability and type of diagnostic tests available and used; - national treatment guidelines; - other chemoprevention activities, in particular seasonal malaria chemoprevention, intermittent preventive treatment of infants or pregnant women; - resistance to antimalarial medicines; - main sources of financing of malaria control activities and implementation; and - mapping of malaria partners; • administrative information: - country borders and administrative divisions and - grey areas or undefined boundaries that might challenge implementation; • mapping of administrative boundaries, cities, villages, location of health structures, main roads; • demographic data, including age distribution of the population and identified marginalized groups; • health care organization: - available health infrastructure: hospitals, health centres, health posts; - available health care staff (number and level of training); and - traditional health care providers; • environmental factors: climate and seasons (rainy, dry), extreme events linked to climate change (floods, droughts); • geography of the target areas and nature of the terrain; • security - existence of armed conflict, ethnic, religious or social tension or clashes; and - civil unrest, demonstrations, corruption; • challenges to the health system: public health emergencies and disease outbreaks; • experience and lessons learnt from previous MDA campaigns for neglected tropical diseases or malaria; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 7 • previous crises in communication and rumours about the safety of MDA for neglected tropical disease or vaccination campaigns and lessons learnt; • important local events: national and religious holidays, market days, elections, planned demonstrations, food distribution, MDA for neglected tropical diseases or vaccination campaigns, which may result in poor participation; • local perceptions and beliefs (see section 2.2.4); • supply: national and local purchase and storage possibilities, formalities for importing medicines, registration status of antimalarial medicine eligible for MDA (section 2.2.2); • communications system: e.g. existing networks (providers of mobile communications), availability of Internet; and • population displacement due to security problems, seasonal migration or nomadic populations. 2.1.4 Determine the target population and geographical areas A thorough analysis of the epidemiology of malaria and of the aim of MDA – for epidemic control, malaria elimination or in a complex emergency – should guide decisions on the target population and the geographical areas that will benefit from the campaign. The larger the target population, the more challenging is implementation and the more resources (human, financial, logistic) will be required, as MDA coverage in the target areas is the major determinant of impact. The demographic data used to calculate the target population should be as accurate as possible. This may be difficult to obtain in certain developing countries. If feasible, data should be provided by official sources. Estimates of population numbers can be acquired from (Fig. 1): • head counts (census) or household registration before MDA (unlikely to be feasible in the context of emergencies); • a recent population census (if available); • household surveys; • administrative registration (if available); • data from other recent mass distributions (such as of long-lasting insecticidal nets), mass vaccination campaigns or previous MDA in the same area; or • household mapping done by indoor residual spraying teams in areas where there are strong malaria programmes. If no recent data are available to establish a realistic estimate, the annual population growth rate may be applied to the latest available population estimate. Population displacement into or out of the targeted geographical area should also be considered. If several estimates are available, it is advisable to use the highest figures. Underestimation of the target population may result in errors in calculating orders and consequently a shortage of medicines, an inadequate number of distribution teams or inadequate time required to reach the entire target population. Such errors will ultimately compromise coverage and could also have a negative impact on the perception of the population that is excluded. 8FIG. 1. Sources of demographic information for calculating target population SOURCES OF POPULATION NUMBERS Recent population census Household surveys Head count or household registration Recent distribution of long-lasting insectidal nets / indoor residual spraying Administrative registration After the first round of distribution is completed, the results may be used to recalculate the target population for subsequent rounds. The target population should be calculated by age group. If specific data on the age distribution in the country are not available, the standard age distribution for developing countries can be used (see Annex 1). Certain population groups might have to be excluded from the campaign, depending on the medicine chosen for MDA: • pregnant women in the first trimester: a decision to use pregnancy tests or self-reported pregnancy to exclude pregnant women should be guided by the health authorities and local context; • infants < 6 months of age or weighing < 5 kg; • people recently treated with the same medicine; • people with known allergy to the medicine; • severely ill people; • people taking medication known to interact with the MDA medicine; and • people with specific contraindications to the medicine used. At the design phase, inclusion and exclusion criteria for participation in the MDA campaign should be clearly established. Estimation of the expected number of individuals who will be excluded from participation in the MDA may be useful for calculating orders, for planning purposes and for analysis of coverage. The geographical area to be targeted must be defined on the basis of the size of the population in each zone or area, the population density and whether it is an urban or a rural setting. Table 1 indicates differences in implementation between urban and rural settings. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 9 TABLE 1. Main differences in MDA in urban and rural settings ELEMENT URBAN SETTING RURAL SETTING Demographic data More difficult to estimate: mobile population, slum areas Difficult to determine administrative boundaries of neighbourhoods and other areas within cities Household census before MDA difficult Estimates may be more reliable or more easily obtained Boundaries of villages are easily defined Easier to perform household census before MDA Logistic resources Fewer resources required, as population is densely distributed More resources requires, as population is scattered, and more teams and time are required Accessibility More readily accessible Access may be difficult when there is insecurity Access may be limited by distances, poor road conditions and effects of climate (rain) Human resources Easier to find qualified human resources Community health workers (CHW) and volunteers may be less well known to the population Less qualified HR available CHW and volunteers are well known to and trusted by the population Community leaders More difficult to identify Important role in micro-planning and social mobilization Door-to-door strategy Easier to miss households People less willing to allow access to their house, especially in higher socioeconomic strata People refuse to participate or are absent when they are in their workplace 15–20 households can be visited per team per day (75–100 people) Difficult to miss households People less suspicious and more welcoming of distribution teams People absent usually because of farming activities 10–15 households can be visited per team per day (50–75 people) DOT strategy More difficult to achieve as people are less likely to be at home May be easier to achieve Coverage More difficult to obtain high coverage Higher coverage is easier to obtain Adherence to treatment Lower Higher Rumours More quickly generated and disseminated More difficult to control May be generated but easier to control and limit their dissemination 10 2.1.5 Choose the antimalarial medicine A number of elements should be considered when choosing which medicine to use. • Efficacy: the 28-day cure rate for uncomplicated malaria patients should be > 90%. • Safety profile: low frequency of medicine-related adverse effects, contraindications and consequences of inadvertent exposure of excluded individuals, such as pregnant women or HIV-positive patients on antiretroviral therapy. Even rare adverse events could occur in a considerable number of healthy recipients when the medicine is administered to a large population. • Ease of administration: few tablets per dose and short duration of treatment. • Reputation and acceptability: tolerance of the population to frequent even minor side-effects (e.g. nausea, weakness) and perception of risks and benefits, sometimes affected by rumours, may influence the acceptability of the medicines used in MDA. • How to identify and exclude special populations groups for which at present there are no available options for malaria MDA: pregnant women in the 1st trimester and children weighing < 5 kg. • Interactions: with other medicines used in the population, including other MDA interventions to the same population and antiretroviral agents used by HIV-positive patients. • First-line ACT used in the country should preferably be avoided to limit the emergence of resistance and the impact on the supply for regular programmes and to avoid creating confusion and misconceptions in the population regarding the use of the medicine (prophylactic versus treatment) (9,10). Under certain circumstances, however, such as complex emergencies, the first-line treatment may be considered, as it will be well known by the population and the supply may be easier to guarantee. • Availability of required quantities from suppliers at relatively short notice. • Cost (available budget). The best treatment is one that results in the greatest reduction in parasitaemia and transmissibility and the longest period of post-treatment prophylaxis, hence preventing reinfection. Long-acting ACT is the most suitable treatment in most contexts. The artemisinin component, which quickly clears asexual parasitaemia and also has gametocytocidal activity, has a short half-life, while the partner drugs provide different durations of post-treatment prophylaxis (see elimination half-life of partner drugs in Annex 2). The post-treatment prophylactic effect prevents acquisition of infection while the medicine remains in the bloodstream, protecting the individual as well as reducing transmission. A complete (three-day) course of ACT should be administered; it is important to ensure adherence to the full regimen. Only co-formulated, fixed-dose combination tablets should be used in order to facilitate adherence and avoid resistance due to errors in administration of the medication. The five formulations of ACT currently recommended by WHO for the treatment of P. falciparum malaria are: • artemether + lumefantrine • artesunate + amodiaquine • artesunate + mefloquine • artesunate + sulfadoxine–pyrimethamine • dihydroartemisinin + piperaquine M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 11 The ACTs listed above are recommended on the basis of their therapeutic efficacy, safety, impact on transmissibility and availability. Annex 2 gives the treatment doses and presentations of the ACT currently recommended by WHO. Research is currently under way on new compounds, and the above list may be updated in the near future. Table 2 (on page 12) presents the characteristics of ACTs, which may assist in choosing a suitable antimalarial medicine for MDA. The above comparisons indicate that dihydroartemisinin–piperaquine might be a suitable option for MDA, in view of to its good efficacy, long post-treatment prophylaxis and good tolerability. It is not the first-line treatment for malaria in many countries, and resistance has been reported only in a few areas. Special population groups that might have to be excluded from MDA Pregnant women. No adverse effects on mothers or fetuses in the second and third trimesters of pregnancy have been reported, and ACT is considered safe for use in this population. As there are insufficient data on the safety of ACT in the first trimester of pregnancy, they should be avoided in women at this stage of pregnancy (16). Identification of women in the first trimester of pregnancy who are not yet visibly pregnant may be difficult in mass campaigns. The method for assessing pregnancy, through interview and / or testing, should be decided by the health authorities and based on the local context. Use of screening tests for pregnancy may be problematic, as many women or younger girls may not wish to disclose their pregnancy status, particularly in certain cultural settings. Before MDA, it is crucial to explain to the community the purpose of performing pregnancy tests and to assure them that they will be done confidentially. It is strongly recommended that interviews and pregnancy tests be performed by trained female community health workers in order to ensure privacy and discretion. A culturally sensitive approach is essential taking into consideration the values and perceptions of the communities. Infants < 6 months of age or weighing < 5 kg. Although ACT is considered to be well tolerated by young infants, the operational difficulty of ensuring accurate dosing, because of the lack of infant formulations, the proper administration and retention of the treatment leads to the exclusion of young infants in MDA programmes. Primaquine (8-aminoquinolines) WHO recommends addition of a single low dose (0.25 mg / kg body weight) of primaquine (administered on the first day of the treatment with ACT) as a P. falciparum gametocytocide if the objective of MDA is to eliminate falciparum malaria or reduce the transmission of drug-resistant P. falciparum strains. Primaquine should, however, not be administered to infants < 6 months of age, pregnant women or women breastfeeding infants < 6 months of age. Administration of the single low dose is safe and effective, even in G6PD-deficient individuals. In a recent review, WHO concluded that individuals with G6PD deficiency given a single low dose of primaquine are at very low risk of clinically significant haemolysis (17–19); therefore, it can be given without G6PD testing. The haemolytic effect of primaquine is dose-dependent and is observed mainly in individuals with G6PD deficiency given the 14-day regimen recommended for radical cure of P. vivax malaria. 12 CH AR AC TE RI ST IC A ND SE LE CT IO N CR IT ER IA AR TE M ET HE R– LU M EF AN TR IN E (A L) AR TE SU NA TE – AM O DI AQ UI NE (A S- AQ ) AR TE SU NA TE –M EF LO Q UI NE (A S- M Q ) AR TE SU NA TE -S UL FA DO XI NE PY RI M ET HA M IN E (A S- SP ) DI HY DR O AR TE M IS IN IN – PI PE RA Q UI NE (D HA -P PQ ) Effi ca cy H ig h in m os t s et tin gs Va ria bl e, d ue to e m er gi ng re si st an ce H ig h in m os t s et tin gs W id es pr ea d re si st an ce to S P H ig h in m os t s et tin gs Ha lf- lif e (d ay s) (a ct iv e dr ug ) 1.4 –1 1.4 (lu m ef an tr in e) 3. 7– 10 (d es et hy la m od ia qu in e) 8. 1– 15 .2 (m efl oq ui ne ) 2. 5– 18 .8 (S P) 13 .5 –2 8 (p ip er aq ui ne ) Sa fe ty Sa fe a nd g en er al ly w el l to le ra te d G en er al ly w el l t ol er at ed b ut as so ci at ed w ith a h ig he r in ci de nc e of g as tro in te st in al di st ur ba nc es th an o th er A CT s. AQ m ay p ro lo ng th e Q T in te rv al a nd sh ou ld n ot b e gi ve n to p eo pl e ta kin g Q T- pr ol on gi ng m ed ic in es or w ho h av e co ng en ita l Q T pr ol on ga tio n.* AQ is a ss oc ia te d w ith n eu tro pe ni a an d he pa to to xic ity a nd sh ou ld n ot be u se d in H IV -p os iti ve p at ie nt s ta kin g zid ov ud in e, e fa vi re nz an d / o r c ot rim ox az ol e. M efl oq ui ne in du ce s na us ea , v om iti ng a nd ne ur op sy ch ia tr ic s ym pt om s. M on th ly tr ea tm en t o f h ea lth y pe op le is p oo rly to le ra te d. SP is g en er al ly w el l t ol er at ed bu t m us t n ot b e us ed in pa tie nt s w ith a h is to ry o f hy pe rs en si tiv ity to s ul fa d ru gs or in H IV -p os iti ve p at ie nt s re ce iv in g co tr im ox az ol e, be ca us e of in cr ea se d ris k fo r ad ve rs e ev en ts . Pi pe ra qu in e pr ol on gs th e Q T in te rv al a nd s ho ul d no t be g iv en to p eo pl e ta ki ng Q T- pr ol on gi ng m ed ic in es or w ho h av e co ng en ita l Q T pr ol on ga tio n. * Pr eg na nc y Th e ris k– be ne fit ra tio o f a dm in is tr at io n of a nt im al ar ia l m ed ic in es g iv en to p re gn an t w om en a s pa rt o f a n M D A is d iff er en t f ro m th at fo r m al ar ia p at ie nt s. A s th er e ar e in su ffi ci en t d at a on th e sa fe ty o f A C Ts g iv en d ur in g th e fir st tr im es te r o f p re gn an cy , w om en in e ar ly p re gn an cy s ho ul d be e xc lu de d w he n AC Ts a re gi ve n fo r m al ar ia M D A. Ad m in is tr at io n Tw ic e da ily fo r 3 d ay s, pr ef er ab ly w ith fa tty fo od s (a dh er en ce is m or e di ffi cu lt co m pa re d to tr ea tm en ts w ith sin gl e da ily d os es a nd n o fo od in ta ke re qu ire m en ts ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s o n an em pt y st om ac h (id ea lly 3 h be fo re o r a fte r m ea ls, w hi ch is un lik el y to b e fe as ib le in M D A) Pr es en ta tio n Fi xe d- do se c om bi na tio n; di sp er sib le ta bl et s an d hi gh er -d os e ta bl et s av ai la bl e fo r d iff er en t a ge a nd w ei gh t gr ou ps Fi xe d- do se c om bi na tio n Fi xe d- do se c om bi na tio n N o fix ed -d os e co m bi na tio n av ai la bl e. U se o f b lis te r p ac ks m ay re su lt in d is tr ib ut io n of lo os e AS ta bl et s as m on ot he ra py . Fi xe d- do se c om bi na tio n C om m er ci al a va ila bi lit y of p re qu al ifi ed p ro du ct W id e av ai la bi lit y of pr eq ua lifi ed o rig in al a nd ge ne ric p ro du ct s by m an y co m pa ni es W id e av ai la bi lit y of pr eq ua lifi ed o rig in al a nd ge ne ric p ro du ct s by m an y co m pa ni es Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty * Ex cl us io n of p at ie nt s w ith c on ge ni ta l Q T pr ol on ga tio n w ou ld n ot b e fe as ib le in M D A, b ut p eo pl e ta ki ng s pe ci fic m ed ic in es m ig ht b e id en tifi ed b ef or e M D A. TA BL E 2. Ch ar ac te ris tic s of W H O -r ec om m en de d AC Ts fo r c ho os in g su ita bl e an tim al ar ia l m ed ic in es fo r M DA M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 13 2.1.6 Estimate the requirement for antimalarial medicine, and order it Registration and authorization to import As part of the drug selection criteria, especially for rapid deployment in emergency, it is necessary to consider the availability and requirements for registering the medicine, or obtaining a waiver, for its importation. Authorization to import the medicine and customs clearance should be agreed with the authorities beforehand to allow smooth, quick handling. These processes can take some time, especially if the medication is not licensed in the country. Depending on the country’s regulations, a post-shipment quality control test may be required for each batch of the medicine after it arrives in the country, and the necessary time should be included in planning. Procurement It is essential to ensure that the selected medicine meets international quality standards. The use of substandard, ineffective or unsafe medicines could be harmful for the population treated, affect the credibility of the campaign, increase the burden on the health care system and promote the spread of resistant strains if parasites are exposed to sub-therapeutic blood levels. Only prequalified medicines approved by WHO or by a stringent regulatory authority should be selected for MDA (20). The two main sources of relevant information are the WHO prequalification programme (21) and the Global Fund list (22). Consideration should be given to whether the supplier will be able to deliver the full required quantity at short notice, as not all suppliers have sufficiently large production capacity to deliver large quantities in a short time. Moreover, some manufacturers start production only once a purchase order has been received. These possible delays should be taken into consideration in planning procurement and in setting the dates of distribution. Calculating the required quantity of medicine for different age groups • Determine the size of the target population which will equal the total number of treatment courses needed, often in course-of-therapy packs, for each round. • Calculate number of treatments per age group per round (according to the age- categories for which the selected ACT has specific presentations). • Multiply the needs per round by the number of rounds that will be performed. • Add a buffer stock of approximately 25% (depending on the reliability of demographic data) to cover wastage or underestimation of population. See Annex 3 for examples of estimated orders of different presentations of artesunate–amodiaquine and dihydroartemisinin–piperaquine. The calculation should also take into consideration the number of individuals expected to be excluded from coverage with MDA (e.g. pregnant women, infants, HIV patients, depending on the medicine selected for use). 2.1.7 Determine the delivery strategy There are three possible distribution strategies: • door-to-door distribution: the preferred strategy for high coverage, if logistically possible; • centralized distribution at a fixed site; and 14 • a combination of door-to-door and centralized, fixed-site distribution: - centralized with door-to-door distribution for hard-to-reach groups or - door-to-door distribution followed by centralized distribution to follow up missed participants. With combined strategies, care must be taken not to dose individuals repeatedly. The choice of strategy will depend on logistic capacity, the objective of MDA and analysis of the local context, including security and any outbreak or other special circumstance. DOT is the preferred delivery strategy for ensuring adherence and reducing the potential for mistakes in taking the medicine. Although DOT is more challenging operationally, it has been used successfully in very large-scale campaigns, including with multi-day drug regimens (4). As it may not be feasible to give all three doses of ACT by DOT, a health worker may administer the first dose and give the remaining tablets to the person or carer for days 2 and 3 of the intervention, with instructions on their administration. Because of the high risk of non-adherence to treatment on the two days following the administration of the first dose by DOT and consequent misuse of the medicine, adherence must be strongly emphasized both by the distributor and in the social mobilization campaign. An alternative that promotes and allows assessment of adherence to treatment and safety is giving the first and third doses by DOT. These different delivery options – full DOT, DOT on days 1 and 3 and DOT only on day 1 – have resource implications, which should be considered in planning the intervention. If DOT for all three doses is not feasible, a strategy should be devised to encourage and monitor adherence. For example, CHWs could revisit the houses to which they have already distributed the medicine after finishing the distribution on days 2 and 3, or teams responsible for monitoring adherence could be appointed. Guaranteeing DOT in door-to-door strategies, when there is little likelihood that every member will be at home at the time of the health worker’s visit, is laborious and complicated. When MDA is planned as part of an elimination strategy and there is less time pressure than in an emergency intervention, a small-scale pilot MDA project is strongly encouraged to optimize the delivery strategy. 2.1.8 Determine the period of intervention The best time for MDA depends on the setting and the aim of MDA (see Table 3). MDA to reduce transmission and eliminate malaria In an area with seasonal transmission, a campaign should be executed during the low-transmission season when the number of parasites is lowest, immediately before the start of the malaria transmission season (6,9,13,23). If MDA is conducted at the peak or during the main transmission season, there is less probability of influencing malaria transmission and the parasite prevalence will increase rapidly (13). Timing should also take into consideration seasonal movements of the population in and out of the target area. Untreated people returning to an area after MDA constitute potential reservoirs and sources of re-infection. The access of teams to certain rural and remote settings may also determine the period of MDA, as some areas may not be accessible during the rainy season. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 15 MDA to help contain a malaria epidemic MDA should be performed as soon as possible in order rapidly to reduce morbidity and mortality while outbreak containment measures are put in place. MDA in complex emergencies The period of the intervention will correspond to that of the highest risk for morbidity and mortality – the high malaria transmission season. If the burden of malaria is high all year round, MDA can be considered at any time of the year. Certain complex public health emergencies, such as the 2014–2015 outbreak of Ebola virus disease (EVD), have major impacts on existing health care systems. During that epidemic, health care structures were overwhelmed, and access to regular health care was reduced, due to fewer functioning health facilities, loss of health care staff and fear among the population attending health structures and treatment centres of becoming contaminated with the Ebola virus. Laboratory testing was generally unavailable, and blood testing for malaria diagnosis was suspended. All these factors affected malaria case management, resulting in increased morbidity and mortality due to malaria. In addition, as the clinical presentation of malaria and EVD are similar, patients with malaria were suspected of having EVD, increasing the burden on EVD treatment units and also exposing non-EVD patients to nosocomial infection. Antimalarial MDA was provided in this context in an attempt to reduce malaria morbidity and mortality rapidly and thus to reduce the number of non-EVD patients presenting with fever to EVD treatment centres. Reduction of malaria transmission was not the objective of MDA in the context of the EVD epidemic. 2.1.9 Determine the number of rounds Multiple rounds of MDA at regular intervals are recommended, although there is insufficient evidence at present to establish the optimal number and timing (3). Most MDA campaigns for falciparum malaria have consisted of two or three rounds at monthly intervals, and further research should be conducted to determine whether one or two rounds would be sufficient in certain situations (9). Special situations are listed in Table 3. In MDA to reduce transmission or eliminate malaria, repeated rounds are necessary to clear parasites in the population. If some people remain untreated during a single round, with no additional intervention, the coverage will be partial and the impact in term of malaria transmission and burden will be lower. The aim of successive rounds is total coverage, reaching people who were initially missed and people who were treated in the previous rounds but may have been reinfected after MDA, reducing the probability of reinfecting mosquitoes. Multiple rounds may be required to obtain a major decrease in prevalence (6,8). In MDA as part of an epidemic response, the number of rounds may depend on the epidemic curve (incidence rate and attack rate) and the expected duration of transmission. In MDA in complex emergencies, the rounds should be repeated to cover the duration of the period of highest morbidity and mortality. 16 TABLE 3. Main strategic differences between planning MDA for malaria elimination and for emergency response (epidemic or other complex emergencies) ELIMINATION SETTING (ELIMINATION AND CONTAINMENT OF MULTI-DRUG RESISTANCE) EMERGENCY SETTING (EPIDEMIC, COMPLEX EMERGENCY) Source of demographic data Ideally, head count (census) or household registration before MDA Head count or household registration less feasible Recent census (if available) Household surveys (if available) Other past mass distributions or MDA Timetable for implementation Usually allows sufficient time for planning and preparation Short time for planning and preparation (≤ 1 month) Urgency + +++ Coordination of partners and institutions Required for successful campaign and easy to achieve More challenging, as many actors may be involved, but essential to guarantee an effective campaign in a short time Choice of medicines First-line antimalarial agent should be avoided First-line antimalarial agent may be considered Timing in relation to malaria transmission for intervention During the low transmission season, immediately before the start of the transmission season During the peak of transmission (highest morbidity and mortality), depending on emergency context Number of rounds per year 3 3 (but could be fewer) Administration of antimalarial medicine Must be synchronized in the target population in order to have an impact on transmission Synchronous administration is important in epidemics in order to reduce transmission In other complex emergencies, the requirement for simultaneous medicine intake is less critical Concomitant malaria control activities Preconditions for using MDA for elimination are the availability of active case finding and surveillance, rapid testing and treatment of all cases of suspected malaria and intensified vector control As the objective is to reduce malaria morbidity and mortality, MDA is deployed as an immediate response while other malaria control interventions, notably case management and vector control, are being put in place Criteria for stopping MDA Documentation of 0 indigenous cases (cases contracted locally with no evidence of importation or direct link to transmission from imported cases) Reduction of malaria burden to a level that can be maintained with case management, vector control and routine surveillance, implemented in the same area M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 17 2.1.10 Establish a chronogram A chronogram of activities (see Annex 4) will limit unexpected events, avoid forgetting things in the different planning phases and contribute to a successful intervention. Once distribution has begun, it might be difficult to correct a planning error. Poor planning, such as underestimating amounts or timelines for delivery of medicines, may lead to stock ruptures and will not only compromise the results of the campaign but also have a detrimental effect on the perception of the population. The chronogram should show the evolution of all the tasks to be carried out during the phases of design, preparation, implementation and evaluation of the campaign. It will help to coordinate the many activities to be conducted at the same time and will indicate the role of each person. The chronogram should contain: • a list of tasks to be performed, including quantification and ordering of medicines and other supplies, training, distribution of materials, community mobilization and deployment of teams; • a timeframe for the completion of each activity; and • the name of the person responsible for each activity. When deciding the actual dates on which distribution will take place, the activities and work schedules of the population and religious festivities and holidays should be considered to ensure high coverage. 2.1.11 Draw up a budget The following items should be included in the estimated budget: • MDA medicine; • logistics: - registration fees; - international transport of medicine (e.g. international freight, insurance, customs clearance, importation fees or taxes, options for waivers); - pre- or post-shipment quality control testing (as applicable); - storage of antimalarial medicine and other logistics supplies; - transport: vehicles (cars, trucks, motorcycles, boats, bicycles), fuel; • additional equipment and supplies for distribution: large-scale maps for overall planning and detailed maps to guide teams during the intervention, ropes, fencing, plastic sheeting, megaphones, chalk or other material for marking houses, rainwear (if MDA is conducted in the rainy season), backpacks, cups, other context-specific material (for biosafety for example) (See the comprehensive list of additional materials required for door-to-door and centralized fixed-site distribution in section 2.3.1); • administrative material: e.g. cards, date stamp, daily tally sheets, summary sheets, supervisor sheets, attendance sheets, registration books, stationery; • material for social mobilization and communication campaigns; • staff salaries, per diem, food or transport allowances, identification material; 18 • materials for training and supervision; • communication means: telephone, credit top-up for staff, radio; • material for monitoring and evaluation: e.g. monitors, surveys, resistance monitoring; and • material for drug safety monitoring. It is important not only to estimate the cost of each budget line but also to identify the sources of funding. All partners and task forces should have the opportunity to review and provide suggestions to the budget plan, and the final version should be made available. The exercise should estimate the total cost of the activity and a final analysis of the cost per person treated. 2.2 PLANNING AND PREPARATION 2.2.1 Micro-planning Once the overall design of the campaign has been completed at national level, the next phase is to outline a micro-plan at local (regional, district or community) level for the strategies selected and according to national guidelines. The micro-plan should guarantee that the correct treatment and other materials are available in the right amounts, in the right places and at the right time to cover the entire targeted population. This will require distribution of supplies, training of staff, engagement of the community, well-coordinated distribution and proper management of resources. Micro-planning is used to manage these details by calculating requirements on the basis of local needs, identifying what is available and requesting what is missing. Relevant partners should be involved in micro-planning, including: • health centre staff, • CHWs and community volunteers, • local councils, • community leaders or village representatives, • religious leaders, • the media, • civil society organizations, • women’s groups, • youth organizations, • nongovernmental organizations, • community organizations and • schools and colleges. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 19 The micro-plan should cover the following elements: • demographic information: - total target population of the MDA-eligible district; - the numbers of communities, villages and neighbourhoods in the district; - the target population in each community, village and neighbourhood, with a breakdown by age group; - familiarity of the population with MDA for neglected tropical diseases; - proportions of people in urban and rural areas, in order to adapt logistic requirements (see Table 1 for details of differences in implementation of MDA in urban and rural contexts); - population movement; - depending on the size of the target population and context (emergency setting or elimination), household registration or census books of the target population that list all the households in a community, with an identification number and include the name, age and sex, village, head of household, contact details (if available) and resident status (permanent, temporary or visitor). This list can later be used during distribution to monitor coverage and to keep track of households that have been visited, missing people in a household and other details. • information on the area: - maps showing main roads, villages, towns and neighbourhoods; - infrastructure in the area (e.g. availability of electricity, water, fuel); - location of health facilities and catchment areas; - areas or population that are difficult to reach because of geography, climate, lack of security or cultural reasons and suggested solutions for reaching them; - location at which medicines and other materials will be stored and then prepositioned for distribution; and - distances and travel times from the central area to each community, village or neighbourhood, health structures, storage sites and distribution sites (for centralized, fixed-site strategy) and road conditions; • calendar timing of MDA in the district: ideally specifying days and times for certain streets or neighbourhoods, so that people can arrange to be at home; • delivery strategies (centralized, fixed-site or door-to-door); • human resources and training: - number of people expected to be covered by each team of distributors (whether door-to-door or centralized, fixed-site distribution); - number of teams required to cover all communities in the district; - number of teams per supervisor; - number of supervisors required per district; - human resources available in the district; - number of teams and supervisors that can be brought together per training session; and - number of days required to train staff. 20 • logistics information: - if centralized, fixed-site distribution is decided, the number and location of distribution sites, population per site, teams per site, etc.; - areas where staff may spend the night; - number of vehicles required to transport teams and supervisors and number of vehicles available locally; - amount of fuel required for transport; - amount of material required per team; and - material required for training; • a social mobilization and communications plan; and • a pharmacovigilance plan: - training of CHWs and community volunteers; - timing of active follow-up visits (days 3–7), depending on the safety profile of the medicine; - number and location of health facilities that will provide rescue treatment for any side-effects; - referral health facilities to manage severe adverse events; - distribution and completion of ADR report forms and narratives in health facilities; and - reporting and communication with stakeholders. See Annex 5 for an example of a micro-plan used in Sierra Leone in 2014–2015 for antimalarial MDA during the outbreak of EVD. 2.2.2 Logistics Supply and stock management When the antimalarial medicine ordered for the MDA campaign is received in the country, it should be stored in a central warehouse or storage facility, which should be in an accessible location, with proper temperature and humidity conditions and well secured. Other essential material for the campaign (such as cups, sugar, mortars or pill crushers, stationery, soap, megaphones, rope, fencing) should be kept in the same location. It is vital to estimate the volume of medicine (see Annex 3) and other logistics supplies beforehand to ensure enough storage capacity. The antimalarial medicine should be stocked by presentation (age-specific blisters), batch number and expiration date. A stock card should be prepared for each item in the store in order to monitor quantities and ensure traceability. The stock cards of the antimalarial medicine should include the international non-proprietary name (not brand names) and the dosage. Antimalarial medicines and other logistic material will be distributed from central to district level, where intermediate centralized storage may be necessary, which should conform to the same indications. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 21 Prepositioning of supplies Antimalarial medicines and other logistic elements for distribution should be prepositioned in distribution points according to the micro-plan (e.g. peripheral health facilities) before MDA is launched. Therefore, the stock of each distribution point should be prepared in the central warehouse before delivery. Pre-printed order and delivery forms should be available. All movement of medication between individuals or organizations should be documented, and signed copies should be saved for future reference. See Annex 6 for a step-by-step procedure for prepositioning supplies. Transport Reliable transport is essential for all activities. The number and type of vehicles depend on: • the strategy chosen (door-to-door or centralized, fixed-site distribution), • the duration of the campaign, • the number of distribution teams or distribution points (if centralized, fixed-site), • the number of supervisors, • whether the area is urban or rural, • the social mobilization plan and • the supply system. Motorcycles, bicycles or boats may be required in some contexts. During transport, medicines should be protected from weather such as rain and sunlight. It is essential to check the local availability of vehicles and fuel. If cars are available, they should be evaluated for: • type, size and condition; • type of fuel and consumption; and • the conditions of loan or rent (with or without driver, cost, insurance, etc.). One person should be responsible for following up all issues related to transport, which is a potential target for fraud and / or theft. Accessibility The means for reaching all the eligible population should be assessed thoroughly, covering: • the road network and the condition of roads, • distances and travel times to the different locations and • roads with limited or interrupted access during the rainy season and alternatives for reaching the populations. 22 “Difficult-to-reach” populations include not only those in remote areas with poor road access but also those isolated due to lack of security or social constraints. To ensure that these populations are covered, approaches such as assigning teams specifically to those areas or extending the duration of the campaign might be considered. Distribution sites for centralized, fixed-site distribution Sites should be chosen and prepared in advance. They should be selected in collaboration with local authorities and ideally have the following characteristics: • easy access; • be well-known to the population; • possibility for creating a one-way flow of people (entry and exit points) to facilitate movement; • large enough to work comfortably but not too vast that it is difficult to manage; and • a large, shaded waiting area. Possible locations could be schools, religious centres (churches, mosques, temples) or administrative buildings in urban areas; and, if there are no suitable buildings, open public spaces or temporary shelters, including tents, in rural areas. If pregnancy testing of women of reproductive age is required before administration of the MDA medicine, the distribution site should also have bathrooms and private spaces where the test can be performed and the results communicated privately. Sites should not be set up in health structures, so as to not disrupt normal activities. Waste management Waste will be generated during an MDA campaign, and waste collection and disposal should be considered in the planning phase. The waste will consist almost entirely of soft waste, including packaging, disposable cups (if used) and pregnancy tests, if performed. For door-to door distribution campaigns, waste may be handled at household or community level if adequate waste disposal systems exist. Otherwise, distributors should collect the waste and bring it back to the distribution point, where it should be incinerated. A decision to handle waste at community level or to centralize it at health facilities should be guided by the local context. For centralized, fixed-site distribution campaigns, waste can be disposed of at the distribution site or be transported to a central location (e.g. health facility). 2.2.3 Human resources An MDA will require a significant number of dedicated staff. The number of teams required and their composition will depend on: • the intended duration of the campaign, • the distribution system (door-to-door or centralized, fixed-site), • the target population, • the target area and its accessibility, • the expected performance of each team (number of people treated per day), M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 23 • data forms to be completed and • addition of other interventions. Team composition As the antimalarial medicine is given orally, a large number of skilled health personnel will not be required. The number of qualified health workers taken from health structures should be minimized in order to disrupt the regular health activities as little as possible. A census of all locally available human resources should be carried out during micro-planning. If a network of CHWs or volunteers is already present, they should ideally be engaged in delivering the medicine, as they understand the local environment, speak the local language and are familiar with and trusted by the population. If this is not the case or there are not enough staff according to the estimate, volunteers may be selected from e.g. civil society organizations, nongovernmental organizations, Red Cross or Red Crescent societies, youth associations, schools and nursing schools. If possible, the volunteers who serve as distributors should represent the demographics of the community. When selecting volunteers to distribute treatment or conduct social mobilization, local community leaders should be consulted, as they may help to identify people who are well known, recognized and respected by the community. Each member of the team should have a job description, so that each clearly understands their role and responsibilities and those of the other members. Distribution team Door-to-door strategy. Teams should ideally be composed of two CHWs or volunteer distributors, if possible from the same village: one to provide information and administer the treatment and the other to record the necessary information on appropriate data collection tools. If pregnancy testing is planned, at least one of the two CHWs should be female. Centralized, fixed-site distribution. Teams will consist of: • 1 triage agent to check eligibility, • 1 female worker to conduct pregnancy testing (if planned in the campaign), • 2–3 registrars (if an MDA card is issued to each beneficiary or another registration system is used), • 2–3 drug dispensers, • 2–3 recorders to fill in a tally sheet (paired with drug dispenser), • 1 health care worker to assess and manage adverse events, • 1 sensitization or information officer, • 1 cleaner and • several crowd controllers and security personnel. 24 Supervision team The supervisors should be health personnel, ideally from the same catchment area. Door-to door-strategy: • Direct supervision of teams is difficult, and a large number of supervisors may be necessary to ensure quality. • Each supervisor should be responsible for supervising no more than five teams in an area. Centralized, fixed site distribution • The number of supervisors will depend on the possibility of managing several sites. • In urban areas, one supervisor might be able to visit up to three sites per day. • In rural settings, one supervisor is likely to be able to visit only one or, at a maximum, two sites per day. There should also be one logistics supervisor to manage the organization of sites, transport, supply, etc. Estimated numbers of people treated per team per day (to be adapted to each setting): Door-to-door strategy: The daily output of the teams will depend on the population density. In urban areas, one team should be able to distribute medicine to a maximum of 75–100 people per day (average of 15–20 households of five people, visits lasting 15–20 min per household). In rural areas, where the population is more dispersed, one team should be able to distribute medicine to a maximum of 50–75 people (10–15 households) per day, in view of the time for transfer and communication to individual households. An approach used in several campaigns targeting large numbers of people has been to divide the population into small units and assign each to a distribution team (4). Centralized, fixed-site strategy: One team should be able to distribute medicine to an estimated 400–500 people per day. As this strategy is likely to miss a higher proportion of the population than door-to door distribution, special activities are required to mobilize and ensure the participation of the population. The daily output of the teams will also depend on whether MDA cards are issued to participants or a registration book is completed, which is more time-consuming. It will also depend on the local context and previous experience in similar activities. Specific teams might be considered for distribution in schools, prisons, military camps and orphanages and perhaps for the main local companies, such as factories, mines and plantations. Training Training of staff is an essential component of the preparation phase. Everyone participating in MDA should take part in training sessions, including coordinators, supervisors, distributors, community mobilizers, logistics officers and any other staff. Training should be provided at national, regional, district and sub-district levels. The plan should cover the objectives, which should be defined for each aspect; the length of training; the number of participants; the contents and methods; training materials and an evaluation (e.g. a pre- and post-test). Training should provide each team member and supervisor with the minimum information required to carry out their task properly. Training should be scheduled as close as possible to the date of implementation, ensuring, however, that all teams will have been trained by the time distribution begins. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 25 All teams should be trained in a standardized way. If many partners are involved, they should all provide the same training to avoid any variations that could confuse trainees and lead to mistakes in drug delivery. Training should include: • explaining MDA; • goal of this MDA; • where and when MDA will take place; • the distribution strategy: door-to-door or centralized, fixed-site; • treatment protocol and administration, including possible side-effects and contraindications; • inclusion and exclusion criteria; • performance of pregnancy tests and confidential communication of results (if applicable); • DOT; • team composition; • roles and responsibilities of all team members; • expected daily targets and overall coverage to be achieved; • access to the medicine and other supplies; • practicalities of distribution; • reporting and management of side-effects and severe adverse events; • information, education and communication and community engagement; • dealing with rumours and any concerns or doubts in the target population; • data collection tools: tally sheets, summary sheets, registration books, referral forms, ADR report forms; • procedures for reporting; • contingency plans for unforeseen events; • management of stocks of medicines and other items; • waste management; • logistics; • administrative issues (e.g. incentives and salaries); • supervision and troubleshooting (for supervisors); and • special measures (e.g. “no touch policy” or accidental exposure as in the outbreak of EVD). Training plans should be adapted to the delivery strategy (door-to-door or centralized, fixed-site) to ensure that teams are well prepared. Job descriptions and any other reference documents or guidelines can be distributed during training after they have been discussed with the participants. 26 The methods used during training may include role-play, practical demonstrations, case studies and simulations, ideally with the material and equipment to be used, in order to cover all the details and correct any misunderstanding. Anticipating difficulties and responses in these scenarios is a fundamental part of training. An efficient way to train many people quickly is cascade training, in which certain people are trained as trainers, and each in turn provides the same training course to others. More than one level of cascade should be avoided. Supervision of this training system is important to ensure that the information being passed down is accurate and the messages are not being changed as they are passed down. Providing adequate training material, cooperative supervision and meticulous evaluation will guarantee that the skills in which distributors have been trained are applied appropriately. Salaries and per diem Large-scale MDA involves a significant number of people who are widely distributed geographically; they should be compensated accurately and in an opportune manner. Payment of salaries and / or incentives, per diem and food or transport allowances must be clearly discussed with all staff involved in distribution to avoid confusion and demotivation. CHWs and volunteers who are unhappy with their position and reward can jeopardize a campaign. It is essential to determine how the money will be transported and managed at various levels to ensure that each person receives the correct pay, while guaranteeing transparency and avoiding opportunities for theft or corruption. The options for payment are decentralization to district authorities, through banks or “outsourcing” payments. Malaria control programmes may already have relevant experience during distribution of long-lasting insecticidal nets and indoor residual spraying campaigns. When many partners are involved, harmonization of payment to the teams is crucial. An innovative method is use of mobile phones, as used in Sierra Leone. Although some technical difficulties were faced because of the size of the transaction and the fact that it was the first time the phone company had handled such an operation, more than 6000 people were paid with this method in a timely, transparent manner, without having to gather for payment and removing the inherent security risks entailed in the movement of large sums of money (10). 2.2.4 Community engagement, social mobilization and communication One of the main determinants of the success of MDA for malaria is ensuring high coverage of the target population and good adherence to the treatment, both of which depend on people’s willingness to take the medicine (3,4,24). Many asymptomatic, healthy people will be asked to take a medication, potentially exposing them to adverse reactions. Ensuring compliance requires building mutual understanding and trust in the institutions implementing the campaign. Community engagement is a key factor in the success of MDA, in order to obtain the desired participation and uptake of medication. Misconceptions within the eligible population about the treatment being administered, their risk for the disease, side-effects and the need for intervention even in people who are not ill contribute to non-participation (24,25). Effective communication and social mobilization are therefore critical to a successful MDA campaign (26). A communications plan should be developed and agreed upon by the ministry of health and other actors on strategies to reach target audiences. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 27 The steps in preparing a communications plan are: • Define the roles and responsibilities of each partner. • Conduct a community assessment. • Prepare clear, simple, precise, consistent messages about MDA for malaria. • Engage the mass media. • Engage the community. Roles and responsibilities At national level: • Plan advocacy, communication, social mobilization and community engagement. • Develop a tool for community assessment. • Elaborate key messages. • Coordinate activities. • Hold advocacy meetings with stakeholders, including the private sector, at national level. • Hold briefing with media houses, with an official launching, and identify role models who are willing to take the first dose publicly. • Participate in panel discussions on national radio and television. • Produce and air campaign spots in the main languages spoken in the target areas. • Produce information, education and communication material, such as banners, flyers and fact sheets. • Monitor the media during the campaign. At district level: • Carry out community assessment. • Diffuse messages as widely as possible. • Hold advocacy meetings with main stakeholders in the community, such as community leaders, administrative authorities, religious leaders, civil society groups and other associations or groups (women, young people) and traditional healers. • Organize sessions to sensitize the private sector, schools, etc. about potential absenteeism of workers and students during the campaign. • Identify potential participants in the community. • Air jingles spots on local radio stations. • Participate in panel discussions on local radio stations. • Send vehicles with loudspeakers to make announcements about the MDA campaign to each village. 28 At community level: • Hold discussions with chiefs and religious leaders in each village about the campaign. • Disseminate messages through appropriate channels. • Identify and train CHWs to carry out sensitization street to street and house to house in the days before distribution. • Organize group sensitization sessions in communities with the participation of key people. • Organize announcements by a town crier or a vehicle with a loudspeaker during the days before and during distribution. Community assessment Ideally, before planning MDA, a quick assessment and mapping of community groups in the targeted areas should be conducted to obtain qualitative information such as: • social structures in the community; • cultural specificities and customs; • decisional power about health in families; • role of traditional leaders, including community and religious leaders; • behaviour considered acceptable for men and for women; • health-seeking behaviour, including general knowledge about malaria; • role of traditional medicine and traditional healers; • acceptance of allopathic medicine; • use of media; • familiarity and understanding of posters, brochures and banners; • literacy; • languages spoken; • perception of and willingness to participate in this type of intervention; and • any concerns, which will be addressed during the sensitization campaign, This assessment may avoid cultural misunderstandings that could threaten the success of the campaign. Useful lessons can be drawn from previous experience in MDA and similar activities. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 29 Key messages about MDA for malaria The messages to be prepared include: • What: general information about malaria and about the campaign, emphasizing that malaria may be asymptomatic and that people can be infected without realizing it and highlighting the role of asymptomatic carriers in malaria transmission • Why: purpose and benefits of treatment of people who do not feel sick and the importance of not saving the medicine for later use • When: dates of the distribution and number of rounds • Where: door-to-door or centralized, fixed sites • Who: geographical area and eligibility criteria, with special emphasis on the need to exclude women in the first trimester of pregnancy and explaining the screening method which will be used (interview and / or pregnancy test) and assuring that it will be done confidentially. • How: dosage and duration of treatment, adherence to treatment • Potential side-effects: to avoid misconceptions and fear, possible side-effects should be described, with assurance of proper management of any that appear • Importance of continuation and reinforcement of other malaria preventive measures (e.g. use of long-lasting insecticide-treated nets) • Context-specific messages: might have to be prepared for each WHO recommendation for MDA during a malaria epidemic or a complex emergency such as an outbreak of EVD. Engaging the mass media Generally, spokespeople should be identified at the ministry of health and other credible, respected partners that are able to handle challenging interviews where awkward, inopportune questions are asked. Talking points should be prepared for speaking to and engaging with the media, avoiding the use of acronyms or scientific vocabulary that the public will not understand. Relationships should be built with local media representatives to ensure that they provide good news coverage; they should be contacted regularly, not only in response to a critical situation. The campaign should be inaugurated with an opening ceremony covered by the media, in which influential people such as high-ranking administrative authorities and celebrities participate and take a dose of the medicine as an example to the rest of the community. The methods that can be used to disseminate information and promote an MDA campaign include radio, television, newspapers, billboards, online news sites, social media, mobile phones and games. Radio is widely available and very popular in rural areas in malaria-endemic countries and should be a priority for circulating information through radio spots, radio group discussions in which community members engage with campaign health officials and role-play of community members talking about the distribution in order to spread information about the purpose, location and timing of MDA and to discuss the benefits of participating and potential side-effects. Radio also allows listeners to call in and ask questions live. Radio spots (see Annex 7) can also be used. Radio can also be a powerful method, if the micro-planning is good, to disseminate information on the days and estimated times of visits of the distribution teams per street or neighbourhood or, in the case of centralized, fixed-site distribution, location and days. Television spots and phone-in programmes with key stakeholders can be influential. 30 Media messages should address any local concerns and doubts identified either in previous campaigns or during the evaluation phase. Personal testimony of people who have previously taken the medication is valuable. Progress reports should be sent to the media throughout the campaign. Countering negative rumours Unfounded rumours or negative news may circulate, dissuading communities from participating in MDA. Random cases of unrelated severe illness or deaths in the community may be attributed to the antimalarial treatment and reduce the public’s confidence in the campaign. A plan should be prepared in advance to suppress such rumours quickly in a prudent, neutral manner to reassure the population. Distribution teams and supervisors should systematically collect information on rumours and on questions that are frequently asked at meetings with stakeholders and community groups and on radio and television programmes. Media reporting should be closely monitored to detect any negative coverage rapidly and react accordingly. If a relationship of trust is established with the media, they will be more likely to listen to all sides before reporting false information. Community engagement Community engagement at the early stages of planning is a key element of a successful MDA, so that they take ownership of the implementation and success of the campaign. The people to involve are: • community leaders and other influential members, • political leaders, • local councillors and authorities, • religious leaders (priests, imams, monks), • schoolteachers, • celebrities, • other local groups (youth, women), • village health workers or volunteers, • health care staff (to respond to questions and concerns), • traditional healers and • private pharmacy owners and drug sellers (who could potentially interfere with the activity). Cooperation with leaders and other influential members of the community is vital for good results, as their status as decision-makers makes them efficient promoters of the benefits of participating in the campaign; however, they must be well informed. Any negative opinion of the intervention will have a significant impact on the outcome. They can provide organizers with useful information on the best timing for the campaign, suggest people who should be included in sensitization sessions and how the sessions should be organized and identify potential distributors who are well known and respected by the community. See Annex 8 for a list of discussion points that could be used in community meetings. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 31 Social mobilization Group social mobilization sessions in the community can be used to provide information, allow members of the community to ask questions and establish trust between the population and campaign staff. Priority should be given to hard-to-reach and underprivileged populations, and the programme should be adapted or intensified for those groups if necessary. Other effective approaches are street theatre, music, art and other cultural activities. Communication materials should be printed in the local languages and adapted to the literacy level of the community. They could include leaflets, posters, calendars, banners, armbands, t-shirts and caps. Megaphones or town criers could also be used. Social mobilization activities should be held in religious centres, schools, cinemas and other recreational areas and places where people gather for other purposes, such as bus stops and hairdressers. The activities in the different phases of social mobilization and communication are listed below. Before the campaign: • Ideally at least one month before administration of the medicine (depending on the setting and context): information about MDA, the benefits of the campaign, the importance of participation, etc. • In the week before distribution: intensification of the sensitization campaign, with a focus on the practical aspects of starting the campaign and reminders to the population of days and location. Before distribution is begun, several households should be visited to verify that people are aware of the dates and are willing to participate, so that last-minute adjustments can be made to sensitization activities. During distribution: • Social mobilization should focus on encouraging participation and promoting treatment adherence. • Community mobilization messages should be adapted according to inputs from continuous observation by nonparticipants of people’s reactions during MDA. If MDA is conducted during the rainy season, villagers in rural areas might prefer not to participate in the campaign because of farming activities, either because they have to travel out of the eligible area to access their fields or because they fear that adverse effects might limit their capacity to work and thus provide for their families. This issue should be tackled in the communication plan to prevent or minimize refusal. During distribution, the general perception and comments of the population towards the MDA campaign should be monitored to detect any problems, which should be addressed quickly. Community leaders could signal negative perceptions to the distribution teams or identify areas or neighbourhoods that have not been adequately covered. 32 After MDA is completed: • Communities should be informed of the results by appropriate local platforms, such as radio, posters and CHWs. • Teams or MDA representatives should remain in the target communities for some time after completion of MDA to identify and address rumours, concerns or other issues that could affect future rounds of MDA or other health interventions. 2.3 IMPLEMENTATION The distribution of antimalarial medication should be started only if: • the medicines and all other material (as outlined below) are in place; • supervisory material is available (see section 2.3.3); • teams are trained (see section 2.2.3); • the logistics is ready (see section 2.2.2); • the population has been informed of the details of the campaign (see section 2.2.4) and • pharmacovigilance, including management of ADRs, is planned (see section 3.4). 2.3.1 Stock management Distribution kits should be prepared ahead of time at the distribution point or at the peripheral health facility where supplies are prepositioned. Different kits should be prepared for distributors and supervisors. The quantities in the kits should be adequate for the number of people estimated to be reached per day. Material required per distribution team For door-to-door strategy (with DOT): Each team of distributors should be provided with the following materials at initiation of the campaign: • backpacks (1 per CHW) • mortar or pill crusher (for crushing tablets for infants) • clipboards • pens • staff identification badge, t-shirt or armband • hygiene material (soap) • chalk to mark houses • pad to note any concern • printed information, education and communication material (drawings of age-specific dosages, adherence to treatment, expected adverse events, use of long-lasting insecticidal nets) M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 33 • umbrellas or clothing to protect against the rain The rest of the material should be provided daily according to consumption and remaining stocks: • the required number of treatment blisters to meet the daily target (including buffer stock) • pregnancy test kits and urine containers if pregnancy tests are to be performed • sugary solution for children if medicines with a bitter taste are used • material for documentation: MDA cards, registration book, tally sheets, referral forms • bags for waste collection For centralized, fixed-site distribution: In addition to the above, the following should be considered: • tables and chairs • ropes or fence and poles • shade net and / or plastic sheeting • waste buckets • drinking-water containers • weighing scales • disposable or reusable cups (if strict hygiene measures are in place) • hygiene material (soap and other cleaning material) • date stamp and ink • identification panels for distribution site. Material required for supervisors´ kits • clipboards and pens • identification material, e.g. shirts, arm bands • supervisory checklist, daily summary sheet, ADR report forms, referral forms • pad to note any concerns. For door-to-door distribution, the distribution teams should pick up the material at the distribution point or health facility at which it is prepositioned every morning, making sure that all the necessary supplies have been packed. At the end of the distribution day, the remaining stock should be brought back to the distribution point, where an inventory is made and recorded. All movement of antimalarial medicine and other supplies should be recorded by the person responsible for stock management. The kits should then be refilled in preparation for the following day. If a team or a site requires further supplies because of shortages, the person responsible for logistics should be contacted to arrange transport, and the movement should be clearly documented to ensure accurate accountability. At the end of each round of distribution, the remaining stock of medicines and other items must be counted and reported at district, regional and national levels. 34 The supplies must be stored correctly for the next round, and antimalarial medicine and other supplies should be ordered for the next round. After the last round is finalized, the remaining doses should be returned to district or national level, where appropriate storage should be ensured. Expiry dates should be checked. All other logistical material should be counted and also sent back to central level. 2.3.2 Distribution of antimalarial medicine Actual distribution of medicine will depend on the distribution strategy chosen. Door-to-door strategy In urban areas, it may be difficult to ensure that all members of a household are present, waiting for the distribution team throughout the campaign. It is therefore advisable that each household be informed of the date and approximate time at which the distribution team will visit them. The schedule of visits should be flexible in order to increase the chances of finding people at home. According to the context, visits should be made either early in the morning or in the evening for rural farmers or at midday for workers. The distributors should follow the steps below when visiting each household (see also Annex 9): • Greet the residents politely in their language, and introduce themselves. • Ask for the head of the household, and verify whether all members of the household are present. • Explain the objectives and provide information about the campaign. Distribution teams should have visual aids to transmit key messages translated into local languages. • Obtain oral consent to participate. • Check eligibility criteria. Anyone meeting any of the exclusion criteria (first trimester of pregnancy, infant < 6 months of age, known allergy to medicines, critically ill or presenting contraindications to the medication) should be told why they will not be given the treatment. Annex 10 presents an algorithm that could be used by CHWs to apply exclusion criteria. • Individuals who are seriously ill, e.g. children with danger signs, should be excluded from MDA and be referred to the nearest health facility. All other ill patients should first receive the antimalarial treatment as part of the MDA and then be referred to a health facility for full assessment. • A female health worker should speak to all women of reproductive age (15–49 years) alone, in a private setting to explain that ACT are not recommended in the first trimester of pregnancy and ahould also determine pregnancy status on the basis of personal history or a pregnancy test (see Annex 11 for an algorithm for determining pregnancy in women of reproductive age). Women who are visibly pregnant (assumed second or third trimester) may receive the medicine. If pregnancy is not apparent, the CHW may ask the following questions to help exclude a first trimester pregnancy: - Are you currently pregnant? - Do you think you could be pregnant? - Are you using any family planning method? M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 35 If the woman is unsure of her pregnancy status, a pregnancy test should be offered. If the test is positive, the woman is considered to be in the first trimester of pregnancy and should be excluded from the MDA. Women who do not agree to have a pregnancy test should be warned of the risks and benefits of receiving ACT in the first trimester and given the choice to take it or refuse it. Interviewing adolescent girls about pregnancy may pose an ethical issue, as parental consent might be required and is a subject of strong cultural sensitivity. Appropriate procedures should be defined in collaboration with the national reproductive health programme. • Distribute a blister appropriate for the age category. The first dose should be administered under DOT. If a child is unable to swallow a tablet, the dispenser should teach the carer how to crush it and dissolve it in water and give the first dose to the child. If the medicine has a bitter taste, it may be given with a small amount of sugary solution to encourage the child to take it. If the dose is vomited (or rejected) within 30 min, the same dose should be repeated. The parent or guardian should request another dose from the CHW to complete the treatment. • Teach the participants to take the remaining doses (on days 2 and 3), unless DOT is used for all doses. A laminated card with treatment doses should be used as a visual aid to support the explanations, and printed leaflets may be distributed (see Annex 12 for the leaflet used in MDA in Sierra Leone in 2014–2015). • Clearly explain the importance of adherence to the full treatment course. Participants may be advised to keep the empty blister packs for assessment during post-distribution monitoring. • Provide information on possible side-effects and what to do if they occur, including clear instructions for contacting the relevant services for assistance or queries. • Ask the members of the household whether they have any questions, and allay any doubts they may have. • Mark the tally sheet (see section 2.3.4 and Annex 13) after the person has taken the first dose, or fill in the registration book (see section 2.3.4 and Annex 14) and record the necessary information (e.g. name, age, gender, address, residency status, medication and dose given), including whether the entire household was covered or whether some members were missing, and specify the number missing. • When the distribution team leaves the house, they may mark it with chalk as “complete” or “incomplete” according to the household members present; if no one was at home at the time of the visit, it should not be marked. If distribution in a household was incomplete or no one was at home, the team should revisit the house later in the day or the following day. To simplify operations, the antimalarial medicine should also be given to people present in the community at the time of MDA who are not resident in the area (visitors), as long as they have no contraindication. In certain settings, such as in the context of elimination, they should be recorded separately, as they were not included in the calculation of coverage. On days 2 and 3, once CHWs have finished dispensing daily treatment, they should return to households in their area in order to reinforce sensitization, promote treatment adherence and monitor ADRs. 36 Centralized, fixed-site distribution All distribution sites must have been identified in the planning stage and should be prepared the day before distribution begins. The site should be set up as follows (Fig. 2): • Delimitation of the site with a rope or fence is recommended, and the site should be clearly identified. • Waiting lines should be organized with rope or barrier tape and should be narrow enough for only one person to pass at a time. Crowd controllers may be necessary to ensure a smooth flow. • Sensitization should be conducted in the waiting area. • People should pass through an initial triage area, where their eligibility is verified. If they are considered eligible, they will continue through the circuit. If not, they will leave the area after the reasons for non-inclusion and registration have been explained. • A private area should be identified for pregnancy screening of women of reproductive age as previously described. • If it is decided that MDA cards will be handed to participants or a registration book completed (see section 2.3.4 and Annex 14), the next step will be registration. As this may be time-consuming, enough staff should be assigned to avoid bottlenecks and long waiting times. • People will then proceed to the point where they will receive an appropriate blister for their weight or age category. The treatment distributors will administer the first dose under direct observation, and inform the recipients on how to take the medication on days 2 and 3 (unless DOT for all three doses is done). • The tally sheet is completed for each participant after the medicine has been dispensed. • An observation area may be set aside where people spend 30 min to ensure that they do not vomit and no severe adverse events or adverse events of special interest (see section 3.4.1) appear and where they will be sensitized about possible side-effects, what to do if they occur, administration of the remaining doses and the importance of adherence. • All ill people attending the distribution should be referred to the nearest health facility. FIG. 2. Example of layout of a distribution site Drug distribution station DOT Drug distribution station DOT W ai tin g ar ea , w ith in fo rm at io n, ed uc at io n an d co m m un ic at io n Registration Registration O bs er va tio n an d se ns iti za tio n ar ea Triage Tally sheet Tally sheet M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 37 2.3.3 Supervision Supervision is important to ensure an effective, efficient, successful MDA campaign. Supervision should be conducted at various levels, with clearly defined communication lines between them. Supervisors should be appointed for the distribution teams and at the levels of districts, region or province (where applicable). National supervisors and coordinators should also be available. Distribution team supervisor The roles and responsibilities of the distribution team supervisor are: Before distribution: • Ensure proper reception and management of antimalarial medicine and other supplies at the peripheral health facility. • Verify that all distributors are identified and trained and that local activities are organized and coordinated. • Prepare the daily schedules of the distribution teams. During distribution: Morning - Present the micro-plan and daily work plan for each distribution team. - Check attendance, and find replacements in case of absence. - Ensure that each team has the necessary medicine and material. - Fill in part of the supervisory checklist. - Deliver the daily data collection tools. During distribution hours - Visit distribution teams in their area of supervision, and provide technical support when needed. - Randomly visit households, and interview members of communities that have already received the distribution team’s visit to verify that they did receive the medicine and what they understood about taking the remaining doses. End of the day - Meet the distribution teams. - Collect the remaining medicine and material (guarantee stock follow-up, and confirm consumption). - Collect daily tally sheets and analyses. - Compile data, fill in daily summary forms, and report to the district supervisor. - Ask about any problem encountered during MDA or stock out, and report. - Provide feedback to the teams, correct any mistakes, inform them of the progress of the campaign, and address any concerns. - Prepare the medicines and material for the next day. - Complete the supervisory checklist. - Report to the district supervisor any difficulties or problems to be dealt with, rumours and refusal on the part of the population. 38 End of the campaign: • Report the stock level. • Return the remaining medicine and materials (to be arranged in collaboration with logistics department). • Conduct debriefing with district supervisors and task force. Supervisors should have the proper tools for their tasks, such as a supervisory checklist (see Annex 15). District supervisor The roles and responsibilities of the district team supervisor are to: • supervise and support the distribution team supervisors; • ensure that there is a team supervisor for all eligible geographical areas; • visit peripheral health structures daily and react rapidly to questions and problems; • ensure the daily presence of all teams; • brief and debrief the team supervisors before and after each day’s work, with particular attention to: - stock ruptures, - problems in data collection, - rumours circulating in the community, - insufficient information by distributors on correct administration of the medicine, - lack of motivation of health workers, - insufficient response to ADRs and - coverage of hard-to-reach populations; • inform the district task force of any problem requiring immediate action that cannot be resolved locally; • collect and compile the information on the daily summary sheets for the district; • collect and review the team supervisors‘ checklists (may be done at the end of the campaign if there is not enough time during distribution) to identify any issues and lessons to be applied in subsequent rounds; • present daily summaries to the district task force during evening debriefings and • submit a written report to national supervisor. Regional or provincial supervisor (if applicable) The regional or provincial supervisor is responsible for supervising the district supervisors. He or she must follow up daily on the progress of the campaign and on any difficulties or problems, such as rumours. He or she must collect and analyse district summary findings and present a report to the national supervisor or coordinator. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 39 National supervisor or coordinator He or she oversees the regional or provincial supervisors, follows up the overall progress of the campaign and major difficulties, such as rumours, and analyses the summaries from regions or provinces before reporting to the national task force. 2.3.4 Data collection Data collection is a vital component of an MDA in order to guarantee adequate follow-up of operations. The person responsible for collecting each type of data at each level and the mechanism of transfer from one level to another should be clearly defined (Table 4 and Fig. 3). This is particularly important when several partners are involved in order to avoid duplication of data collection, missing data or mistakes in the destination of tallies or summary sheets. FIG. 3. Recommended information flow among levels CHWs and distribution teams • daily tally sheet • daily household registration Distribution team supervisor • daily summary sheet District supervisor • district summary Regional or provincial supervisor • regional summary National supervisor • national summary Community Health facility District Region or province National level 40 TABLE 4. Data to be recorded at each level during door-to-door and centralized distribution LEVEL DISTRIBUTION STRATEGY DOOR-TO-DOOR CENTRALIZED, FIXED-SITE Community Census of people in each household or family (obtained before MDA, when feasible) List of people in community, ideally with age and sex by family; otherwise, number of people per family Daily tally sheet with stock management (medicines, pregnancy tests and other consumables) per distribution team Daily tally sheet with stock management (medicines, pregnancy tests and other consumables) per distribution site Record of each person, family treated, excluded, refused or not found (see household registration) ADRs (name, age, sex, village, head of household, contact details, treatment taken, type of ADR, day of ADR) during days 2–7 ADR reporting (observations for 30 min while still at treatment centre) Referral form (in case of severe illness, ADR, pregnant woman who inadvertently received the treatment, other reasons) Health facility Daily summary sheet and analysis of coverage by community in the health facility catchment area ADR reporting (standard form) Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables in health facility stock Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables (stock may not always be prepositioned in health facility) District District summary sheet and analysis of coverage by health facility in the district Compilation of ADR report forms from health facilities in the district Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables if district storage is used and when stock is returned from health facility Region or province Regional or provincial summary sheet and analysis of coverage by districts in region or province Compilation of ADR report forms from districts Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables if regional storage is used and / or when stock is returned from district level National National total and analysis of coverage by region or province Compilation of ADR report forms from regions or provinces Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables in national stock and when stock is returned from lower levels M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 41 MDA cards Provision of MDA cards (see Annex 16) to participants as proof that they received the treatment is optional and should be decided by the national task force during the design phase. If the task force decides that an MDA card will be provided, it should contain: • last and first names of the drug recipient, • age and sex, • address, • name and dose of the antimalarial medicine given and • date of administration of the first dose if given by DOT or of each dose if all three doses are given by DOT. Daily tally sheet Tally sheets (see Annex 13) should be completed by each team on each day of distribution and handed to the supervisor at the end of the day. The following information should be recorded: • date and place of distribution; • distribution team identification; • number of households visited; • number of people who received the medicine, by age group (defined by age categories for the medicine) and by sex if considered relevant; • individuals excluded and reason; • residence status: resident or visitor (especially useful in elimination contexts, as all may not be included in the coverage calculation) and • number of treatment blisters for each age category received at the start of the day and that remaining at the end of the day. The quantities of medicine consumed should correspond to the number of people treated, as recorded on the tally sheet. Discrepancies should be investigated to determine the cause, such as a mistake in distribution or theft. Household or line list registration Depending on the context (emergency or elimination), a household or line list registration (see Annex 14) may be used, with the following information collected: • household identification; • head of household; • name of recipient; • age; • sex; • village; • contact details (if available); 42 • residency status (permanent resident, temporary resident, visitor); • treatment taken; • refusal, excluded (reason) or not found and • observations. Daily summary sheet The distribution team supervisor should collect the completed tally sheets and compile the data corresponding to a certain geographical area (health centre catchment area, neighbourhood or village) on a daily summary form (see Annex 17). The tally sheets should be reviewed to ensure that they were properly completed and that the team is meeting the daily target. If not, the reason should be investigated (e.g. lack of sensitization, shortage of medicine, problems in recording). Feedback should be given to the teams on their performance and adjustments made, such as increasing the number of teams, changing the distribution site (in centralized distribution) or adapting mobilization. Database The data on the summary forms should be entered by a trained data manager into a centralized database at district, regional or national level (see Annex 18 for the database used in MDA in Sierra Leone), which will allow, at a later stage, a thorough analysis of the number of people treated, the number excluded, distribution coverage by age group and location and other information. Referral form A CHW who identifies a person who is ill, a pregnant woman in the first trimester who inadvertently took the antimalarial medicine or anyone presenting a potentially drug-related adverse reaction must fill in a referral form and refer the person to a health facility for proper management. ADR form If an individual presents symptoms that could be attributed to the antimalarial medication, an ADR form (see Annex 19) must be completed at a health facility or by a pharmacovigilance team. See section 3.4 for more details of pharmacovigilance and reporting of ADRs. 2.3.5 Coordination During the days of distribution, daily meetings should be held at district and national levels, with the participation of all involved in the campaign in order to: • monitor daily coverage; take action in problematic or challenging areas by targeting social mobilization or planning “catch up” distribution, ensure that hard-to-reach areas have been visited and guarantee that supplies have not run out; • monitor stocks, and ensure an uninterrupted supply of the medicine; • address any identified rumours or generalized refusal of the population; • manage enquiries from the press; • identify and correct any programme errors that could lead to failure of the campaign; • share any pertinent information, and coordinate the activities of all partners; and • mobilize the necessary resources in a coordinated way to respond to unforeseen events. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 43 2.3.6 Treatment of malaria cases after mass drug administration An individual treated during MDA who presents to a health facility with suspected malaria within 4–6 weeks should be assessed for possible malaria treatment failure or new infection. A positive result in a HRP2-based rapid diagnostic test cannot be relied upon, as a positive result may be obtained weeks after successful treatment due to persistent antigenaemia. Thus, microscopy should be used to confirm malaria. Ideally, health facilities should have antimalarial medicines in stock that are different from those used in the MDA. If microscopy confirms malaria, the health worker should enquire whether the patient adhered to the full course of treatment and if he or she vomited within the first 30 min of drug intake. If adherence was poor or the patient vomited, the same treatment used for MDA can be repeated. If adherence to treatment was good, a different antimalarial should be given, as possible treatment failure cannot be differentiated from a new infection in routine health care settings. 44 3. MONITORING AND EVALUATION 3.1 MONITORING SYSTEM Given the complexity of the intervention, the limited number of times MDA can be done and the importance of the coverage of the intervention, monitoring is essential for success. The monitoring should be of high quality and not considered routine. Use of a monitoring system during a campaign allows full allocation of resources to operations and efficient implementation of activities while dedicating resources and capacity for a separate set of activities that allow identification in real time of constraints that require immediate action and will provide lessons for subsequent rounds of MDA. The monitoring system should assess all phases of the campaign, by: • interviewing distribution teams to determine the effectiveness of training; • evaluating the logistics; • interviewing community members to appraise the effectiveness of the social mobilization campaign; • randomly visiting distribution teams to observe administration of the medication and counselling for adherence; • assessing the quality of data collection; • estimating actual coverage; • evaluating adherence to treatment and rational drug use; • monitoring drug safety and reporting adverse events; • and monitoring impact. Deployment of monitoring teams (internal or independent monitors) should be planned during the design phase in order to ensure adequate training in use of the monitoring tools. 3.2 ESTIMATE OF COVERAGE After each round is completed, coverage is estimated to determine the proportion of people reached. Areas of low coverage might be identified to improve planning for the following round. 3.2.1 Distribution coverage Distribution coverage can be defined as the proportion of the population who received the first dose of the treatment in that round, with the number of people who received the first dose as the numerator and the number of people in the target area as the denominator: Distribution coverage = number of people who received the first dose x 100 number of people targeted for treatment M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 45 The distribution coverage for each round and then the total MDA distribution coverage can be calculated. Additionally, distribution coverage should be estimated for each demographic group (age and sex) and geographical area, as applicable for campaign management. Although analysis by gender is not essential, it may be useful in settings where certain groups are likely to be underserved (e.g. girls). Such calculations do not, however, necessarily reflect the reality, because of difficulties in obtaining reliable demographic information, errors in data collection or inclusion of people from outside the target area in distribution. The estimate of coverage will be more accurate if a household census was conducted before distribution, providing the denominator. In emergencies or other situations in which performing a census is not feasible, the recommended approach is to perform a coverage survey. As stated previously, the desirable coverage is > 80%. Coverage of < 80% may be due to poor participation, a shortage of supplies or an inadequate strategy for the campaign. The reasons for not participating may be (12,26,27): • population mobility (seasonal or routine movements of people out of the area targeted for MDA); • unavailability or inability to participate at the time of MDA; • difficulty in reaching the distribution site or a long waiting time (in case of centralized distribution); • refusal to take the treatment because not sick; • fear of ADRs; • treatment considered to involve too many tablets and too long; • rumours about the medicine; • lack of engagement with community leaders and civil society in general; • lack of trust in the campaign; • misunderstanding and lack of adequate information about MDA; • interference with other community events; and • confusion between MDA for malaria and for other neglected tropical diseases, such as administration of praziquantel, which has side-effects that some people find difficult to tolerate. Although MDA in rural settings is logistically more demanding, it may be more difficult to obtain high coverage in urban than in rural settings because of differences in the characteristics and dynamics of the population, including socioeconomic status, educational level, occupation and work schedules (28,29). Some studies have shown that populations with higher social status are more reluctant to participate in MDA (28). Young people and adults who drink alcohol regularly are unwilling to participate in MDA unless they are sick. 46 The reasons for non-adherence to full treatment include (12,27): • not feeling sick, • wanting to save the medicine for when they are sick, • sharing the treatment with someone else, • forgetting to take the tablets, • fear of or appearance of side-effects, • rumours about the side-effects of the medicine and • inadequate health promotion or information on how to take the treatment correctly or on the importance of completing the full course. 3.2.2 Post-MDA campaign survey A post-campaign survey is recommended when feasible, ideally within the week after distribution. The survey comprises visiting a representative sample of the population and systematically administering a questionnaire (see sample in Annex 20) to selected household members. The results can be used to estimate the coverage of the larger population with confidence intervals. Additional information about the campaign can also be collected during the survey. Cluster sampling may be used. For information on performing a cluster survey of coverage, see Annex 4 of Monitoring and epidemiological assessment of mass drug administration in the global programme to eliminate lymphatic filariasis: a manual for national elimination programmes (30). A post-distribution survey is useful to: • estimate the coverage of the MDA, • evaluate adherence to treatment (the number of people who completed the full course of antimalarial medicine), • determine the reasons for non-participation, • determine the reasons for non-adherence, • estimate the proportion of people who experienced adverse events and • evaluate the main adverse events reported. 3.3 MONITORING CONSUMPTION The consumption of antimalarial medicine (number of treatments used) must be monitored daily and compared with the number of people reported to have been given the medication. Discrepancies between the two numbers should be investigated. They may be due to problems in recording the doses administered, errors in counting stocks, mistakes in administering the medicine or theft. Any of these problems must be suitably addressed with the teams. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 47 A major problem that could arise as a consequence of lack of reliable demographic data is that the true population at a given site largely exceeds that expected. By monitoring consumption, an eventual stock rupture can be determined. A shortage of stock linked to reports from distribution teams or from community leaders that parts of the population have not yet received MDA may alert supervisors to this possibility. Under such circumstances, the buffer stock in central storage should be used. A more logistically demanding alternative would be to shift medication from over-stocked locations to under-stocked ones. 3.4 PHARMACOVIGILANCE Even when medicines that have good safety and tolerability profiles are used, exposure of a large population may result in the appearance of rare side-effects in a number of cases. “Pharmacovigilance” is defined by WHO as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems (31). Pharmacovigilance in the context of MDA should be planned and implemented in collaboration with the national pharmacovigilance centre, which might be part of the national medicines regulatory authority or a research or academic institution. Pharmacovigilance systems depend on the performance and motivation of general health services staff, require centralized reporting lines and methods and skills for review, analysis and assessment of the causality of spontaneous reports of suspected drug reactions. The pharmacovigilance system should be organized at national, regional, district, state and municipal levels and also at health facilities and at community level in targeted populations. The objectives of pharmacovigilance during MDA are to: • detect unusually high rates of adverse events; • ensure that coincidental events are not falsely associated with MDA; • support timely detection and management of all adverse events (even those not attributed to MDA) to ensure the safety of the population; • maintain confidence in the campaign by proper responses to community concerns about the safety of the medicine while increasing awareness about its benefits and risks; • generate data about adverse events in certain populations such as asymptomatic carriers and healthy people for whom there may be no safety data, as these populations are not included in testing during development of medicines; • promote and monitor adherence to the medicine by the targeted population, and detect reasons for non-compliance and the underlying causes, if possible; • assess health systems preparedness to ensure drug safety monitoring at district and national levels by identifying appropriate responses in terms of knowledge of drug use (safety), training, knowledge and practice of pharmacovigilance; and • evaluate the expected severity, frequency, distribution and outcome of ADRs in the targeted population in order to: - identify adverse event that are not listed in the product information leaflet or are not described in populations that were not tested during development of the medicine, such as asymptomatic carriers and healthy people; - assess the association between the ADR and the antimalarial; - provide a spectrum of the ADRs associated with use of the antimalarial in large populations; and - inform health care workers about patient counselling and monitoring in health facilities. 48 The expected ADRs and the toxicity of the medicine to be used in MDA should be well known to the organizing committee. Groups at all levels should be sensitized about potential ADRs, including the general public, CHWs (treatment distributors), supervisors and health care staff. Communities should be informed about expected mild reactions, with the information that they are usually transient and self- limiting or manageable by simple treatment; they should be encouraged to seek medical care for any rare or severe symptoms. Special attention should be paid to side-effects that may reduce tolerability and lead to poor adherence, such as nausea, vomiting, diarrhoea and abdominal discomfort. This could be done via television and radio, print media, social media, press conferences, community outreach and meetings. 3.4.1 Definitions Adverse event: any untoward medical occurrence that may occur during treatment with a pharmaceutical product that is not necessarily causally associated with the treatment (32) Adverse drug reaction (ADR): a response to a drug that is noxious and unintended and that occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease or for modifying physiological function (32) Serious adverse event or reaction: any untoward medical occurrence that, at any dose: • results in death, • is life threatening, • requires hospitalization or prolongation of hospitalization, • results in persistent significant disability or incapacity or • results in congenital abnormality or birth defect (33,34). The detection of congenital abnormalities would require creation of a pregnancy registry, with enrolment and surveillance of all new pregnancies detected at antenatal care and in communities during the three months after MDA, and an evaluation to determine whether the women were pregnant at the time of exposure to the medicine. These women should be followed up to delivery to assess the outcome of the pregnancy, in terms of the health of both the foetus and infant and the mother (31). The cohort of pregnant women should be interviewed about any treatment with ACT or other medicines, with precise information on time of exposure and type of medicine and possible miscarriage, stillbirth or malformations. Analysis of data at the time of birth will allow a comparison of the frequency of miscarriage, stillbirth and congenital malformations among pregnant women who have inadvertently received various types of medicines during the first trimester. Adverse event of special interest: refers to adverse events (serious or non-serious) of significant scientific, medical and public interest, for which monitoring and rapid communication to the provider and regulators could be appropriate (35). The event should be defined and reported if some safety signals were detected during the development of a drug that required additional monitoring. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 49 3.4.2 Safety communication Reports of ADRs and rumours about the safety of the drug can damage an MDA campaign and can also influence future MDAs or even use of the medicine in the country. A communication strategy should be prepared with the national pharmacovigilance centre before the MDA campaign, in line with internationally accepted best practices (36). Relations with the media and selected spokespeople should be defined well in advance, as timeliness and efficiency in crisis communication are essential to contain serious damage by circulating rumours. Reported or perceived ADRs should be communicated appropriately to the media, with responses to any enquiries. Every serious adverse event must be properly recognized, reported and investigated. Once the assessment has been completed, the results of the investigation should be communicated to the community through appropriate media. 3.4.3 Surveillance of adverse drug reactions Routine ADR surveillance must be enhanced during an MDA campaign to identify any potentially severe cases and to manage them adequately, to detect any programmatic errors and to reassure the general public. Rescue medicine and emergency medical material required for managing potential adverse reactions should be available in health facilities. Medication errors, such as in dose administration by distributors or in taking the medicine because of inadequate sensitization, could be at the origin of adverse events and should be duly reported. In order to establish a functioning safety surveillance system, all personnel involved in an MDA campaign, especially health care staff, should be trained before the campaign on their roles and responsibilities, emphasizing prevention, early detection and management of adverse events and severe adverse events linked to the campaign as well as on the use of standard forms for reporting and the procedure to follow in case of a suspected severe ADR (notification system). Most countries have standard forms for documenting ADRs (see example in Annex 19). Forms for reporting suspected ADRs should be widely distributed, and clear guidance should be provided to health care staff and local health structures on completing the form. Any reported severe ADR must be investigated to determine its relation with the antimalarial medicine, and all responses should be documented, including treatment. The reporting form adopted by the national pharmacovigilance centre should be used for spontaneous reporting. The forms may be adapted for active monitoring of a sample of the exposed population to include days of follow-up and findings of home visits. All reporting forms should record data on the patient, the suspected drug(s), concomitant medication, medical history, detailed description of the clinical course of the event(s), diagnosis, outcome, relevant laboratory or other diagnostic procedures and treatment received and any other information that supports causality (37). Two pharmacovigilance methods may be used during MDAs. • Passive monitoring or spontaneous reporting: reporting of a suspected adverse reaction by a health practitioner who becomes aware of a safety concern or by a patient. Thus, reporting is not solicited systematically. Nevertheless, both health workers and people receiving MDA should be advised (with clear contact details) to report any untoward event they may observe during or after MDA. • Active monitoring and reporting: follow-up home visits by pharmacovigilance mobile teams or health workers trained in detecting adverse events after exposure to medicines for detection of short-term ADRs (during the week after administration) in every village, town or city in which the medicine was given. This is particularly important in settings where pharmacovigilance systems are weak and underreporting is significant. It involves active case finding and follow-up (“search, find, identify, refer and manage”). Any ADR detected should be reported to a health facility, and serious ADRs should be referred for further investigation and management. 50 To ensure effective communication and reporting of ADRs, a dedicated round-the-clock pharmacovigilance call centre or hotline could be set up to address queries from recipients of the medicine during the campaign. In countries where the national pharmacovigilance centre has an online electronic reporting system for ADRs, this can be used to enhance reporting if there is nationwide sensitization of consumers and health care professionals to the availability of the system. All ADR reports collected during or after the campaign should be forwarded to the national pharmacovigilance centre for assessment and onward submission to the WHO global ADR database. A health facility pharmacovigilance preparedness checklist (see example in Annex 21) could be used by pharmacovigilance monitors in communities to assess whether: • there are adequate quantities of rescue medications to treat ADRs; • staff are aware of the need for pharmacovigilance monitoring during the MDA; • all staff have been apprised of and trained in pharmacovigilance monitoring and the adverse reactions to the antimalarial medicine that will be used in the campaign; • staff were involved in advocacy and social mobilization before the campaign about the importance of adherence to the medicine; and • ADR reporting forms are readily available at MDA sites, with clear forwarding instructions and contact details. All health workers involved in the mass drug administration should be trained in pharmacovigilance (see example of training curriculum for drug dispensers in Annex 22). 3.5 MONITORING DRUG RESISTANCE One of the main concerns about MDA is the emergence and spread of resistance to the drug, which spreads because resistant parasites develop greater transmission potential in the presence of the antimalarial medicine. In the past, indirect MDA (in which antimalarial drugs were added to salt distributed to the population) resulted in the development of resistance because of the use of sub-therapeutic doses of antimalarial medication (5,38). MDA is likely to increase selection pressure on parasites. As antimalarial medicines with a long half-life are eliminated slowly from the body, during MDA, a large proportion of the population will have variable concentrations of the medicine in the blood over time. This increases the chances that malaria parasites will be exposed to sub-therapeutic concentrations of long-acting drugs (13,40,41). Thus, the post-treatment prophylactic effect, which is an important component of the protective and transmission-blocking effect of MDA, may also lead to selection pressure. Low adherence to treatment by a proportion of the population is expected to be higher in people with asymptomatic parasitaemia, which will also contribute to the exposure of malaria parasites to sub-therapeutic doses. Until now, there has been no evidence that MDA of antimalarial medicines given at therapeutic doses results in the emergence of resistance (39). While the use of combination treatment reduces the possibility of selecting drug-resistant parasites (23), limited evidence on the impact of MDA on drug resistance indicates that resistance to antimalarial medicines should be monitored in areas where MDA is implemented on a large scale. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 51 Several means for monitoring parasite (P. falciparum) resistance are relevant to MDA (42). • In vivo trials of therapeutic efficacy: treatment of symptomatic patients with a standard dose of antimalarial medicine and measurement of the clinical (signs and symptoms) and parasitological (parasitaemia) efficacy of medicines and treatment outcome over a defined period. Although trials of therapeutic efficacy are considered the “gold standard” and are used in national malaria control programs to guide treatment policy, they are relatively complex to perform and not always easy to implement after MDA. • Detection of molecular drug resistance markers: confirmation of genetic changes associated with resistance by molecular techniques. Serial detection of molecular markers is an accurate way of monitoring drug resistance and probably the preferred option. It has the advantage that samples can be easily obtained, transported and stored on filter paper, but it also requires expensive equipment. It can provide early evidence of resistance, particularly if pre-intervention data are available. Molecular markers of drug resistance are available for only a limited number of antimalarial medicines, notably chloroquine, amodiaquine, sulfadoxine + pyrimethamine, mefloquine, piperaquine and artemisinin. The correlation between molecular markers and the therapeutic efficacy of many antimalarials is imperfect and should be interpreted with caution. In any scenario, at least one of the two methods should be available. Monitoring drug resistance will require collaboration with reference laboratories and with research entities at national or international level. 3.6 EVALUATING IMPACT The ideal way of determining impact, especially when the objective is to reduce malaria transmission, is to monitor malaria prevalence by serial measurements of parasitaemia. The method used in pre- and post-MDA surveys should be the same in order to identify an effect. A more practical way of evaluating the impact of MDA for malaria is monitoring routine surveillance data. The following indicators should be measured, ideally weekly, but at least at monthly: • total number of consultations (outpatients), • total number of suspected cases tested for malaria, • total number of cases of confirmed malaria, • total number of admissions of severe cases of malaria, • number of deaths due to malaria, • test positivity rate and • total number of locally transmitted and imported malaria cases. For epidemics and complex emergencies, a minimum set of MDA monitoring and evaluation activities should be defined in order to document impact and for reporting. Facilities that record confirmed malaria cases continuously can be identified in most settings, in order monitor over time the numbers of consultations and of cases of confirmed malaria in the target groups exposed to MDA and, if possible, in unexposed population groups. 52 These data should be compared before and after MDA in the targeted area; in a district covered by MDA and one that was not targeted, with a similar prevalence of malaria; and in the same district in a year in which MDA was carried out and one in which it was not. More detailed analyses could indicate the contributions of aspects such as environmental or demographic factors and concomitant interventions that also influence malaria trends. When MDA is used as an emergency measure to reduce the burden of malaria and febrile illness rapidly, as was the case in the outbreak of EVD, the effectiveness in reducing both malaria morbidity and the number of febrile cases presenting to health services should be monitored (11,12). In an epidemic, the effect of MDA is difficult to document, as the temporal change may be reflected simply as a plateau, or a reduction in the rate of increasing incidence in the epidemic curve. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 53 4. REPORTING After each round and at the end of the intervention, all partners at different levels (community, health facility, district, region, province, national) should gather for a debriefing and review to assess how the campaign went, share their experiences and impressions and make recommendations for the following rounds or future MDA. A report should be written in order to capitalize on the experience and identify lessons that could improve subsequent rounds or similar experiences. It should provide: • the coverage achieved; • the main findings, challenges and difficulties faced and successful or unsuccessful solutions; • any practices that gave good results, including effective social mobilization activities; • any useful tools that were developed ad hoc in response to unpredicted events, which could be incorporated into reference documents and included in training material; • the final cost of the intervention (analysis per line item) and the cost per person treated; • transparency and accountability for all resources used, including final inventories, destination of remaining treatment, return of logistic equipment, any donations made; and • an evaluation of the whole operation. The following is a proposed outline of the essential topics that should be covered in the report to be prepared at district level at the end of each MDA round: • Introduction and background • Objectives • Duration of campaign • Geographical area of intervention and target population • Treatment regimen • Details of methods used during the campaign - Preparation and planning o Recruitment and training of human resources o Social mobilization and community engagement o Logistics and supply - Distribution o Strategy o Practical aspects o Supervision o Data collection o Results - Total number of people reached - Coverage - Excluded individuals and reasons for non-inclusion 54 • Monitoring: adverse events reported • Other relevant aspects of monitoring • Finance and administration, including breakdown per cost • Strong points, difficulties, lessons learnt and recommendations • Annexes Another important component of reporting is feedback to the communities on the outcomes of the campaign and its impact. This will improve people’s perception of the activity and build trust in the health authorities for future campaigns. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 55 5. K EY S TE PS IN A M AS S DR UG A DM IN IS TR AT IO N CA M PA IG N FO R M AL AR IA Pl an ni ng an d pr ep ar at io n Im pl em en ta tio n M on ito rin g an d ev al ua tio n Re po rt in g D es ig n ph as e (m ac ro -p la nn in g) • O bt ai n co m m itm en t f ro m po lic y- m ak er s, an d id en tif y ag en ci es to su pp or t t he m in ist ry o f h ea lth • E st ab lis h a ta sk fo rc e or co or di na tin g co m m itt ee • C on du ct a c on te xt a na lys is • D et er m in e ta rg et p op ul at io n an d ge og ra ph ica l a re as • D et er m in e an tim al ar ia l m ed ic in e to b e us ed • E st im at e re qu ire m en ts , a nd or de r m ed ic in e • D et er m in e de liv er y st ra te gy : - D oo r t o do or - C en tra liz ed - M ix ed • D et er m in e pe rio d of in te rv en tio n • E st ab lis h nu m be r o f r ou nd s • E st ab lis h a ch ro no gr am • E st im at e a bu dg et • D o m ic ro -p la nn in g • E ns ur e eff ec tiv e lo gi st ic s - Pr oc ur em en t, st or ag e an d di st rib ut io n - Tr an sp or t - Ac ce ss ib ili ty - D ist rib ut io n sit es - W as te m an ag em en t • H um an re so ur ce s - Id en tif y re qu ire m en ts - Tr ai ni ng - Sa la rie s a nd p er d ie m • C om m un ity e ng ag em en t an d so ci al m ob iliz at io n - D efi ne ro le s a nd re sp on sib ilit ie s - Co m m un ity as se ss m en t - Ke y m es sa ge s - En ga ge m as s m ed ia - A dd re ss ru m ou rs - En ga ge c om m un ity • S to ck m an ag em en t • D ist rib ut io n of a nt im al ar ia l m ed ic in e • S up er vi sio n • D at a co lle ct io n • C oo rd in at io n • R ea l-t im e m on ito rin g • E st im at io n of c ov er ag e • P os t- ca m pa ig n su rv ey • M on ito rin g of c on su m pt io n • P ha rm ac ov ig ila nc e • M on ito rin g of d ru g re sis ta nc e • E va lu at io n of im pa ct • D eb rie f a nd re vi ew in te rv en tio n • W rit e a fin al re po rt 56 REFERENCES 1. 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M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 59 Annex 1 STANDARD DISTRIBUTION OF POPULATIONS IN A DEVELOPING COUNTRY CHILDREN < 5 YEARS AGE RANGE (MONTHS) PERCENTAGE OF TOTAL POPULATION 0–11 4% 12–23 3% 24–35 3% 36–47 3% 48–59 3% Total 16% TOTAL POPULATION AGE RANGE (YEARS) PERCENTAGE OF TOTAL POPULATION 0–4 16% 5–14 27% 15–29 27% 30–44 16% ≥ 45 14% Total 100% 60 Annex 2 AVAILABLE ARTEMISININ-BASED COMBINATION THERAPY: DOSING, FORMULATION AND PRESENTATION DIHYDROARTEMISININ–PIPERAQUINE WHO recommended doses BODY WEIGHT (KG) DOSES (MG) OF DIHYDROARTEMISININ AND PIPERAQUINE GIVEN DAILY FOR 3 DAYS 5 to < 8 20 + 160 8 to < 11 30 + 240 11 to < 17 40 + 320 17 to < 25 60 + 480 25 to < 36 80 + 640 36 to < 60 120 + 960 60 to < 80 160 + 1280 ≥ 80 200 + 1600 Formulations available Fixed-dose combination in: • Paediatric tablets containing 20 mg dihydroartemisinin and 160 mg piperaquine • Tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine Presentations • Blister containing 3 tablets of 20 mg dihydroartemisinin and 160 mg piperaquine • Blister containing 3 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 6 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 9 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 12 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 61 Remarks • Dihydroartemisinin–piperaquine is an ideal candidate because of its efficacy and long post- treatment prophylactic effect. The elimination half-life of piperaquine is 13.5–28 days (1). • Piperaquine prolongs the QT interval and should not be used with medication that prolongs the QT interval or in patients with congenital QT prolongation (1). Excluding patients with congenital QT prolongation would not be feasible in MDA. A single report of a sudden unexplained death considered potentially related to lethal cardiotoxicity has been reported among approximately 200 000 individuals closely followed up after treatment with this medicine (2-4). • Dihydroartemisinin–piperaquine should ideally be administered to a person with an empty stomach, as high-fat meals accelerate the absorption of piperaquine, increasing the risk for a prolonged QT interval. Each dose should be taken at least 3 h after the last food intake; no food should be taken within 3 h of each dose. 62 ARTESUNATE–AMODIAQUINE Recommended doses BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTESUNATE + AMODIAQUINE DAILY FOR 3 DAYS 4.5 to < 9 2–11 months 25 + 67.5 9 to < 18 1–5 years 50 + 135 18 to < 36 6–13 years 100 + 270 ≥ 36 ≥ 14 years 200 + 540 Formulations available Fixed-dose combination in tablets containing • 25 mg artesunate and 67.5 mg amodiaquine • 50 mg artesunate and 135 mg amodiaquine • 100 mg artesunate and 270 mg amodiaquine Presentations • Blister containing 4.5 to < 9 kg (infant): 3 tablets of 25 mg artesunate and 67.5 mg amodiaquine • Blister containing 9 to < 18 kg (toddler): 3 tablets of 50 mg artesunate and 135 mg amodiaquine • Blister containing 18 to < 36 kg (child): 3 tablets of 100 mg artesunate and 270 mg amodiaquine • Blister containing ≥ 36 kg (adult): 6 tablets of 100 mg artesunate and 270 mg amodiaquine Remarks • Artesunate–amodiaquine is associated with neutropenia, especially in HIV-positive patients on zidovudine and / or co-trimoxazole. Concomitant use of efavirenz may also increase the hepatotoxicity of amodiaquine (1). • Although limited data is available, artesunate-amodiaquine is associated with QT interval prolongation similar to other antimalarial medicine such as quinine, chloroquine and dihydroartemisinin-piperaquine. No sudden unexplained death suggestive of cardiac arrhythmia at the doses used for malaria treatment have been reported despite widespread use suggesting that while cardiotoxicity may occur it is rare (4). • Elimination half-life: 4–10 days (1). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 63 ARTESUNATE–MEFLOQUINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTESUNATE + MEFLOQUINE GIVEN DAILY FOR 3 DAYS 5 to < 9 6 to 12 months 25 + 55 9 to < 18 1 to 6 years 50 + 110 18 to < 30 7 to 12 years 100 + 220 ≥ 30 ≥ 13 years 200 + 440 Formulations available Fixed-dose combination in: • Paediatric tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Adult tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) Presentations • Strip of 3 tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Strip of 6 tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Strip of 3 tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) • Strip of 6 tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) Remarks • Artesunate–mefloquine has a long post-treatment prophylactic effect (elimination half-life, ≤ 3 weeks) (1) but is associated with nausea, vomiting and neuropsychiatric symptoms, which may reduce its tolerability in MDA operations. 64 ARTEMETHER–LUMEFANTRINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTEMETHER + LUMEFANTRINE GIVEN TWICE DAILY FOR 3 DAYS 5 to < 15 2 to 59 months 20 + 120 15 to < 25 5 to 7 years 40 + 240 25 to < 35 8 to 12 years 60 + 360 ≥ 35 ≥ 13 years 80 + 480 Formulations available • Dispersible or standard tablets containing 20 mg artemether and 120 mg lumefantrine • Standard tablets containing 40 mg artemether and 120 mg lumefantrine Presentation • Blister containing 5 to < 15 kg: 6 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing 15 to < 25 kg: 12 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing 25 to < 35 kg: 18 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing ≥ 35 kg: 24 tablets of 20 mg artemether and 120 mg lumefantrine Remarks Artemether–lumefantrine is probably not a suitable choice for MDA. • It is currently used as first-line treatment in many countries. • The complexity of the treatment regimen of two daily doses would probably compromise adherence. • It has a short post-treatment prophylactic effect (elimination half-life, 3–6 days) (1). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 65 ARTESUNATE + SULFADOXINE–PYRIMETHAMINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSE (MG) OF ARTESUNATE GIVEN DAILY FOR 3 DAYS DOSES (MG) OF SULFADOXINE + PYRIMETHAMINE GIVEN AS A SINGLE DOSE ON DAY 1 5 to < 10 6–11 months 25 250 +12.5 10 to < 25 1–7 years 50 500 + 25 25 to < 50 8–14 years 100 1000 + 50 ≥ 50 ≥ 15 years 200 1500 + 75 Formulations available Co-blister pack (there is no fixed-dose combination): • Tablets containing 50 mg artesunate and fixed dose combination tablets containing 500 mg sulfadoxine and 25 mg pyrimethamine Presentations • Blister containing 3 tablets of 50 mg artesunate and 1 tablet of 500 mg sulfadoxine and 25 mg pyrimethamine • Blister containing 6 tablets of 50 mg artesunate and 2 tablets of 500 mg sulfadoxine and 25 mg pyrimethamine Remarks • Artesunate–sulfadoxine + pyrimethamine does not exist as a fixed-dose combination, which would result in massive distribution of loose artesunate tablets, potentially leading to the emergence of resistance. • Elimination half-life is 4.1–10.9 days for sulfadoxine and 2.5–18.8 days for pyrimethamine (1). • The combination of sulfadoxine + pyrimethamine–amodiaquine, currently used in the Sahel as seasonal malaria chemoprevention, provides protection from reinfection for 28 days; however, it is available in a co-blister formulation and currently not recommended for individuals over 5 years of age. The efficacy of both sulfadoxine–pyrimethamine and amodiaquine is limited geographically due to increasing drug resistance to both medicines. • Sulfadoxine + pyrimethamine should not be administered to people on co-trimoxazole (1). References 1. Guidelines for the treatment of malaria. 3rd edition. Geneva: World Health Organization; 2015 (http://www.who.int/malaria/publications/atoz/9789241549127/en/, accessed 17 August 2017). 2. Myint HY, Ashley EA, Daya NPJ, Nosten F, White NJ. Efficacy and safety of dihydroartemisinin- piperaquine. Trans R Soc Trop Med Hyg. 2007;101:858–66. 3. Kabanywanyi AM, Baiden R, Ali AM, Mahende MK, Ogutu BR, Oduro A et al. Multi-country evaluation of safety of dihydroartemisinin / piperaquine post-licensure in African public hospitals with electrocardiograms. PLoS One. 2016;11:e0164851. 4. The cardiotoxicity of antimalarials. Report of the WHO Evidence Review Group Meeting, 13–14 October 2016, Geneva: World Health Organization; 2017 (http://www.who.int/malaria/mpac/ mpac-mar2017-erg-cardiotoxicity-report-session2.pdf?ua=1, accessed 17 August 2017). 66 Annex 3 EXAMPLE OF CALCULATION OF ORDERS FOR ANTIMALARIAL MEDICINE EXAMPLE OF CALCULATION FOR ARTESUNATE–AMODIAQUINE Artesunate–amodiaquine comes in fixed-dose combination tablets, packed in age-appropriate blisters, in four presentations: Dosage based on body weight or age BODY WEIGHT (KG) APPROXIMATE AGE GROUP BLISTER PRESENTATION DOSAGE 4.5 to < 9 kg 2–11 months 25 mg / 67.5 mg tablets in blisters of 3 tablets 1 per day for 3 days 9 to < 18 kg 1–5 years 50 mg / 135 mg tablets in blisters of 3 tablets 1 per day for 3 days 18 to < 36 6–13 years 100 mg artesunate + 270 mg amodiaquine in blisters of 3 tablets 1 per day for 3 days ≥ 36 ≥14 years 100 mg artesunate + 270 mg amodiaquine in blisters of 6 tablets 2 per day for 3 days Total population: 100 000 Age distribution (from standard age distribution for developing countries in Annex 1): • 2–11 months ≈ 4% (0–11 months = 4%) • 1–5 years = 12% • 6–13 years ≈ 27% (5–14 years = 27%) • ≥ 14 years ≈ 57% (≥ 15 years = 57%) Target population by age group BREAKDOWN BY AGE GROUP (ACCORDING TO BLISTER PRESENTATION) 2–11 MONTHS 12–59 MONTHS 5–13 YEARS ≥ 14 YEARS Percentage of total population 100 000 x 0.04 100 000 x 0.12 100 000 x 0.27 100 000 x 0.57 Total population per age group 4000 12 000 27 000 57 000 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 67 Estimate of number of treatments (= number of blisters) per presentation and volume requirement 6–11 MONTHS 12–59 MONTHS 5–13 YEARS ≥ 14 YEARS TOTAL For one round 4 000 12 000 27 000 57 000 100 000 For three rounds 12 000 36 000 81 000 171 000 300 000 25% buffer stock 3 000 9 000 20 250 42 750 75 000 Total number of treatments 15 000 45 000 101 250 213 750 375 000 Estimated volume per treatment (in dm³) 0.02 0.03 0.04 0.04 Total estimated volume (in dm³) 300 1 350 4 050 8 550 14 250 68 EXAMPLE OF CALCULATION FOR DIHYDROARTEMISININ–PIPERAQUINE Dihydroartemisinin–piperaquine is available as fixed-dose combinations in tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine and in paediatric tablets containing 20 mg dihydroartemisinin and 160 mg piperaquine. WHO dose recommendations based on weight BODY WEIGHT (ESTIMATED AGE) DAILY DOSE FOR 3 DAYS TABLET STRENGTH AND NUMBER OF TABLETS PER DOSE 5 to < 8 kg (2–11 months) 20 + 160 1 x 20 mg / 160 mg tablet 8 to < 11 kg (12–23 months) 30 + 240 1½ x 20 mg / 160 mg tablet 11 to < 17 kg (2–4 years) 40 + 320 1 x 40 mg / 320 mg tablet 17 to < 25 kg (5–7 years) 60 + 480 1½ x 40 mg / 320 mg tablet 25 to < 36 kg (8–13 years) 80 + 640 2 x 40 mg / 320 mg tablet 36 to < 60 kg (≥ 14 years) 120 + 960 3 x 40 mg / 320 mg tablet 60 to < 80 kg (adults) 160 + 1280 4 x 40 mg / 320 mg tablet ≥ 80 kg (adults) 200 + 1600 5 x 40 mg / 320 mg tablet Total population: 100 000 Age distribution (based on standard age distribution for developing countries, Annex 1): • 2–11 months ≈ 4% (0–11 months = 4%) • 12–23 months = 3% • 2–4 years ≈ 9% (2–5 years) • 5–7 years ≈ 9% (5–14 years = 27%) • 8–13 years ≈ 18% (5–14 years = 27%) • ≥ 14 years ≈ 57% (≥ 15 years = 57%) Target population by age group AGE GROUP 2–11 MONTHS 12–23 MONTHS 2–4 YEARS 5–7 YEARS 8–13 YEARS ≥ 14 YEARS Percentage of total population 100 000 x 0.04 100 000 x 0.03 100 000 x 0.09 100 000 x 0.09 100 000 x 0.18 100 000 x 0.57 Total population per age group 4 000 3 000 9 000 9 000 18 000 57 000 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 69 Estimation of number of treatments (= number of blisters) per presentation REQUIREMENT DIHYDROARTEMISININ / PIPERAQUINE 20 mg / 160mg 3-tablet blister 40 mg / 320mg 3-tablet blister 40 mg / 320mg 6-tablet blister 40 mg / 320mg 9-tablet blister 40 mg / 320mg 12-tablet blister 1 round 10 000 9 000 27 000 28 500 28 500 3 rounds 30 000 27 000 81 000 85 500 85 500 25% buffer stock 7 500 6 750 20 250 21 375 21 375 Total number of treatments 37 500 33 750 101 250 106 875 106 875 The total number ordered should be adjusted according to existing stocks, back orders and other sources. 70 Annex 4 EXAMPLE OF A CHRONOGRAM FOR MASS DRUG ADMINISTRATION FOR MALARIA (DISTRIBUTION AT 8 WEEKS) DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Coordination Creation of task force and define composition Definition of roles, tasks Creation of subcommittees Task force meeting Sub-committees Meeting (National & District Levels) Written proposal of MDA Development of tools Conduct micro planning at district level Final report Antimalarial medicines Estimation of medicine needs Check existing stocks / backorders Make medicine order Reception of medicine order Stock management (cards, batch number) Distribution of medicines to district level Pre-positioning of medicines in peripheral health structures Other equipment (team supplies, data collection tools, stationary, etc.) Estimation of needs Evaluation of available resources Order necessary supplies Reception of supplies Preparation of kits M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 71 DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Distribution of supplies to district level Pre-positioning of logistic kits in peripheral health structures Logistics and transport Evaluation of needs Evaluation of available resources Order or rental of vehicles Verification and maintenance Vehicle movement plan and follow up Human resources Estimation of needs Evaluation of available personnel Selection and recruitment of missing personnel Identification of allocation of staff and supervisors Create training materials Training of trainers Training of supervisors Training of distribution teams Training of monitors Training of drug safety monitoring teams Supervision Salaries / perdiem Social mobilisation Develop communication plan Develop key messages Produce and distribute IEC material Advocacy meetings with Key actors at national level Advocacy meetings with Key actors at district level 72 DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Sensitization of specific groups at community level (traditional leaders, authorities, religious leaders, women's groups, etc.) House to house and street to street sensitization Town criers / megaphones Press briefing Monitoring of press Planning of radio and TV programming / ads Participation in radio / TV panel discussions Elaboration of radio jingles Airing of radio jingles Distribution sites (for centralised strategies only) Define number of sites needed Identification of sites Visit sites Organisation of sites for distribution (tables, chairs, etc.) Antimalarial medicine distribution Preparation of materials Checking of materials Supply during campaign Implementation of round one Implementation of round 2 Implementation of round 3 Supervision activities Monitoring and evaluation Data analysis Evaluation of distribution coverage Monitoring activities Post distribution survey M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 73 UR BA N W ES TE RN A RE A PO PU LA TI O N PE R AG E G RO UP (+ 5 % BU FF ER S TO CK ) BO X VO LU M E (M 3 ) TOTAL VOLUME No . Na m e of fa ci lit y Ty pe o f f ac ili ty O w ne r Lo ca lit y Ch ie fd om /z on e Po pu la tio n DH M T Po pu la tio n DH M T + 5% b uff er st oc k 6– 11 m (2 %) 12 –5 9 m (1 3. 7% ) 5– 13 y (2 8% ) > 14 y (5 4. 5% ) 6– 11 m (2 %) 12 –5 9 m (1 3. 7% ) 5– 13 y (2 8% ) > 14 y (5 4. 5% ) 12 W el lin gt on C H C G ov t W el lin gt on 1 34 4 60 36 18 3 72 4 49 57 10 13 1 19 7 20 0. 09 0. 60 1.2 2 3. 16 5. 05 14 Ko ya T ow n C H C G ov t U pp er W el lin gt on 1 10 0 93 10 5 98 21 2 14 52 29 67 57 76 0. 03 0. 18 0. 36 0. 93 1.4 8 16 Al le n To w n C H C G ov t Al le n To w n 1 40 16 1 42 16 9 84 3 57 77 11 8 07 22 9 82 0. 10 0. 69 1.4 2 3. 68 5. 89 19 Al -K ha ta b C lin ic C H C M is si on C al ab a To w n 1 10 5 99 11 12 9 22 3 15 25 31 16 60 65 0. 03 0. 18 0. 37 0. 97 1.5 6 20 C al ab a To w n C H C G ov t C al ab a To w n 1 20 3 30 21 3 47 42 7 29 24 59 77 11 6 34 0. 05 0. 35 0. 72 1.8 6 2. 98 22 St L uk e' s C lin ic C lin ic M is si on C on go W at er 1 17 9 51 18 8 49 37 7 25 82 52 78 10 2 72 0. 05 0. 31 0. 63 1.6 4 2. 63 34 AW AK E C lin ic Pr iv at e Al le n To w n 1 42 30 44 42 89 60 8 12 44 24 21 0. 01 0. 07 0. 15 0. 39 0. 62 41 Fa m ily H om e M ov em en t C H P M is si on U pp er C al ab a To w n 1 86 03 90 33 18 1 12 38 25 29 49 23 0. 02 0. 15 0. 30 0. 79 1.2 6 44 Ad -B an gs Q ua rr y M C H P G ov t Bl ac kh al l R oa d 1 10 0 39 10 5 41 21 1 14 44 29 51 57 45 0. 03 0. 17 0. 36 0. 92 1.4 8 48 M ay em ie M C H P G ov t M ay em ie 1 12 6 02 13 2 32 26 5 18 13 37 05 72 11 0. 03 0. 22 0. 45 1.1 5 1.8 5 54 Ph ili p St re et M C H P Pr iv at e Ph ili p St re et 1 10 6 15 11 14 6 22 3 15 27 31 21 60 74 0. 03 0. 18 0. 38 0. 97 1.5 6 63 O ld D om in io n (E PI ) H os pi ta l Pr iv at e U pp er M el lo n W el lin gt on 1 10 3 00 10 8 15 21 6 14 82 30 28 58 94 0. 03 0. 18 0. 36 0. 94 1.5 1 To ta l W es te rn A re a 1 1 41 7 38 1 1 98 8 25 23 9 76 16 4 23 9 33 5 67 16 53 3 60 13 0 67 89 5 10 18 2 94 1 35 6 08 1 7 12 2 D H M T, d ist ric t h ea lth m an ag em en t t ea m ; m = m on th s; y = ye ar s; C H C , c om m un ity h ea lth c en tre ; C H P, c om m un ity h ea lth p os t; M C H P, m at er na l a nd c hi ld he al th p os t; EP I, Ex pa nd ed P ro gr am m e on Im m un iz at io n An ne x 5 EX AM PL E O F M IC RO -P LA NN IN G IN U RB AN W ES TE RN A RE A, S IE RR A LE O NE D es cr ip tio n of e ac h he al th fa ci lit y, ta rg et p op ul at io n pe r f ac ili ty , a ge d is tr ib ut io n an d vo lu m e of m at er ia l 74 Zo ne Na m e of fa ci lit y No . To ta l p op ul at io n pe r f ac ili ty Fa m ili es p er fa ci lit y Fa m ili es /d ay Fa m ili es /d ay / te am No . o f t ea m s re qu ire d No . o f t ea m s pr op os ed No . o f t ea m su pe rv iso rs No . o f C HW s pr op os ed 1 W el lin gt on 12 34 4 60 68 92 17 23 30 57 .4 57 11 114 Ko ya To w n 14 10 0 93 20 19 50 5 30 16 .8 17 3 34 Al le n To w n/ UP AL 16 40 16 1 80 32 20 08 30 66 .9 67 13 13 4 Al -K ha ta b Cl in ic 19 10 5 99 21 20 53 0 30 17 .7 18 3 36 Ca la ba To w n CH C 20 20 3 30 40 66 10 17 30 33 .9 34 7 68 St L uk e' s C lin ic 22 17 9 51 35 90 89 8 30 29 .9 30 6 60 AW AK E Cl in ic 34 4 23 0 84 6 21 2 30 7.1 7 1 14 Fa m ily H om e M ov em en t 41 8 60 3 17 21 43 0 30 14 .3 14 3 28 Ad -B an gs Q ua rr y 44 10 0 39 20 08 50 2 30 16 .7 17 8 34 M ay em ie 48 12 6 02 25 20 63 0 30 21 .0 21 42 Ph ilip S tre et 54 10 6 15 21 23 53 1 30 17 .7 18 7 36 O ld D om in io n (E PI ) 63 10 3 00 20 60 51 5 30 17 .2 17 34 H ol y M ar y Cl in ic 64 5 80 0 116 0 29 0 30 9. 7 10 2 20 To ta l Z on e 1 30 32 7 64 65 4 Nu m be rs o f t ea m s an d hu m an re so ur ce s re qu ire d pe r c at ch m en t a re a M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 75 Re qu ire m en ts fo r m at er ia l p er te am p er c at ch m en t a re a PH U, p er ip he ra l h ea lth u ni t; AS –A Q , a rte su na te + a m od ia qu in e No. OF PHUs Number of teams proposed Clipboard (1  /  team) Pen (4  /  team) Backpack (2  /  team) Badge holder (2  /  team) Badge for CHW (2  /  team) Daily tally sheet (2  /  team and day) Daily summary form (1  /  day   /  20 teams) Supervision check-list (1  /  day   /  20 teams) CHW briefing note (2  /  supervisor) Leaflet on AS–AQ, 2 faces, laminated Stock card (20  /  PHU) Badge for supervisor (1  /  supervisor) Badge holder for supervisor Folder with clip (2 per supervisor) A5 notebook (2  /  supervisor) Blue pen (2  /  supervisor) A5 thin notebook (2  /  team) Permanent marker (1  /  5 teams) Plastic pocket for SC (1  /  supervisor) Dosage chart (1  /  family) Plastic folder for documents (1  /  team) Plastic bag (1  /  team) 12 57 57 22 8 114 114 114 45 6 12 12 4 114 20 11 11 22 22 22 114 12 11 30 57 57 14 17 17 68 34 34 34 13 6 4 4 2 34 20 3 3 6 6 6 34 4 3 30 17 17 16 67 67 26 8 13 4 13 4 13 4 53 6 14 14 4 13 4 20 13 13 26 26 26 13 4 14 13 30 67 67 19 18 18 72 36 36 36 14 4 4 4 2 36 20 3 3 6 6 6 36 4 3 30 18 18 20 34 34 13 6 68 68 68 27 2 7 7 4 68 20 7 7 14 14 14 68 7 7 30 34 34 22 30 30 80 40 40 40 16 0 4 4 2 40 20 6 6 12 12 12 40 4 6 30 20 20 34 7 7 28 14 14 14 56 2 2 2 14 20 1 1 2 2 2 14 2 1 30 7 7 41 14 14 56 28 28 28 112 4 4 2 28 20 3 3 6 6 6 28 3 3 30 14 14 44 17 17 68 34 34 34 13 6 4 4 2 34 20 8 8 16 16 16 34 4 8 30 17 17 48 21 21 84 42 42 42 16 8 5 5 2 42 42 5 30 21 21 54 18 18 72 36 36 36 14 4 4 4 2 36 20 7 7 14 14 14 36 4 7 30 18 18 63 17 17 68 34 34 34 13 6 4 4 0 34 34 4 30 17 17 64 10 10 40 20 20 20 80 2 2 0 20 20 2 2 4 4 4 20 2 2 30 10 10 … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … 68 1 8 29 1 8 29 7 31 6 3 65 8 3 65 8 3 65 8 14 6 32 38 6 38 6 14 60 36 58 13 60 73 0 73 0 14 60 14 60 14 60 3 65 8 1 8 29 73 0 2 04 0 1 8 29 1 8 29 76 Annex 6 STEP-BY-STEP PROCEDURE FOR PREPOSITIONING SUPPLIES Identify and train the person who will be responsible for following up and managing stocks at each distribution point. Deliver the material. Calculate the quantity of medicines to be dispatched to each distribution point according to the estimated target population of the catchment area by age group. Include a buffer stock. It may be advisable to keep part of the buffer stock (about half) in a central or district storage place to ensure capacity to react to unpredicted shortages. Organize all other necessary logistic material into kits to simplify distribution. The amounts per kit should be calculated according to the numbers of teams and supervisors. Calculate the volume and weight of the supplies in order to organize adequate transport. Use tracking tools, such as waybills, for transport of supplies, with details of quantities and batch numbers to ensure traceability. Upon reception of the order, the person responsible in each peripheral health facility should verify that the delivered goods correspond to those listed on the waybill before signing the receipt form. CC: Icons created by Gan Khoon Lay, BomSymbols, Symbolon, Jose Morbán, Sribala, David, BomSymbols Maxim David, ProSymbols for the Noun Project 1 4 7 2 5 3 6 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 77 Annex 7 EXAMPLE OF RADIO SPOT ON MDA FOR MALARIA (USED IN SIERRA LEONE IN 2014–2015) V1. Good morning, friend!! V2. Good morning. How are you? V1. Fine. Yesterday, I received the blister for the malaria treatment. Did you? V2. Yes. All my family and I took the first dose yesterday in the afternoon. And you? V1. No, we didn’t take it. V2. Why didn’t you take it? V1. Because nobody in the family has fever. V2. In our family nobody had fever, but we took it to prevent malaria fever because we don’t want to get sick. V1. But before we never took it when we were not sick. Why should we do it now? V2. Because now there is an EVD outbreak ongoing, so if you have fever you can become a suspect of EVD. A lot of EVD symptoms can be mistaken with malaria symptoms. (*) In any case, you and your family will be protected against malaria for 1 month and it is for free. V1: Ok, you are right. I’m going home now to start the treatment with my family. V2: Do you remember how to take it? V1: Yes. The community health worker explained to me that we have to take it during three consecutive days to finish the treatment properly. V2: Do you have any other doubt? V1: No, we are going to take the tablets according to the age category like the CHW told me. But if I have any doubt I will ask the CHW. V2: Good!!!! Have a nice day V1: You too and thank you. Now we will be malaria free!!!! *This section should be adapted to each MDA situation 78 Annex 8 EXAMPLES OF DISCUSSION POINTS ON MDA FOR USE AT COMMUNITY MEETINGS (ADAPTED FROM THOSE USED IN SIERRA LEONE IN 2014–2015) 1. What is MDA? 2. Goal of the campaign 3. The medication, how to take it and exclusion criteria The medication: How to take it Exclusion criteria (people who must NOT take it) Stick to the medicine and dosage for the age group. Wrong doses can cause: • Incomplete treatment = incomplete protection • Overdose = increase in possible side-effects 4. Possible side-effects and what to do 5. Explanation of the process 6. Roles of community leaders • ensure community awareness and acceptance of the campaign • sensitize importance of adherence (taking full treatment) • ensure awareness of correct dosage 7. Role of distributors and CHWs • sensitize community before and during MDA • distribute antimalarial tablets to target beneficiaries • tally all medicines distributed with the data collection tools 8.Team members: Two CHWs per team will be assigned by area and community. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 79 Annex 9 HOUSEHOLD VISIT FOR MDA, STEP BY STEP MASS DRUG ADMINISTRATION, VISIT STEP BY STEP Obtain oral consent to participate. Greet the people politely in local language and introduce yourselves. Ask for the head of the household and verify whether all members of the household are present.Explain the objectives and provide information about the MDA using visual aids. Check eligibility criteria - Exclusion criteria: » First trimester of pregnancy » Infants under 6 months old » Known allergy to any of the medication » Critically ill patients » Contraindications to the medicines Explain to excluded people why they don’t receive the treatment. Distribution of an appropriate blister according to age category. Administer the first dose under DOT. For small children, crush the tablet and dissolve it with water. Repeat dose if vomiting occurs within 30 minutes of administration. Educate the participants on how to take the remaining doses for day 2 and day 3 using a visual aid to support the explanations and / or printed leaflets. Provide clear messages on the need to ensure adherence to full treatment course. Provide information concerning possible side effects and what to do in case they occur. For women of reproductive age (15-49 years old): » If visibility pregnant (assume second or third trimester): she may receive the medicine » If pregnancy not apparent: first trimester pregnancy should be excluded either based on personal history or on pregnancy test. Ask the members of the household if they have any specific questions and clarify any doubts they may have. Mark the tally sheet after the person has taken the first dose and / or fill in the registration book. Thank the household members and move to the next household. Where applicable, upon departure, mark the house with chalk as either “complete”, “incomplete” and if no one is home at the time of the visit, do not mark it. Revisit the house at a later time in the day or the following day in the case that the distribution was incomplete or no one was home. 1 4 7 8 9 10 5 6 2 3 CC: Icons created by Wilson Joseph, Gregor Cresnar, Dinosoft Labs, 23 icons, Yorlmar Campos, To Uyen, Loudoun Design Co., Arthur Shlain, from the Noun Project 80 Annex 10 ALGORITHM TO ASSIST COMMUNITY HEALTH WORKERS IN APPLYING EXCLUSION CRITERIA * A list of medicines that prolong the QT interval that are available and are the most frequently used in the country should be given to the CHW. DHA-PPQ, dihydroartemisinin–piperaquine; AS-AQ, artesunate–amodiaquine Ask and observe whether the person is severely ill. Do not administer antimalarial medicine, and refer to nearest health facility. Do not administer antimalarial medicine. The person is not taking other medicine. Administer the antimalarial medicine, and advise the patient where to seek care if adverse events occur. Do not administer DHA-PPQ or AS-AQ. Do not administer AS-AQ. The person is taking medication with no known interactions. The person is taking medicine that prolongs the QT interval.* The person is taking zidovudine, efavirenz or co-trimoxazole. Follow algorithm to exclude pregnancy. Is the individual a woman of reproductive age (15–49 years old)? Ask about known allergy to the antimalarial medicine or other ACT. Ask if the person is taking any medicine and, if so, to show it to you. Yes No No No Yes Yes M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 81 Annex 11 ALGORITHM FOR DETERMINING THE PREGNANCY STATUS OF WOMEN OF REPRODUCTIVE AGE (15–49 YEARS) (BASED ON AND ADAPTED FROM ALGORITHMS USED IN MALARIA MDA IN MOZAMBIQUE BY THE CENTRO DE INVESTIGAÇÃO EM SAÚDE DE MANHIÇA) Ensure privacy and explain risk and benefits of ACT in pregnancy. AdultAdolescent Assume not pregnant trimester Report pregnancy Visibly pregnant Assume in second or third trimester. Administer ACT. Do not administer ACT. Pregnancy not apparent Positive Consider that the woman may be in the first trimester. Refuses pregnancy test Report not pregnant or does not know. Ask if menstrual periods have started Ask about pregnancy status. Negative Offer options according to risk and benefits. Offer a pregnancy test. No Yes Yes 82 Annex 12 EXAMPLE OF LAMINATED LEAFLET USED BY COMMUNITY HEALTH WORKERS IN SIERRA LEONE IN 2014-2015 TO EXPLAIN TREATMENT DOSAGE • Take the tablets ONLY according to age. • Take tablets each day for 3 consecutive days (at the same time). DAY 1 DAY 2 DAY 3 6-11 months 1 crushed baby tablet 1 crushed baby tablet 1 crushed baby tablet 1-5 years 1 young child tablet 1 young child tablet 1 young child tablet 6-13 years 1 child tablet 1 child tablet 1 child tablet Adult 2 adult tablets 2 adult tablets 2 adult tablets • For children, crush the tablet in a clean eating spoon and mix with water. • This treatment may cause temporary side effects (vomiting, headache, dizziness, skin itch) which may last for 1 or 2 hours. • This treatment protects against malaria for ONE month M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 83 An ne x 13 DA IL Y TA LL Y SH EE T – AN TI M AL AR IA M DA To ta l H ou se ho ld s vi si te d O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O T ot al : RE SI DE NC Y ST AT US RE SI DE NT VI SI TO R O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Te am N um be r . ... ... ... ... ... ... ... ... ... ... ... ... ... ... D at e ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . D ay o f c am pa ig n . ... ... ... ... ... ... ... ... ... ... ... . D ist ric t: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. 6- 11 M O NT HS 1- 5 YE AR S 6- 13 Y EA RS 14 Y EA RS A ND A BO VE Total distributed Tr ea tm en ts d is tr ib ut ed O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Total excluded C as es e xc lu de d du e to re fu sa l t o pa rt ic ip at e O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: C as es e xc lu de d du e to pr eg na nc y (1 st tr im es te r) O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: C as es e xc lu de d du e to ot he r e xc lu si on c ri te ri a O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Zo ne / Ar ea : . ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. H ea lth fa ci lit y ca tc hm en t a re a: ... ... ... Vi lla ge /n ei gh bo ur ho od : . ... ... ... ... ... ... ... . EX AM PL E O F TA LL Y SH EE T (A DA PT ED F RO M T H AT U SE D IN S IE RR A LE O NE IN 2 01 4– 20 15 ) D ai ly m on ito rin g of a nt im al ar ia l co ns um pt io n N ot e: a ge g ro up s sh ou ld b e ad ap te d to b lis te r p re se nt at io n of a nt im al ar ia l m ed ic in e us ed N am e of T ea m L ea de r . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . N am e of S up er vi so r: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. BL IS TE R PA CK NU M BE R O F BL IS TE RS R EC EI VE D NU M BE R O F BL IS TE RS R EM AI NI NG A T TH E EN D O F TH E DA Y NU M BE R O F BL IS TE RS U SE D Bl is te rs 2 -1 1 m on th s (4 .5 k g- 9 k g) Bl is te rs 1- 5 ye ar s (9 -1 8 kg ) Bl is te rs 6 -1 3 (1 8- 35 k g) Bl is te rs ≥ 14 y ea rs (> 3 5 kg ) 84 An ne x 14 EX AM PL E O F A H O US EH O LD R EG IS TR AT IO N FO RM (A DA PT ED F RO M T H E ZA M BI A M DA P RO G RA M M E D EL IV ER Y H AN D BO O K) H O US EH O LD R EG IS TR AT IO N FO RM Household Number/ID Head of household Date Name of participant Age (years) Sex (M/F) Relation to head of household Occupation (C: child, S: student, H: housewife, F: farmer U: unemployed, O: other) Residency status (P: permanent resident, T: Temporary resident, V: visitor) Resent at the time of visit (Y/N) Received treatment (Y/N) If treatment not received, state reason (R. refusal E: exclusion criteria) State reason for refusal to participate DO T Comments D1 D2 D3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15D ist ric t ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . Zo ne .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... N am e of C H W .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... H ea lth fa ci lit y ca tc hm en t a re a ... ... ... ... ... ... ... ... ... ... ... . Vi lla ge N am e .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 85 Annex 15 EXAMPLE OF SUPERVISORS’ CHECKLIST USED IN SIERRA LEONE IN 2014-2015 SIERRA LEONE HOUSE TO HOUSE MDA OF ASAQ-DECEMBER 2014 Supervisor Checklist for House to House Teams 1. Are all team members present? Y or N 2. Is any of the team members a CHW in the area? Y or N 3. How many team members were trained? Write number 4. Does the team carry a movement map / plan with them? Y or N 5. Does the team have sufficient chalk for house marking? Y or N 6. Does the team have sufficient ASAQ doses for all categories? Y or N 7. Does the team have all the recording tools? Y or N 8. Does the team record information on the correct form? Y or N 9. Does the team mark the houses before leaving? Y or N 10. Was the team supervised at least once a day by the team supervisor (in the field)? Y or N 11. Did the supervisor sign and indicate time of visit on the daily tally sheet? Y or N 13. Does the team have any problems that require immediate intervention? Y or N If Yes, explain in comments field Comments: 12. Are the teams meeting their daily target? Y or N If No, provide reason(s) and action intended: A. .......................................................................................................................... B. .......................................................................................................................... C. ......................................................................................................................... TEAM NUMBER 1 2 3 4 5 District ............................................................................... Chiefdom / Zone ............................................................. Urban: Rural: Supervisor Name ........................................................... Function ............................................................................ Date ................................................................................... INSTRUCTIONS Use this form to supervise distribution of ASAQ teams during Mass drug administration implementation. Take corrective actions as needed. Give feedback to team after supervision. Thank and encourage the teams. Household Number/ID Head of household Date Name of participant Age (years) Sex (M/F) Relation to head of household Occupation (C: child, S: student, H: housewife, F: farmer U: unemployed, O: other) Residency status (P: permanent resident, T: Temporary resident, V: visitor) Resent at the time of visit (Y/N) Received treatment (Y/N) If treatment not received, state reason (R. refusal E: exclusion criteria) State reason for refusal to participate DO T Comments D1 D2 D3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 86 Annex 16 EXAMPLE OF MDA CARD MALARIA MDA CARD FOR PARTICIPANT DATE TREATMENT PROVIDED NUMBER OF TABLETS DOT (Y / N) OBSERVATIONS ROUND 1 D1 D2 D3 ROUND 2 D1 D2 D3 ROUND 3 D1 D2 D3 District ............................................................................... Name ................................................................................. Adress ................................................................................ Health Center .................................................................. Age ..................................................................................... Weight ............................................................................... M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 87 Annex 17 EXAMPLE OF DAILY SUMMARY SHEET TO BE COMPLETED BY DISTRIBUTION TEAM SUPERVISORS (ADAPTED FROM THAT USED IN SIERRA LEONE IN 2014–2015) DAILY SUMMARY SHEET - MALARIA MDA Note: age groups should be adapted to blister presentation of antimalarial medicine used Supervisor ........................................................................ Date ................................................................................... Day of campaign .......................................................... District ............................................................................... Zone/area ........................................................................ Health facility catchment area .................................. Resident status 6 to 11 months 1 to 5 years 6 to 13 years 14 years and above TE AM N UM BE R NU M BE R O F HO US EH O LD S VI SI TE D RE SI DE NT S VI SI TO RS TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O P RE G NA NC Y 1S T TR IM ES TE R EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O P RE G NA NC Y 1S T TR IM ES TE R EX CL UD ED D UE T O O TH ER E XC LU SI O NC RI TE RI A TOTAL 88 An ne x 18 EX AM PL E O F DA TA BA SE F O R DA TA C O M PI LA TI O N (U SE D IN S IE RR A LE O NE IN 2 01 4– 20 15 ) DA IL Y SU M M AR Y RE PO RT IN G F O RM D ist ric t… …… …… …… …. . W AR NI NG ! O NL Y CO M PL ET E BL AN K CE LL S! !! D at e: … …… …… …… …. . IN FA NT 6 -1 1 M O NT HS TO DD LE R 1- 4 YE AR S PHU NUMBER NAME OF CHIEFDOM/ZONE NAME OF PHU CATCHMENT AREA TOTAL NUMBER OF HOUSEHOLDS TO BE VISITED FOR THE ENTIRE CAMPAIGN (TARGET) NUMBER OF HOUSEHOLDS (ACTUAL RESULT) % HOUSEHOLD COVERED % HOUSEHOLD COVERED TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! To ta l 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 89 AD O LE SC EN T 5- 14 Y EA RS AD UL TS 14 Y EA RS A ND A BO VE G RA ND T O TA L TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TOTAL TARGET POPULATION TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL % ASAQ DISTRIBUTED (COVERAGE) 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 90 Annex 19 EXAMPLE OF STANDARD TEMPLATE FOR REPORTING A SUSPECTED ADVERSE DRUG REACTION PATIENT DETAILS Name .......................................................................... Date of report: .......................................................... Age ................................ Sex ................................. Weight (kg) ................................................................. Address: ................................................................................................................................................................................. Pregnant: Yes No If yes, trimester of pregnancy .......................................................................................................................................... Hospital or treatment centre ........................................................................................................................................... Relevant medical history .................................................................................................................................................. ................................................................................................................................................................................................... SUSPECTED DRUG OR PRODUCT Brand name ................................ Strength ....................................... Generic name ............................. Name of manufacturer ............................................. Daily dose .................................................................. Date of manufacture ................. Expiry date .................................. Batch number ............................. Starting date of medication ..................................... Route of administration ............................................ Drug discontinued because of event: Yes No Date .............................................. DRUGS OR PRODUCTS TAKEN CONCOMITANTLY (INCLUDING HERBAL MEDICATION) Specify brand and generic name, dosage, route, day started, day stopped ................................................................................................................................................................................................... ................................................................................................................................................................................................... M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 91 ADVERSE REACTION Details of the reaction experienced by the patient: ................................................................................................................................................................................................... ................................................................................................................................................................................................... ................................................................................................................................................................................................... Date and time the reaction started ........................ Date and time the reaction ended ......................... Did patient require hospital admission? Yes No Duration of hospitalization ............................... Reason for reporting Requires or prolongs hospitalization Permanently disabling or incapacitating Other (please specify) .................................................................................................................................................. CONDITION OR OUTCOME AT TIME OF LATEST OBSERVATION Full recovery Ongoing illness Persistent, significant disability, incapacity Other (please specify) .................................................................................................................................................. DETAILS OF HEALTH CARE PROFESSIONAL OR REPORTER Life threatening Congenital anomaly Death Overdose Name ................................................................................. Adress ................................................................................ Signature .......................................................................... Function. ........................................................................... Telephone number ........................................................ Institution .......................................................................... 92 GUIDELINES FOR FILLING IN THE FORM An adverse event is “serious” if it • is life threatening • results in hospitalization • prolongs hospitalization • causes malignancy • is an overdose resulting in clinically relevant signs and symptoms • results in permanent disability • is fatal • causes a birth defect • causes relevant organ toxicity An adverse drug may be a manifestation of: • complications of an underlying disease • coincidental accident • concomitant medication • intercurrent disease • drug-associated effect M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 93 Annex 20 EXAMPLE OF QUESTIONNAIRE FOR POST-MDA SURVEY The following questions should be asked of each person over 6 months of age (parent or guardian of children). A. SOCIODEMOGRAPHICS 1) Age (years) ........................................................................................................................................................................ 2) Sex: Male Female 3) Status of residence in the household: Permanent Temporary visitor 4) Marital status: Single Married Widower or widow Divorced or separated Uncertain or no response 5) Level of education completed: None Primary level Secondary level Tertiary level (college or university degree) Uncertain or no response 6) Occupation: Student Farmer Herdsman Merchant or trader Village ............................................................................... Household no. ................................................................. Interviewer’s name ....................................................... Cluster no. ........................................................................ Survey date ..................................................................... Supervisors’ names ....................................................... 94 Constructor Driver Professional or civil servant Labourer (daily, seasonal or long-term) Retired or too old to work None or unemployed Uncertain or no response Other. Specify: ................................................................................................................................................................ B. INFORMATION ON MDA CAMPAIGN 1) Were you informed about the malaria MDA campaign? Yes No Uncertain or no response 2) Did you receive the malaria medication during the campaign? Yes No Uncertain or no response If yes, go to question 4. 3) Why didn’t you receive the medicines? I was travelling or I was not in town I was too busy to wait for the distributors or to go to the distribution site I do not trust the organizers of the campaign or the ministry of health Malaria is not a problem for me I never take any medicine I only take traditional medicine I did not know what the medicine was for I was pregnant I was taking other medicine at the time I was too sick I am allergic to the medicine Other. Specify ................................................................................................................................................................. Uncertain or no response Questionnaire ends here. 4) Did the person who gave you the medicine watch you take the first dose? Yes No Uncertain or no response M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 95 5) Did the person who gave you the medicine explain to you how to take the next doses? Yes No Uncertain or no response If no, go to question 7. 6) Tell us how she or he explained how to take the medicine. Correctly Incorrectly Uncertain or no response The interviewer should mark “correctly” or “incorrectly” according to the interviewee’s explanation. 7) How many doses of the medicine given by the distributor did you take? None 1 dose 2 doses 3 doses Uncertain or no answer 8) Can you show us evidence that you completed the treatment (empty blister or pill count)? Yes No 9) Did you take the complete treatment as recommended? Yes No Uncertain or no response If yes, go to question 11. 10) Why didn’t you take the treatment as recommended by the distributor? I forgot to take the medicine. I did not want to take it. Reason: I was too sick I saved the tablets for when I get sick I gave the treatment to or shared the treatment with someone else I was afraid of side-effects of the medicine I was told by a family member or friend not to take it I was told by a health professional not to take it Other people became sick after taking the medicine The medicine tastes disgusting Other, specify ................................................................................................................................................................. Uncertain or no answer 11) Did you experience any side-effects after taking the medicine? Yes No Uncertain or no response If no, end of questionnaire. 96 12) Which side-effects did you have? (More than one answer possible) : 13) How long after taking the tablets did you experience the side-effect? Less than 30 min Between 30 min and 1 h Between 1 h and 24 h Other. Specify ................................................................................................................................................................ 14) How did you manage the side-effect? I did nothing I took some medicine I visited a health professional or health facility Uncertain or no answer 15) Did you know of any emergency centre or hotline to call in case of side-effects? Yes No Uncertain or no response If no, end of questionnaire. 16) Did you call the emergency centre or hotline for help? Yes No Uncertain or no answer Loss of appetite Headache Weakness Other, specify ............................................................. Skin reaction Abdominal pain Nausea and / or vomiting Diarrhoea Dizziness Difficulty in sleeping Drowsiness Heart palpitations M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 97 Annex 21 EXAMPLE OF PHARMACOVIGILANCE PREPAREDNESS CHECKLIST (USED IN SIERRA LEONE IN 2014–2015) Instructions This is a working document. Start using it now by ticking (√ ) those items that have been accomplished. District: .................................................................................................................................................................................... Chiefdom ............................................................................................................................................................................... Facility .................................................................................................................................................................................... SUBJECT COMPLETED COMMENTS Staff 1. Is at least one person aware of pharmacovigilance monitoring during the artesunate–amodiaquine campaign? 2. Have all staff been apprised of the basics of pharmacovigilance monitoring? 3. Have all staff been trained in recognizing ADRs? 4. Do all staff know the correct dose of artesunate–amodiaquine 5. Is a plan in place to cover hard-to-reach areas? 5. Is there a map of the catchment area? 5. Are there adequate quantities of the following (Assess quantities supplied against target population) artesunate–amodiaquine oral rehydration salts paracetamol chlorphenamine Advocacy and social mobilization 1. Has there been a health talk in the community about compliance and adherence to artesunate–amodiaquine? 2. Is information available at the public health unit about ADR monitoring? Name of person completing the checklist ................................................................................................................... Signature ......................................................................... Date .................................................................................. 98 Annex 22 EXAMPLE OF AN MDA PHARMACOVIGILANCE TRAINING MODULE CURRICULUM FOR DRUG DISPENSERS The curriculum is divided into four modules, based on the chronology and structure of the WHO–ISOP curriculum (1). The content should be adapted to the pharmacovigilance requirements in the country and opportunities taken to integrate it with other training sessions for drug dispensers. Introduction The curriculum is based on several packages of topics and concepts of PV teaching used by WHO and WHO collaborating centres (2). It was designed for programmes of seasonal malaria chemoprevention and adapted for use in malaria MDA. Purpose of the course The aim of the course is to enable health workers and drug dispensers to detect, report and follow-up on suspected adverse drug reactions during malaria MDA. Target group The course is designed for drug dispensers involved in MDA, who may have very have limited medical knowledge but are present in the community at the time of the operation. They interact directly with all household members when administering the first dose, dispense and counsel carers on administering the remaining doses and provide advice on possible adverse drug reactions and where to report them. They should be able to refer people with serious adverse events and report them. Course duration The material is designed to be covered in 1 day. Sections can be reduced and prioritized if training time is limited. Course content Module one: What are adverse drug reactions and why should we monitor them? • Importance of adverse drug reactions in the context of MDA Module two: Adverse drug reactions and medication errors • Serious adverse drug reactions • Adverse events associated with medicines and concomitant medication • Administration of medicines in MDA, medication errors and their consequences, particularly over-dosing M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 99 Module three: Reporting suspected adverse reactions • Completion and use of reports and referral notes Module four: Communication • Effective communication with patients and health professionals • Managing rumours at community level References 1. Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ et al. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf. 2014;37:743–59. 2. §ISoP – PV curriculum – search. London: International Society of Pharmacovigilance; 2017 (http://isoponline.org/pv-links/, accessed 17 August 2017).

For further information please contact: Global Malaria Programme World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Email: infogmp@who.int ISBN 978-92-4-151310-4

Mass drug administration for falciparum malaria A practical field manual

Mass drug administration for falciparum malaria A practical field manual ii Mass drug administration for falciparum malaria: a practical field manual ISBN 978-92-4-151310-4 (electronic version) ISBN 978-92-4-000773-4 (print version) © World Health Organization 2017 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 disclaimer 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. Mass drug administration for falciparum malaria: a practical field manual. Geneva: World Health Organization; 2017. 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. Contents Acknowledgements vii Abbreviations and acronyms viii Executive summary ix 1. INTRODUCTION 1 1.1 Background 1 1.2 Definitions 1 1.3 Objective 1 1.4 WHO recommendations 2 2. ORGANIZATION AND IMPLEMENTATION OF MASS DRUG ADMINISTRATION 3 2.1 Design phase (macroplanning) 3 2.1.1 Identify agencies to support the ministry of health 3 2.1.2 Establish a task force or coordinating committee 4 2.1.3 Conduct a context analysis 6 2.1.4 Determine the target population and geographical areas 7 2.1.5 Choose the antimalarial medicine 10 2.1.6 Estimate the requirement for antimalarial medicine, and order it 13 2.1.7 Determine the delivery strategy 13 2.1.8 Determine the period of intervention 14 2.1.9 Determine the number of rounds 15 2.1.10 Establish a chronogram 17 2.1.11 Draw up a budget 17 2.2 Planning and preparation 18 2.2.1 Micro-planning 18 2.2.2 Logistics 20 2.2.3 Human resources 22 2.2.4 Community engagement, social mobilization and communication 26 2.3 Implementation 32 2.3.1 Stock management 32 2.3.2 Distribution of antimalarial medicine 34 2.3.3 Supervision 37 2.3.4 Data collection 39 iii 2.3.5 Coordination 42 2.3.6 Treatment of malaria cases after mass drug administration 43 3. MONITORING AND EVALUATION 44 3.1 Monitoring system 44 3.2 Estimate of coverage 44 3.2.1 Distribution coverage 44 3.2.2 Post-MDA campaign survey 46 3.3 Monitoring consumption 46 3.4 Pharmacovigilance 47 3.4.1 Definitions 48 3.4.2 Safety communication 49 3.4.3 Surveillance of adverse drug reactions 49 3.5 Monitoring drug resistance 50 3.6 Evaluating impact 51 4. REPORTING 53 5. KEY STEPS IN A MASS DRUG ADMINISTRATION CAMPAIGN FOR MALARIA 55 REFERENCES 56 ANNEXES 59 Annex 1 - Standard distribution of populations in a developing country 59 Annex 2 - Available artemisinin-based combination therapy: dosing, formulation and presentation 60 Annex 3 - Example of calculation of orders for antimalarial medicine 66 Annex 4 - Example of a chronogram for mass drug administration for malaria (distribution at 8 weeks) 69 Annex 5 - Example of micro-planning in urban Western Area, Sierra Leone 72 Annex 6 - Step-by-step procedure for prepositioning supplies 75 Annex 7 - Example of radio spot on MDA for malaria (used in Sierra Leone in 2014–2015) 76 Annex 8 - Examples of discussion points on MDA for use at community meetings (adapted from those used in Sierra Leone in 2014–2015) 77 iv Annex 9 - Household visit for MDA, step by step 78 Annex 10 - Algorithm to assist community health workers in applying exclusion criteria 79 Annex 11 - Algorithm for determining the pregnancy status of women of reproductive age (15–49 years) (based on and adapted from algorithms used in malaria MDA in Mozambique by the Centro de Investigação em Saúde de Manhiça) 80 Annex 12 - Example of laminated leaflet used by community health workers in Sierra Leone in 2014-2015 to explain treatment dosage 81 Annex 13 - Example of tally sheet (adapted from that used in Sierra Leone in 2014–2015) 82 Annex 14 - Example of a household registration form (adapted from the Zambia MDA programme delivery handbook) 83 Annex 15 - Example of supervisors’ checklist used in Sierra Leone in 2014-2015 84 Annex 16 - Example of MDA Card 85 Annex 17 - Example of daily summary sheet to be completed by distribution team supervisors (adapted from that used in Sierra Leone in 2014–2015) 86 Annex 18 - Example of database for data compilation (used in Sierra Leone in 2014–2015) 87 Annex 19 - Example of standard template for reporting a suspected adverse drug reaction 89 Annex 20 - Example of questionnaire for post-MDA survey 92 Annex 21 - Example of pharmacovigilance preparedness checklist (used in Sierra Leone in 2014–2015) 96 Annex 22 - Example of an MDA pharmacovigilance training module 97 v

M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL vii Acknowledgements This operational manual on mass drug administration (MDA) for malaria is based on practical field experience in the great majority of MDA operations that have been completed over the past 10 years in malaria-endemic countries. The main author was Dr Carolina Nanclares (Médecins Sans Frontières, Spain), who prepared an excellent first draft and finalized it after careful consideration of the suggestions of multiple reviewers. Dr Nanclares based the first draft on experience and lessons learnt during widescale MDA in Sierra Leone during the epidemic of Ebola virus disease, completed in 2014–2015. The following colleagues from MSF Spain who participated in that campaign provided input on the first draft: Jonathan Caplan, Fernanda Falero, Adriana Ferracin Kleivan, Segimon Garcia, Maria Green, Yves Houedakor, Cristina Imaz, Nines Lima and Charlotte Oliveira. The WHO Global Malaria Programme then convened a drafting committee consisting of technical resource officers who contributed to control of malaria by MDA and research in: Cambodia, Comoros, Mozambique, Myanmar, Sierra Leone, Thailand, Viet Nam and Zambia. The first draft was sent by email to all the invited participants one month before the meeting, and all input received before the meeting was included in the second version, which was used as the basis of the work of the drafting committee. The meeting was held on 22–23 November 2016 in Geneva, where the members of the committee (listed below) were divided into four working groups to review and finalize the practical aspects of the different sections of the manual. During the last session of the meeting, the groups presented their conclusions in plenary, bringing to resolution the points that required consensus. Dr Nanclares, as rapporteur of the meeting, then compiled a third version that included all the input from the four working groups, which was circulated to all participants by email for final review. The text of the manual is the result of a fourth round of reviews by members of the drafting committee and the WHO Secretariat. We are very grateful to the following members of the drafting committee, who graciously reviewed all the sections of the report in several rounds, providing substantive comments that were instrumental for its finalization and improvement: Gilles Delmas (Mahidol-Oxford Tropical Medicine Research unit, Thailand), Stephan Duparc (Medicines for Malaria Venture, Switzerland), Busiku Hamainza (National Malaria Control Centre, Zambia), James Heaton (Mahidol-Oxford Tropical Medicine Research unit, Myanmar), Umu Jalloh (Pharmacy Board, Sierra Leone), Anitta Renitta Yokoe Kamara (National Malaria Control Programme, Ministry of Health and Sanitation, Sierra Leone), Calveston Machila (District Medical Office, Zambia), Joseph Mberikunashe (National Malaria Programme Control, Zimbabwe), Thuy-Nhien Thanh Nguyen (Centre for Tropical Medicine, Viet Nam), Francisco Saute (Manhiça Health Research Center, Mozambique), Jianping Song (Guangzhou University of Chinese Medicine, China) and Khieu Virak (National Centre for Parasitology, Entomoloy and Malaria Control, Cambodia). The draft manual also received input from the WHO Malaria Policy Advisory Committee at its session on 22–24 March 2017, which, with additional suggestions from the WHO Secretariat at the Global Malaria Programme, were taken into account in the final version of the document. At WHO, Andrea Bosman, Global Malaria Programme, coordinated preparation of the manual and represented the WHO Secretariat in the the drafting committee. Precious contributions were also made by Dr Maru Aregawi, Peter Olumese and Silvia Schwarte, Global Malaria Programme, and by Prabhjot Singh, WHO Regional Office for the Americas. Funding for the production of this report was provided the Bill & Melinda Gates Foundation. viii Abbreviations and acronyms ACT artemisinin-based combination therapy ADR adverse drug reaction CHW community health workers DOT directly observed treatment EVD Ebola virus disease G6PD glucose-6-phosphate dehydrogenase MDA mass drug administration M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL ix Executive summary Mass drug administration (MDA) consists of administering a full therapeutic course of antimalarial medicine (irrespective of the presence of symptoms or infection) to a defined population living in a defined geographical area (except for those for whom the medicine is contraindicated) at approximately the same time and often repeated at intervals. Recent progress in malaria control, including the use of others forms of preventive chemotherapy such as intermittent prevent treatment of malaria in pregnancy and seasonal malaria chemoprevention, the drive towards elimination of malaria in some settings and the availability of new antimalarial medicines, has renewed interest in the role that MDA can play in some settings. MDA should be viewed as a time-limited intervention with specific targets for when it should be discontinued, defined before implementation. Currently, on the basis of the evidence, WHO recommends MDA: • for interruption of transmission of falciparum malaria in areas approaching elimination, • to reduce the risk for spread of multi-drug resistance in the Greater Mekong subregion, • during malaria epidemics and • in exceptional complex emergencies. WHO recommends use of MDA for falciparum malaria, with two distinct, complementary objectives. The first is to reduce transmission of malaria, which is the primary aim of elimination and reduction of multi-drug resistance and is also relevant in malaria epidemics and complex emergencies. The objective is to quickly reduce the parasite biomass in a community and to prevent new infections for a certain period. Repeated rounds of MDA are given to remove parasites and prevent new infections in persons who were not reached in previous rounds. The expected result is a large reduction in transmission intensity. Synchronization of the intervention with high coverage of the entire population at risk is essential. In order quickly to reduce and potentially entirely interrupt transmission and avoid resurgence, several rounds are required, in combination with other malaria control tools and strategies such as effective vector control, access to prompt diagnosis and treatment and intensified surveillance. The second objective of MDA for falciparum malaria is rapid reduction of morbidity and mortality. This is a primary aim when falciparum transmission results in high mortality rates, as in epidemics and complex emergencies when health systems are overwhelmed and unable to provide core malaria preventive and curative services. In these settings, MDA is used as an initial emergency measure; several rounds are implemented while access to case management and vector control are being put in place. It is important to identify the population at risk for severe malaria and death in order to define the target groups for MDA. These may be either an entire population or specific vulnerable groups who are at high risk for mortality because of lack of vector control and access to effective case management. High coverage of such target populations is more important than synchronization, as the primary aim is to reduce morbidity and mortality in the target population and not to reduce malaria transmission. For MDA to be successful, high coverage and adherence of the target population (i.e. > 80%) must be ensured, which require a high level of community engagement and participation. Implementation strategies should therefore guarantee the highest level of participation possible. Door-to-door distribution is generally preferred to centralized distribution at a fixed site, and directly observed treatment (DOT), where feasible, is the best way to ensure adherence to treatment. xImplementing MDA for malaria is a complex, logistically challenging operation, which requires significant investments of resources (human, financial and logistic) as well as careful planning and organization. The intent of this manual is to provide technical and operational guidance on the practical aspects of organizing a successful MDA campaign for malaria. The main steps for efficient management are listed below. Design phase In this phase, the main strategies for MDA are established at national level: • Obtain commitment from policy-makers, and identify agencies to support the ministry of health. • Establish a task force or coordinating committee. • Conduct a context analysis. • Decide to implement MDA for falciparum malaria. • Define target areas and target population. • Choose the antimalarial medicine. • Estimate the requirements for the medicine, and procure it. • Determine the MDA strategy. • Estimate the budget. Planning and preparation phase This phase involves planning the operational aspects of the framework defined at national level: • Conduct micro-planning at province or district level according to the strategies defined by the national task force to guarantee an effective campaign by ensuring adequate distribution of supplies, training of staff, engagement of the community and proper management of resources. The micro-plan should include: - demographic information on the province or districts eligible for MDA; - information on the area (e.g. maps, infrastructure, location of health facilities, hard-to-reach areas); - timing of MDA in the district; - delivery strategies; - human resources (number required, number available) and training plan; - logistical information; - social mobilization and communications plan; and - pharmacovigilance plan. • Ensure effective logistics, taking into consideration: - procurement, storage and distribution of antimalarial medication; - procurement, storage and distribution of other supplies necessary for MDA; - transport; - accessibility to the entire target population, including those in hard-to-reach areas; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL xi - identification and preparation of distribution sites; and - waste management. • Plan human and financial resources: - number of teams required and composition, - training and - adequate payment of salaries and per diem. • Plan community engagement and social mobilization by - defining the roles and responsibilities of all partners; - assessing communities to understand the characteristics and social dynamics of the target population in order to orient the social mobilization plan; - preparing clear, simple, precise, consistent messages about MDA for malaria; - engaging the mass media by building relationships with local media representatives and diseminating information through the different media; - preparing to address negative rumours that may arise during the campaign, which could affect participation; and - Involving community leaders and other influential people in planning, so they will feel ownership of the campaign and its success. Implementation phase The implementation phase involves the actual distribution of antimalarial treatment and includes: • stock management: preparation of distribution kits with all the necessary materials ahead of time at the distribution point or peripheral health facility at which supplies are prepositioned; • distribution of the antimalarial medicine itself, either door to door or at a centralized, fixed site; • supervision, an essential component to ensure the quality of the campaign: at peripheral, district, regional and national levels; • data collection: collection and reporting of information on the number of people who receive treatment at community level, adverse drug reactions (ADRs) and analysis and compilation of data at higher levels through a well-established pathway of information flow; and • coordination of all actors to monitor activities, detect any difficulties or constraints, address them and react to unforeseen events. Monitoring and evaluation • intra-campaign monitoring system: a high-quality system for monitoring the campaign allows identification of constraints that require immediate action; can be done by monitors identified within the team or by independent monitors; • estimate of distribution coverage: the proportion of the target population that has been reached by distribution; • post-MDA survey: recommended, if feasible, after each round or at least at the end of the entire campaign to obtain more reliable information on coverage and to evaluate adherence to treatment, determine reasons for non-participation or non-adherence and evaluate the presentation of ADRs; xii • monitoring consumption: daily monitoring of the number of treatments distributed and the number taken; • pharmacovigilance: a vital component of an MDA, which should be planned to ensure training, detection, reporting, management of follow-up of adverse events and to promote and monitor adherence by both passive and active surveillance. This component is also essential to obtain and maintain good understanding and compliance of the population; • monitoring drug resistance: one of the main concerns with regard to MDA is the emergence and spread of drug resistance; although there is no evidence that MDA of artemisinin-based combined therapy (ACT) at therapeutic doses is related to the emergence of resistance, monitoring of resistance should be an essential component of an MDA campaign; • evaluation of impact: through routine surveillance and parasitological surveys to support a decision to stop; and • reporting: after each round and at the end of the intervention, of the coverage achieved, challenges and difficulties faced and solutions found, lessons learnt, practices with good results, effective social mobilization activities, useful tools and the costs of the intervention. In epidemics and complex emergencies, a minimum set of MDA monitoring and evaluation activities should be defined in order to document impact and for reporting. Although these steps are common to all settings, MDA for the purposes of reducing transmission of malaria or its elimination, for containing resistance, in response to an epidemic or in the event of a complex emergency may differ in ways outlined below in the corresponding sections. This manual is intended to provide general guidance. Some sections may not be relevant in all contexts and should be adapted to local circumstances (for instance, urban or rural settings). The manual also provides templates and examples from previous experience with MDA for malaria in various contexts that may be useful for developing training material or data collection. The majority of the tools are included in the annexes to this manual. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 1 1. INTRODUCTION 1.1 BACKGROUND Mass drug administration (MDA) has played a crucial role in the control and elimination of a number of prevalent neglected tropical diseases. The aim of the programmes has been to treat prevalent infection and to reduce transmission in the population simultaneously, hence decreasing the burden of the disease (1,2). Since the 1970s, MDA was not recommended as an anti-malaria intervention because of concern about its efficacy, especially the sustainability of the results, the logistical feasibility and the risk for accelerating drug resistance (3–5). Recent progress in malaria control, including the use of others forms of preventive chemotherapy, such as intermittent preventive treatment of malaria in pregnancy and seasonal malaria chemoprevention, together with the drive towards elimination of malaria in some settings and the availability of new antimalarial medicines, have renewed interest in the role that MDA can play in some settings (3,4,6,7), for example as part of work to contain multi- drug resistance and eliminate malaria transmission in the Greater Mekong subregion (8,9) and in certain complex emergencies, such as the 2013-2016 outbreak of Ebola virus disease (EVD) in West Africa (9–12). 1.2 DEFINITIONS Mass drug administration consists of the administration of a full therapeutic course of antimalarial medicine (irrespective of the presence of symptoms or infection) to every member of a defined population or person living in a defined geographical area (except for those for which the medicine is contraindicated) at approximately the same time and often at repeated intervals. (3,9). In order for MDA to be successful, a very high proportion, generally more than 80% of the targeted population must be reached during the campaign, depending on the intensity of transmission and the exact objective of the campaign (4,6,9,13,14). This requires a high level of community participation and engagement. It is not enough to reach the majority of the population with distribution: coverage will be effective only if the number of people in the community who correctly complete the full course of antimalarial treatment is adequate. To achieve this, the population must accept the intervention and be willing to take the medicine as prescribed. 1.3 OBJECTIVE The objective of malaria MDA is to provide therapeutic doses of antimalarial medicine to as large a proportion of the population as possible in order to cure all symptomatic and asymptomatic malaria infections at the time of the intervention and to prevent reinfection during the period of post-treatment prophylaxis. MDA at high coverage rapidly reduces the prevalence and incidence of malaria in the short term. Once MDA is stopped, however, malaria endemicity will return to its original level if importation of malaria is not prevented, in the absence of high coverage with other interventions such as vector control, case management, surveillance and response. The risk of such a return and the rapidity with which it occurs depend on the size of the residual parasite reservoir in humans, the rate of importation of new infections and the capacity of the vectors to transmit malaria in the target area. 21.4 WHO RECOMMENDATIONS On the basis of a recent review of the evidence (9) and the advice of the WHO Malaria Policy Advisory Committee, the current WHO recommendations for use of MDA, mass screening and treatment and focal screening and treatment for malaria (15) are listed below. 1. Use of MDA for the elimination of P. falciparum malaria can be considered in areas approaching interruption of transmission where there is good access to treatment, effective implementation of vector control and surveillance, and a minimal risk of re-introduction of infection. 2. Given the threat of multidrug resistance and the WHO call for malaria elimination in the Greater Mekong subregion (GMS), MDA may be considered as a component of accelerated malaria elimination efforts in areas of the GMS with good access to treatment, vector control and surveillance. 3. Use of Time-limited MDA to rapidly reduce malaria morbidity and mortality may be considered for epidemic control as part of the initial response, along with the urgent introduction of other interventions. 4. Use of Time-limited MDA to reduce malaria morbidity and mortality may be considered in complex emergencies, during exceptional circumstances when the health system is overwhelmed and unable to serve the affected communities. 5. In the absence of sufficient evidence, WHO does not recommend the use of MDA in situations other than for areas approaching elimination, epidemics, and complex emergencies, as specified above (see 1-4). 6. Mass primaquine prophylactic treatment, requiring pre-seasonal MDA with daily administration of primaquine for two weeks without G6PD testing, is not recommended for the interruption of vivax transmission. 7. Mass screening and treatment and focal screening and treatment for malaria are not recommended as interventions to interrupt malaria transmission. 8. Medicines used for MDA must be of proven efficacy in the implementation area and preferably have a long half-life. WHO recommends that a medicine different from that used for first-line treatment be used for MDA. Programmes should include monitoring of efficacy, safety and the potential emergence of resistance to the antimalarial medicines deployed for MDA. 9. WHO supports the need for mowre research on the optimum methods of implementing MDA programmes, promoting community participation and compliance with treatment, and evaluating their effectiveness. Modelling can help guide the optimum method of administering MDA in different epidemiological circumstances and predict its likely impact. In line with the above recommendations, this manual addresses use of MDA only for the control and elimination of falciparum malaria. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 3 2. ORGANIZATION AND IMPLEMENTATION OF MASS DRUG ADMINISTRATION 2.1 DESIGN PHASE (MACROPLANNING) Once it has been decided that MDA will be conducted, macroplanning should be started. This initial design phase, done at national level, is important to ensure a successful campaign and should involve the ministry of health and other key stakeholders. When MDA for malaria is done to impact on malaria transmission, the administration of antimalarial medicine must be done in such a way that all targeted individuals are treated in a synchronized manner and each round is completed in a very short time, generally not more than one week. In complex emergencies, when the main objective is rapid reduction of malaria morbidity and mortality, synchronous administration is less critical. Steps of the design phase: • Obtain commitment from policy-makers, and identify agencies to support the ministry of health. • Establish a task force or coordinating committee. • Conduct a context analysis. • Decide to implement MDA for falciparum malaria. • Define the target areas and target population. • Choose the medicine. • Estimate the requirements for the medicine and procure it. • Determine the delivery strategy (including period of intervention and number of rounds). • Estimate the budget. • Define the criteria for stopping MDA. As MDA targets every individual in a given population (except those with contraindications to the medicines used), it may be combined with other public health interventions, such as health education, deworming and distribution of long-lasting insecticide-treated nets; however, experience in combining multiple medicines or programmes is limited, and careful consideration should be given in advance. 2.1.1 Identify agencies to support the ministry of health MDA for malaria is a logistically challenging intervention, which will require careful planning and significant resources in order to be successful. Therefore, partners that can provide technical, financial and operational support should be identified and included in planning from the initial stages. The partners may be national (national and local government, the private sector, nongovernmental organizations, other civil society organizations, the media, community leaders, religious leaders) or international (funding agencies, procurement agencies and international nongovernmental organizations). Mapping donors and implementing partners is critical to the success of MDA. All should be encouraged to work within the framework of the “three ones” – one plan, one coordination and one monitoring and evaluation – under the oversight of the task force or coordinating committee. 4As MDA usually comprises multiple rounds for high coverage and, if the purpose is to interrupt transmission or elimination, may be repeated in subsequent years, it is therefore important to secure sustained support to ensure satisfactory completion of the intervention. Malaria services should be in place and supported in monitoring communities in the long term after the MDA has been completed. 2.1.2 Establish a task force or coordinating committee A task force or coordinating committee, under the stewardship of the Ministry of Health, must be created with representation from national, regional and target district level to serve as an oversight body in charge of implementation of the MDA campaign and ensure adequate allocation of resources. Composition The committee may include representatives from: • the national malaria control programme; • other relevant entities of the ministry of health, for example medicines, community health, neglected tropical diseases or other programmes with experience in MDA; • national research institutions; • the national medicines regulatory authority; • the national pharmacovigilance centre; • national, regional and relevant district health authorities; • technical personnel from relevant hospitals; • administrative authorities; • support agencies (the United Nation Children’s Fund, WHO, other United Nations agencies, nongovernmental organizations); • other concerned ministries; • local representatives of civil society; and • the private sector. A campaign will be successful only with close collaboration and coordination among partners. All of them should agree and, if possible, sign a formal agreement that describes the tasks and responsibilities of each. If MDA is used in an emergency, decisions will have to be made quickly. In order to avoid delay in trying to reach consensus among different agencies on any conflicting issues, a defined decision-making authority (normally the ministry of health) should be identified that will be responsible for taking rapid decisions if necessary. Responsibilities of the committee The committee will be responsible for: • agree whether MDA is appropriate to reduce transmission and / or morbidity and mortality • preparing strategic guidance for MDA implementation and preparing a plan of action; • mobilizing the necessary human and financial resources; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 5 • coordinating partners and sharing information; • identifying the target population and target geographical areas (section 2.1.4); • establishing the chronogram (section 2.1.10); • preparing, reviewing, adapting and updating guidelines and training materials; • developing data collection and monitoring tools (section 2.3.4); • drawing up the social mobilization and community engagement plan (section 2.2.4); • ensuring a functioning drug safety monitoring system (strengthening any existing pharmacovigilance body or establishing one) to guarantee effective detection, management and reporting of adverse events related to administration of the antimalarial medicine and access to consultation and hospitalization, including any necessary rescue medication, free of cost (section 3.4); • establishing monitoring and evaluation, determining objectives and methods and defining indicators (section 3); • ensuring comprehensive malaria control activities are implemented in the context of elimination: diagnosis and treatment, vector control and detection and investigation of all cases; • planning additional malaria control activities in the context of complex emergencies, such as diagnosis and treatment, vector control and surveillance; • establishing the criteria for termination of MDA; and • ensuring an effective surveillance system to compile and analyse changes in malaria burden; Responsibilities of the regional or district task force • micro-planning (section 2.2) in the framework of the strategy defined by the national task force and • coordinating and monitoring the operational aspects of the campaign. Subcommittees could be set up within the task force at both national and district levels, including, for example: • a technical committee; • a committee for information, education, communication, social mobilization and community engagement; • a human resources committee; • a training committee; • a logistics committee; • and a monitoring and evaluation committee. 62.1.3 Conduct a context analysis Planning an MDA requires a systematic context analysis and information on a number of aspects that may have major practical implications for execution of the campaign: • malaria situation in the country and neighbouring countries: - major human malaria species present; - malaria endemicity or transmission intensity (high, moderate, low or epidemic prone); - peak malaria transmission season; - malaria prevalence, incidence of uncomplicated and severe malaria and mortality; - high-risk groups: by age, gender and occupation; - other malaria control activities that are being (or have been) used, in particular distribution of long lasting insecticidal nets, indoor residual spraying, larval source management; - availability and type of diagnostic tests available and used; - national treatment guidelines; - other chemoprevention activities, in particular seasonal malaria chemoprevention, intermittent preventive treatment of infants or pregnant women; - resistance to antimalarial medicines; - main sources of financing of malaria control activities and implementation; and - mapping of malaria partners; • administrative information: - country borders and administrative divisions and - grey areas or undefined boundaries that might challenge implementation; • mapping of administrative boundaries, cities, villages, location of health structures, main roads; • demographic data, including age distribution of the population and identified marginalized groups; • health care organization: - available health infrastructure: hospitals, health centres, health posts; - available health care staff (number and level of training); and - traditional health care providers; • environmental factors: climate and seasons (rainy, dry), extreme events linked to climate change (floods, droughts); • geography of the target areas and nature of the terrain; • security - existence of armed conflict, ethnic, religious or social tension or clashes; and - civil unrest, demonstrations, corruption; • challenges to the health system: public health emergencies and disease outbreaks; • experience and lessons learnt from previous MDA campaigns for neglected tropical diseases or malaria; M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 7 • previous crises in communication and rumours about the safety of MDA for neglected tropical disease or vaccination campaigns and lessons learnt; • important local events: national and religious holidays, market days, elections, planned demonstrations, food distribution, MDA for neglected tropical diseases or vaccination campaigns, which may result in poor participation; • local perceptions and beliefs (see section 2.2.4); • supply: national and local purchase and storage possibilities, formalities for importing medicines, registration status of antimalarial medicine eligible for MDA (section 2.2.2); • communications system: e.g. existing networks (providers of mobile communications), availability of Internet; and • population displacement due to security problems, seasonal migration or nomadic populations. 2.1.4 Determine the target population and geographical areas A thorough analysis of the epidemiology of malaria and of the aim of MDA – for epidemic control, malaria elimination or in a complex emergency – should guide decisions on the target population and the geographical areas that will benefit from the campaign. The larger the target population, the more challenging is implementation and the more resources (human, financial, logistic) will be required, as MDA coverage in the target areas is the major determinant of impact. The demographic data used to calculate the target population should be as accurate as possible. This may be difficult to obtain in certain developing countries. If feasible, data should be provided by official sources. Estimates of population numbers can be acquired from (Fig. 1): • head counts (census) or household registration before MDA (unlikely to be feasible in the context of emergencies); • a recent population census (if available); • household surveys; • administrative registration (if available); • data from other recent mass distributions (such as of long-lasting insecticidal nets), mass vaccination campaigns or previous MDA in the same area; or • household mapping done by indoor residual spraying teams in areas where there are strong malaria programmes. If no recent data are available to establish a realistic estimate, the annual population growth rate may be applied to the latest available population estimate. Population displacement into or out of the targeted geographical area should also be considered. If several estimates are available, it is advisable to use the highest figures. Underestimation of the target population may result in errors in calculating orders and consequently a shortage of medicines, an inadequate number of distribution teams or inadequate time required to reach the entire target population. Such errors will ultimately compromise coverage and could also have a negative impact on the perception of the population that is excluded. 8FIG. 1. Sources of demographic information for calculating target population SOURCES OF POPULATION NUMBERS Recent population census Household surveys Head count or household registration Recent distribution of long-lasting insectidal nets / indoor residual spraying Administrative registration After the first round of distribution is completed, the results may be used to recalculate the target population for subsequent rounds. The target population should be calculated by age group. If specific data on the age distribution in the country are not available, the standard age distribution for developing countries can be used (see Annex 1). Certain population groups might have to be excluded from the campaign, depending on the medicine chosen for MDA: • pregnant women in the first trimester: a decision to use pregnancy tests or self-reported pregnancy to exclude pregnant women should be guided by the health authorities and local context; • infants < 6 months of age or weighing < 5 kg; • people recently treated with the same medicine; • people with known allergy to the medicine; • severely ill people; • people taking medication known to interact with the MDA medicine; and • people with specific contraindications to the medicine used. At the design phase, inclusion and exclusion criteria for participation in the MDA campaign should be clearly established. Estimation of the expected number of individuals who will be excluded from participation in the MDA may be useful for calculating orders, for planning purposes and for analysis of coverage. The geographical area to be targeted must be defined on the basis of the size of the population in each zone or area, the population density and whether it is an urban or a rural setting. Table 1 indicates differences in implementation between urban and rural settings. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 9 TABLE 1. Main differences in MDA in urban and rural settings ELEMENT URBAN SETTING RURAL SETTING Demographic data More difficult to estimate: mobile population, slum areas Difficult to determine administrative boundaries of neighbourhoods and other areas within cities Household census before MDA difficult Estimates may be more reliable or more easily obtained Boundaries of villages are easily defined Easier to perform household census before MDA Logistic resources Fewer resources required, as population is densely distributed More resources requires, as population is scattered, and more teams and time are required Accessibility More readily accessible Access may be difficult when there is insecurity Access may be limited by distances, poor road conditions and effects of climate (rain) Human resources Easier to find qualified human resources Community health workers (CHW) and volunteers may be less well known to the population Less qualified HR available CHW and volunteers are well known to and trusted by the population Community leaders More difficult to identify Important role in micro-planning and social mobilization Door-to-door strategy Easier to miss households People less willing to allow access to their house, especially in higher socioeconomic strata People refuse to participate or are absent when they are in their workplace 15–20 households can be visited per team per day (75–100 people) Difficult to miss households People less suspicious and more welcoming of distribution teams People absent usually because of farming activities 10–15 households can be visited per team per day (50–75 people) DOT strategy More difficult to achieve as people are less likely to be at home May be easier to achieve Coverage More difficult to obtain high coverage Higher coverage is easier to obtain Adherence to treatment Lower Higher Rumours More quickly generated and disseminated More difficult to control May be generated but easier to control and limit their dissemination 10 2.1.5 Choose the antimalarial medicine A number of elements should be considered when choosing which medicine to use. • Efficacy: the 28-day cure rate for uncomplicated malaria patients should be > 90%. • Safety profile: low frequency of medicine-related adverse effects, contraindications and consequences of inadvertent exposure of excluded individuals, such as pregnant women or HIV-positive patients on antiretroviral therapy. Even rare adverse events could occur in a considerable number of healthy recipients when the medicine is administered to a large population. • Ease of administration: few tablets per dose and short duration of treatment. • Reputation and acceptability: tolerance of the population to frequent even minor side-effects (e.g. nausea, weakness) and perception of risks and benefits, sometimes affected by rumours, may influence the acceptability of the medicines used in MDA. • How to identify and exclude special populations groups for which at present there are no available options for malaria MDA: pregnant women in the 1st trimester and children weighing < 5 kg. • Interactions: with other medicines used in the population, including other MDA interventions to the same population and antiretroviral agents used by HIV-positive patients. • First-line ACT used in the country should preferably be avoided to limit the emergence of resistance and the impact on the supply for regular programmes and to avoid creating confusion and misconceptions in the population regarding the use of the medicine (prophylactic versus treatment) (9,10). Under certain circumstances, however, such as complex emergencies, the first-line treatment may be considered, as it will be well known by the population and the supply may be easier to guarantee. • Availability of required quantities from suppliers at relatively short notice. • Cost (available budget). The best treatment is one that results in the greatest reduction in parasitaemia and transmissibility and the longest period of post-treatment prophylaxis, hence preventing reinfection. Long-acting ACT is the most suitable treatment in most contexts. The artemisinin component, which quickly clears asexual parasitaemia and also has gametocytocidal activity, has a short half-life, while the partner drugs provide different durations of post-treatment prophylaxis (see elimination half-life of partner drugs in Annex 2). The post-treatment prophylactic effect prevents acquisition of infection while the medicine remains in the bloodstream, protecting the individual as well as reducing transmission. A complete (three-day) course of ACT should be administered; it is important to ensure adherence to the full regimen. Only co-formulated, fixed-dose combination tablets should be used in order to facilitate adherence and avoid resistance due to errors in administration of the medication. The five formulations of ACT currently recommended by WHO for the treatment of P. falciparum malaria are: • artemether + lumefantrine • artesunate + amodiaquine • artesunate + mefloquine • artesunate + sulfadoxine–pyrimethamine • dihydroartemisinin + piperaquine M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 11 The ACTs listed above are recommended on the basis of their therapeutic efficacy, safety, impact on transmissibility and availability. Annex 2 gives the treatment doses and presentations of the ACT currently recommended by WHO. Research is currently under way on new compounds, and the above list may be updated in the near future. Table 2 (on page 12) presents the characteristics of ACTs, which may assist in choosing a suitable antimalarial medicine for MDA. The above comparisons indicate that dihydroartemisinin–piperaquine might be a suitable option for MDA, in view of to its good efficacy, long post-treatment prophylaxis and good tolerability. It is not the first-line treatment for malaria in many countries, and resistance has been reported only in a few areas. Special population groups that might have to be excluded from MDA Pregnant women. No adverse effects on mothers or fetuses in the second and third trimesters of pregnancy have been reported, and ACT is considered safe for use in this population. As there are insufficient data on the safety of ACT in the first trimester of pregnancy, they should be avoided in women at this stage of pregnancy (16). Identification of women in the first trimester of pregnancy who are not yet visibly pregnant may be difficult in mass campaigns. The method for assessing pregnancy, through interview and / or testing, should be decided by the health authorities and based on the local context. Use of screening tests for pregnancy may be problematic, as many women or younger girls may not wish to disclose their pregnancy status, particularly in certain cultural settings. Before MDA, it is crucial to explain to the community the purpose of performing pregnancy tests and to assure them that they will be done confidentially. It is strongly recommended that interviews and pregnancy tests be performed by trained female community health workers in order to ensure privacy and discretion. A culturally sensitive approach is essential taking into consideration the values and perceptions of the communities. Infants < 6 months of age or weighing < 5 kg. Although ACT is considered to be well tolerated by young infants, the operational difficulty of ensuring accurate dosing, because of the lack of infant formulations, the proper administration and retention of the treatment leads to the exclusion of young infants in MDA programmes. Primaquine (8-aminoquinolines) WHO recommends addition of a single low dose (0.25 mg / kg body weight) of primaquine (administered on the first day of the treatment with ACT) as a P. falciparum gametocytocide if the objective of MDA is to eliminate falciparum malaria or reduce the transmission of drug-resistant P. falciparum strains. Primaquine should, however, not be administered to infants < 6 months of age, pregnant women or women breastfeeding infants < 6 months of age. Administration of the single low dose is safe and effective, even in G6PD-deficient individuals. In a recent review, WHO concluded that individuals with G6PD deficiency given a single low dose of primaquine are at very low risk of clinically significant haemolysis (17–19); therefore, it can be given without G6PD testing. The haemolytic effect of primaquine is dose-dependent and is observed mainly in individuals with G6PD deficiency given the 14-day regimen recommended for radical cure of P. vivax malaria. 12 CH AR AC TE RI ST IC A ND SE LE CT IO N CR IT ER IA AR TE M ET HE R– LU M EF AN TR IN E (A L) AR TE SU NA TE – AM O DI AQ UI NE (A S- AQ ) AR TE SU NA TE –M EF LO Q UI NE (A S- M Q ) AR TE SU NA TE -S UL FA DO XI NE PY RI M ET HA M IN E (A S- SP ) DI HY DR O AR TE M IS IN IN – PI PE RA Q UI NE (D HA -P PQ ) Effi ca cy H ig h in m os t s et tin gs Va ria bl e, d ue to e m er gi ng re si st an ce H ig h in m os t s et tin gs W id es pr ea d re si st an ce to S P H ig h in m os t s et tin gs Ha lf- lif e (d ay s) (a ct iv e dr ug ) 1.4 –1 1.4 (lu m ef an tr in e) 3. 7– 10 (d es et hy la m od ia qu in e) 8. 1– 15 .2 (m efl oq ui ne ) 2. 5– 18 .8 (S P) 13 .5 –2 8 (p ip er aq ui ne ) Sa fe ty Sa fe a nd g en er al ly w el l to le ra te d G en er al ly w el l t ol er at ed b ut as so ci at ed w ith a h ig he r in ci de nc e of g as tro in te st in al di st ur ba nc es th an o th er A CT s. AQ m ay p ro lo ng th e Q T in te rv al a nd sh ou ld n ot b e gi ve n to p eo pl e ta kin g Q T- pr ol on gi ng m ed ic in es or w ho h av e co ng en ita l Q T pr ol on ga tio n.* AQ is a ss oc ia te d w ith n eu tro pe ni a an d he pa to to xic ity a nd sh ou ld n ot be u se d in H IV -p os iti ve p at ie nt s ta kin g zid ov ud in e, e fa vi re nz an d / o r c ot rim ox az ol e. M efl oq ui ne in du ce s na us ea , v om iti ng a nd ne ur op sy ch ia tr ic s ym pt om s. M on th ly tr ea tm en t o f h ea lth y pe op le is p oo rly to le ra te d. SP is g en er al ly w el l t ol er at ed bu t m us t n ot b e us ed in pa tie nt s w ith a h is to ry o f hy pe rs en si tiv ity to s ul fa d ru gs or in H IV -p os iti ve p at ie nt s re ce iv in g co tr im ox az ol e, be ca us e of in cr ea se d ris k fo r ad ve rs e ev en ts . Pi pe ra qu in e pr ol on gs th e Q T in te rv al a nd s ho ul d no t be g iv en to p eo pl e ta ki ng Q T- pr ol on gi ng m ed ic in es or w ho h av e co ng en ita l Q T pr ol on ga tio n. * Pr eg na nc y Th e ris k– be ne fit ra tio o f a dm in is tr at io n of a nt im al ar ia l m ed ic in es g iv en to p re gn an t w om en a s pa rt o f a n M D A is d iff er en t f ro m th at fo r m al ar ia p at ie nt s. A s th er e ar e in su ffi ci en t d at a on th e sa fe ty o f A C Ts g iv en d ur in g th e fir st tr im es te r o f p re gn an cy , w om en in e ar ly p re gn an cy s ho ul d be e xc lu de d w he n AC Ts a re gi ve n fo r m al ar ia M D A. Ad m in is tr at io n Tw ic e da ily fo r 3 d ay s, pr ef er ab ly w ith fa tty fo od s (a dh er en ce is m or e di ffi cu lt co m pa re d to tr ea tm en ts w ith sin gl e da ily d os es a nd n o fo od in ta ke re qu ire m en ts ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s (n o re qu ire m en ts fo r f oo d in ta ke ) O nc e da ily fo r 3 d ay s o n an em pt y st om ac h (id ea lly 3 h be fo re o r a fte r m ea ls, w hi ch is un lik el y to b e fe as ib le in M D A) Pr es en ta tio n Fi xe d- do se c om bi na tio n; di sp er sib le ta bl et s an d hi gh er -d os e ta bl et s av ai la bl e fo r d iff er en t a ge a nd w ei gh t gr ou ps Fi xe d- do se c om bi na tio n Fi xe d- do se c om bi na tio n N o fix ed -d os e co m bi na tio n av ai la bl e. U se o f b lis te r p ac ks m ay re su lt in d is tr ib ut io n of lo os e AS ta bl et s as m on ot he ra py . Fi xe d- do se c om bi na tio n C om m er ci al a va ila bi lit y of p re qu al ifi ed p ro du ct W id e av ai la bi lit y of pr eq ua lifi ed o rig in al a nd ge ne ric p ro du ct s by m an y co m pa ni es W id e av ai la bi lit y of pr eq ua lifi ed o rig in al a nd ge ne ric p ro du ct s by m an y co m pa ni es Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty Si ng le p re qu al ifi ed p ro du ct ; lim ite d pr od uc tio n ca pa ci ty * Ex cl us io n of p at ie nt s w ith c on ge ni ta l Q T pr ol on ga tio n w ou ld n ot b e fe as ib le in M D A, b ut p eo pl e ta ki ng s pe ci fic m ed ic in es m ig ht b e id en tifi ed b ef or e M D A. TA BL E 2. Ch ar ac te ris tic s of W H O -r ec om m en de d AC Ts fo r c ho os in g su ita bl e an tim al ar ia l m ed ic in es fo r M DA M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 13 2.1.6 Estimate the requirement for antimalarial medicine, and order it Registration and authorization to import As part of the drug selection criteria, especially for rapid deployment in emergency, it is necessary to consider the availability and requirements for registering the medicine, or obtaining a waiver, for its importation. Authorization to import the medicine and customs clearance should be agreed with the authorities beforehand to allow smooth, quick handling. These processes can take some time, especially if the medication is not licensed in the country. Depending on the country’s regulations, a post-shipment quality control test may be required for each batch of the medicine after it arrives in the country, and the necessary time should be included in planning. Procurement It is essential to ensure that the selected medicine meets international quality standards. The use of substandard, ineffective or unsafe medicines could be harmful for the population treated, affect the credibility of the campaign, increase the burden on the health care system and promote the spread of resistant strains if parasites are exposed to sub-therapeutic blood levels. Only prequalified medicines approved by WHO or by a stringent regulatory authority should be selected for MDA (20). The two main sources of relevant information are the WHO prequalification programme (21) and the Global Fund list (22). Consideration should be given to whether the supplier will be able to deliver the full required quantity at short notice, as not all suppliers have sufficiently large production capacity to deliver large quantities in a short time. Moreover, some manufacturers start production only once a purchase order has been received. These possible delays should be taken into consideration in planning procurement and in setting the dates of distribution. Calculating the required quantity of medicine for different age groups • Determine the size of the target population which will equal the total number of treatment courses needed, often in course-of-therapy packs, for each round. • Calculate number of treatments per age group per round (according to the age- categories for which the selected ACT has specific presentations). • Multiply the needs per round by the number of rounds that will be performed. • Add a buffer stock of approximately 25% (depending on the reliability of demographic data) to cover wastage or underestimation of population. See Annex 3 for examples of estimated orders of different presentations of artesunate–amodiaquine and dihydroartemisinin–piperaquine. The calculation should also take into consideration the number of individuals expected to be excluded from coverage with MDA (e.g. pregnant women, infants, HIV patients, depending on the medicine selected for use). 2.1.7 Determine the delivery strategy There are three possible distribution strategies: • door-to-door distribution: the preferred strategy for high coverage, if logistically possible; • centralized distribution at a fixed site; and 14 • a combination of door-to-door and centralized, fixed-site distribution: - centralized with door-to-door distribution for hard-to-reach groups or - door-to-door distribution followed by centralized distribution to follow up missed participants. With combined strategies, care must be taken not to dose individuals repeatedly. The choice of strategy will depend on logistic capacity, the objective of MDA and analysis of the local context, including security and any outbreak or other special circumstance. DOT is the preferred delivery strategy for ensuring adherence and reducing the potential for mistakes in taking the medicine. Although DOT is more challenging operationally, it has been used successfully in very large-scale campaigns, including with multi-day drug regimens (4). As it may not be feasible to give all three doses of ACT by DOT, a health worker may administer the first dose and give the remaining tablets to the person or carer for days 2 and 3 of the intervention, with instructions on their administration. Because of the high risk of non-adherence to treatment on the two days following the administration of the first dose by DOT and consequent misuse of the medicine, adherence must be strongly emphasized both by the distributor and in the social mobilization campaign. An alternative that promotes and allows assessment of adherence to treatment and safety is giving the first and third doses by DOT. These different delivery options – full DOT, DOT on days 1 and 3 and DOT only on day 1 – have resource implications, which should be considered in planning the intervention. If DOT for all three doses is not feasible, a strategy should be devised to encourage and monitor adherence. For example, CHWs could revisit the houses to which they have already distributed the medicine after finishing the distribution on days 2 and 3, or teams responsible for monitoring adherence could be appointed. Guaranteeing DOT in door-to-door strategies, when there is little likelihood that every member will be at home at the time of the health worker’s visit, is laborious and complicated. When MDA is planned as part of an elimination strategy and there is less time pressure than in an emergency intervention, a small-scale pilot MDA project is strongly encouraged to optimize the delivery strategy. 2.1.8 Determine the period of intervention The best time for MDA depends on the setting and the aim of MDA (see Table 3). MDA to reduce transmission and eliminate malaria In an area with seasonal transmission, a campaign should be executed during the low-transmission season when the number of parasites is lowest, immediately before the start of the malaria transmission season (6,9,13,23). If MDA is conducted at the peak or during the main transmission season, there is less probability of influencing malaria transmission and the parasite prevalence will increase rapidly (13). Timing should also take into consideration seasonal movements of the population in and out of the target area. Untreated people returning to an area after MDA constitute potential reservoirs and sources of re-infection. The access of teams to certain rural and remote settings may also determine the period of MDA, as some areas may not be accessible during the rainy season. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 15 MDA to help contain a malaria epidemic MDA should be performed as soon as possible in order rapidly to reduce morbidity and mortality while outbreak containment measures are put in place. MDA in complex emergencies The period of the intervention will correspond to that of the highest risk for morbidity and mortality – the high malaria transmission season. If the burden of malaria is high all year round, MDA can be considered at any time of the year. Certain complex public health emergencies, such as the 2014–2015 outbreak of Ebola virus disease (EVD), have major impacts on existing health care systems. During that epidemic, health care structures were overwhelmed, and access to regular health care was reduced, due to fewer functioning health facilities, loss of health care staff and fear among the population attending health structures and treatment centres of becoming contaminated with the Ebola virus. Laboratory testing was generally unavailable, and blood testing for malaria diagnosis was suspended. All these factors affected malaria case management, resulting in increased morbidity and mortality due to malaria. In addition, as the clinical presentation of malaria and EVD are similar, patients with malaria were suspected of having EVD, increasing the burden on EVD treatment units and also exposing non-EVD patients to nosocomial infection. Antimalarial MDA was provided in this context in an attempt to reduce malaria morbidity and mortality rapidly and thus to reduce the number of non-EVD patients presenting with fever to EVD treatment centres. Reduction of malaria transmission was not the objective of MDA in the context of the EVD epidemic. 2.1.9 Determine the number of rounds Multiple rounds of MDA at regular intervals are recommended, although there is insufficient evidence at present to establish the optimal number and timing (3). Most MDA campaigns for falciparum malaria have consisted of two or three rounds at monthly intervals, and further research should be conducted to determine whether one or two rounds would be sufficient in certain situations (9). Special situations are listed in Table 3. In MDA to reduce transmission or eliminate malaria, repeated rounds are necessary to clear parasites in the population. If some people remain untreated during a single round, with no additional intervention, the coverage will be partial and the impact in term of malaria transmission and burden will be lower. The aim of successive rounds is total coverage, reaching people who were initially missed and people who were treated in the previous rounds but may have been reinfected after MDA, reducing the probability of reinfecting mosquitoes. Multiple rounds may be required to obtain a major decrease in prevalence (6,8). In MDA as part of an epidemic response, the number of rounds may depend on the epidemic curve (incidence rate and attack rate) and the expected duration of transmission. In MDA in complex emergencies, the rounds should be repeated to cover the duration of the period of highest morbidity and mortality. 16 TABLE 3. Main strategic differences between planning MDA for malaria elimination and for emergency response (epidemic or other complex emergencies) ELIMINATION SETTING (ELIMINATION AND CONTAINMENT OF MULTI-DRUG RESISTANCE) EMERGENCY SETTING (EPIDEMIC, COMPLEX EMERGENCY) Source of demographic data Ideally, head count (census) or household registration before MDA Head count or household registration less feasible Recent census (if available) Household surveys (if available) Other past mass distributions or MDA Timetable for implementation Usually allows sufficient time for planning and preparation Short time for planning and preparation (≤ 1 month) Urgency + +++ Coordination of partners and institutions Required for successful campaign and easy to achieve More challenging, as many actors may be involved, but essential to guarantee an effective campaign in a short time Choice of medicines First-line antimalarial agent should be avoided First-line antimalarial agent may be considered Timing in relation to malaria transmission for intervention During the low transmission season, immediately before the start of the transmission season During the peak of transmission (highest morbidity and mortality), depending on emergency context Number of rounds per year 3 3 (but could be fewer) Administration of antimalarial medicine Must be synchronized in the target population in order to have an impact on transmission Synchronous administration is important in epidemics in order to reduce transmission In other complex emergencies, the requirement for simultaneous medicine intake is less critical Concomitant malaria control activities Preconditions for using MDA for elimination are the availability of active case finding and surveillance, rapid testing and treatment of all cases of suspected malaria and intensified vector control As the objective is to reduce malaria morbidity and mortality, MDA is deployed as an immediate response while other malaria control interventions, notably case management and vector control, are being put in place Criteria for stopping MDA Documentation of 0 indigenous cases (cases contracted locally with no evidence of importation or direct link to transmission from imported cases) Reduction of malaria burden to a level that can be maintained with case management, vector control and routine surveillance, implemented in the same area M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 17 2.1.10 Establish a chronogram A chronogram of activities (see Annex 4) will limit unexpected events, avoid forgetting things in the different planning phases and contribute to a successful intervention. Once distribution has begun, it might be difficult to correct a planning error. Poor planning, such as underestimating amounts or timelines for delivery of medicines, may lead to stock ruptures and will not only compromise the results of the campaign but also have a detrimental effect on the perception of the population. The chronogram should show the evolution of all the tasks to be carried out during the phases of design, preparation, implementation and evaluation of the campaign. It will help to coordinate the many activities to be conducted at the same time and will indicate the role of each person. The chronogram should contain: • a list of tasks to be performed, including quantification and ordering of medicines and other supplies, training, distribution of materials, community mobilization and deployment of teams; • a timeframe for the completion of each activity; and • the name of the person responsible for each activity. When deciding the actual dates on which distribution will take place, the activities and work schedules of the population and religious festivities and holidays should be considered to ensure high coverage. 2.1.11 Draw up a budget The following items should be included in the estimated budget: • MDA medicine; • logistics: - registration fees; - international transport of medicine (e.g. international freight, insurance, customs clearance, importation fees or taxes, options for waivers); - pre- or post-shipment quality control testing (as applicable); - storage of antimalarial medicine and other logistics supplies; - transport: vehicles (cars, trucks, motorcycles, boats, bicycles), fuel; • additional equipment and supplies for distribution: large-scale maps for overall planning and detailed maps to guide teams during the intervention, ropes, fencing, plastic sheeting, megaphones, chalk or other material for marking houses, rainwear (if MDA is conducted in the rainy season), backpacks, cups, other context-specific material (for biosafety for example) (See the comprehensive list of additional materials required for door-to-door and centralized fixed-site distribution in section 2.3.1); • administrative material: e.g. cards, date stamp, daily tally sheets, summary sheets, supervisor sheets, attendance sheets, registration books, stationery; • material for social mobilization and communication campaigns; • staff salaries, per diem, food or transport allowances, identification material; 18 • materials for training and supervision; • communication means: telephone, credit top-up for staff, radio; • material for monitoring and evaluation: e.g. monitors, surveys, resistance monitoring; and • material for drug safety monitoring. It is important not only to estimate the cost of each budget line but also to identify the sources of funding. All partners and task forces should have the opportunity to review and provide suggestions to the budget plan, and the final version should be made available. The exercise should estimate the total cost of the activity and a final analysis of the cost per person treated. 2.2 PLANNING AND PREPARATION 2.2.1 Micro-planning Once the overall design of the campaign has been completed at national level, the next phase is to outline a micro-plan at local (regional, district or community) level for the strategies selected and according to national guidelines. The micro-plan should guarantee that the correct treatment and other materials are available in the right amounts, in the right places and at the right time to cover the entire targeted population. This will require distribution of supplies, training of staff, engagement of the community, well-coordinated distribution and proper management of resources. Micro-planning is used to manage these details by calculating requirements on the basis of local needs, identifying what is available and requesting what is missing. Relevant partners should be involved in micro-planning, including: • health centre staff, • CHWs and community volunteers, • local councils, • community leaders or village representatives, • religious leaders, • the media, • civil society organizations, • women’s groups, • youth organizations, • nongovernmental organizations, • community organizations and • schools and colleges. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 19 The micro-plan should cover the following elements: • demographic information: - total target population of the MDA-eligible district; - the numbers of communities, villages and neighbourhoods in the district; - the target population in each community, village and neighbourhood, with a breakdown by age group; - familiarity of the population with MDA for neglected tropical diseases; - proportions of people in urban and rural areas, in order to adapt logistic requirements (see Table 1 for details of differences in implementation of MDA in urban and rural contexts); - population movement; - depending on the size of the target population and context (emergency setting or elimination), household registration or census books of the target population that list all the households in a community, with an identification number and include the name, age and sex, village, head of household, contact details (if available) and resident status (permanent, temporary or visitor). This list can later be used during distribution to monitor coverage and to keep track of households that have been visited, missing people in a household and other details. • information on the area: - maps showing main roads, villages, towns and neighbourhoods; - infrastructure in the area (e.g. availability of electricity, water, fuel); - location of health facilities and catchment areas; - areas or population that are difficult to reach because of geography, climate, lack of security or cultural reasons and suggested solutions for reaching them; - location at which medicines and other materials will be stored and then prepositioned for distribution; and - distances and travel times from the central area to each community, village or neighbourhood, health structures, storage sites and distribution sites (for centralized, fixed-site strategy) and road conditions; • calendar timing of MDA in the district: ideally specifying days and times for certain streets or neighbourhoods, so that people can arrange to be at home; • delivery strategies (centralized, fixed-site or door-to-door); • human resources and training: - number of people expected to be covered by each team of distributors (whether door-to-door or centralized, fixed-site distribution); - number of teams required to cover all communities in the district; - number of teams per supervisor; - number of supervisors required per district; - human resources available in the district; - number of teams and supervisors that can be brought together per training session; and - number of days required to train staff. 20 • logistics information: - if centralized, fixed-site distribution is decided, the number and location of distribution sites, population per site, teams per site, etc.; - areas where staff may spend the night; - number of vehicles required to transport teams and supervisors and number of vehicles available locally; - amount of fuel required for transport; - amount of material required per team; and - material required for training; • a social mobilization and communications plan; and • a pharmacovigilance plan: - training of CHWs and community volunteers; - timing of active follow-up visits (days 3–7), depending on the safety profile of the medicine; - number and location of health facilities that will provide rescue treatment for any side-effects; - referral health facilities to manage severe adverse events; - distribution and completion of ADR report forms and narratives in health facilities; and - reporting and communication with stakeholders. See Annex 5 for an example of a micro-plan used in Sierra Leone in 2014–2015 for antimalarial MDA during the outbreak of EVD. 2.2.2 Logistics Supply and stock management When the antimalarial medicine ordered for the MDA campaign is received in the country, it should be stored in a central warehouse or storage facility, which should be in an accessible location, with proper temperature and humidity conditions and well secured. Other essential material for the campaign (such as cups, sugar, mortars or pill crushers, stationery, soap, megaphones, rope, fencing) should be kept in the same location. It is vital to estimate the volume of medicine (see Annex 3) and other logistics supplies beforehand to ensure enough storage capacity. The antimalarial medicine should be stocked by presentation (age-specific blisters), batch number and expiration date. A stock card should be prepared for each item in the store in order to monitor quantities and ensure traceability. The stock cards of the antimalarial medicine should include the international non-proprietary name (not brand names) and the dosage. Antimalarial medicines and other logistic material will be distributed from central to district level, where intermediate centralized storage may be necessary, which should conform to the same indications. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 21 Prepositioning of supplies Antimalarial medicines and other logistic elements for distribution should be prepositioned in distribution points according to the micro-plan (e.g. peripheral health facilities) before MDA is launched. Therefore, the stock of each distribution point should be prepared in the central warehouse before delivery. Pre-printed order and delivery forms should be available. All movement of medication between individuals or organizations should be documented, and signed copies should be saved for future reference. See Annex 6 for a step-by-step procedure for prepositioning supplies. Transport Reliable transport is essential for all activities. The number and type of vehicles depend on: • the strategy chosen (door-to-door or centralized, fixed-site distribution), • the duration of the campaign, • the number of distribution teams or distribution points (if centralized, fixed-site), • the number of supervisors, • whether the area is urban or rural, • the social mobilization plan and • the supply system. Motorcycles, bicycles or boats may be required in some contexts. During transport, medicines should be protected from weather such as rain and sunlight. It is essential to check the local availability of vehicles and fuel. If cars are available, they should be evaluated for: • type, size and condition; • type of fuel and consumption; and • the conditions of loan or rent (with or without driver, cost, insurance, etc.). One person should be responsible for following up all issues related to transport, which is a potential target for fraud and / or theft. Accessibility The means for reaching all the eligible population should be assessed thoroughly, covering: • the road network and the condition of roads, • distances and travel times to the different locations and • roads with limited or interrupted access during the rainy season and alternatives for reaching the populations. 22 “Difficult-to-reach” populations include not only those in remote areas with poor road access but also those isolated due to lack of security or social constraints. To ensure that these populations are covered, approaches such as assigning teams specifically to those areas or extending the duration of the campaign might be considered. Distribution sites for centralized, fixed-site distribution Sites should be chosen and prepared in advance. They should be selected in collaboration with local authorities and ideally have the following characteristics: • easy access; • be well-known to the population; • possibility for creating a one-way flow of people (entry and exit points) to facilitate movement; • large enough to work comfortably but not too vast that it is difficult to manage; and • a large, shaded waiting area. Possible locations could be schools, religious centres (churches, mosques, temples) or administrative buildings in urban areas; and, if there are no suitable buildings, open public spaces or temporary shelters, including tents, in rural areas. If pregnancy testing of women of reproductive age is required before administration of the MDA medicine, the distribution site should also have bathrooms and private spaces where the test can be performed and the results communicated privately. Sites should not be set up in health structures, so as to not disrupt normal activities. Waste management Waste will be generated during an MDA campaign, and waste collection and disposal should be considered in the planning phase. The waste will consist almost entirely of soft waste, including packaging, disposable cups (if used) and pregnancy tests, if performed. For door-to door distribution campaigns, waste may be handled at household or community level if adequate waste disposal systems exist. Otherwise, distributors should collect the waste and bring it back to the distribution point, where it should be incinerated. A decision to handle waste at community level or to centralize it at health facilities should be guided by the local context. For centralized, fixed-site distribution campaigns, waste can be disposed of at the distribution site or be transported to a central location (e.g. health facility). 2.2.3 Human resources An MDA will require a significant number of dedicated staff. The number of teams required and their composition will depend on: • the intended duration of the campaign, • the distribution system (door-to-door or centralized, fixed-site), • the target population, • the target area and its accessibility, • the expected performance of each team (number of people treated per day), M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 23 • data forms to be completed and • addition of other interventions. Team composition As the antimalarial medicine is given orally, a large number of skilled health personnel will not be required. The number of qualified health workers taken from health structures should be minimized in order to disrupt the regular health activities as little as possible. A census of all locally available human resources should be carried out during micro-planning. If a network of CHWs or volunteers is already present, they should ideally be engaged in delivering the medicine, as they understand the local environment, speak the local language and are familiar with and trusted by the population. If this is not the case or there are not enough staff according to the estimate, volunteers may be selected from e.g. civil society organizations, nongovernmental organizations, Red Cross or Red Crescent societies, youth associations, schools and nursing schools. If possible, the volunteers who serve as distributors should represent the demographics of the community. When selecting volunteers to distribute treatment or conduct social mobilization, local community leaders should be consulted, as they may help to identify people who are well known, recognized and respected by the community. Each member of the team should have a job description, so that each clearly understands their role and responsibilities and those of the other members. Distribution team Door-to-door strategy. Teams should ideally be composed of two CHWs or volunteer distributors, if possible from the same village: one to provide information and administer the treatment and the other to record the necessary information on appropriate data collection tools. If pregnancy testing is planned, at least one of the two CHWs should be female. Centralized, fixed-site distribution. Teams will consist of: • 1 triage agent to check eligibility, • 1 female worker to conduct pregnancy testing (if planned in the campaign), • 2–3 registrars (if an MDA card is issued to each beneficiary or another registration system is used), • 2–3 drug dispensers, • 2–3 recorders to fill in a tally sheet (paired with drug dispenser), • 1 health care worker to assess and manage adverse events, • 1 sensitization or information officer, • 1 cleaner and • several crowd controllers and security personnel. 24 Supervision team The supervisors should be health personnel, ideally from the same catchment area. Door-to door-strategy: • Direct supervision of teams is difficult, and a large number of supervisors may be necessary to ensure quality. • Each supervisor should be responsible for supervising no more than five teams in an area. Centralized, fixed site distribution • The number of supervisors will depend on the possibility of managing several sites. • In urban areas, one supervisor might be able to visit up to three sites per day. • In rural settings, one supervisor is likely to be able to visit only one or, at a maximum, two sites per day. There should also be one logistics supervisor to manage the organization of sites, transport, supply, etc. Estimated numbers of people treated per team per day (to be adapted to each setting): Door-to-door strategy: The daily output of the teams will depend on the population density. In urban areas, one team should be able to distribute medicine to a maximum of 75–100 people per day (average of 15–20 households of five people, visits lasting 15–20 min per household). In rural areas, where the population is more dispersed, one team should be able to distribute medicine to a maximum of 50–75 people (10–15 households) per day, in view of the time for transfer and communication to individual households. An approach used in several campaigns targeting large numbers of people has been to divide the population into small units and assign each to a distribution team (4). Centralized, fixed-site strategy: One team should be able to distribute medicine to an estimated 400–500 people per day. As this strategy is likely to miss a higher proportion of the population than door-to door distribution, special activities are required to mobilize and ensure the participation of the population. The daily output of the teams will also depend on whether MDA cards are issued to participants or a registration book is completed, which is more time-consuming. It will also depend on the local context and previous experience in similar activities. Specific teams might be considered for distribution in schools, prisons, military camps and orphanages and perhaps for the main local companies, such as factories, mines and plantations. Training Training of staff is an essential component of the preparation phase. Everyone participating in MDA should take part in training sessions, including coordinators, supervisors, distributors, community mobilizers, logistics officers and any other staff. Training should be provided at national, regional, district and sub-district levels. The plan should cover the objectives, which should be defined for each aspect; the length of training; the number of participants; the contents and methods; training materials and an evaluation (e.g. a pre- and post-test). Training should provide each team member and supervisor with the minimum information required to carry out their task properly. Training should be scheduled as close as possible to the date of implementation, ensuring, however, that all teams will have been trained by the time distribution begins. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 25 All teams should be trained in a standardized way. If many partners are involved, they should all provide the same training to avoid any variations that could confuse trainees and lead to mistakes in drug delivery. Training should include: • explaining MDA; • goal of this MDA; • where and when MDA will take place; • the distribution strategy: door-to-door or centralized, fixed-site; • treatment protocol and administration, including possible side-effects and contraindications; • inclusion and exclusion criteria; • performance of pregnancy tests and confidential communication of results (if applicable); • DOT; • team composition; • roles and responsibilities of all team members; • expected daily targets and overall coverage to be achieved; • access to the medicine and other supplies; • practicalities of distribution; • reporting and management of side-effects and severe adverse events; • information, education and communication and community engagement; • dealing with rumours and any concerns or doubts in the target population; • data collection tools: tally sheets, summary sheets, registration books, referral forms, ADR report forms; • procedures for reporting; • contingency plans for unforeseen events; • management of stocks of medicines and other items; • waste management; • logistics; • administrative issues (e.g. incentives and salaries); • supervision and troubleshooting (for supervisors); and • special measures (e.g. “no touch policy” or accidental exposure as in the outbreak of EVD). Training plans should be adapted to the delivery strategy (door-to-door or centralized, fixed-site) to ensure that teams are well prepared. Job descriptions and any other reference documents or guidelines can be distributed during training after they have been discussed with the participants. 26 The methods used during training may include role-play, practical demonstrations, case studies and simulations, ideally with the material and equipment to be used, in order to cover all the details and correct any misunderstanding. Anticipating difficulties and responses in these scenarios is a fundamental part of training. An efficient way to train many people quickly is cascade training, in which certain people are trained as trainers, and each in turn provides the same training course to others. More than one level of cascade should be avoided. Supervision of this training system is important to ensure that the information being passed down is accurate and the messages are not being changed as they are passed down. Providing adequate training material, cooperative supervision and meticulous evaluation will guarantee that the skills in which distributors have been trained are applied appropriately. Salaries and per diem Large-scale MDA involves a significant number of people who are widely distributed geographically; they should be compensated accurately and in an opportune manner. Payment of salaries and / or incentives, per diem and food or transport allowances must be clearly discussed with all staff involved in distribution to avoid confusion and demotivation. CHWs and volunteers who are unhappy with their position and reward can jeopardize a campaign. It is essential to determine how the money will be transported and managed at various levels to ensure that each person receives the correct pay, while guaranteeing transparency and avoiding opportunities for theft or corruption. The options for payment are decentralization to district authorities, through banks or “outsourcing” payments. Malaria control programmes may already have relevant experience during distribution of long-lasting insecticidal nets and indoor residual spraying campaigns. When many partners are involved, harmonization of payment to the teams is crucial. An innovative method is use of mobile phones, as used in Sierra Leone. Although some technical difficulties were faced because of the size of the transaction and the fact that it was the first time the phone company had handled such an operation, more than 6000 people were paid with this method in a timely, transparent manner, without having to gather for payment and removing the inherent security risks entailed in the movement of large sums of money (10). 2.2.4 Community engagement, social mobilization and communication One of the main determinants of the success of MDA for malaria is ensuring high coverage of the target population and good adherence to the treatment, both of which depend on people’s willingness to take the medicine (3,4,24). Many asymptomatic, healthy people will be asked to take a medication, potentially exposing them to adverse reactions. Ensuring compliance requires building mutual understanding and trust in the institutions implementing the campaign. Community engagement is a key factor in the success of MDA, in order to obtain the desired participation and uptake of medication. Misconceptions within the eligible population about the treatment being administered, their risk for the disease, side-effects and the need for intervention even in people who are not ill contribute to non-participation (24,25). Effective communication and social mobilization are therefore critical to a successful MDA campaign (26). A communications plan should be developed and agreed upon by the ministry of health and other actors on strategies to reach target audiences. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 27 The steps in preparing a communications plan are: • Define the roles and responsibilities of each partner. • Conduct a community assessment. • Prepare clear, simple, precise, consistent messages about MDA for malaria. • Engage the mass media. • Engage the community. Roles and responsibilities At national level: • Plan advocacy, communication, social mobilization and community engagement. • Develop a tool for community assessment. • Elaborate key messages. • Coordinate activities. • Hold advocacy meetings with stakeholders, including the private sector, at national level. • Hold briefing with media houses, with an official launching, and identify role models who are willing to take the first dose publicly. • Participate in panel discussions on national radio and television. • Produce and air campaign spots in the main languages spoken in the target areas. • Produce information, education and communication material, such as banners, flyers and fact sheets. • Monitor the media during the campaign. At district level: • Carry out community assessment. • Diffuse messages as widely as possible. • Hold advocacy meetings with main stakeholders in the community, such as community leaders, administrative authorities, religious leaders, civil society groups and other associations or groups (women, young people) and traditional healers. • Organize sessions to sensitize the private sector, schools, etc. about potential absenteeism of workers and students during the campaign. • Identify potential participants in the community. • Air jingles spots on local radio stations. • Participate in panel discussions on local radio stations. • Send vehicles with loudspeakers to make announcements about the MDA campaign to each village. 28 At community level: • Hold discussions with chiefs and religious leaders in each village about the campaign. • Disseminate messages through appropriate channels. • Identify and train CHWs to carry out sensitization street to street and house to house in the days before distribution. • Organize group sensitization sessions in communities with the participation of key people. • Organize announcements by a town crier or a vehicle with a loudspeaker during the days before and during distribution. Community assessment Ideally, before planning MDA, a quick assessment and mapping of community groups in the targeted areas should be conducted to obtain qualitative information such as: • social structures in the community; • cultural specificities and customs; • decisional power about health in families; • role of traditional leaders, including community and religious leaders; • behaviour considered acceptable for men and for women; • health-seeking behaviour, including general knowledge about malaria; • role of traditional medicine and traditional healers; • acceptance of allopathic medicine; • use of media; • familiarity and understanding of posters, brochures and banners; • literacy; • languages spoken; • perception of and willingness to participate in this type of intervention; and • any concerns, which will be addressed during the sensitization campaign, This assessment may avoid cultural misunderstandings that could threaten the success of the campaign. Useful lessons can be drawn from previous experience in MDA and similar activities. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 29 Key messages about MDA for malaria The messages to be prepared include: • What: general information about malaria and about the campaign, emphasizing that malaria may be asymptomatic and that people can be infected without realizing it and highlighting the role of asymptomatic carriers in malaria transmission • Why: purpose and benefits of treatment of people who do not feel sick and the importance of not saving the medicine for later use • When: dates of the distribution and number of rounds • Where: door-to-door or centralized, fixed sites • Who: geographical area and eligibility criteria, with special emphasis on the need to exclude women in the first trimester of pregnancy and explaining the screening method which will be used (interview and / or pregnancy test) and assuring that it will be done confidentially. • How: dosage and duration of treatment, adherence to treatment • Potential side-effects: to avoid misconceptions and fear, possible side-effects should be described, with assurance of proper management of any that appear • Importance of continuation and reinforcement of other malaria preventive measures (e.g. use of long-lasting insecticide-treated nets) • Context-specific messages: might have to be prepared for each WHO recommendation for MDA during a malaria epidemic or a complex emergency such as an outbreak of EVD. Engaging the mass media Generally, spokespeople should be identified at the ministry of health and other credible, respected partners that are able to handle challenging interviews where awkward, inopportune questions are asked. Talking points should be prepared for speaking to and engaging with the media, avoiding the use of acronyms or scientific vocabulary that the public will not understand. Relationships should be built with local media representatives to ensure that they provide good news coverage; they should be contacted regularly, not only in response to a critical situation. The campaign should be inaugurated with an opening ceremony covered by the media, in which influential people such as high-ranking administrative authorities and celebrities participate and take a dose of the medicine as an example to the rest of the community. The methods that can be used to disseminate information and promote an MDA campaign include radio, television, newspapers, billboards, online news sites, social media, mobile phones and games. Radio is widely available and very popular in rural areas in malaria-endemic countries and should be a priority for circulating information through radio spots, radio group discussions in which community members engage with campaign health officials and role-play of community members talking about the distribution in order to spread information about the purpose, location and timing of MDA and to discuss the benefits of participating and potential side-effects. Radio also allows listeners to call in and ask questions live. Radio spots (see Annex 7) can also be used. Radio can also be a powerful method, if the micro-planning is good, to disseminate information on the days and estimated times of visits of the distribution teams per street or neighbourhood or, in the case of centralized, fixed-site distribution, location and days. Television spots and phone-in programmes with key stakeholders can be influential. 30 Media messages should address any local concerns and doubts identified either in previous campaigns or during the evaluation phase. Personal testimony of people who have previously taken the medication is valuable. Progress reports should be sent to the media throughout the campaign. Countering negative rumours Unfounded rumours or negative news may circulate, dissuading communities from participating in MDA. Random cases of unrelated severe illness or deaths in the community may be attributed to the antimalarial treatment and reduce the public’s confidence in the campaign. A plan should be prepared in advance to suppress such rumours quickly in a prudent, neutral manner to reassure the population. Distribution teams and supervisors should systematically collect information on rumours and on questions that are frequently asked at meetings with stakeholders and community groups and on radio and television programmes. Media reporting should be closely monitored to detect any negative coverage rapidly and react accordingly. If a relationship of trust is established with the media, they will be more likely to listen to all sides before reporting false information. Community engagement Community engagement at the early stages of planning is a key element of a successful MDA, so that they take ownership of the implementation and success of the campaign. The people to involve are: • community leaders and other influential members, • political leaders, • local councillors and authorities, • religious leaders (priests, imams, monks), • schoolteachers, • celebrities, • other local groups (youth, women), • village health workers or volunteers, • health care staff (to respond to questions and concerns), • traditional healers and • private pharmacy owners and drug sellers (who could potentially interfere with the activity). Cooperation with leaders and other influential members of the community is vital for good results, as their status as decision-makers makes them efficient promoters of the benefits of participating in the campaign; however, they must be well informed. Any negative opinion of the intervention will have a significant impact on the outcome. They can provide organizers with useful information on the best timing for the campaign, suggest people who should be included in sensitization sessions and how the sessions should be organized and identify potential distributors who are well known and respected by the community. See Annex 8 for a list of discussion points that could be used in community meetings. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 31 Social mobilization Group social mobilization sessions in the community can be used to provide information, allow members of the community to ask questions and establish trust between the population and campaign staff. Priority should be given to hard-to-reach and underprivileged populations, and the programme should be adapted or intensified for those groups if necessary. Other effective approaches are street theatre, music, art and other cultural activities. Communication materials should be printed in the local languages and adapted to the literacy level of the community. They could include leaflets, posters, calendars, banners, armbands, t-shirts and caps. Megaphones or town criers could also be used. Social mobilization activities should be held in religious centres, schools, cinemas and other recreational areas and places where people gather for other purposes, such as bus stops and hairdressers. The activities in the different phases of social mobilization and communication are listed below. Before the campaign: • Ideally at least one month before administration of the medicine (depending on the setting and context): information about MDA, the benefits of the campaign, the importance of participation, etc. • In the week before distribution: intensification of the sensitization campaign, with a focus on the practical aspects of starting the campaign and reminders to the population of days and location. Before distribution is begun, several households should be visited to verify that people are aware of the dates and are willing to participate, so that last-minute adjustments can be made to sensitization activities. During distribution: • Social mobilization should focus on encouraging participation and promoting treatment adherence. • Community mobilization messages should be adapted according to inputs from continuous observation by nonparticipants of people’s reactions during MDA. If MDA is conducted during the rainy season, villagers in rural areas might prefer not to participate in the campaign because of farming activities, either because they have to travel out of the eligible area to access their fields or because they fear that adverse effects might limit their capacity to work and thus provide for their families. This issue should be tackled in the communication plan to prevent or minimize refusal. During distribution, the general perception and comments of the population towards the MDA campaign should be monitored to detect any problems, which should be addressed quickly. Community leaders could signal negative perceptions to the distribution teams or identify areas or neighbourhoods that have not been adequately covered. 32 After MDA is completed: • Communities should be informed of the results by appropriate local platforms, such as radio, posters and CHWs. • Teams or MDA representatives should remain in the target communities for some time after completion of MDA to identify and address rumours, concerns or other issues that could affect future rounds of MDA or other health interventions. 2.3 IMPLEMENTATION The distribution of antimalarial medication should be started only if: • the medicines and all other material (as outlined below) are in place; • supervisory material is available (see section 2.3.3); • teams are trained (see section 2.2.3); • the logistics is ready (see section 2.2.2); • the population has been informed of the details of the campaign (see section 2.2.4) and • pharmacovigilance, including management of ADRs, is planned (see section 3.4). 2.3.1 Stock management Distribution kits should be prepared ahead of time at the distribution point or at the peripheral health facility where supplies are prepositioned. Different kits should be prepared for distributors and supervisors. The quantities in the kits should be adequate for the number of people estimated to be reached per day. Material required per distribution team For door-to-door strategy (with DOT): Each team of distributors should be provided with the following materials at initiation of the campaign: • backpacks (1 per CHW) • mortar or pill crusher (for crushing tablets for infants) • clipboards • pens • staff identification badge, t-shirt or armband • hygiene material (soap) • chalk to mark houses • pad to note any concern • printed information, education and communication material (drawings of age-specific dosages, adherence to treatment, expected adverse events, use of long-lasting insecticidal nets) M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 33 • umbrellas or clothing to protect against the rain The rest of the material should be provided daily according to consumption and remaining stocks: • the required number of treatment blisters to meet the daily target (including buffer stock) • pregnancy test kits and urine containers if pregnancy tests are to be performed • sugary solution for children if medicines with a bitter taste are used • material for documentation: MDA cards, registration book, tally sheets, referral forms • bags for waste collection For centralized, fixed-site distribution: In addition to the above, the following should be considered: • tables and chairs • ropes or fence and poles • shade net and / or plastic sheeting • waste buckets • drinking-water containers • weighing scales • disposable or reusable cups (if strict hygiene measures are in place) • hygiene material (soap and other cleaning material) • date stamp and ink • identification panels for distribution site. Material required for supervisors´ kits • clipboards and pens • identification material, e.g. shirts, arm bands • supervisory checklist, daily summary sheet, ADR report forms, referral forms • pad to note any concerns. For door-to-door distribution, the distribution teams should pick up the material at the distribution point or health facility at which it is prepositioned every morning, making sure that all the necessary supplies have been packed. At the end of the distribution day, the remaining stock should be brought back to the distribution point, where an inventory is made and recorded. All movement of antimalarial medicine and other supplies should be recorded by the person responsible for stock management. The kits should then be refilled in preparation for the following day. If a team or a site requires further supplies because of shortages, the person responsible for logistics should be contacted to arrange transport, and the movement should be clearly documented to ensure accurate accountability. At the end of each round of distribution, the remaining stock of medicines and other items must be counted and reported at district, regional and national levels. 34 The supplies must be stored correctly for the next round, and antimalarial medicine and other supplies should be ordered for the next round. After the last round is finalized, the remaining doses should be returned to district or national level, where appropriate storage should be ensured. Expiry dates should be checked. All other logistical material should be counted and also sent back to central level. 2.3.2 Distribution of antimalarial medicine Actual distribution of medicine will depend on the distribution strategy chosen. Door-to-door strategy In urban areas, it may be difficult to ensure that all members of a household are present, waiting for the distribution team throughout the campaign. It is therefore advisable that each household be informed of the date and approximate time at which the distribution team will visit them. The schedule of visits should be flexible in order to increase the chances of finding people at home. According to the context, visits should be made either early in the morning or in the evening for rural farmers or at midday for workers. The distributors should follow the steps below when visiting each household (see also Annex 9): • Greet the residents politely in their language, and introduce themselves. • Ask for the head of the household, and verify whether all members of the household are present. • Explain the objectives and provide information about the campaign. Distribution teams should have visual aids to transmit key messages translated into local languages. • Obtain oral consent to participate. • Check eligibility criteria. Anyone meeting any of the exclusion criteria (first trimester of pregnancy, infant < 6 months of age, known allergy to medicines, critically ill or presenting contraindications to the medication) should be told why they will not be given the treatment. Annex 10 presents an algorithm that could be used by CHWs to apply exclusion criteria. • Individuals who are seriously ill, e.g. children with danger signs, should be excluded from MDA and be referred to the nearest health facility. All other ill patients should first receive the antimalarial treatment as part of the MDA and then be referred to a health facility for full assessment. • A female health worker should speak to all women of reproductive age (15–49 years) alone, in a private setting to explain that ACT are not recommended in the first trimester of pregnancy and ahould also determine pregnancy status on the basis of personal history or a pregnancy test (see Annex 11 for an algorithm for determining pregnancy in women of reproductive age). Women who are visibly pregnant (assumed second or third trimester) may receive the medicine. If pregnancy is not apparent, the CHW may ask the following questions to help exclude a first trimester pregnancy: - Are you currently pregnant? - Do you think you could be pregnant? - Are you using any family planning method? M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 35 If the woman is unsure of her pregnancy status, a pregnancy test should be offered. If the test is positive, the woman is considered to be in the first trimester of pregnancy and should be excluded from the MDA. Women who do not agree to have a pregnancy test should be warned of the risks and benefits of receiving ACT in the first trimester and given the choice to take it or refuse it. Interviewing adolescent girls about pregnancy may pose an ethical issue, as parental consent might be required and is a subject of strong cultural sensitivity. Appropriate procedures should be defined in collaboration with the national reproductive health programme. • Distribute a blister appropriate for the age category. The first dose should be administered under DOT. If a child is unable to swallow a tablet, the dispenser should teach the carer how to crush it and dissolve it in water and give the first dose to the child. If the medicine has a bitter taste, it may be given with a small amount of sugary solution to encourage the child to take it. If the dose is vomited (or rejected) within 30 min, the same dose should be repeated. The parent or guardian should request another dose from the CHW to complete the treatment. • Teach the participants to take the remaining doses (on days 2 and 3), unless DOT is used for all doses. A laminated card with treatment doses should be used as a visual aid to support the explanations, and printed leaflets may be distributed (see Annex 12 for the leaflet used in MDA in Sierra Leone in 2014–2015). • Clearly explain the importance of adherence to the full treatment course. Participants may be advised to keep the empty blister packs for assessment during post-distribution monitoring. • Provide information on possible side-effects and what to do if they occur, including clear instructions for contacting the relevant services for assistance or queries. • Ask the members of the household whether they have any questions, and allay any doubts they may have. • Mark the tally sheet (see section 2.3.4 and Annex 13) after the person has taken the first dose, or fill in the registration book (see section 2.3.4 and Annex 14) and record the necessary information (e.g. name, age, gender, address, residency status, medication and dose given), including whether the entire household was covered or whether some members were missing, and specify the number missing. • When the distribution team leaves the house, they may mark it with chalk as “complete” or “incomplete” according to the household members present; if no one was at home at the time of the visit, it should not be marked. If distribution in a household was incomplete or no one was at home, the team should revisit the house later in the day or the following day. To simplify operations, the antimalarial medicine should also be given to people present in the community at the time of MDA who are not resident in the area (visitors), as long as they have no contraindication. In certain settings, such as in the context of elimination, they should be recorded separately, as they were not included in the calculation of coverage. On days 2 and 3, once CHWs have finished dispensing daily treatment, they should return to households in their area in order to reinforce sensitization, promote treatment adherence and monitor ADRs. 36 Centralized, fixed-site distribution All distribution sites must have been identified in the planning stage and should be prepared the day before distribution begins. The site should be set up as follows (Fig. 2): • Delimitation of the site with a rope or fence is recommended, and the site should be clearly identified. • Waiting lines should be organized with rope or barrier tape and should be narrow enough for only one person to pass at a time. Crowd controllers may be necessary to ensure a smooth flow. • Sensitization should be conducted in the waiting area. • People should pass through an initial triage area, where their eligibility is verified. If they are considered eligible, they will continue through the circuit. If not, they will leave the area after the reasons for non-inclusion and registration have been explained. • A private area should be identified for pregnancy screening of women of reproductive age as previously described. • If it is decided that MDA cards will be handed to participants or a registration book completed (see section 2.3.4 and Annex 14), the next step will be registration. As this may be time-consuming, enough staff should be assigned to avoid bottlenecks and long waiting times. • People will then proceed to the point where they will receive an appropriate blister for their weight or age category. The treatment distributors will administer the first dose under direct observation, and inform the recipients on how to take the medication on days 2 and 3 (unless DOT for all three doses is done). • The tally sheet is completed for each participant after the medicine has been dispensed. • An observation area may be set aside where people spend 30 min to ensure that they do not vomit and no severe adverse events or adverse events of special interest (see section 3.4.1) appear and where they will be sensitized about possible side-effects, what to do if they occur, administration of the remaining doses and the importance of adherence. • All ill people attending the distribution should be referred to the nearest health facility. FIG. 2. Example of layout of a distribution site Drug distribution station DOT Drug distribution station DOT W ai tin g ar ea , w ith in fo rm at io n, ed uc at io n an d co m m un ic at io n Registration Registration O bs er va tio n an d se ns iti za tio n ar ea Triage Tally sheet Tally sheet M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 37 2.3.3 Supervision Supervision is important to ensure an effective, efficient, successful MDA campaign. Supervision should be conducted at various levels, with clearly defined communication lines between them. Supervisors should be appointed for the distribution teams and at the levels of districts, region or province (where applicable). National supervisors and coordinators should also be available. Distribution team supervisor The roles and responsibilities of the distribution team supervisor are: Before distribution: • Ensure proper reception and management of antimalarial medicine and other supplies at the peripheral health facility. • Verify that all distributors are identified and trained and that local activities are organized and coordinated. • Prepare the daily schedules of the distribution teams. During distribution: Morning - Present the micro-plan and daily work plan for each distribution team. - Check attendance, and find replacements in case of absence. - Ensure that each team has the necessary medicine and material. - Fill in part of the supervisory checklist. - Deliver the daily data collection tools. During distribution hours - Visit distribution teams in their area of supervision, and provide technical support when needed. - Randomly visit households, and interview members of communities that have already received the distribution team’s visit to verify that they did receive the medicine and what they understood about taking the remaining doses. End of the day - Meet the distribution teams. - Collect the remaining medicine and material (guarantee stock follow-up, and confirm consumption). - Collect daily tally sheets and analyses. - Compile data, fill in daily summary forms, and report to the district supervisor. - Ask about any problem encountered during MDA or stock out, and report. - Provide feedback to the teams, correct any mistakes, inform them of the progress of the campaign, and address any concerns. - Prepare the medicines and material for the next day. - Complete the supervisory checklist. - Report to the district supervisor any difficulties or problems to be dealt with, rumours and refusal on the part of the population. 38 End of the campaign: • Report the stock level. • Return the remaining medicine and materials (to be arranged in collaboration with logistics department). • Conduct debriefing with district supervisors and task force. Supervisors should have the proper tools for their tasks, such as a supervisory checklist (see Annex 15). District supervisor The roles and responsibilities of the district team supervisor are to: • supervise and support the distribution team supervisors; • ensure that there is a team supervisor for all eligible geographical areas; • visit peripheral health structures daily and react rapidly to questions and problems; • ensure the daily presence of all teams; • brief and debrief the team supervisors before and after each day’s work, with particular attention to: - stock ruptures, - problems in data collection, - rumours circulating in the community, - insufficient information by distributors on correct administration of the medicine, - lack of motivation of health workers, - insufficient response to ADRs and - coverage of hard-to-reach populations; • inform the district task force of any problem requiring immediate action that cannot be resolved locally; • collect and compile the information on the daily summary sheets for the district; • collect and review the team supervisors‘ checklists (may be done at the end of the campaign if there is not enough time during distribution) to identify any issues and lessons to be applied in subsequent rounds; • present daily summaries to the district task force during evening debriefings and • submit a written report to national supervisor. Regional or provincial supervisor (if applicable) The regional or provincial supervisor is responsible for supervising the district supervisors. He or she must follow up daily on the progress of the campaign and on any difficulties or problems, such as rumours. He or she must collect and analyse district summary findings and present a report to the national supervisor or coordinator. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 39 National supervisor or coordinator He or she oversees the regional or provincial supervisors, follows up the overall progress of the campaign and major difficulties, such as rumours, and analyses the summaries from regions or provinces before reporting to the national task force. 2.3.4 Data collection Data collection is a vital component of an MDA in order to guarantee adequate follow-up of operations. The person responsible for collecting each type of data at each level and the mechanism of transfer from one level to another should be clearly defined (Table 4 and Fig. 3). This is particularly important when several partners are involved in order to avoid duplication of data collection, missing data or mistakes in the destination of tallies or summary sheets. FIG. 3. Recommended information flow among levels CHWs and distribution teams • daily tally sheet • daily household registration Distribution team supervisor • daily summary sheet District supervisor • district summary Regional or provincial supervisor • regional summary National supervisor • national summary Community Health facility District Region or province National level 40 TABLE 4. Data to be recorded at each level during door-to-door and centralized distribution LEVEL DISTRIBUTION STRATEGY DOOR-TO-DOOR CENTRALIZED, FIXED-SITE Community Census of people in each household or family (obtained before MDA, when feasible) List of people in community, ideally with age and sex by family; otherwise, number of people per family Daily tally sheet with stock management (medicines, pregnancy tests and other consumables) per distribution team Daily tally sheet with stock management (medicines, pregnancy tests and other consumables) per distribution site Record of each person, family treated, excluded, refused or not found (see household registration) ADRs (name, age, sex, village, head of household, contact details, treatment taken, type of ADR, day of ADR) during days 2–7 ADR reporting (observations for 30 min while still at treatment centre) Referral form (in case of severe illness, ADR, pregnant woman who inadvertently received the treatment, other reasons) Health facility Daily summary sheet and analysis of coverage by community in the health facility catchment area ADR reporting (standard form) Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables in health facility stock Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables (stock may not always be prepositioned in health facility) District District summary sheet and analysis of coverage by health facility in the district Compilation of ADR report forms from health facilities in the district Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables if district storage is used and when stock is returned from health facility Region or province Regional or provincial summary sheet and analysis of coverage by districts in region or province Compilation of ADR report forms from districts Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables if regional storage is used and / or when stock is returned from district level National National total and analysis of coverage by region or province Compilation of ADR report forms from regions or provinces Stock or logistics management form: antimalarial medication, pregnancy tests and other consumables in national stock and when stock is returned from lower levels M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 41 MDA cards Provision of MDA cards (see Annex 16) to participants as proof that they received the treatment is optional and should be decided by the national task force during the design phase. If the task force decides that an MDA card will be provided, it should contain: • last and first names of the drug recipient, • age and sex, • address, • name and dose of the antimalarial medicine given and • date of administration of the first dose if given by DOT or of each dose if all three doses are given by DOT. Daily tally sheet Tally sheets (see Annex 13) should be completed by each team on each day of distribution and handed to the supervisor at the end of the day. The following information should be recorded: • date and place of distribution; • distribution team identification; • number of households visited; • number of people who received the medicine, by age group (defined by age categories for the medicine) and by sex if considered relevant; • individuals excluded and reason; • residence status: resident or visitor (especially useful in elimination contexts, as all may not be included in the coverage calculation) and • number of treatment blisters for each age category received at the start of the day and that remaining at the end of the day. The quantities of medicine consumed should correspond to the number of people treated, as recorded on the tally sheet. Discrepancies should be investigated to determine the cause, such as a mistake in distribution or theft. Household or line list registration Depending on the context (emergency or elimination), a household or line list registration (see Annex 14) may be used, with the following information collected: • household identification; • head of household; • name of recipient; • age; • sex; • village; • contact details (if available); 42 • residency status (permanent resident, temporary resident, visitor); • treatment taken; • refusal, excluded (reason) or not found and • observations. Daily summary sheet The distribution team supervisor should collect the completed tally sheets and compile the data corresponding to a certain geographical area (health centre catchment area, neighbourhood or village) on a daily summary form (see Annex 17). The tally sheets should be reviewed to ensure that they were properly completed and that the team is meeting the daily target. If not, the reason should be investigated (e.g. lack of sensitization, shortage of medicine, problems in recording). Feedback should be given to the teams on their performance and adjustments made, such as increasing the number of teams, changing the distribution site (in centralized distribution) or adapting mobilization. Database The data on the summary forms should be entered by a trained data manager into a centralized database at district, regional or national level (see Annex 18 for the database used in MDA in Sierra Leone), which will allow, at a later stage, a thorough analysis of the number of people treated, the number excluded, distribution coverage by age group and location and other information. Referral form A CHW who identifies a person who is ill, a pregnant woman in the first trimester who inadvertently took the antimalarial medicine or anyone presenting a potentially drug-related adverse reaction must fill in a referral form and refer the person to a health facility for proper management. ADR form If an individual presents symptoms that could be attributed to the antimalarial medication, an ADR form (see Annex 19) must be completed at a health facility or by a pharmacovigilance team. See section 3.4 for more details of pharmacovigilance and reporting of ADRs. 2.3.5 Coordination During the days of distribution, daily meetings should be held at district and national levels, with the participation of all involved in the campaign in order to: • monitor daily coverage; take action in problematic or challenging areas by targeting social mobilization or planning “catch up” distribution, ensure that hard-to-reach areas have been visited and guarantee that supplies have not run out; • monitor stocks, and ensure an uninterrupted supply of the medicine; • address any identified rumours or generalized refusal of the population; • manage enquiries from the press; • identify and correct any programme errors that could lead to failure of the campaign; • share any pertinent information, and coordinate the activities of all partners; and • mobilize the necessary resources in a coordinated way to respond to unforeseen events. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 43 2.3.6 Treatment of malaria cases after mass drug administration An individual treated during MDA who presents to a health facility with suspected malaria within 4–6 weeks should be assessed for possible malaria treatment failure or new infection. A positive result in a HRP2-based rapid diagnostic test cannot be relied upon, as a positive result may be obtained weeks after successful treatment due to persistent antigenaemia. Thus, microscopy should be used to confirm malaria. Ideally, health facilities should have antimalarial medicines in stock that are different from those used in the MDA. If microscopy confirms malaria, the health worker should enquire whether the patient adhered to the full course of treatment and if he or she vomited within the first 30 min of drug intake. If adherence was poor or the patient vomited, the same treatment used for MDA can be repeated. If adherence to treatment was good, a different antimalarial should be given, as possible treatment failure cannot be differentiated from a new infection in routine health care settings. 44 3. MONITORING AND EVALUATION 3.1 MONITORING SYSTEM Given the complexity of the intervention, the limited number of times MDA can be done and the importance of the coverage of the intervention, monitoring is essential for success. The monitoring should be of high quality and not considered routine. Use of a monitoring system during a campaign allows full allocation of resources to operations and efficient implementation of activities while dedicating resources and capacity for a separate set of activities that allow identification in real time of constraints that require immediate action and will provide lessons for subsequent rounds of MDA. The monitoring system should assess all phases of the campaign, by: • interviewing distribution teams to determine the effectiveness of training; • evaluating the logistics; • interviewing community members to appraise the effectiveness of the social mobilization campaign; • randomly visiting distribution teams to observe administration of the medication and counselling for adherence; • assessing the quality of data collection; • estimating actual coverage; • evaluating adherence to treatment and rational drug use; • monitoring drug safety and reporting adverse events; • and monitoring impact. Deployment of monitoring teams (internal or independent monitors) should be planned during the design phase in order to ensure adequate training in use of the monitoring tools. 3.2 ESTIMATE OF COVERAGE After each round is completed, coverage is estimated to determine the proportion of people reached. Areas of low coverage might be identified to improve planning for the following round. 3.2.1 Distribution coverage Distribution coverage can be defined as the proportion of the population who received the first dose of the treatment in that round, with the number of people who received the first dose as the numerator and the number of people in the target area as the denominator: Distribution coverage = number of people who received the first dose x 100 number of people targeted for treatment M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 45 The distribution coverage for each round and then the total MDA distribution coverage can be calculated. Additionally, distribution coverage should be estimated for each demographic group (age and sex) and geographical area, as applicable for campaign management. Although analysis by gender is not essential, it may be useful in settings where certain groups are likely to be underserved (e.g. girls). Such calculations do not, however, necessarily reflect the reality, because of difficulties in obtaining reliable demographic information, errors in data collection or inclusion of people from outside the target area in distribution. The estimate of coverage will be more accurate if a household census was conducted before distribution, providing the denominator. In emergencies or other situations in which performing a census is not feasible, the recommended approach is to perform a coverage survey. As stated previously, the desirable coverage is > 80%. Coverage of < 80% may be due to poor participation, a shortage of supplies or an inadequate strategy for the campaign. The reasons for not participating may be (12,26,27): • population mobility (seasonal or routine movements of people out of the area targeted for MDA); • unavailability or inability to participate at the time of MDA; • difficulty in reaching the distribution site or a long waiting time (in case of centralized distribution); • refusal to take the treatment because not sick; • fear of ADRs; • treatment considered to involve too many tablets and too long; • rumours about the medicine; • lack of engagement with community leaders and civil society in general; • lack of trust in the campaign; • misunderstanding and lack of adequate information about MDA; • interference with other community events; and • confusion between MDA for malaria and for other neglected tropical diseases, such as administration of praziquantel, which has side-effects that some people find difficult to tolerate. Although MDA in rural settings is logistically more demanding, it may be more difficult to obtain high coverage in urban than in rural settings because of differences in the characteristics and dynamics of the population, including socioeconomic status, educational level, occupation and work schedules (28,29). Some studies have shown that populations with higher social status are more reluctant to participate in MDA (28). Young people and adults who drink alcohol regularly are unwilling to participate in MDA unless they are sick. 46 The reasons for non-adherence to full treatment include (12,27): • not feeling sick, • wanting to save the medicine for when they are sick, • sharing the treatment with someone else, • forgetting to take the tablets, • fear of or appearance of side-effects, • rumours about the side-effects of the medicine and • inadequate health promotion or information on how to take the treatment correctly or on the importance of completing the full course. 3.2.2 Post-MDA campaign survey A post-campaign survey is recommended when feasible, ideally within the week after distribution. The survey comprises visiting a representative sample of the population and systematically administering a questionnaire (see sample in Annex 20) to selected household members. The results can be used to estimate the coverage of the larger population with confidence intervals. Additional information about the campaign can also be collected during the survey. Cluster sampling may be used. For information on performing a cluster survey of coverage, see Annex 4 of Monitoring and epidemiological assessment of mass drug administration in the global programme to eliminate lymphatic filariasis: a manual for national elimination programmes (30). A post-distribution survey is useful to: • estimate the coverage of the MDA, • evaluate adherence to treatment (the number of people who completed the full course of antimalarial medicine), • determine the reasons for non-participation, • determine the reasons for non-adherence, • estimate the proportion of people who experienced adverse events and • evaluate the main adverse events reported. 3.3 MONITORING CONSUMPTION The consumption of antimalarial medicine (number of treatments used) must be monitored daily and compared with the number of people reported to have been given the medication. Discrepancies between the two numbers should be investigated. They may be due to problems in recording the doses administered, errors in counting stocks, mistakes in administering the medicine or theft. Any of these problems must be suitably addressed with the teams. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 47 A major problem that could arise as a consequence of lack of reliable demographic data is that the true population at a given site largely exceeds that expected. By monitoring consumption, an eventual stock rupture can be determined. A shortage of stock linked to reports from distribution teams or from community leaders that parts of the population have not yet received MDA may alert supervisors to this possibility. Under such circumstances, the buffer stock in central storage should be used. A more logistically demanding alternative would be to shift medication from over-stocked locations to under-stocked ones. 3.4 PHARMACOVIGILANCE Even when medicines that have good safety and tolerability profiles are used, exposure of a large population may result in the appearance of rare side-effects in a number of cases. “Pharmacovigilance” is defined by WHO as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems (31). Pharmacovigilance in the context of MDA should be planned and implemented in collaboration with the national pharmacovigilance centre, which might be part of the national medicines regulatory authority or a research or academic institution. Pharmacovigilance systems depend on the performance and motivation of general health services staff, require centralized reporting lines and methods and skills for review, analysis and assessment of the causality of spontaneous reports of suspected drug reactions. The pharmacovigilance system should be organized at national, regional, district, state and municipal levels and also at health facilities and at community level in targeted populations. The objectives of pharmacovigilance during MDA are to: • detect unusually high rates of adverse events; • ensure that coincidental events are not falsely associated with MDA; • support timely detection and management of all adverse events (even those not attributed to MDA) to ensure the safety of the population; • maintain confidence in the campaign by proper responses to community concerns about the safety of the medicine while increasing awareness about its benefits and risks; • generate data about adverse events in certain populations such as asymptomatic carriers and healthy people for whom there may be no safety data, as these populations are not included in testing during development of medicines; • promote and monitor adherence to the medicine by the targeted population, and detect reasons for non-compliance and the underlying causes, if possible; • assess health systems preparedness to ensure drug safety monitoring at district and national levels by identifying appropriate responses in terms of knowledge of drug use (safety), training, knowledge and practice of pharmacovigilance; and • evaluate the expected severity, frequency, distribution and outcome of ADRs in the targeted population in order to: - identify adverse event that are not listed in the product information leaflet or are not described in populations that were not tested during development of the medicine, such as asymptomatic carriers and healthy people; - assess the association between the ADR and the antimalarial; - provide a spectrum of the ADRs associated with use of the antimalarial in large populations; and - inform health care workers about patient counselling and monitoring in health facilities. 48 The expected ADRs and the toxicity of the medicine to be used in MDA should be well known to the organizing committee. Groups at all levels should be sensitized about potential ADRs, including the general public, CHWs (treatment distributors), supervisors and health care staff. Communities should be informed about expected mild reactions, with the information that they are usually transient and self- limiting or manageable by simple treatment; they should be encouraged to seek medical care for any rare or severe symptoms. Special attention should be paid to side-effects that may reduce tolerability and lead to poor adherence, such as nausea, vomiting, diarrhoea and abdominal discomfort. This could be done via television and radio, print media, social media, press conferences, community outreach and meetings. 3.4.1 Definitions Adverse event: any untoward medical occurrence that may occur during treatment with a pharmaceutical product that is not necessarily causally associated with the treatment (32) Adverse drug reaction (ADR): a response to a drug that is noxious and unintended and that occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease or for modifying physiological function (32) Serious adverse event or reaction: any untoward medical occurrence that, at any dose: • results in death, • is life threatening, • requires hospitalization or prolongation of hospitalization, • results in persistent significant disability or incapacity or • results in congenital abnormality or birth defect (33,34). The detection of congenital abnormalities would require creation of a pregnancy registry, with enrolment and surveillance of all new pregnancies detected at antenatal care and in communities during the three months after MDA, and an evaluation to determine whether the women were pregnant at the time of exposure to the medicine. These women should be followed up to delivery to assess the outcome of the pregnancy, in terms of the health of both the foetus and infant and the mother (31). The cohort of pregnant women should be interviewed about any treatment with ACT or other medicines, with precise information on time of exposure and type of medicine and possible miscarriage, stillbirth or malformations. Analysis of data at the time of birth will allow a comparison of the frequency of miscarriage, stillbirth and congenital malformations among pregnant women who have inadvertently received various types of medicines during the first trimester. Adverse event of special interest: refers to adverse events (serious or non-serious) of significant scientific, medical and public interest, for which monitoring and rapid communication to the provider and regulators could be appropriate (35). The event should be defined and reported if some safety signals were detected during the development of a drug that required additional monitoring. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 49 3.4.2 Safety communication Reports of ADRs and rumours about the safety of the drug can damage an MDA campaign and can also influence future MDAs or even use of the medicine in the country. A communication strategy should be prepared with the national pharmacovigilance centre before the MDA campaign, in line with internationally accepted best practices (36). Relations with the media and selected spokespeople should be defined well in advance, as timeliness and efficiency in crisis communication are essential to contain serious damage by circulating rumours. Reported or perceived ADRs should be communicated appropriately to the media, with responses to any enquiries. Every serious adverse event must be properly recognized, reported and investigated. Once the assessment has been completed, the results of the investigation should be communicated to the community through appropriate media. 3.4.3 Surveillance of adverse drug reactions Routine ADR surveillance must be enhanced during an MDA campaign to identify any potentially severe cases and to manage them adequately, to detect any programmatic errors and to reassure the general public. Rescue medicine and emergency medical material required for managing potential adverse reactions should be available in health facilities. Medication errors, such as in dose administration by distributors or in taking the medicine because of inadequate sensitization, could be at the origin of adverse events and should be duly reported. In order to establish a functioning safety surveillance system, all personnel involved in an MDA campaign, especially health care staff, should be trained before the campaign on their roles and responsibilities, emphasizing prevention, early detection and management of adverse events and severe adverse events linked to the campaign as well as on the use of standard forms for reporting and the procedure to follow in case of a suspected severe ADR (notification system). Most countries have standard forms for documenting ADRs (see example in Annex 19). Forms for reporting suspected ADRs should be widely distributed, and clear guidance should be provided to health care staff and local health structures on completing the form. Any reported severe ADR must be investigated to determine its relation with the antimalarial medicine, and all responses should be documented, including treatment. The reporting form adopted by the national pharmacovigilance centre should be used for spontaneous reporting. The forms may be adapted for active monitoring of a sample of the exposed population to include days of follow-up and findings of home visits. All reporting forms should record data on the patient, the suspected drug(s), concomitant medication, medical history, detailed description of the clinical course of the event(s), diagnosis, outcome, relevant laboratory or other diagnostic procedures and treatment received and any other information that supports causality (37). Two pharmacovigilance methods may be used during MDAs. • Passive monitoring or spontaneous reporting: reporting of a suspected adverse reaction by a health practitioner who becomes aware of a safety concern or by a patient. Thus, reporting is not solicited systematically. Nevertheless, both health workers and people receiving MDA should be advised (with clear contact details) to report any untoward event they may observe during or after MDA. • Active monitoring and reporting: follow-up home visits by pharmacovigilance mobile teams or health workers trained in detecting adverse events after exposure to medicines for detection of short-term ADRs (during the week after administration) in every village, town or city in which the medicine was given. This is particularly important in settings where pharmacovigilance systems are weak and underreporting is significant. It involves active case finding and follow-up (“search, find, identify, refer and manage”). Any ADR detected should be reported to a health facility, and serious ADRs should be referred for further investigation and management. 50 To ensure effective communication and reporting of ADRs, a dedicated round-the-clock pharmacovigilance call centre or hotline could be set up to address queries from recipients of the medicine during the campaign. In countries where the national pharmacovigilance centre has an online electronic reporting system for ADRs, this can be used to enhance reporting if there is nationwide sensitization of consumers and health care professionals to the availability of the system. All ADR reports collected during or after the campaign should be forwarded to the national pharmacovigilance centre for assessment and onward submission to the WHO global ADR database. A health facility pharmacovigilance preparedness checklist (see example in Annex 21) could be used by pharmacovigilance monitors in communities to assess whether: • there are adequate quantities of rescue medications to treat ADRs; • staff are aware of the need for pharmacovigilance monitoring during the MDA; • all staff have been apprised of and trained in pharmacovigilance monitoring and the adverse reactions to the antimalarial medicine that will be used in the campaign; • staff were involved in advocacy and social mobilization before the campaign about the importance of adherence to the medicine; and • ADR reporting forms are readily available at MDA sites, with clear forwarding instructions and contact details. All health workers involved in the mass drug administration should be trained in pharmacovigilance (see example of training curriculum for drug dispensers in Annex 22). 3.5 MONITORING DRUG RESISTANCE One of the main concerns about MDA is the emergence and spread of resistance to the drug, which spreads because resistant parasites develop greater transmission potential in the presence of the antimalarial medicine. In the past, indirect MDA (in which antimalarial drugs were added to salt distributed to the population) resulted in the development of resistance because of the use of sub-therapeutic doses of antimalarial medication (5,38). MDA is likely to increase selection pressure on parasites. As antimalarial medicines with a long half-life are eliminated slowly from the body, during MDA, a large proportion of the population will have variable concentrations of the medicine in the blood over time. This increases the chances that malaria parasites will be exposed to sub-therapeutic concentrations of long-acting drugs (13,40,41). Thus, the post-treatment prophylactic effect, which is an important component of the protective and transmission-blocking effect of MDA, may also lead to selection pressure. Low adherence to treatment by a proportion of the population is expected to be higher in people with asymptomatic parasitaemia, which will also contribute to the exposure of malaria parasites to sub-therapeutic doses. Until now, there has been no evidence that MDA of antimalarial medicines given at therapeutic doses results in the emergence of resistance (39). While the use of combination treatment reduces the possibility of selecting drug-resistant parasites (23), limited evidence on the impact of MDA on drug resistance indicates that resistance to antimalarial medicines should be monitored in areas where MDA is implemented on a large scale. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 51 Several means for monitoring parasite (P. falciparum) resistance are relevant to MDA (42). • In vivo trials of therapeutic efficacy: treatment of symptomatic patients with a standard dose of antimalarial medicine and measurement of the clinical (signs and symptoms) and parasitological (parasitaemia) efficacy of medicines and treatment outcome over a defined period. Although trials of therapeutic efficacy are considered the “gold standard” and are used in national malaria control programs to guide treatment policy, they are relatively complex to perform and not always easy to implement after MDA. • Detection of molecular drug resistance markers: confirmation of genetic changes associated with resistance by molecular techniques. Serial detection of molecular markers is an accurate way of monitoring drug resistance and probably the preferred option. It has the advantage that samples can be easily obtained, transported and stored on filter paper, but it also requires expensive equipment. It can provide early evidence of resistance, particularly if pre-intervention data are available. Molecular markers of drug resistance are available for only a limited number of antimalarial medicines, notably chloroquine, amodiaquine, sulfadoxine + pyrimethamine, mefloquine, piperaquine and artemisinin. The correlation between molecular markers and the therapeutic efficacy of many antimalarials is imperfect and should be interpreted with caution. In any scenario, at least one of the two methods should be available. Monitoring drug resistance will require collaboration with reference laboratories and with research entities at national or international level. 3.6 EVALUATING IMPACT The ideal way of determining impact, especially when the objective is to reduce malaria transmission, is to monitor malaria prevalence by serial measurements of parasitaemia. The method used in pre- and post-MDA surveys should be the same in order to identify an effect. A more practical way of evaluating the impact of MDA for malaria is monitoring routine surveillance data. The following indicators should be measured, ideally weekly, but at least at monthly: • total number of consultations (outpatients), • total number of suspected cases tested for malaria, • total number of cases of confirmed malaria, • total number of admissions of severe cases of malaria, • number of deaths due to malaria, • test positivity rate and • total number of locally transmitted and imported malaria cases. For epidemics and complex emergencies, a minimum set of MDA monitoring and evaluation activities should be defined in order to document impact and for reporting. Facilities that record confirmed malaria cases continuously can be identified in most settings, in order monitor over time the numbers of consultations and of cases of confirmed malaria in the target groups exposed to MDA and, if possible, in unexposed population groups. 52 These data should be compared before and after MDA in the targeted area; in a district covered by MDA and one that was not targeted, with a similar prevalence of malaria; and in the same district in a year in which MDA was carried out and one in which it was not. More detailed analyses could indicate the contributions of aspects such as environmental or demographic factors and concomitant interventions that also influence malaria trends. When MDA is used as an emergency measure to reduce the burden of malaria and febrile illness rapidly, as was the case in the outbreak of EVD, the effectiveness in reducing both malaria morbidity and the number of febrile cases presenting to health services should be monitored (11,12). In an epidemic, the effect of MDA is difficult to document, as the temporal change may be reflected simply as a plateau, or a reduction in the rate of increasing incidence in the epidemic curve. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 53 4. REPORTING After each round and at the end of the intervention, all partners at different levels (community, health facility, district, region, province, national) should gather for a debriefing and review to assess how the campaign went, share their experiences and impressions and make recommendations for the following rounds or future MDA. A report should be written in order to capitalize on the experience and identify lessons that could improve subsequent rounds or similar experiences. It should provide: • the coverage achieved; • the main findings, challenges and difficulties faced and successful or unsuccessful solutions; • any practices that gave good results, including effective social mobilization activities; • any useful tools that were developed ad hoc in response to unpredicted events, which could be incorporated into reference documents and included in training material; • the final cost of the intervention (analysis per line item) and the cost per person treated; • transparency and accountability for all resources used, including final inventories, destination of remaining treatment, return of logistic equipment, any donations made; and • an evaluation of the whole operation. The following is a proposed outline of the essential topics that should be covered in the report to be prepared at district level at the end of each MDA round: • Introduction and background • Objectives • Duration of campaign • Geographical area of intervention and target population • Treatment regimen • Details of methods used during the campaign - Preparation and planning o Recruitment and training of human resources o Social mobilization and community engagement o Logistics and supply - Distribution o Strategy o Practical aspects o Supervision o Data collection o Results - Total number of people reached - Coverage - Excluded individuals and reasons for non-inclusion 54 • Monitoring: adverse events reported • Other relevant aspects of monitoring • Finance and administration, including breakdown per cost • Strong points, difficulties, lessons learnt and recommendations • Annexes Another important component of reporting is feedback to the communities on the outcomes of the campaign and its impact. This will improve people’s perception of the activity and build trust in the health authorities for future campaigns. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 55 5. K EY S TE PS IN A M AS S DR UG A DM IN IS TR AT IO N CA M PA IG N FO R M AL AR IA Pl an ni ng an d pr ep ar at io n Im pl em en ta tio n M on ito rin g an d ev al ua tio n Re po rt in g D es ig n ph as e (m ac ro -p la nn in g) • O bt ai n co m m itm en t f ro m po lic y- m ak er s, an d id en tif y ag en ci es to su pp or t t he m in ist ry o f h ea lth • E st ab lis h a ta sk fo rc e or co or di na tin g co m m itt ee • C on du ct a c on te xt a na lys is • D et er m in e ta rg et p op ul at io n an d ge og ra ph ica l a re as • D et er m in e an tim al ar ia l m ed ic in e to b e us ed • E st im at e re qu ire m en ts , a nd or de r m ed ic in e • D et er m in e de liv er y st ra te gy : - D oo r t o do or - C en tra liz ed - M ix ed • D et er m in e pe rio d of in te rv en tio n • E st ab lis h nu m be r o f r ou nd s • E st ab lis h a ch ro no gr am • E st im at e a bu dg et • D o m ic ro -p la nn in g • E ns ur e eff ec tiv e lo gi st ic s - Pr oc ur em en t, st or ag e an d di st rib ut io n - Tr an sp or t - Ac ce ss ib ili ty - D ist rib ut io n sit es - W as te m an ag em en t • H um an re so ur ce s - Id en tif y re qu ire m en ts - Tr ai ni ng - Sa la rie s a nd p er d ie m • C om m un ity e ng ag em en t an d so ci al m ob iliz at io n - D efi ne ro le s a nd re sp on sib ilit ie s - Co m m un ity as se ss m en t - Ke y m es sa ge s - En ga ge m as s m ed ia - A dd re ss ru m ou rs - En ga ge c om m un ity • S to ck m an ag em en t • D ist rib ut io n of a nt im al ar ia l m ed ic in e • S up er vi sio n • D at a co lle ct io n • C oo rd in at io n • R ea l-t im e m on ito rin g • E st im at io n of c ov er ag e • P os t- ca m pa ig n su rv ey • M on ito rin g of c on su m pt io n • P ha rm ac ov ig ila nc e • M on ito rin g of d ru g re sis ta nc e • E va lu at io n of im pa ct • D eb rie f a nd re vi ew in te rv en tio n • W rit e a fin al re po rt 56 REFERENCES 1. 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Geneva: World Health Organization, Global Malaria Programme; 2015 (WHO/HTM/GMP/2015.8) (http://www.who.int/malaria/publications/atoz/role-of-mda-for- malaria.pdf, accessed 17 August 2017). 16. Guidelines for the treatment of malaria. 3rd edition. Geneva: World Health Organization; 2015 (http://www.who.int/malaria/publications/atoz/9789241549127/en/, accessed 17 August 2017). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 57 17. Recht J, Ashley E, White N. Safety of 8-aminoquinoline antimalarial medicines. Geneva: World Health Organization; 2014 (http://www.who.int/malaria/publications/atoz/9789241506977/en/, accessed 17 August 2017). 18. Policy brief on single-dose primaquine as a gametocytocide in Plasmodium falciparum malaria. Geneva: World Health Organization; 2015 (WHO/HTM/GMP/2015.1) (http://www.who.int/ malaria/publications/atoz/policy-brief-single-dose-primaquine-pf/en/, accessed 17 August 2017). 19. Testing for G6PD deficiency for use of primaquine in radical cure of Plasmodium vivax and P. ovale malaria. Policy brief. Geneva: World Health Organization; 2016 (WHO/HTM/GMP/2016.9) (http://apps.who.int/iris/bitstream/10665/250297/1/WHO-HTM-GMP-2016.9-eng.pdf , accessed 17 August 2017). 20. Good procurement practices for artemisinin-based antimalarial medicines. Geneva: World Health Organization; 2010 (http://apps.who.int/iris/bitstream/10665/44248/1/9789241598927_ eng.pdf. Accessed 17 August 2017). 21. Prequalified lists. Medicines/finished pharmaceutical products. Geneva: World Health Organization; 2017 (https://extranet.who.int/prequal/content/prequalified-lists, accessed 17 August 2017). 22. List of malaria pharmaceutical products classified according to the Global Fund Quality Assurance Policy. Geneva: Global Fund to Fight AIDS, Tuberculosis and Malaria; (https://www. theglobalfund.org/media/4756/psm_productsmalaria_list_en.pdf, accessed 17 August 2017). 23. Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011;17:1617–23. 24. Dial NJ, Ceesay SJ, Gosling RD, D’Alessandro U, Baltzell KA. A qualitative study to assess community barriers to malaria mass drug administration trials in the Gambia. Malar J. 2014;13:47. 25. Shuford K, Were F, Awino N, Samuels A, Ouma P, Kariuki S et al. Community perceptions of mass screening and treatment for malaria in Siaya County, western Kenya. Malar J. 2016;15:71. 26. Nguyen TN, Thu PNH, Hung NT, Son DH, Tien NT, Dung NV et al. Community perceptions of targeted anti-malarial mass drug administrations in two provinces in Vietnam: a quantitative survey. Malar J. 2017;16:17. 27. Dierickx S, Gryseels C, Mwesigwa J, O’Neill S, Bannister-Tyrell M, Ronse M et al. Factors associated with non-participation and non-adherence in directly observed mass drug administration for malaria in The Gambia. PLoS One. 2016;11: e0148627. 28. Njomo DW, Mukoko DA, Nyamongo NK, Karanja J. Increasing coverage in mass drug administration for lymphatic filariasis elimination in an urban setting: a study of Malindi Town, Kenya. PLoS One. 2014;9:e83413. 29. Kumar P, Prajapati P, Saxena D, Kavishwar AB, Kurian G. An evaluation of coverage and compliance of mass drug administration 2006 for elimination of lymphatic filariasis in endemic areas of Gujarat. Indian J Commun Med. 2008;33:38–42. 30. Monitoring and epidemiological assessment of mass drug administration. Lymphatic filariasis. A manual for national elimination programmes. Geneva: World Health Organization; 2011 (http:// apps.who.int/iris/bitstream/10665/44580/1/9789241501484_eng.pdf, accessed 17 August 2017). 31. The safety of medicines in public health programmes: pharmacovigilance an essential tool. Geneva: World Health Organization; 2006 (http://www.who.int/medicines/areas/quality_safety/ safety_efficacy/Pharmacovigilance_B.pdf, accessed 17 August 2017). 58 32. The importance of pharmacovigilance – safety monitoring of medicinal products. Geneva: World Health Organization; 2002 (http://apps.who.int/medicinedocs/en/d/Js4893e/, accessed 17 August 2017). 33. Assuring safety of preventive chemotherapy interventions for the control of neglected tropical diseases. Practical advice for national programme managers on the prevention, detection and management of serious adverse events. Geneva: World Health Organization; 2011 (http://apps. who.int/iris/bitstream/10665/44683/1/9789241502191_eng.pdf , accessed 17 August 2017). 34. SAE handbook (A handbook for managing adverse events following mass drug administration and serious adverse events). Washington DC: Envision; 2014. 35. ICH guideline E2F on development safety update report. London: European Medicines Agency; 2010 (EMA/CHMP/ICH/309348/2008) (http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2010/09/WC500097061.pdf, accessed 17 August 2017). 36. Guideline on good pharmacovigilance practices (GVP) – module XV – Safety communication (Rev 1) (EMA/118465/2012 Rev 1). London: European Medicines Agency; 2013 (http://www.ema. europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/12/ WC500198759.pdf, accessed 17 August 2017). 37. ICH harmonised tripartite guideline. Post-approval safety data management: definitions and standards for expedited reporting E2D. Geneva: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2003 (https:// www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_ Guideline.pdf, accessed 17 August 2017). 38. Greenwood B. The use of anti-malarial drugs to prevent malaria in the population of malaria-endemic areas. J Trop Med Hyg. 2004;70:1–7. 39. von Seidlein L, Dondorp A. Fighting fire with fire: mass antimalarial drug administrations in an era of antimalarial resistance. Expert Rev Anti Infect Ther. 2015;13:715–30. 40. White N. The role of anti-malarial drugs in eliminating malaria. Malar J. 2008;7(Suppl 1):S8. 41. Kay K, Hastings I. Measuring windows of selection for anti-malarial drug treatments. Malar J. 2015;14:292. 42. Global report on antimalarial drug efficacy and drug resistance: 2000–2010. Geneva: World Health Organization; 2010 (http://apps.who.int/iris/bitstream/10665/44449/1/9789241500470_ eng.pdf, accessed 17 August 2017). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 59 Annex 1 STANDARD DISTRIBUTION OF POPULATIONS IN A DEVELOPING COUNTRY CHILDREN < 5 YEARS AGE RANGE (MONTHS) PERCENTAGE OF TOTAL POPULATION 0–11 4% 12–23 3% 24–35 3% 36–47 3% 48–59 3% Total 16% TOTAL POPULATION AGE RANGE (YEARS) PERCENTAGE OF TOTAL POPULATION 0–4 16% 5–14 27% 15–29 27% 30–44 16% ≥ 45 14% Total 100% 60 Annex 2 AVAILABLE ARTEMISININ-BASED COMBINATION THERAPY: DOSING, FORMULATION AND PRESENTATION DIHYDROARTEMISININ–PIPERAQUINE WHO recommended doses BODY WEIGHT (KG) DOSES (MG) OF DIHYDROARTEMISININ AND PIPERAQUINE GIVEN DAILY FOR 3 DAYS 5 to < 8 20 + 160 8 to < 11 30 + 240 11 to < 17 40 + 320 17 to < 25 60 + 480 25 to < 36 80 + 640 36 to < 60 120 + 960 60 to < 80 160 + 1280 ≥ 80 200 + 1600 Formulations available Fixed-dose combination in: • Paediatric tablets containing 20 mg dihydroartemisinin and 160 mg piperaquine • Tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine Presentations • Blister containing 3 tablets of 20 mg dihydroartemisinin and 160 mg piperaquine • Blister containing 3 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 6 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 9 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine • Blister containing 12 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 61 Remarks • Dihydroartemisinin–piperaquine is an ideal candidate because of its efficacy and long post- treatment prophylactic effect. The elimination half-life of piperaquine is 13.5–28 days (1). • Piperaquine prolongs the QT interval and should not be used with medication that prolongs the QT interval or in patients with congenital QT prolongation (1). Excluding patients with congenital QT prolongation would not be feasible in MDA. A single report of a sudden unexplained death considered potentially related to lethal cardiotoxicity has been reported among approximately 200 000 individuals closely followed up after treatment with this medicine (2-4). • Dihydroartemisinin–piperaquine should ideally be administered to a person with an empty stomach, as high-fat meals accelerate the absorption of piperaquine, increasing the risk for a prolonged QT interval. Each dose should be taken at least 3 h after the last food intake; no food should be taken within 3 h of each dose. 62 ARTESUNATE–AMODIAQUINE Recommended doses BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTESUNATE + AMODIAQUINE DAILY FOR 3 DAYS 4.5 to < 9 2–11 months 25 + 67.5 9 to < 18 1–5 years 50 + 135 18 to < 36 6–13 years 100 + 270 ≥ 36 ≥ 14 years 200 + 540 Formulations available Fixed-dose combination in tablets containing • 25 mg artesunate and 67.5 mg amodiaquine • 50 mg artesunate and 135 mg amodiaquine • 100 mg artesunate and 270 mg amodiaquine Presentations • Blister containing 4.5 to < 9 kg (infant): 3 tablets of 25 mg artesunate and 67.5 mg amodiaquine • Blister containing 9 to < 18 kg (toddler): 3 tablets of 50 mg artesunate and 135 mg amodiaquine • Blister containing 18 to < 36 kg (child): 3 tablets of 100 mg artesunate and 270 mg amodiaquine • Blister containing ≥ 36 kg (adult): 6 tablets of 100 mg artesunate and 270 mg amodiaquine Remarks • Artesunate–amodiaquine is associated with neutropenia, especially in HIV-positive patients on zidovudine and / or co-trimoxazole. Concomitant use of efavirenz may also increase the hepatotoxicity of amodiaquine (1). • Although limited data is available, artesunate-amodiaquine is associated with QT interval prolongation similar to other antimalarial medicine such as quinine, chloroquine and dihydroartemisinin-piperaquine. No sudden unexplained death suggestive of cardiac arrhythmia at the doses used for malaria treatment have been reported despite widespread use suggesting that while cardiotoxicity may occur it is rare (4). • Elimination half-life: 4–10 days (1). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 63 ARTESUNATE–MEFLOQUINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTESUNATE + MEFLOQUINE GIVEN DAILY FOR 3 DAYS 5 to < 9 6 to 12 months 25 + 55 9 to < 18 1 to 6 years 50 + 110 18 to < 30 7 to 12 years 100 + 220 ≥ 30 ≥ 13 years 200 + 440 Formulations available Fixed-dose combination in: • Paediatric tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Adult tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) Presentations • Strip of 3 tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Strip of 6 tablets containing 25 mg artesunate and 55 mg mefloquine hydrochloride (equivalent to 50 mg mefloquine base) • Strip of 3 tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) • Strip of 6 tablets containing 100 mg artesunate and 220 mg mefloquine hydrochloride (equivalent to 200 mg mefloquine base) Remarks • Artesunate–mefloquine has a long post-treatment prophylactic effect (elimination half-life, ≤ 3 weeks) (1) but is associated with nausea, vomiting and neuropsychiatric symptoms, which may reduce its tolerability in MDA operations. 64 ARTEMETHER–LUMEFANTRINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSES (MG) OF ARTEMETHER + LUMEFANTRINE GIVEN TWICE DAILY FOR 3 DAYS 5 to < 15 2 to 59 months 20 + 120 15 to < 25 5 to 7 years 40 + 240 25 to < 35 8 to 12 years 60 + 360 ≥ 35 ≥ 13 years 80 + 480 Formulations available • Dispersible or standard tablets containing 20 mg artemether and 120 mg lumefantrine • Standard tablets containing 40 mg artemether and 120 mg lumefantrine Presentation • Blister containing 5 to < 15 kg: 6 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing 15 to < 25 kg: 12 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing 25 to < 35 kg: 18 tablets of 20 mg artemether and 120 mg lumefantrine • Blister containing ≥ 35 kg: 24 tablets of 20 mg artemether and 120 mg lumefantrine Remarks Artemether–lumefantrine is probably not a suitable choice for MDA. • It is currently used as first-line treatment in many countries. • The complexity of the treatment regimen of two daily doses would probably compromise adherence. • It has a short post-treatment prophylactic effect (elimination half-life, 3–6 days) (1). M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 65 ARTESUNATE + SULFADOXINE–PYRIMETHAMINE Recommended dose BODY WEIGHT (KG) AGE (APPROXIMATE) DOSE (MG) OF ARTESUNATE GIVEN DAILY FOR 3 DAYS DOSES (MG) OF SULFADOXINE + PYRIMETHAMINE GIVEN AS A SINGLE DOSE ON DAY 1 5 to < 10 6–11 months 25 250 +12.5 10 to < 25 1–7 years 50 500 + 25 25 to < 50 8–14 years 100 1000 + 50 ≥ 50 ≥ 15 years 200 1500 + 75 Formulations available Co-blister pack (there is no fixed-dose combination): • Tablets containing 50 mg artesunate and fixed dose combination tablets containing 500 mg sulfadoxine and 25 mg pyrimethamine Presentations • Blister containing 3 tablets of 50 mg artesunate and 1 tablet of 500 mg sulfadoxine and 25 mg pyrimethamine • Blister containing 6 tablets of 50 mg artesunate and 2 tablets of 500 mg sulfadoxine and 25 mg pyrimethamine Remarks • Artesunate–sulfadoxine + pyrimethamine does not exist as a fixed-dose combination, which would result in massive distribution of loose artesunate tablets, potentially leading to the emergence of resistance. • Elimination half-life is 4.1–10.9 days for sulfadoxine and 2.5–18.8 days for pyrimethamine (1). • The combination of sulfadoxine + pyrimethamine–amodiaquine, currently used in the Sahel as seasonal malaria chemoprevention, provides protection from reinfection for 28 days; however, it is available in a co-blister formulation and currently not recommended for individuals over 5 years of age. The efficacy of both sulfadoxine–pyrimethamine and amodiaquine is limited geographically due to increasing drug resistance to both medicines. • Sulfadoxine + pyrimethamine should not be administered to people on co-trimoxazole (1). References 1. Guidelines for the treatment of malaria. 3rd edition. Geneva: World Health Organization; 2015 (http://www.who.int/malaria/publications/atoz/9789241549127/en/, accessed 17 August 2017). 2. Myint HY, Ashley EA, Daya NPJ, Nosten F, White NJ. Efficacy and safety of dihydroartemisinin- piperaquine. Trans R Soc Trop Med Hyg. 2007;101:858–66. 3. Kabanywanyi AM, Baiden R, Ali AM, Mahende MK, Ogutu BR, Oduro A et al. Multi-country evaluation of safety of dihydroartemisinin / piperaquine post-licensure in African public hospitals with electrocardiograms. PLoS One. 2016;11:e0164851. 4. The cardiotoxicity of antimalarials. Report of the WHO Evidence Review Group Meeting, 13–14 October 2016, Geneva: World Health Organization; 2017 (http://www.who.int/malaria/mpac/ mpac-mar2017-erg-cardiotoxicity-report-session2.pdf?ua=1, accessed 17 August 2017). 66 Annex 3 EXAMPLE OF CALCULATION OF ORDERS FOR ANTIMALARIAL MEDICINE EXAMPLE OF CALCULATION FOR ARTESUNATE–AMODIAQUINE Artesunate–amodiaquine comes in fixed-dose combination tablets, packed in age-appropriate blisters, in four presentations: Dosage based on body weight or age BODY WEIGHT (KG) APPROXIMATE AGE GROUP BLISTER PRESENTATION DOSAGE 4.5 to < 9 kg 2–11 months 25 mg / 67.5 mg tablets in blisters of 3 tablets 1 per day for 3 days 9 to < 18 kg 1–5 years 50 mg / 135 mg tablets in blisters of 3 tablets 1 per day for 3 days 18 to < 36 6–13 years 100 mg artesunate + 270 mg amodiaquine in blisters of 3 tablets 1 per day for 3 days ≥ 36 ≥14 years 100 mg artesunate + 270 mg amodiaquine in blisters of 6 tablets 2 per day for 3 days Total population: 100 000 Age distribution (from standard age distribution for developing countries in Annex 1): • 2–11 months ≈ 4% (0–11 months = 4%) • 1–5 years = 12% • 6–13 years ≈ 27% (5–14 years = 27%) • ≥ 14 years ≈ 57% (≥ 15 years = 57%) Target population by age group BREAKDOWN BY AGE GROUP (ACCORDING TO BLISTER PRESENTATION) 2–11 MONTHS 12–59 MONTHS 5–13 YEARS ≥ 14 YEARS Percentage of total population 100 000 x 0.04 100 000 x 0.12 100 000 x 0.27 100 000 x 0.57 Total population per age group 4000 12 000 27 000 57 000 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 67 Estimate of number of treatments (= number of blisters) per presentation and volume requirement 6–11 MONTHS 12–59 MONTHS 5–13 YEARS ≥ 14 YEARS TOTAL For one round 4 000 12 000 27 000 57 000 100 000 For three rounds 12 000 36 000 81 000 171 000 300 000 25% buffer stock 3 000 9 000 20 250 42 750 75 000 Total number of treatments 15 000 45 000 101 250 213 750 375 000 Estimated volume per treatment (in dm³) 0.02 0.03 0.04 0.04 Total estimated volume (in dm³) 300 1 350 4 050 8 550 14 250 68 EXAMPLE OF CALCULATION FOR DIHYDROARTEMISININ–PIPERAQUINE Dihydroartemisinin–piperaquine is available as fixed-dose combinations in tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine and in paediatric tablets containing 20 mg dihydroartemisinin and 160 mg piperaquine. WHO dose recommendations based on weight BODY WEIGHT (ESTIMATED AGE) DAILY DOSE FOR 3 DAYS TABLET STRENGTH AND NUMBER OF TABLETS PER DOSE 5 to < 8 kg (2–11 months) 20 + 160 1 x 20 mg / 160 mg tablet 8 to < 11 kg (12–23 months) 30 + 240 1½ x 20 mg / 160 mg tablet 11 to < 17 kg (2–4 years) 40 + 320 1 x 40 mg / 320 mg tablet 17 to < 25 kg (5–7 years) 60 + 480 1½ x 40 mg / 320 mg tablet 25 to < 36 kg (8–13 years) 80 + 640 2 x 40 mg / 320 mg tablet 36 to < 60 kg (≥ 14 years) 120 + 960 3 x 40 mg / 320 mg tablet 60 to < 80 kg (adults) 160 + 1280 4 x 40 mg / 320 mg tablet ≥ 80 kg (adults) 200 + 1600 5 x 40 mg / 320 mg tablet Total population: 100 000 Age distribution (based on standard age distribution for developing countries, Annex 1): • 2–11 months ≈ 4% (0–11 months = 4%) • 12–23 months = 3% • 2–4 years ≈ 9% (2–5 years) • 5–7 years ≈ 9% (5–14 years = 27%) • 8–13 years ≈ 18% (5–14 years = 27%) • ≥ 14 years ≈ 57% (≥ 15 years = 57%) Target population by age group AGE GROUP 2–11 MONTHS 12–23 MONTHS 2–4 YEARS 5–7 YEARS 8–13 YEARS ≥ 14 YEARS Percentage of total population 100 000 x 0.04 100 000 x 0.03 100 000 x 0.09 100 000 x 0.09 100 000 x 0.18 100 000 x 0.57 Total population per age group 4 000 3 000 9 000 9 000 18 000 57 000 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 69 Estimation of number of treatments (= number of blisters) per presentation REQUIREMENT DIHYDROARTEMISININ / PIPERAQUINE 20 mg / 160mg 3-tablet blister 40 mg / 320mg 3-tablet blister 40 mg / 320mg 6-tablet blister 40 mg / 320mg 9-tablet blister 40 mg / 320mg 12-tablet blister 1 round 10 000 9 000 27 000 28 500 28 500 3 rounds 30 000 27 000 81 000 85 500 85 500 25% buffer stock 7 500 6 750 20 250 21 375 21 375 Total number of treatments 37 500 33 750 101 250 106 875 106 875 The total number ordered should be adjusted according to existing stocks, back orders and other sources. 70 Annex 4 EXAMPLE OF A CHRONOGRAM FOR MASS DRUG ADMINISTRATION FOR MALARIA (DISTRIBUTION AT 8 WEEKS) DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Coordination Creation of task force and define composition Definition of roles, tasks Creation of subcommittees Task force meeting Sub-committees Meeting (National & District Levels) Written proposal of MDA Development of tools Conduct micro planning at district level Final report Antimalarial medicines Estimation of medicine needs Check existing stocks / backorders Make medicine order Reception of medicine order Stock management (cards, batch number) Distribution of medicines to district level Pre-positioning of medicines in peripheral health structures Other equipment (team supplies, data collection tools, stationary, etc.) Estimation of needs Evaluation of available resources Order necessary supplies Reception of supplies Preparation of kits M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 71 DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Distribution of supplies to district level Pre-positioning of logistic kits in peripheral health structures Logistics and transport Evaluation of needs Evaluation of available resources Order or rental of vehicles Verification and maintenance Vehicle movement plan and follow up Human resources Estimation of needs Evaluation of available personnel Selection and recruitment of missing personnel Identification of allocation of staff and supervisors Create training materials Training of trainers Training of supervisors Training of distribution teams Training of monitors Training of drug safety monitoring teams Supervision Salaries / perdiem Social mobilisation Develop communication plan Develop key messages Produce and distribute IEC material Advocacy meetings with Key actors at national level Advocacy meetings with Key actors at district level 72 DATES Person Responsible W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 EN D Sensitization of specific groups at community level (traditional leaders, authorities, religious leaders, women's groups, etc.) House to house and street to street sensitization Town criers / megaphones Press briefing Monitoring of press Planning of radio and TV programming / ads Participation in radio / TV panel discussions Elaboration of radio jingles Airing of radio jingles Distribution sites (for centralised strategies only) Define number of sites needed Identification of sites Visit sites Organisation of sites for distribution (tables, chairs, etc.) Antimalarial medicine distribution Preparation of materials Checking of materials Supply during campaign Implementation of round one Implementation of round 2 Implementation of round 3 Supervision activities Monitoring and evaluation Data analysis Evaluation of distribution coverage Monitoring activities Post distribution survey M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 73 UR BA N W ES TE RN A RE A PO PU LA TI O N PE R AG E G RO UP (+ 5 % BU FF ER S TO CK ) BO X VO LU M E (M 3 ) TOTAL VOLUME No . Na m e of fa ci lit y Ty pe o f f ac ili ty O w ne r Lo ca lit y Ch ie fd om /z on e Po pu la tio n DH M T Po pu la tio n DH M T + 5% b uff er st oc k 6– 11 m (2 %) 12 –5 9 m (1 3. 7% ) 5– 13 y (2 8% ) > 14 y (5 4. 5% ) 6– 11 m (2 %) 12 –5 9 m (1 3. 7% ) 5– 13 y (2 8% ) > 14 y (5 4. 5% ) 12 W el lin gt on C H C G ov t W el lin gt on 1 34 4 60 36 18 3 72 4 49 57 10 13 1 19 7 20 0. 09 0. 60 1.2 2 3. 16 5. 05 14 Ko ya T ow n C H C G ov t U pp er W el lin gt on 1 10 0 93 10 5 98 21 2 14 52 29 67 57 76 0. 03 0. 18 0. 36 0. 93 1.4 8 16 Al le n To w n C H C G ov t Al le n To w n 1 40 16 1 42 16 9 84 3 57 77 11 8 07 22 9 82 0. 10 0. 69 1.4 2 3. 68 5. 89 19 Al -K ha ta b C lin ic C H C M is si on C al ab a To w n 1 10 5 99 11 12 9 22 3 15 25 31 16 60 65 0. 03 0. 18 0. 37 0. 97 1.5 6 20 C al ab a To w n C H C G ov t C al ab a To w n 1 20 3 30 21 3 47 42 7 29 24 59 77 11 6 34 0. 05 0. 35 0. 72 1.8 6 2. 98 22 St L uk e' s C lin ic C lin ic M is si on C on go W at er 1 17 9 51 18 8 49 37 7 25 82 52 78 10 2 72 0. 05 0. 31 0. 63 1.6 4 2. 63 34 AW AK E C lin ic Pr iv at e Al le n To w n 1 42 30 44 42 89 60 8 12 44 24 21 0. 01 0. 07 0. 15 0. 39 0. 62 41 Fa m ily H om e M ov em en t C H P M is si on U pp er C al ab a To w n 1 86 03 90 33 18 1 12 38 25 29 49 23 0. 02 0. 15 0. 30 0. 79 1.2 6 44 Ad -B an gs Q ua rr y M C H P G ov t Bl ac kh al l R oa d 1 10 0 39 10 5 41 21 1 14 44 29 51 57 45 0. 03 0. 17 0. 36 0. 92 1.4 8 48 M ay em ie M C H P G ov t M ay em ie 1 12 6 02 13 2 32 26 5 18 13 37 05 72 11 0. 03 0. 22 0. 45 1.1 5 1.8 5 54 Ph ili p St re et M C H P Pr iv at e Ph ili p St re et 1 10 6 15 11 14 6 22 3 15 27 31 21 60 74 0. 03 0. 18 0. 38 0. 97 1.5 6 63 O ld D om in io n (E PI ) H os pi ta l Pr iv at e U pp er M el lo n W el lin gt on 1 10 3 00 10 8 15 21 6 14 82 30 28 58 94 0. 03 0. 18 0. 36 0. 94 1.5 1 To ta l W es te rn A re a 1 1 41 7 38 1 1 98 8 25 23 9 76 16 4 23 9 33 5 67 16 53 3 60 13 0 67 89 5 10 18 2 94 1 35 6 08 1 7 12 2 D H M T, d ist ric t h ea lth m an ag em en t t ea m ; m = m on th s; y = ye ar s; C H C , c om m un ity h ea lth c en tre ; C H P, c om m un ity h ea lth p os t; M C H P, m at er na l a nd c hi ld he al th p os t; EP I, Ex pa nd ed P ro gr am m e on Im m un iz at io n An ne x 5 EX AM PL E O F M IC RO -P LA NN IN G IN U RB AN W ES TE RN A RE A, S IE RR A LE O NE D es cr ip tio n of e ac h he al th fa ci lit y, ta rg et p op ul at io n pe r f ac ili ty , a ge d is tr ib ut io n an d vo lu m e of m at er ia l 74 Zo ne Na m e of fa ci lit y No . To ta l p op ul at io n pe r f ac ili ty Fa m ili es p er fa ci lit y Fa m ili es /d ay Fa m ili es /d ay / te am No . o f t ea m s re qu ire d No . o f t ea m s pr op os ed No . o f t ea m su pe rv iso rs No . o f C HW s pr op os ed 1 W el lin gt on 12 34 4 60 68 92 17 23 30 57 .4 57 11 114 Ko ya To w n 14 10 0 93 20 19 50 5 30 16 .8 17 3 34 Al le n To w n/ UP AL 16 40 16 1 80 32 20 08 30 66 .9 67 13 13 4 Al -K ha ta b Cl in ic 19 10 5 99 21 20 53 0 30 17 .7 18 3 36 Ca la ba To w n CH C 20 20 3 30 40 66 10 17 30 33 .9 34 7 68 St L uk e' s C lin ic 22 17 9 51 35 90 89 8 30 29 .9 30 6 60 AW AK E Cl in ic 34 4 23 0 84 6 21 2 30 7.1 7 1 14 Fa m ily H om e M ov em en t 41 8 60 3 17 21 43 0 30 14 .3 14 3 28 Ad -B an gs Q ua rr y 44 10 0 39 20 08 50 2 30 16 .7 17 8 34 M ay em ie 48 12 6 02 25 20 63 0 30 21 .0 21 42 Ph ilip S tre et 54 10 6 15 21 23 53 1 30 17 .7 18 7 36 O ld D om in io n (E PI ) 63 10 3 00 20 60 51 5 30 17 .2 17 34 H ol y M ar y Cl in ic 64 5 80 0 116 0 29 0 30 9. 7 10 2 20 To ta l Z on e 1 30 32 7 64 65 4 Nu m be rs o f t ea m s an d hu m an re so ur ce s re qu ire d pe r c at ch m en t a re a M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 75 Re qu ire m en ts fo r m at er ia l p er te am p er c at ch m en t a re a PH U, p er ip he ra l h ea lth u ni t; AS –A Q , a rte su na te + a m od ia qu in e No. OF PHUs Number of teams proposed Clipboard (1  /  team) Pen (4  /  team) Backpack (2  /  team) Badge holder (2  /  team) Badge for CHW (2  /  team) Daily tally sheet (2  /  team and day) Daily summary form (1  /  day   /  20 teams) Supervision check-list (1  /  day   /  20 teams) CHW briefing note (2  /  supervisor) Leaflet on AS–AQ, 2 faces, laminated Stock card (20  /  PHU) Badge for supervisor (1  /  supervisor) Badge holder for supervisor Folder with clip (2 per supervisor) A5 notebook (2  /  supervisor) Blue pen (2  /  supervisor) A5 thin notebook (2  /  team) Permanent marker (1  /  5 teams) Plastic pocket for SC (1  /  supervisor) Dosage chart (1  /  family) Plastic folder for documents (1  /  team) Plastic bag (1  /  team) 12 57 57 22 8 114 114 114 45 6 12 12 4 114 20 11 11 22 22 22 114 12 11 30 57 57 14 17 17 68 34 34 34 13 6 4 4 2 34 20 3 3 6 6 6 34 4 3 30 17 17 16 67 67 26 8 13 4 13 4 13 4 53 6 14 14 4 13 4 20 13 13 26 26 26 13 4 14 13 30 67 67 19 18 18 72 36 36 36 14 4 4 4 2 36 20 3 3 6 6 6 36 4 3 30 18 18 20 34 34 13 6 68 68 68 27 2 7 7 4 68 20 7 7 14 14 14 68 7 7 30 34 34 22 30 30 80 40 40 40 16 0 4 4 2 40 20 6 6 12 12 12 40 4 6 30 20 20 34 7 7 28 14 14 14 56 2 2 2 14 20 1 1 2 2 2 14 2 1 30 7 7 41 14 14 56 28 28 28 112 4 4 2 28 20 3 3 6 6 6 28 3 3 30 14 14 44 17 17 68 34 34 34 13 6 4 4 2 34 20 8 8 16 16 16 34 4 8 30 17 17 48 21 21 84 42 42 42 16 8 5 5 2 42 42 5 30 21 21 54 18 18 72 36 36 36 14 4 4 4 2 36 20 7 7 14 14 14 36 4 7 30 18 18 63 17 17 68 34 34 34 13 6 4 4 0 34 34 4 30 17 17 64 10 10 40 20 20 20 80 2 2 0 20 20 2 2 4 4 4 20 2 2 30 10 10 … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … 68 1 8 29 1 8 29 7 31 6 3 65 8 3 65 8 3 65 8 14 6 32 38 6 38 6 14 60 36 58 13 60 73 0 73 0 14 60 14 60 14 60 3 65 8 1 8 29 73 0 2 04 0 1 8 29 1 8 29 76 Annex 6 STEP-BY-STEP PROCEDURE FOR PREPOSITIONING SUPPLIES Identify and train the person who will be responsible for following up and managing stocks at each distribution point. Deliver the material. Calculate the quantity of medicines to be dispatched to each distribution point according to the estimated target population of the catchment area by age group. Include a buffer stock. It may be advisable to keep part of the buffer stock (about half) in a central or district storage place to ensure capacity to react to unpredicted shortages. Organize all other necessary logistic material into kits to simplify distribution. The amounts per kit should be calculated according to the numbers of teams and supervisors. Calculate the volume and weight of the supplies in order to organize adequate transport. Use tracking tools, such as waybills, for transport of supplies, with details of quantities and batch numbers to ensure traceability. Upon reception of the order, the person responsible in each peripheral health facility should verify that the delivered goods correspond to those listed on the waybill before signing the receipt form. CC: Icons created by Gan Khoon Lay, BomSymbols, Symbolon, Jose Morbán, Sribala, David, BomSymbols Maxim David, ProSymbols for the Noun Project 1 4 7 2 5 3 6 M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 77 Annex 7 EXAMPLE OF RADIO SPOT ON MDA FOR MALARIA (USED IN SIERRA LEONE IN 2014–2015) V1. Good morning, friend!! V2. Good morning. How are you? V1. Fine. Yesterday, I received the blister for the malaria treatment. Did you? V2. Yes. All my family and I took the first dose yesterday in the afternoon. And you? V1. No, we didn’t take it. V2. Why didn’t you take it? V1. Because nobody in the family has fever. V2. In our family nobody had fever, but we took it to prevent malaria fever because we don’t want to get sick. V1. But before we never took it when we were not sick. Why should we do it now? V2. Because now there is an EVD outbreak ongoing, so if you have fever you can become a suspect of EVD. A lot of EVD symptoms can be mistaken with malaria symptoms. (*) In any case, you and your family will be protected against malaria for 1 month and it is for free. V1: Ok, you are right. I’m going home now to start the treatment with my family. V2: Do you remember how to take it? V1: Yes. The community health worker explained to me that we have to take it during three consecutive days to finish the treatment properly. V2: Do you have any other doubt? V1: No, we are going to take the tablets according to the age category like the CHW told me. But if I have any doubt I will ask the CHW. V2: Good!!!! Have a nice day V1: You too and thank you. Now we will be malaria free!!!! *This section should be adapted to each MDA situation 78 Annex 8 EXAMPLES OF DISCUSSION POINTS ON MDA FOR USE AT COMMUNITY MEETINGS (ADAPTED FROM THOSE USED IN SIERRA LEONE IN 2014–2015) 1. What is MDA? 2. Goal of the campaign 3. The medication, how to take it and exclusion criteria The medication: How to take it Exclusion criteria (people who must NOT take it) Stick to the medicine and dosage for the age group. Wrong doses can cause: • Incomplete treatment = incomplete protection • Overdose = increase in possible side-effects 4. Possible side-effects and what to do 5. Explanation of the process 6. Roles of community leaders • ensure community awareness and acceptance of the campaign • sensitize importance of adherence (taking full treatment) • ensure awareness of correct dosage 7. Role of distributors and CHWs • sensitize community before and during MDA • distribute antimalarial tablets to target beneficiaries • tally all medicines distributed with the data collection tools 8.Team members: Two CHWs per team will be assigned by area and community. M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 79 Annex 9 HOUSEHOLD VISIT FOR MDA, STEP BY STEP MASS DRUG ADMINISTRATION, VISIT STEP BY STEP Obtain oral consent to participate. Greet the people politely in local language and introduce yourselves. Ask for the head of the household and verify whether all members of the household are present.Explain the objectives and provide information about the MDA using visual aids. Check eligibility criteria - Exclusion criteria: » First trimester of pregnancy » Infants under 6 months old » Known allergy to any of the medication » Critically ill patients » Contraindications to the medicines Explain to excluded people why they don’t receive the treatment. Distribution of an appropriate blister according to age category. Administer the first dose under DOT. For small children, crush the tablet and dissolve it with water. Repeat dose if vomiting occurs within 30 minutes of administration. Educate the participants on how to take the remaining doses for day 2 and day 3 using a visual aid to support the explanations and / or printed leaflets. Provide clear messages on the need to ensure adherence to full treatment course. Provide information concerning possible side effects and what to do in case they occur. For women of reproductive age (15-49 years old): » If visibility pregnant (assume second or third trimester): she may receive the medicine » If pregnancy not apparent: first trimester pregnancy should be excluded either based on personal history or on pregnancy test. Ask the members of the household if they have any specific questions and clarify any doubts they may have. Mark the tally sheet after the person has taken the first dose and / or fill in the registration book. Thank the household members and move to the next household. Where applicable, upon departure, mark the house with chalk as either “complete”, “incomplete” and if no one is home at the time of the visit, do not mark it. Revisit the house at a later time in the day or the following day in the case that the distribution was incomplete or no one was home. 1 4 7 8 9 10 5 6 2 3 CC: Icons created by Wilson Joseph, Gregor Cresnar, Dinosoft Labs, 23 icons, Yorlmar Campos, To Uyen, Loudoun Design Co., Arthur Shlain, from the Noun Project 80 Annex 10 ALGORITHM TO ASSIST COMMUNITY HEALTH WORKERS IN APPLYING EXCLUSION CRITERIA * A list of medicines that prolong the QT interval that are available and are the most frequently used in the country should be given to the CHW. DHA-PPQ, dihydroartemisinin–piperaquine; AS-AQ, artesunate–amodiaquine Ask and observe whether the person is severely ill. Do not administer antimalarial medicine, and refer to nearest health facility. Do not administer antimalarial medicine. The person is not taking other medicine. Administer the antimalarial medicine, and advise the patient where to seek care if adverse events occur. Do not administer DHA-PPQ or AS-AQ. Do not administer AS-AQ. The person is taking medication with no known interactions. The person is taking medicine that prolongs the QT interval.* The person is taking zidovudine, efavirenz or co-trimoxazole. Follow algorithm to exclude pregnancy. Is the individual a woman of reproductive age (15–49 years old)? Ask about known allergy to the antimalarial medicine or other ACT. Ask if the person is taking any medicine and, if so, to show it to you. Yes No No No Yes Yes M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 81 Annex 11 ALGORITHM FOR DETERMINING THE PREGNANCY STATUS OF WOMEN OF REPRODUCTIVE AGE (15–49 YEARS) (BASED ON AND ADAPTED FROM ALGORITHMS USED IN MALARIA MDA IN MOZAMBIQUE BY THE CENTRO DE INVESTIGAÇÃO EM SAÚDE DE MANHIÇA) Ensure privacy and explain risk and benefits of ACT in pregnancy. AdultAdolescent Assume not pregnant trimester Report pregnancy Visibly pregnant Assume in second or third trimester. Administer ACT. Do not administer ACT. Pregnancy not apparent Positive Consider that the woman may be in the first trimester. Refuses pregnancy test Report not pregnant or does not know. Ask if menstrual periods have started Ask about pregnancy status. Negative Offer options according to risk and benefits. Offer a pregnancy test. No Yes Yes 82 Annex 12 EXAMPLE OF LAMINATED LEAFLET USED BY COMMUNITY HEALTH WORKERS IN SIERRA LEONE IN 2014-2015 TO EXPLAIN TREATMENT DOSAGE • Take the tablets ONLY according to age. • Take tablets each day for 3 consecutive days (at the same time). DAY 1 DAY 2 DAY 3 6-11 months 1 crushed baby tablet 1 crushed baby tablet 1 crushed baby tablet 1-5 years 1 young child tablet 1 young child tablet 1 young child tablet 6-13 years 1 child tablet 1 child tablet 1 child tablet Adult 2 adult tablets 2 adult tablets 2 adult tablets • For children, crush the tablet in a clean eating spoon and mix with water. • This treatment may cause temporary side effects (vomiting, headache, dizziness, skin itch) which may last for 1 or 2 hours. • This treatment protects against malaria for ONE month M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 83 An ne x 13 DA IL Y TA LL Y SH EE T – AN TI M AL AR IA M DA To ta l H ou se ho ld s vi si te d O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O T ot al : RE SI DE NC Y ST AT US RE SI DE NT VI SI TO R O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Te am N um be r . ... ... ... ... ... ... ... ... ... ... ... ... ... ... D at e ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . D ay o f c am pa ig n . ... ... ... ... ... ... ... ... ... ... ... . D ist ric t: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. 6- 11 M O NT HS 1- 5 YE AR S 6- 13 Y EA RS 14 Y EA RS A ND A BO VE Total distributed Tr ea tm en ts d is tr ib ut ed O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Total excluded C as es e xc lu de d du e to re fu sa l t o pa rt ic ip at e O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: C as es e xc lu de d du e to pr eg na nc y (1 st tr im es te r) O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: C as es e xc lu de d du e to ot he r e xc lu si on c ri te ri a O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l: Zo ne / Ar ea : . ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. H ea lth fa ci lit y ca tc hm en t a re a: ... ... ... Vi lla ge /n ei gh bo ur ho od : . ... ... ... ... ... ... ... . EX AM PL E O F TA LL Y SH EE T (A DA PT ED F RO M T H AT U SE D IN S IE RR A LE O NE IN 2 01 4– 20 15 ) D ai ly m on ito rin g of a nt im al ar ia l co ns um pt io n N ot e: a ge g ro up s sh ou ld b e ad ap te d to b lis te r p re se nt at io n of a nt im al ar ia l m ed ic in e us ed N am e of T ea m L ea de r . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . N am e of S up er vi so r: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. BL IS TE R PA CK NU M BE R O F BL IS TE RS R EC EI VE D NU M BE R O F BL IS TE RS R EM AI NI NG A T TH E EN D O F TH E DA Y NU M BE R O F BL IS TE RS U SE D Bl is te rs 2 -1 1 m on th s (4 .5 k g- 9 k g) Bl is te rs 1- 5 ye ar s (9 -1 8 kg ) Bl is te rs 6 -1 3 (1 8- 35 k g) Bl is te rs ≥ 14 y ea rs (> 3 5 kg ) 84 An ne x 14 EX AM PL E O F A H O US EH O LD R EG IS TR AT IO N FO RM (A DA PT ED F RO M T H E ZA M BI A M DA P RO G RA M M E D EL IV ER Y H AN D BO O K) H O US EH O LD R EG IS TR AT IO N FO RM Household Number/ID Head of household Date Name of participant Age (years) Sex (M/F) Relation to head of household Occupation (C: child, S: student, H: housewife, F: farmer U: unemployed, O: other) Residency status (P: permanent resident, T: Temporary resident, V: visitor) Resent at the time of visit (Y/N) Received treatment (Y/N) If treatment not received, state reason (R. refusal E: exclusion criteria) State reason for refusal to participate DO T Comments D1 D2 D3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15D ist ric t ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . Zo ne .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... N am e of C H W .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... H ea lth fa ci lit y ca tc hm en t a re a ... ... ... ... ... ... ... ... ... ... ... . Vi lla ge N am e .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 85 Annex 15 EXAMPLE OF SUPERVISORS’ CHECKLIST USED IN SIERRA LEONE IN 2014-2015 SIERRA LEONE HOUSE TO HOUSE MDA OF ASAQ-DECEMBER 2014 Supervisor Checklist for House to House Teams 1. Are all team members present? Y or N 2. Is any of the team members a CHW in the area? Y or N 3. How many team members were trained? Write number 4. Does the team carry a movement map / plan with them? Y or N 5. Does the team have sufficient chalk for house marking? Y or N 6. Does the team have sufficient ASAQ doses for all categories? Y or N 7. Does the team have all the recording tools? Y or N 8. Does the team record information on the correct form? Y or N 9. Does the team mark the houses before leaving? Y or N 10. Was the team supervised at least once a day by the team supervisor (in the field)? Y or N 11. Did the supervisor sign and indicate time of visit on the daily tally sheet? Y or N 13. Does the team have any problems that require immediate intervention? Y or N If Yes, explain in comments field Comments: 12. Are the teams meeting their daily target? Y or N If No, provide reason(s) and action intended: A. .......................................................................................................................... B. .......................................................................................................................... C. ......................................................................................................................... TEAM NUMBER 1 2 3 4 5 District ............................................................................... Chiefdom / Zone ............................................................. Urban: Rural: Supervisor Name ........................................................... Function ............................................................................ Date ................................................................................... INSTRUCTIONS Use this form to supervise distribution of ASAQ teams during Mass drug administration implementation. Take corrective actions as needed. Give feedback to team after supervision. Thank and encourage the teams. Household Number/ID Head of household Date Name of participant Age (years) Sex (M/F) Relation to head of household Occupation (C: child, S: student, H: housewife, F: farmer U: unemployed, O: other) Residency status (P: permanent resident, T: Temporary resident, V: visitor) Resent at the time of visit (Y/N) Received treatment (Y/N) If treatment not received, state reason (R. refusal E: exclusion criteria) State reason for refusal to participate DO T Comments D1 D2 D3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 86 Annex 16 EXAMPLE OF MDA CARD MALARIA MDA CARD FOR PARTICIPANT DATE TREATMENT PROVIDED NUMBER OF TABLETS DOT (Y / N) OBSERVATIONS ROUND 1 D1 D2 D3 ROUND 2 D1 D2 D3 ROUND 3 D1 D2 D3 District ............................................................................... Name ................................................................................. Adress ................................................................................ Health Center .................................................................. Age ..................................................................................... Weight ............................................................................... M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 87 Annex 17 EXAMPLE OF DAILY SUMMARY SHEET TO BE COMPLETED BY DISTRIBUTION TEAM SUPERVISORS (ADAPTED FROM THAT USED IN SIERRA LEONE IN 2014–2015) DAILY SUMMARY SHEET - MALARIA MDA Note: age groups should be adapted to blister presentation of antimalarial medicine used Supervisor ........................................................................ Date ................................................................................... Day of campaign .......................................................... District ............................................................................... Zone/area ........................................................................ Health facility catchment area .................................. Resident status 6 to 11 months 1 to 5 years 6 to 13 years 14 years and above TE AM N UM BE R NU M BE R O F HO US EH O LD S VI SI TE D RE SI DE NT S VI SI TO RS TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O P RE G NA NC Y 1S T TR IM ES TE R EX CL UD ED D UE T O O TH ER E XC LU SI O N CR IT ER IA TO TA L TR EA TM EN TS D IS TR IB UT ED EX CL UD ED D UE T O R EF US AL T O P AR TI CI PA TE EX CL UD ED D UE T O P RE G NA NC Y 1S T TR IM ES TE R EX CL UD ED D UE T O O TH ER E XC LU SI O NC RI TE RI A TOTAL 88 An ne x 18 EX AM PL E O F DA TA BA SE F O R DA TA C O M PI LA TI O N (U SE D IN S IE RR A LE O NE IN 2 01 4– 20 15 ) DA IL Y SU M M AR Y RE PO RT IN G F O RM D ist ric t… …… …… …… …. . W AR NI NG ! O NL Y CO M PL ET E BL AN K CE LL S! !! D at e: … …… …… …… …. . IN FA NT 6 -1 1 M O NT HS TO DD LE R 1- 4 YE AR S PHU NUMBER NAME OF CHIEFDOM/ZONE NAME OF PHU CATCHMENT AREA TOTAL NUMBER OF HOUSEHOLDS TO BE VISITED FOR THE ENTIRE CAMPAIGN (TARGET) NUMBER OF HOUSEHOLDS (ACTUAL RESULT) % HOUSEHOLD COVERED % HOUSEHOLD COVERED TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! To ta l 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 89 AD O LE SC EN T 5- 14 Y EA RS AD UL TS 14 Y EA RS A ND A BO VE G RA ND T O TA L TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TARGET POPULATION EXCLUDED INFANT ALLERGY TO ASAQ EXCLUDED ARV EXCLUDED ASAQ IN THE LAST MONTH EXCLUDED SEVERE ILLNESS EXCLUDED OTHER REASONS TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL SEEN % INFANT ASAQ DISTRIBUTED (COVERAGE) TOTAL TARGET POPULATION TOTAL EXCLUDED TOTAL DISTRIBUTED TOTAL % ASAQ DISTRIBUTED (COVERAGE) 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 90 Annex 19 EXAMPLE OF STANDARD TEMPLATE FOR REPORTING A SUSPECTED ADVERSE DRUG REACTION PATIENT DETAILS Name .......................................................................... Date of report: .......................................................... Age ................................ Sex ................................. Weight (kg) ................................................................. Address: ................................................................................................................................................................................. Pregnant: Yes No If yes, trimester of pregnancy .......................................................................................................................................... Hospital or treatment centre ........................................................................................................................................... Relevant medical history .................................................................................................................................................. ................................................................................................................................................................................................... SUSPECTED DRUG OR PRODUCT Brand name ................................ Strength ....................................... Generic name ............................. Name of manufacturer ............................................. Daily dose .................................................................. Date of manufacture ................. Expiry date .................................. Batch number ............................. Starting date of medication ..................................... Route of administration ............................................ Drug discontinued because of event: Yes No Date .............................................. DRUGS OR PRODUCTS TAKEN CONCOMITANTLY (INCLUDING HERBAL MEDICATION) Specify brand and generic name, dosage, route, day started, day stopped ................................................................................................................................................................................................... ................................................................................................................................................................................................... M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 91 ADVERSE REACTION Details of the reaction experienced by the patient: ................................................................................................................................................................................................... ................................................................................................................................................................................................... ................................................................................................................................................................................................... Date and time the reaction started ........................ Date and time the reaction ended ......................... Did patient require hospital admission? Yes No Duration of hospitalization ............................... Reason for reporting Requires or prolongs hospitalization Permanently disabling or incapacitating Other (please specify) .................................................................................................................................................. CONDITION OR OUTCOME AT TIME OF LATEST OBSERVATION Full recovery Ongoing illness Persistent, significant disability, incapacity Other (please specify) .................................................................................................................................................. DETAILS OF HEALTH CARE PROFESSIONAL OR REPORTER Life threatening Congenital anomaly Death Overdose Name ................................................................................. Adress ................................................................................ Signature .......................................................................... Function. ........................................................................... Telephone number ........................................................ Institution .......................................................................... 92 GUIDELINES FOR FILLING IN THE FORM An adverse event is “serious” if it • is life threatening • results in hospitalization • prolongs hospitalization • causes malignancy • is an overdose resulting in clinically relevant signs and symptoms • results in permanent disability • is fatal • causes a birth defect • causes relevant organ toxicity An adverse drug may be a manifestation of: • complications of an underlying disease • coincidental accident • concomitant medication • intercurrent disease • drug-associated effect M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 93 Annex 20 EXAMPLE OF QUESTIONNAIRE FOR POST-MDA SURVEY The following questions should be asked of each person over 6 months of age (parent or guardian of children). A. SOCIODEMOGRAPHICS 1) Age (years) ........................................................................................................................................................................ 2) Sex: Male Female 3) Status of residence in the household: Permanent Temporary visitor 4) Marital status: Single Married Widower or widow Divorced or separated Uncertain or no response 5) Level of education completed: None Primary level Secondary level Tertiary level (college or university degree) Uncertain or no response 6) Occupation: Student Farmer Herdsman Merchant or trader Village ............................................................................... Household no. ................................................................. Interviewer’s name ....................................................... Cluster no. ........................................................................ Survey date ..................................................................... Supervisors’ names ....................................................... 94 Constructor Driver Professional or civil servant Labourer (daily, seasonal or long-term) Retired or too old to work None or unemployed Uncertain or no response Other. Specify: ................................................................................................................................................................ B. INFORMATION ON MDA CAMPAIGN 1) Were you informed about the malaria MDA campaign? Yes No Uncertain or no response 2) Did you receive the malaria medication during the campaign? Yes No Uncertain or no response If yes, go to question 4. 3) Why didn’t you receive the medicines? I was travelling or I was not in town I was too busy to wait for the distributors or to go to the distribution site I do not trust the organizers of the campaign or the ministry of health Malaria is not a problem for me I never take any medicine I only take traditional medicine I did not know what the medicine was for I was pregnant I was taking other medicine at the time I was too sick I am allergic to the medicine Other. Specify ................................................................................................................................................................. Uncertain or no response Questionnaire ends here. 4) Did the person who gave you the medicine watch you take the first dose? Yes No Uncertain or no response M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 95 5) Did the person who gave you the medicine explain to you how to take the next doses? Yes No Uncertain or no response If no, go to question 7. 6) Tell us how she or he explained how to take the medicine. Correctly Incorrectly Uncertain or no response The interviewer should mark “correctly” or “incorrectly” according to the interviewee’s explanation. 7) How many doses of the medicine given by the distributor did you take? None 1 dose 2 doses 3 doses Uncertain or no answer 8) Can you show us evidence that you completed the treatment (empty blister or pill count)? Yes No 9) Did you take the complete treatment as recommended? Yes No Uncertain or no response If yes, go to question 11. 10) Why didn’t you take the treatment as recommended by the distributor? I forgot to take the medicine. I did not want to take it. Reason: I was too sick I saved the tablets for when I get sick I gave the treatment to or shared the treatment with someone else I was afraid of side-effects of the medicine I was told by a family member or friend not to take it I was told by a health professional not to take it Other people became sick after taking the medicine The medicine tastes disgusting Other, specify ................................................................................................................................................................. Uncertain or no answer 11) Did you experience any side-effects after taking the medicine? Yes No Uncertain or no response If no, end of questionnaire. 96 12) Which side-effects did you have? (More than one answer possible) : 13) How long after taking the tablets did you experience the side-effect? Less than 30 min Between 30 min and 1 h Between 1 h and 24 h Other. Specify ................................................................................................................................................................ 14) How did you manage the side-effect? I did nothing I took some medicine I visited a health professional or health facility Uncertain or no answer 15) Did you know of any emergency centre or hotline to call in case of side-effects? Yes No Uncertain or no response If no, end of questionnaire. 16) Did you call the emergency centre or hotline for help? Yes No Uncertain or no answer Loss of appetite Headache Weakness Other, specify ............................................................. Skin reaction Abdominal pain Nausea and / or vomiting Diarrhoea Dizziness Difficulty in sleeping Drowsiness Heart palpitations M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 97 Annex 21 EXAMPLE OF PHARMACOVIGILANCE PREPAREDNESS CHECKLIST (USED IN SIERRA LEONE IN 2014–2015) Instructions This is a working document. Start using it now by ticking (√ ) those items that have been accomplished. District: .................................................................................................................................................................................... Chiefdom ............................................................................................................................................................................... Facility .................................................................................................................................................................................... SUBJECT COMPLETED COMMENTS Staff 1. Is at least one person aware of pharmacovigilance monitoring during the artesunate–amodiaquine campaign? 2. Have all staff been apprised of the basics of pharmacovigilance monitoring? 3. Have all staff been trained in recognizing ADRs? 4. Do all staff know the correct dose of artesunate–amodiaquine 5. Is a plan in place to cover hard-to-reach areas? 5. Is there a map of the catchment area? 5. Are there adequate quantities of the following (Assess quantities supplied against target population) artesunate–amodiaquine oral rehydration salts paracetamol chlorphenamine Advocacy and social mobilization 1. Has there been a health talk in the community about compliance and adherence to artesunate–amodiaquine? 2. Is information available at the public health unit about ADR monitoring? Name of person completing the checklist ................................................................................................................... Signature ......................................................................... Date .................................................................................. 98 Annex 22 EXAMPLE OF AN MDA PHARMACOVIGILANCE TRAINING MODULE CURRICULUM FOR DRUG DISPENSERS The curriculum is divided into four modules, based on the chronology and structure of the WHO–ISOP curriculum (1). The content should be adapted to the pharmacovigilance requirements in the country and opportunities taken to integrate it with other training sessions for drug dispensers. Introduction The curriculum is based on several packages of topics and concepts of PV teaching used by WHO and WHO collaborating centres (2). It was designed for programmes of seasonal malaria chemoprevention and adapted for use in malaria MDA. Purpose of the course The aim of the course is to enable health workers and drug dispensers to detect, report and follow-up on suspected adverse drug reactions during malaria MDA. Target group The course is designed for drug dispensers involved in MDA, who may have very have limited medical knowledge but are present in the community at the time of the operation. They interact directly with all household members when administering the first dose, dispense and counsel carers on administering the remaining doses and provide advice on possible adverse drug reactions and where to report them. They should be able to refer people with serious adverse events and report them. Course duration The material is designed to be covered in 1 day. Sections can be reduced and prioritized if training time is limited. Course content Module one: What are adverse drug reactions and why should we monitor them? • Importance of adverse drug reactions in the context of MDA Module two: Adverse drug reactions and medication errors • Serious adverse drug reactions • Adverse events associated with medicines and concomitant medication • Administration of medicines in MDA, medication errors and their consequences, particularly over-dosing M AS S DR UG A DM IN IS TR AT IO N FO R FA LC IP AR UM M AL AR IA A PR AC TI C AL F IE LD M AN U AL 99 Module three: Reporting suspected adverse reactions • Completion and use of reports and referral notes Module four: Communication • Effective communication with patients and health professionals • Managing rumours at community level References 1. Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ et al. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf. 2014;37:743–59. 2. §ISoP – PV curriculum – search. London: International Society of Pharmacovigilance; 2017 (http://isoponline.org/pv-links/, accessed 17 August 2017).

For further information please contact: Global Malaria Programme World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Email: infogmp@who.int ISBN 978-92-4-151310-4

Administração massiva de medicamentos para o paludismo falciparum Um manual de campo prático

Um manual de campo prático Administração massiva de medicamentos para o paludismo falciparum ii Administração massiva de medicamentos para o paludismo falciparum: um manual de campo prático [Mass drug administration for falciparum malaria: a practical field manual] ISBN 978-92-4-000593-8 (versão electrónica) ISBN 978-92-4-000594-5 (versão impressa) © Organização Mundial da Saúde 2020 Alguns direitos reservados. Este trabalho é disponibilizado sob licença de Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc- sa/3.0/igo/deed.pt). Nos termos desta licença, é possível copiar, redistribuir e adaptar o trabalho para fins não comerciais, desde que dele se faça a devida menção, como abaixo se indica. Em nenhuma circunstância, deve este trabalho sugerir que a OMS aprova uma determinada organização, produtos ou serviços. O uso do logótipo da OMS não é autorizado. Para adaptação do trabalho, é preciso obter a mesma licença de Creative Commons ou equivalente. Numa tradução deste trabalho, é necessário acrescentar a seguinte isenção de responsabilidade, juntamente com a citação sugerida: “Esta tradução não foi criada pela Organização Mundial da Saúde (OMS). A OMS não é responsável, nem pelo conteúdo, nem pelo rigor desta tradução. A edição original em inglês será a única autêntica e vinculativa”. Qualquer mediação relacionada com litígios resultantes da licença deverá ser conduzida em conformidade com o Regulamento de Mediação da Organização Mundial da Propriedade Intelectual. Citação sugerida. Administração massiva de medicamentos para o paludismo falciparum: um manual de campo prático [Mass drug administration for falciparum malaria: a practical field manual]. Genebra: Organização Mundial da Saúde; 2020. Licença: CC BY-NC-SA 3.0 IGO. Dados da catalogação na fonte (CIP). Os dados da CIP estão disponíveis em http://apps.who.int/iris/. Vendas, direitos e licenças. Para comprar as publicações da OMS, ver http://apps.who.int/bookorders. Para apresentar pedidos para uso comercial e esclarecer dúvidas sobre direitos e licenças, consultar http://www. who.int/about/licensing. Materiais de partes terceiras. Para utilizar materiais desta publicação, tais como quadros, figuras ou imagens, que sejam atribuídos a uma parte terceira, compete ao utilizador determinar se é necessária autorização para esse uso e obter a devida autorização do titular dos direitos de autor. O risco de pedidos de indemnização resultantes de irregularidades pelo uso de componentes da autoria de uma parte terceira é da responsabilidade exclusiva do utilizador. Isenção geral de responsabilidade. As denominações utilizadas nesta publicação e a apresentação do material nela contido não significam, por parte da Organização Mundial da Saúde, nenhum julgamento sobre o estatuto jurídico ou as autoridades de qualquer país, território, cidade ou zona, nem tampouco sobre a demarcação das suas fronteiras ou limites. As linhas ponteadas e tracejadas nos mapas representam de modo aproximativo fronteiras sobre as quais pode não existir ainda acordo total. A menção de determinadas companhias ou do nome comercial de certos produtos não implica que a Organização Mundial da Saúde os aprove ou recomende, dando-lhes preferência a outros análogos não mencionados. Salvo erros ou omissões, uma letra maiúscula inicial indica que se trata dum produto de marca registado. A OMS tomou todas as precauções razoáveis para verificar a informação contida nesta publicação. No entanto, o material publicado é distribuído sem nenhum tipo de garantia, nem expressa nem implícita. A responsabilidade pela interpretação e utilização deste material recai sobre o leitor. Em nenhum caso se poderá responsabilizar a OMS por qualquer prejuízo resultante da sua utilização. Índice Agradecimentos vii Abreviaturas e acrónimos viii Sumário executivo ix 1. INTRODUÇÃO 1 1.1 Contexto 1 1.2 Definições 1 1.3 Objectivo 1 1.4 Recomendações da OMS 2 2. ORGANIZAÇÃO E IMPLEMENTAÇÃO DA ADMINISTRAÇÃO MASSIVA DE MEDICAMENTOS 3 2.1 Fase de concepção (macro-planeamento) 3 2.1.1 Identificar agências para apoiar o ministério da saúde 3 2.1.2 Criar uma força-tarefa ou comité de coordenação 4 2.1.3 Realizar uma análise do contexto 6 2.1.4 Determinar a população-alvo e áreas geográficas 7 2.1.5 Escolher o medicamento antipalúdico 9 2.1.6 Estimar a necessidade de medicamento antipalúdico, e encomendá-lo 12 2.1.7 Determinar a estratégia de distribuição 14 2.1.8 Determinar o período de intervenção 15 2.1.9 Determinar o número de rondas 16 2.1.10 Estabelecer um cronograma 18 2.1.11 Elaborar um orçamento 18 2.2 Planeamento e elaboração 19 2.2.1 Micro-planeamento 19 2.2.2 Logística 21 2.2.3 Recursos humanos 23 2.2.4 Participação da comunidade, mobilização social e comunicação 27 2.3 Implementação 33 2.3.1 Gestão de estoque 33 2.3.2 Distribuição do medicamento antipalúdico 35 2.3.3 Supervisão 38 2.3.4 Recolha de dados 41 iii 2.3.5 Coordenação 44 2.3.6 Tratamento de casos de paludismo após a administração massiva de medicamentos 45 3. MONITORIZAÇÃO E AVALIAÇÃO 46 3.1 Sistema de monitorização 46 3.2 Estimativa de cobertura 46 3.2.1 Cobertura de distribuição 46 3.2.2 Pesquisa pós campanha de AMM 48 3.3 Monitorização do consumo 48 3.4 Farmacovigilância 49 3.4.1 Definições 50 3.4.2 Comunicação de segurança 51 3.4.3 Vigilância de reacções adversas aos medicamentos 51 3.5 Monitorização da resistência aos medicamentos 52 3.6 Avaliação do impacto 53 4. NOTIFICAÇÃO 55 5. PRINCIPAIS ETAPAS NUMA CAMPANHA DE ADMINISTRAÇÃO MASSIVA DE MEDICAMENTOS PARA O PALUDISMO 57 REFERÊNCIAS 58 ANEXOS 61 Anexo 1 - Distribuição padrão das populações num país em desenvolvimento 61 Anexo 2 - Terapia combinada à base de artemisinina disponível: dosagem, formulação e apresentação 62 Anexo 3 - Exemplo de cálculo de pedidos de medicamento antipalúdico 68 Anexo 4 - Exemplo de um cronograma de administração massiva de medicamentos para o paludismo (distribuição em 8 semanas) 72 Anexo 5 - Exemplo de micro-planeamento na Área Ocidental urbana, Serra Leoa 76 Anexo 6 - Procedimento passo a passo para a colocação dos materiais 79 Anexo 7 - Exemplo de anúncio radiofónico sobre AMM para o paludismo (utilizado na Serra Leoa em 2014-2015) 80 iv Anexo 8 - Exemplos de pontos de discussão sobre AMM para utilização nas reuniões comunitárias (adaptados dos utilizados na Serra Leoa em 2014-2015) 81 Anexo 9 - Visita domiciliar para a AMM, Passo a passo 82 Anexo 10 - Algoritmo para ajudar os trabalhadores comunitários de saúde na aplicação dos critérios de exclusão 83 Anexo 11 - Algoritmo para determinar o estado de gravidez de mulheres em idade reprodutiva (15-49 anos) (com base e adaptado dos algoritmos utilizados na AMM para o paludismo em Moçambique pelo Centro de Investigação em Saúde de Manhiça) 84 Anexo 12 - Exemplo de folheto laminado utilizado pelos trabalhadores comunitários de saúde na Serra Leoa em 2014-2015 para explicar a dosagem de tratamento 85 Anexo 13 - Exemplo de folha de controlo (adaptado do utilizado na Serra Leoa 2014-2015) 86 Anexo 14 - Exemplo de um formulário de registo de famílias (adaptado do manual de distribuição do programa de AMM da Zâmbia) 87 Anexo 15 - Exemplo de lista de verificação dos supervisores utilizada na Serra Leoa em 2014-2015 88 Anexo 16 - Exemplo de cartão de AMM 89 Anexo 17 - Exemplo de folha de resumo diário a ser preenchida pelos supervisores das equipas de distribuição (adaptada da utilizada na Serra Leoa em 2014-2015) 90 Anexo 18 - Exemplo de base de dados para compilação de dados (utilizada na Serra Leoa em 2014-2015) 91 Anexo 19 - Exemplo de modelo padrão para notificação de uma suspeita de reacção adversa a medicamentos 93 Anexo 20 - Exemplo de questionário para perquisa pós-AMM 96 Anexo 21 - Exemplo de lista de verificação de preparação de farmacovigilância (utilizada na Serra Leoa em 2014-2015) 100 Anexo 22 - Exemplo de um módulo de formação em farmacovigilância sobre AMM 101 v

AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O vii Agradecimentos Este manual operacional sobre a administração massiva de medicamentos (AMM) para o paludismo é baseado na experiência prática na grande maioria das operações de AMM que foram concluídas ao longo dos últimos 10 anos nos países onde o paludismo é endémico. A autora principal foi a Dr.ª Carolina Nanclares (Médecins Sans Frontières, Espanha), que elaborou uma excelente primeira versão e a finalizou após análise cuidadosa das sugestões de vários avaliadores. A Dr.ª Nanclares baseou a primeira versão na experiência e ensinamentos obtidos ao longo da AMM em grande escala na Serra Leoa durante a epidemia da doença por vírus Ebola, concluída em 2014-2015. Os seguintes colegas de MSF Espanha que participaram nessa campanha, proporcionaram contributos na primeira versão: Jonathan Caplan, Fernanda Falero, Adriana Ferracin Kleivan, Segimon Garcia, Maria Green, Yves Houedakor, Cristina Imaz, Nines Lima e Charlotte Oliveira. O Programa Mundial do Paludismo da OMS organizou um comité de redacção, constituído por funcionários técnicos que contribuíram para o controlo do paludismo através da AMM e pesquisa em: Camboja, Comores, Moçambique, Serra Leoa, Mianmar, Tailândia, Vietname e Zâmbia. A primeira versão foi enviada por email a todos os participantes convidados, um mês antes da reunião, e todas as contribuições recebidas antes da reunião foram incluídas na segunda versão, que foi utilizada como base do trabalho do comité de redacção. A reunião foi realizada em 22 e 23 de Novembro de 2016 em Genebra, e os membros do comité (indicados a seguir) foram divididos em quatro grupos de trabalho para analisar e finalizar os aspectos práticos das diferentes secções do manual. Durante a última sessão da reunião, os grupos apresentaram as suas conclusões em plenária, trazendo para a resolução os pontos que exigiam consenso. Dr.ª Nanclares, como relatora da reunião, compilou depois uma terceira versão,que incluiu todas as contribuições dos quatro grupos de trabalho, que foi distribuída a todos os participantes por e-mail para avaliação final. O texto do manual é o resultado de uma quarta ronda de análises pelo membros do comité de redacção e pelo Secretariado da OMS. Agradecemos aos seguintes membros do comité de redacção, que gentilmente analisaram todas as secções do relatório em várias rondas, proporcionando observações significativas que foram fundamentais para a sua conclusão e aperfeiçoamento: Gilles Delmas (Mahidol-Oxford Tropical Medicine Research unit, Tailândia), Stephan Duparc (Medicines for Malaria Venture, Suiça), Busiku Hamainza (Centro Nacional de Controlo do Paludismo, Zâmbia), James Heaton (Mahidol-Oxford Tropical Medicine Research unit, Mianmar), Umu Jalloh (Pharmacy Board, Serra Leoa), Anitta Renitta Yokoe Kamara (Programa Nacional de Controlo do Paludismo, Ministério de Saúde e Saneamento, Serra Leoa), Calveston Machila (Posto Médico Distrital, Zâmbia), Joseph Mberikunashe (Programa Nacional de Controlo do Paludismo, Zimbabué), ThuyNhien Thanh Nguyen (Centro de Medicina Tropical, Vietname), Francisco Saute (Centro de Investigação em Saúde de Manhiça, Moçambique), Jianping Song (Universidade de Medicina Chinesa de Guangzhou, China) e Khieu Virak (Centro Nacional de Parasitologia, Entomologia e Controlo do Paludismo, Camboja). O projecto de manual recebeu também contribuições do Comité Consultivo de Políticas sobre o Paludismo na sua sessão de 22 a 24 de Março de 2017 que, com sugestões adicionais do Secretariado da OMS no Programa Mundial do Paludismo, foram levadas em consideração na versão final do documento. Na OMS, Andrea Bosman, Programa Mundial do Paludismo, coordenou a elaboração do manual e representou o Secretariado da OMS no comitê de redacção. Contribuições preciosas foram feitas igualmente pelo Dr. Maru Aregawi, Peter Olumese e Silvia Schwarte, Programa Mundial do Paludismo, e por Prabhjot Singh, Escritório Regional da OMS para as Américas. O financiamento para a produção deste relatório foi proporcionado pela Fundação Bill & Melinda Gates. viii Abreviaturas e acrónimos TCA terapia de combinação à base de artemisinina RAM reacção adversa a medicamentos TCS trabalhadores comunitários de saúde TDO tratamento directamente observado DVE doença por virus Ébola G6PD glicose-6-fosfato desidrogenase AMM administração massiva de medicamentos AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O ix Sumário executivo A administração massiva de medicamentos (AMM) consiste em administrar um curso terapêutico completo de medicamentos antipalúdicos (independentemente da presença de sintomas ou infecção) para uma população definida que vive numa área geográfica determinada (excepto as pessoas para as quais o medicamento é contra-indicado) aproximadamente ao mesmo tempo, e muitas vezes em intervalos repetidos. Recentes progressos no controlo do paludismo, incluindo o uso de outras formas de quimioterapia preventiva como tratamento preventivo intermitente do paludismo na gravidez e quimioprevenção do paludismo sazonal, os esforços desenvolvidos para a eliminação do paludismo em alguns ambientes e a disponibilidade de novos medicamentos antipalúdicos, têm renovado o interesse no papel que a AMM pode desempenhar em alguns contextos. A AMM deve ser considerada como uma intervenção limitada no tempo com metas específicas para quando deve ser interrompida, definidas antes da implementação. Actualmente, com base nas evidências, a OMS recomenda a AMM: • para a interrupção da transmissão do paludismo falciparum em áreas que se aproximam da eliminação, • para reduzir o risco de disseminação de resistência a múltiplos medicamentos na maior sub-região de Mekong, • durante as epidemias de paludismo e • em emergências complexas excepcionais. A OMS recomenda a utilização da AMM para o paludismo falciparum, com dois objectivos complementares distintos. O primeiro é reduzir a transmissão do paludismo, que é o principal objectivo da eliminação e redução da resistência a múltiplos medicamentos e também é relevante em epidemias de paludismo e emergências complexas. O objectivo é reduzir rapidamente a biomassa parasitária numa comunidade e evitar novas infecções durante um determinado período. Rondas repetidas de AMM são realizadas para eliminar os parasitas que não foram atingidos em rondas anteriores. O resultado esperado é uma grande redução na intensidade da transmissão. A sincronização da intervenção com elevada cobertura de toda a população em risco é essencial. Para reduzir rapidamente e potencialialmente interromper inteiramente a transmissão e evitar o ressurgimento, são necessárias várias rondas, em combinação com outras ferramentas e estratégias de luta contra o paludismo, tais como controlo de vector eficaz, o acesso ao diagnóstico rápido e tratamento e vigilância intensificada. O segundo objectivo da AMM para o paludismo falciparum é a redução rápida da morbidade e mortalidade. Este é o principal objectivo quando a transmissão de falciparum resulta em elevadas taxas de mortalidade, como nas epidemias e emergências complexas quando os sistemas de saúde estão sobrecarregados e incapazes de proporcionar os principais serviços preventivos e curativos do paludismo. Nestes contextos, a AMM é utilizada como uma medida de emergência inicial; várias rondas são implementadas, enquanto o acesso à gestão de casos e controlo de vectores estão a ser implementados. É importante identificar a população em risco de paludismo grave e morte para definir os grupos-alvo para a AMM. Estes podem ser toda uma população ou grupos vulneráveis específicos que estão em alto risco de mortalidade por causa da falta de controlo de vectores e acesso a uma gestão eficaz dos casos. Elevada cobertura dessas populações específicas é mais importante do que a sincronização, porque o principal objectivo é reduzir a morbidade e mortalidade na população-alvo e não reduzir a transmissão do paludismo. xPara que a AMM seja bem sucedida, elevada cobertura e adesão da população alvo (i.e. > 80%) deve ser assegurada, o que requer um alto nível de envolvimento e participação das comunidades. Estratégias de implementação devem, por conseguinte, garantir o mais alto nível de participação possível. A distribuição porta-a-porta é geralmente preferida à distribuição centralizada num local fixo, e tratamento directamente observado (TDO), sempre que possível, é a melhor forma de assegurar a adesão ao tratamento. A implementação de AMM para o paludismo é uma operação complexa, logisticamente desafiadora, que requer investimentos significativos de recursos (humanos, financeiros e logísticos), bem como um planeamento cuidadoso e organização. O objectivo deste manual é fornecer orientações técnicas e operacionais sobre os aspectos práticos da organização de uma campanha bem sucedida para o paludismo. As principais etapas para uma gestão eficiente são indicadas a seguir. Fase de concepção Nesta fase, as principais estratégias para a AMM, são estabelecidas a nível nacional: • Obter o compromisso dos decisores políticos, e identificar agências para apoiar o ministério da saúde. • Criar uma força-tarefa ou comité de coordenação. • Realizar uma análise do contexto. • Decidir implementar a AMM para o paludismo falciparum. • Definir áreas específicas e população-alvo. • Escolher o medicamento antipalúdico. • Estimar as necessidades do medicamento antipalúdico, e adquiri-lo. • Determinar a estratégia da AMM. • Estimar o orçamento. Fase de planeamento e elaboração Esta fase envolve o planeamento de aspectos operacionais do quadro definido a nível nacional: • Realização de micro-planeamento a nível provincial ou distrital de acordo com as estratégias definidas pela força-tarefa nacional para garantir uma campanha eficaz, garantindo uma distribuição adequada de materiais, formação de pessoal, envolvimento comunitário e gestão adequada dos recursos. O micro-plano deve incluir: - informações demográficas sobre a província ou distritos elegíveis para a AMM; - informações sobre a área (por exemplo, mapas, infra-estrutura, localização de unidades de saúde, áreas de difícil acesso); - calendarização da AMM no distrito; - estratégias de distribuição; - recursos humanos (número necessário, número disponível) e plano de formação; - informações logísticas; - mobilização social e plano de comunicação e - plano de farmacovigilância. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O xi • Assegurar uma logística eficaz, levando em consideração: - aquisição, armazenamento e distribuição de medicamentos antipalúdicos; - aquisição, armazenamento e distribuição de outros materiais necessários para a AMM; - transporte; - acesso a toda a população-alvo, incluindo a que se encontra em áreas de difícil acesso; - identificação e preparação de locais de distribuição; e - gestão dos resíduos. • Planeamento de recursos humanos e financeiros: - número de equipas necessárias e composição, - formação e - pagamento adequado de salários e ajudas de custo. • Planeamento da participação comunitária e mobilização social através de - definição das funções e responsabilidades de todos os parceiros; - avaliação das comunidades para compreender as características e a dinâmica social da população-alvo, a fim de orientar o plano de mobilização social; - preparação de mensagens claras, simples, precisas e consistentes sobre a AMM para o paludismo; - envolvimento dos meios de comunicação social, desenvolvendo relações com os representantes dos meios de comunicação locais e divulgando informações através dos diferentes meios de comunicação; - preparação para enfrentar boatos negativos que possam surgir durante a campanha, que poderão afectar a participação; e - Envolvimento dos líderes comunitários e outras pessoas influentes no planeamento, para que se apropriem da campanha e do seu sucesso. Fase de implementação A fase de implementação envolve a distribuição real do tratamento antipalúdico e inclui: • gestão de estoques: preparação de kits de distribuição com todo o material necessário antecipadamente no ponto de distribuição ou unidade de saúde periférica em que os suprimentos são colocados; • distribuição do medicamento antipalúdico, quer porta-a-porta ou num local fixo centralizado; • supervisão, uma componente essencial para garantir a qualidade da campanha: a níveis periférico, distrital, regional e nacional; • recolha de dados: recolha e comunicação de informações sobre o número de pessoas que recebem tratamento a nível comunitário, reacções adversas a medicamentos (RAM) e análise e compilação de dados nos níveis mais elevados através de uma via bem estabelecida de fluxo de informações; e • coordenação de todos os intervenientes para monitorizar actividades, detectar quaisquer dificuldades ou restrições, resolvê-los e reagir a acontecimentos imprevistos. xii Monitorização e avaliação • Sistema de monitorização intra-campanha: um sistema de alta qualidade para a monitorização da campanha permite a identificação de restrições que exigem acção imediata; pode ser feito por monitores identificados na equipa ou por monitores independentes; • estimativa de cobertura de distribuição: a proporção da população-alvo que foi alcançada pela distribuição; • pesquisa pós-AMM: recomendada, se possível, após cada ronda ou, pelo menos, no final de toda a campanha para obter mais informações fiáveis sobre a cobertura e avaliar a adesão ao tratamento, determinar as razões para a não participação ou não- adesão e avaliar a apresentação das RAM; • Monitorização do consumo: acompanhamento diário do número de tratamentos distribuídos e o número tomado; • farmacovigilância: uma componente essencial de uma AMM que deve ser planeada para garantir a formação, detecção, notificação, gestão de acompanhamento de ocorrências adversas e promover e monitorizar a adesão pela vigilância passiva e activa. Esta componente é também essencial para obter e manter uma boa compreensão e adesão da população; • Monitorização da resistência aos medicamentos: uma das principais preocupações em relação a AMM é o surgimento e a propagação da resistência aos medicamentos; embora não haja evidências de que a AMM de terapia combinada à base de artemisinina (TCA) em doses terapêuticas esteja relacionada com o surgimento de resistências, a monitorização da resistência deve ser uma componente essencial de uma campanha de AMM; • avaliação de impacto: através da vigilância de rotina e inquéritos parasitológicos para apoiar uma decisão de suspender; e • notificação: após cada ronda e no final da intervenção, da cobertura alcançada, desafios e problemas enfrentados e as soluções encontradas, os ensinamentos obtidos, as práticas com bons resultados, actividades de mobilização social eficaz, ferramentas úteis e os custos da intervenção. Em situações de epidemias e emergências complexas, um conjunto mínimo de actividades de monitorização e avaliação de AMM deve ser definido para documentar o impacto e para a notificação. Embora estas etapas sejam comuns a todos os contextos, a AMM, para efeitos de redução da transmissão do paludismo ou de sua eliminação, para conter a resistência, em resposta a um surto ou em caso de uma emergência complexa, pode divergir nas formas descritas a seguir nas secções correspondentes. Este manual destina-se a proporcionar orientações gerais. Algumas secções podem não ser relevantes em todos os contextos e devem ser adaptados às circunstâncias locais (por exemplo, ambientes urbanos ou rurais). O manual também apresenta modelos e exemplos de experiência prévia com a AMM para o paludismo em vários contextos que podem ser úteis para o desenvolvimento do material de formação ou recolha de dados. A maioria das ferramentas são incluídas nos anexos deste manual. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 1 1. INTRODUÇÃO 1.1 CONTEXTO A administração massiva de medicamentos (AMM) tem desempenhado um papel crucial no controlo e eliminação de um certo número de doenças tropicais negligenciadas prevalentes. O objectivo dos programas tem sido tratar a infecção prevalente e reduzir a transmissão na população simultaneamente e, portanto, diminuir a carga da doença (1,2). Desde a década de 1970, a AMM não foi recomendada como uma intervenção contra o paludismo por causa da preocupação sobre a sua eficácia, especialmente a sustentabilidade dos resultados, a viabilidade logística e o risco de acelerar a resistência aos medicamentos (3-5). Recentes progressos no controlo do paludismo, incluindo o uso de outras formas de quimioterapia preventiva, tais como tratamento preventivo intermitente do paludismo na gravidez e quimioprevenção do paludismo sazonal, aliados aos esforços para a eliminação do paludismo em alguns ambientes e a disponibilidade de novos medicamentos antipalúdicos, têm renovado o interesse no papel que a AMM pode desempenhar em alguns contextos (3,4,6,7), por exemplo, no quadro do trabalho para conter a resistência a múltiplos medicamentos e eliminar a transmissão do paludismo na sub-região do Grande Mekong (8,9) e em certas emergências complexas, como o surto da doença por vírus Ebola (DVE) em 2013-2016 na África Ocidental (9-12). 1.2 DEFINIÇÕES A administração massiva de medicamentos (AMM) consiste em administrar um curso terapêutico completo de medicamento antipalúdico (independentemente da presença de sintomas ou infecção) para cada membro de uma população definida ou pessoa que vive numa área geográfica determinada (excepto as pessoas para as quais o medicamento é contra-indicado) aproximadamente ao mesmo tempo, e muitas vezes em intervalos repetidos (3,9). Para a AMM ser bem sucedida, uma proporção muito elevada, geralmente mais de 80% da população alvo deve ser atingida durante a campanha, dependendo da intensidade da transmissão e do objectivo exacto da campanha (4,6,9,13,14). Isto requer um alto nível de participação e envolvimento da comunidade. Não basta alcançar a maioria da população com a distribuição: a cobertura será efectiva apenas se o número de pessoas na comunidade que concluírem correctamente o curso completo de tratamento antipalúdico for adequado. Para conseguir isso, a população deve aceitar a intervenção e estar disposta a tomar o medicamento como prescrito. 1.3 OBJECTIVO O objectivo da AMM para o paludismo é fornecer doses terapêuticas de medicamentos antipalúdicos para uma parte da população tão alargada quanto possível, para curar todas as infecções sintomáticas e assintomáticas do paludismo no momento da intervenção, e prevenir nova infecção durante a profilaxia pós-tratamento. A AMM reduz rapidamente a prevalência e incidência do paludismo a curto prazo. Uma vez concluído o tratamento do paludismo, contudo, a endemicidade do paludismo poderá atingir o seu nível original se a importação do paludismo não for impedida, na ausência de elevada cobertura com outras intervenções, tais como controlo de vectores, gestão de casos, vigilância e resposta. O risco desse regresso e a rapidez com que ocorre depende da dimensão do reservatório de parasitas residuais nos seres humanos e da capacidade dos vectores para a transmissão da malária na área visada. 21.4 RECOMENDAÇÕES DA OMS Com base numa recente análise das provas (9) e o parecer do Comité Consultivo da OMS para as Políticas do Paludismo, as actuais recomendações para a utilização da AMM, rastreio e tratamento em massa e o rastreio e tratamento focal do paludismo (15) são apresentadas a seguir. 1. A utilização de AMM para a eliminação do paludismo P. falciparum pode ser considerada nas zonas que se aproximam da interrupção da transmissão, onde existe um bom acesso ao tratamento, implementação eficaz de controlo de vectores e vigilância, e um risco mínimo de reintrodução da infecção. 2. Considerando a ameaça de resistência a múltiplos medicamentos e o apelo da OMS para a eliminação do paludismo na sub-região do Grande Mekong (GMS), a AMM pode ser considerada como uma componente da aceleração dos esforços de eliminação do paludismo nas zonas do GMS com bom acesso ao tratamento, controlo de vectores e vigilância. 3. A utilização de AMM por tempo limitado para reduzir rapidamente a morbidade e mortalidade por paludismo pode ser considerada para o controlo de epidemias no âmbito da resposta inicial, juntamente com a introdução urgente de outras intervenções. 4. A utilização de AMM por tempo limitado para reduzir a morbidade e mortalidade por paludismo pode ser considerada em emergências complexas, em circunstâncias excepcionais, quando o sistema de saúde está sobrecarregado e não consegue atender as comunidades afectadas. 5. Na ausência de provas suficientes, a OMS não recomenda a utilização de AMM em situações diferentes das áreas que se aproximam da eliminação, epidemias e emergências complexas, como especificado acima (ver 1-4). 6. Tratamento profiláctico com primaquina em massa, que exige AMM pré-sazonal com administração diária de primaquina durante duas semanas sem o teste de G6PD, não é recomendado para a interrupção da transmissão de vivax. 7. Rastreio e tratamento em massa e o rastreio focal e tratamento do paludismo não são recomendados como intervenções para interromper a transmissão do paludismo. 8. Os medicamentos utilizados para a AMM devem ser de eficácia comprovada na área de implementação e de preferência ter uma meia-vida longa. A OMS recomenda que um medicamento diferente do que é utilizado para o tratamento de primeira linha seja utilizado para a AMM. Os programas devem incluir a monitorização da eficácia, segurança e a potencial emergência de resistência aos medicamentos antipalúdicos destacados para a AMM. 9. A OMS apoia a necessidade de mais pesquisas sobre os melhores métodos de implementação de programas de AMM, promovendo a participação comunitária e adesão ao tratamento, e avaliando a sua eficácia. A modelização pode ajudar a orientar o melhor método de administração de AMM em diferentes circunstâncias epidemiológicas e prever o seu provável impacto. Em linha com as recomendações acima mencionadas, este manual aborda o uso de AMM apenas para o controlo e eliminação do paludismo falciparum. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 3 2. ORGANIZAÇÃO E IMPLEMENTAÇÃO DA ADMINISTRAÇÃO MASSIVA DE MEDICAMENTOS 2.1 FASE DE CONCEPÇÃO (MACRO-PLANEAMENTO) Assim que se decidir que a AMM será realizada, o macro-planeamento deve ser iniciado. Esta fase de concepção inicial, efectuada a nível nacional, é importante para assegurar uma campanha bem sucedida e deve envolver o ministério da saúde e outros principais intervenientes. Quando a AMM para o paludismo é efectuada para ter impacto na transmissão do paludismo, a administração dos medicamentos antipalúdicos deve ser feita de tal modo que todos os indivíduos identificados sejam tratados de uma forma sincronizada e cada ronda seja concluída num período de tempo muito curto, geralmente não mais de uma semana. Em situações de emergências complexas, quando o principal objectivo é a rápida redução da morbidade e mortalidade por paludismo, a administração síncrona é menos crítica. Etapas da fase de concepção: • Obter o compromisso dos decisores políticos, e identificar agências para apoiar o ministério da saúde. • Criar uma força-tarefa ou comité de coordenação. • Realizar uma análise do contexto. • Decidir implementar a AMM para o paludismo falciparum. • Definir áreas específicas e população-alvo. • Escolher o medicamento. • Estimar as necessidades do medicamento, e adquiri-lo. • Determinar a estratégia de execução (incluindo o período de intervenção e o número de rondas). • Calcular o orçamento. • Definir os critérios para a interrupção da AMM. Como a AMM visa cada indivíduo numa determinada população (excepto as pessoas com contra-indicações em relação aos medicamentos usados), pode ser combinada com outras intervenções de saúde pública, como educação para a saúde, desparasitação e distribuição de redes mosquiteiras tratadas com insecticidas de longa duração; no entanto, a experiência na combinação de vários medicamentos ou programas é limitada, e atenção especial deve ser dada antecipadamente. 2.1.1 Identificar agências para apoiar o ministério da saúde A AMM para o paludismo é uma intervenção complexa do ponto de vista logístico, que exigirá um planeamento cuidadoso e recursos significativos para ser bem sucedida. Por conseguinte, os parceiros que podem proporcionar apoio técnico, financeiro e operacional devem ser identificados 4e envolvidos no planeamento das fases iniciais. Os parceiros podem ser nacionais (governo nacional e local, sector privado, organizações não-governamentais, outras organizações da sociedade civil, meios de comunicação social, líderes comunitários, líderes religiosos) ou internacionais (agências de mídia) financiamento, agências de aquisições e organizações não-governamentais internacionais). Identificar os doadores e parceiros de implementação é fundamental para o sucesso da AMM. Todos devem ser encorajados a trabalhar no quadro dos “três uns” - um plano, uma coordenação e uma monitorização e avaliação - sob a supervisão do grupo de trabalho ou comité de coordenação. Como a AMM geralmente é constituída por várias rondas para elevada cobertura e, se o objectivo é interromper a transmissão ou eliminação, pode ser repetida nos anos subsequentes, por conseguinte é importante garantir o apoio continuado para assegurar a conclusão satisfatória da intervenção. Os serviços de tratamento do paludismo devem ser implementados e apoiados na monitorização das comunidades a longo prazo após a conclusão da AMM. 2.1.2 Criar uma força-tarefa ou comité de coordenação Um grupo de trabalho ou comité de coordenação, sob a orientação do Ministério da Saúde, deve ser criado com a representação de nível nacional, regional e distrital para servir como um órgão de supervisão encarregado da implementação da campanha de AMM e assegurar a alocação adequada de recursos. Composição O comité pode incluir representantes de: • o programa nacional de controlo do paludismo; • outras entidades relevantes do ministério da saúde, por exemplo, medicamentos, saúde pública, doenças tropicais negligenciadas ou outros programas com experiência em AMM; • instituições de investigação nacionais; • a autoridade reguladora nacional de medicamentos; • o centro nacional de farmacovigilância; • autoridades sanitárias nacionais, regionais e distritais relevantes; • pessoal técnico de hospitais relevantes; • autoridades administrativas; • agências de apoio (Fundo das Nações Unidas para a Infância, OMS, outras agências das Nações Unidas, organizações não-governamentais); • outros ministérios envolvidos; • representantes locais da sociedade civil; e • o sector privado, Uma campanha só será bem sucedida com uma estreita colaboração e coordenação entre os parceiros. Todos devem concordar e, se possível, assinar um acordo formal que descreve as tarefas e responsabilidades de cada um. Se AMM for utilizada numa situação de emergência, as decisões terão de ser tomadas rapidamente. Para evitar atrasos na tentativa de chegar a um consenso entre as várias agências sobre quaisquer questões polémicas, uma autoridade de decisão definida AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 5 (normalmente o ministério da saúde) deve ser identificada, e será responsável pela tomada de decisões rápidas, se necessário. Responsabilidades do comité O comité será responsável por: • concordar se a AMM é apropriada para a redução de transmissão e/ou a redução da morbidade e mortalidade • elaboração das principais linhas estratégicas para a implementação da AMM e preparação de um plano de acção; • mobilização dos recursos humanos e financeiros necessários; • coordenação de parceiros e partilha de informações; • identificação da população-alvo e áreas geográficas específicas (secção 2.1.4); • criação do cronograma (secção 2.1.10); • preparação, avaliação, adaptação e actualização de orientações e materiais de formação; • desenvolvimento de recolha de dados e ferramentas de monitorização (secção 2.3.4); • elaboração do plano de mobilização social e de envolvimento comunitário (secção 2.2.4); • assegurar o funcionamento de um sistema de monitorização da segurança de medicamentos (reforço de qualquer órgão de farmacovigilância existente ou a criação de um) para garantir a eficácia da detecção, gestão e notificação de ocorrências adversas relacionadas com a administração de medicamentos antipalúdicos e o acesso à consulta e hospitalização, incluindo qualquer medicação de emergência, sem custos (secção 3.4); • estabelecimento de monitorização e avaliação, determinação de objectivos e métodos e definição de indicadores (secção 3); • garantia de que as actividades de controlo alargado do paludismo sejam implementadas no contexto de eliminação: diagnóstico e tratamento, controlo de vectores e detecção e investigação de todos os casos; • actividades de planeamento adicionais de controlo do paludismo no contexto de emergências complexas, tais como diagnóstico e tratamento, controlo de vectores e vigilância; • estabelecimento dos critérios para a interrupção de AMM; e • garantia de um sistema de vigilância eficaz para compilar e analisar as alterações na carga do paludismo; Responsabilidades do grupo de trabalho regional ou distrital • micro-planeamento (secção 2.2) no quadro da estratégia definida pelo grupo de trabalho nacional e • coordenação e monitorização dos aspectos operacionais da campanha. 6Subcomités poderão ser criados no âmbito do grupo de trabalho a níveis nacional e distrital, nomeadamente: • um comité técnico; • um comité de informação, educação, comunicação, mobilização social e envolvimento da comunidade; • um comité de recursos humanos; • um comité de formação; • um comité de logística; • e um comité de monitorização e avaliação. 2.1.3 Realizar uma análise do contexto Planeamento de uma AMM requer uma análise sistemática do contexto e informações sobre vários aspectos que podem ter grandes implicações práticas para a execução da campanha: • situação do paludismo no país e nos países vizinhos: - principais espécies do paludismo nos seres humanos presentes; - endemicidade do paludismo ou intensidade da transmissão (elevada, moderada, baixa ou propensa a epidemias); - pico da época de transmissão do paludismo; - a prevalência do paludismo, incidência do paludismo grave e sem complicações e mortalidade; - grupos de alto risco: por idade, género e ocupação; - outras actividades de controlo do paludismo que estão a ser (ou foram) utilizadas, particularmente as redes mosquiteiras tratadas com insecticida de longa duração, pulverização residual interna, gestão de fontes de larvas; - testes de diagnósticos disponíveis e utilizados - directrizes nacionais sobre o tratamento; - outras actividades de quimioprevenção, em especial a quimioprevenção do paludismo sazonal, tratamento preventivo intermitente de crianças ou mulheres grávidas; resistência a medicamentos antipalúdicos; - principais fontes de financiamento das actividades de controlo do paludismo e implementação; e identificação de parceiros para o controlo do paludismo; • informação administrativa: - fronteiras dos países e divisões administrativas e - áreas de indefinição ou limites não definidos que podem constituir uma ameaça para a implementação; • mapeamento das fronteiras administrativas, cidades, vilas, localização de estruturas sanitárias, estradas principais; • dados demográficos, nomeadamente a distribuição etária da população e grupos marginalizados identificados; • organização dos cuidados de saúde: AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 7 - infra-estruturas sanitárias existentes: hospitais, centros de saúde, postos de saúde; - pessoal de cuidados de saúde existente (número e nível de formação); e - profissionais de saúde tradicionais; • factores ambientais: clima e estações (chuvosa e seca), eventos extremos ligados às alterações climáticas (inundações, secas); • geografia das áreas específicas e natureza do terreno; • segurança - existência de conflitos armados, tensões ou confrontos étnicos, religiosos ou sociais; e - distúrbios civis, demonstrações, corrupção; • desafios ao sistema de saúde: emergências de saúde pública e surtos de doenças; • experiência e ensinamentos obtidos de campanhas de AMM anteriores para as doenças tropicais negligenciadas ou paludismo; • crises anteriores em comunicação e rumores sobre a segurança de AMM para doenças tropicais negligenciadas ou campanhas de vacinação e lições aprendidas; • ocorrências locais importantes: feriados nacionais e religiosos, dias de mercado, eleições, manifestações previstas, distribuição de alimentos, AMM para doenças tropicais negligenciadas ou campanhas de vacinação, o que pode resultar numa fraca participação; • percepções e crenças locais (ver secção 2.2.4); • fornecimento: compras e possibilidades de armazenamento a níveis nacional e local, formalidades para importação de medicamentos, estado de registo de medicamentos antipalúdicos elegíveis para AMM (secção 2.2.2); • sistema de comunicações: por exemplo, as redes existentes (prestadores de serviços de comunicações móveis), a disponibilidade de Internet; e • deslocamento da população devido aos problemas de segurança, migração sazonal ou populações nómadas. 2.1.4 Determinar a população-alvo e áreas geográficas Uma análise aprofundada da epidemiologia do paludismo e do objectivo de AMM - para o controlo de epidemias, eliminação do paludismo ou numa emergência complexa - deve orientar as decisões sobre a população-alvo e as áreas geográficas que beneficiarão da campanha. Quanto maior for a população-alvo, mais difícil é a implementação e serão necessários mais recursos (humanos, financeiros, logísticos), uma vez que a cobertura da AMM nas áreas específicas é o maior determinante de impacto. Os dados demográficos utilizados para calcular a população-alvo devem ser mais exactos quanto possível. Isto pode ser difícil de obter em certos países em desenvolvimento. Se possível, os dados devem ser fornecidos por fontes oficiais. Estimativas dos números relativos à população podem ser adquiridas de (Fig. 1): • contagem individual (recenseamento) ou registo de domicílios antes da AMM (dificilmente será realizado no contexto de emergências); • um recenseamento populacional recente (se disponível); 8• inquérito às famílias; • registo administrativo (se disponível); • dados de outras recentes distribuições em massa (como redes mosquiteiras tratadas com insecticida de longa duração), campanhas de vacinação em massa ou AMM anterior na mesma área; ou • recenseamento de famílias feito por equipas de pulverização residual interna em áreas onde há programas eficazes de paludismo. Se não houver dados recentes para estabelecer uma projecção mais realista, a taxa de crescimento anual da população pode ser utilizada. Deslocamento da população para dentro ou para fora da área geográfica em causa também deve ser considerada. Se várias estimativas estiverem disponíveis, é aconselhável utilizar os números mais elevados. A subestimação da população-alvo pode causar erros no cálculo de pedidos e, consequentemente, escassez de medicamentos, número insuficiente de equipas de distribuição ou tempo inadequado necessário para atingir toda a população-alvo. Esses erros, em última análise, comprometerão a cobertura e também poderão ter um impacto negativo na percepção da população que é excluída. FIG. 1. Fontes de informações demográficas para o cálculo da população-alvo FONTES DE ESTIMATIVA POPULACIONAL Recenseamento recente populacional Inquéritos de domicílios familiares Contagem individial ou registo de famílias Distribuição recente de redes mosquiteiras com insecticida de longa duração/pulverização interna Registo administrativo Após a conclusão da primeira ronda de distribuição, os resultados podem ser utilizados para recalcular a população-alvo para rondas posteriores. A população-alvo deve ser calculada por grupo etário. Se dados específicos sobre a distribuição etária no país não estiverem disponíveis, o padrão de distribuição etária para os países em desenvolvimento pode ser utilizado (ver Anexo 1). Determinados grupos da população podem ser excluídos da campanha, dependendo do medicamento escolhido para AMM: • mulheres grávidas no primeiro trimestre: uma decisão de utilização de testes de gravidez ou gravidez auto-declarada para excluir as mulheres grávidas deve ser orientada pelas autoridades de saúde e contexto local; • lactentes < 6 meses de idade ou peso < 5 kg; AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 9 • pessoas recentemente tratadas com o mesmo medicamento; • pessoas com alergia conhecida ao medicamento; • pessoas gravemente doentes; • pessoas que tomam medicamentos com interacções conhecidas com medicamento de AMM; e • pessoas com contra-indicações específicas em relação ao medicamento utilizado. Na fase de concepção, os critérios de inclusão e exclusão para a participação na campanha de AMM devem ser claramente estabelecidos. A estimativa do número previsto de indivíduos que serão excluídos da participação na AMM pode ser útil para o cálculo de pedidos, para fins de planeamento e de análise de cobertura. A área geográfica a ser visada deve ser definida com base na dimensão da população em cada zona ou área, a densidade populacional e se se trata de um meio urbano ou rural. O Quadro 1 (na página 10) indica as diferenças na implementação entre os meios urbanos e rurais. 2.1.5 Escolher o medicamento antipalúdico. Vários elementos devem ser considerados na escolha do medicamento a utilizar. • Eficácia: a taxa de cura de 28 dias para pacientes com paludismo não complicado deve ser > 90%. • Perfil de segurança: baixa frequência de efeitos adversos relacionados com o medicamento, contra-indicações e consequências da exposição inadvertida de indivíduos excluídos, como mulheres grávidas ou doentes seropositivos em terapia anti-retroviral. Até mesmo ocorrências adversas raras podem surgir num número considerável de casos, quando o medicamento é administrado a uma grande população. • Facilidade de administração: poucos comprimidos por dose e curta duração do tratamento • Reputação e aceitação: a tolerância e a aceitação da população a frequentes efeitos secundários menos graves (por exemplo, náuseas, fraqueza) e a percepção de riscos e benefícios, algumas vezes afectados por rumores, podem influenciar a aceitação dos medicamentos utilizados e na AMM. • Como identificar e excluir grupos de populações especiais para os quais actualmente não existem opções para a MDA do paludismo: gestantes no 1º trimestre de gestação e crianças com peso < 5 kg • Interacções: com outros medicamentos usados na população, incluindo outras intervenções de AMM para a mesma população e agentes anti-retrovirais utilizados pelos pacientes seropositivos • TCA de primeira linha utilizada no país deve, de preferência, ser evitada para limitar o aparecimento de resistência e o impacto na oferta de programas regulares e para evitar criar confusão e equívocos na população em relação ao uso do medicamento (profilático versus tratamento) (9,10). Em certas circunstâncias, no entanto, como emergências complexas, o tratamento de primeira linha pode ser considerado, porque será bem conhecido pela população e pode ser mais fácil garantir o fornecimento. 10 QUADRO 1. Principais diferenças na AMM nos ambientes urbanos e rurais ELEMENTO AMBIENTE URBANO AMBIENTE RURAL Dados demográficos Mais difícil de estimar: população móvel, áreas em bairros de baixa renda. Difícil determinar os limites administrativos de bairros e outras áreas dentro das cidades. Recenseamento das famílias antes de AMM era difícil. Estimativas podem ser mais confiáveis ou mais facilmente obtidas. Limites das aldeias são facilmente definidas. Mais fácil realizar recenseamento das famílias antes da AMM. Recursos logísticos Menos recursos necessários, uma vez que a população é densamente distribuída. Mais recursos necessários, uma vez que a população é dispersa, e serão necessários mais equipas e mais tempo. Acessibilidade Mais facilmente acessível O acesso pode ser difícil quando houver insegurança. O acesso pode ser limitado por distâncias, más condições das estradas e efeitos do clima (chuva). Recursos humanos Mais fácil encontrar recursos humanos qualificados. Os trabalhadores comunitários de saúde (TCS) e voluntários podem ser menos conhecidos para a população. RH menos qualificados disponíveis Os TCS e voluntários são muito conhecidos e contam com a confiança da população. Líderes comunitários Mais difícil identificar. Papel importante no micro-planeamento e mobilização social Estratégia porta-a-porta Maior facilidade de não incluir domicílios familiares Pessoas menos dispostas a permitir o acesso à sua casa, especialmente nas camadas socioeconómicas mais elevadas As pessoas recusam-se a participar ou ausentes quando estão no seu local de trabalho 15-20 famílias podem ser visitadas por equipa por dia (75-100 pessoas). Maior facilidade de incluir domicílios familiares Pessoas menos desconfiadas e mais simpáticas para as equipas de distribuição Pessoas geralmente ausentes por causa de actividades agrícolas 10-15 famílias podem ser visitadas por equipa por dia (50-75 pessoas). Estratégia de TDO Mais difícil realizar, porque é menos provável encontrar as pessoas em casa Mais fácil realizar Cobertura Mais difícil obter cobertura elevada É mais fácil obter uma cobertura mais elevada Adesão ao tratamento Menor Maior Rumores Gerados e divulgados mais rapidamente Mais difícil controlar Podem ser gerados, mas é mais fácil controlar e limitar a sua divulgação AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 11 • Disponibilidade de quantidades necessárias de fornecedores num período relativamente curto. • Custo (orçamento disponível). O melhor tratamento é aquele que resulta na maior redução em termos de parasitemia e transmissibilidade e o maior período de profilaxia pós-tratamento e, portanto, prevenção de novas infecções. TCA de longa duração é o tratamento mais adequado na maioria dos contextos. A componente de artemisinina, que rapidamente elimina a parasitemia assexuada e também tem uma actividade gametocitocida, tem uma meia vida curta, enquanto os medicamentos associados proporcionam diferentes durações de profilaxia pós-tratamento (ver a meia vida de eliminação de medicamentos associados no Anexo 2). O efeito profilático pós-tratamento impede a aquisição de infecção enquanto o medicamento continue na corrente sanguínea, protegendo o indivíduo assim como reduzindo a transmissão. Um curso completo de três dias de TCA deve ser administrado; é importante assegurar a adesão a esse regime. Só os comprimidos de combinação em dose fixa, co-formulados, devem ser usados para facilitar a adesão e evitar a resistência devido a erros na administração da medicação. As cinco formulações de TCA actualmente recomendadas pela OMS para o tratamento de paludismo P. falciparum são: • artemeter + lumefantrina • artesunato + amodiaquina • artesunato + mefloquina • artesunato + sulfadoxina-pirimetamina • diidroartemisinina + piperaquina As TCA enumeradas acima são recomendadas com base na sua eficácia terapêutica, segurança, impacto na transmissibilidade e disponibilidade. O Anexo 2 indica as doses do tratamento e apresentações de TCA actualmente recomendadas pela OMS. Está em curso a investigação sobre novas componentes, e a lista acima referida pode ser actualizada no futuro próximo. O Quadro 2 (na página 13) apresenta as características das TCA, que podem ajudar na escolha de um medicamento antipalúdico adequado para AMM. As comparações acima mencionadas indicam que diidroartemisinina - piperaquina pode ser uma opção adequada para a AMM, tendo em conta a sua boa eficácia, longa profilaxia pós-tratamento e boa tolerabilidade. Não é o tratamento de primeira linha para o paludismo em muitos países, e a resistência tem sido notificada em algumas áreas. Grupos populacionais especiais que poderão ser excluídos da AMM Mulheres grávidas. Não foram relatados efeitos adversos nas mães ou nos fetos no segundo e terceiro trimestres de gravidez, e ACT é considerada segura do ponto de vista da sua utilização nesta população. Como não existem dados suficientes sobre a segurança das ACT no primeiro trimestre de gravidez, devem ser evitadas nas mulheres nessa fase de gestação (16). A identificação das mulheres no primeiro trimestre de gravidez, que ainda não são visivelmente grávidas, pode ser difícil nas campanhas massivas. O método para avaliação da gravidez, através de entrevista e/ou testes, deverá ser decidido pelas autoridades sanitárias e, com base no contexto local. A utilização de testes de triagem para a gravidez pode ser problemática, porque muitas mulheres 12 ou raparigas mais jovens podem não desejar divulgar o seu estado de gravidez, especialmente em determinados meios culturais. Antes da AMM, é crucial explicar para a comunidade o objectivo da realização dos testes de gravidez e assegurar-lhes que serão feitos de forma confidencial. É altamente recomendável que as entrevistas e testes de gravidez sejam efectuados por trabalhadores comunitários da saúde qualificados do sexo feminino, para garantir a privacidade e discrição. Uma abordagem culturalmente sensível é essencial, tendo em consideração os valores e percepções das comunidades. Lactentes < 6 meses de idade ou peso < 5 kg; Embora ACT seja considerada como sendo bem tolerada pelos lactentes mais novos, a dificuldade em garantir a dosagem exacta, devido à falta de formulações infantis e de boa administração e retenção do tratamento pode indicar a exclusão de lactentes mais novos, principalmente para considerações operacionais. Primaquina (8-aminoquinolinas) A OMS recomenda a adição de uma dose baixa única (0,25 mg/kg de peso corporal) de primaquina (administrada no primeiro dia do tratamento com ACT) como um gametocitocida de P. falciparum, se o objectivo de AMM é eliminar o paludismo falciparum ou reduzir a transmissão de tipos de P. falciparum resistentes a medicamentos. Primaquina deve, contudo, não deve ser administrada a lactentes < 6 meses de idade, mulheres grávidas ou mulheres que estejam amamentado os filhos < 6 meses de idade. A administração de uma dose baixa única é segura e eficaz, mesmo em indivíduos com deficiência de G6PD. Numa avaliação recente, a OMS concluiu que os indivíduos com deficiência de G6PD que tomaram uma única dose baixa de primaquina apresentam um nível de risco muito baixo de hemólise clinicamente significativa (17-19); por conseguinte, pode ser administrada sem teste de G6PD. O efeito hemolítico de primaquina é proporcional à dose e é observado principalmente em indivíduos com deficiência de G6PD, tendo em conta o regime de 14 dias recomendado para a cura radical de paludismo P. vivax. 2.1.6 Estimar a necessidade de medicamento antipalúdico, e encomendá-lo Registo e autorização de importação No âmbito dos critérios de selecção, sobretudo para implementação rápida em situações de emergência, é necessário considerar a disponibilidade e os requisitos para o registo do medicamento ou obtenção de uma isenção para a sua importação. A autorização para importar o medicamento e despacho aduaneiro deve ser previamente acordada com as autoridades para permitir a gestão eficaz e rápida. Esses processos podem levar algum tempo, especialmente se a medicação não estiver licenciada no país. Dependendo da regulamentação do país, um teste de controlo de qualidade pós-embarque pode ser necessário para cada lote do medicamento após a sua chegada no país, e o tempo necessário deve ser incluído no planeamento. Aquisições Identificação de medicamentos adequados para a AMM é outro elemento importante no planeamento de uma campanha. É essencial assegurar que o medicamento seleccionado a ser utilizado atenda às normas internacionais de qualidade. O uso de medicamentos inadequados, ineficazes ou inseguros poderia ser prejudicial para a população atendida, afectar a credibilidade da campanha, aumentar o encargo no sistema de cuidados de saúde e promover a disseminação de tipos resistentes, se os parasitas forem expostos a níveis sanguíneos sub-terapêuticos. Apenas AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 13 CA RA CT ER ÍS TI CA S E CR IT ÉR IO S DE SE LE CÇ ÃO AR TE M ET ER - L UM EF AN TR IN A (A L) AR TE SU NA TO – A M O DI AQ UI NA (A S- AQ ) AR TE SU NA TO - M EF LO Q UI NA (A S- M Q ) AR TE SU NA TO –S UL FA DO XI NA PI RI M ET AM IN A (A S- SP ) DI ID RO AR TE M IS IN IN A - PI PE RA Q UI NA (D HA -P PQ ) Efi cá ci a El ev ad a em m ui to s co nt ex to s Va riá ve l, de vi do à re si st ên ci a em er ge nt e El ev ad a em m ui to s co nt ex to s Re si st ên ci a ge ne ra liz ad a em re la çã o a SP El ev ad a em m ui to s co nt ex to s M ei a vi da (d ia s) (m ed ic am en to a ct iv o) 1.4 –1 1.4 (l um ef an tr in a) 3. 7- 10 (d es et il- am od ia qu in a) 8. 1- 15 .2 (m efl oq ui na ) 2. 5- 18 .8 (S P) 13 .5 -2 8 (p ip er aq ui na ) Se gu ra nç a Se gu ro e g er al m en te b em to le ra do G er al m en te b em to le ra do , m as a ss oc ia do a um a m ai or in ci dê nc ia d e di st úr bi os ga st ro in te st in ai s d o qu e ou tra s T CA . A Q po de p ro lo ng ar o in te rv al o Q T e nã o de ve se r d ad a a pe ss oa s q ue to m am m ed ica m en to s q ue p ro lo ng am Q T ou q ue tê m p ro lo ng am en to d e Q T co ng én ito .* AQ e st á as so ci ad a a ne ut ro pe ni a e a he pa to to xic id ad e e nã o de ve se r u sa da em d oe nt es se ro po sit ivo s q ue to m am zid ov ud in a, e fa vi re nz e /o u co tri m ox az ol . M efl oq ui na pr ov oc a ná us ea s, vó m ito s e si nt om as ne ur op si qu iá tr ic os . O tr at am en to m en sa l d e pe ss oa s sa ud áv ei s é m al to le ra do . SP é g er al m en te b em to le ra da , m as n ão d ev e se r us ad a em p ac ie nt es c om hi st ór ic o de H ip er se ns ib ili da de a su lfo na m id as e o u pa ci en te s se ro po si tiv os q ue to m am co tr im ox az ol , p or c au sa do a um en to d o ris co d e oc or rê nc ia s ad ve rs as . Pi pe ra qu in a pr ol on ga o in te rv al o Q T e nã o de ve se r d ad a a pe ss oa s qu e to m am m ed ic am en to s qu e pr ol on ga m Q T ou q ue tê m p ro lo ng am en to d e Q T co ng én ito .* G ra vi de z A re la çã o ris co -b en ef íc io d a ad m in is tr aç ão d e m ed ic am en to s an tip al úd ic os a m ul he re s gr áv id as a tr av és d a AM M é d ife re nt e da d os p ac ie nt es c om p al ud is m o. C om o ex is te m d ad os in su fic ie nt es s ob re a s eg ur an ça d as T C A da da s du ra nt e o pr im ei ro tr im es tr e de g ra vi de z, a s m ul he re s no in íc io d a gr av id ez d ev em s er e xc lu íd as qu an do a s TC A sã o pr op or ci on ad as à A M M p ar a o pa lu di sm o. Ad m in is tr aç ão D ua s ve ze s ao d ia p or 3 d ia s, de p re fe rê nc ia c om a lim en to s go rd ur os os (A a de rê nc ia é m ai s di fic il qu an do c om pa ra da a d os tra ta m en to s co m d os e ún ic a di ár ia e do s qu e pr ec isa m d e in ge st a de al im en to s) U m a ve z ao d ia p or 3 d ia s (n ão re qu er in ge st ão d e al im en to s) U m a ve z ao d ia p or 3 di as (n ão re qu er in ge st ão d e al im en to s) U m a ve z ao d ia p or 3 d ia s (n ão re qu er in ge st ão d e al im en to s) Um a ve z ao d ia p or 3 d ia s co m o e st om ag o va zi o ( id ea lm en te 3 h or as a nt es o u ap ós a s r ef ei çõ es , o q ue p od e nã o se r p os sív el n a AM M ) Ap re se nt aç ão C om bi na çã o de d os e fix a; co m pr im id os d isp er sív ei s e co m pr im id os c om d os es m ai s el ev ad as d isp on ív ei s pa ra di fe re nt es g ru po s et ár io s e de pe so s di fe re nt es C om bi na çã o de d os e fix a C om bi na çã o de d os e fix a N ão e xi st e ne nh um a co m bi na çã o de d os e fix a. U so de p la ca s al ve ol ar es p od e da r o rig em à d is tr ib ui çã o de c om pr im id os g ra nu la do s co m o m on ot er ap ia . C om bi na çã o de d os e fix a D is po ni bi lid ad e co m er ci al d e pr od ut o pr é- qu al ifi ca do G ra nd e di sp on ib ilid ad e de pr od ut os o rig in ai s e ge né ric os p ré - qu al ifi ca do s po r m ui ta s em pr es as G ra nd e di sp on ib ilid ad e de p ro du to s or ig in ai s e ge né ric os p ré -q ua lifi ca do s po r m ui ta s em pr es as Ú ni co p ro du to pr é- qu al ifi ca do ; ca pa ci da de d e pr od uç ão li m ita da Ú ni co p ro du to p ré - qu al ifi ca do ; c ap ac id ad e de pr od uç ão li m ita da Ú ni co p ro du to p ré - qu al ifi ca do ; c ap ac id ad e de pr od uç ão li m ita da * A ex cl us ão d e pa ci en te s co m p ro lo ng am en to d e Q T co ng én ito n ão s er ia v iá ve l n a AM M , m as a s pe ss oa s qu e to m am m ed ic am en to s es pe cí fic os p od em s er id en tifi ca da s an te s de A M M . Q U AD RO 2 . Ca ra ct er ís tic as d as T CA re co m en da da s pe la O M S pa ra a e sc ol ha a de qu ad a de m ed ic am en to s an tip al úd ic os p ar a a AM M 14 os fornecedores pré-qualificados aprovados pela OMS ou por uma autoridade reguladora rigorosa devem ser seleccionados para a AMM (20). As duas principais fontes de informação para a selecção são o programa de pré-qualificação da OMS (21) e a lista do Fundo Global (22). Ao seleccionar um medicamento, deve-se ter em consideração se o fornecedor será capaz de entregar toda a quantidade necessária a curto prazo, porque nem todos os fornecedores têm uma grande capacidade de produção suficiente para fornecer grandes quantidades num curto espaço de tempo. Além disso, alguns fabricantes só iniciam a produção quando a ordem de compra for recebida. Estes possíveis atrasos devem ser levados em consideração no planeamento de compras e na definição de datas de distribuição. Calcular a quantidade necessária de medicamento para diferentes grupos etários • Determinar a dimensão da população-alvo, que será igual ao número total de tratamentos necessários, frequentemente em numero de cartelas de tratamento, para cada ronda. • Calcular o número de tratamentos por grupo etário por ronda (de acordo com as categorias etárias para qual a TCA selecionada tem apresentações específicas) • Multiplicar as necessidades por ronda pelo número de rondas que serão realizadas. • Adicionar um estoque de segurança de aproximadamente 25% (dependendo da confiabilidade dos dados demográficos) para cobrir perdas ou sub-avaliação da população. Ver Anexo 3 para exemplos de estimativa de ordens de diferentes apresentações de artesunato- amodiaquina e diidroartemisinina-piperaquina. O cálculo deve também levar em consideração o número de pessoas que devem ser excluídas da cobertura com AMM (por exemplo, mulheres grávidas, lactentes, pacientes com VIH, dependendo do medicamento seleccionado para uso). 2.1.7 Determinar a estratégia de distribuição Há três possíveis estratégias de distribuição: • distribuição porta-a-porta: a estratégia preferida para uma cobertura elevada, se logisticamente possível; • Distribuição centralizada num local fixo; e • uma combinação de distribuição porta-a-porta e da distribuição centralizada em local fixo: - centralizada com distribuição porta-a-porta para grupos difíceis de contactar ou - distribuição porta-a-porta, seguida pela distribuição centralizada para acompanhamento dos participantes omitidos. Com a aplicação de estratégias combinadas, deve-se tomar cuidado para não tomar doses individuais repetidamente. A escolha da estratégia dependerá da capacidade logística, do objectivo da AMM e da análise do contexto local, incluindo segurança e qualquer surto ou outras circunstâncias especiais. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 15 TDO é a melhor estratégia de execução para garantir a adesão e reduzir o potencial de erros ao tomar o medicamento. Embora TDO seja mais exigente do ponto de vista operacional, tem sido utilizado com sucesso em campanhas de grande escala, incluindo regimes de tratamento de vários dias (4). Como pode não ser viável dar todas as três doses de TCA através de TDO, um profissional de saúde pode administrar a primeira dose e dar os restantes comprimidos à pessoa ou cuidador para o 2º e 3º dias da intervenção, com instruções sobre a sua administração. Devido ao elevado risco de não adesão ao tratamento nos dois dias após a administração da primeira dose por TDO e consequente uso indevido do medicamento, a adesão deve ser fortemente enfatizada pelo distribuidor e na campanha de mobilização social. Uma alternativa que promove e permite a avaliação da adesão ao tratamento e segurança é dar a primeira e a terceira doses por TDO. Estas diferentes opções de execução - TDO completo, TDO no 1º dia e 3º dia e TDO apenas no 1º dia - têm implicações em termos de recursos, que devem ser considerados no planeamento da intervenção. Se TDO para todas as três doses não for viável, uma estratégia deve ser concebida para incentivar e monitorizar a adesão. Por exemplo, os TCS podem revisitar as casas a que tenham já distribuído o medicamento após terminar a distribuição no 2º dia e 3º dia, ou equipas responsáveis pelo acompanhamento da adesão poderão ser designadas. Garantir TDO em estratégias de porta-a- porta, quando há pouca probabilidade de todos os membros estarem em casa no momento da visita do agente de saúde, é difícil e complicado. Quando a AMM é planeada no âmbito de uma estratégia de eliminação e não existe nenhuma pressão de tempo de uma intervenção de emergência, um projecto piloto de AMM de pequena escala deve ser encorajado para optimizar a estratégia de execução. 2.1.8 Determinar o período de intervenção O melhor momento para a AMM depende do contexto e do objectivo da AMM (ver Quadro 3). AMM para reduzir a transmissão e eliminar o paludismo Numa área com transmissão sazonal, uma campanha deve ser executada durante a época de baixa transmissão, quando o número de parasitas é menor, imediatamente antes do início da época da transmissão do paludismo (6,9,13,23). Se AMM for realizada na época alta ou durante a época de transmissão principal, há menos probabilidade de influenciar a transmissão do paludismo e a prevalência parasitária aumentará rapidamente (13). A calendarização deve também levar em consideração os movimentos sazonais da população dentro e fora da área visada. As pessoas não tratadas que regressam a uma zona depois da AMM constituem potenciais reservatórios e fontes de novas infecções. O acesso de equipas a determinados locais rurais e remotos também pode determinar o período de AMM, porque algumas áreas podem não ser acessíveis durante a estação chuvosa. AMM para ajudar a conter uma epidemia de paludismo AMM deve ser realizada o mais rapidamente possível, para reduzir rapidamente a morbidade e mortalidade, enquanto as medidas de contenção da epidemia são implementadas. AMM em emergências complexas O período da intervenção irá corresponder ao de maior risco de morbidade e mortalidade - a época alta de transmissão do paludismo. Se o fardo do paludismo for elevado durante todo o ano, AMM pode ser considerada em qualquer época do ano. 16 Certas emergências de saúde pública complexas, como o surto de DVE de 2014-2015, têm grandes impactos nos sistemas de cuidados de saúde existentes. Durante a epidemia, as estruturas de saúde foram sobrecarregadas, e o acesso a cuidados de saúde regulares foi reduzido, devido ao menor funcionamento das unidades de saúde, perda do pessoal de cuidados de saúde e medo no seio das populações que frequentam as estruturas sanitárias e centros de tratamento de ficarem contaminadas com o vírus Ebola. Os testes laboratoriais geralmente não estavam disponíveis, e os testes de sangue para o diagnóstico do paludismo foram suspensos. Todos estes factores afectaram a gestão dos casos de paludismo, resultando num aumento da morbidade e da mortalidade causadas pelo paludismo. Além disso, como a apresentação clínica do paludismo e da DVE são semelhantes, suspeitava-se que os pacientes com paludismo tinham DVE, aumentando o fardo nas unidades de tratamento da DVE e expondo também os pacientes que não têm DVE à contaminação hospitalar. A AMM contra o paludismo foi proporcionada neste contexto, na tentativa de reduzir a morbilidade e mortalidade por paludismo rapidamente e, deste modo, reduzir o número de pacientes que não têm DVE e se apresentam com febre nos centros de tratamento da DVE. A redução da transmissão do paludismo não era o objectivo da AMM no âmbito da epidemia de DVE. 2.1.9 Determinar o número de rondas. Várias rondas de AMM em intervalos regulares são recomendadas, embora não haja evidências suficientes para estabelecer o número e o momento adequados (3). A maioria das campanhas da AMM para o paludismo falciparum consistiam de duas ou três rondas em intervalos mensais, e novas pesquisas devem ser realizadas para determinar se uma ou duas rondas seriam suficientes em determinadas situações (9). Situações especiais são apresentadas no Quadro 3. No âmbito da AMM para reduzir a transmissão ou erradicar o paludismo, repetidas rondas são necessárias para eliminar os parasitas na população. Se algumas pessoas permanecerem sem tratamento durante uma única ronda, sem nenhuma intervenção adicional, a cobertura será parcial e o impacto em termos de transmissão e fardo do paludismo será menor. O objectivo das sucessivas rondas é a cobertura total, atingindo pessoas que inicialmente foram ignoradas e as pessoas que foram tratadas nas rondas anteriores, mas podem ter sido afectadas por novas infecções depois de AMM, reduzindo a probabilidade de novas infecções de mosquitos. Além disso, as rondas repetidas permitem a extensão da cobertura, atingindo pessoas que não foram abrangidas nas rondas anteriores, evitando assim novas infecções humanas durante o período de profilaxia pós-tratamento. Várias rondas podem ser necessárias para obter uma grande diminuição na prevalência (6,8). Na AMM como parte de uma resposta à epidemia, o número de rondas pode depender da curva epidémica (taxa de incidência e taxa de ataque) e a duração prevista da transmissão. Na AMM em situações de emergências complexas, as rondas devem ser repetidas para cobrir a duração do período de maior morbidade e mortalidade. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 17 QUADRO 3. As principais diferenças estratégicas entre planeamento da AMM para a eliminação do paludismo e para uma resposta de emergência (epidêmica ou outras emergências complexas) CONTEXTO DE ELIMINAÇÃO (ELIMINAÇÃO E CONTENÇÃO DE MULTI-RESISTÊNCIA A MEDICAMENTOS) CONTEXTO DE EMERGÊNCIA (EPIDEMIA, EMERGÊNCIA COMPLEXA) Fonte de dados demográficos De preferência, a contagem de pessoas presentes (recenseamento) ou registo de famílias antes de AMM Contagem de pessoas presentes ou registo de famílias é menos viável Recenseamento (se disponível) Inquéritos às famílias (se disponível) Outras distribuições em massa ou AMM anteriores Calendário de implementação Geralmente permite que haja tempo suficiente para o planeamento e a preparação Pouco tempo para planeamento e preparação (< 1 mês) Urgência + +++ Coordenação de parceiros e instituições Necessário para o sucesso da campanha e fácil de alcançar Mais difícil, porque muitos intervenientes podem estar envolvidos, mas é essencial garantir uma campanha eficaz num curto espaço de tempo Escolha de medicamentos Agente antipalúdico de primeira linha deve ser evitado. Agente antipalúdico de primeira linha pode ser considerado. Calendário em relação à transmissão do paludismo para intervenção Durante a baixa época de transmissão, imediatamente antes do início da época de transmissão Durante a época alta de transmissão (maior morbidade e mortalidade), dependendo do contexto de emergência Número de rondas por ano 3 3 (mas poderá ser menos) Administração do medicamento antipalúdico Deve ser sincronizada na população-alvo, para ter um impacto na transmissão Administração simultânea é importante nas epidemias para reduzir a transmissão. Em outras emergências complexas, o requisito para consumo simultâneo de medicamento é menos crucial. As actividades concomitantes de controlo do paludismo As condições prévias para a utilização de AMM para eliminação são a disponibilidade de constatação e vigilância de casos activos, testes rápidos e tratamento de todos os casos suspeitos de paludismo e controlo de vectores intensificado. Como o objectivo é reduzir a morbidade e mortalidade por paludismo, a AMM é utilizada como uma resposta imediata, enquanto outras intervenções de controlo do paludismo, nomeadamente a gestão de casos e controlo de vectores, estão a ser implementadas. Critérios de suspensão de AMM Documentação de zero casos autóctones (casos contraídos localmente sem nenhuma evidência de importação ou ligação directa à transmissão de casos importados) Redução do fardo do paludismo para um nível que pode ser mantido com a gestão de casos, controlo de vectores e vigilância de rotina, implementados na mesma área 18 2.1.10 Estabelecer um cronograma Um cronograma de actividades (ver Anexo 4) irá limitar ocorrências imprevistas, evitar esquecer coisas nas diferentes fases de planeamento e contribuir para o sucesso da intervenção. Uma vez iniciada a distribuição, poderá ser difícil corrigir um erro de planeamento. Um planeamento deficiente, como subestimar montantes ou prazos para a entrega de medicamentos, pode conduzir a rupturas de estoque e não só irá comprometer os resultados da campanha, mas também tem um efeito prejudicial na percepção da população. O cronograma deve mostrar a evolução de todas as tarefas a serem executadas durante as fases de concepção, preparação, implementação e avaliação da campanha. Ajudará a coordenar as muitas actividades a serem realizadas ao mesmo tempo e indicará o papel de cada pessoa. O cronograma deve conter: • Uma lista de tarefas a serem realizadas, incluindo a quantificação e pedidos de medicamentos e outros suprimentos, formação, distribuição de materiais, mobilização da comunidade e destacamento de equipas; • um cronograma para a realização de cada actividade; e • o nome da pessoa responsável por cada actividade. Quando decidir as datas efectivas em que a distribuição ocorrerá, as actividades e os planos de trabalho da população e festividades religiosas e feriados devem ser considerados para garantir uma cobertura elevada. 2.1.11 Elaborar um orçamento Os seguintes itens devem ser incluídos na estimativa do orçamento: • medicamentos da AMM; • logística - o taxas de inscrição; - transporte internacional de medicamentos (por exemplo, frete internacional, seguros, despacho aduaneiro, taxas de importação ou impostos, opções de isenções); - testes de controlo de qualidade antes e depois do embarque (conforme for o caso); - armazenamento de medicamentos antipalúdicos e outros materiais logísticos; - transporte: veículos (carros, camiões, motocicletas, barcos, bicicletas), combustível; • outros equipamentos e materiais para distribuição: mapas de grande escala para o planeamento geral e mapas detalhados para orientar as equipas durante a intervenção, cordas, cercas, cobertura de plástico, megafones, giz ou outro material para marcação de casas, impermeável para a chuva (se AMM for realizada no período de chuva), mochilas, copos, outro material específico do contexto (material de biossegurança, por exemplo) (Ver a lista completa de materiais adicionais necessários para a distribuição porta-a-porta e centralizada de local fixo na Secção 2.3.1); • material administrativo: por exemplo, cartões, carimbo de data, folha de controlo diário, fichas de síntese, folhas de supervisão, folhas de presença, livros de registo, artigos de papelaria; • material para campanhas de comunicação e de mobilização social; AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 19 • salários dos funcionários, ajudas de custo, subsídios de alimentação e de transporte, material de identificação; • materiais de formação e supervisão; • meios de comunicação: telefone, recarga de créditos para o pessoal, rádio; • material para a monitorização e avaliação: por exemplo, monitores, pesquisas, monitorização de resistência; e • material para a monitorização de segurança de medicamentos. É importante não só calcular o custo de cada rubrica orçamental, mas também identificar as fontes de financiamento. Todos os parceiros e grupos de trabalho devem ter a oportunidade de analisar e dar sugestões para o plano de orçamento, e a versão final deverá ser disponibilizada. O exercício deve calcular o custo total da actividade e a análise final do custo por pessoa tratada. 2.2 PLANEAMENTO E ELABORAÇÃO 2.2.1 Micro-planeamento Assim que a concepção global da campanha for concluída a nível nacional, a fase seguinte é esboçar um micro plano a nível local (regional, distrital ou comunitário) para as estratégias seleccionadas e de acordo com as directrizes nacionais. O micro plano deve garantir que o tratamento correcto e outros materiais sejam disponibilizados nos devidos montantes, nos lugares certos e na hora certa para cobrir toda a população-alvo. Isso exigirá a distribuição de suprimentos, formação do pessoal, envolvimento da comunidade, distribuição bem coordenada e gestão adequada dos recursos. Micro-planeamento é utilizado para gerir esses pormenores através do cálculo dos requisitos com base nas necessidades locais, identificando o que está disponível e solicitando o que está a faltar. Parceiros relevantes devem ser envolvidos no micro-planeamento, incluindo: • pessoal do centro de saúde, • TCS e voluntários comunitários, • conselhos locais, • líderes comunitários ou representantes das aldeias, • líderes religiosos, • meios de comunicação, • organizações da sociedade civil, • grupo das mulheres, • organizações juvenis, • organizações não governamentais, • organizações comunitárias e • escolas e colégios 20 O micro plano deve abranger os seguintes elementos: • informações demográficas: - total da população-alvo total do distrito elegível para AMM; - os números de comunidades, aldeias e bairros do distrito; - a população-alvo em cada comunidade, aldeia e bairro, com uma distribuição por faixa etária; - a familiaridade da população com AMM para as doenças tropicais negligenciadas; - proporções de pessoas nas áreas rurais e urbanas, a fim de adaptar os requisitos de logística (ver Quadro 1 para pormenores de diferenças na implementação de AMM nos contextos urbanos e rurais); - movimento da população; - dependendo da dimensão da população-alvo e contexto (definição de emergência ou eliminação), registo das famílias ou livros de recenseamento da população- alvo que apresentam uma lista de todos os domicílios numa comunidade, com um número de identificação e incluem o nome, idade e sexo, aldeia, chefe de família, dados de contacto (se houver) e o estado de residente (permanente, temporário ou visitante). Esta lista pode ser utilizada mais tarde durante a distribuição para monitorizar a cobertura e para acompanhar as famílias que foram visitadas, as pessoas ausentes no domícilio famíliar e outros dados. • informações sobre a área: - mapas indicando as estradas principais, aldeias, vilas e bairros; - infra-estruturas na área (por exemplo, disponibilidade de água, electricidade, combustível); - localização das unidades de saúde e áreas de abrangência; - áreas ou população que são de difícil acesso por causa da geografia, clima, falta de segurança ou razões culturais e soluções sugeridas para as alcançar; - local onde os medicamentos e outros materiais serão armazenados e depois posicionados previamente para distribuição; e - distâncias e tempos de viagem da área central para cada comunidade, aldeia ou bairro, estruturas sanitárias, locais de armazenamento e locais de distribuição (para estratégia centralizada, de local fixo) e as condições das estradas; • calendarização da AMM no distrito: especificar, de preferência, os dias e horas para determinadas ruas ou bairros para que as pessoas se organizem para estar em casa; • estratégias de execução (centralizada, de local fixo ou porta-a-porta); • recursos humanos e formação: - lnúmero de pessoas que devem ser abrangidas por cada equipa de distribuidores (distribuição porta-a-porta ou centralizada, de local fixo); - número de equipas necessárias para cobrir todas as comunidades no distrito; - número de equipas por supervisor ; - número de supervisores necessários por distrito; - recursos humanos disponíveis no distrito; - número de equipas e supervisores que podem ser reunidos por sessão de formação; e o número de dias necessários para formar o pessoal. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 21 • informações de logística: - se for decidida a distribuição centralizada, de local fixo, o número e os locais de distribuição, população por local, equipas por local, etc.; - áreas onde o pessoal pode passar a noite; - número de veículos necessários para o transporte de equipas e supervisores e número de veículos disponíveis localmente; - quantidade de combustível necessário para o transporte; - quantidade de material necessário por equipa; e - material necessário para a formação; • um plano de mobilização social e de comunicações; e • um plano de farmacovigilância: - formação de TCS e voluntários comunitários; - calendarização das visitas de acompanhamento activo (3-7 dias), dependendo do perfil de segurança dos medicamentos; - número e localização das unidades de saúde que proporcionarão o tratamento de emergência para quaisquer efeitos secundários; - encaminhamento às unidades de saúde para o tratamento de ocorrências adversas graves; - distribuição e conclusão dos formulários de notificação e relatos de RAM nas unidades de saúde; e - notificação e comunicação com os intervenientes. Ver Anexo 5 para um exemplo de um micro plano utilizado na Serra Leoa em 2014-2015 para AMM contra o paludismo durante o surto de DVE. 2.2.2 Logística Fornecimento e gestão de estoque Quando o medicamento antipalúdico encomendado para a campanha de AMM for recebido no país, deve ser guardado num armazém central ou instalação de armazenamento, que deve ser num local acessível, com condições de temperatura e humidade adequadas e bem protegidas. Outros materiais essenciais para a campanha (como copos, açúcar, almofariz ou trituradores de comprimidos, artigos de papelaria, sabão, megafones, corda, vedações) devem ser mantidos no mesmo local. É fundamental estimar o volume do medicamento (ver Anexo 3) e outros materiais logísticos com antecedência para assegurar a capacidade de armazenamento suficiente. O medicamento antipalúdico deve ser armazenado de acordo com apresentação (embalagens específicas por idade), número de lote e data de validade. Um cartão de estoque deve ser elaborado para cada item no armazém para controlar as quantidades e garantir a rastreabilidade. Os cartões de estoque do medicamento antipalúdico devem incluir a denominação comum internacional (sem marcas) e a dosagem. Os medicamentos antipalúdicos e outros materiais logísticos serão distribuídos do nível central ao distrital, onde o armazenamento centralizado intermédio pode ser necessário, que deve estar em conformidade com as mesmas indicações. 22 Posicionamento prévio dos fornecimentos Os medicamentos antipalúdicos e outros elementos de logística para distribuição devem ser previamente posicionados nos pontos de distribuição de acordo com o micro plano (por exemplo, unidades de saúde periféricas) antes da AMM ser lançada. Por conseguinte, o estoque de cada ponto de distribuição deve ser preparado no armazém central antes da entrega. Os formulários pré-impressos de encomenda e entrega devem ser disponibilizados. Toda a circulação de medicamentos entre indivíduos ou organizações deve ser documentada, e cópias assinadas devem ser guardados para futura referência. Ver Anexo 6 para um procedimento passo a passo para o posicionamento prévio de suprimentos. Transporte Transporte seguro é essencial para todas as actividades. O número e tipo de veículos dependem de: • a estratégia escolhida (distribuição porta-a-porta ou centralizada, de local fixo), • a duração da campanha, • o número de equipas de distribuição ou pontos de distribuição (se centralizada, local fixo), • o número de supervisores, • se a área é urbana ou rural, • o plano de mobilização social e • o sistema de abastecimento. Motocicletas, bicicletas, barcos podem ser necessários em alguns contextos. Durante o transporte, os medicamentos devem ser protegidos de intempéries como chuva e luz solar. É essencial verificar a disponibilidade local de veículos e combustível. Se os carros estiverem disponíveis, devem ser avaliados de acordo com: • tipo, dimensão e condição; • tipo de combustível e consumo; e • as condições de empréstimo ou aluguer (com ou sem condutor, custo, seguro, etc.). Uma pessoa deve ser responsável pelo seguimento de todas as questões relacionadas com o transporte, que é um potencial alvo de fraude e/ou roubo. Acessibilidade Os meios para atingir toda a população elegível devem ser avaliados cuidadosamente, abrangendo: • a rede de estradas e o estado das estradas, • distâncias e tempos de viagem para os diferentes locais e • estradas com acesso limitado ou interrompido durante a estação chuvosa e alternativas para alcançar as populações. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 23 Populações “difíceis de alcançar” incluem não só as populações em áreas remotas com estradas pouco acessíveis, mas também as isoladas devido à falta de segurança ou restrições sociais. Para garantir que essas populações sejam abrangidas, abordagens como a atribuição de equipas especificamente para essas áreas ou prorrogação da duração da campanha poderão ser consideradas. Locais de distribuição para distribuição centralizada, de local fixo Os locais devem ser escolhidos e preparados com antecedência. Devem ser seleccionados em colaboração com as autoridades locais e idealmente devem ter as seguintes características: • facilidade de acesso; • serem bem conhecidas da população; • Possibilidade de criação de um fluxo de pessoas num só sentido (pontos de entrada e de saída), para facilitar a circulação; • suficientemente grande para trabalhar de forma confortável, mas não demasiado grande que seja difícil de gerir; e • uma grande área de espera sombreada. Os possíveis locais podem ser escolas, centros religiosos (igrejas, mesquitas, templos) ou edifícios administrativos nas áreas urbanas; e, se não houver edifícios adequados, espaços públicos abertos ou abrigos temporários, incluindo tendas, nas áreas rurais. Se o teste de gravidez de mulheres em idade reprodutiva for necessário antes da administração do medicamento de AMM, o local de distribuição deve ter também casas de banho e espaços privados onde o teste pode ser realizado e os resultados comunicados a título particular. Os locais não devem ser instituídos nas estruturas de saúde, para não interromper as actividades normais. Gestão de resíduos Resíduos serão produzidos durante uma campanha de AMM, e a recolha e a eliminação de resíduos devem ser consideradas na fase de planeamento. Os resíduos serão constituídos quase inteiramente de resíduos comuns não perfurantes ou contaminados, nomeadamente embalagens, copos descartáveis (se utilizados) e testes de gravidez, se realizados. Para campanhas de distribuição porta-a-porta, o lixo pode ser tratado a nível doméstico ou comunitário, se existirem sistemas adequados de eliminação de resíduos. Caso contrário, os distribuidores devem recolher o lixo e levá- lo para o ponto de distribuição, onde deverá ser incinerado. A decisão de tratar os resíduos a nível comunitário ou de os centralizar nas unidades de saúde deve ser orientada pelo contexto local. Para campanhas de distribuição centralizada, de local fixo, os resíduos podem ser eliminados no local de distribuição ou ser transportados para um local central (por exemplo, unidade de saúde). 2.2.3 Recursos humanos Uma AMM exigirá um número significativo de funcionários especializados. O número de equipas necessárias e sua composição dependerá de: • a duração prevista da campanha, • o sistema de distribuição (porta-a-porta ou centralizado, local fixo), • a população-alvo, • a área específica e a sua acessibilidade, 24 • o desempenho esperado de cada equipa (número de pessoas tratadas por dia), • formulários de dados a serem preenchidos e • outras intervenções adicionais. Composição da equipa Como o medicamento antipalúdico é dado por via oral, não será necessário um grande número de profissionais de saúde qualificados. O número de trabalhadores de saúde qualificados retirados das estruturas de saúde deve ser reduzido, com vista a perturbar o mínimo possível as actividades de saúde regulares. Um recenseamento de todos os recursos humanos existentes localmente deve ser realizado durante o micro-planeamento. Se existir uma rede de TCS ou de voluntários, devem ser envolvidos na entrega de medicamentos, uma vez que conhecem o ambiente local, falam a língua local e estão familiarizados e têm a confiança da população. Se não for este o caso, ou não houver um número suficiente de funcionários de acordo com a estimativa, os voluntários podem ser seleccionados a partir, por exemplo, das organizações da sociedade civil, organizações não governamentais, sociedades da Cruz Vermelha ou do Crescente Vermelho, escolas, associações juvenis, e escolas de enfermagem. Se possível, os voluntários que servem como distribuidores devem representar a demografia da comunidade. Na selecção de voluntários para a distribuição do tratamento ou realização da mobilização social, os líderes comunitários locais devem ser consultados, uma vez que podem ajudar a identificar as pessoas que são bem conhecidas, reconhecidas e respeitadas pela comunidade. Cada membro da equipa deve ter uma descrição das funções, para que cada um entenda claramente o seu papel e responsabilidades e os dos outros membros. Equipa de distribuição Estratégia porta-a-porta. Convém que as equipas sejam constituídas por dois TCS ou distribuidores voluntários, se possível da mesma aldeia: um para fornecer informações e administrar o tratamento e o outro para gravar as informações necessárias sobre as ferramentas adequadas de recolha de dados. Se forem previstos testes de gravidez, pelo menos um dos TCS deve ser do sexo feminino. Distribuição centralizada, de local fixo. As equipas serão constituídas por: • 1 agente de triagem para verificar a elegibilidade, • 1 trabalhador do sexo feminino para realizar os testes de gravidez (se forem previstos na campanha) • 2-3 agentes de registo (se um cartão de AMM for emitido para cada um dos beneficiários ou um outro sistema de registo for utilizado), • 2-3 distribuidores de medicamentos, • 2-3 agentes de gravação para preencherem uma folha de controlo (juntamente com o distribuidor de medicamentos), • 1 profissional de cuidados de saúde para avaliar e tratar ocorrências adversas, • 1 funcionário de sensibilização ou de informação, • 1 empregado de limpeza e • vários controladores e pessoal de segurança. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 25 Equipa de supervisão Os supervisores devem ser pessoal de saúde, de preferência da mesma área de abrangência. Estratégia porta-a-porta: • A supervisão directa de equipas é difícil, e um grande número de supervisores podem ser necessários para assegurar a qualidade. • Cada supervisor deverá ser responsável pela supervisão de até cinco equipas numa área. Distribuição centralizada, local fixo • O número de supervisores dependerá da possibilidade de gerir vários locais. • Nas áreas urbanas, um supervisor poderá visitar até três locais por dia. • Nas zonas rurais, um supervisor poderá visitar apenas um ou, no máximo, dois locais por dia. Deve haver também um supervisor de logística para gerir a organização dos locais, transporte, fornecimento, etc. O número estimado de pessoas tratadas por equipa por dia (a ser adaptado para cada cenário) Estratégia porta-a-porta. A produção diária das equipas dependerá da densidade populacional. Nas áreas urbanas, uma equipa poderá distribuir medicamentos para um máximo de 75-100 pessoas por dia (média de 15-20 domícilios familiares de cinco pessoas, visitas com a duração de 15-20 minutos por domícilio). Nas áreas rurais, onde a população é mais dispersa, uma equipa poderá distribuir medicamentos para um máximo de 50-75 pessoas (10-15 domicílios) por dia, tendo em conta o tempo de transferência e comunicação às famílias individuais. Uma abordagem utilizada em várias campanhas orientadas para um grande número de pessoas tem sido dividir a população em pequenas unidades e designar cada unidade a uma equipa de distribuição (4). Estratégia centralizada, de local fixo. Uma equipa poderá distribuir medicamentos para um número estimado de 400-500 pessoas por dia. Como é provável que essa estratégia perca uma proporção mais elevada da população do que a distribuição porta-a-porta, actividades especiais são necessárias para mobilizar e garantir a participação da população. A produção diária das equipas também irá depender de se os cartões de AMM forem emitidos para os participantes ou um livro de registo for concluído, o que é mais demorado. Dependerá também do contexto local e experiência anterior em actividades semelhantes. Equipas específicas poderão ser consideradas para distribuição nas escolas, prisões, campos militares e orfanatos e, talvez, para as principais empresas locais, como fábricas, minas e plantações. Formação A formação do pessoal é uma componente essencial da fase de preparação. Todos os participantes na AMM devem tomar parte nas sessões de formação, incluindo coordenadores, supervisores, distribuidores, agentes mobilizadores comunitários, técnicos de logística e quaisquer outros funcionários. A formação deve ser proporcionada a níveis nacional, regional, distrital e sub-distrital. O plano deve abranger os objectivos, que devem ser definidos para cada aspecto; a duração da formação; o número de participantes; os conteúdos e métodos, materiais de formação e uma avaliação (por exemplo, pré e pós-teste). A formação deve proporcionar a cada membro da equipa e supervisor o mínimo de informações necessárias para realizar a sua tarefa de forma 26 adequada. A formação deve ser programada o mais próximo possível da data de implementação, garantindo, no entanto, que todas as equipas tenham sido formadas até o momento em que a distribuição começa. Todas as equipas devem receber formação de forma uniformizada. Se muitos parceiros forem envolvidos, todos devem proporcionar a mesma formação para evitar quaisquer variações que poderão confundir os formandos e conduzir a erros na administração de medicamentos. A formação deve incluir: • descrição da AMM; • objectivo da AMM; • onde e quando a AMM será realizada; • a estratégia de distribuição: porta-a-porta ou centralizada, local fixo; • protocolo de tratamento e administração, incluindo possíveis efeitos secundários e contra-indicações; • critérios de inclusão e exclusão; • Execução de testes de gravidez e comunicação confidencial dos resultados (se aplicável); • TDO; • composição da equipa; • funções e responsabilidades de todos os membros da equipa; • metas diárias previstas e cobertura global a atingir; • acesso aos medicamentos e outros materiais; • aspectos práticos relacionados com a distribuição; • notificação e gestão dos efeitos secundários e ocorrências adversas graves; • informação, educação e comunicação e envolvimento com a comunidade; • lidar com rumores e quaisquer preocupações ou dúvidas na população-alvo; • ferramentas de recolha de dados: folhas de controlo, fichas de síntese, livros de registo, formulários de referência, formulários de relatórios de RAM; • procedimentos de notificação; • planos de contingência para situações imprevistas; • gestão de estoques de medicamentos e outros artigos; • gestão de resíduos; • logística; • questões administrativas (p. ex. incentivos e salários); • supervisão e resolução de problemas (para supervisores); e • medidas especiais (p. ex. “política de não tocar” ou exposição acidental como no surto de DVE). AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 27 Os planos de formação devem ser adaptados à estratégia de execução (porta-a-porta ou centralizada, local fixo) para garantir que as equipas estejam bem preparadas. Descrições de funções e quaisquer outros documentos de referência ou orientações podem ser distribuídos durante a formação, depois de terem sido discutidos com os participantes. Os métodos utilizados durante a formação podem incluir encenação, demonstrações práticas, estudos de casos e simulações, de preferência com o material e equipamento a ser utilizado, a fim de abranger todos os pormenores e corrigir qualquer mal-entendido. Prever dificuldades e respostas nestes cenários é uma parte fundamental da formação. Uma forma eficaz de formar muitas pessoas rapidamente é a formação em cascata, em que certas pessoas recebem a formação de formadores, e cada um, por sua vez, proporciona o mesmo curso de formação aos outros. Mais do que um nível de cascata deve ser evitado. A supervisão deste sistema de formação é importante para garantir que a informação a ser transmitida é exacta e as mensagens não estão a ser alteradas à medida que são transmitidas. O fornecimento de material de formação adequado, supervisão cooperativa e avaliação meticulosa irão garantir que as competências em que os distribuidores foram formados são aplicadas de forma adequada. Salários e ajudas de custo A AMM em grande escala envolve um número significativo de pessoas que estão amplamente distribuídas geograficamente; devem ser compensadas com precisão e de uma forma oportuna. O pagamento de salários e/ou incentivos, ajudas de custo e subsídios de alimentação e de transporte devem ser claramente discutidos com todos os funcionários envolvidos na distribuição para evitar confusão e desmotivação. Os TCS e os voluntários que não estão satisfeitos com a sua posição e recompensa podem comprometer a campanha. É essencial determinar a forma como o dinheiro será transportado e gerido em vários níveis, para assegurar que cada pessoa receba o pagamento correcto, ao mesmo tempo, garantir a transparência e evitar oportunidades de roubo ou corrupção. As opções de pagamento são a descentralização para autoridades distritais, através de bancos ou “terceirização” de pagamentos. Os programas de controlo do paludismo podem já ter experiência relevante durante a distribuição de redes mosquiteiras tratadas com insecticida de longa duração e campanhas de pulverização residual interior. Quando muitos parceiros são envolvidos, a harmonização do pagamento às equipas é fundamental. Um método inovador é o uso de telemóveis, como utilizado na Serra Leoa. Embora algumas dificuldades técnicas fossem enfrentadas por causa da dimensão da transacção e o facto de que era a primeira vez que a companhia telefónica tinha lidado com essa operação, mais de 6000 pessoas foram pagas com este método de forma oportuna, transparente, sem ter de se reunir para pagamento e eliminar os riscos de segurança inerentes que a circulação de grandes somas de dinheiro acarreta (10). 2.2.4 Participação da comunidade, mobilização social e comunicação Um dos principais determinantes do sucesso da AMM para o paludismo é a garantia de elevada cobertura da população-alvo e boa adesão ao tratamento, os quais dependem da vontade das pessoas de tomar o medicamento (3,4,24). Muitas pessoas assintomáticas, saudáveis serão solicitadas a tomar uma medicação, expondo-as a reacções adversas. Assegurar o cumprimento requer criar compreensão mútua e confiança nas instituições de execução da campanha. O envolvimento da comunidade é um factor essencial no sucesso da AMM, para obter a desejada participação e adopção dos medicamentos. Concepções errôneas, no seio da população elegível, sobre o tratamento a ser administrado, o seu risco para a doença, efeitos secundários e a necessidade de intervenção, mesmo nas pessoas que não estão doentes, contribuem para a não participação (24,25). Comunicação e mobilização 28 social eficazes são, por conseguinte, essenciais para uma campanha de AMM bem sucedida (26). Um plano de comunicação deve ser elaborado e aprovado pelo ministério da saúde e outros intervenientes sobre estratégias para atingir o público-alvo. As etapas na preparação de um plano de comunicações são: • Definir as funções e responsabilidades de cada parceiro. • Realizar uma avaliação da comunidade. • Preparar mensagens claras, simples, precisas e consistentes sobre AMM para o paludismo. • Envolver os meios de comunicação social. • Envolver a comunidade. Funções e responsabilidades A nível nacional: • Planear a advocacia, comunicação, mobilização social e participação comunitária. • Desenvolver uma ferramenta para a avaliação da comunidade. • Elaboração de mensagens-chave. • Coordenar as actividades • Realizar reuniões de advocacia com os intervenientes, incluindo o sector privado, a nível nacional. • Realizar uma sessão de informação com os órgãos de comunicação, com um lançamento oficial, e identificar indivíduos modelos na sociedade que estão dispostos a tomar a primeira dose publicamente. • Participar em discussões sobre painel de rádio e televisão nacional. • Produzir e divulgar anúncios da campanha nas principais línguas faladas nas áreas visadas. • Produzir material de informação, educação e comunicação, como faixas, folhetos e fichas de informação. • Monitorizar os meios de comunicação social durante a campanha. A nível distrital: • Realizar avaliação da comunidade. • Divulgar mensagens o mais amplamente possível. • Realizar reuniões de advocacia com as principais partes interessadass na comunidade, como, por exemplo, líderes comunitários, autoridades administrativas, líderes religiosos, grupos da sociedade civil e outras associações ou grupos (mulheres, jovens) e curandeiros tradicionais. • Organizar sessões para sensibilizar o sector privado, escolas, etc. sobre o potencial do absentismo dos trabalhadores e dos estudantes durante a campanha. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 29 • Identificar potenciais participantes na comunidade. • Difundir anúncios nas rádios locais. • Participar nos painéis de discussão nas estações de rádio locais. • Enviar veículos com altifalantes para fazer anúncios sobre a campanha da AMM a cada aldeia. A nível comunitário: • Realizar debates com os chefes e líderes religiosos em cada aldeia sobre a campanha. • Divulgar mensagens através de canais apropriados. • Identificar e formar os TCS para realizar acções de sensibilização de rua a rua e de casa em casa nos dias que precedem a distribuição. • Organizar sessões de sensibilização de grupos nas comunidades, com a participação de pessoas-chave. • Organizar anúncios através de um pregoeiro público ou um veículo com um altifalante durante os dias anteriores e posteriores à distribuição. Avaliação da comunidade Antes do planeamento da AMM, uma rápida avaliação e identificação de grupos comunitários em áreas específicas devem ser feitas para a obtenção de informações qualitativas, como: • estruturas sociais na comunidade; • especificidades e costumes culturais; • Poder de decisão sobre a saúde nas famílias; • papel dos líderes tradicionais, incluindo líderes comunitários e religiosos; • comportamento considerado aceitável para os homens e para as mulheres; • comportamentos saudáveis, incluindo conhecimentos gerais sobre a paludismo; • papel de medicina tradicional e curandeiros tradicionais; • aceitação da medicina alopática • utilização dos meios de comunicação social; • familiaridade e compreensão de cartazes, brochuras e faixas publicitárias; • alfabetização; • línguas faladas; • percepção de e vontade de participar neste tipo de intervenção; e • quaisquer preocupações, que serão abordadas durante a campanha de sensibilização, Esta avaliação pode evitar equívocos culturais que poderiam ameaçar o sucesso da campanha. Ensinamentos úteis podem ser extraídos da experiência anterior na AMM e actividades semelhantes. 30 Principais mensagens sobre a AMM para o paludismo As mensagens a serem elaboradas incluem: • O que: informações gerais sobre o paludismo e sobre a campanha, realçando que o paludismo pode ser assintomático e que as pessoas podem ser infectadas sem perceber isso, e destacando o papel de portadores assintomáticos na transmissão do paludismo • Por que: a finalidade e os benefícios do tratamento de pessoas que não se sentem doentes e a importância de não guardar o medicamento para uso posterior • Quando: datas de distribuição e o número de rondas • Onde: porta-a-porta ou centralizada, locais fixos • Quem: área geográfica e critérios de elegibilidade, com especial ênfase para a necessidade de excluir as mulheres no primeiro trimestre de gravidez e explicar o método de triagem que será utilizado (entrevista e/ou teste de gravidez) e garantir que será feito de forma confidencial. • Como: dosagem e duração do tratamento, adesão ao tratamento • Possíveis efeitos secundários: para evitar equívocos e receio, possíveis efeitos secundários devem ser descritos, com a garantia de uma gestão adequada de qualquer que surgir • Importância da continuação e reforço de outras medidas preventivas do paludismo (p. ex., uso de redes mosquiteiras tratadas com insecticida de longa duração) • Mensagens contexto específicas: poderão ser elaboradas para cada recomendação da OMS para a AMM durante uma epidemia de paludismo ou uma emergência complexa, como um surto de DVE. Envolver os meios de comunicação social Geralmente, os interlocutores devem ser identificados no ministério da saúde e outros parceiros credíveis e respeitados que são capazes de lidar com entrevistas desafiadoras onde serão feitas perguntas constrangedoras e inoportunas. Tópicos devem ser preparados para falar e colaborar com os meios de comunicação, evitando o uso de siglas ou vocabulário científico que o público não irá entender. Devem ser construídas relações com os representantes dos meios de comunicação locais para assegurar que proporcionem uma boa cobertura de notícias; elesdevem ser contactados regularmente, não apenas em resposta a uma situação crítica. A campanha deverá ser iniciada com uma cerimónia de abertura coberta pelos meios de comunicação, em que pessoas influentes, como altas autoridades administrativas e celebridades participam e tomam uma dose do medicamento como um exemplo para o resto da comunidade. Os métodos que podem ser utilizados para divulgar informações e promover uma campanha da AMM incluem rádio, televisão, jornais, painéis, sites de notícias online, meios de comunicação social, telemóveis e jogos. A rádio é amplamente disponível e muito popular nas áreas rurais nos países onde o paludismo é endémico e deve ser uma prioridade para a circulação de informações por meio de anúncios radiofónicos, debates de grupos na rádio, em que os membros da comunidade colaboram com os funcionários de saúde da campanha, e o desempenho dos membros da comunidade falando sobre a distribuição para difundir informações sobre a finalidade, localização e oportunidade de AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 31 AMM e para discutir as vantagens da participação e possíveis efeitos secundários. A rádio também permite que os ouvintes telefonem e façam perguntas ao vivo. Os anúncios radiofónicos (ver Anexo 7) também podem ser utilizados. A rádio também pode ser um poderoso método, se o micro planeamento for bom, para divulgar informações sobre os dias e as horas previstas de visitas das equipas de distribuição por rua ou bairro ou, no caso de distribuição centralizada, de local fixo, localização e dias. Anúncios televisivos e programas com participação directa dos ouvintes por telefone com os principais intervenientes podem ser influentes. Mensagens dos meios de comunicação devem abordar quaisquer preocupações e dúvidas locais identificadas nas campanhas anteriores ou durante a fase de avaliação. O testemunho pessoal de pessoas que já tenham tomado a medicação previamente é valioso. Os relatórios sobre os progressos deverão ser enviados aos meios de comunicação social durante a campanha. Combatendo boatos negativos Boatos infundados ou notícias negativas podem circular, dissuadindo as comunidades de participar na AMM. Casos aleatórios de doenças graves ou mortes não relacionadas na comunidade podem ser atribuídos ao tratamento antipalúdico e reduzir a confiança do público na campanha. Um plano deve ser elaborado com antecedência para suprimir esses boatos rapidamente de uma forma prudente e neutra para tranquilizar a população. As equipas de distribuição e os supervisores devem sistematicamente recolher informações sobre os boatos e sobre as perguntas que são muitas vezes feitas nas reuniões com os intervenientes e grupos comunitários e em programas de rádio e televisão. A reportagem dos meios de comunicação social deve ser cuidadosamente monitorizada para detectar qualquer cobertura negativa rapidamente e reagir em conformidade. Se uma relação de confiança for estabelecida com os meios de comunicação, terão mais possibilidades de ouvir todos os lados antes de relatar informações falsas. Envolvimento da comunidade O envolvimento da comunidade nas fases iniciais de planeamento é um elemento-chave para o sucesso de uma AMM, para que se apropriem da implementação e do sucesso da campanha. As pessoas a envolver são: • líderes comunitários e outros membros influentes, • líderes políticos, • conselheiros e autoridades locais, • líderes religiosos (sacerdotes, imãs, monges), • professores das escolas, • celebridades, • outros grupos locais (jovens, mulheres), • trabalhadores de saúde ou voluntários locais, • pessoal de cuidados de saúde (para responder às questões e preocupações), • curandeiros tradicionais e 32 • Proprietários de farmácias privadas e vendedores de medicamentos (que poderão interferir na actividade). A cooperação com os líderes e outros membros influentes da comunidade é fundamental para a obtenção de bons resultados, porque com seu status de decisores poderão tornar-se promotores eficazes dos benefícios de participar na campanha; contudo, devem estar bem informados. Qualquer parecer negativo sobre a intervenção irá ter um impacto significativo sobre os resultados. Podem proporcionar organizadores com informações úteis sobre o melhor momento para a campanha, sugerir as pessoas que devem ser incluídas nas sessões de sensibilização e como as sessões devem ser organizadas e identificar potenciais distribuidores que são bem conhecidos e respeitados pela comunidade. Ver Anexo 8 para uma lista de tópicos que poderia ser utilizada nas reuniões comunitárias. A mobilização social As sessões de mobilização social de grupos na comunidade podem ser utilizadas para fornecer informações, permitir que os membros da comunidade façam perguntas e estabelecer a confiança entre a população e o pessoal da campanha. Deverá ser dada prioridade às populações menos privilegiadas e de locais de difícil acesso, e o programa, se necessário, deve ser adaptado ou intensificado para esses grupos. Outras abordagens eficazes são teatro de rua, música, arte e outras actividades culturais. Materiais de comunicação devem ser impressos nas línguas locais e adaptados ao nível de alfabetização da comunidade. Poderão incluir, folhetos, cartazes, calendários, faixas publicitárias, braçadeiras, t-shirts e bonés. Megafones ou pregoeiros oficiais podem também ser utilizados As actividades de mobilização social devem ser realizadas nos centros religiosos, escolas, cinemas e outras áreas de lazer e locais onde as pessoas se reúnem para outros fins, como paragens de autocarro e salões de cabeleireiros. As actividades nas diversas fases de mobilização social e comunicação são indicadas a seguir. Antes da campanha: • De preferência, pelo menos um mês antes da administração do medicamento (dependendo da definição e contexto): informações sobre a AMM, os benefícios da campanha, a importância da participação, etc. • Na semana antes da distribuição: intensificação da campanha de sensibilização, com ênfase nos aspectos práticos de iniciar a campanha e lembretes para a população sobre os dias e a localização. Antes de a distribuição ser iniciada, várias famílias devem ser visitadas para verificar se as pessoas estão cientes das datas e estão dispostas a participar, para que os ajustamentos de última hora possam ser feitos para actividades de sensibilização. Durante a distribuição: • A mobilização social deverá concentrar-se no incentivo à participação e promoção da adesão ao tratamento. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 33 • As mensagens da mobilização comunitária devem ser adaptadas de acordo com os contributos de observação contínua pelos não participantes das reacções das pessoas durante a AMM. Se a AMM for realizada durante a estação chuvosa, os moradores das zonas rurais podem preferir não participar na campanha por causa das actividades agrícolas, ou porque tenham de viajar para fora da área elegível para terem acesso aos seus campos ou porque temem que os efeitos adversos possam limitar a sua capacidade de trabalho e, assim, sustentar as suas famílias. Esta questão deve ser abordada no plano da comunicação para prevenir ou minimizar a recusa. Durante a distribuição, a percepção geral e os comentários da população em relação à campanha de AMM devem ser monitorizados para detectar eventuais problemas, que devem ser tratados rapidamente. Os líderes comunitários poderão assinalar percepções negativas para as equipas de distribuição ou identificar áreas ou bairros que não foram abrangidos de forma adequada. Após a AMM ser concluída: • As comunidades devem ser informadas dos resultados através de plataformas locais apropriadas, como rádio, cartazes e TCS. • Grupos ou representantes da AMM devem permanecer nas comunidades específicas por algum tempo após a conclusão da AMM para identificar e resolver os rumores, preocupações ou outros problemas que possam afectar futuras rondas de AMM ou outras intervenções em matéria de saúde. 2.3 IMPLEMENTAÇÃO A distribuição de medicamentos antipalúdicos só deve ser iniciada se: • os medicamentos e todos os outros materiais (como descritos a seguir) estiverem no local; • material de supervisão estiver disponível (ver secção 2.3.3); • as equipas estão formadas (ver secção 2.2.3); • a logística está pronta (ver secção 2.2.2); • a população foi informada sobre os pormenores da campanha (ver secção 2.2.4) e • a farmacovigilância, incluindo a gestão de RAM, está planeada (ver secção 3.4). 2.3.1 Gestão de estoque Kits de distribuição devem ser preparados com antecedência no ponto de distribuição ou na unidade de saúde periférica onde os suprimentos estarão previamente distibuidos. Diferentes kits devem ser preparados para os distribuidores e supervisores. As quantidades nos kits devem ser adequadas para o número de pessoas que devem ser alcançadas por dia. Material necessário por grupo de distribuição Para estratégia de porta-a-porta (com TDO): Devem ser concedidos os seguintes materiais a cada equipa de distribuidores no início da campanha: • mochilas (1 por TCS) 34 • almofariz ou triturador de comprimidos (para triturar comprimidos para crianças) • pranchetas • canetas • crachá de identificação do pessoal, t-shirt ou braçadeira • material de higiene (sabão) • giz para marcar as casas • Bloco para anotar qualquer questão • Material impresso de informação, educação e comunicação (desenhos de dosagens específicas por idade, adesão ao tratamento, ocorrências adversas previstas, uso de redes mosquiteiras tratadas com insecticida de longa duração) • Guarda-chuvas ou vestuário para a protecção contra a chuva O resto do material deve ser fornecido diariamente de acordo com o consumo e o estoque restante: • O número de embalagens de tratamento para atingir a meta do dia (incluindo estoque de segurança) • Os kits de teste de gravidez e recipientes para análise de urina, se os testes de gravidez forem ser realizados • Solução açucarada para crianças se medicamentos com um gosto amargo forem utilizados • material de documentação: Cartões de AMM, livro de registo, folhas de controlo, formulários de encaminhamento • sacos para recolha de resíduos Para distribuição centralizada, de local fixo: Para além do acima exposto, devem ser considerados os seguintes: • mesas e cadeiras • cordas ou vedações e postes • rede de protecção e/ou lonas de plástico • baldes de lixo • recipientes de água potável • balanças • copos descartáveis ou reutilizáveis (se forem implementadas medidas de higiene rigorosas) • material de higiene (sabão e outros materiais de limpeza) • carimbo de datas e tinta • painéis de identificação para local de distribuição AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 35 Material necessário para kits dos supervisores • pranchetas e canetas • material de identificação, p, ex. camisas, braçadeiras • lista de verificação de supervisão, ficha de síntese diária, formulários de relatório de RAM, formulários de encaminhamento • bloco para anotar qualquer questão. Para distribuição porta-a-porta, as equipas de distribuição devem recolher o material no ponto de distribuição ou na unidade de saúde em que é colocado todas as manhãs, certificando-se de que todos os suprimentos necessários foram embalados. No final do dia de distribuição, o estoque remanescente deverá ser devolvido ao ponto de distribuição, onde um inventário é feito e registado. Toda a circulação do medicamento antipalúdico e outros suprimentos deve ser registada pela pessoa responsável pela gestão das existências. Os kits devem então ser reabastecidos como preparação para o dia seguinte. Se uma equipa ou um local necessitar de mais suprimentos por causa da escassez, a pessoa responsável pela logística deve ser contactada para providenciar o transporte, e a circulação deve ser claramente documentada para garantir a precisão da responsabilização. No final de cada ronda de distribuição, o restante estoque de medicamentos e outros artigos devem ser contabilizados e comunicados a níveis distrital, regional e nacional. Os materiais devem ser armazenados correctamente para a próxima ronda, e o medicamento antipalúdico e outros suprimentos devem ser solicitados para a próxima ronda. Depois de ser concluída a última ronda, as restantes doses devem ser devolvidas a nível distrital ou nacional, onde o armazenamento adequado deve ser assegurado. As datas de validade devem ser verificadas. Todos os outros materiais logísticos devem ser contabilizados e também devolvidos ao nível central. 2.3.2 Distribuição do medicamento antipalúdico A distribuição efectiva de medicamentos dependerá da estratégia de distribuição escolhida. Estratégia porta-a-porta Nas áreas urbanas, pode ser difícil garantir que todos os membros de uma família estejam presentes, esperando a equipa de distribuição durante a campanha. Por conseguinte, recomenda- se que as famílias sejam informadas da data e da hora aproximada em que a equipa de distribuição irá visitá-las. O horário de visitas deve ser flexível, a fim de aumentar as oportunidades de encontrar as pessoas em casa. De acordo com o contexto, as visitas devem ser feitas no início da manhã ou à noite para os agricultores, ou ao meio-dia para os trabalhadores. Os distribuidores devem seguir as etapas abaixo indicadas quando visitam cada família (ver também o Anexo 9): • Cumprimentar os residentes de forma educada na sua língua, e apresentar-se. • Perguntar pelo chefe de família, e verificar se todos os membros da família estão presentes. • Explicar os objectivos e fornecer informações sobre a campanha. Equipas de distribuição devem ter recursos de ajuda visuais para transmitir as principais mensagens traduzidas nas línguas locais. 36 • Obter consentimento oral para participar. • Verificar os critérios de elegibilidade Qualquer pessoa que preencher qualquer dos critérios de exclusão (primeiro trimestre de gravidez, criança < 6 meses de idade, alergia conhecida a medicamentos, gravemente doente ou que apresenta contra- indicações à medicação) deve ser informada por que razão não lhe será concedido o tratamento. O Anexo 10 apresenta um algoritmo que poderá ser utilizado pelos TCS para a aplicação dos critérios de exclusão. • Os indivíduos que estão gravemente doentes, por exemplo, crianças com sinais de perigo, devem ser excluídos da AMM e ser encaminhados para a unidade de saúde mais próxima. Todos os outros pacientes devem primeiro receber o tratamento antipalúdico no âmbito da AMM e, em seguida, serem encaminhados a uma unidade de saúde para avaliação completa. • Uma agente sanitária deve falar com todas as mulheres em idade reprodutiva (15-49 anos) sozinha, num ambiente privado para explicar que TCA não são recomendadas no primeiro trimestre de gravidez e devem também determinar o estado de gravidez com base nos antecedentes pessoais ou num teste de gravidez (ver Anexo 11 sobre um algoritmo para determinar a gravidez nas mulheres em idade reprodutiva). As mulheres que estão visivelmente grávidas (segundo ou terceiro trimestre assumido) podem receber o medicamento. Se a gravidez não for aparente, o TCS pode fazer as seguintes perguntas para ajudar a excluir uma gravidez de primeiro trimestre: - Está grávida? - Acha que poderá estar grávida? - Está a usar algum método de planeamento familiar? Se a mulher não tem certeza do seu estado de gravidez, um teste de gravidez deve ser proporcionado. Se o teste for positivo, considera-se que a mulher está no primeiro trimestre da gravidez e deve ser excluída da AMM. As mulheres que não aceitam fazer um teste de gravidez devem ser advertidas dos riscos e benefícios de receber TCA no primeiro trimestre e é-lhes concedida a opção de tomar ou de recusar o tratamento. Entrevistar as raparigas adolescentes sobre gravidez pode representar uma questão ética, uma vez que o consentimento dos pais pode ser necessário e é um assunto de forte sensibilidade cultural. Procedimentos adequados devem ser definidos em colaboração com o programa nacional de saúde reprodutiva. • Distribuir uma embalagem apropriada para a categoria etária. A primeira dose deve ser administrada nos termos do TDO. Se uma criança não for capaz de engolir um comprimido, o distribuidor deve ensinar o cuidador como triturar o comprimido e dissolvê-lo na água e dar a primeira dose à criança. Se o medicamento tiver um gosto amargo, pode-se dar à criança uma pequena quantidade de solução açucarada para a encorajar a tomar o referido medicamento. Se a dose for vomitada (ou rejeitada) no prazo de 30 minutos, a mesma dose deverá ser repetida. Os pais ou responsáveis devem solicitar ao TCS uma outra dose para completar o tratamento. • Ensinar os participantes a tomar as restantes doses (no 2º e 3º dia), salvo se TDO for utilizado para todas as doses. Um cartão laminado com doses de tratamento deve ser utilizado como recurso visual para apoiar as explicações, e folhetos impressos podem ser distribuídos (ver Anexo 12 para o folheto utilizado na AMM na Serra Leoa em 2014-2015). AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 37 • Explicar claramente a importância da adesão ao processo de tratamento completo. Os participantes podem ser aconselhados a guardar as embalagens de comprimidos vazias para avaliação drante a monitorização de pós- distribuição. • Fornecer informações sobre possíveis efeitos secundários e o que fazer se eles ocorrerem, incluindo instruções claras no sentido de contactar os serviços relevantes para assistência ou dúvidas. • Perguntar aos membros da família se têm quaisquer perguntas e esclarecer quaisquer dúvidas que possam ter. • Marcar a folha de controlo (ver secção 2.3.4 e Anexo 13) depois que a pessoa tenha tomado a primeira dose, ou preencher o livro de registo (ver secção 2.3.4 e Anexo 14) e registar as informações necessárias (por exemplo, nome, idade, sexo, endereço, residência, medicação e dose concedida, incluindo se toda a família foi abrangida, ou se ninguém estava casa, e especificar o número em falta. • Quando a equipa de distribuição deixar a casa, podem marcar com giz como “completa” ou “incompleta” de acordo com os membros da família presentes; se ninguém estiver em casa no momento da visita, não se deve marcar. Se a distribuição num domicílio foi incompleta ou ninguém estava em casa, a equipa deve voltar a visitar a casa mais tarde no final do dia ou no dia seguinte. Para simplificar as operações, o medicamento antipalúdico também deve ser dado às pessoas presentes na comunidade, no momento da AMM, que não residem na área (visitantes), desde que não tenham nenhuma contra-indicação. Em algumas situações, como no contexto de eliminação, devem ser registadas separadamente, uma vez que não foram incluídas no cálculo da cobertura. No 2º e 3º dias, assim que os TCS tiverem terminado a distribuição do tratamento diário, deverão regressar às famílias na sua área, a fim de reforçar a sensibilização, promover a adesão ao tratamento e monitorizar as RAM. Distribuição centralizada, de local fixo Todos os locais de distribuição deverão ser identificados na fase de planeamento e deverão ser preparados um dia antes de começar a distribuição. O local deve ser organizado como se segue (Fig. 2): • Recomenda-se a delimitação do local com uma corda ou vedação, e o local deve ser claramente identificado. • Filas de espera devem ser organizadas com corda ou fita de vedação e com a largura suficiente para a passagem de apenas uma pessoa de cada vez. Controladores de multidão podem ser necessários para assegurar um fluxo suave. • Acções de sensibilização devem ser realizadas na área de espera. • As pessoas devem passar por uma área de triagem inicial, onde é verificada a sua elegibilidade. Se forem consideradas elegíveis, seguirão adiante no circuito. Se não, deverão deixar a área após a devida explicação das razões de não-inclusão e registo. • Uma área privada deve ser identificada para o rastreio da gravidez de mulheres em idade reprodutiva como descrito anteriormente. • Se for decidido que cartões de AMM serão entregues aos participantes ou um livro de registo completo (ver secção 2.3.4 e Anexo 14), a próxima etapa será o registo. Como isso pode ser demorado, um número suficiente de funcionários deve ser designado para evitar gargalos e longo tempo de espera. 38 • As pessoas avançarão até o ponto onde irão receber uma embalagem apropriada para a sua categoria de peso ou idade. Os distribuidores do tratamento irão administrar a primeira dose sob observação directa, e informar os destinatários sobre como tomar a medicação no 2º e 3º dias (a menos que TDO para todas as três doses seja feito). • A folha de controlo é preenchida para cada participante depois da distribuição do medicamento. • Uma área de observação pode ser reservada onde as pessoas passam 30 minutos para se certificar que não vomitam e que não surgem ocorrências adversas graves ou ocorrências adversas de especial interesse (ver secção 3.4.1) e onde serão sensibilizadas sobre possíveis efeitos secundários, o que fazer se ocorrerem, a administração de doses restantes e a importância da adesão. • Todas as pessoas doentes que aguardam a distribuição devem ser encaminhadas para a unidade de saúde mais próxima. FIG. 2. Exemplo de layout de um local de distribuição Distribuição de medicamentos posto TDO Distribuição de medicamentos posto TDO Ár ea d e es pe ra c om in fo rm aç õe s ed uc aç ão e c om un ic aç ão Registo Registo Ár ea d e ob se rv aç ão e se ns ib ili za çã o Triagem Folha de controlo Folha de controlo 2.3.3 Supervisão A supervisão é importante para garantir uma campanha de AMM eficaz, eficiente e bem- sucedida. A supervisão deve ser realizada em vários níveis, com linhas de comunicação claramente definidas entre os mesmos. Os supervisores devem ser designados para as equipas de distribuição e a níveis dos distritos, região ou província (quando aplicável). Supervisores e coordenadores nacionais devem também ser disponibilizados. Supervisor de equipas de distribuição As funções e responsabilidades do supervisor da equipa de distribuição são: Antes de distribuição: • Assegurar a recepção e gestão adequadas dos medicamentos antipalúdicos e outros suprimentos no unidade de saúde periférica. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 39 • Verificar se todos os distribuidores são identificados e formados e que as actividades locais são organizadas e coordenadas. • Preparar as agendas diárias das equipas de distribuição. Durante a distribuição: De manhã - Apresentar o micro plano e o plano de trabalho diário de cada equipa de distribuição. - Verificar o atendimento, e encontrar substitutos em caso de ausência. - Garantir que cada equipa tenha os medicamentos e materiais necessários. - Preencher parte da lista de verificação de supervisão. - Fornecer as ferramentas para a recolha de dados diários Durante as horas de distribuição - Visitar equipas de distribuição na suas áreas de supervisão, e proporcionar apoio técnico, quando necessário. - Visitar as famílias de forma aleatória, e entrevistar os membros de comunidades que já receberam o medicamento, para verificar se receberam o medicamento e o que compreenderam sobre a tomada das restantes doses. Final do dia - Reunião com as equipas de distribuição. - Recolher o restante do medicamento e do material (garantir o acompanhamento do estoque, e confirmar o consumo). - Recolher diariamente as folhas de controlo e as análises. - Compilar dados, preencher formulários de resumos diários e informar o supervisor do distrito. - Perguntar sobre qualquer problema encontrado durante a AMM ou ruptura de estoque, e apresentar relatório. - Dar feedback às equipas, corrigir eventuais erros, informá-las sobre o andamento da campanha, e abordar quaisquer preocupações. - Preparar os medicamentos e o material para o dia seguinte. - Concluir a lista de verificação de supervisão. - Relatar ao supervisor do distrito quaisquer dificuldades ou problemas a tratar, rumores e recusa por parte da população. Término da campanha: • Notificar o nível do estoque. • Devolver os restantes medicamentos e materiais (a serem organizados em colaboração com o departamento de logística). • Realizar reunião de balanço com os supervisores distritais e grupo de trabalho. 40 Os supervisores devem ter as ferramentas adequadas para suas tarefas, como uma lista de verificação de supervisão (ver Anexo 15). Supervisor do distrito As funções e responsabilidades do supervisor das equipas do distrito são: • supervisionar e apoiar os supervisores da equipa de distribuição; • certificar-se de que existe uma equipa responsável para todas as áreas geográficas elegíveis; • Visitar as estruturas de saúde periféricas diariamente e reagir rapidamente às perguntas e problemas; • assegurar a presença diária de todas as equipas; • informar e debater com os supervisores da equipa antes e depois do trabalho de cada dia, com especial atenção para: - rupturas de estoque, - problemas na recolha de dados, - rumores que circulam na comunidade, - informações insuficientes pelos distribuidores sobre uma correcta administração do medicamento, - falta de motivação dos profissionais de saúde, - resposta insuficiente às RAM e - cobertura de populações nos locais de difícil acesso; • Informar o grupo de trabalho do distrito de qualquer problema que exige uma acção imediata que não pode ser resolvida localmente; • Recolher e compilar as informações sobre as fichas de síntese diária do distrito; • recolher e analisar as listas de verificação dos supervisores das equipas (pode ser feito no final da campanha, se não houver tempo suficiente durante a distribuição) para identificar os problemas e ensinamentos a serem aplicados nas rondas posteriores; • apresentar resumos diários ao grupo de trabalho do distrito durante as reuniões de balanço da noite; • submeter um relatório escrito ao supervisor nacional. Supervisor regional ou provincial (se aplicável) O supervisor regional ou provincial é responsável pela supervisão dos supervisores distritais. Ele ou ela deve fazer diariamente o acompanhamento dos progressos da campanha e de quaisquer dificuldades ou problemas, como rumores. Ele ou ela deve recolher e analisar o resumo das conclusões do distrito e apresentar um relatório ao supervisor ou coordenador nacional. Supervisor ou coordenador nacional Ele ou ela fiscaliza os supervisores regionais ou provinciais, acompanha a totalidade dos progressos da campanha e os principais problemas, como, por exemplo, rumores, e analisa os resumos de regiões ou províncias antes de notificar ao grupo de trabalho nacional. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 41 2.3.4 Recolha de dados A recolha de dados é uma componente essencial de uma AMM para garantir um acompanhamento adequado das operações. A pessoa responsável pela recolha de cada tipo de dados em cada nível e o mecanismo de transferência de um nível para outro devem ser claramente definidos (Quadro 4 e Fig. 3). Isto é particularmente importante quando vários parceiros são envolvidos, a fim de evitar a duplicação de recolha de dados, dados em falta ou erros nas folhas de controlo ou de resumos. FIG. 3. Fluxo de informações recomendadas entre os níveis TCS e equipas de distribuição • folha de controlo diário • registo diário de famílias Supervisor de equipas de distribuição • folha de resumo diário Supervisor distrital • resumo distrital Supervisor regional ou provincial • resumo regional Supervisor nacional • resumo nacional Comunidade Unidade de Saúde Distrito Região ou província Nível Nacional 42 QUADRO 4. Dados a serem gravados em cada nível durante a distribuição porta-a-porta e centralizada NÍVEL ESTRATÉGIA DE DISTRIBUIÇÃO PORTA-A-PORTA DISTRIBUIÇÃO CENTRALIZADA, LOCAL FIXO Comunidade Recenseamento de pessoas em cada domicílio ou família (obtido antes de AMM, quando possível) Lista de pessoas na comunidade, de preferência com a idade e sexo por família; ou então, o número de pessoas por família Folha de controlo diário com gestão de estoque (medicamentos, testes de gravidez e outros consumíveis) por equipa de distribuição Folha de controlo diário com gestão de estoque (medicamentos, testes de gravidez e outros consumíveis)) por local de distribuição Registo de cada pessoa, família tratada, excluída, recusada ou não encontrada (Ver registo de domicílios) As RAM (nome, idade, sexo, aldeia, chefe de família, dados de contacto, tratamento administrado, tipo de RAM, dia do RAM) durante 2-7 dias Notificação RAM (Observações por 30 min enquanto estiver no centro de tratamento) Formulário de encaminhamento (em caso de doença grave, RAM, mulher grávida que, inadvertidamente, recebeu o tratamento, outras razões) Unidade de Saúde Folha de resumo diário e análise de cobertura pela comunidade na área de abrangência da unidade de saúde Notificação de RAM (formulário padrão) Formulário de gestão de estoque e logística: medicação antipalúdica, testes de gravidez, e outros consumíveis no estoque da unidade de saúd Formulário de gestão de estoque ou de logística: medicação antipalúdica, testes de gravidez, e outros consumíveis (o estoque poderá não estar sempre previamente posicionado na unidade de saúde) Distrito Folha de resumo do distrito e análise de cobertura pela unidade de saúde no distrito Compilação de formulários de relatório de RAM das unidades de saúde no distrito Formulário de gestão de estoque ou de logística: medicação antipalúdica, testes de gravidez e outros consumíveis, se o armazenamento distrital for utilizado quando o estoque é devolvido da unidade de saúde. Região ou província Folha de resumo regional ou provincial e análise da cobertura por distritos na região ou província Compilação de formulários de relatório de RAM dos distritos Formulário de gestão de estoque ou de logística: medicação antipalúdica, testes de gravidez e outros consumíveis, se o armazenamento regional for utilizado e/ou quando o estoque é devolvido do nível distrital. Nacional Total nacional e análise de cobertura por região ou província Compilação de formulários de relatório de RAM de regiões ou províncias Formulário de gestão de estoque ou de logística: medicação antipalúdica, testes de gravidez e outros consumíveis no estoque nacional e quando o estoque é devolvido dos níveis mais baixos. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 43 Cartões de AMM O fornecimento de cartões de AMM (ver Anexo 16) aos participantes como prova de que não receberam o tratamento é opcional, e deve ser decidido pelo grupo de trabalho nacional durante a fase de concepção. Se o grupo de trabalho decidir que um cartão de AMM será fornecido, deverá conter: • último e primeiro nome do beneficiário do medicamento, • idade e sexo, • endereço, • nome e dose do medicamento antipalúdico concedido e • data de administração da primeira dose se for dada por TDO ou de cada dose se todas as três doses são dadas por TDO. Folha de controlo diário As folhas de controlo (ver Anexo 13) devem ser preenchidas por cada equipa em cada dia de distribuição e entregue ao supervisor no fim do dia. As seguintes informações devem ser registadas: • data e local de distribuição; • identificação das equipas de distribuição; • número de famílias visitadas; • número de pessoas que receberam o medicamento, por grupo etário (definidas por categorias de idade para o medicamento) e por sexo, se for considerado relevante; • os indivíduos excluídos e justificação; • condição de residência: residente ou visitante particularmente útil nos contextos de eliminação, porque todos podem não estar incluídos no cálculo de cobertura) e • número de embalagens de tratamento para cada categoria etária recebidas no início do dia e das restantes no final do dia. As quantidades de medicamentos consumidos devem corresponder ao número de pessoas tratadas, tal como registadas na folha de controlo. Discrepâncias devem ser investigadas para determinar a causa, como, por exemplo, um erro na distribuição ou roubo. Registo de famílias ou de lista de linhas Dependendo do contexto (emergência ou eliminação), um registo de uma família ou registo de lista de linhas (ver Anexo 14), pode ser utilizado com as seguintes informações recolhidas: • Identificação de famílias; • chefe de família; • nome de beneficiário; • idade: • sexo; • aldeia; 44 • dados de contacto (se houver); • condição de residência (residente permanente, residente temporário, visitante); • tratamento efectuado; • recusa, excluído (motivo) ou não encontrado e • observações. Folha de resumo diário O supervisor da equipa de distribuição deve recolher as folhas de controlo completas e compilar os dados correspondentes a uma determinada área geográfica (área de abrangência do centro de saúde, bairro ou aldeia) num formulário de resumo diário (ver Anexo 17). As folhas de controlo devem ser analisadas para verificar se foram devidamente concluídas e se a equipa está a cumprir a meta diária. Se não, o motivo deve ser investigado (p. ex. falta de sensibilização, falta de medicamentos, problemas na gravação). Feedback deve ser dado às equipas sobre o seu desempenho e ajustamentos feitos, como o aumento do número de equipas, mudança do local de distribuição (na distribuição centralizada) ou adaptação de mobilização. Base de dados Os dados nos formulários de resumo devem ser introduzidos por um gestor de dados numa base de dados centralizados a nível distrital, regional ou nacional (ver Anexo 18 para base de dados utilizada na AMM na Serra Leoa), que irá permitir, numa fase posterior, uma análise detalhada do número de pessoas tratadas, o número excluído, a cobertura de distribuição por grupo etário e localização e outras informações. Formulário de encaminhamento Um TCS que identifica uma pessoa que está doente, uma mulher grávida no primeiro trimestre, que inadvertidamente tomou o medicamento antipalúdico ou qualquer pessoa que apresente uma potencial reacção adversa relacionada com medicamentos deve preencher um formulário de encaminhamento e encaminhar a pessoa a uma unidade de saúde para o tratamento adequado. Formulário de RAM Se um indivíduo apresentar sintomas que poderão ser atribuídos ao medicamento antipalúdico, um formulário de RAM (ver Anexo 19) deve ser preenchido numa unidade de saúde ou por uma equipa de farmacovigilância. Consulte a secção 3.4 para mais pormenores da farmacovigilância e notificação de RAM. 2.3.5 Coordenação Durante os dias de distribuição, reuniões diárias devem ser realizadas a níveis distrital e nacional, com a participação de todos os envolvidos na campanha a fim de: • monitorizar a cobertura diária; agir nas áreas problemáticas ou difíceis visando a mobilização social ou planeamento da distribuição de “recuperação”, assegurar que as áreas mais difíceis de alcançar, foram visitadas e garantir que os suprimentos não foram esgotados; • monitorizar os estoques e garantir um fornecimento ininterrupto dos medicamentos; • abordar quaisquer rumores identificados ou recusa generalizada da população; • gerir as solicitações da imprensa; AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 45 • identificar e corrigir quaisquer erros do programa que possam levar ao fracasso da campanha; • partilhar quaisquer informações pertinentes, e coordenar as actividades de todos os parceiros; e • mobilizar os recursos necessários de uma forma coordenada para responder a ocorrências imprevistas. 2.3.6 Tratamento de casos de paludismo após a administração massiva de medicamentos Uma pessoa tratada durante a AMM que se apresenta numa unidade de saúde com suspeita de paludismo dentro de 4-6 semanas deve ser avaliado para possível fracasso no tratamento do paludismo ou nova infecção. Um resultado positivo num teste diagnóstico rápido baseado em HRP2 não pode ser utilizado, porque um resultado positivo pode ser obtido semanas após o tratamento bem sucedido devido à antigenemia persistente. Sendo assim, a microscopia deve ser utilizada para confirmar o paludismo. Os serviços de saúde devem ter medicamentos antipalúdicos em estoque que sejam diferentes dos utilizados na AMM. Se a microscopia confirmar paludismo, o profissional de saúde deve perguntar se o paciente aderiu ao programa completo de tratamento e se vomitou nos primeiros 30 minutos de ingestão de medicamentos. Se a adesão foi fraca ou se o paciente vomitou, o mesmo tratamento utilizado para a AMM pode ser repetido. Se a adesão ao tratamento foi boa, um antipalúdico diferente deve ser dado, uma vez que um possível fracasso do tratamento não pode ser diferenciado de uma nova infecção nos estabelecimentos de cuidados de saúde de rotina. 46 3. MONITORIZAÇÃO E AVALIAÇÃO 3.1 SISTEMA DE MONITORIZAÇÃO Considerando a complexidade da intervenção, o número limitado de vezes que a AMM pode ser efectuada e a importância da cobertura da intervenção, a monitorização é essencial para o sucesso. A monitorização deve ser de elevada qualidade e não considerada de rotina. A utilização de um sistema de monitorização durante uma campanha permite a alocação de recursos para as operações e implementação eficaz das actividades enquanto atribui recursos e capacidades para um conjunto separado de actividades que permitem a identificação em tempo real de restrições que exigem acção imediata, e irá proporcionar lições para fases posteriores da AMM. O sistema de monitorização deverá avaliar todas as fases da campanha, através de: • entrevista às equipas de distribuição para determinar a eficácia da formação; • avaliação da logística; • entrevista aos membros da comunidade para avaliar a eficácia da campanha de mobilização social; • visitas aleatórias às equipas de distribuição para observar a administração da medicação e aconselhamento para a adesão; • avaliação da qualidade da recolha de dados; • estimativa da cobertura real; • avaliação da adesão ao tratamento e utilização racional de medicamentos; • monitorização da segurança de medicamentos e notificação de ocorrências adversas; • monitorização do impacto. O destacamento de equipas de monitorização (monitores internos ou independentes) deve ser planeado durante a fase de concepção, para garantir uma formação adequada no uso das ferramentas de monitorização. 3.2 ESTIMATIVA DE COBERTURA Após a conclusão de cada ronda, a cobertura é estimada para determinar a proporção de pessoas atingidas. Áreas de baixa cobertura podem ser identificadas para melhorar o planeamento para a ronda seguinte. 3.2.1 Cobertura de distribuição A cobertura de distribuição pode ser definida como a proporção da população que recebeu a primeira dose do tratamento nessa ronda, com o número de pessoas que receberam a primeira dose, como o numerador e o número de pessoas na área específica como o denominador: Cobertura de distribuição = número de pessoas que receberam a primeira dose × 100 número de pessoas identificadas para tratamento AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 47 A distribuição de cobertura para cada ronda e, em seguida, a cobertura total de distribuição da AMM pode ser calculada. Além disso, a cobertura de distribuição deve ser estimada para cada grupo demográfico (idade e sexo) e área geográfica, conforme aplicável para a gestão de campanhas. Embora a análise por sexo não seja essencial, pode ser útil nos contextos em que certos grupos poderão ser desfavorecidas (p, ex. raparigas). Esses cálculos, no entanto, não reflectem a realidade, devido às dificuldades na obtenção de informações demográficas seguras, erros na recolha de dados ou inclusão de pessoas de fora da área visada na distribuição. A estimativa de cobertura será mais precisa se um recenseamento das famílias for realizado antes da distribuição, proporcionando o denominador. Em situações de emergência ou outras situações em que a realização de um recenseamento não é viável, a abordagem recomendada é a realização de uma pesquisa sobre a cobertura. Como mencionado anteriormente, a cobertura desejável é > 80%. Cobertura de < 80% pode ser devido à fraca participação, escassez de suprimentos ou uma estratégia inadequada para a campanha. Os motivos da não participação podem ser (12,26,27): • mobilidade da população (circulação sazonal ou de rotina de pessoas fora da área definida para a AMM); • não disponibilidade ou incapacidade para participar no momento da AMM; • dificuldade em alcançar o local da distribuição ou de um longo tempo de espera (no caso de distribuição centralizada); • recusa de tomar o tratamento porque não está doente; • medo de RAM; • considera-se que o tratamento envolve muitos comprimidos e é demasiado longo; • rumores sobre o medicamento; • falta de envolvimento com os líderes comunitários e a sociedade civil em geral; • falta de confiança na campanha; • mal-entendidos e falta de informação adequada sobre AMM; • interferência com outros eventos da comunidade; e • confusão entre AMM para paludismo e outras doenças tropicais negligenciadas, como a administração de praziquantel, que tem efeitos secundários que algumas pessoas dificilmente podem tolerar. Embora a AMM nas zonas rurais seja logisticamente mais exigente, pode ser mais difícil obter uma elevada cobertura nas áreas urbanas do que nas rurais, devido a diferenças nas características e dinâmica da população, incluindo a situação socioeconómica, nível educacional, ocupação e horários de trabalho (28,29). Alguns estudos têm demonstrado que as populações com a situação social mais elevada são mais relutantes em participar na AMM (28). Os jovens e adultos que bebem álcool regularmente não estão dispostos a participar na AMM, a menos que estejam doentes. As razões para a não-adesão ao tratamento completo incluem (12,27): • não se sentir doente, 48 • querer guardar o medicamento para quando estiver doente, • partilhar o tratamento com mais alguém, • esquecer de tomar os comprimidos, • Medo de ou aparecimento de efeitos secundários, • Rumores sobre os efeitos secundários do medicamento e • Promoção ou informação inadequada da saúde sobre como adoptar o tratamento correctamente ou sobre a importância da conclusão do programa completo. 3.2.2 Pesquisa pós campanha de AMM Recomenda-se uma pesquisa pós campanha, quando possível, de preferência no período de uma semana após a distribuição. A pesquisa compreende visitar uma amostra representativa da população e sistematicamente realizar um questionário (ver exemplos no Anexo 20) aos membros selecionados da família. Os resultados podem ser utilizados para calcular a cobertura da população com maior nível de confiança. Informações adicionais sobre a campanha também podem ser recolhidas durante a pesquisa. A amostragem por conglomerados pode ser utilizada. Para obter informações sobre como implementar uma pesquisa de cobertura por conglomerados, ver Anexo 4 de Monitorização e avaliação epidemiológica da administração massiva de medicamentos no programa global para eliminar a filaríase linfática: um manual para os programas nacionais de eliminação (30). Uma pesquisa pós distribuição é útil para: • estimar a cobertura da AMM, • avaliar a adesão ao tratamento (o número de pessoas que completaram o programa completo de medicamentos antipalúdicos), • determinar as razões de não-participação, • determinar as razões de não-adesão, • estimar a proporção de pessoas que enfrentaram ocorrências adversas e • avaliar as principais ocorrências adversas notificadas. 3.3 MONITORIZAÇÃO DO CONSUMO O consumo de medicamentos antipalúdicos (número de tratamentos utilizados) deve ser monitorizado diariamente e comparado com o número de pessoas que informaram que lhes foi fornecida a medicação. As discrepâncias entre os dois números devem ser investigadas. Podem ser causadas por problemas no registo das doses administradas, erros na contagem das existências, erros na administração dos medicamentos ou roubo. Qualquer desses problemas deve ser devidamente tratado com as equipas. Um grande problema que poderá surgir como consequência da falta de dados demográficos confiáveis é se o número real de elementos da população num determinado local exceder largamente o previsto. Através da monitorização do consumo, uma eventual ruptura de estoque pode ser determinada. A escassez de estoque ligada aos relatórios das equipas de distribuição, ou dos líderes comunitários informando que partes da população ainda não receberam AMM, pode AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 49 alertar os supervisores para esta possibilidade. Nessas circunstâncias, o estoque de segurança no armazém central deve ser utilizado. Uma alternativa mais exigente do ponto de vista logístico seria a transferência de medicação dos locais com excessiva quantidade de estoque para os locais sub- aprovisionados. 3.4 FARMACOVIGILÂNCIA Mesmo quando os medicamentos que têm perfis de boa segurança e tolerabilidade são utilizados, a exposição de uma grande população pode resultar no aparecimento de alguns casos de efeitos secundários raros. “Farmacovigilância” é definida pela OMS como a ciência e as actividades relacionadas com a detecção, avaliação, compreensão e prevenção de efeitos adversos ou quaisquer outros possíveis problemas relacionados com os medicamentos (31). A farmacovigilância no contexto de AMM deve ser planeada e implementada em colaboração com o centro nacional de farmacovigilância, que poderá integrar a autoridade reguladora nacional de medicamentos ou de uma instituição de investigação ou académica. Os sistemas de farmacovigilância dependem do desempenho e motivação do pessoal de serviços gerais de saúde, requerem estruturas hierárquicas centralizadas e métodos e competências para revisão, análise e avaliação da causalidade das notificações espontâneas de suspeitas de reacções a medicamentos. O sistema de farmacovigilância deve ser organizado a níveis nacional, regional, distrital, estatal e municipal e também nas unidades de saúde e a nível comunitário nas populações identificadas. Os objectivos de farmacovigilância durante a AMM são: • detectar extraordinariamente elevadas taxas de ocorrências adversas; • assegurar que as ocorrências coincidentes não sejam falsamente associadas a AMM; • apoiar a detecção oportuna e gestão de todas as ocorrências adversas (mesmo as que não são atribuídas a AMM) para garantir a segurança da população; • manter confiança na campanha através de respostas adequadas às preocupações da comunidade sobre a segurança do medicamento, reforçando a sensibilização sobre os seus benefícios e riscos; • gerar dados sobre ocorrências adversas em certas populações como portadores assintomáticos e pessoas saudáveis das quais poderá não haver dados de segurança, porque estas populações não estão incluídas nos testes durante o desenvolvimento de medicamentos; • promover e monitorizar a adesão ao medicamento pela população alvo, e detectar as razões do incumprimento e as causas subjacentes, se possível; • avaliar a preparação dos sistemas de saúde para garantir a monitorização da segurança dos medicamentos a níveis distrital e nacional, identificando as respostas adequadas em termos de conhecimento do uso de medicamentos (segurança), formação, conhecimento e prática da farmacovigilância; e • avaliar a gravidade, frequência, distribuição e resultados previstos das RAM na população alvo, a fim de: - identificar as RAM que não estão indicadas no folheto de informações do produto ou não são descritas nas populações que não foram testadas durante o desenvolvimento do medicamento, tais como portadores assintomáticos e pessoas saudáveis; - avaliar a associação entre a AMM e os antipalúdicos; - fornecer um espectro das RAM associadas ao uso de antipalúdicos nas grandes populações; e 50 - informar os trabalhadores sobre o aconselhamento e o acompanhamento de pacientes nas unidades de saúde. A comissão organizadora deve conhecer muito bem as RAM previstas e a toxicidade do medicamento a ser utilizado na AMM. Os grupos em todos os níveis devem estar sensibilizados sobre potenciais RAM, incluindo o público em geral, os TCS (distribuidores do tratamento), supervisores e pessoal de cuidados de saúde. As comunidades devem ser informadas sobre as reacções leves previstas, com a informação de que são geralmente transitórias e auto-limitadas ou resolvidas por um tratamento simples; devem ser incentivadas a procurar cuidados médicos para quaisquer sintomas raros ou graves. Uma atenção especial deve ser dada aos efeitos secundários que podem reduzir a tolerabilidade e levar à baixa adesão, como náuseas, vómitos, diarreia e desconforto abdominal. Isto poderia ser feito através da televisão e rádio, imprensa escrita, meios de comunicação social e reuniões. 3.4.1 Definições Incidente adverso: qualquer manifestação nociva registada que pode ocorrer durante o tratamento com um produto farmacêutico e que não está necessariamente ligada de forma causal a esse tratamento (32) Reacção adversa a medicamentos (RAM): considera-se reacção adversa a um medicamento um efeito nocivo e imprevisto que ocorra com as doses normalmente utilizadas no homem para a profilaxia, diagnóstico ou terapêutica de doenças ou para a modificação de uma função fisiológica. Incidente ou reacção adversa grave: uma ocorrência médica desagradável que, em qualquer dose: • leve à morte, • ponha a vida em perigo, • exija hospitalização ou prolongamento de hospitalização, • conduza a uma deficiência ou incapacidade persistente ou significativa ou • provoque uma anomalia congénita ou defeito de nascença (33,34). A detecção de anormalidades congénitas exigirá a criação de um registo de gravidez, com a inscrição e a vigilância de todas as novas gestações detectadas nos cuidados pré-natais e nas comunidades durante os três meses após a AMM, e uma avaliação para determinar se as mulheres estavam grávidas no momento da exposição ao medicamento. Estas mulheres devem ser seguidas até o parto para avaliar os resultados da gravidez, em termos da saúde do feto e da criança e da mãe (31). O grupo de mulheres grávidas deve ser entrevistado sobre qualquer tratamento com TCA ou outros medicamentos, com informações precisas sobre o tempo de exposição e tipo de medicamento e possível aborto espontâneo, nado morto ou malformações. A análise de dados no momento do nascimento irá permitir uma comparação da frequência de aborto espontâneo, nado morto e malformações congénitas em mulheres grávidas que tenham inadvertidamente recebido vários tipos de medicamentos durante o primeiro trimestre. Eventos adversos de interesse especial: refere-se a eventos adversos (graves ou sem gravidade) de interesse científico, médico e público significativo, para as quais a monitorização e a comunicação rápida ao fornecedor e às entidades reguladoras poderiam ser adequadas (35). O evento deverá ser definido e notificado se alguns sinais de segurança forem detectados durante o desenvolvimento de um medicamento que necessitou de monitorização adicional. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 51 3.4.2 Comunicação de segurança Relatos de RAM e rumores sobre a segurança dos medicamentos pode prejudicar uma campanha de AMM e pode também influenciar as futuras AMM ou até mesmo o uso dos medicamentos no país. Uma estratégia de comunicação deve ser elaborada com o centro nacional de farmacovigilância, antes da campanha de AMM, em conformidade com as melhores práticas internacionalmente aceitas (36). As relações com os meios de comunicação e os interlocutores seleccionados devem ser definidas com antecedência, porque a oportunidade e eficiência na comunicação de crises são essenciais para conter os danos graves causados pela circulação de boatos. As RAM notificadas ou consideradas deverão ser comunicadas de forma adequada aos meios de comunicação social, com respostas a quaisquer perguntas. Todas as ocorrências adversas devem ser devidamente reconhecidas, relatadas e analisadas. Assim que a avaliação for concluída, os resultados da investigação devem ser comunicados à comunidade através dos meios de comunicação social adequados. 3.4.3 Vigilância de reacções adversas aos medicamentos A vigilância de RAM de rotina deve ser reforçada durante uma campanha de AMM para identificar quaisquer casos potencialmente graves e para os tratar de forma adequada, detectar eventuais erros programáticos e tranquilizar o público em geral. Medicamentos de urgência e material médico de emergência necessários para o tratamento de possíveis reacções adversas devem estar disponíveis nas unidades de saúde. Os erros de medicação, como na administração de doses pelos distribuidores ou na ingestão de medicamentos por causa da falta de sensibilização, poderão estar na origem de ocorrências adversas e devem ser devidamente notificados. Para estabelecer um sistema de vigilância de segurança funcional, todo o pessoal envolvido numa campanha de AMM, sobretudo o pessoal de cuidados de saúde, deve ser formado antes da campanha sobre as suas funções e responsabilidades, enfatizando a prevenção, a detecção precoce e o tratamento de ocorrências adversas e ocorrências adversas graves ligadas à campanha, bem como sobre a utilização de formulários padronizados para notificação e o procedimento a seguir em caso de suspeita grave de RAM (sistema de notificação). A maioria dos países tem formulários padronizados para a documentação das RAM (ver exemplo no Anexo 19). Os formulários para notificação de RAM suspeitas devem ser amplamente distribuídos, e orientações claras devem ser fornecidas ao pessoal de cuidados saúde e estruturas de saúde locais sobre o preenchimento do formulário. Qualquer RAM grave deve ser investigada para determinar a sua relação com o medicamento antipalúdico, e todas as respostas devem ser documentadas, incluindo o tratamento. O formulário de notificação adoptado pelo centro nacional de farmacovigilância deve ser utilizado para notificação espontânea. Os formulários podem ser adaptados para a monitorização de uma amostra da população exposta de modo a incluir os dias de seguimento e as conclusões das visitas domiciliares. Todos os formulários de notificação devem registar os dados sobre o paciente, o(s) medicamento(s) suspeito(s), a medicação concomitante, a história clínica, a descrição detalhada da evolução clínica da(s) ocorrência(s), o diagnóstico, os resultados, os procedimentos laboratoriais relevantes ou outros procedimentos de diagnóstico e tratamento recebido e qualquer outra informação que apoie a causalidade (37). Dois métodos de farmacovigilância podem ser utilizados durante as AMM. • Relatórios de monitoração passiva ou notificação espontânea: notificação de suspeita de reacção adversa por um profissional de saúde ou por um paciente, que toma conhecimento de um facto preocupante para a segurança.. Por isso, a notificação não é 52 solicitada sistematicamente. Contudo, tanto os trabalhadores de saúde como as pessoas que recebem AMM devem ser aconselhados (com dados pormenorizados de contacto) a relatar qualquer evento desagradável que possam observar durante ou depois de AMM. • Monitorização activa e notificação: acompanhamento das visitas domiciliares por equipas móveis de farmacovigilância ou trabalhadores de saúde formados na detecção de ocorrências adversas após a exposição a medicamentos para detecção de RAM de curto prazo (durante a semana após a administração) em cada aldeia, vila ou cidade em que o medicamento foi administrado. Isto é particularmente importante nos meios em que os sistemas de farmacovigilância são ineficientes e a sub-notificação é significativa. Envolve a detecção ativa e seguimento de casos (“procurar, encontrar, identificar, encaminhar e tratar”). Qualquer RAM detectada deve ser notificada a uma unidade de saúde, e as RAM graves devem ser submetidas a nova investigação e tratamento. Para garantir uma comunicação e notificação efectivas de RAM, um centro de atendimento ou linha de apoio de farmacovigilância 24 horas por dia, pode ser criado para esclarecer as questões dos beneficiários dos medicamentos durante a campanha. Nos países em que o centro de farmacovigilância nacional tem um sistema de notificação electrónica online de RAM, isto pode ser utilizado para melhorar a notificação, se houver sensibilização nacional de consumidores e profissionais da área de saúde para a disponibilidade do sistema. Todos os relatórios de RAM recolhidos durante ou após a campanha devem ser enviados ao centro de farmacovigilância nacional para avaliação e posterior submissão à base de dados global de RAM da OMS. Uma lista de verificação de preparação da farmacovigilância da unidade de saúde (ver exemplo no Anexo 21) poderia ser utilizada por monitores de farmacovigilância nas comunidades para avaliar se: • existem quantidades adequadas de medicamentos de emergência para o tratamento das RAM; • os funcionários estão cientes da necessidade de monitorização da farmacovigilância durante a AMM; • todos os funcionários foram informados e formados em monitorização da farmacovigilância e reacções adversas ao medicamento antipalúdico que será utilizado na campanha; • os funcionários foram envolvidos na sensibilização e mobilização social antes da campanha sobre a importância da adesão aos medicamentos; e • os formulários de notificação de RAM são disponibilizados nos locais de AMM, com instruções claras de envio e dados de contacto. Todos os profissionais de saúde envolvidos na administração massiva de medicamentos devem ser formados em farmacovigilância (ver exemplo de currículo de formação para distribuidores de medicamentos no Anexo 22). 3.5 MONITORIZAÇÃO DA RESISTÊNCIA AOS MEDICAMENTOS Uma das principais preocupações sobre AMM é o aparecimento e propagação da resistência ao medicamento, que se espalha porque os parasitas resistentes desenvolvem maior potencial de transmissão na presença do medicamento antipalúdico. No passado, a AMM indirecta (em que medicamentos antipalúdicos foram adicionados ao sal distribuído à população) resultou AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 53 no desenvolvimento da resistência devido ao uso de doses sub-terapêuticas de medicamentos antipalúdicos (5,38). A AMM pode aumentar a pressão de selecção sobre os parasitas. Como os medicamentos antipalúdicos com uma meia-vida longa são eliminados lentamente do corpo, durante a AMM, uma grande parte da população terá concentrações variáveis do medicamento no sangue ao longo do tempo. Isso aumenta as oportunidades dos parasitas do paludismo serem expostos a concentrações sub-terapêuticas de medicamentos de acção longa (13,40,41). Assim, o efeito profilático pós-tratamento, que é uma componente importante do efeito protector e de bloqueio da transmissão de AMM, pode também levar à pressão de selecção. A baixa adesão ao tratamento por uma parte da população deverá ser maior em pessoas com parasitemia assintomática, o que contribuirá também para a exposição dos parasitas da malária às doses sub-terapêuticas. Até agora, não há nenhuma evidência de que a AMM de medicamentos antipalúdicos utilizados em doses terapêuticas resulta no aparecimento de resistência (39). Embora o uso de tratamento combinado reduza a possibilidade de selecção de parasitas resistentes aos medicamentos (23), poucas provas sobre o impacto da AMM na resistência aos medicamentos indicam que a resistência aos medicamentos antipalúdicos deve ser monitorizada nas áreas em que a AMM é implementada em grande escala. Vários meios para a monitorização de resistência ao parasita (P. falciparum) são relevantes para a AMM (42). • Ensaios in vivo de eficácia terapêutica: tratamento de pacientes sintomáticos com uma dose padrão de medicamentos antipalúdicos e avaliação da eficácia clínica (sinais e sintomas) e parasitológica (parasitemia) dos medicamentos e resultados do tratamento durante um período definido. Embora os testes de eficácia terapêutica sejam considerados o “padrão de referência” e sejam utilizados nos programas nacionais de controlo do paludismo para orientar a política de tratamento, são relativamente complexos para executar, e nem sempre fáceis de implementar após a AMM. • Detecção de marcadores moleculares de resistência aos medicamentos: confirmação de alterações genéticas associadas à resistência através de técnicas moleculares. A detecção em série de marcadores moleculares é uma forma precisa de monitorização da resistência aos medicamentos e, provavelmente, a opção preferida. Tem a vantagem de assegurar que as amostras podem ser facilmente obtidas, transportadas e armazenadas em papel-filtro, mas também exigem equipamentos caros. Pode proporcionar evidências iniciais de resistência, particularmente se os dados de pré- intervenção estão disponíveis. Marcadores moleculares de resistência aos medicamentos estão disponíveis apenas para um número limitado de medicamentos antipalúdicos, nomeadamente cloroquina, amodiaquina, sulfadoxina + pirimetamina, mefloquina, piperaquina, e artemisinina. A correlação entre marcadores moleculares e a eficácia terapêutica de muitos antipalúdicos é imperfeita e deve ser interpretada com cautela. Em qualquer cenário, pelo menos um dos dois métodos deve estar disponível. A monitorização da resistência aos medicamentos exigirá uma colaboração com laboratórios de referência e com os organismos de investigação a nível nacional ou internacional. 3.6 AVALIAÇÃO DO IMPACTO A forma ideal de determinar o impacto, sobretudo quando o objectivo é reduzir a transmissão do paludismo, é monitorizar a prevalência do paludismo através de medidas em série de parasitemia. O método utilizado nas pesquisas anteriores e posteriores a AMM deve ser o mesmo para identificar um efeito. 54 Uma forma mais prática de avaliar o impacto da AMM para o paludismo é a monitorização de dados de vigilância de rotina. Os seguintes indicadores devem ser ponderados, de preferência semanalmente, mas pelo menos mensalmente: • número total de consultas (pacientes ambulatórios), • número total de casos suspeitos, testados para o paludismo, • número total de casos de paludismo confirmados, • número total de internamentos de casos graves de paludismo, • número de mortes por paludismo, • taxa de positividade dos testes e • número total de casos de paludismo transmitidos e importados localmente. Para as situações de epidemias e emergências complexas, um conjunto mínimo de actividades de monitorização e avaliação de AMM deve ser definido para documentar o impacto e para a notificação. Mecanismos que gravam casos de paludismo confirmados continuamente podem ser identificados em muitas situaçoes, para monitorizar ao longo do tempo o número de consultas e de casos de malária confirmados nos grupos identificados expostos à AMM e, se possível, em grupos de população não expostos. Estes dados devem ser comparados antes e depois da AMM na área visada; num distrito abrangido pela AMM e num que não foi abrangido, com uma prevalência semelhante do paludismo; e no mesmo distrito num ano em que AMM foi realizada e num ano em que não foi. Análises mais detalhadas podem indicar as contribuições de aspectos como os factores ambientais demográficos e intervenções concomitantes que também influenciam as tendências do paludismo. Quando a AMM é utilizada como uma medida de emergência para reduzir o fardo do paludismo e afecção febril rapidamente, como foi o caso no surto da DVE, a eficácia na redução da morbidade por paludismo e o número de casos febris que se apresentam aos serviços de saúde devem ser monitorizados (11,12). Numa epidemia, o efeito da AMM é difícil de documentar, porque a mudança temporal pode ser reflectida simplesmente como um patamar estável, uma diminuição ou uma redução na taxa de aumento da incidência da curva epidémica. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 55 4. NOTIFICAÇÃO Após cada ronda e no final da intervenção, todos os parceiros nos vários níveis (comunidade, unidade de saúde, distrito, região, província, região, nacional) devem reunir-se para um balanço e revisão para avaliar como decorreu a campanha, partilhar as suas experiências e impressões e fazer recomendações para as rondas seguintes ou uma futura AMM. Um relatório deve ser escrito com vista a capitalizar a experiência e identificar ensinamentos que poderão melhorar as rondas posteriores ou experiências semelhantes. Deve proporcionar: • a cobertura alcançada; • os principais resultados, desafios e problemas enfrentados e as soluções bem sucedidas ou fracassadas; • quaisquer práticas que deram bons resultados, incluindo actividades de mobilização social eficazes; • todas as ferramentas úteis que foram desenvolvidas ad hoc em resposta a ocorrências imprevistas, que podem ser incorporadas nos documentos de referência e incluídas no material de formação; • o custo final da intervenção (análise por cada item) e o custo por pessoa tratada; • a transparência e a responsabilização de todos os recursos utilizados, incluindo inventários finais, destino do restante tratamento, devolução do equipamento logístico, quaisquer doações feitas; e • uma avaliação de toda a operação. Segue-se um resumo dos principais tópicos que devem ser contemplados no relatório a ser elaborado a nível de distrito no final de cada ronda da AMM: • Introdução e contexto • Objectivos • Duração da campanha • Área geográfica de intervenção e população-alvo • Regime de tratamento • Pormenores dos métodos utilizados durante a campanha - Preparação e planeamento o Recrutamento e formação de recursos humanos o Mobilização social e envolvimento da comunidade o Logística e abastecimento - Distribuição o Estratégia o Aspectos práticos o Supervisão o Recolha de dados o Resultados - Número total de pessoas atingidas 56 - Cobertura - Indivíduos excluídos e razões para a não-inclusão • Monitorização: eventos adversos notificados • Outros aspectos relevantes de monitorização • Finanças e administração, incluindo detalhamento por custo • Pontos fortes, dificuldades, ensinamentos obtidos e recomendações • Anexos Outra componente importante de notificação é informar as comunidades sobre os resultados da campanha e seu impacto. Isto irá melhorar a percepção das pessoas sobre a actividade e fomentar a confiança nas autoridades sanitárias para futuras campanhas. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 57 5. P RI NC IP AI S ET AP AS N UM A CA M PA NH A DE A DM IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O Pl an ea m en to e pr ep ar aç ão Im pl em en ta çã o M on ito riz aç ão e av al ia çã o No tifi ca çã o Fa se d e co nc ep çã o (m ac ro p la ne am en to ) • O bt er o c om pr om iss o do s d ec iso re s po lít ico s, e id en tifi ca r a gê nc ia s p ar a ap oi ar o m in ist ér io d a sa úd e. • C ria r u m a fo rç a- ta re fa o u co m ité d e co or de na çã o. • R ea liz ar u m a an ál ise d o co nt ex to . • D et er m in ar a p op ul aç ão -a lvo e ár ea s g eo gr áfi ca s • D et er m in ar o m ed ica m en to an tip al úd ico a se r u til iza do • A va lia r o s r eq ui sit os , e e nc om en da r os m ed ica m en to s • D et er m in ar a e st ra té gi a de di st rib ui çã o: - Po rta -a -p or ta - Ce nt ra liz ad a - M ist a • D et er m in ar o p er ío do d e in te rv en çã o • E st ab el ec er o n úm er o de ro nd as • E st ab el ec er u m c ro no gr am a • C al cu la r u m o rç am en to . • F az er o m ic ro p la ne am en to • A ss eg ur ar a lo gí st ica e fic az - A qu isi çõ es , ar m az en am en to e di st rib ui çã o - T ra ns po rte - A ce ss ib ilid ad e - Lo ca is de d ist rib ui çã o - G es tã o de re síd uo s • R ec ur so s h um an os - Id en tifi ca r r eq ui sit os - Fo rm aç ão - Sa lá rio s e a ju da s d e cu st o • E nv ol vim en to d a co m un id ad e e m ob iliz aç ão so cia l - D efi ni r f un çõ es e re sp on sa bi lid ad es - A va lia çã o da c om un id ad e - Pr in ci pa is m en sa ge ns - En vo lve r o s m ei os d e co m un ica çã o so ci al - A bo rd ar ru m or es - En vo lve r a c om un id ad e • G es tã o de e st oq ue s • D ist rib ui çã o do m ed ica m en to an tip al úd ico • S up er vi sã o • R ec ol ha d e da do s • C oo rd en aç ão • M on ito riz aç ão e m te m po re al • E st im at iva d e co be rtu ra • I nq ué rit o so br e a ca m pa nh a pó s A M M • M on ito riz aç ão d o co ns um o • F ar m ac ov ig ilâ nc ia • M on ito riz aç ão d a re sis tê nc ia a os m ed ica m en to s • A va lia çã o do im pa ct o • D eb at e e in te rv en çã o de av al ia çã o • E sc re ve r u m re la tó rio fi na l 58 REFERÊNCIAS 1. 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Community perceptions of targeted anti-malarial mass drug administrations in two provinces in Vietnam: a quantitative survey. Malar J. 2017;16:17. 27. Dierickx S, Gryseels C, Mwesigwa J, O’Neill S, Bannister-Tyrell M, Ronse M et al. Factors associated with non-participation and non-adherence in directly observed mass drug administration for malaria in The Gambia. PLoS One. 2016;11: e0148627. 28. Njomo DW, Mukoko DA, Nyamongo NK, Karanja J. Increasing coverage in mass drug administration for lymphatic filariasis elimination in an urban setting: a study of Malindi Town, Kenya. PLoS One. 2014;9:e83413. 29. Kumar P, Prajapati P, Saxena D, Kavishwar AB, Kurian G. An evaluation of coverage and compliance of mass drug administration 2006 for elimination of lymphatic filariasis in endemic areas of Gujarat. Indian J Commun Med. 2008;33:38–42. 30. Monitoring and epidemiological assessment of mass drug administration. Lymphatic filariasis. A manual for national elimination programmes. 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AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 61 Anexo 1 DISTRIBUIÇÃO PADRÃO DAS POPULAÇÕES NUM PAÍS EM DESENVOLVIMENTO CRIANÇAS < 5 ANOS FAIXA ETÁRIA (MESES) PERCENTAGEM DA POPULAÇÃO TOTAL 0–11 4% 12–23 3% 24–35 3% 36–47 3% 48–59 3% Total 16% POPULAÇÃO TOTAL FAIXA ETÁRIA (ANOS) PERCENTAGEM DA POPULAÇÃO TOTAL 0–4 16% 5–14 27% 15–29 27% 30–44 16% ≥ 45 14% Total 100% 62 Anexo 2 TERAPIA COMBINADA À BASE DE ARTEMISININA DISPONÍVEL: DOSAGEM, FORMULAÇÃO E APRESENTAÇÃO DIIDROARTEMISININA - PIPERAQUINA Doses recomendadas pela OMS: PESO CORPORAL (KG) DOSES (MG) DE DIIDROARTEMISININA E PIPERAQUINA ADMINISTRADAS DIARIAMENTE DURANTE 3 DIAS 5 a < 8 20 + 160 8 a < 11 30 + 240 11 a < 17 40 + 320 17 a < 25 60 + 480 25 a < 36 80 + 640 36 a < 60 120 + 960 60 a < 80 160 + 1280 ≥ 80 200 + 1600 Formulações disponíveis: Combinação de dose fixa em: • Comprimidos pediátricos contendo diidroartemisinina 20mg e 160 mg de piperaquina • Comprimidos contendo diidroartemisinina 40 mg e piperaquina 320 mg Apresentações: • Embalagens contendo 3 comprimidos de diidroartemisinina 20 mg e piperaquina 160 mg • Embalagens contendo 3 comprimidos de diidroartemisinina 40 mg e piperaquina 320 mg • Embalagens contendo 6 comprimidos de diidroartemisinina 40 mg e piperaquina 320 mg • Embalagens contendo 9 comprimidos de de diidroartemisinina 40 mg e piperaquina 320 mg • Embalagens contendo 12 comprimidos de de diidroartemisinina 40 mg e piperaquina 320 mg AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 63 Comentários: • Diidroartemisinina - piperaquina é uma combinação ideal devido à sua eficácia e longo efeito profilático pós-tratamento. A meia-vida de eliminação é de 13,5-28 dias (1). • Piperaquina prolonga o intervalo QT e não deve ser utilizado com medicação que prolongue o intervalo QT ou nos pacientes com prolongamento do QT congénito (1) Excluir os pacientes com prolongamento do QT congénito não seria viável na AMM. Um único relato de morte súbita inexplicável considerado potencialmente relacionado com a cardiotoxicidade letal foi notificado entre aproximadamente 200 000 pessoas acompanhadas muito de perto após o tratamento com este medicamento (2-4). • Diidroartemisinina-piperaquina devem ser de preferência administradas a uma pessoa com o estômago vazio, uma vez que as refeições ricas em gorduras aceleram a absorção da piperaquina, aumentando o risco de prolongamento do intervalo QT. Cada dose deve ser tomada pelo menos 3 horas após a última ingestão de alimentos; nenhum alimento deve ser ingerido num período de 3 horas após cada dose. 64 ARTESUNATO - AMODIAQUINA Doses recomendadas: PESO CORPORAL (KG) IDADE (APROXIMADAMENTE) DOSES (MG) DE ARTESUNATO + AMODIAQUINA DIARIAMENTE DURANTE 3 DIAS 4,5 a < 9 2–11 meses 25 + 67,5 9 a < 18 1-5 anos 50 + 135 18 a < 36 6-13 anos 100 + 270 ≥ 36 ≥ 14 anos 200 + 540 Formulações disponíveis: Combinação de dose fixa em comprimidos contendo: • Artesunato 25 mg e amodiaquina 67,5 mg • Artesunato 50 mg e amodiaquina 135 mg • Artesunato 100 mg e amodiaquina 270 mg Apresentações: • Embalagem contendo 4,5 a < 9 kg (bebé): 3 comprimidos de artesunato 25 mg e amodiaquina 67,5 mg • Embalagem contendo 9 a < 18 kg (criança pequena): 3 comprimidos de artesunato 50 mg e amodiaquina 135 mg • Embalagem contendo 18 a < 36 kg (criança): 3 comprimidos de artesunato 100 mg e amodiaquina 270 mg • Embalagem contendo ≥ 36 kg (adulto): 6 comprimidos de artesunato 100 mg e amodiaquina 270 mg Comentários: • A combinação artesunato-amodiaquina está associada a neutropenia, especialmente em pacientes seropositivos com zidovudina e/ou cotrimoxazol. O uso concomitante de efavirenz pode também aumentar a hepatotoxicidade de amodiaquina (1). • Embora haja poucos dados disponíveis, artesunato-amodiaquina está associado ao prolongamento do intervalo QT semelhante a outros medicamentos antipalúdicos como quinino, cloroquina e diidroartemisinina- piperaquina. Não foi notificada nenhuma morte súbita inexplicável causada por arritmia cardíaca nas doses utilizadas para o tratamento do paludismo, apesar do uso generalizado sugerir que, embora a cardiotoxicidade possa ocorrer, é rara (4). • Meia-vida de eliminação: 4–10 dias (1). AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 65 ARTESUNATO-MEFLOQUINA Dose recomendada: PESO CORPORAL (KG) IDADE (APROXIMADAMENTE) DOSES (MG) DE ARTESUNATO + MEFLOQUINA DIARIAMENTE DURANTE 3 DIAS 5 a < 9 6 a 12 meses 25 + 55 9 a < 18 1 a 6 anos 50 + 110 18 a < 30 7 a 12 anos 100 + 220 ≥ 30 ≥ 13 anos 200 + 440 Formulações disponíveis: combinação de dose fixa em: • Comprimidos pediátricos contendo artesunato 25 mg e hidrocloreto de mefloquina 55 mg (equivalente a mefloquina base 55 mg) • Comprimidos para adultos contendo artesunato 100 mg e hidrocloreto de mefloquina 220 mg (equivalente a mefloquina base 200 mg) Apresentações: • Faixa de 3 comprimidos contendo artesunato 25 mg e hidrocloreto de mefloquina 55 mg (equivalente a mefloquina base 50 mg) • Faixa de 6 comprimidos contendo artesunato 25 mg e hidrocloreto de mefloquina 55 mg (equivalente a mefloquina base 50 mg) • Faixa de 3 comprimidos contendo artesunato 100 mg e hidrocloreto de mefloquina 220 mg (equivalente a mefloquina base 200 mg ) • Faixa de 6 comprimidos contendo artesunato 100 mg e hidrocloreto de mefloquina 220 mg (equivalente a mefloquina base 200 mg) Comentários: • Artesunato-mefloquina tem um longo efeito profilático pós-tratamento (meia-vida de eliminação, ≤ 3 semanas) (1), mas está associado a náuseas, vómitos e sintomas neuropsiquiátricos, o que pode reduzir a sua tolerabilidade nas operações da AMM. 66 ARTEMETER–LUMEFANTRINA Dose recomendada: PESO CORPORAL (KG) IDADE (APROXIMADAMENTE) DOSES (MG) DE ARTEMETER + LUMEFANTRINA UTILIZADAS DUAS VEZES POR DIA DURANTE 3 DIAS 5 a < 15 2 a 59 meses 20 + 120 15 a < 25 5 a 7 anos 40 + 240 25 a < 35 8 a 12 anos 60 + 360 ≥ 35 ≥ 13 anos 80 + 480 Formulações disponíveis: • Comprimidos dispersíveis ou padrão contendo artemeter 20 mg e lumefantrina 120 mg • Comprimidos padrão contendo artemeter 40 mg e lumefantrina 120 mg Apresentação: • Embalagem contendo 5 a < 15 kg: 6 comprimidos de artemeter 20 mg e lumefantrina 120 mg • Embalagem contendo 15 a < 25 kg: 12 comprimidos de artemeter 20 mg e lumefantrina 120 mg • Embalagem contendo 25 a < 35 kg: 18 comprimidos de artemeter 20 mg e lumefantrina 120 mg • Embalagem contendo ≥ 35 kg: 24 comprimidos de artemeter 20 mg e lumefantrina 120 mg Comentários: Artemeter-lumefantrina não é provavelmente uma escolha adequada para a AMM. • Actualmente é utilizada como tratamento de primeira linha em muitos países. • A complexidade do regime de tratamento de duas doses diárias provavelmente iria comprometer a adesão. • Tem um curto efeito profilático pós-tratamento (meia-vida de eliminação de 3-6 dias) (1). AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 67 ARTESUNATO + SULFADOXINA-PIRIMETAMINA Dose recomendada: PESO CORPORAL (KG) IDADE (aproximadamente) DOSE (MG) DE ARTESUNATO DADA DIARIAMENTE DURANTE 3 DIAS DOSES (MG) DE SULFADOXINA + PIRIMETAMINA DADAS COMO UMA ÚNICA DOSE NO PRIMEIRO DIA 5 a < 10 6–11 meses 25 250 + 12,5 10 a < 25 1-7 anos 50 500 + 25 25 a < 50 8-14 anos 100 1000 + 50 ≥ 50 ≥ 15 anos 200 1500 + 75 Formulações disponíveis: Embalagem alveolar (não há nenhuma combinação de dose fixa): • Comprimidos contendo artesunato 50 mg e comprimidos de combinação de dose fixa contendo sulfadoxina 500 mg e pirimetamina 25 mg Apresentações: • Embalagem contendo 3 comprimidos de artesunato 50 mg e 1 comprimido de sulfadoxina 500 mg e pirimetamina 25 mg • Embalagem contendo 6 comprimidos de artesunato 50 mg e 2 comprimidos de sulfadoxina 500 mg e pirimetamina 25 mg Comentários: • Artesunato-sulfadoxina+pirimetamina não existe como uma combinação de dose fixa, que implicaria a distribuição massiva de comprimidos de artesunato a granel, podendo conduzir à emergência da resistência. • Meia-vida de eliminação é de 4,1-10,9 dias para sulfadoxina e 2,5-18,8 dias para pirimetamina (1). • A combinação de sulfadoxina + pirimetamina - amodiaquina, actualmente utilizada no Sahel como quimioprevenção do paludismo sazonal, assegura a protecção contra a nova infecção por 28 dias; contudo, está disponível na formulação de uma co- embalagem e actualmente não é recomendada para indivíduos com mais de 5 anos de idade. A eficácia tanto de sulfadoxina-pirimetamina como de amodiaquina é limitada geograficamente devido ao aumento da resistência aos dois medicamentos. • Sulfadoxina + pirimetamina não deve ser administrada a pessoas que estejam a tomar cotrimoxazol (1). Referências 1. Guidelines for the treatment of malaria. 3rd edition. Geneva: World Health Organization; 2015 (http://www.who. int/malaria/publications/atoz/9789241549127/en/, consultado em 17 de Agosto de 2017). 2. Myint HY, Ashley EA, Daya NPJ, Nosten F, White NJ. Efficacy and safety of dihydroartemisinin-piperaquine. Trans R Soc Trop Med Hyg. 2007;101:858–66. 3. Kabanywanyi AM, Baiden R, Ali AM, Mahende MK, Ogutu BR, Oduro A et al. Multi-country evaluation of safety of dihydroartemisinin / piperaquine post-licensure in African public hospitals with electrocardiograms. PLoS One. 2016;11:e0164851. 4. A cardiotoxicidade de antipalúdicos. Relatório da Reunião do Grupo de Análise de Provas da OMS, 13-14 de Outubro de 2016, Genebra: Organização Mundial da Saúde; 2017 (http://www.who.int/malaria/mpac/mpacmar2017-erg- cardiotoxicity-report-session2.pdf, consultado em 17 de Agosto de 2017). 68 Anexo 3 EXEMPLO DE CÁLCULO DE PEDIDOS DE MEDICAMENTO ANTIPALÚDICO EXAMPLO DE CÁLCULO DE ARTESUNATO–AMODIAQUINA Artesunato-amodiaquina vem em comprimidos de combinação de dose fixa, em embalagens adequadas à idade, em quatro apresentações: Dose baseada no peso corporal ou idade PESO CORPORAL (KG) GRUPO ETÁRIO APROXIMADO APRESENTAÇÃO DA EMBALAGEM DOSAGEM 4,5 a < 9 kg 2–11 meses Comprimidos de 25 mg/67,5 mg em embalagens de 3 comprimidos 1 por dia durante 3 dias 9 a < 18 kg 1-5 anos Comprimidos de 50 mg/135 mg em embalagens de 3 comprimidos 1 por dia durante 3 dias 18 a < 36 6-13 anos Artesunato 100 mg + amodiaquina 270 mg em embalagens de 3 comprimidos 1 por dia durante 3 dias ≥ 36 ≥ 14 anos Artesunato 100 mg + amodiaquina 270 mg em embalagens de 6 comprimidos 2 por dia durante 3 dias Total da população 100 000 A distribuição por idade (da distribuição etária padrão dos países em desenvolvimento no Anexo 1): • 2-11 meses ≈ 4% (0-11 meses = 4%) • 1–5 anos = 12% • 6-13 anos ≈ 27% (5-14 anos = 27%) • ≥ 14 anos ≈ 57% (≥ 15 anos = 57%) AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 69 População alvo por grupo etário DISCRIMINAÇÃO POR GRUPO ETÁRIO (DE ACORDO COM A APRESENTAÇÃO DA EMBALAGEM) 2–11 MESES 12-59 MESES 5-13 ANOS ≥ 14 ANOS Percentagem da população total 100 000 × 0,04 100 000 × 0,12 100 000 × 0,27 100 000 × 0,57 Total da população por grupo etário 4000 12 000 27 000 57 000 Estimativa do número de tratamentos (= número de embalagens) por apresentação e requisito de volume 6-11 MESES 12-59 MESES 5-13 ANOS ≥ 14 ANOS TOTAL Para uma ronda 4 000 12 000 27 000 57 000 100 000 Para três rondas 12 000 36 000 81 000 171 000 300 000 25% estoque de segurança 3 000 9 000 20 250 42 750 75 000 Número total de tratamentos 15 000 45 000 101 250 213 750 375 000 Estimativa do volume por tratamento (em dm³) 0,02 0,03 0,04 0,04 Estimativa do total do volume (em dm³) 300 1 350 4 050 8 550 14 250 70 EXEMPLO DE CÁLCULO DE DIIDROARTEMISININA–PIPERAQUINA Diidroartemisinina-piperaquina está disponível como combinações de doses fixas em comprimidos contendo diidroartemisinina 40 mg e piperaquina 320 mg e em comprimidos pediátricos contendo diidroartemisinina 20mg e piperaquina 160 mg. Recomendações de doses da OMS com base no peso PESO CORPORAL (IDADE ESTIMADA) DOSE DIÁRIA DURANTE 3 DIAS CAPACIDADE DO COMPRIMIDO E NÚMERO DE COMPRIMIDOS POR DOSE 5 a < 8 kg (2–11 meses) 20 + 160 1 comprimido x 20 mg/160 mg 8 a < 11 kg (12-23 meses) 30 + 240 1½ comprimido x 20 mg/160 mg 11 a < 17 kg (2-4 anos) 40 + 320 1 comprimido x 40 mg/320 mg 17 a < 25 kg (5-7 anos) 60 + 480 1½ comprimido x 40 mg/320 mg 25 a < 36 kg (8-13 anos) 80 + 640 2 comprimidos x 40 mg/320 mg 36 a < 60 kg (≥ 14 anos) 120 + 960 3 comprimidos x 40 mg/320 mg 60 a < 80 kg (adultos) 160 + 1280 4 comprimidos x 40 mg/320 mg ≥ 80 kg (adultos) 200 + 1600 5 comprimidos x 40 mg/320 mg Total da população 100 000 Distribuição etária (com base na distribuição etária padrão dos países em desenvolvimento, Anexo 1): • 2-11 meses ≈ 4% (0-11 meses = 4%) • 12-23 meses = 3% • 2-4 anos ≈ 9% (2-5 anos) • 5-7 anos ≈ 9% (5-14 anos = 27%) • 8-13 anos ≈ 18% (5-14 anos = 27%) • ≥ 14 anos ≈ 57% (≥ 15 anos = 57%) População alvo por grupo etário GRUPO ETÁRIO 2-11 MESES 12-23 MESES 2-4 ANOS 5-7 ANOS 8-13 ANOS ≥ 14 ANOS Percentagem da população total 100 000 x 0,04 100 000 x 0,03 100 000 x 0,09 100 000 x 0,09 100 000 x 0,18 100 000 x 0,57 Total da população por grupo etário 4 000 3 000 9 000 9 000 18 000 57 000 AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 71 Estimativa do número de tratamentos (= número de embalagens) por apresentação REQUISITO DIIDROARTEMISININA/PIPERAQUINA 20 mg/160mg Embalagem de 3 comprimidos 40 mg/320mg Embalagem de 3 comprimidos 40 mg/320mg Embalagem de 6 comprimidos 40 mg/320mg Embalagem de 9 comprimidos 40 mg/320mg Embalagem de 12 comprimidos 1 ronda 10 000 9 000 27 000 28 500 28 500 3 rondas 30 000 27 000 81 000 85 500 85 500 25% estoque de segurança 7 500 6 750 20 250 21 375 21 375 Número total de tratamentos 37 500 33 750 101 250 106 875 106 875 O total do número solicitado deve ser ajustado de acordo com as existências, pedidos em atraso e outras fontes. 72 Anexo 4 EXEMPLO DE UM CRONOGRAMA DE ADMINISTRAÇÃO MASSIVA DE MEDICAMENTOS PARA O PALUDISMO (DISTRIBUIÇÃO EM 8 SEMANAS) DATAS Pessoa Responsável W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 FI M Coordenação Criação de grupo de trabalho e definição da composição Definição de funções, tarefas Criação de subcomités Reunião do grupo de trabalho Reunião dos Subcomités (Níveis Nacional & Distrital) Proposta escrita de AMM Desenvolvimento de ferramentas Realizar micro- planeamento a nível distrital Relatório final Medicamentos antipalúdicos Estimativa das necessidades de medicamentos Verificar os estoques existentes/pedidos em atraso Efectuar pedido de medicamentos Recepção de pedido de medicamentos Gestão de Estoques (cartões, número de lote) Distribuição de medicamentos a nível distrital Posicionamento prévio de medicamentos nas estruturas de saúde periféricas AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 73 DATAS Pessoa Responsável W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 FI M Outros equipamentos (suprimentos da equipa, ferramentas de recolha de dados, artigos de papelaria, etc.). Estimativa das necessidades Avaliação dos recursos disponíveis Pedido de outros materiais necessários Recepção dos fornecimentos Preparação de kits Distribuição de fornecimentos a nível distrital Posicionamento prévio de kits logísticos nas estruturas de saúde periféricas Logística e transporte Avaliação das necessidades Avaliação dos recursos disponíveis Pedido ou aluguer de veículos Verificação e manutenção Plano de circulação de veículos e seguimento Recursos humanos Estimativa das necessidades Avaliação do pessoal disponível Selecção e recrutamento de pessoal em falta Identificação de alocação de funcionários e supervisores Criação de materiais de formação Formação de formadores Formação de supervisores Formação de equipas de distribuição Formação de monitores 74 DATAS Pessoa Responsável W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 FI M Formação de equipas de vigilância de segurança dos medicamentos Supervisão Salários/ajudas de custo Mobilização social Desenvolvimento de um plano de comunicação Elaboração de mensagens-chave. Produção e distribuição de material de IEC Reuniões de sensibilização com principais intervenientes a nível nacional Reuniões de sensibilização com principais intervenientes a nível distrital Sensibilização de grupos específicos a nível comunitário (líderes tradicionais, autoridades, líderes religiosos, grupos de mulheres, etc.). Sensibilização casa a casa e rua a rua Pregoeiros públicos/ megafones Conferência de imprensa Monitorização da imprensa Planeamento de programação e anúncios de rádio e TV Participação nos debates em painel na rádio/TV Elaboração de anúncios radiofónicos Difusão de anúncios radiofónicos AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 75 DATAS Pessoa Responsável W 1 W 2 W 3 W 4 W 5 W 6 W 7 W 8 W 9 W 10 W 11 W 12 W 13 W 14 W 15 W 16 FI M Locais de distribuição (para estratégias centralizadas apenas) Definição do número de locais necessários Identificação dos locais Visita aos locais Organização de locais para distribuição (mesas, cadeiras, etc.). Distribuição de medicamentos antipalúdicos Preparação de materiais Verificação de materiais Abastecimento durante a campanha Implementação da primeira ronda Implementação da segunda ronda Implementação da terceira ronda Actividades de supervisão Monitorização e avaliação Análise de dados Avaliação da cobertura da distribuição Monitorização das actividades Inquérito posterior à distribuição 76 ÁR EA O CI DE NT AL U RB AN A PO PU LA ÇÃ O P O R G RU PO ET ÁR IO (+ 5 % ES TO Q UE D E SE G UR AN ÇA ) VO LU M E DA C AI XA (M 3 ) VOLUME TOTAL Nº No m e do e st ab el ec im en to Ti po d e es ta be le ci m en to Pr op rie tá rio Lo ca lid ad e Co m un id ad e lo ca l/z on a Po pu la çã o EG SD P op ul aç ão E G SD + 5% e st oq ue d e se gu ra nç a 6– 11 m es es (2 %) 12 -5 9 m es es (1 3, 7% ) 5- 13 an os (2 8% ) > 14 an os (5 4, 5% ) 6– 11 m es es (2 %) 12 -5 9 m es es (1 3, 7% ) 5- 13 an os (2 8% ) > 14 an os (5 4, 5% ) 12 W el lin gt on C C S G ov W el lin gt on 1 34 4 60 36 18 3 72 4 49 57 10 13 1 19 7 20 0, 09 0, 60 1,2 2 3, 16 5, 05 14 Ko ya T ow n C C S G ov U pp er W el lin gt on 1 10 0 93 10 5 98 21 2 14 52 29 67 57 76 0, 03 0, 18 0, 36 0, 93 1,4 8 16 Al le n To w n C C S G ov Al le n To w n 1 40 16 1 42 16 9 84 3 57 77 11 8 07 22 9 82 0, 10 0, 69 1,4 2 3, 68 5, 89 19 Al -K ha ta b C lín ic a C C S M is sã o C al ab a To w n 1 10 5 99 11 12 9 22 3 15 25 31 16 60 65 0, 03 0, 18 0, 37 0, 97 1,5 6 20 C al ab a To w n C C S G ov C al ab a To w n 1 20 3 30 21 3 47 42 7 29 24 59 77 11 6 34 0, 05 0, 35 0, 72 1,8 6 2, 98 22 St L uk e' s C lin ic C lín ic a M is sã o C on go W at er 1 17 9 51 18 8 49 37 7 25 82 52 78 10 2 72 0, 05 0, 31 0, 63 1,6 4 2, 63 34 AW AK E C lín ic a Pr iv ad o Al le n To w n 1 42 30 44 42 89 60 8 12 44 24 21 0, 01 0, 07 0, 15 0, 39 0, 62 41 Fa m ily H om e M ov em en t PS C M is sã o U pp er C al ab a To w n 1 86 03 90 33 18 1 12 38 25 29 49 23 0, 02 0, 15 0, 30 0, 79 1,2 6 44 Ad -B an gs Q ua rr y PS M I G ov Bl ac kh al l R oa d 1 10 0 39 10 5 41 21 1 14 44 29 51 57 45 0, 03 0, 17 0, 36 0, 92 1,4 8 48 M ay em ie PS M I G ov M ay em ie 1 12 6 02 13 2 32 26 5 18 13 37 05 72 11 0, 03 0, 22 0, 45 1,1 5 1,8 5 54 Ph ili p St re et PS M I Pr iv ad o Ph ili p St re et 1 10 6 15 11 14 6 22 3 15 27 31 21 60 74 0, 03 0, 18 0, 38 0, 97 1,5 6 63 O ld D om in io n (P AV ) H os pi ta l Pr iv ad o U pp er M el lo n W el lin gt on 1 10 3 00 10 8 15 21 6 14 82 30 28 58 94 0, 03 0, 18 0, 36 0, 94 1,5 1 To ta l d a Ár ea O ci de nt al 1 1 41 7 38 1 1 98 8 25 23 9 76 16 4 23 9 33 5 67 16 53 3 60 13 0 67 89 5 10 18 2 94 1 35 6 08 1 7 12 2 EG SD , e qu ip a de g es tã o da s aú de d ist rit al ; m = m es es ; y = an os ; C C S, c en tro c om un itá rio d e sa úd e; P SC , p os to d e sa úd e da c om un id ad e; PS M I, po st o de s aú de m at er na e in fa nt il; P AV , P ro gr am a Al ar ga do d e Va ci na çã o An ex o 5 EX EM PL O D E M IC RO -P LA NE AM EN TO N A ÁR EA O CI D EN TA L UR BA NA , S ER RA L EO A De sc riç ão d e ca da u ni da de d e sa úd e, p op ul aç ão -a lv o po r i ns ta la çã o, d ist rib ui çã o et ár ia e vo lu m e do m at er ia l AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 77 Zo na No m e do es ta be le ci m en to Nº Po pu la çã o to ta l p or es ta be le ci m en to Fa m íli as p or es ta be le ci m en to Fa m íli as /d ia Fa m íli as /d ia / eq ui pa Nº d e eq ui pa s ne ce ss ár ia s Nº d e eq ui pa s pr op os ta s Nº d e su pe rv iso re s d e eq ui pa s Nº d e T CS pr op os to s 1 W el lin gt on 12 34 4 60 68 92 17 23 30 57 ,4 57 11 114 Ko ya To w n 14 10 0 93 20 19 50 5 30 16 ,8 17 3 34 Al le n To w n 16 40 16 1 80 32 20 08 30 66 ,9 67 13 13 4 Al -K ha ta b Cl in ic 19 10 5 99 21 20 53 0 30 17 ,7 18 3 36 Ca la ba To w n CC S 20 20 3 30 40 66 10 17 30 33 ,9 34 7 68 St L uk e' s C lin ic 22 17 9 51 35 90 89 8 30 29 ,9 30 6 60 AW AK E Cl in ic 34 4 23 0 84 6 21 2 30 7,1 7 1 14 Fa m ily H om e M ov em en t 41 8 60 3 17 21 43 0 30 14 ,3 14 3 28 Ad -B an gs Q ua rr y 44 10 0 39 20 08 50 2 30 16 ,7 17 8 34 M ay em ie 48 12 6 02 25 20 63 0 30 21 ,0 21 42 Ph ilip S tre et 54 10 6 15 21 23 53 1 30 17 ,7 18 7 36 O ld D om in io n (P AV ) 63 10 3 00 20 60 51 5 30 17 ,2 17 34 H ol y M ar y Cl in ic 64 5 80 0 116 0 29 0 30 9, 7 10 2 20 To ta l d a Zo na 1 30 32 7 64 65 4 Nú m er os d e eq ui pa s e re cu rs os h um an os n ec es sá rio s po r á re a de a br an gê nc ia 78 Re qu is ito s de m at er ia l p or e qu ip a po r á re a de a br an gê nc ia U SP , u ni da de d e sa úd e pe rif ér ic a; A S- AQ , a rte su na to + a m od ia qu in a Nº de USP Número de equipas propostas Prancheta (1/equipa) Caneta (4/equipa) Mochila (2/equipa) Suporte de crachá (2/equipa) Crachá para TCS (2/equipa) Folha de controlo diário (2/Equipa e dia) Formulário de resumo diário (1/dia / 20 equipas) Lista de verificação de supervisão (1/dia / 20 equipas) Nota de informação dos TCS (2/supervisor) Folheto sobre AS–AQ, 2 faces, laminadas Ficha de inventário (20/PHU) Crachá para supervisor (1 /supervisor) Suporte de crachá para supervisor Pasta com clip (2 por supervisor) Bloco de notas A5 (2/supervisor) Caneta azul (2/supervisor) Bloco de notas fino A5 (2/equipa) Marcador permanente (1/5 /equipas) Bolsa de plástico para SC (1 /supervisor) Dosagem (1/família) Pasta de plástico para documentos (1/equipa) Saco de plástico (1/equipa) 12 57 57 22 8 114 114 114 45 6 12 12 4 114 20 11 11 22 22 22 114 12 11 30 57 57 14 17 17 68 34 34 34 13 6 4 4 2 34 20 3 3 6 6 6 34 4 3 30 17 17 16 67 67 26 8 13 4 13 4 13 4 53 6 14 14 4 13 4 20 13 13 26 26 26 13 4 14 13 30 67 67 19 18 18 72 36 36 36 14 4 4 4 2 36 20 3 3 6 6 6 36 4 3 30 18 18 20 34 34 13 6 68 68 68 27 2 7 7 4 68 20 7 7 14 14 14 68 7 7 30 34 34 22 30 30 80 40 40 40 16 0 4 4 2 40 20 6 6 12 12 12 40 4 6 30 20 20 34 7 7 28 14 14 14 56 2 2 2 14 20 1 1 2 2 2 14 2 1 30 7 7 41 14 14 56 28 28 28 112 4 4 2 28 20 3 3 6 6 6 28 3 3 30 14 14 44 17 17 68 34 34 34 13 6 4 4 2 34 20 8 8 16 16 16 34 4 8 30 17 17 48 21 21 84 42 42 42 16 8 5 5 2 42 42 5 30 21 21 54 18 18 72 36 36 36 14 4 4 4 2 36 20 7 7 14 14 14 36 4 7 30 18 18 63 17 17 68 34 34 34 13 6 4 4 0 34 34 4 30 17 17 64 10 10 40 20 20 20 80 2 2 0 20 20 2 2 4 4 4 20 2 2 30 10 10 … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … … 68 1 8 29 1 8 29 7 31 6 3 65 8 3 65 8 3 65 8 14 6 32 38 6 38 6 14 60 36 58 13 60 73 0 73 0 14 60 14 60 14 60 3 65 8 1 8 29 73 0 2 04 0 1 8 29 1 8 29 AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 79 Anexo 6 PROCEDIMENTO PASSO A PASSO PARA A COLOCAÇÃO DOS MATERIAIS Identificar e formar a pessoa que será responsável pelo acompanhamento e gestão dos estoques em cada ponto de distribuição. Entregar o material. Calcular a quantidade de medicamentos a ser enviada a cada ponto de distribuição, de acordo com a estimativa da população-alvo da área de abrangência por grupo etário. Incluir um estoque de reserva Poderá ser aconselhável manter parte do estoque de reserva (cerca de metade), num local de armazenamento central ou distrital para garantir a capacidade de reagir à escassez imprevista. Organizar todos os outros materiais logísticos necessários em kits para simplificar a distribuição. Os quantitativos por kit devem ser calculados de acordo com o número de equipas e de supervisores. Calcular o volume e o peso dos suprimentos para organizar o transporte adequado. Utilizar ferramentas de rastreio, com conhecimentos de guia de embarque, para transporte de suprimentos, com indicação de dados de quantidades e números de lote para garantir a rastreabilidade. Na recepção do pedido, a pessoa responsável em cada unidade de saúde periférica deve verificar se as mercadorias entregues estão em conformidade com as indicadas na guia de embarque antes de assinar o formulário do recibo. CC: Icones criados por Gan Khoon Lay, BomSymbols, Symbolon, Jose Morban, Sribala, David, BomSymbols Maxim David, ProSymbols para o Projecto de Nomes 1 4 7 2 5 3 6 80 Anexo 7 EXEMPLO DE ANÚNCIO RADIOFÓNICO SOBRE AMM PARA O PALUDISMO (UTILIZADO NA SERRA LEOA EM 2014-2015) V1. Bom dia, amigo(a)!! V2. Bom dia. Como está? V1. Estou bem. Ontem, recebi a embalagem para o tratamento do paludismo. Recebeu? V2. Sim. Eu e toda a minha família tomámos a primeira dose ontem à tarde. E vocês? V1. Não, não tomámos. V2. Por que não tomaram o medicamento? V1. Porque ninguém na família tem febre. V2. Na nossa família ninguém tinha febre, mas tomámos o medicamento para prevenir a febre do paludismo, porque não queremos ficar doentes. V1. Mas nunca tomámos o medicamento quando não estamos doentes. Porque devemos fazer isso agora? V2. Porque existe actualmente um surto da DVE, e se tiver febre, pode-se suspeitar que tenha DVE Muitos sintomas da DVE podem ser confundidos com os sintomas do paludismo. (*) De qualquer modo, você e a sua família ficarão protegidos contra o paludismo durante 1 mês e é gratuito. V1: Está bem, tem razão. Vou para a casa agora e iniciarei o tratamento com a minha família. V2: Lembra-se como se deve tomar o medicamento? V1: Sim. O trabalhador comunitário de saúde explicou-me que temos de tomá-lo durante três dias consecutivos para terminar o tratamento adequadamente. V2: Tem alguma outra dúvida? V1: Não, vamos tomar os comprimidos de acordo com a faixa etária como o TCS me disse. Mas se eu tiver alguma dúvida vou perguntar ao TCS. V2: Boa!!!! Tenha um bom dia V1: O mesmo para si e obrigado. Agora ficaremos livres do paludismo!!!! *Esta secção deve ser adaptada a cada situação de AMM AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 81 Anexo 8 EXEMPLOS DE PONTOS DE DISCUSSÃO SOBRE AMM PARA UTILIZAÇÃO NAS REUNIÕES COMUNITÁRIAS (ADAPTADOS DOS UTILIZADOS NA SERRA LEOA EM 2014-2015) 1. O que é AMM? 2. Objectivo da campanha 3. A medicação, como tomá-la e os critérios de exclusão A medicação: Como tomá-la Critérios de exclusão (pessoas que NÃO devem tomá-la) Continue a tomar o medicamento e a dosagem para a faixa etária. Doses erradas podem causar: • Tratamento incompleto = protecção incompleta • Overdose = aumento de possíveis efeitos secundários 4. Possíveis efeitos secundários e o que fazer 5. Explicação do processo 6. Funções dos líderes comunitários • assegurar a sensibilização da comunidade e aceitação da campanha • sensibilizar sobre a importância da adesão (realizando o tratamento completo) • assegurar a sensibilização da dosagem correcta 7. Papel dos distribuidores e TCS • sensibilizar a comunidade antes e durante a AMM • distribuir comprimidos antipalúdicos aos beneficiários identificados • Registar todos os medicamentos distribuídos com as ferramentas de recolha de dados 8. Membros da equipa: Dois TCS por equipa serão alocados por área e comunidade. 82 Anexo 9 VISITA DOMICILIAR PARA A AMM, PASSO A PASSO ADMINISTRAÇÃO MASSIVA DE MEDICAMENTOS. VISITA DOMICILIAR PASSO A PASSO Obter consentimento oral para participar. Cumprimentar as pessoas de forma educada na língua local e apresentar-se. Perguntar pelo chefe de família, e verificar se todos os membros da família estão presentes. Explicar os objectivos e fornecer informações sobre a AMM utilizando recursos visuais. Verificar os critérios de elegibilidade Critérios de exclusão » Primeiro trimestre de gravidez » Bebés com menos de 6 meses de idade » Alergia conhecida a qualquer dos medicamentos » Pacientes gravemente doentes » Contra-indicações aos medicamentos Explicar às pessoas excluídas porque não recebem o tratamento. Distribuição de uma embalagem apropriada de acordo com a faixa etária. Administrar a primeira dose no âmbito de TDO. Para crianças pequenas, triturar o comprimido e dissolvê-lo com água. Repetir a dose se o vómito ocorrer antes de 30 minutos apos administração. Educar os participantes sobre como tomar as doses restantes no segundo e terceiro dia utilizando um recurso visual para apoiar as explicações e/ou folhetos impressos. Fornecer mensagens claras sobre a necessidade de garantir a adesão ao tratamento completo. Fornecer informações sobre possíveis efeitos secundários e o que fazer no caso de ocorrerem. Para mulheres em idade fértil (15-49 anos de idade): » Se as mulheres estiverem visivelmente grávidas (provavelmente no segundo ou terceiro trimestre): podem receber o medicamento » Se a gravidez não for visível: gravidez no primeiro trimestre deve ser excluída, quer com base na história pessoal ou no teste de gravidez Perguntar aos membros da família se têm quaisquer perguntas específicas e esclarecer quaisquer dúvidas que possam ter. Marcar a folha de controlo depois de a pessoa ter tomado a primeira dose e/ ou preencher o livro de registo. Agradecer aos membros da família e avançar para a casa seguinte. Quando for adequado, à partida, marcar a casa com giz: “completo”, “incompleto” ou se ninguém estiver em casa no momento da visita, não se deve marcar. Visitar de novo a casa mais tarde no dia ou no dia seguinte, se a distribuição foi incompleta ou se ninguém estava em casa. 1 4 7 8 9 10 5 2 3 6 CC: Icons created by Wilson Joseph, Gregor Cresnar, Dinosoft Labs, 23 icons, Yorlmar Campos, To Uyen, Loudoun Design Co., Arthur Shlain, from the Noun Project AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 83 Anexo 10 ALGORITMO PARA AJUDAR OS TRABALHADORES COMUNITÁRIOS DE SAÚDE NA APLICAÇÃO DOS CRITÉRIOS DE EXCLUSÃO * Uma lista de medicamentos que prolongam o intervalo QT, que estão disponíveis e são os mais frequentemente utilizados no país, deve ser dada ao TCS. DHA-PPQ, diidroartemisinina-piperaquina; AS-AQ, artesunato–amodiaquina Perguntar e observar se a pessoa está gravemente doente. Não administrar o medicamento antipalúdico e encaminhar à unidade de saúde mais próxima. Não administrar medicamento antipalúdico. A pessoa não está a tomar outra medicação Administrar o medicamento antipalúdico, e aconselhar o paciente onde procurar tratamento se ocorrências adversas surgirem Não administrar DHA-PPQ ou AS-AQ. Não administrar AS-AQ. A pessoa está a tomar medicação sem nenhuma interacção conhecida. A pessoa está a tomar medicação que prolonga o intervalo QT* A pessoa está a tomar zidovudina, efavirenz ou cotrimoxazol Seguir o algoritmo para excluir a gravidez. Trata-se de uma mulher em idade reprodutiva (15-49 anos de idade)? Perguntar sobre alergia conhecida a Medicamento antipalúdico ou outra ACT. Pergunte se a pessoa está a tomar qualquer medicamento e, em caso afirmativo, deve mostrar-lho. Sim Não Não Não Sim Sim 84 Anexo 11 ALGORITMO PARA DETERMINAR O ESTADO DE GRAVIDEZ DE MULHERES EM IDADE REPRODUTIVA (15-49 ANOS) (COM BASE E ADAPTADO DOS ALGORITMOS UTILIZADOS NA AMM PARA O PALUDISMO EM MOÇAMBIQUE PELO CENTRO DE INVESTIGAÇÃO EM SAÚDE DE MANHIÇA) Garantir a privacidade e explicar os riscos e benefícios de TCA na gravidez AdultoAdolescente Presumir não estar grávida Visivelmente grávida Assumir no segundo ou terceiro trimestre Administrar TCA Não administrar TCA Gravidez não evidente Positivo Considerar que a mulher pode estar no primeiro trimestre Recusa o teste de gravidez Informar não estar grávida ou não sabe Perguntar se os períodos menstruais iniciaram Perguntar sobre o estado de gravidez Negativo Proporcionar opções de acordo com os riscos e benefícios Proporcionar um teste de gravidez Não Sim Sim Relatar a gravidez AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 85 Anexo 12 EXEMPLO DE FOLHETO LAMINADO UTILIZADO PELOS TRABALHADORES COMUNITÁRIOS DE SAÚDE NA SERRA LEOA EM 2014-2015 PARA EXPLICAR A DOSAGEM DE TRATAMENTO • Tomar os comprimidos APENAS de acordo com a idade. • Tomar comprimidos diariamente durante 3 dias consecutivos (ao mesmo tempo). 1º DIA 2º DIA 3º DIA 6-11 meses 1 comprimido infantil triturado 1 comprimido infantil triturado 1 comprimido infantil triturado 1-5 anos 1 comp. para criança de tenra idade 1 comp. para criança de tenra idade 1 comp. para criança de tenra idade 6-13 anos 1 comprimido para criança 1 comprimido para criança 1 comprimido para criança Adulto 2 comprimidos para adulto 2 comprimidos para adulto 2 comprimidos para adulto • Para crianças, triturar o comprimido numa colher limpa e misturar com água. • Este tratamento pode causar efeitos secundários temporários (vómitos, cefaleia, tontura, coceira da pele), o que pode durar por 1 ou 2 horas • Este tratamento protege contra o paludismo durante UM mês 86 An ex o 13 FO LH A D E CO NT RO LO D IÁ RI O - A M M C O NT RA O P AL UD IS M O To ta l d e Ca sa s v is ita da s O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O T ot al : ST AT US D E RE SI DÊ NC IA RE SI DÊ NC IA VI SI TA NT E O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : N úm er o da E qu ip a ... ... ... ... ... ... ... ... ... ... ... D at a ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . D ia d a ca m pa nh a ... ... ... ... ... ... ... ... ... ... .. D ist rit o: . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 6- 11 M ES ES 1- 5 AN O S 6- 13 A NO S IG UA L E SU PE RI O R A 14 A NO S Total distribuído Tr at am en to s di st ri bu íd os O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : Total de Excluídos Ca so s e xc lu íd os d ev id o a re cu sa d e pa rt ic ip aç ão O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : Ca so s e xc lu íd os d ev id o a gr av id ez (1 º t rim es tr e) O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : Ca so s e xc lu íd os d ev id o a ou tr os c rit ér io s d e ex cl us ão O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O To ta l : Zo na / Á re a: . ... ... ... ... ... ... ... ... ... ... ... ... ... .. Ár ea d e ab ra ng ên ci a da u ni da de d e sa úd e: . ... ... ... ... ... ... ... ... .. Vi la /b ai rr o: .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . EX EM PL O D E FO LH A D E CO NT RO LO M on ito riz aç ão d iá ria d e co ns um o de m ed ic am en to s an tip al úd ic os N ot a: o s gr up os e tá rio s de ve m s er a da pt ad os à a pr es en ta çã o da s em ba la ge ns d e m ed ic am en to s an tip al úd ic os u til iz ad os N om e do C he fe d e Eq ui pa : . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... N om e do S up er vi so r: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . PA CO TE D E EM BA LA GE NS NÚ M ER O D E EM BA LA GE NS R EC EB ID AS NÚ M ER O D E EM BA LA GE NS R ES TA NT ES N O F IN AL D O D IA NÚ M ER O D E EM BA LA GE NS U TI LI ZA DA S Em ba la ge ns 2 -1 1 m es es (4 ,5 - 9 k g) Em ba la ge ns 1- 5 an os (9 -1 8 kg ) Em ba la ge ns 6 -1 3 m es es (1 8- 35 k g) Em ba la ge ns ≥ 14 a no s ( > 35 k g) (A DA PT AD O D A FO LH A UT IL IZ AD A NA SE RR A LE O A EM 2 01 4- 20 15 ) AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 87 An ex o 14 EX EM PL O D E UM F O RM UL ÁR IO D E RE G IS TO D E FA M ÍL IA S (A DA PT AD O D O M AN UA L D E D IS TR IB UI Ç ÃO D O P RO G RA M A D E A M M D A ZÂ M BI A) FO RM UL ÁR IO D E RE G IS TO D E FA M ÍL IA S Número do Domicílio Familiar/ID Chefe de família Data Nome de participante Idade (anos) Sexo (M/F) Relação ao chefe de família Ocupação (C: criança, E: estudante, DC: dona de casa, A: agricultor, D: desempregado, O: outro) Status de residência (P: residente permanente, T: residente temporário, V: visitante) Presente na hora da visita (S/N) Tratamento efectuado (S/N) Se o tratamento não foi efectuado, Indicar motivo. (R: recusa, CE: critério cde exclusão ) Mencionar o motivo da recusa em relação à participaçãoo DO T Comentários D1 D2 D3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15D ist rit o: .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. Zo na : ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... N om e do T C S: .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... Ár ea d e ab ra ng ên ci a da u ni da de d e sa úd e: . ... ... ... ... ... ... ... ... N om e da V ila : .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. 88 Anexo 15 EXEMPLO DE LISTA DE VERIFICAÇÃO DOS SUPERVISORES UTILIZADA NA SERRA LEOA EM 2014-2015 AMM CASA A CASA NA SERRA LEOA DE ASAQ-DEZEMBRO DE 2014 Lista de verificação do supervisor para as Equipas de Casa a Casa 1. Todos os membros da equipa estão presentes? S ou N 2. Algum dos membros da equipa é um TCS na área? S ou N 3. Quantos membros da equipa foram formados? Escreva o número 4. A equipa carrega algum mapa/plano de deslocação? S ou N 5. A equipa tem giz suficiente para a marcação das casas? S ou N 6. A equipa tem doses suficientes de ASAQ para todas as categorias? S ou N 7. A equipa tem todas as ferramentas de gravação? S ou N 8. A equipa regista as informações no formulário adequado? S ou N 9. Os membros da equipa marcam as casas antes de saírem? S ou N 10. A equipa foi supervisionada pelo menos uma vez por dia pelo supervisor da equipa (no terreno)? S ou N 11. O supervisor assinou e indicou a hora da visita na folha de controlo diário? S ou N 13. A equipa teve algum problema que exigiu intervenção imediata? S ou N Se sim explicar na área para comentários. Comentários: 12. As equipas estão a cumprir a meta diária? S ou N Se não, apresente a(s) razão(ões) e acção prevista: A. .......................................................................................................................... B. .......................................................................................................................... C. ......................................................................................................................... NÚMERO DE EQUIPAS 1 2 3 4 5 Distrito: .............................................................................. Comunidade local/Zona: ............................................ Urbana Rural Nome do Supervisor: ...................................................... Função: ............................................................................. Data: .................................................................................. INSTRUÇÕES Utilizar este formulário para supervisionar a distribuição de equipas de ASAQ durante a implementação da Administração Massiva de Medicamentos. Tomar medidas correctivas conforme necessário. Dar feedback à equipa após a supervisão. Agradecer e incentivar as equipas. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 89 Anexo 16 EXEMPLO DE CARTÃO DE AMM CARTÃO DE AMM CONTRA O PALUDISMO DESTINADA AOS PARTICIPANTES DATA TRATAMENTO PROPORCIONADO NÚMERO DE COMPRIMIDOS TDO (S/N) OBSERVAÇÕES 1ª RONDA D1 D2 D3 2ª RONDA D1 D2 D3 3ª RONDA D1 D2 D3 Distrito: .............................................................................. Nome: ................................................................................ Endereço: ......................................................................... Centro de Saúde: .......................................................... Idade: ............................................................................... Peso: .................................................................................. 90 Anexo 17 EXEMPLO DE FOLHA DE RESUMO DIÁRIO A SER PREENCHIDA PELOS SUPERVISORES DAS EQUIPAS DE DISTRIBUIÇÃO (ADAPTADA DA UTILIZADA NA SERRA LEOA EM 2014-2015) FOLHA DE RESUMO DIÁRIO - AMM PARA O PALUDISMO Nota: os grupos etários devem ser adaptados à apresentação das embalagens de medicamentos antipalúdicos utilizados Supervisor: .............................................................. Data: ......................................................................... Dia da campanha: ............................................... Distrito: .................................................................................. Zona/área: ........................................................................... Área de abrangência da unidade de saúde: ................ Status de residência 6 a 11 meses 1 a 5 anos 6 a 13 anos Igual e superior a 14 anos NÚ M ER O D E EQ UI PA S NÚ M ER O D E FA M ÍL IA S VI SI TA DA S RE SI DE NT ES VI SI TA NT ES TO TA L DE T RA TA M EN TO S DI ST RI BU ÍD O S EX CL UÍ DO S DE VI DO A R EC US A DE PA RT IC IP AÇ ÃO EX CL UÍ DO S DE VI DO A O UT RO S CR IT ÉR IO S DE EX CL US ÃO TO TA L DE T RA TA M EN TO S DI ST RI BU ÍD O S EX CL UÍ DO S DE VI DO A R EC US A DE PA RT IC IP AÇ ÃO EX CL UÍ DO S DE VI DO A O UT RO S CR IT ÉR IO S DE E XC LU SÃ O TO TA L DE T RA TA M EN TO S DI ST RI BU ÍD O S EX CL UÍ DO S DE VI DO A R EC US A DE PA RT IC IP AÇ ÃO CA SO S EX CL UÍ DO S DE VI DO A 1º T RI M ES TR E DE G RA VI DE Z EX CL UÍ DO S DE VI DO A O UT RO S CR IT ÉR IO S DE E XC LU SÃ O TO TA L DE T RA TA M EN TO S DI ST RI BU ÍD O S EX CL UÍ DO S DE VI DO A R EC US A DE PA RT IC IP AÇ ÃO CA SO S EX CL UÍ DO S DE VI DO A 1º T RI M ES TR E DE G RA VI DE Z EX CL UÍ DO S DE VI DO A O UT RO S CR IT ÉR IO S DE E XC LU SÃ O TOTAL AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 91 An ex o 18 EX EM PL O D E BA SE D E DA DO S PA RA C O M PI LA ÇÃ O D E DA DO S (U TI LI ZA DA N A SE RR A LE O A EM 2 01 4- 20 15 ) FO RM UL ÁR IO D E NO TI FI CA Ç ÃO D E RE SU M O D IÁ RI O D ist rit o: … …… …… …… …. . AV IS O ! P RE EN CH A AP EN AS A S CÉ LU LA S EM B RA NC O !!! D at a: … …… …… …… …. . BE BÉ 6 -1 1 M ES ES CR IA NÇ A PE Q UE NA 1- 4 AN O S NÚMERO DE USP NOME DA COMUNIDADE LOCAL/ZONA NOME DA ÁREA DE ABRANGÊNCIA DE USP O NÚMERO TOTAL DE DOMICÍLIOS A SEREM VISITADOS PARA TODA A CAMPANHA (META) NÚMERO DE DOMICÍLIOS (RESULTADO REAL) % DE DOMICÍLIOS ABRANGIDOS TOTAL DA POPULAÇÃO- ALVO DA ÁREA DE ABRANGÊNCIA DA USP POPULAÇÃO-ALVO EXCLUÍDA A ALERGIA A ASAQ NAS CRIANÇAS EXCLUÍDO ARV EXCLUÍDA ASAQ NO ÚLTIMO MÊS EXCLUÍDA DOENÇA GRAVE EXCLUÍDAS OUTRAS RAZÕES TOTAL DE EXCLUÍDOS TOTAL DISTRIBUÍDO TOTAL CONSIDERADO % ASAQ DISTRIBUÍDA AOS BEBÉS (COBERTURA) POPULAÇÃO-ALVO EXCLUÍDA A ALERGIA A ASAQ EXCLUÍDO ARV EXCLUÍDA ASAQ NO ÚLTIMO MÊS EXCLUÍDA DOENÇA GRAVE EXCLUÍDAS OUTRAS RAZÕES TOTAL DE EXCLUÍDOS TOTAL DISTRIBUÍDO TOTAL CONSIDERADO % ASAQ DISTRIBUÍDA ÀS CRIANÇAS PEQUENAS (COBERTURA) #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! #D IV /O ! 0 0 #D IV /O ! 0 0 0 #D IV /O ! To ta l 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 92 AD O LE SC EN TE 5 -1 3 AN O S AD UL TO S ID AD E IG UA L E SU PE RI O R A 14 A NO S TO TA L G ER AL POPULAÇÃO-ALVO EXCLUÍDA A ALERGIA A ASAQ EXCLUÍDO ARV EXCLUÍDA ASAQ NO ÚLTIMO MÊS EXCLUÍDA DOENÇA GRAVE EXCLUÍDAS OUTRAS RAZÕES TOTAL DE EXCLUÍDOS TOTAL DISTRIBUÍDO TOTAL CONSIDERADO % ASAQ DISTRIBUÍDA AOS ADOLESCENTES (COBERTURA) POPULAÇÃO-ALVO EXCLUÍDA A ALERGIA A ASAQ EXCLUÍDO ARV EXCLUÍDA ASAQ NO ÚLTIMO MÊS EXCLUÍDA DOENÇA GRAVE EXCLUÍDAS OUTRAS RAZÕES TOTAL DE EXCLUÍDOS TOTAL DISTRIBUÍDO TOTAL CONSIDERADO % ASAQ DISTRIBUÍDA AOS ADULTOS (COBERTURA) TOTAL DA POPULAÇÃO- ALVO TOTAL DE EXCLUÍDOS TOTAL DISTRIBUÍDO TOTAL DA % ASAQ DISTRIBUÍDA (COBERTURA) 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 0 0 0 0 0 0 #D IV /O ! 0 0 0 #D IV /O ! AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 93 Anexo 19 EXEMPLO DE MODELO PADRÃO PARA NOTIFICAÇÃO DE UMA SUSPEITA DE REACÇÃO ADVERSA A MEDICAMENTOS DADOS DO PACIENTE Nome: ............................................................. Data da notificação: ............................................................ Idade: ................................ Sexo: ................................ Peso corporal (kg): .............................................. Endereço: .............................................................................................................................................................................. Grávida: Sim Não Em caso afirmativo, trimestre de gravidez: ............................................................................................................... Hospital ou centro de tratamento: ................................................................................................................................ Historial médico relevante: .............................................................................................................................................. ................................................................................................................................................................................................... MEDICAMENTO OU PRODUTO SUSPEITO Marca comercial: .......................... Comcentração: ................................ Nome genérico: ......................... Nome do fabricante: ................................................. Dose diária: .................................................................. Data de fabrico: ................. Data de validade: ............................... Número do lote: ............................ Data de início da medicação: .................................. Via de administração: ............................................... Interrupção do medicamento devido a uma ocorrência: Sim Não Data: ............................. MEDICAMENTOS OU PRODUTOS TOMADOS CONCOMITANTEMENTE (INCLUINDO MEDICAÇÃO À BASE DE ERVAS) Especifique a marca e o nome genérico, a dosagem, a via, dia do início, dia do término ................................................................................................................................................................................................... ................................................................................................................................................................................................... 94 REACÇÃO ADVERSA Dados da reacção sentida pelo paciente: ................................................................................................................................................................................................... ................................................................................................................................................................................................... ................................................................................................................................................................................................... Data e hora de início da reacção: ........................ Data e hora do término da reacção: ....................... O estado do paciente exigia internamento hospitalar? Sim Não Duração da hospitalização: ............................ Motivo para notificação Exige ou prolonga hospitalização Dano ou incapacidade permanente Outros (queira especificar) ...................................................................................................................................... CONDIÇÕES OU RESULTADOS NO MOMENTO DA ÚLTIMA OBSERVAÇÃO Plena recuperação Doença em curso Deficiência persistente, significativa, incapacidade Outros (especifique) ................................................................................................................................................... DADOS DO PROFISSIONAL DE CUIDADOS DE SAÚDE OU REPÓRTER Risco de vida Anomalia congénita Morte Overdose Nome: ................................................................................ Endereço: ......................................................................... Assinatura: ....................................................................... Função: ............................................................................. Número de telefone: ..................................................... Instituição: ........................................................................ AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 95 ORIENTAÇÕES PARA PREENCHER O FORMULÁRIO Uma evento adverso é “grave” se • constitui uma ameaça para a vida • resulta na hospitalização • prolonga a hospitalização • causa malignidade • é uma overdose, que provoca sinais e sintomas clinicamente relevantes • causa incapacidade permanente • é fatal • provoca uma deficiência congénita • causa toxicidade para os órgãos relevantes Uma reacção adversa aos medicamentos pode ser uma manifestação de: • complicações de uma doença subjacente • acidente casual • medicação concomitante • doença intercorrente • efeito associado a medicamentos 96 Anexo 20 EXEMPLO DE QUESTIONÁRIO PARA PERQUISA PÓS-AMM As seguintes perguntas devem ser feitas a todas as pessoas com mais de 6 meses de idade (pai, mãe ou guardião das crianças). A. SOCIODEMOGRÁFICAS 1) Idade (anos): ..................................................................................................................................................................... 2) Sexo: Masculino Feminino 3) Estatuto de residência nos domicílios familiar: Permanente Visitante temporário 4) Estado civil: Solteiro Casado Viúvo ou viúva Divorciado ou separado Incerto ou sem resposta 5) Nível de ensino concluído Nenhum Nível primário Nível secundário Nível superior (diploma de ensino superior ou universitário) Incerto ou sem resposta Aldeia; ............................................................................... Domicílio nº .................................................................... Nome do entrevistador: ............................................... Conglomerado nº ......................................................... Data da pesquisa: ......................................................... Nomes dos supervisores: ............................................ AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 97 6) Ocupação: Estudante Agricultor Pastor Negociante ou comerciante Construtor Condutor Profissional ou funcionário público Operário (regime diário, sazonal ou de longa duração) Aposentado ou demasiado velho para trabalhar Nenhum ou desempregado Incerto ou sem resposta Outro. Especificar: .............................................. B. INFORMAÇÃO SOBRE A CAMPANHA DE AMM 1) Está informado sobre a campanha de AMM para o paludismo? Sim Não Incerto ou sem resposta 2) Recebeu a medicação para o paludismo durante a campanha? Sim Não Incerto ou sem resposta Em caso afirmativo, vá à pergunta 4. 3) Porque não recebeu os medicamentos? Eu estava a viajar, ou não estava na cidade Estava muito ocupado para esperar os distribuidores ou para ir ao local da distribuição Não confio nos organizadores da campanha ou no ministério da saúde Paludismo não constitui um problema para mim Nunca tomo nenhum medicamento Só tomo medicamento tradicional Não sei para que serve o medicamento Estava grávida Estava a tomar outro medicamento no momento Estava muito doente Sou alérgico(a) ao medicamento Outros. Especificar ...................................................................................................................................................... Incerto ou sem resposta Questionário termina aqui. 4) A pessoa que lhe deu o medicamento verificou se tomou a primeira dose? Sim Não Incerto ou sem resposta 98 5) A pessoa que lhe deu o medicamento explicou-lhe como deve tomar a próxima dose? Sim Não Incerto ou sem resposta Em caso negativo, vá à pergunta 7. 6) Diga-nos como ela ou ele explicou como tomar o medicamento. De forma correcta De forma incorrecta Incerto ou sem resposta O entrevistador deve marcar “correctamente” ou “incorrectamente”, de acordo com a explicação do entrevistado. 7) Tomou quantas doses do medicamento fornecido pelo distribuidor? Nenhuma 1 dose 2 doses 3 doses Incerto ou sem resposta 8) Pode apresentar-nos provas que concluiu o tratamento (embalagem vazia ou contagem dos comprimidos)? Sim Não 9) Tomou o tratamento completo como recomendado? Sim Não Incerto ou sem resposta Em caso afirmativo, vá à pergunta 11. 10) Porque não efectuou o tratamento tal como recomendado pelo distribuidor? Esqueci-me de tomar o medicamento. Não quis tomá-lo. Motivo: Estava muito doente Guardei os comprimidos para quando estiver doente Dei o tratamento ou partilhei o tratamento com outra pessoa Tive medo dos efeitos secundários do medicamento Um membro da família ou um amigo disse-me para não tomar o medicamento Um profissional de saúde disse-me para não tomar Outras pessoas ficaram doentes depois de tomar o medicamento O medicamento tem sabor desagradável Outros, especifique ...................................................................................................................................................... Incerto ou sem resposta AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 99 11) Sentiu alguns efeitos secundários depois de tomar o medicamento? Sim Não Incerto ou sem resposta Em caso negativo, termine o questionário. 12) Que efeitos secundários sentiu? (Mais de uma resposta possível)1: Reacção cutânea Dores abdominais Náusea e/ou vómito Diarreia Perda de apetite Dores de cabeça Tontura Dificuldade em dormir Sonolência Palpitações cardíacas Fraqueza Outros, especifique .................................................. 13) Quanto tempo depois de tomar os comprimidos sentiu o efeito secundário? Menos de 30 min Entre 30 min e 1 h Entre 1 h e 24 h Outros. Especifique ..................................................................................................................................................... 14) Como geriu o efeito secundário? Não fiz nada Tomei algum medicamento Visitei um profissional de saúde ou unidade de saúde Incerto ou sem resposta 15) Conhecia algum centro de emergência ou linha de apoio para chamar em caso de efeitos secundários? Sim Não Incerto/sem resposta Em caso negativo, fim do questionário. 16) Chamou o centro de emergência ou linha de apoio para obter ajuda? Sim Não Incerto ou sem resposta 1 Reacções adversas específicas devem ser adicionadas à lista de acordo com os medicamentos utilizados 100 Anexo 21 EXEMPLO DE LISTA DE VERIFICAÇÃO DE PREPARAÇÃO DE FARMACOVIGILÂNCIA (UTILIZADA NA SERRA LEOA EM 2014-2015) Instruções Este é um documento de trabalho. Comece a utilizá-lo agora, assinalando (√ ) os itens que foram concluídos. Distrito: .................................................................................................................................................................................... Comunidade local: ............................................................................................................................................................ Instalação: ............................................................................................................................................................................ ASSUNTO CONCLUÍDO COMENTÁRIOS Pessoal 1. Pelo menos uma pessoa tem conhecimento da monitorização de farmacovigilância durante a campanha de artesunato - amodiaquina? 2. Todos os funcionários foram informados dos princípios de monitorização de farmacovigilância? 3. Todos os funcionários foram formados no reconhecimento das RAM? 4. Todos os funcionários conhecem a dose correcta de artesunato – amodiaquina 5. Existe um plano para cobrir as áreas de difícil acesso? 5. Existe um mapa da área de abrangência? 5. Existem quantidades adequadas dos seguintes (Avaliar as quantidades fornecidas contra a população-alvo). artesunato - amodiaquina Sais de hidratação oral paracetamol clorofenamina Sensibilização e mobilização social 1. Houve uma palestra sobre a saúde na comunidade acerca da conformidade e adesão a artesunato - amodiaquina? 2. São disponibilizadas informações na unidade de saúde pública sobre a monitorização de RAM? Nome da pessoa que completa a lista de verificação .......................................................................................... Assinatura ....................................................................... Data .................................................................................. AD M IN IS TR AÇ ÃO M AS SI VA D E M ED IC AM EN TO S PA RA O P AL UD IS M O F AL CI PA RU M U M M AN U AL D E C AM PO P RÁ TI C O 101 Anexo 22 EXEMPLO DE UM MÓDULO DE FORMAÇÃO EM FARMACOVIGILÂNCIA SOBRE AMM CURRÍCULO PARA OS DISTRIBUIDORES DE MEDICAMENTOS O currículo é dividido em quatro módulos, com base na cronologia e estrutura do curriculo WHO-ISOP (1). O conteúdo deve ser adaptado às exigências de farmacovigilância no país e oportunidades tidas para a sua integração com outras sessões de formação para os distribuidores de medicamentos. Introdução O currículo é baseado em vários pacotes de temas e conceitos de ensino de FV utilizados Pela OMS e centros colaboradores da OMS (2). Foi concebido para programas de quimioprevenção do paludismo sazonal e adaptado para utilização na AMM para o paludismo. Objectivo do curso O objectivo do curso é permitir que os trabalhadores da saúde e distribuidores de medicamentos detectem, notifiquem e façam o seguimento das reacções adversas aos medicamentos durante a AMM para o paludismo. Grupo-Alvo O curso destina-se aos distribuidores de medicamentos envolvidos na AMM, que podem ter conhecimentos médicos muito limitados, mas estão presentes na comunidade no momento da operação. Eles interagem directamente com todos os membros da família na administração da primeira dose, distribuem e aconselham os prestadores de cuidados sobre a administração das restantes doses e proporcionam aconselhamento sobre possíveis reacções adversas aos medicamentos e onde notificá-las. Devem ser capazes de encaminhar as pessoas com graves efeitos adversos e fazer a notificação do caso. Duração do curso O material foi concebido para ser abrangido em um dia. As secções podem ser reduzidas e priorizadas, se o tempo de formação for limitado. Conteúdo do curso Módulo um: O que são reacções adversas a medicamentos e por que devemos monitorizá-las? • Importância das reacções adversas a medicamentos no contexto da AMM Módulo dois: Reacções adversas a medicamentos e erros de medicação • Reacções adversas graves a medicamentos • Ocorrências adversas associadas com medicamentos e medicação concomitante • Administração de medicamentos na AMM, erros de medicação e suas consequências, particularmente dosagem excessiva 102 Módulo três: Notificação de reacções adversas suspeitas • Conclusão e utilização de relatórios e notas de referência Módulo quatro Comunicação • Uma comunicação eficaz com os pacientes e profissionais de saúde • Gestão de rumores a nível comunitário Referências 1. Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ et al. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf. 2014;37:743-59. 2. ISoP – PV curriculum – search. London: International Society of Pharmacovigilance; 2017 (http://isoponline.org/pv-links/, consultado em 17 de Agosto de 2017).

Para mais informação, por favor contactar: Programa Mundial do Paludismo Organização Mundial da Saúde 20 Avenue Appia 1211 Genebra 27 Suíça