WHO methodology for point prevalence survey on antibiotic use in hospitals

for Point Prevalence Survey on Antibiotic Use in Hospitals Version 1.1 WHO Methodology

WHO Methodology for Point Prevalence Survey on Antibiotic Use in Hospitals Version 1.1 WHO_HAMUPPS Protocol.indd i Manila Typesetting Company 01/10/2019 07:55PM WHO Methodology for Point Prevalence Survey on Antibiotic Use in Hospitals, version 1.1 WHO/EMP/IAU/2018.01 © World Health Organization 2018 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. WHO_HAMUPPS Protocol.indd ii Manila Typesetting Company 01/10/2019 07:55PM iii Contents Acknowledgments vii Abbreviations and Acronyms viii Background 1 Objectives 4 Framework 5 Inclusion Criteria 6 1. Hospital 7 Hospital types 7 Hospital groups 8 Hospital ownership 8 2. Ward 10 Ward types 10 High risk wards 11 3. Patient 12 4. Antibiotics 13 Data Collection 14 1. Structure and coordination 14 Hospital coordinator 14 Investigator team 14 Training 14 Survey coordination 15 Timeline 15 Patient sampling 16 Representative hospital sampling 17 2. Ethical review and data privacy 21 Informed consent 21 Patient privacy 22 Hospital staff privacy 22 Data storage 23 Ethical committee 23 WHO_HAMUPPS Protocol.indd iii Manila Typesetting Company 01/10/2019 07:55PM iv WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 3. Data analysis and dissemination 24 4. Data structure 25 Country level data 25 Hospital level data 25 Ward level data 26 Patient level data 26 Variables 31 1. Country data 32 Core variables 32 2. Hospital data 34 Core variables 34 3. Ward data 37 Core variables 37 Optional variables 38 4. Patient data 39 Core variables 39 Optional variables 41 5. Indication data 44 Core variables 44 6. Antibiotic data 47 Core variables 47 Optional variables 48 References 51 Annex I. Types of ward 53 Annex II. Specialties 54 Annex III. McCabe score 55 Annex IV. Diagnoses 56 Annex V. Definition of hospital-associated infection 57 Annex VI. Microorganism codes 58 Annex VII. Category of microbiology specimen 62 Annex VIII. Resistant phenotypes 63 Annex IX. Surgical categories 65 Annex X. Sites for surgical prophylaxis 67 Annex XI. Antibiotic and enzyme inhibitor names 68 WHO_HAMUPPS Protocol.indd iv Manila Typesetting Company 01/10/2019 07:55PM CONTENTS v Annex XII. Hospital questionnaire 74 Annex XIII. Measurement units 76 Annex XIV. ISO country codes 77 Annex XV. Data collection forms 81 WHO_HAMUPPS Protocol.indd v Manila Typesetting Company 01/10/2019 07:55PM WHO_HAMUPPS Protocol.indd vi Manila Typesetting Company 01/10/2019 07:55PM vii In October 2016, the World Health Organization (WHO) convened an expert meeting to define the objectives and contents of two methodologies to survey antimicrobial use in hospitals and community settings. Based on input from the meeting, a draft protocol for point prevalence survey on antibiotic use in hospitals was drafted by the WHO. Comments and contributions to the protocol have been received from participants of the expert meeting, WHO staff members from the Department of Essential Medicines and Health Products and WHO Regional Offices. The protocol has been reviewed and approved by the WHO Ethical Review Committee and undergone piloting in low- and middle-income countries before finalization. Some section of this protocol are adapted from the technical document on Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals (1) by the European Centre for Disease Prevention and Control (ECDC). WHO gratefully acknowledge all contributors (in alphabetical order): External reviewers Lilith Ghazaryan, Brian Goodman, Mohammad Azmi Hassali, Gabriel Levy Hara, Rodney S. James, Monet M. Loquias, Shelley S. Magill, Marc Mendelson, Michael Moore, Bene Anand Paramadhas, Céline Pulcini, Elizabeth Ellen Roughead, Mike Sharland, Fatemeh Soleymani, Arjun Srinivasan, Carl Suetens, Visanu Thamlikitkul, Ann Versporten, Klaus Weist, Veronika Wirtz, Antony Zorzi Developers and co-authors Arno Muller, Wenjing Tao, Peter Zarb Financial support Funding for the development of this protocol was kindly provided by the European Commission and the Fleming Fund. Acknowledgments WHO_HAMUPPS Protocol.indd vii Manila Typesetting Company 01/10/2019 07:55PM viii AMR Antimicrobial resistance ATC Anatomical Therapeutic Chemical DDD Defined daily dose DOT Days of therapy DRIVE-AB Driving reinvestment in research and development and responsible antibiotic use ECDC European Centre for Disease Prevention and Control GAP Global Action Plan ICU Intensive Care Unit INN International Nonproprietary Name IPC Infection prevention and control ISO International Organization for Standardization IU International unit IV Intravenous MURIA Medicines Utilisation Research in Africa OPAT Outpatient parenteral antibiotic therapy PPS Point prevalence survey TATFAR Transatlantic Taskforce on Antimicrobial Resistance WHA World Health Assembly WHO World Health Organization Abbreviations and Acronyms WHO_HAMUPPS Protocol.indd viii Manila Typesetting Company 01/10/2019 07:55PM 1Antimicrobial resistance (AMR) is a significant global health problem. Resistance occurs when bacteria, parasites, viruses or fungi are exposed to antimicrobials but not killed by them. Resistance is a natural phenomenon which gives organisms the opportunity to adapt and change, rendering medicines ineffective (2). Existing resistance patterns are spreading and new resistance patterns are emerging around the world (2). Growing resistance is of extreme concern for public health because resistant organisms lead to longer illnesses, increased costs of treatment and increased mortality (2,3). Patients with infections caused by multidrug-resistant bacteria are generally at increased risk of worse clinical outcomes and death, and consume more healthcare resources than patients infected with the same bacteria that are not resistant. In addition to its direct impact on population health, AMR is associated with significant economic costs. When infections are resistant to first-line drugs more expensive therapies must be used, often requiring longer duration of treatment and hospitalized care, which increases healthcare costs and contributes to the economic burden of disease (3). The current global AMR crisis is the result of a number of factors, including overprescribing and overdispensing of antimicrobial medicines by health workers, noncompliance with treatment courses, low-quality medicines and incorrect prescription with wrong dosage, poor infection prevention and control practices in hospitals and clinics, and lack of hygiene and poor sanitation. AMR is a complex problem with many interrelated causes. Inappropriate use of antimicrobials and lack of surveillance systems are core contributors to the spread of AMR. Other factors influencing AMR, such as poor infection prevention and control in healthcare facilities and lack of available, inexpensive and rapid diagnostic tests, are also important factors that require urgent address (3). In response, WHO has developed a Global Action Plan (GAP), as mandated by the World Health Assembly (WHA) 2015 resolution WHA 68.7 (4). The goal of the GAP is to ensure, for as long as possible, the successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them (5). The GAP takes an integrated approach which promotes the principles of society engagement with a One Health approach, prevention of infection, and equitable access to healthcare and medicines. The GAP was reinforced by the political declaration on AMR made by the Heads of State during the UN General Assembly on 21 September 2016. Optimizing the use of antimicrobial agents is one of the five key strategic objectives outlined in the GAP, and available studies indicate a high proportion of Background WHO_HAMUPPS Protocol.indd 1 Manila Typesetting Company 01/10/2019 07:55PM 2 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 inappropriate use of antimicrobials (6). Optimizing the use of antibacterial agents, referred to as antibiotics in this document, is a challenge and selecting the right antibiotic may not be straightforward. The number of antibacterial subclasses and substances is relatively large compared to other antimicrobial classes, antibiotics often target not one specific microorganism but a range of pathogens depending on the spectrum of activity of the antibiotic, bacteria may develop different mechanisms of resistance to antibiotics, and finally, the majority of the antibiotic treatments, at least in the community, are given empirically. It is likely that inappropriate use of antibiotics is widespread; however, information on antibiotic consumption and use is scarce in low- and middle-income countries. In order to inform effective policies and interventions that optimize use and promote equitable access to medicines, it is essential to collect information on the current situation of antibiotic use in all countries. Harmonized data collection and strengthening of monitoring systems is needed to provide a reliable global picture of the use of antibiotics. High level data on the quantity of antibiotics used nationally, e.g. through sales, provide important information on antibiotic consumption. In 2016, WHO developed a global methodology for monitoring antimicrobial consumption (7), including antibiotics, and supports countries in implementing surveillance of antimicrobial consumption to obtain national estimates of antimicrobial consumption. However, one limitation of consumption data is the lack of information on how antibiotics are prescribed and used at the patient level. Data on antibiotic use at the patient level is sparse, due to the difficulties associated with collecting prescribing data from fragmented data sources. Hospitals are excellent settings for gaining understanding of antibiotic prescribing. They have a high concentration of patients with diverse pathologies, often requiring antibiotic treatment. This creates high selection pressure on bacteria due to the quantities and broader spectrum of antibiotics used, contributing to the development and emergence of resistant bacteria. Collecting hospital data and subsequently implementing informed interventions to optimize antibiotic use in hospitals has significant potential to lower antibiotic resistance at local and higher levels. Furthermore, the concentration of patients requiring antibiotics provides an excellent opportunity to survey antibiotic prescribing while reducing the workload of collecting prescribing data and providing a range of different situations where antibiotics are used. In the vast majority of countries worldwide, continuous data collection on antibiotic prescribing is not possible due to the high workload and level of resources needed for regular monitoring. A viable alternative is to collect data at a specific point in time, which can be done successfully using the point prevalence survey (PPS) methodology. PPS on antibiotic use are already in use in hospitals around the world. The European Union (8) and the United States (9) have developed and carried out regional surveys using PPS. WHO has aimed to develop a similar methodology that meets the needs and reflects the level of resources in low- and middle-income countries while maintaining comparability with data collected in high-income countries. WHO_HAMUPPS Protocol.indd 2 Manila Typesetting Company 01/10/2019 07:55PM BACKGROUND 3 A common methodology to survey antibiotic prescribing in hospitals encourages standardization and facilitates comparisons of antibiotic use over time and between hospitals, districts, countries, and regions. The WHO PPS methodology is an adaptation of the ECDC protocol for Point Prevalence Survey of healthcare- associated infections and antimicrobial use (1), complemented by methodologies from the Global PPS project from University of Antwerp (10), the US Centers for Disease Control and Prevention (9), and the Medicines Utilisation Research in Africa (MURIA) (11). To account for challenges associated with data collection in resource-limited settings, the methodology has been developed with flexibility in mind. A set of core variables has been selected by the WHO that is necessary for data analysis and interpretation, and provides the possibility to implement follow-up activities. Depending on the resources and availability of information, hospitals and countries may include additional variables (e.g. microbiology results) that improve the understanding of antibiotic use in hospitals. For better comparability and interpretation of results, it is advisable to select the variables to be collected (core and optional) at country level and by hospital category, and not differ between hospitals. The WHO PPS methodology collects basic information from medical records and associated patient documentation on all hospitalized patients, which are of relevance for treatment and management of infectious diseases regardless of whether these patients are on antibiotic treatment at the time of data collection. In addition to assessing the use of antibiotic treatment the information can be used for other objectives, such as improving quality of care or infection prevention and control (IPC) in hospitals. It is important to emphasize that this methodology does not collect additional information aside from what is already recorded through routine processes. Thus, there is no direct contact with patients where they are asked to provide supplementary information. The WHO methodology has been developed with the aim of collecting baseline information on the use of antibiotics in hospitals, and is expected to be repeated once every few years. It is, however, possible to adapt and tailor the methodology for specific purposes, such as follow-up surveys to assess specific interventions or to support the objectives of improving quality of care or IPC. WHO_HAMUPPS Protocol.indd 3 Manila Typesetting Company 01/10/2019 07:55PM 4The WHO methodology is a tool for surveillance and public health. The specific objectives are: • To provide a standardized methodology for use in low-, middle- and high- income countries to estimate the prevalence of antibiotic use in hospitals; • To collect information on the prescribing of antibiotics — by substance name; — by indication and category of patient; and — by specialty and healthcare facility. • To support policy-makers and practitioners for improving antibiotic use — by raising awareness of antibiotic use in hospitals; — by training and building capacity in monitoring and evaluation; — by identifying problems related to antibiotic prescribing and use, and setting up priorities accordingly; — by informing local, regional and national policies, strategies and inter- ventions; and — by evaluating the effect of policies, strategies and interventions to improve antibiotic use. • To provide a standardized tool for hospitals — to monitor antibiotic use; — to identify targets for improved antibiotic use; and — to inform hospital interventions aiming to improve antibiotic prescribing and use, and antimicrobial stewardship programs. Objectives WHO_HAMUPPS Protocol.indd 4 Manila Typesetting Company 01/10/2019 07:55PM 5This methodology can be used for single-centre or multicentre surveys. In single-centre surveys, hospitals can carry out surveys independently in terms of objectives, organization, timeline and reporting. The survey might be part of a local antimicrobial stewardship programme and can serve as either baseline survey to understand the appropriateness of antibiotic prescribing or as follow-up survey after a local intervention has been carried out, to improve antibiotic prescribing. A hospital coordinator should be appointed to manage the survey at the facility level. Multicentre surveys include surveys in selected hospitals, national surveys irrespective of representativeness at country level, and supranational surveys such as regional and global surveys. For national multicentre surveys, a national coordinator should be in charge of leading and coordinating the survey. For regional and global surveys, it might be necessary to appoint a regional or global coordinator for the participating countries in addition to the national coordinator. If the sample size and composition of the participating hospitals is representative at the country level, then the results from the multicentre survey can be considered a valid estimate of antibiotic use in other hospitals across the country. The implementation of single-centre and multicentre surveys is described in the chapter “Data collection”. Framework WHO_HAMUPPS Protocol.indd 5 Manila Typesetting Company 01/10/2019 07:55PM 6Inclusion criteria are stratified according to the following levels: 1. Hospital 2. Ward 3. Patient 4. Antibiotic The inclusion criteria should first be applied to hospitals, secondly to wards in the hospitals that meet the inclusion criteria, then to patients in the selected wards, and finally to the antibiotics prescribed or dispensed to those patients. Table 1 provides a detailed overview of the inclusion criteria. Inclusion Criteria Table 1. Inclusion criteria and examples of exclusion criteria by the levels of stratification Level Include Exclude (examples) Hospital Acute care hospitals Nursing homes Rehabilitation centres Psychiatric centres Ward Acute care inpatient wards Long-term care wards Emergency departments (except for wards attached to the departments) Day surgery wards Day care wards (e.g. renal dialysis) Patient Patients hospitalized as an inpatient at or before 08:00 Hospitalized after 08:00 Outpatient clinic Day surgery/day treatment Emergency room Outpatient dialysis Discharged patients waiting for transportation Parents/relatives of admitted children Outpatient parenteral antibiotic therapy (OPAT) Antibiotic Listed antibiotics (Annex XI) Administered oral, parenteral, rectal or through inhalation Ongoing treatment at 08:00 Topical antibiotics Ophthalmologic antibiotics Treatment initiated after 08:00 Treatment discontinued before 08:00 WHO_HAMUPPS Protocol.indd 6 Manila Typesetting Company 01/10/2019 07:55PM 7All types of acute care hospitals are eligible to carry out a survey based on this protocol. Non-acute care facilities, such as institutions providing only nursing care, rehabilitation centres or psychiatric centres, should not be included. Hospital types This protocol focuses on acute care hospitals. However, it is important to consider the type of care provided by the different hospitals as it has impact on the intensity of antibiotic prescribing and classes of antibiotics prescribed. Consequently, registering the type of hospital surveyed is necessary for interpretation of results for the individual hospitals. The classification of hospitals in this protocol is based on the Disease Control Priorities in Developing Countries (12) complemented by ECDC. Hospital types are divided into four categories: • Primary hospital • Secondary hospital • Tertiary hospital • Specialized hospital These categories are defined as follows1: 1. Primary hospital a. Few specialities (mainly internal medicine, obstetrics-gynaecology, paediatrics, general surgery or only general practice); b. Limited laboratory services are available for general, but not for specialized pathological analysis; c. Commonly referred to as “district hospital”, “rural hospital”, “community hospital”, or “general hospital”. 2. Secondary hospital a. Hospital is highly differentiated by function with five to ten clinical specialities, such as haematology, oncology, nephrology, and intensive care unit (ICU); b. Takes some referrals from other (primary) hospitals; c. Can have teaching activities; d. Commonly referred to as “regional hospital”, “provincial (county) hospital”, or “general hospital”. 1 Adapted from ECDC (1). 1. Hospital WHO_HAMUPPS Protocol.indd 7 Manila Typesetting Company 01/10/2019 07:55PM 8 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 3. Tertiary hospital a. Highly specialized staff and technical equipment (ICU, haematology, transplantation, cardiothoracic surgery, and neurosurgery); b. Clinical services are highly differentiated by function; c. Specialized imaging units; d. Regularly takes referrals from other (primary and secondary) hospitals; e. Often a university hospital or associated to a university; f. Commonly referred to as “national hospital”, “central hospital”, or “academic or university hospital”. 4. Specialized hospital a. Single clinical specialty, possibly with subspecialties; b. Highly specialized staff and technical equipment. When a hospital has facilities with different levels of care, then the highest hospital category should be reported. For example, if one facility of the hospital belongs to the primary level and another facility belongs to the tertiary level, then the reported category should be tertiary hospital. Hospital groups A hospital group consists of multiple hospitals (sites) linked together administratively. Hospital groups can be referred to as trusts, mergers, fusions, boards, chains, and so forth. As part of a hospital group, the hospitals must follow the same common rules in terms of management, care to patients, policies or guidelines, and so forth. This tight relationship between hospitals of the same hospital group may affect their individual results by making them more homogenous than when compared with hospitals not belonging to the hospital group. It is not mandatory for all hospitals (sites) belonging to a particular hospital group to participate in the survey; however, data must be reported separately for each surveyed hospital (site). When hospital groups participate in the survey, the variable “HospitalGroupCode” will anonymously identify the hospital group. All hospitals belonging to the same hospital group have the same value under “HospitalGroupCode”, making it possible to group them together for analysis. When selecting and registering the participating hospitals, the national coordinator will request the hospitals to indicate if they are part of a hospital group. If one or more hospital groups are participating in the survey, the national coordinator should contact the management of the hospital groups and provide them with an anonymous “HospitalGroupCode” and request them to specify if all hospitals (sites) in the hospital group are participating in the survey. The variable “HospitalGroupAllSitesIncluded” is indicated as “Yes” if all hospitals are participating, and otherwise “No”. Hospital ownership1 Hospital ownership is defined as: • Public (PUB): Hospitals that are owned or controlled by a government unit or a public corporation (where control is defined as the ability to determine the general corporate policy). 1 Adapted from ECDC (1). WHO_HAMUPPS Protocol.indd 8 Manila Typesetting Company 01/10/2019 07:55PM 1. HOSPITAL 9 • Private, not for profit (PRVNFP): Hospitals that are legal or social entities created for the purpose of producing goods and services, whose status does not permit them to be a source of income, profit, or other financial gain for the unit(s) that establish, control, or finance them. • Private, for profit (PRVFP): Hospitals that are legal entities set up for the purpose of producing goods and services and are capable of generating a profit or other financial gain for their owners. • Other (OTH) or unknown (UNK): Hospital ownership that cannot be categorized as one of the above, or hospital ownership is unknown. If hospital ownership is unclear, prioritize management over ownership of the building and/or funding. For instance, if a hospital is managed privately (for profit) but the building is state-owned or the hospital receives public funding, then select “private, for profit”. WHO_HAMUPPS Protocol.indd 9 Manila Typesetting Company 01/10/2019 07:55PM 10 All acute care inpatient wards in the facilities should be included. Non-acute wards should be excluded. Excluded wards are defined as: • Long-term care wards in the facilities (for example nursing homes, post-treatment) • Emergency departments (except for wards attached to this type of department where patients are monitored for more than 24 hours) • Day surgery wards, day care wards (for example renal dialysis ward) Within one ward, some patients may fall into one of the above-mentioned excluded categories and other patients may meet the inclusion criteria. For example, a nephrology ward may include both outpatient care (for example day care dialysis patients) and inpatient care (for example kidney transplant patients). The ward should be included if the proportion of patients in the ward meeting the inclusion criteria is greater than or equal to 80%. If the proportion is lower, the ward should not be considered an inpatient ward and should thus be excluded entirely from the survey. Ward types Wards are categorized according to the following types1: • Paediatric departments — PMW: paediatric medical ward — PSW: paediatric surgical ward — PHRW: paediatric high risk ward (see high risk units) — PICU: paediatric intensive care unit • Neonatal departments — NMW: neonatal medical ward — NICU: neonatal intensive care unit • Adult departments — AMW: adult medical ward — ASW: adult surgical ward — AHRW: adult high risk ward (see high risk units) — AICU: adult intensive care unit • Mixed departments — MXW: mixed adult/paediatric ward — MXAW: mixed adult ward — MXPW: mixed paediatric ward 1 Adapted from the University of Antwerp Global PPS (10). 2. Ward WHO_HAMUPPS Protocol.indd 10 Manila Typesetting Company 01/10/2019 07:55PM 2. WARD 11 If patients within a ward belong to different specialties, the ward should be reported as a mixed specialty ward. High risk wards High risk units are defined as units or wards that are high consumers of antibiotics due to the type of care they provide. High risk units consist of wards with the following specialties: • Haematology • Oncology • Burns • Transplantation • Infectious diseases (general or specialized infectious disease wards; e.g. HIV units) Note that ICU is excluded as they have a separate category under “Ward type”. WHO_HAMUPPS Protocol.indd 11 Manila Typesetting Company 01/10/2019 07:55PM 12 Only patients who are hospitalized in the ward at 08:00 on the day of the survey should be included in the survey. Patients admitted to the ward after 08:00 must be excluded. Note that: • All neonates born before 08:00 on the day of the survey are included and counted separately from their mother, that is mother and baby count as two different patients. • All patients meeting the eligibility criteria should be included in the survey irrespective of whether they are receiving antibiotic treatment or not. • If informed consent is required, all eligible patients should go through the consent approval processes. All day care patients must be excluded, such as: • Patients undergoing treatment or surgery and are discharged the same day • Patients seen at outpatient departments • Patients in the emergency room • Outpatient dialysis patients • Discharged patients who remain as lodgers while waiting for transportation • Parents/relatives of admitted children who reside as lodgers in the ward to nurse them • Patients receiving outpatient parenteral antibiotic therapy (OPAT) 3. Patient WHO_HAMUPPS Protocol.indd 12 Manila Typesetting Company 01/10/2019 07:55PM 13 Antibiotics are classified according to the ATC methodology developed by the WHO Collaborating Centre for Drug Statistics Methodology in Oslo, Norway (13). Only antibiotics listed in Annex XI and administered through oral, parenteral, rectal or inhalation routes are included in the survey. For example, topical applications, eye drops, ear drops and vaginal suppositories are excluded. The following inclusion and exclusion criteria for antibiotic therapy (treatment or prophylaxis) apply: • Include if the patient is on antibiotic therapy at 08:00 on the day of the survey. • Exclude if the antibiotic therapy is initiated after 08:00 on the day of the survey. • Exclude if the antibiotic therapy was stopped before 08:00 on the day of the survey. Special cases: • If the patient is on antibiotic therapy at 08:00 on the day of the survey but the antibiotic is not administered daily, then the antibiotic should still be reported. This includes, for example, patients with renal impairment with reduced dosing frequency or long-acting antibiotics that are administered with prolonged intervals, such as every 48 hours or more. • Single-dose regimes, such as gentamycin in combination with other antibiotics, should be included if the dose was given within 24 hours prior to 08:00 on the day of the survey. • If the patient is on treatment with antibiotic A at 08:00 on the day of the survey but the treatment is changed to antibiotic B at 10:00, then only antibiotic A should be reported. 4. Antibiotics WHO_HAMUPPS Protocol.indd 13 Manila Typesetting Company 01/10/2019 07:55PM 14 Hospital coordinator A lead hospital investigator (hospital coordinator) should be identified for each participating hospital. The hospital coordinator will be in charge of coordinating the survey in the hospital, and responsible for reporting the results to the hospital management and relevant staff. For multicentre surveys, the hospital coordinator is also responsible for submitting the data to the national coordinator. To reduce the workload, it is advisable to establish a team of investigators who will be responsible for conducting the survey under the supervision of the hospital coordinator. Investigator team The hospital and the hospital coordinator should establish an investigator team consisting of healthcare professionals from different disciplines at the hospital (for example infectious disease physicians, microbiologists, infection control practitioners and nurses, pharmacists, data managers). Patient privacy is best protected if the investigating team consists of members who would normally review clinical notes of the surveyed patients as part of their routine work. Where hospital staff cannot be released from routine duties to conduct the survey, it may be possible to have staff specifically employed to conduct the survey under the supervision of the hospital or unit staff, provided that the surveyors have been trained in data privacy and confidentiality and have signed a confidentiality agreement that can be enforced under national law. It is essential that at least some of the team members have knowledge of local therapeutic guidelines to be able to assess compliance to the guidelines. The investigator team can consist of multiple groups comprising either one investigator or multiple investigators, preferably with a mix of senior and junior staff, who will be dispatched to the different wards of the hospitals. More than one investigator may be required to survey the large wards in order to complete the entire ward within one day. The hospital coordinator should assign anonymous codes to each investigator or investigator group in order to assess auditor biases. Training The hospital coordinator must be trained in the PPS methodology, is responsible for ensuring that the investigator team receives adequate training on the survey according to this protocol, and is expected to supervise the data collection. Before initiating the full survey, a pilot study should be conducted in the participating hospitals by, for example, reviewing clinical notes for up to 10 patients involving the whole investigator team. The pilot provides the team with an Data Collection 1. Structure and coordination WHO_HAMUPPS Protocol.indd 14 Manila Typesetting Company 01/10/2019 07:55PM 1. STRUCTURE AND COORDINATION 15 opportunity to review and agree on the data extraction procedure, which reduces auditor bias. It is recommended that each investigator assesses the 10 patients independently and then compare the results to ensure internal validity. Survey coordination The organization of the survey can be split into four main phases: 1. Preparation of the survey (ethical clearance, identifying investigators, survey design etc); 2. Conducting the survey (day-to-day management, daily ward surveys); 3. Data validation, analysis (entry, cleaning, storage) and reporting of results to the hospital; 4. Dissemination of the results outside the participating hospitals, for example in national reports, at scientific conferences, and to policy makers. The specific roles of the hospital coordinator include: • Applying for ethical clearance from the hospital management and/or the local research and ethics committees of the hospital depending on local and national requirements. If the hospital is part of a national survey, ethical clearance may have already been sought by the national coordinator. The national coordinator should then support the hospitals to obtain local ethical clearance if required; • Identifying and establishing a team of investigators and supporting them in conducting the survey at the hospital; • Practical planning for the survey, including identification of included wards, ensuring access to materials for data collection etc.; • Informing relevant stakeholders at the hospital about the survey, such as the hospital medical council, the drug and therapeutic committee and the antimicrobial stewardship teams of the survey; • Obtaining information from the hospital administrative departments in order to complete the hospital-related information (see “Hospital level data”); • Coordinating the survey, including informing and agreeing with each ward on a day to conduct the survey; • Day-to-day management of the investigator team; • Coordinating data validation and data entry; • Coordinating data analysis and reporting results to the hospital management and other relevant stakeholders in the hospital; and • Submitting survey data to the national coordinator if the hospital is part of a multicentre survey. Timeline Data collection should be completed for the entire hospital within maximum three consecutive weeks from the first day of data collection. The duration of the survey will vary depending on the size of the hospital and the investigator team. It is advisable to keep the duration as short as possible in order to avoid unexpected events that could change the context of the survey (for example holidays, strikes etc.). Note that all wards meeting the inclusion criteria must be included in the survey. WHO_HAMUPPS Protocol.indd 15 Manila Typesetting Company 01/10/2019 07:55PM 16 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 To minimize the impact of patients moving between wards, each ward must be completely surveyed within one day. The hospital coordinator should ensure that the capacity of the investigator team is adequate to meet this requirement. For example, a large ward may require more than one investigator. It is recommended to avoid conducting the survey during weekends and public holidays due to reduced staff availability. As the survey collects information on surgical prophylaxis during a 24-hour period prior to 08:00 on the day of the survey, it is recommended to avoid conducting the survey in surgical wards following a weekend or a public holiday since elective procedures may be reduced during these days. Patient sampling In hospitals with < 500 total inpatient beds, all patients meeting the inclusion criteria must be surveyed. In large hospitals, however, including all eligible patients in the survey may become very resource-demanding and impossible to conduct within 3 weeks. Thus, in hospitals with 500 or more total inpatient beds, it may be acceptable to sample the eligible patients. While patient sampling is optional, in order to ensure representativeness it is important that sampling be conducted at the patient level and not at the ward level or facility level (if a hospital consists of several facilities). The patient sampling is defined as follows: • In hospitals with < 500 total inpatient beds, include all eligible patients in the wards. • In hospitals with 500 to 800 total inpatient beds, one out of two patients per ward can be included in the survey. • In hospitals with over 800 total inpatient beds, one out of three patients per ward can be included in the survey. The sampling will be done in each ward on the day of the survey through the following procedure: 1. The staff of the surveyed ward will prepare a list of all eligible patients according to the inclusion criteria. The list should be ordered alphabetically according to patients’ surnames (not by bed or patient number). 2. For hospitals with 500 to 800 beds: a. Before reviewing patient records, the investigator will randomly select between the first and the second patient on the list as the starting point for the sampling (i.e. the first patient to be surveyed). b. From this random starting point, the investigator will select every second patient until the end of the list is reached. 3. For hospitals with over 800 beds: a. The investigator will randomly select between the first three patients on the list as the starting point for sampling. b. From this random starting point, the investigator will select every third patient from the list until the end of the list is reached. If a selected patient is not present in the ward, for example due to surgery or radiology exams, and his/her patient records and associated documentation are WHO_HAMUPPS Protocol.indd 16 Manila Typesetting Company 01/10/2019 07:55PM not available at the time of survey, the investigator may either choose to return at a later time during the same day or select the next person on the list. However, the approach should be consistent across wards and defined from the beginning by the hospital coordinator and the investigator team. Representative hospital sampling Sampling methodology In order to collect representative data at the national level, either all hospitals should be included in the survey or a representative random sample of hospitals should be selected. When random sampling is not possible, convenience sampling can be considered. However, this may not provide nationally representative estimates. In cases of convenience sampling, it is important to include different hospital types. A representative random sample of hospitals can be achieved using the following systematic sampling design developed by ECDC. This should be done for each country either by the survey coordinator or the national subcoordinator. Steps1: 1. Obtain a list (for example in spreadsheet format) of all hospitals in the country, including the number of inpatient beds (use the total number of beds if the number of inpatient beds is unknown). 2. Rank the list in ascending order according to the number of beds. 3. Calculate the number of hospitals to be sampled according to the “Sample size and design effect” approach specified below. 4. Divide the total number of hospitals by the number to be sampled = sampling interval k. 5. Choose a random number between 1 and k = i. 6. Select the ith hospital, the ith +k hospital, the ith +2k hospital, the ith +3k hospital, etc. 7. If the first selected hospital declines participation in the survey, select the next hospital on the list (ith+1 hospital, ith+k +1 hospital, etc.). If it is expected that more than one hospital will decline participation, make a second list of reserve hospitals. 8. Invite the sampled hospitals and replace them in case of decline. Sorting the hospitals according to the number of inpatient beds before the selection procedure ensures that hospitals of different sizes are represented according to the same proportion as the actual distribution in the country. In addition to sorting by number of beds, it is also possible to sort according to hospital type (for example primary, secondary or tertiary) or any other categories of hospitals related to case-mix in order to achieve representativeness of the different types of hospitals. In these cases, replace step 2 with (a) first sort the hospitals according to hospital type, and then (b) within the same hospital type, sort according to number of beds. Then continue the systemic sampling on this list according to step 3. 1 Adapted from ECDC (1). 1. STRUCTURE AND COORDINATION 17 WHO_HAMUPPS Protocol.indd 17 Manila Typesetting Company 01/10/2019 07:55PM 18 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Examples Country A has 127 hospitals and should include at least 36 hospitals in the sample to achieve representativeness. For details on the calculation of the sample size, see “Sample size and design effect” below. All 127 hospitals should be listed according to the number of inpatient beds. The sampling interval k is 127/36 = 3 (3.5 rounded down to 3). The random number i is chosen between 1 and 3. If the random number is 3, then you select the 3rd, 6th, 9th,…,120th, 123rd, 126th. In this case using a sampling interval k of 3 will result in 42 hospitals in the sample. Sample size calculation and design effect The number of hospitals to include in the survey (sample size) depends on the expected prevalence of antibiotic use, the total number of hospital beds at the national level and the average number of inpatient beds per hospital (hospital size). In the sample size calculation, the prevalence of antibiotic use among hospitalized patients is estimated to 40% with a precision of ± 4% at the national level. Since hospitals can be considered as clusters of patients of the total population of hospital patients, there is a clustering effect that needs to be taken into consideration. For this reason, a correction has to be applied when calculating sample size. The number of hospitals to be included depends on the expected cluster effect (design effect) and on the average hospital size in each country, as the design effect depends on the size of the hospitals. The design effect is not known at the time of sampling. However, ECDC have developed a table of design effects for antibiotic use based on PPS conducted in acute care hospitals in the European Union. The ECDC design effects will be used to estimate the sample size for the national surveys and is listed in Table 2. To calculate the sample size, the national coordinator should collect information on the total number of inpatient beds at the national level, number of hospitals, and average hospital size according to the number of inpatient beds. Chose the correct design effect based on the average hospital size in Table 2. The sample size can be calculated using statistical tools that are freely available online. For example, the OpenEpi tool (www.openepi.com) can compute sample size using the design effect. Table 2. Design effect for antibiotic use (8) Hospital size Design effect for antibiotic use < 80 beds 6.5 [80 beds – 140 beds] 10.1 [140 beds – 230 beds] 11.7 [230 beds – 380 beds] 16.7 ≥ 380 beds 18.7 WHO_HAMUPPS Protocol.indd 18 Manila Typesetting Company 01/10/2019 07:55PM Examples Country A has 23  114 hospital beds divided into 127 hospitals, generating an average hospital size of 182 beds per hospital. To calculate sample size: The total number of hospital beds (population) is 23 114, the expected prevalence of antibiotic use is 40% ± 4%, and the design effect equals 11.7 that corresponds to the average of 182 beds per hospital (design effect value for hospital size between 140 and 230 beds). Based on these values, the calculated sample size is 6579 beds (at a 95% confidence level). As the average hospital size is 182 beds, 36 (6579/182) hospitals should be included in the survey. Country A: Calculation using the OpenEpi tool Country B has 230 045 hospital beds divided into 1655 hospitals, generating an average hospital size of 139 beds per hospital. To calculate sample size: The total number of hospital beds (population) is 230 045, the expected prevalence of antibiotic use is 40% ± 4%, and the design effect corresponding to an average hospital size of 139 beds is 10.1 (design effect value for hospital size between 80 and 140 beds). Based on these values, the calculated sample size is 5806 beds (at a 95% confidence level). As the average hospital size is 139 beds, 42 (5806/139) hospitals should be included in the survey. 1. STRUCTURE AND COORDINATION 19 WHO_HAMUPPS Protocol.indd 19 Manila Typesetting Company 01/10/2019 07:55PM 20 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Country B: Results from the calculation in the OpenEpi tool WHO_HAMUPPS Protocol.indd 20 Manila Typesetting Company 01/10/2019 07:55PM 21 The survey is designed for public health surveillance purposes; it is non- experimental, does not involve any patient examination or patient interviews, and does not introduce any interventions. Collected data will be de-identified during data collection and it can therefore be considered to be a minimal risk study. Informed consent Depending on the national policies, it might be necessary to ask patients for consent before inclusion in the survey. The consent can be oral or written. If required, it is advisable that the informed consent is obtained by someone who has no direct impact on patient care, due to power balances. For example. if the treating health professional requests for consent, the patient may feel obliged to accept. It should be noted that the information will be gathered from patient notes or other medical records, so no interaction with the patient is necessary to obtain additional information. Also, this is not an intervention study so no experimental changes will be made to the care or treatment regime. In cases where patient interaction is unavoidable, for example if the medical records and clinical notes are kept with the patient, an information and assent procedure may be necessary also in cases where informed consent is not required. In countries that do not require informed consent by individual patients, a broader informed consent can be sought as substitution. This can be achieved through an informed opt-out procedure, i.e. the medical records and associated patient documentation are reviewed unless the patient in question explicitly objects. According to the International Ethical Guidelines for Health-related Research Involving Humans (14), the informed opt-out procedure must fulfil the following requirements: — Patient should be aware that the survey is taking place — Patient should be provided with sufficient information about the survey — Patient should be informed that they can withdraw from the survey, and be given a genuine opportunity to do so In practice, this can be achieved through several means, and patients may be informed verbally or in writing, for example through posters and pamphlets at the health facility. In addition to the surveyed patients, hospital staff and in some cases medical associations and unions should also be informed about the PPS. Necessary information includes: — Purpose of the survey — How and when the data collection will take place 2. Ethical review and data privacy WHO_HAMUPPS Protocol.indd 21 Manila Typesetting Company 01/10/2019 07:55PM 22 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 — How data related to their practice will be used (see “Hospital staff privacy” on fair processes to address prescribing or dispensing errors) This information should be conveyed to the staff by the hospital management and hospital coordinator. In cases where external investigators are employed to conduct the survey, they should be introduced to the hospital staff in advance and briefed on, amongst other things, the best time of the day to conduct the survey in order to cause as little disruption to health service delivery as possible (for example, after the ward rounds). Patient privacy In a multicentre national or international survey, hospitals will be provided with an anonymous identifier by the survey coordinator or the national subcoordinator. In addition, wards will be assigned an anonymous code provided by the lead hospital investigator. In a single-centre survey, anonymizing the hospital and ward data is not mandatory. It is always mandatory to anonymize the patients. The patient identifier (i.e. “Patient ID”) should not contain any directly identifiable information, such as name and/ or date of birth, but registration number or patient record number consisting of numbers and letters can be used. The hospital coordinator should also assign an anonymous code to each surveyed patient (i.e. “Patient Code”). This code should be unique for each surveyed patient at the hospital level. In multicentre surveys, the combination of the hospital identifier and the patient identifier can generate unique identifiers for all patients. The patient identifier and the key between the patient identifier and the patient code may be stored safely for up to 6 months for validation purposes, but should be eliminated after this time period to irreversibly de-identify the individual patients. The hospital coordinator is responsible for ensuring that the de-identification of patient data takes place within the specified time period and that the data collected at the hospital by means of the PPS is safely stored. Some information may be difficult to de-identify, especially when the diagnosis or treatment is rare. In the context of this protocol, most diagnosis or treatments are general. However, it is important that data continue to be stored safely and be accessible only to authorized personnel after de-identification. Hospital staff privacy While patient data are being collected and used, hospital staff members are, in effect, the subjects of the PPS. As antibiotics are prescribed, dispensed and administered by staff members, their performance of these tasks may come under scrutiny. For example, the collected data may reveal inappropriate prescribing or dispensing, including missed doses, by one or a number of staff members. While errors should be addressed, staff members are entitled to be protected by ensuring that a “no-blame approach” is implemented at the facilities where the survey will be conducted. It is the responsibility of the hospital coordinator and the investigator team to ensure that a fair process is put in place to address such errors, where the focus should be on improving processes for prescribing and dispensing at the facility rather than reprimanding individual staff members. The WHO_HAMUPPS Protocol.indd 22 Manila Typesetting Company 01/10/2019 07:55PM 2. ETHICAL REVIEW AND DATA PRIVACY 23 national coordinator is responsible for supervising these processes and ensuring that a “no-blame approach” is indeed adopted. Data storage As the data collected by means of this survey may contain sensitive information identifiable at the patient level, it is important that the data are stored safely with only authorized personnel able to obtain access. The means of storage may vary depending on the resources of the hospital, but the lead investigator should ensure that safe storage is achieved and is in accordance with the ethical and data safety regulations in that country. For example, the data files may be encrypted with a password. When available, data files should preferably be stored on secure networks and VPNs of a hospital or university; permanent storage on external disks, e.g. USBs, should be avoided, as these devices may be lost. Ethical committee Before conducting the survey, the national and hospital coordinators must seek ethical clearance from the hospital management and/or the national, regional or local ethical committees as per institutional policies. As the scope of the methodology is public health surveillance, ethical clearance should be sought for surveillance and not for medical research when applicable. WHO published guidelines addressing ethical considerations in public health surveillance in 2017 (15). In addition to approval for data collection, it is also advisable to simultaneously seek clearance for sharing of de-identified data with the WHO. It is important to note that different rules may apply for local or national use versus international use of the collected data. For example, local regulations may not require informed consent for local use of data collected by means of this survey, but may require informed consent if the data are to be shared outside of the national borders. In these cases, the national coordinator is responsible for ensuring that necessary requirements are met before sharing data with the WHO. WHO_HAMUPPS Protocol.indd 23 Manila Typesetting Company 01/10/2019 07:55PM 24 It is important that data are analyzed at the hospital level and that the results are shared with the hospital administration and relevant hospital staff, including hospital pharmacies, drug and therapeutic committees, IPC, and antimicrobial stewardship teams. In the case of multicentre surveys, the survey coordinator should ensure that any comparisons of hospitals take case-mix and level of care into account. Depending on the aim of the analysis, aggregated data can be reported by ward, hospital or country, or alternatively by patient demographics (for example age groups, gender, comorbidities and risk factors etc.). Note that data should not be reported at the patient level or by responsible prescriber or dispenser. Publications based on data collected by means of this protocol should reference the protocol and the version number. 3. Data analysis and dissemination WHO_HAMUPPS Protocol.indd 24 Manila Typesetting Company 01/10/2019 07:55PM 25 The data to be collected are structured according to the following four levels: 1. Country level data 2. Hospital level data 3. Ward level data 4. Patient level data Hospital data Hospital quesonnaire Ward data Paent data Indicaon data Anbioc data Figure 1. Schematic representation of the data structure Country level data Country level data are collected in the event of national multicentre surveys and the main purpose is to gain understanding of the representativeness of the participating hospitals. The information to be collected addresses the total number of hospitals by level and ownership in the country and the sampling strategy used, if any. Hospital level data The hospital level data provides general information on the type and size of the hospitals. The hospital questionnaire (see Annex XII, page 76) contains three 4. Data structure WHO_HAMUPPS Protocol.indd 25 Manila Typesetting Company 01/10/2019 07:55PM 26 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 dimensions: infrastructure, policy and practices, and monitoring and feedback. The questionnaire integrates antimicrobial stewardship indicators defined by TATFAR (17) and DRIVE AB (18). Ward level data The ward level data include information on the type of ward, number of eligible and included patients, and characteristics of the ward. Patient level data The patient level data are split into three categories: 1. Information on the patient 2. Information on the indication of antibiotic use 3. Information on the antibiotic therapy Patient data include information on patient characteristics and should be collected for all surveyed patients, irrespective of antibiotic treatment. The data collected includes sociodemographic information (e.g. age and gender) and information on risk factors for receiving antibiotic treatment during the current hospital stay. This information will be used to adjust for the case-mix population between hospitals. Indication data include information on the reason for prescribing antibiotics, such as diagnosis, type of indication (treatment or prophylaxis), type of infection (healthcare associated, community acquired), etc. There may be several indications for antibiotic treatment, or the indication may be unknown. Antibiotic data include information on the antibiotics prescribed, such as the type of antibiotics, route of administration, strength and dosing frequency, etc. There is also information on the adherence to clinical guidelines. One or more indications may be associated with the prescribed antibiotic (e.g. if the antibiotic has been prescribed to treat multiple coinfections) or the indication may be unknown. Country-, hospital-, ward-, patient-, indication-, and antibiotic data are collected through paper or electronic forms, and contextual information is collected through the hospital questionnaire. Templates of the questionnaire and the data collection forms are accessible through a separate package. Antibiotics Information on antibiotic therapy is only to be registered for patients on treatment according to the inclusion criteria. Antibiotics should be reported both with the written name according to the clinical notes and with International Nonproprietary Names (INN) of the substance(s) (16). If the INN name is unknown at the time of review, the investigator can input the INN at a later stage but before data submission. For patients on antibiotic therapy, report the total number of antibiotic substances prescribed to the patient since admission. Count each antibiotic substance only once, regardless of whether different formulations were prescribed or if the same substance was prescribed more than once with interrupted treatment in between. WHO_HAMUPPS Protocol.indd 26 Manila Typesetting Company 01/10/2019 07:55PM 4. DATA STRUCTURE 27 Examples 1. If a patient received benzylpenicillin followed by ceftriaxone, the reported number of antibiotics should be 2. 2. If a patient received amoxicillin followed by amoxicillin and clavulanic acid, the reported number of antibiotics should be 2. 3. If a patient received ciprofloxacin but then the treatment was interrupted and reinitiated after a few days, the reported number of antibiotics should be 1 and not 2, as the same antibiotic substance was given at both occasions. Dosing Prescribed daily dose is an important parameter for assessing antibiotic use. This parameter will be captured by collecting information on the unit dose and the daily frequency of the unit doses administered. The prescribed daily dose is thus calculated by multiplying the unit dose by the daily frequency. Examples 1. If an antibiotic is prescribed at 1 g three times daily, the unit dose is 1 g and the frequency 3. The prescribed daily dose is 1 g × 3 = 3 g. 2. For long-acting antibiotics, for example 1 g administered once every 2 days, the unit dose will be 1 g and the frequency will be 0.5 (1/2), and the prescribed daily dose will be 1 g × 0.5 = 0.5 g. 3. If 2 g of an antibiotic is administered once every 30 hours, the unit dose will be 2 g and the frequency is 0.8 (24/30). The prescribed daily dose will be 2 g × 0.8 = 1.6 g. When the dose is expressed in mg (or IU) per kg in adult patients, the dose should be translated into g (or IU) by using a standard weight of 70 kg regardless of the actual weight of the patient. In children below age 13, the dose should be calculated in g (or IU) using the actual weight of the patient. Children aged 13 and above are considered adults and a weight of 70 kg should be applied. A list of conversion factors between MU (millions of IU) and g is provided in Annex XIII for selected antibiotics. Example A male child of 7 kg is receiving treatment with amoxicillin. He is receiving a daily dose of 25 mg/kg administered every 8 hours. Thus the prescribed daily dose should be 25 mg × 7 kg = 175 mg. Since the doses are administered three times daily, the UnitDose variable should be reported as 58 (175/3), the UnitDoseMeasureUnit as mg, and the UnitDoseFrequency variable as 3. Combination products Combination products contain two or more antibiotic substances or an antibiotic substance combined with an enzyme inhibitor. To report the dose of combination products, the sum of each antibiotic substance excluding the enzyme inhibitors should be reported in the UnitDose variable, and WHO_HAMUPPS Protocol.indd 27 Manila Typesetting Company 01/10/2019 07:55PM 28 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 the dose of each substance including the enzyme inhibitors should be reported in the UnitDosesCombination variable in the same order as they are reported under the AntibioticINNName variable. Thus for combination products of penicillins (e.g. amoxicillin, ampicillin, piperacillin or ticarcillin), cephalosporins and carbapenems, the amount of enzyme inhibitors (e.g. clavulanic acid, sulbactam or tazobactam) is not included in the UnitDose variable. Examples Product A contains trimethoprim and sulfamethoxazole with strength of 160 mg/800 mg, one tablet administered every 12 hours: • AntibioticINNName: trimethoprim, sulfamethoxazole • UnitDose: 960 • UnitDoseMeasureUnit: mg • UnitDosesCombination: 160 mg, 800 mg • UnitDoseFrequency: 2 Product B contains amoxicillin and clavulanic acid with strength of 500 mg/125 mg, one tablet administered every 12 hours: • AntibioticINNName: amoxicillin, clavulanic acid • UnitDose: 500 • UnitDoseMeasureUnit: mg • UnitDosesCombination: 500 mg, 125 mg • UnitDoseFrequency: 2 Medical prophylaxis Indications for medical prophylaxis include, amongst others, prevention of opportunistic infections in immunocompromised patients (e.g. HIV/AIDS patients), prevention of bacterial infections in patients with late-stage cirrhosis, upper gastrointestinal bleeding, and acute necrotizing pancreatitis. If the patient is on medical prophylaxis during the day of the survey, medical prophylaxis should be reported as MP in the IndicationType variable. Surgical prophylaxis and site For surgical patients present in the ward at 08:00 on the day of survey, the investigator should check if the patient has been prescribed surgical prophylaxis in the 24 hours prior to 08:00 on the day of survey. If the patient was on surgical prophylaxis during this period, report IndicationType as SP and report duration of the prophylaxis in the SurgicalProphylaxisDuration variable as: • SP1: if one dose was administrated to the patient; • SP2: if multiple doses were administered to the patient within 24 hours; • SP3: if multiple doses were administered to the patient for a duration extending 24 hours. If the patient had surgery within 24 hours from 08:00 on the day of survey, then select SP1 or SP2. If the patient had surgery more than 24 hours before 08:00 on the day of survey, then select SP3. WHO_HAMUPPS Protocol.indd 28 Manila Typesetting Company 01/10/2019 07:55PM For patients receiving surgical prophylaxis, specify the anatomical location where the patient will undergo or already has undergone surgery. The surgical sites are listed in Annex X. Antibiotic stock out Antibiotic stock out information is recorded at two levels: at the hospital level through the hospital questionnaire and at the patient level through the patient form. Stock out in hospital questionnaire Review of the availability of antibiotics in the hospital pharmacy will be undertaken during the period of data collection for the survey and will include antibiotics that are routinely procured by the hospital. Antibiotics are considered as out of stock when products for a specific substance are lacking for at least 1 day during the period of data collection. The missing antibiotic should be reported in the hospital questionnaire under the stock out variable using its INN. If a product is lacking but another product of a different brand containing the same substance is available, then the antibiotic is not considered as out of stock. If antibiotics are out of stock more than once during the data collection period, it should be listed as stock out only once. If multiple antibiotics are unavailable during the period of the survey, list them all, separated by commas. Examples • If no product with antibiotic A is available for 3 days, list antibiotic A in the stock out variable. • If product X containing antibiotic A is missing from day 1 to 5 but available on day 6, and product Z containing antibiotic A is available during day 1 and 2 but missing from day 3 to 6, then antibiotic A is considered as out of stock between day 3 and 5, as product Z is available during day 1 to 2 and product X is available from day 6 and onwards. List antibiotic A in the stock out variable. • If antibiotic A that is unavailable from day 1 to 5 becomes available from day 6 to 8, but then becomes unavailable again from day 9 to 11, then antibiotic A should be listed as out of stock only once (even if the stock out occurred during two different periods). • If there is an antibiotic A unavailable from day 1 to 3, an antibiotic B from day 2 to 5 and an antibiotic C from day 9 to 11, then antibiotic A, antibiotic B and antibiotic C should be listed in the stock out variable as A, B, C. Missed doses in the patient form The variable NbMissedDoses registers the number of times a dose could not be administered to the patient since the start of the current treatment. The variable MissedDosesReason registers the reason for the missed doses, including whether they are related to stock out issues at the hospital. If the reason for missed doses is not specified in the patient records, ward staff may be consulted. 4. DATA STRUCTURE 29 WHO_HAMUPPS Protocol.indd 29 Manila Typesetting Company 01/10/2019 07:55PM 30 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Examples • Patient A started antibiotic treatment 2 days before the survey, one tablet 3 times daily. On the second day, the second and third tablets were not administered due to unavailability. NbMissedDoses should be set to 2 and MissedDosesReason to S (stock out issues). • Patient B started antibiotic treatment 3 days before the survey, one tablet 3 times daily. On the second day, doses were not administered because the patient was unable to purchase the treatment for that day. NbMissedDoses should be set to 3 and MissedDosesReason to P. • Patient C started antibiotic treatment 3 days before the survey, one tablet 3 times a day. The second tablet on day 1 and all tablets on day 3 were not administered because the patient could not afford the antibiotic on day 1 and the antibiotic was unavailable on day 3 and onwards. NbMissedDoses should be set to 6 and MissedDosesReason to M (missed for multiple reasons). WHO_HAMUPPS Protocol.indd 30 Manila Typesetting Company 01/10/2019 07:55PM 31 The variables are categorized as core and optional: core variables collect information that is necessary to achieve the objectives of the survey, including estimating the prevalence of antibiotic use and assessing the indication of treatment. The optional variables provide additional information on, amongst others, case-mix of the hospitals that is useful for in-depth analysis. Some optional variables might be more relevant to some regions than others. In national and multicentre surveys it is advised to predetermine which optional variables to include based on the objectives and available resources. Discarding optional variables should not impede on the analysis and interpretation of the results from the survey. The different variables are split into four levels: country-, hospital-, ward-, and patient-level information. Patient-level information also includes specific variables on indications and antibiotics. For ease of data management and analysis, it is necessary that responses to the survey are entered uniformly between the wards and hospitals. Refer to the variable description on the following pages. For Boolean and categorical variables, enter one of the options marked in bold. Enter dates in the following format as indicated in the variable list, i.e. YYYY-MM-DD. Variables WHO_HAMUPPS Protocol.indd 31 Manila Typesetting Company 01/10/2019 07:55PM 32 Core variables Country-specific information is collected by means of the country form, and contains information on the number of hospitals per level and hospital sampling procedure. The purpose is to obtain an overview of representativeness for the hospitals included in the national survey. 1. Country data CountryName Country Name Free text Name of country. CountryISO ISO code of the country Free text Three letter country code according to ISO alpha-3. See Annex XIV. TotalNumberHospital Number of hospitals in the country Number Positive integer Total number of hospitals at any level (tertiary, secondary, primary and specialized) in the country. NumberPublicHospital Number of public hospitals in the country Number Positive integer Number of public hospitals in the country. See section on Hospital ownership (page 10). This variable refers to hospitals classified as PUB. NumberNonPublicHospital Number of private hospitals in the country Number Positive integer Estimated number of private hospitals in the country. See section on Hospital ownership (page 10). This variable refers to all hospitals not classified as PUB. NumberTertiaryHospital Number of tertiary level hospitals in the country Number Positive integer Estimated number of tertiary level (central or university) hospitals in the country. See section on Hospital types (page 9). NumberSecondaryHospital Number of secondary level hospitals in the country Number Positive integer Number of secondary level (regional or provincial) hospitals in the country. See section on Hospital types (page 9). WHO_HAMUPPS Protocol.indd 32 Manila Typesetting Company 01/10/2019 07:55PM 1. COUNTRY DATA 33 NumberPrimaryHospital Number of primary level hospitals in the country Number Positive integer Estimated number of primary level (district) hospitals in the country. See section on Hospital types (page 9). NumberSpecialityHospital Number of specialized hospitals in the country Number Positive integer Estimated number of specialized hospitals in the country. See section on Hospital types (page 9). NationalHospitalGroups Hospital groups exist in the country Boolean Y: yes N: no If hospital groups exist in the country, respond Yes. See section on Hospital group (page 10). HospitalSampling Hospital sampling strategy Coded value A: All hospitals included R: Random sampling C: Convenience sampling Specify the sampling strategy for selection of hospitals to enrol in the survey. See section Representative hospital sampling (page 19). HospConvenSampling Describe convenience sampling approach Free text If convenience sampling was conducted, describe the approach. For example, what were the criteria for selection of hospitals, whether hospital type, ownership and geographical location were taken into account etc. InvitedHospital Number of hospitals in the country selected and invited for the survey Number Positive integer Total number of hospitals at any level (tertiary, secondary, primary and specialized) in the country that were invited to participate in the survey. Note that this variable specifies the number of hospitals invited to enrol in the survey, and not the number that has conducted and submitted data from the survey. NationalGuideline National treatment guidelines exist Boolean Y: yes N: no Respond Yes if national treatment guidelines exist and are updated regularly. LocalGuideline Facility-based treatment guidelines exist Boolean Y: yes N: no Respond Yes if facilities (such as hospitals) can develop their own treatment guidelines. NationalAMS A national hospital antimicrobial stewardship programme exists Boolean Y: yes N: no Respond Yes if there is a national antimicrobial stewardship programme for hospitals. WHO_HAMUPPS Protocol.indd 33 Manila Typesetting Company 01/10/2019 07:55PM 34 The hospital data are collected through the hospital form that includes variables related to the hospital, in addition to the hospital questionnaire (Annex XII) that collects information on structural indicators related to antibiotic use. Core variables 2. Hospital data HospitalID Official identifier of the hospital Free text This variable is an official identifier of the hospital. In a multicentre survey, this variable must be discarded before sending the data to the survey coordinator. HospitalCode Anonymous code of the hospital Free text This variable is an anonymous code that uniquely identifies the hospital. This is important in multicentric survey in order to anonymize the participating hospitals. This anonymous code should be provided to the hospital by the survey coordinator (or national subcoordinator). Only the survey coordinator (or national subcoordinator) can link the anonymous HospitalCode to the HospitalID. SurveyStartDate Starting date of the data collection in the hospital Date YYYY-MM-DD This date corresponds to the first day of the data collection and not the date when the survey was initiated in the hospital. SurveyEndDate Ending date of the data collection in the hospital Date YYYY-MM-DD This date corresponds to the last day of the data collection and not the date when the survey was ended in the hospital (data submission and analysis will be performed after the end of the data collection). HospitalGroup Hospital is part of a hospital group Boolean Y: the hospital is part of a hospital group N: the hospital is not part of a hospital group The hospital is either a part of a hospital group or not. See section on Hospital groups (page 10). WHO_HAMUPPS Protocol.indd 34 Manila Typesetting Company 01/10/2019 07:55PM 2. HOSPITAL DATA 35 HospitalGroupCode Anonymous code of the hospital group Free text When the hospital is part of a hospital group, provide an anonymous code of the hospital group. This will allow grouping hospitals from the same hospital group together. The anonymous code should be provided by the survey coordinator (or national subcoordinator). Only relevant when HospitalGroup is Yes. HospitalGroupAllSites Included All sites of the hospital group have been included in the survey Boolean Y: all sites of the hospital group included N: only some sites of the hospital group included If all the sites of the hospital group have been included in the survey, specify Yes; otherwise No. Only relevant when the HospitalGroup is set to Y. The survey coordinator (or national subcoordinator) should contact the hospital group to ascertain whether all hospitals of the hospital group have been included in the survey. HospitalType Type of hospital Coded value Primary: primary hospital Secondary: secondary hospital Tertiary: tertiary hospital Specialized: specialized hospital The type of the hospital. See section on Hospital types (page 9). HospitalTypeSpeciality Specialty of the specialized hospital Free text The speciality of specialized hospitals. Only relevant when the HospitalType is Specialized. HospitalOwnership The ownership of hospital according to public/private status Coded value PUB: public PRVNFP: private, not-for-profit PRVFP: private, for-profit OTH: other UNK: unknown If the hospital is publicly owned, privately owned or if it is a public/private partnership. See section on Hospital ownership (page 10). HospitalTotalBeds Total number of beds in the hospital Number Positive integer The total number of beds in the hospital including acute and non-acute beds. HospitalAcuteBeds Number of acute beds in the hospital Number Positive integer The number of acute beds in the hospital. WHO_HAMUPPS Protocol.indd 35 Manila Typesetting Company 01/10/2019 07:55PM 36 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 HospitalICUBeds Number of ICU beds in the hospital Number 0 or positive integer The number of ICU beds in the hospital. HospitalHighRiskBeds Number of high risk beds in the hospital Number 0 or positive integer The number of beds in high risk units in the hospital, excluding ICU. See section on high risk units (page 13). HospitalAnnualAdmissions Annual number of overall admissions Number Positive integer The annual number of overall admissions in the hospital for the year prior to the year of the survey. If number of admissions is not available, use the number of discharges (separations). HospitalAnnualPatientDays Annual number of overall patient-days Number Positive integer The annual number of overall patient days in the hospital for the year prior to the year of the survey. If the number of patient days is not available, use the number of bed days. HospitalIncludedBeds Number of beds included in the survey Number Positive integer Sum of the number of beds of the wards included in the survey. HospitalEligiblePatients Number of eligible patients Number Positive integer Number of patients eligible for inclusion in the survey. HospitalIncludedPatients Number of patients included in the survey Number Positive integer Number of patients included in the survey. This number should correspond to the sum of patient data forms. The difference between the number of eligible and included patients is the number of patients who did not consent. PatientSampling Sampling of patients was conducted Boolean Y: patient sampling conducted N: no patient sampling conducted, all patients included Specify if a patient sampling strategy was used or not. See section on Patient sampling (page 18). Patient sampling must be done according to the protocol. WHO_HAMUPPS Protocol.indd 36 Manila Typesetting Company 01/10/2019 07:55PM 37 The ward data consists of information related to the ward such as ward type and number of patients present or eligible for the survey. Core variables 3. Ward data WardID Official identifier of the ward Free text This variable is an official identifier of the ward. It should be unique within the hospital. In a multicentre survey, this variable must be discarded by the lead hospital investigator before sending the data to the survey coordinator. WardCode Anonymous code of the ward Free text This variable is an anonymous code that uniquely identifies the ward within the hospital. This anonymous code should be assigned by the lead hospital investigator. Only the lead hospital investigator can link the anonymous WardCode to the official WardID. WardInvestigator Code of the investigator or investigator team Free text The code of the investigator or of the investigating team that audited the ward. WardSurveyDate Date data are collected in the ward Date YYYY-MM-DD The date the ward was surveyed. It must be between SurveyStartDate and SurveyEndDate. It corresponds to the date of the 08:00 anchor period that is used by the survey. WardType Type of ward Coded value The type of ward. See Annex I. WardTotalPatients Total number of patients present in the ward at 08:00 Number Positive integer The total number of patients including inpatients, outpatients (also patients who are temporarily away, e.g. in the operating theatres, recovery and diagnostic suites, but who have a bed in the ward) at 08:00 on the day of the audit. This information should be collected by the ward staff. WardEligiblePatients Number of eligible patients present in the ward at 08:00 Number Positive integer The number of eligible patients (inpatient) hospitalized in the ward at 08:00 on the day of the audit. This information should be collected by the ward staff. WHO_HAMUPPS Protocol.indd 37 Manila Typesetting Company 01/10/2019 07:55PM 38 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 WardIncludedPatients Number of included patients Number Positive integer The number of patients included in the survey. This is the number of eligible patients minus patients who did not give consent to participate in the survey. Optional variables WardSpecialties List of specialties in the ward Coded values The speciality/ies under which the audited patients were admitted. If the ward contains patients belonging to more than one speciality, register all specialities separated by comma. See Annex II. WHO_HAMUPPS Protocol.indd 38 Manila Typesetting Company 01/10/2019 07:55PM 39 Patient data consist of a set of demographic variables and variables related to risk factors for receiving antibiotics. The core variables should be collected in all hospitals, independent of the type of hospital, country, or region where the survey is conducted. These variables facilitate global comparison of the results by taking into account the case-mix of patients. As the epidemiological context varies across the world, some patient data might be more relevant in some countries or regions. Thus the protocol includes an optional set of variables that can be collected when relevant. These optional variables are grouped according to themes (for example underlying infectious diseases). Patient data should be collected for all eligible patients irrespective of whether they are receiving antibiotics or not (excluding patients who have not given their consent when applicable). Core variables 4. Patient data PatientID Official identifier of the patient Free text This variable is an official identifier of the patient. It should be unique within the hospital. This variable must be discarded by the hospital coordinator before analyzing the data or before sending the data to the national coordinator in cases of multicentre surveys. PatientCode Anonymous code of the patient Free text This variable is an anonymous code that uniquely identifies the patient within the hospital. Only the hospital coordinator should be able to link the anonymous PatientCode to the official PatientID. Gender Gender of the patient Coded value M: male F: female T: transgender UNK: unknown The gender of the patient. AgeYear Age of the patient as number of years Number Integer ≥ 2 For patients aged greater or equal to 2 years; age must be entered as a number of years. WHO_HAMUPPS Protocol.indd 39 Manila Typesetting Company 01/10/2019 07:55PM 40 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 AgeMonth Age of the patient as number of months Number Integer between 0 and 23 For patients aged less than 2 years, age must be entered as number of months. When the baby is less than a month, enter 0. PreTermBirth Type of preterm Coded value LP: late preterm, born between 34 and 36 weeks of pregnancy MP: moderately preterm, born between 32 and 34 weeks of pregnancy VP: very preterm, born at less than 32 weeks of pregnancy EP: extremely preterm, born at or before 25 weeks of pregnancy For preterm babies, specify the category. Only relevant for newborns. Child12YearWeight Weight of the child below age 13 in kg Number Up to 3 decimals The weight of the child at the date of the survey. Take the latest available weight in the patient notes. Only relevant for children below age 13. For neonates, report weight up to grams (for example 2.758 kg). NeonatesBirthWeight Weight of the neonates in kg Number Up to 3 decimals The birth weights of the neonates. Report weight up to grams (for example 2.758 kg). AdmissionDate Date of admission of the patient Date YYYY-MM-DD The date of admission of the patient to the hospital, not to the ward. SurgerySinceAdmission Surgery since admission Boolean Y: yes N: no UNK: unknown If the patient had surgery between the date of admission and the date of the survey. CentralVascularCatheter Presence of central vascular catheter Boolean Y: yes N: no UNK: unknown If the patient has a central vascular catheter at 08:00 on the day of the survey. PeripheralVascularCatheter Presence of peripheral vascular catheter Boolean Y: yes N: no UNK: unknown If the patient has a peripheral vascular catheter at 08:00 on the day of the survey. WHO_HAMUPPS Protocol.indd 40 Manila Typesetting Company 01/10/2019 07:55PM 4. PATIENT DATA 41 Optional variables Underlying infectious disease variables UrinaryCatheter Presence of urinary catheter Boolean Y: yes N: no UNK: unknown If the patient has a urinary catheter at 08:00 on the day of the survey. Intubation Presence of intubation device Boolean Y: yes N: no UNK: unknown If the patient has an intubation device present at 08:00 on the day of the survey. PatientOnAntibiotic The patient is on antibiotic Boolean Y: yes N: no If the patient is on antibiotic according to the inclusion criteria. PatientNumberAntibiotics Number of antibiotics prescribed since admission Number The number of different antibiotics prescribed to the patient since admission. This includes antibiotics that have been discontinued before 8 a.m. on the day of the survey. Only relevant if PatientOnAntibiotic is Y. MalariaStatus The patient has malaria Boolean Y: yes N: no UNK: unknown The current malaria status of the patient. Indicate as Y if the patient has or had malaria during the current hospitalization. TuberculosisStatus The patient has tuberculosis Boolean Y: yes N: no UNK: unknown The current tuberculosis status of the patient. Indicate as Y if the patient has or had active tuberculosis during the current hospitalization. HIVStatus The patient has HIV Boolean Y: yes N: no UNK: unknown The HIV status of the patient. WHO_HAMUPPS Protocol.indd 41 Manila Typesetting Company 01/10/2019 07:55PM 42 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Comorbidity variables McCabeScore McCabe score of the patient Coded value RF: rapidly fatal, death within a year UF: ultimately fatal, death between 1 year and 4 years NF: nonfatal, death after 5 years The McCabe score of the patient. See Annex III. MalnutritionStatus The patient is malnourished Boolean Y: yes N: no UNK: unknown If the patient is malnourished or not. COPDStatus The patient has COPD Boolean Y: yes N: no UNK: unknown If the patient has COPD or not. Hospitalisation variables TransferFromHospital Transfer from another hospital Boolean Y: yes N: no UNK: unknown If the patient has been transferred from another hospital. HIVOnART The patient is on ART Boolean Y: yes N: no UNK: unknown If the patient is on ART or not. Only relevant if HIVStatus is Yes. HIVCD4Count The CD4 count of HIV patient on ART Number UNK: unknown The CD4 count in the past 6 months. Specify in cells/mm3. Only relevant if HIVStatus is Yes. Report the last available count if multiple counts are reported WHO_HAMUPPS Protocol.indd 42 Manila Typesetting Company 01/10/2019 07:55PM TransferFromNonHospital Facility Transfer from another health facility other than hospital Boolean Y: yes N: no UNK: unknown The patient has been transferred from a health facility that is not a hospital (for example nursing homes, residential care facility, rehabilitation centre). Hospitalization90Days Hospitalization within 90 days Boolean Y: yes N: no UNK: unknown If the patient had another hospitalization within 90 days prior to the current admission. Surgery variables TypeSurgerySinceAdmission Type of surgery since admission Coded value M: minimal invasive surgery/ non NHSN NHSN: NHSN coded surgery UNK: unknown The patient has surgery between his admission and the date of survey. Only relevant if SurgerySinceAdmission is Y. See Annex IX. 4. PATIENT DATA 43 WHO_HAMUPPS Protocol.indd 43 Manila Typesetting Company 01/10/2019 07:55PM 44 These variables collect information on the indication of antibiotic treatment and are to be filled out for all eligible patients on antibiotic treatment(s) at 08:00 on the day of the survey. If applicable, more than one indication may be filled out per patient. Core variables 5. Indication data IndicationCounter Counter of the indication Number Sequential number The count value of the indication for antibiotic therapy in the patient. For the first indication, insert 1; for the second indication, insert 2 etc. IndicationType The type of indication Coded value HAI: hospital-associated infection CAI: community-acquired infection SP: surgical prophylaxis MP: medical prophylaxis O: Other The type of indication for antibiotic therapy in the patient. HAI is based on the date of onset of symptoms since admission. See Annex V. SurgicalProphylaxisDuration Duration of surgical prophylaxis Coded value SP1: one dose SP2: multiple doses on one day SP3: multiple doses on more than one day The duration of surgical prophylaxis. Only relevant if IndicationType is SP. See section Surgical prophylaxis (page 30). SurgicalProphylaxisSite Site of surgery Coded Value CNS: Central nervous system EYE: Ophthalmic ENT: Otolaryngology RESP: Respiratory CVS: Cardiovascular system GI: Gastrointestinal tract SSTBJ: Skin, soft tissue, bone and joint UTI: Urinary tract GO: Gynaecology & obstetrics UNK: Site not defined Only applicable if IndicationType is SP. See Annex X. WHO_HAMUPPS Protocol.indd 44 Manila Typesetting Company 01/10/2019 07:55PM 5. INDICATION DATA 45 Diagnosis Diagnosis Coded value The diagnosis underlying the indication for antibiotic therapy. See Annex IV. Only relevant if IndicationType is CAI or HAI. StartDateTreatment The start date of treatment Date The date on which the first antibiotic treatment was initiated for this particular indication. If the antibiotic treatment has changed during hospitalization, record the date when the first dose of the first antibiotic treatment was initiated for this indication. This variable informs on the entire duration of antibiotic treatment for this indication. The duration of treatment for the current antibiotic is recorded in the antibiotic variable StartDateAntibiotic. ReasonInNotes Reasons for antibiotics written in patient’s notes Boolean Y: yes, the indication was written in patient notes N: no, the indication was not written in patient notes If the indication for treatment is written in the patient notes or other routine patient documentation, e.g. temperature charts, drug list etc. CultureSampleTaken A sample has been taken for microbiology diagnostic Boolean Y: yes N: no UNK: unknown If a sample has been taken for microbiology diagnostics according to the patient notes or other routine patient documentation, or according to ward staff (doctor or nurses). Only relevant if IndicationType is CAI or HAI. If Y, continue with the Microbiology variables. Microbiology variables Microbiology data refers to any culture and susceptibility test result from relevant clinical samples. Screening samples should not be reported. The microbiology variables are to be filled out when CultureSampleTaken is Yes. If the results from the sample(s) are not available, indicate NA under CultureResults and proceed to the next section. SpecimenType Type of specimen Coded value The type of specimen used for the microbiology diagnostics. Only relevant if CultureSampleTaken is Y. See Annex VII. CultureResults Results from the culture Boolean NA: not available Pos: positive Neg: negative Report the culture results when available, only relevant if CultureSampleTaken is Y. Negative samples include cultures with no growth or growth of microbes without clinical significance, for example normal flora and mixed flora without clinical significance. For growth of mixed flora with clinical significance select Pos, and indicate "Microorganism not identified" [_NONID] under the Microorganism variable. WHO_HAMUPPS Protocol.indd 45 Manila Typesetting Company 01/10/2019 07:55PM 46 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Microorganism1 Isolated microorganism 1 Coded value The first isolated microorganism. Only relevant if CommunicatedCultureResults is Y. See Annex VI. Microorganism2 Isolated microorganism 2 Coded value The second isolated microorganism. Only relevant if CommunicatedCultureResults is Y. See Annex VI. Microorganism3 Isolated microorganism 3 Coded value The third isolated microorganism. Only relevant if CommunicatedCultureResults is Y. See Annex VI. AntibioticSusceptibility TestResults Antibiotic susceptibility test conducted Boolean Y: yes N: no UNK: unknown If an antibiotic susceptibility test has been undertaken and communicated to the ward. Only relevant if CommunicatedCultureResults is Y. ResistantPhenotype1 Resistant phenotype 1 Coded value The first resistant phenotype. Only relevant if AntibioticSusceptibilityTestResults is Y. See Annex VIII. ResistantPhenotype2 Resistant phenotype 2 Coded value The second resistant phenotype. Only relevant if AntibioticSusceptibilityTestResults is Y. See Annex VIII. ResistantPhenotype3 Resistant phenotype 3 Coded value The third resistant phenotype. Only relevant if AntibioticSusceptibilityTestResults is Y. See Annex VIII. WHO_HAMUPPS Protocol.indd 46 Manila Typesetting Company 01/10/2019 07:55PM 47 Collects information on each antibiotic prescribed and/or dispensed to the patient. When the antibiotic is a combination product, register the combination product as one antibiotic. Conversely, if two or more single products have been prescribed to replace a combination product, enter each single product independently. Note that one antibiotic can be linked to several indications, and one indication can be linked to several antibiotics using the variable IndicationCounters. Core variables 6. Antibiotic data AntibioticCounter Count of the antibiotic Number Sequential number The count value of the antibiotic prescribed to the patient. For the first antibiotic, insert 1; for the second antibiotic, insert 2 etc. IndicationCounters Count(s) of the related indications List of integers 1, 2, 3… The count value of the indication(s). If the antibiotic cannot be linked to one indication, the field should be kept empty. If more than one indication is linked to the antibiotic, specify all the count values of the linked indications separated by comma. AntibioticNotesName Name of the antibiotic in patient notes Free text The name of the antibiotic as written in the patient notes. AntibioticINNName INN Name of the antibiotic Coded value See list of INN antibiotics The name of the antibiotic in INN. If the product is a combination of antibiotics or antibiotic and enzyme inhibitor, list all active substances in the combination. See section on Combination products (page 29) and Annex XI. AntibioticWrittenInINN Antibiotic written in INN Boolean Y: yes N: no The name of the antibiotic was written in INN in the patient’s notes. StartDateAntibiotic The start date of the current antibiotic Date The date on which the first dose of the current antibiotic was administered. If the patient received the antibiotic upon admission, record the date of admission. WHO_HAMUPPS Protocol.indd 47 Manila Typesetting Company 01/10/2019 07:55PM 48 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Optional variables Prescriber variables PrescriberType The type of prescriber Coded value SP: specialist physician GP: non-specialist physician O: other UNK: unknown Specifies the professional training of the prescriber (specialist, non-specialist physician or other). UnitDose The unit dose Number The unit dose administered to the patient. See section on Dosing (page 29). For combination products, report the sum of the dose of each active substances except when stated. See section on Combination products (page 29). UnitDosesCombination The doses of each active substance in the combination product Free text The list of the doses of each active substance in the combination, listed in the same order as in AntibioticINNName. See section on Combination products (page 29). Only relevant when the product is a combination product. UnitDoseMeasureUnit The measurement unit of the unit dose Coded value The measurement unit of the unit dose. See Annex XIII. UnitDoseFrequency The daily frequency of the administration of the unit dose Number The daily frequency of the administered unit dose. If the antibiotic is given once a day, enter 1; twice a day, enter 2; once every two days, enter 0.5; every 30 hours, enter 0.8. Multiplying the single dose by the daily frequency allows calculation of the prescribed daily dose. See section on Dosing (page 29). AdministrationRoute The route of administration of the antibiotic Coded value O: oral P: parenteral INH: inhalation R: rectal The route of administration of the antibiotic. WHO_HAMUPPS Protocol.indd 48 Manila Typesetting Company 01/10/2019 07:55PM 6. ANTIBIOTIC DATA 49 Route of administration variables ParenteralType Type of parenteral administration Coded value IM: intramuscular IV-B: intermittent intravenous IV-C: continuous intravenous IV-E: extended intravenous O: other The type of parenteral administration, either bolus or continuous. Only relevant when AdministrationRoute is P. OralSwitch Oral switch Boolean Y: yes N: no UNK: unknown If the oral antibiotic is the result of switching from a parenteral formulation. Only relevant when AdministrationRoute is 0. Dose administration variables NbMissedDoses Number of missed doses Number UNK: unknown The number of missed doses from the start date of the current antibiotic treatment until the date of the survey. If no doses have been missed, report as 0. If unknown, report as UNK. MissedDosesReason Reason for missed doses Coded value S: missed doses due to stock out P: the patient could not purchase the doses O: missed doses due to other reason M: missed doses due to multiple reasons UNK: unknown Report the reason for the missed doses and if it is related to stock out at the hospital pharmacy. Only relevant when NbMissedDoses > 0. WHO_HAMUPPS Protocol.indd 49 Manila Typesetting Company 01/10/2019 07:55PM 50 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Treatment guideline variables GuidelinesCompliance Compliance to the guidelines Coded value Y: yes N: no NA: not assessable NI: no information If the prescribed antibiotic for the indication (antibiotic substance, route of administration and dosing) is in line with the clinical guidelines at the facility (national or local guideline or infectious specialist recommendation). If no guidelines exist (either local or national) or if the antibiotic is used for more than one indication, report as “Not assessable”. If the antibiotic is not linked to any indication, report as “No information”. TreatmentType Directed or empirical treatment Coded value D: Directed treatment E: Empirical treatment If the antibiotic was prescribed in response to microbiology results, report as directed therapy. Otherwise, report as empirical. WHO_HAMUPPS Protocol.indd 50 Manila Typesetting Company 01/10/2019 07:55PM 51 1. ECDC. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals. Protocol version 5.3. Stockholm: European Centre for Disease Prevention and Control; 2016. (https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/ PPS-HAI-antimicrobial-use-EU-acute-care-hospitals-V5-3.pdf, accessed 12 November 2018) 2. WHO. Antimicrobial resistance. Fact sheet. Geneva: World Health Organization; 2018 (http://www.who.int/mediacentre/factsheets/fs194/en/, accessed 12 November 2018) 3. Jim O’Neill. The Review on Antimicrobial Resistance. Tackling drug-resistant infections globally: final report and recommendations. Uk government, Wellcome Trust; 2016 (https://amr-review.org/sites/default/files/160525_ Final%20paper_with%20cover.pdf, accessed 12 November 2018) 4. WHA 68.7 Global action plan on antimicrobial resistance. Geneva: World Health Assembly; 2015 (http://apps.who.int/gb/ebwha/pdf_files/WHA68/ A68_R7-en.pdf, accessed 12 November 2018) 5. WHO. Global Action Plan on Antimicrobial Resistance. Geneva: World Health Organization; 2015 (http://www.wpro.who.int/entity/drug_resistance/ resources/global_action_plan_eng.pdf, accessed 12 November 2018) 6. OECD. Antimicrobial Resistance. Policy Insights. Organisation for Economic Co-operation and Development; 2016 (https://www.oecd.org/health/health- systems/AMR-Policy-Insights-November2016.pdf, accessed 12 November 2018) 7. WHO. WHO methodology for a global programme on surveillance of antimicrobial consumption. Geneva: World Health Organization; 2016 (http:// www.who.int/medicines/areas/rational_use/WHO_AMCsurveillance_ 1.0.pdf?ua=1, accessed 12 November 2018) 8. ECDC. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals. Stockholm: European Centre for Disease Prevention and Control; 2013 (https://ecdc.europa.eu/en/ healthcare-associated-infections-acute-care-hospitals, accessed 12 November 2018) 9. Magill S, Edwards J, Bamber W, Beldavs ZG, Dumyati G, Kainer M et al. Multistate Point-Prevalence Survey of Health Care–Associated Infections. N Engl J Med. 2014;370:1198–1208; doi:1010156/NE/Moa1306801 10. Global PPS Development Group. Point Prevalence Survey of Antimicrobial Consumption and Resistance (2017 GLOBAL-PPS). Global PPS Development Group; 2016 (http://www.global-pps.com/wp-content/uploads/GLOBAL-PPS- 2017-Protocol.pdf , accessed 12 November 2018) References WHO_HAMUPPS Protocol.indd 51 Manila Typesetting Company 01/10/2019 07:55PM 52 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 11. MURIA Medicines Utilisation Research in Africa. PPS Survey. Medicines Utilisation Research in Africa (http://muria.nmmu.ac.za/, accessed 12 November 2018) 12. Jamison, Dean T. Disease Control Priorities in Developing Countries. 2nd ed. NCBI Bookshelf. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; New York: Oxford University Press; 2006. 13. WHO Collaborating Centre for Drug Statistics Methodology, ATC/DDD Index 2017 [online database]. Oslo: WHO Collaborating Centre for Drug Statistics Methodology; 2017 (https://www.whocc.no/atc_ddd_index/, accessed 12 November 2018) 14. CIOMS. International Ethical Guidelines for Health-related Research Involving Humans. Geneva: Council for International Organizations of Medical Sciences; 2016 (https://cioms.ch/wp-content/uploads/2017/01/ WEB-CIOMS-EthicalGuidelines.pdf, accessed 12 November 2018) 15. WHO Guidelines on Ethical Issues in Public Health Surveillance. Geneva: World Health Organization; 2017 (http://www.who.int/ethics/publications/ public-health-surveillance/en/, accessed 12 November 2018) 16. WHO. Guidance on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances. Geneva: World Health Organization; 2017 (http://www.who.int/medicines/services/inn/FINAL_WHO_PHARM_S_ NOM_1570_web.pdf?ua=1, accessed 12 November 2018) 17. Pollack LA, Plachouras D, Sinkowitz-Cochran R, Gruhler H, Monnet DL, Weber JT; Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) Expert Panel on Stewardship Structure and Process Indicators. A Concise Set of Structure and Process Indicators to Assess and Compare Antimicrobial Stewardship Programs Among EU and US Hospitals: Results From a Multinational Expert Panel. Infect Control Hosp Epidemiol. 2016; 37(10):1201–11 18. Drive AB Report on quality indicators and quantity metrics of antibiotic use. Driving reinvestment in R&D and responsible antibiotic use –DRIVE-AB (http://drive-ab.eu/wp-content/uploads/2014/09/WP1A_Final-QMs-QIs_ final.pdf, accessed 12 November 2018) WHO_HAMUPPS Protocol.indd 52 Manila Typesetting Company 01/10/2019 07:55PM 53 Departments Ward type code Ward type name Paediatric PMW Paediatric medical ward PSW Paediatric surgical ward PHRW High risk paediatric ward (see high risk units) PICU Paediatric intensive care unit Neonatal NMW Neonatal medical ward NICU Neonatal intensive care unit Adult AMW Adult medical ward ASW Adult surgical ward AHRW High risk adult ward (see high risk units) AICU Adult intensive care unit Mixed MXW Mixed ward ANNEX I Types of ward WHO_HAMUPPS Protocol.indd 53 Manila Typesetting Company 01/10/2019 07:55PM 54 ANNEX II Specialties1 1 Adapted from ECDC (1). Ward/Patient specialty code Ward/Patient specialty name SURGEN General surgery SURDIG Digestive tract surgery SURORTO Orthopaedics SURTR Traumatology SURCARD Cardio surgery SURVASC Vascular surgery SURTHO Thoracic surgery SURNEU Neurosurgery SURPED Paediatric general surgery SURTRANS Transplantation surgery SURONCO Surgery for cancer SURENT Otorhinolaryngology SUROPH Ophthalmology SURMAXFAC Maxillofacial surgery SURSTODEN Stomatology/Dentistry SURBURN Burn care SURURO Urology SURPLAS Plastic and reconstructive surgery SUROTH Other surgery MEDGEN General medicine MEDGAST Gastroenterology MEDHEP Hepatology MEDENDO Endocrinology MEDONCO Oncology Ward/Patient specialty code Ward/Patient specialty name MEDHEMA Haematology MEDBMT Bone marrow transplantation (BMT) MEDCARD Cardiology MEDDERM Dermatology MEDNEPH Nephrology MEDNEU Neurology MEDPNEU Pneumology MEDRHEU Rheumatology MEDID Infectious diseases MEDTR Medical traumatology MEDOTH Other medical PEDGEN Paediatrics general, not specialized PEDNEO Neonatology ICUNEO Neonatal ICU ICUPED Paediatric ICU ICUMED Medical ICU ICUSUR Surgical ICU ICUMIX Mixed (polyvalent) ICU, general intensive or critical care ICUSPEC Specialized ICU ICUOTH Other ICU GOOBS Obstetrics/Maternity GOGYN Gynaecology WHO_HAMUPPS Protocol.indd 54 Manila Typesetting Company 01/10/2019 07:55PM 55 ANNEX III McCabe score1 Examples of diseases for different McCabe score categories: Rapidly fatal: < 1 year End-stage haematological malignancies (unsuitable for transplant, or relapsed), heart failure (EF < 25%) and end-stage liver disease (unsuitable for transplant with recalcitrant ascites, encephalopathy or varices) Multiple organ failure on intensive care unit – APACHE II score > 30, SAPS II score > 70 Ultimately fatal: 1 year to 4 years Chronic leukaemias, myelomas, lymphomas, metastatic carcinoma, end-stage kidney disease (without transplant) Motor neuron disease, multiple sclerosis nonresponsive to treatment Alzheimer’s disease/dementia Diabetes requiring amputation or post amputation Nonfatal: > 5 years Diabetes Carcinoma/haematological malignancy with > 80% 5-year survival Inflammatory disorders Chronic GI, GU conditions Obstetrics Infections (including HIV, HCV, HBV – unless in above categories) All other diseases 1 Adapted from ECDC (1). WHO_HAMUPPS Protocol.indd 55 Manila Typesetting Company 01/10/2019 07:55PM 56 ANNEX IV Diagnoses1 Diagnosis Examples CNS Infections of the central nervous system EYE Endophthalmitis and other bacterial eye conditions ENT Infections of ear, nose, throat, larynx and mouth BRON Acute bronchitis or exacerbations of chronic bronchitis PNEU Pneumonia CF Cystic fibrosis CVS Cardiovascular infections: endocarditis, vascular graft GI Gastrointestinal infections (e.g. salmonellosis, antibiotic-associated diarrhoea) IA Intra-abdominal sepsis, including hepatobiliary SST-SSI Surgical site infection involving skin or soft tissue but not bone SST-O Cellulitis, wound, deep soft tissue not involving bone, not related to surgery BJ-SSI Septic arthritis, osteomyelitis of surgical site BJ-O Septic arthritis, osteomyelitis, not related to surgery CYS Symptomatic lower urinary tract infection (e.g. cystitis) PYE Symptomatic upper urinary tract infection (e.g. pyelonephritis) ASB Asymptomatic bacteriuria OBGY Obstetric or gynaecological infections GUM Prostatitis, epididymo-orchitis STD Sexually transmitted disease (e.g. syphilis, gonorrhea, chlamydia) BAC Laboratory-confirmed bacteraemia CSEP Clinical sepsis (suspected bloodstream infection without lab confirmation/results are not available, no blood cultures collected or negative blood culture), excluding febrile neutropenia FN Febrile neutropenia or other form of manifestation of infection in immunocompromised host (e.g. HIV, chemotherapy, etc.) with no clear anatomical site SIRS Systemic inflammatory response with no clear anatomical site UND Completely undefined; site with no systemic inflammation NA Not applicable; for antibiotic use other than treatment 1 Adapted from ECDC (1). WHO_HAMUPPS Protocol.indd 56 Manila Typesetting Company 01/10/2019 07:55PM 57 ANNEX V Definition of hospital- associated infection1 Classification for hospital-associated infections (HAI) versus community- acquired infections is based on the date of onset of the infection after admission. Date of onset is defined as the date of first signs or symptoms of the infection. If unknown, record the date when treatment was started for this infection or the date when the first sample was taken. If dates are missing, please estimate. If signs or symptoms were present at admission, then the infection should not be considered as hospital-associated. Infection categorized as HAI if date on onset is on: Day 3 onwards OR Day 1 or Day 2 AND patient transferred from another hospital OR Day 1 or Day 2 AND patient discharged from a hospital (same hospital or another one) in preceding 48 hours 1 Adapted from ECDC (1). WHO_HAMUPPS Protocol.indd 57 Manila Typesetting Company 01/10/2019 07:55PM 58 ANNEX VI Microorganism codes1 The microorganism code list has been defined by ECDC using the following criteria: frequency of occurrence in healthcare-associated infections and/or public health importance. Family Microorganism Code Gram + cocci Staphylococcus aureus STAAUR Staphylococcus epidermidis STAEPI Staphylococcus haemolyticus STAHAE Coagulase-negative staphylococci, not specified STACNS Other coagulase-negative staphylococci (CNS) STAOTH Staphylococcus spp., not specified STANSP Streptococcus pneumoniae STRPNE Streptococcus agalactiae (B) STRAGA Streptococcus pyogenes (A) STRPYO Other haemolytic streptococci (C, G) STRHCG Streptococcus spp., other STROTH Streptococcus spp., not specified STRNSP Enterococcus faecalis ENCFAE Enterococcus faecium ENCFAI Enterococcus spp., other ENCOTH Enterococcus spp., not specified ENCNSP Gram-positive cocci, not specified GPCNSP Other Gram-positive cocci GPCOTH Gram – cocci Moraxella catharralis MORCAT Moraxella spp., other MOROTH Moraxella spp., not specified MORNSP Neisseria meningitides NEIMEN Neisseria spp., other NEIOTH Neisseria spp., not specified NEINSP Gram-negative cocci, not specified GNCNSP Other Gram-negative cocci GNCOTH 1 Adapted from ECDC (1). WHO_HAMUPPS Protocol.indd 58 Manila Typesetting Company 01/10/2019 07:55PM ANNEX VI. MICROORGANISM CODES 59 Family Microorganism Code Gram + bacilli Corynebacterium spp. CORSPP Bacillus spp. BACSPP Lactobacillus spp. LACSPP Listeria monocytogenes LISMON Gram-positive bacilli, not specified GPBNSP Other Gram-positive bacilli GPBOTH Enterobacteriaceae Citrobacter freundii CITFRE Citrobacter koseri (e.g. diversus) CITDIV Citrobacter spp., other CITOTH Citrobacter spp., not specified CITNSP Enterobacter cloacae ENBCLO Enterobacter aerogenes ENBAER Enterobacter agglomerans ENBAGG Enterobacter sakazakii ENBSAK Enterobacter gergoviae ENBGER Enterobacter spp., other ENBOTH Enterobacter spp., not specified ENBNSP Escherichia coli ESCCOL Klebsiella pneumoniae KLEPNE Klebsiella oxytoca KLEOXY Klebsiella spp., other KLEOTH Klebsiella spp., not specified KLENSP Proteus mirabilis PRTMIR Proteus vulgaris PRTVUL Proteus spp., other PRTOTH Proteus spp., not specified PRTNSP Serratia marcescens SERMAR Serratia liquefaciens SERLIQ Serratia spp., other SEROTH Serratia spp., not specified SERNSP Hafnia spp. HAFSPP Morganella spp. MOGSPP Providencia spp. PRVSPP Salmonella enteritidis SALENT Salmonella typhi or paratyphi SALTYP Salmonella typhimurium SALTYM Salmonella spp., not specified SALNSP Salmonella spp., other SALOTH Shigella spp. SHISPP Yersinia spp. YERSPP Other enterobacteriaceae ETBOTH Enterobacteriaceae, not specified ETBNSP WHO_HAMUPPS Protocol.indd 59 Manila Typesetting Company 01/10/2019 07:55PM 60 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Family Microorganism Code Gram – bacilli Acinetobacter baumannii ACIBAU Acinetobacter calcoaceticus ACICAL Acinetobacter haemolyticus ACIHAE Acinetobacter lwoffii ACILWO Acinetobacter spp., other ACIOTH Acinetobacter spp., not specified ACINSP Pseudomonas aeruginosa PSEAER Stenotrophomonas maltophilia STEMAL Burkholderia cepacia BURCEP Pseudomonadaceae family, other PSEOTH Pseudomonadaceae family, not specified PSENSP Haemophilus influenza HAEINF Haemophilus parainfluenzae HAEPAI Haemophilus spp., other HAEOTH Haemophilus spp., not specified HAENSP Legionella spp. LEGSPP Achromobacter spp. ACHSPP Aeromonas spp. AEMSPP Agrobacterium spp. AGRSPP Alcaligenes spp. ALCSPP Campylobacter spp. CAMSPP Flavobacterium spp. FLASPP Gardnerella spp. GARSPP Helicobacter pylori HELPYL Pasteurella spp. PASSPP Gram-negative bacilli, not specified GNBNSP Other Gram-negative bacilli, non enterobacteriaceae GNBOTH Anaerobic bacilli Bacteroïdes fragilis BATFRA Bacteroïdes other BATOTH Clostridium difficile CLODIF Clostridium other CLOOTH Propionibacterium spp. PROSPP Prevotella spp. PRESPP Anaerobes, not specified ANANSP Other anaerobes ANAOTH Other bacteria Mycobacterium, atypical MYCATY Mycobacterium tuberculosis complex MYCTUB Chlamydia spp. CHLSPP Mycoplasma spp. MYPSPP Actinomyces spp. ACTSPP Nocardia spp. NOCSPP Other bacteria BCTOTH WHO_HAMUPPS Protocol.indd 60 Manila Typesetting Company 01/10/2019 07:55PM Family Microorganism Code Fungi _FUNG Microorganism not identified _NONID Examination not done _NOEXA Sterile examination _STERI Result not (yet) available or missing _NA ANNEX VI. MICROORGANISM CODES 61 WHO_HAMUPPS Protocol.indd 61 Manila Typesetting Company 01/10/2019 07:55PM 62 Code Name B Blood U Urine S Sputum/Respiratory sample (incl. bronchoalveolar lavage) W Wound F Sterile fluids (cerebrospinal, synovial, peritoneal) O Other ANNEX VII Category of microbiology specimen WHO_HAMUPPS Protocol.indd 62 Manila Typesetting Company 01/10/2019 07:55PM 63 ANNEX VIII Resistant phenotypes1 Microorganisms Codes Staphylococcus aureus MSSA MRSA VRSA VISA UNK Enterococcus spp. VRE UNK Enterobacteriaceae C3G CAR UNK Pseudomonas aeruginosa CAR UNK Acinotebacter spp. CAR COL UNK UNK, unknown. Staphylococcus aureus • MSSA { Susceptible to oxacillin, or { Susceptible to one of cefoxitin, cloxacillin, dicloxacillin, flucloxacillin, methicillin • MRSA { Resistant to oxacillin, or { Resistant to one of cefoxitin, cloxacillin, dicloxacillin, flucloxacillin, methicillin • VRSA { Resistant to glycopeptides, either vancomycin or teicoplanin • VISA { Intermediate to glycopeptides, either vancomycin or teicoplanin Enterococcus spp. • VRE { Resistant to glycopeptides, either vancomycin or teicoplanin 1 Adapted from ECDC (1). WHO_HAMUPPS Protocol.indd 63 Manila Typesetting Company 01/10/2019 07:55PM 64 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Enterobacteriaceae • C3G { Resistant to third-generation cephalosporins, cefotaxime, ceftriaxone, ceftazidime • CAR { Resistant to carbapenems, ertapenem, imipenem, meropenem, doripenem Pseudomonas aeruginosa • CAR { Resistant to carbapenems, imipenem, meropenem, doripenem Acinetobacter spp. • CAR { Resistant to carbapenems, imipenem, meropenem, doripenem • COL { Resistant to colistin WHO_HAMUPPS Protocol.indd 64 Manila Typesetting Company 01/10/2019 07:55PM 65 ANNEX IX Surgical categories1 Surgery is classified as NHSN or non-NHSN surgery. NHSN surgery is defined in the list below. Any surgery not included in this list is considered as non-NHSN surgery. NHSN Abdominal aortic aneurysm repair Abdominal hysterectomy Appendix surgery Bile duct, liver or pancreatic surgery Breast surgery Cardiac surgery Carotid endarterectomy Cesarean section Colon surgery Coronary artery bypass graft with both chest and donor site incisions Coronary artery bypass graft with chest incision only Craniotomy Exploratory laparotomy Gallbladder surgery Gastric surgery Heart transplant Herniorrhaphy Hip prosthesis Kidney surgery Kidney transplant Knee prosthesis Laminectomy Limb amputation Liver transplant Neck surgery Open reduction of fracture Ovarian surgery Pacemaker surgery Peripheral vascular bypass surgery Prostate surgery Rectal surgery Refusion of spine Shunt for dialysis Small bowel surgery Spinal fusion Spleen surgery Thoracic surgery Thyroid and/or parathyroid surgery Vaginal hysterectomy Ventricular shunt Examples of non-NHSN surgery Obstetrical procedures: peri-delivery/labour (one or more) ICD-9-CM 75.3 and 75.9 Dental extraction: ICD-9-CM code 23.1 Surgical removal Transurethral resection of prostate Incision and drainage of abscess with secondary closure Any diabetic forefoot amputation with healing by secondary intention Any other operation where healing is by secondary intention 1 Adapted from ECDC (1). WHO_HAMUPPS Protocol.indd 65 Manila Typesetting Company 01/10/2019 07:55PM 66 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Examples of non-NHSN surgery Tonsillectomy Application of external fixator/Olizarov Extraventricular drain Hysteroscopic removal of fibroids; evacuation of retained products of conception WHO_HAMUPPS Protocol.indd 66 Manila Typesetting Company 01/10/2019 07:55PM 67 Code Description CNS Central-nervous system EYE Ophthalmic ENT Otolaryngology RESP Respiratory CVS Cardiovascular system GI Gastrointestinal tract SSTBJ Skin, soft tissue, bone and joint UTI Urinary tract GO Gynaecology and obstetrics UNK Site not defined Examples Thorax surgery is classified as RESP for lung surgery, and CVS for heart surgery Liver and pancreatic surgery is classified as GI Spleen surgery is classified as CVS Kidney surgery is classified as UTI ANNEX X Sites for surgical prophylaxis WHO_HAMUPPS Protocol.indd 67 Manila Typesetting Company 01/10/2019 07:55PM 68 Antibiotics (INN) ATC code Notes amikacin J01GB06   amoxicillin J01CA04   ampicillin J01CA01   arbekacin J01GB12   aspoxicillin J01CA19   azanidazole P01AB04   azidocillin J01CE04   azithromycin J01FA10   azlocillin J01CA09   aztreonam J01DF01   bacampicillin J01CA06   bacitracin J01XX10   bekanamycin J01GB13   benzathine benzylpenicillin J01CE08   benzathine phenoxymethylpenicillin J01CE10   benzylpenicillin J01CE01   biapenem J01DH05   brodimoprim J01EA02   carbenicillin J01CA03   carindacillin J01CA05   carumonam J01DF02   catamoxef J01DD06   cefacetrile J01DB10   cefaclor J01DC04   cefadroxil J01DB05   cefalexin J01DB01   cefaloridine J01DB02   cefalotin J01DB03   cefamandole J01DC03   cefapirin J01DB08   cefatrizine J01DB07   cefazedone J01DB06   ANNEX XI Antibiotic and enzyme inhibitor names WHO_HAMUPPS Protocol.indd 68 Manila Typesetting Company 01/10/2019 07:55PM Antibiotics (INN) ATC code Notes cefazolin J01DB04   cefbuperazone J01DC13   cefcapene J01DD17   cefdinir J01DD15   cefditoren J01DD16   cefepime J01DE01   cefetamet J01DD10   cefixime J01DD08   cefmenoxime J01DD05   cefmetazole J01DC09   cefminox J01DC12   cefodizime J01DD09   cefoperazone J01DD12   ceforanide J01DC11   cefotaxime J01DD01   cefotetan J01DC05   cefotiam J01DC07   cefoxitin J01DC01   cefozopran J01DE03   cefpiramide J01DD11   cefpirome J01DE02   cefpodoxime J01DD13   cefprozil J01DC10   cefradine J01DB09   cefroxadine J01DB11   cefsulodin J01DD03   ceftaroline fosamil J01DI02   ceftazidime J01DD02   ceftezole J01DB12   ceftibuten J01DD14   ceftizoxime J01DD07   ceftobiprole medocaril J01DI01   ceftolozane J01DI54   ceftriaxone J01DD04   cefuroxime J01DC02   chloramphenicol J01BA01   chlortetracycline J01AA03   cinoxacin J01MB06   ciprofloxacin J01MA02   clarithromycin J01FA09   ANNEX XI. ANTIBIOTIC AND ENZYME INHIBITOR NAMES 69 WHO_HAMUPPS Protocol.indd 69 Manila Typesetting Company 01/10/2019 07:55PM 70 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Antibiotics (INN) ATC code Notes clindamycin J01FF01   clofoctol J01XX03   clometocillin J01CE07   clomocycline J01AA11   cloxacillin J01CF02   colistin J01XB01   dalbavancin J01XA04   dalfopristin J01FG02   daptomycin J01XX09   demeclocycline J01AA01   dibekacin J01GB09   dicloxacillin J01CF01   dirithromycin J01FA13   doripenem J01DH04   doxycycline J01AA02   efonicide J01DC06   enoxacin J01MA04   epicillin J01CA07   ertapenem J01DH03   erythromycin J01FA01   faropenem J01DI03   fleroxacin J01MA08   flomoxef J01DC14   flucloxacillin J01CF05   flumequine J01MB07   flurithromycin J01FA14   fosfomycin J01XX01   furazidin J01XE03   fusidic acid J01XC01   garenoxacin J01MA19   gatifloxacin J01MA16   gemifloxacin J01MA15   gentamicin J01GB03   grepafloxacin J01MA11   hetacillin J01CA18   iclaprim J01EA03   imipenem J01DH51 Do not refer to cilastatin isepamicin J01GB11   josamycin J01FA07   kanamycin J01GB04   WHO_HAMUPPS Protocol.indd 70 Manila Typesetting Company 01/10/2019 07:55PM Antibiotics (INN) ATC code Notes levofloxacin J01MA12   lincomycin J01FF02   linezolid J01XX08   lomefloxacin J01MA07   loracarbef J01DC08   lymecycline J01AA04   mandelic acid J01XX06   mecillinam J01CA11   meropenem J01DH02   metacycline J01AA05   metampicillin J01CA14   methenamine J01XX05   meticillin J01CF03   metronidazole J01XD01 (parenteral); P01AB01 (oral, rectal) mezlocillin J01CA10   midecamycin J01FA03   minocycline J01AA08   miocamycin J01FA11   moxifloxacin J01MA14   nafcillin J01CF06   nalidixic acid J01MB02   nemonoxacin J01MB08   neomycin J01GB05   netilmicin J01GB07   nifurtoinol J01XE02   nimorazole P01AB06   nitrofurantoin J01XE01   nitroxoline J01XX07   norfloxacin J01MA06   ofloxacin J01MA01   oleandomycin J01FA05   oritavancin J01XA05   ornidazole J01XD03 (parenteral); P01AB03 (oral, rectal) oxacillin J01CF04   oxolinic acid J01MB05   oxytetracycline J01AA06   panipenem J01DH55 Do not refer to betamipron pazufloxacin J01MA18   pefloxacin J01MA03   penamecillin J01CE06   ANNEX XI. ANTIBIOTIC AND ENZYME INHIBITOR NAMES 71 WHO_HAMUPPS Protocol.indd 71 Manila Typesetting Company 01/10/2019 07:55PM 72 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Antibiotics (INN) ATC code Notes penimepicycline J01AA10   pheneticillin J01CE05   phenoxymethylpenicillin J01CE02   pipemidic acid J01MB04   piperacillin J01CA12   piromidic acid J01MB03   pivampicillin J01CA02   pivmecillinam J01CA08   polymyxin b J01XB02   popicillin J01CE03   pristinamycin J01FG01   procaine benzylpenicillin J01CE09   propenidazole P01AB05   prulifloxacin J01MA17   quinupristin J01FG02   ribostamycin J01GB10   rokitamycin J01FA12   rolitetracycline J01AA09   rosoxacin J01MB01   roxithromycin J01FA06   rufloxacin J01MA10   secnidazole P01AB07   sisomicin J01GB08   sitafloxacin J01MA21   solithromycin J01FA16   sparfloxacin J01MA09   spectinomycin J01XX04   spiramycin J01FA02   streptoduocin J01GA02   streptomycin J01GA01   sulbenicillin J01CA16   sulfadiazine J01EC02   sulfadimethoxine J01ED01   sulfadimidine J01EB03   sulfafurazole J01EB05   sulfaisodimidine J01EB01   sulfalene J01ED02   sulfamazone J01ED09   sulfamerazine J01ED07   sulfamethizole J01EB02   WHO_HAMUPPS Protocol.indd 72 Manila Typesetting Company 01/10/2019 07:55PM Antibiotics (INN) ATC code Notes sulfamethoxazole J01EC01   sulfamethoxypyridazine J01ED05   sulfametomidine J01ED03   sulfametoxydiazine J01ED04   sulfametrole no ATC Used in combination with trimethoprim (J01EE03) sulfamoxole J01EC03   sulfanilamide J01EB06   sulfaperin J01ED06   sulfaphenazole J01ED08   sulfapyridine J01EB04   sulfathiazole J01EB07   sulfathiourea J01EB08   talampicillin J01CA15   tedizolid J01XX11   teicoplanin J01XA02   telavancin J01XA03   telithromycin J01FA15   temafloxacin J01MA05   temocillin J01CA17   tetracycline J01AA07   tetroxoprim no ATC Used in combination with sulfadiazine (J01EE06) thiamphenicol J01BA02   ticarcillin J01CA13   tigecycline J01AA12   tinidazole J01XD02 (parenteral); P01AB02 (oral, rectal) tobramycin J01GB01   trimethoprim J01EA01   troleandomycin J01FA08   trovafloxacin J01MA13   vancomycin J01XA01 (parenteral); A07AA09 (oral) xibornol J01XX02   Beta-lactamase inhibitors avibactam cilastatin clavulanic acid sulbactam tazobactam vaborbactam ANNEX XI. ANTIBIOTIC AND ENZYME INHIBITOR NAMES 73 WHO_HAMUPPS Protocol.indd 73 Manila Typesetting Company 01/10/2019 07:55PM 74 ANNEX XII Hospital questionnaire Question Type of answer Infrastructure I1 Does your facility have a functioning Drugs and Therapeutics Committee in the hospital? Y/N I2 Does your facility have a functioning Infection Prevention & Control Committee in the hospital? Y/N I3 Does your facility have a functioning committee on pharmacovigilance in the hospital? Y/N I4 Does your facility have microbiological laboratory/division within the hospital? Y/N I5 Does your facility have access to microbiological services outside the hospital? Y/N I6 Does your facility have a formal antimicrobial stewardship programme accountable for ensuring appropriate antibiotic use? Y/N I7 Does your facility have a formal organizational structure responsible for antimicrobial stewardship? (eg, a multidisciplinary committee focused on appropriate antibiotic use, pharmacy committee, patient safety committee, or other relevant structure) Y/N I8 Is an antimicrobial stewardship team available at your facility? (eg, greater than one staff member supporting clinical decisions and implementing a comprehensive programme [= set of interventions] to ensure appropriate antibiotic use) Y/N I9 How many full-time equivalent staff (physician, pharmacist, nurse…) are part of the antimicrobial stewardship team and running these stewardship activities on a daily basis in your hospital as part of a dedicated antimicrobial stewardship programme? Number I10 Is there a physician identified as a leader for antimicrobial stewardship activities at your facility? Y/N I11 Is there a pharmacist responsible for ensuring appropriate antibiotic use at your facility? Y/N I12 Does your facility provide any salary support for dedicated time for antimicrobial stewardship activities? (eg, percentage of full-time equivalent staff for ensuring appropriate antibiotic use) Y/N I13 Does your facility have the information technology (IT) capability to support the needs of the antimicrobial stewardship activities? Y/N I14 Does your facility have an outpatient parenteral antibiotic therapy (OPAT) unit? Y/N WHO_HAMUPPS Protocol.indd 74 Manila Typesetting Company 01/10/2019 07:55PM Policy and practice P1 Does your facility have an antibiotic formulary (including unrestricted and restricted antibiotics) updated continuously? Y/N P2 Is your antibiotic formulary based on the Essential Drug List? Y/N P3 Does your facility have an antibiotic guideline? Y/N P4 Does your facility have a local antibiotic guideline? Y/N P5 Are your local antibiotic guidelines based on local antibiotic susceptibility to assist with antibiotic selection for common clinical conditions? Y/N P6 Does your facility have a written policy that requires prescribers to document an indication in the medical record or during order entry for all antibiotic prescriptions? Y/N P7 Is it routine practice for specified antibiotic agents to be approved by a physician or pharmacist in your facility? (eg, preauthorization) Y/N P8 Is there a formal procedure for a physician, pharmacist or other staff member to review the appropriateness of an antibiotic at or after 48 hours from the initial order (post-prescription review)? Y/N Monitoring and feedback M1 Does your facility monitor whether the indication is captured in the medical record for all antibiotic prescriptions? Y/N M2 Does your facility audit or review surgical antibiotic prophylaxis choice and duration? Y/N M3 Are results of antibiotic audits or reviews communicated directly with prescribers? Y/N M4 Does your facility monitor antibiotic use? Y/N M5 Does your facility monitor antibiotic use by grams (Defined Daily Dose [DDD]) or counts (Days of Therapy [DOT]) of antibiotic(s) by patient per day? Y/N M6 Is monitored antibiotic use reported by hospital activity denominator (by number of admissions/discharges or by number of bed-days/patient-days)? Y/N M7 Has an annual report focused on antimicrobial stewardship (summary antibiotic use and/or practices improvement initiatives) been produced for your facility in the past year? Y/N M8 Has your facility produced a cumulative antibiotic susceptibility report in the past year? Y/N M9 Is your facility participating in a national antibiotic resistance surveillance programme? Y/N M10 Is your facility participating in a national antibiotic use surveillance programme? M10 How many blood cultures have been made in the past year? Number M11 List of antibiotics out of stock at the facility during the survey period. Text ANNEX XII. HOSPITAL QUESTIONNAIRE 75 WHO_HAMUPPS Protocol.indd 75 Manila Typesetting Company 01/10/2019 07:55PM 76 Code Name G gram MG milligram IU international unit MU millions of international units ANNEX XIII Measurement units WHO_HAMUPPS Protocol.indd 76 Manila Typesetting Company 01/10/2019 07:55PM 77 Country or Area Name ISO ALPHA-3 Code Afghanistan AFG Aland Islands ALA Albania ALB Algeria DZA American Samoa ASM Andorra AND Angola AGO Anguilla AIA Antarctica ATA Antigua and Barbuda ATG Argentina ARG Armenia ARM Aruba ABW Australia AUS Austria AUT Azerbaijan AZE Bahamas BHS Bahrain BHR Bangladesh BGD Barbados BRB Belarus BLR Belgium BEL Belize BLZ Benin BEN Bermuda BMU Bhutan BTN Bolivia BOL Bosnia and Herzegovina BIH Botswana BWA Bouvet Island BVT Brazil BRA British Indian Ocean Territory IOT British Virgin Islands VGB Country or Area Name ISO ALPHA-3 Code Brunei Darussalam BRN Bulgaria BGR Burkina Faso BFA Burundi BDI Cambodia KHM Cameroon CMR Canada CAN Cape Verde CPV Cayman Islands CYM Central African Republic CAF Chad TCD Chile CHL China CHN Hong Kong, SAR China HKG Macao, SAR China MAC Christmas Island CXR Cocos (Keeling) Islands CCK Colombia COL Comoros COM Congo (Brazzaville) COG Congo (Kinshasa) COD Cook Islands COK Costa Rica CRI Côte d’Ivoire CIV Croatia HRV Cuba CUB Cyprus CYP Czech Republic CZE Denmark DNK Djibouti DJI Dominica DMA Dominican Republic DOM Ecuador ECU ANNEX XIV ISO country codes WHO_HAMUPPS Protocol.indd 77 Manila Typesetting Company 01/10/2019 07:55PM 78 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Country or Area Name ISO ALPHA-3 Code Egypt EGY El Salvador SLV Equatorial Guinea GNQ Eritrea ERI Estonia EST Ethiopia ETH Falkland Islands (Malvinas) FLK Faroe Islands FRO Fiji FJI Finland FIN France FRA French Guiana GUF French Polynesia PYF French Southern Territories ATF Gabon GAB Gambia GMB Georgia GEO Germany DEU Ghana GHA Gibraltar GIB Greece GRC Greenland GRL Grenada GRD Guadeloupe GLP Guam GUM Guatemala GTM Guernsey GGY Guinea GIN Guinea-Bissau GNB Guyana GUY Haiti HTI Heard and McDonald Islands HMD Holy See (Vatican City State) VAT Honduras HND Hungary HUN Iceland ISL India IND Indonesia IDN Iran, Islamic Republic of IRN Iraq IRQ Country or Area Name ISO ALPHA-3 Code Ireland IRL Isle of Man IMN Israel ISR Italy ITA Jamaica JAM Japan JPN Jersey JEY Jordan JOR Kazakhstan KAZ Kenya KEN Kiribati KIR Korea (North) PRK Korea (South) KOR Kuwait KWT Kyrgyzstan KGZ Lao PDR LAO Latvia LVA Lebanon LBN Lesotho LSO Liberia LBR Libya LBY Liechtenstein LIE Lithuania LTU Luxembourg LUX Macedonia, Republic of MKD Madagascar MDG Malawi MWI Malaysia MYS Maldives MDV Mali MLI Malta MLT Marshall Islands MHL Martinique MTQ Mauritania MRT Mauritius MUS Mayotte MYT Mexico MEX Micronesia, Federated States of FSM Moldova MDA WHO_HAMUPPS Protocol.indd 78 Manila Typesetting Company 01/10/2019 07:55PM ANNEX XIV. ISO COUNTRY CODES 79 Country or Area Name ISO ALPHA-3 Code Monaco MCO Mongolia MNG Montenegro MNE Montserrat MSR Morocco MAR Mozambique MOZ Myanmar MMR Namibia NAM Nauru NRU Nepal NPL Netherlands NLD Netherlands Antilles ANT New Caledonia NCL New Zealand NZL Nicaragua NIC Niger NER Nigeria NGA Niue NIU Norfolk Island NFK Northern Mariana Islands MNP Norway NOR Oman OMN Pakistan PAK Palau PLW Palestinian Territory PSE Panama PAN Papua New Guinea PNG Paraguay PRY Peru PER Philippines PHL Pitcairn PCN Poland POL Portugal PRT Puerto Rico PRI Qatar QAT Réunion REU Romania ROU Russian Federation RUS Rwanda RWA Saint-Barthélemy BLM Country or Area Name ISO ALPHA-3 Code Saint Helena SHN Saint Kitts and Nevis KNA Saint Lucia LCA Saint-Martin (French part) MAF Saint Pierre and Miquelon SPM Saint Vincent and Grenadines VCT Samoa WSM San Marino SMR Sao Tome and Principe STP Saudi Arabia SAU Senegal SEN Serbia SRB Seychelles SYC Sierra Leone SLE Singapore SGP Slovakia SVK Slovenia SVN Solomon Islands SLB Somalia SOM South Africa ZAF South Georgia and the South Sandwich Islands SGS South Sudan SSD Spain ESP Sri Lanka LKA Sudan SDN Suriname SUR Svalbard and Jan Mayen Islands SJM Swaziland SWZ Sweden SWE Switzerland CHE Syrian Arab Republic (Syria) SYR Taiwan, Republic of China TWN Tajikistan TJK Tanzania, United Republic of TZA Thailand THA Timor-Leste TLS Togo TGO Tokelau TKL Tonga TON WHO_HAMUPPS Protocol.indd 79 Manila Typesetting Company 01/10/2019 07:55PM 80 WHO METHODOLOGY FOR POINT PREVALENCE SURVEY ON ANTIBIOTIC USE IN HOSPITALS 2018 Country or Area Name ISO ALPHA-3 Code Trinidad and Tobago TTO Tunisia TUN Turkey TUR Turkmenistan TKM Turks and Caicos Islands TCA Tuvalu TUV Uganda UGA Ukraine UKR United Arab Emirates ARE United Kingdom GBR United States of America USA US Minor Outlying Islands UMI Country or Area Name ISO ALPHA-3 Code Uruguay URY Uzbekistan UZB Vanuatu VUT Venezuela (Bolivarian Republic) VEN Viet Nam VNM Virgin Islands, US VIR Wallis and Futuna Islands WLF Western Sahara ESH Yemen YEM Zambia ZMB Zimbabwe ZWE WHO_HAMUPPS Protocol.indd 80 Manila Typesetting Company 01/10/2019 07:55PM 81 Country form 82 Hospital form 83 Ward form 84 Patient form 85 Indication form 86 Antibiotic form 87 Microbiology form 89 ANNEX XV Data collection forms 82 Country form: WHO Point Prevalence Survey on Antibiotic Use Question Description Type of answer Answer 1 CountryName Name of country Free Text   2 CountryISO Three letter country code (ISO alpha-3). See Annex XIV Text   3 TotalNumberHospital Total number of hospitals at any level in the country Integer   4 NumberPublicHospital Number of public hospitals in the country Integer   5 NumberNonPublicHospital Estimated number of private hospitals in the country Integer   6 NumberTertiaryHospital Estimated number of tertiary level hospitals in the country Integer   7 NumberSecondaryHospital Estimated number of secondary level hospitals in the country Integer   8 NumberPrimaryHospital Estimated number of primary level hospitals in the country Integer   9 NumberSpecialityHospital Estimated number of especialized hospitals in the country Integer   10 NationalHospitalGroups If hospital groups exist in the country, = ‘Yes’ Yes/No   11 HospitalSampling Specify the sampling strategy for selection of A/R/C   12 HospConvenSampling If convenience sampling used, describe the approach Free Text   13 InvitedHospital Total number of invited hospitals Integer   14 NationalGuideline Are there national treatment guidelines? Yes/No   15 LocalGuideline Are there hospital treatment guidelines? Yes/No   16 NationalAMS Is there a national antimicrobial stewardship program for hospitals Yes/No   83 Hospital form: WHO Point Prevalence Survey on Antibiotic Use HospitalID HospitalCode SurveyStartDate yyyy-mm-dd SurveyEndDate yyyy-mm-dd HospitalGroup Yes / No HospitalGroupCode HospitalGroupAllSitesIncluded Yes / No HospitalType Primary / Secondary /Tertiary / Specialised HospitalSpecialisedTypeSpeciality Hospital Ownership PUB / PRVNFP / PRVFP / OTH / UNK HospitalTotalBeds HospitalAcuteBeds HospitalICUBeds HospitalHighRiskBeds HospitalAnnualAdmissions HospitalAnnualPatientDays HospitalIncludedBeds HospitalEligiblePatients HospitalIncludedPatients PatientSampling Yes / No 84 Ward form: WHO Point Prevalence Survey on Antibiotic Use WardID Hospital code WardCode WardInvestigator WardSurveyDate yyyy-mm-dd WardType Annex I *WardTotalPatients **WardEligiblePatients WardIncludedPatients *Note: WardTotalPatients also includes day cases and/or long term care patients **When sampling is conducted, report the number of patients sampled and not the number of eligible patients in the ward OPTIONAL: WardSpecialties. List all specialties represented in the ward (see Annex II), and separate by comma. 85 Patient form: WHO Point Prevalence Survey on Antibiotic Use CORE: Patient demographics HospitalCode WardID SurveyDate yyyy-mm-dd WardCode PatientID PatientCode Gender M / F /T / UNK AgeYear (>2 years) AgeMonth (0-23 months) PreTermBirth LP / MP / VP / EP Child12YearWeight ___._ _ _ NeonatesBirthWeight ___._ _ _ AdmissionDate yyyy-mm-dd SurgerySinceAdmission Yes / No / UNK CentralVascularCatheter Yes / No / UNK PeripheralVascularCatheter Yes / No / UNK UrinaryCatheter Yes / No / UNK Intubation Yes / No / UNK PatientOnAntibiotic Yes / No PatientNumberAntibiotics OPTIONAL: Underlying infectious diseases variables MalariaStatus Yes / No / UNK TuberculosisStatus Yes / No / UNK HIVStatus Yes / No / UNK HIVOnART* Yes / No / UNK HIVCD4Count* Number/UNKNOWN *Only if HIVStatus = “Yes” OPTIONAL: Comorbidities variables McCabeScore RF / UF / NF MalnutritionStatus Yes / No / UNK COPDStatus Yes /No / UNK OPTIONAL: Hospitalisation variables TransferFromHospital Yes / No / UNK TransferFromNonHospital Yes / No / UNK Hospitalization90Days Yes / No / UNK OPTIONAL: Surgery variable (Only if SurgerySinceAdmission = Yes) TypeSurgerySinceAdmission M / NHSN / UNK Additional Comments: Additional Comments: 86 Indication form: WHO Point Prevalence Survey on Antibiotic Use Core variables PatientCode WardCode HospitalCode IndicationCounter 1 2 3 4 IndicationType HAI / CAI / SP / MP / O HAI / CAI / SP / MP / O HAI / CAI / SP / MP / O HAI / CAI / SP / MP / O If IndicationType is SP: Surg.Proph.Duration SP1 / SP2 / SP3 SP1 / SP2 / SP3 SP1 / SP2 / SP3 SP1 / SP2 / SP3 Surg.Proph.Site Annex X Annex X Annex X Annex X Diagnosis Annex IV Annex IV Annex IV Annex IV StartDateTreatment yyyy-mm-dd yyyy-mm-dd yyyy-mm-dd yyyy-mm-dd ReasonInNotes YES / NO YES / NO YES / NO YES / NO CultureSampleTaken Yes / No / UNK Yes / No / UNK Yes / No / UNK Yes / No / UNK If Culture Sample taken is YES then proceed to Microbiology Form Comments: 87 Antibiotic form (1): WHO Point Prevalence Survey (PPS) on Hospital Antibiotic Use HospitalCode WardCode PatientCode Core variables A n t i b i o t i c C o u n t e r I n d i c a t i o n C o u n t e r s A n t i b i o t i c N o t e s N a m e A n t i b i o t i c I N N N a m e A n t i b i o t i c W r i t t e n I n I N N S t a r t D a t e A n t i b i o t i c U n i t D o s e U n i t D o s e s C o m b i n a t i o n U n i t D o s e M e a s u r e U n i t U n i t D o s e F r e q u e n c y A d m i n i s t r a t i o n R o u t e 1 YES NO yyyy-mm-dd     MG G IU MU   O P I R 2 YES NO yyyy-mm-dd     MG G IU MU   O P I R 3 YES NO yyyy-mm-dd     MG G IU MU   O P I R 4 YES NO yyyy-mm-dd      MG G IU MU   O P I R 5 YES NO yyyy-mm-dd     MG G IU MU    O P I R 6   YES NO yyyy-mm-dd     MG G IU MU    O P I R 88 Antibiotic form (2): WHO Point Prevalence Survey (PPS) on Hospital Antibiotic Use HospitalCode WardCode PatientCode Optional variables A n t i b i o t i c C o u n t e r P r e s c r i b e r T y p e P a r e n t e r a l T y p e O r a l S w i t c h N u m b e r M i s s e d D o s e s M i s s e d D o s e s R e a s o n G u i d e l i n e s C o m p l i a n c e T r e a t m e n t T y p e 1 SP GP O N IM IV-B IV-C IV-E O YES NO UNK S P O M UNK Y N NA NI D E 2 SP GP O N IM IV-B IV-C IV-E O YES NO UNK S P O M UNK  Y N NA NI  D E 3 SP GP O N IM IV-B IV-C IV-E O YES NO UNK S P O M UNK  Y N NA NI  D E 4 SP GP O N IM IV-B IV-C IV-E O YES NO UNK S P O M UNK  Y N NA NI  D E 5 SP GP O N IM IV-B IV-C IV-E O YES NO UNK S P O M UNK  Y N NA NI  D E 6 SP GP O N IM IV-B IV-C IV-E O  YES NO UNK S P O M UNK Y N NA NI   D E 89 Microbiology form: WHO Point Prevalence Survey on Antibiotic Use HospitalCode PatientCode WardCode Microbiology data refers to any culture & susceptibility result from a relevant clinical sample. Screening samples should not be reported.               Specimen 1: SpecimenType Annex VII CultureResult NA / Pos / Neg If CultureResult is Pos: Microorganism: 1 annex VI 2 annex VI 3 annex VI AntibioticSusceptibilityTestResults 1 Yes / No / UNK 2 Yes / No / UNK 3 Yes / No / UNK ResistantPhenotype (Only if AntibioticSusceptibilityTestResults is Yes) 1 annex VIII 2 annex VIII 3 annex VIII               Specimen 2: SpecimenType Annex VII CultureResult NA / Pos / Neg If CultureResult is Pos: Microorganism: 1 annex VI 2 annex VI 3 annex VI AntibioticSusceptibilityTestResults 1 Yes / No / UNK 2 Yes / No / UNK 3 Yes / No / UNK ResistantPhenotype (Only if AntibioticSusceptibilityTestResults is Yes) 1 annex VIII 2 annex VIII 3 annex VIII Specimen 3: SpecimenType Annex VII CultureResult NA / Pos / Neg If CultureResult is Pos: Microorganism: 1 annex VI 2 annex VI 3 annex VI AntibioticSusceptibilityTestResults 1 Yes / No / UNK 2 Yes / No / UNK 3 Yes / No / UNK ResistantPhenotype (Only if AntibioticSusceptibilityTestResults is Yes) 1 annex VIII 2 annex VIII 3 annex VIII               Specimen 4: SpecimenType Annex VII CultureResult NA / Pos / Neg If CultureResult is Pos: Microorganism: 1 annex VI 2 annex VI 3 annex VI AntibioticSusceptibilityTestResults 1 Yes / No / UNK 2 Yes / No / UNK 3 Yes / No / UNK ResistantPhenotype (Only if AntibioticSusceptibilityTestResults is Yes) 1 annex VIII 2 annex VIII 3 annex VIII

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