GLASS methodology for surveillance of national antimicrobial consumption

GLASS Methodology for surveillance of national antimicrobial consumption Global Antimicrobial Resistance and Use Surveillance System (GLASS)

GLASS Methodology for surveillance of national antimicrobial consumption Global Antimicrobial Resistance and Use Surveillance System (GLASS) GLASS methodology for surveillance of national antimicrobial consumption ISBN 978-92-4-001263-9 (electronic version) ISBN 978-92-4-001264-6 (print version) © World Health Organization 2020 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. Design and layout by 400 Communications Limited. iii Contents Abbreviations v 1 Introduction 2 2 The GLASS component on surveillance of national antimicrobial consumption 4 2.1. Global Antimicrobial Resistance and Use Surveillance System (GLASS) 4 2.2. Aim and objectives of GLASS-AMC 4 2.2.1. Aim 4 2.2.2. Objectives 5 2.3. Three-level structure of surveillance of national AMC 5 2.3.1. National level 5 2.3.2. Regional level 5 2.3.3. Global level 5 2.4 Setting up a national surveillance system for AMC 6 3 Methodology 8 3.1. Definitions 8 3.2. Measurement issues 8 3.3. The ATC/DDD system 8 3.3.1. The ATC classification 8 3.3.2. Unit of measurement (DDD) 9 3.4. Antimicrobials 9 3.5. Health care sectors and levels 10 3.5.1. The community health care level 10 3.5.2. The hospital health care level 10 3.5.3. Public and private health care sectors 10 3.6. Data sources for consumption estimates 11 3.6.1. Flow of antimicrobials 11 3.6.2. Potential sources of information on AMC 11 4 Data collection for AMC 16 4.1. Elements of data collection 16 4.2. AMC data 16 4.2.1. Product level data 17 4.2.2. Substance level data 17 4.3. Denominator data 17 4.3.1. Global reporting 17 4.3.2. National reporting 18 4.4. Reporting metrics 18 4.5. Contextual information relating to data collection 18 5 Data management 20 5.1. Data flow between countries and WHO 20 5.2. Data collection 20 5.2.1. Collection of AMC data 20 5.2.2. WHO template for data collection 21 5.3. Data submission 21 5.4. Data analysis 22 5.5. Dissemination of data 22 6 GLASS-AMC IT platform 24 6.1. Users 24 6.2. Data submission 24 6.2.1. Data upload 24 6.3. AMC data questionnaire 25 Annexes 27 Annex 1 Introduction to ATC and DDD methodology 28 Annex 2 List of ATC subgroups under surveillance 35 Annex 3 Definition of variables for AMC surveillance 37 Annex 4 AMC data questionnaire 45 Annex 5 Specification of the GLASS-AMC product level data file 48 Annex 6 Specification of the GLASS-AMC Substance Level Data file 53 Annex 7 Measurement unit list 55 Annex 8 Administration route list 55 Annex 9 Salt list 55 Annex 10 List of DDD for combined products 56 Annex 11 Product origin list 60 Annex 12 Conversion factor list 60 Annex 13 Health care sector list 60 Annex 14 Health care level list 60 iv Abbreviations AMC antimicrobial consumption AMR antimicrobial resistance ATC Anatomical Therapeutic Chemical classification system CC collaborating centre DDD Defined Daily Dose DID Defined Daily Doses/1000 inhabitants/ day EphMRA European Pharmaceutical Market Research Association FAO Food and Agriculture Organization GAP-AMR Global Action Plan on antimicrobial resistance GLASS Global Antimicrobial Resistance and Use Surveillance System INN international nonproprietary name NGO nongovernmental organization NFP national focal point OIE World Organisation for Animal Health OTC over-the-counter PBIRG Pharmaceutical Business Intelligence and Research Group PDD prescribed daily dose PIY packages/1000 inhabitants/year UN United Nations WHO World Health Organization S E C T I O N 01 2GLASS Methodology for surveillance of national antimicrobial consumption 1. Introduction At the Sixty-eighth World Health Assembly held in May 2015, Member States adopted the Global Action Plan on antimicrobial resistance (GAP-AMR). The World Health Assembly urged Member States to implement the action plan, recognizing that this may need to be adapted to specific contexts and national priorities. The GAP-AMR has five objectives: 1. Improve awareness and understanding of antimicrobial resistance. 2. Strengthen surveillance and research. 3. Reduce the incidence of infection. 4. Optimize the use of antimicrobial medicines. 5. Ensure sustainable investment in countering antimicrobial resistance. In Objective 2, surveillance and monitoring are acknowledged as critical components of the response to AMR. In 2015, the World Health Organization (WHO) launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) to: • improve understanding of the spread and drivers of AMR, including the use of antimicrobial medicines; • standardize surveillance based on officially recognized data across countries; and • inform effective control strategies to tackle AMR. Specifically related to GAP-AMR Objective 4, Member States are requested to provide “stewardship programmes that monitor and promote optimization of antimicrobial use at national and local levels in accordance with international standards in order to ensure the correct choice of medicine at the right dose on the basis of evidence”. Thus, an important element of the GAP-AMR is monitoring the use of antimicrobials, both in terms of strengthening the surveillance and optimizing the use of antimicrobials. Data on the use of antimicrobials can be used, for example, to: • relate exposure to antimicrobials to the development of antimicrobial resistance; • identify and provide early warning of issues relating to changes in exposure and use of antimicrobials, and develop interventions to address identified problematic areas; • monitor the outcomes of interventions aimed at changing the use of antimicrobials; • assess the quality of prescribing against practice guidelines; • raise awareness in health professionals, consumers and policy-makers about the contribution of inappropriate use of antimicrobials in human health to the emergence and spread of antimicrobial resistance. In 2016, in response to the lack of data on antimicrobial consumption (AMC) in many Member States, especially in low- and middle-income countries, WHO initiated the surveillance of AMC for the collection, analysis and reporting of data on AMC in human health. This included two main components: development of standardized surveillance tools, and support to countries in establishing corresponding national surveillance systems. After developing the methodological tools, WHO rolled out its first cycle of data collection to gather consumption data for the 2014–2016 period in an initial set of countries enrolled in the programme. This first phase included supporting implementation of national surveillance systems in certain low- and middle-income countries. As a result of this pilot phase of data collection, WHO published its first global report and presented data on antimicrobial consumption from 65 countries and areas around the world.1 In 2020, following the pilot phase, the surveillance of AMC became mainstream within GLASS, allowing Member States to report their national AMC data to WHO in a systematic manner. This reporting provides a unique opportunity to access data on both AMC and AMR in a central repository, facilitating the coordinated global fight against AMR. The Tripartite organizations - WHO, FAO and OIE - have developed a joint monitoring and evaluation framework for the GAP-AMR.2 Using this framework, countries can follow their progress on implementation of national programmes for surveillance of AMC. In addition, the framework defines specific indicators related to the use of antimicrobials under Outcome 4: Optimized use of antimicrobials in human and animal health, with some of these indicators being based on data generated by national surveillance programmes on AMC. 1 See https://apps.who.int/iris/bitstream/handle/10665/277359/9789241514880-eng.pdf?ua=1 2 See https://www.who.int/antimicrobial-resistance/global-action-plan/monitoring-evaluation/tripartite-framework/en/ The GLASS component on surveillance of national antimicrobial consumption 3 S E C T I O N 02 4GLASS Methodology for surveillance of national antimicrobial consumption 2.1.Global Antimicrobial Resistance and Use Surveillance System (GLASS) In alignment with the work on the GAP-AMR, GLASS promotes integration with other surveillance programmes in public health, and in the animal, agriculture, and environment sectors. GLASS evolves continuously; for example three types AMR-related surveillance activities have been developed and added to the system. The various types of AMR-related surveillance activities led by GLASS are grouped into technical modules. (Fig. 2.1). A major step forward in 2020 was the addition of global surveillance of AMC to be reported on an annual basis. In addition, focused surveillance and survey approaches have been developed, some of which are already starting to be implemented. Focused surveillance activities include the emerging AMR reporting component (the GLASS-EAR), the special project on AMR in Neisseria gonorrhoeae (Enhanced Gonococcal Antimicrobial Surveillance Programme [EGASP]), and surveillance of AMR in bloodstream infections caused by Candida spp. Studies that have been successfully applied in several countries include the “One Health” AMR surveillance model assessing the occurrence of ESBL-producing Escherichia coli across human, environment and animal sectors (the “Tricycle”) and point prevalence studies on antimicrobial use in humans. 2.2. Aim and objectives of GLASS-AMC 2.2.1. Aim The aim of the GLASS component on surveillance of national AMC (GLASS-AMC) is to provide a common and standardized methodology for measuring and reporting the consumption of antimicrobial agents at country level. This standardization allows the monitoring of trends over time, facilitates comparisons between countries, and provides a common metric for reporting antimicrobial use at regional and global levels. The surveillance of AMC is a key to inform strategies to optimize the use of antimicrobials. AMC data can indicate the availability and affordability of antimicrobial agents, and in conjunction with other data, such as AMR data, inform the development of clinical guidelines and protocols, as well as restrictions on use of agents for particular clinical conditions or to nominated prescribers. These steps, which are necessary to ensure optimal use of antimicrobials, are beyond the scope of this document. Fig. 2.1. GLASS activities 2. The GLASS component on surveillance of national antimicrobial consumption ROUTINE DATA SURVEILLANCE FOCUSSED SURVEILLANCE SURVEYS AND STUDIES Antimicrobial Resistance surveillance (GLASS-AMR) Emerging Antimicrobial Resistance Reporting (GLASS-EAR) Enhanced Gonorrhoeae surveillance (GLASS-EGASP) Antimicrobial Consumption surveillance (GLASS-AMC) Candida spp. AMR surveillance (GLASS-Fungi) One Health AMR surveillance (GLASS-One Health) Point Prevalence Survey methodology for AMU in hospital GLASS methodology for estimating attributable mortality of AMR bloodstream infections The GLASS component on surveillance of national antimicrobial consumption 5 2.2.2. Objectives The specific objectives of the surveillance of national AMC are to provide: • a methodology that can be integrated in the package of tools to assist the national strategy on optimising the use of antimicrobials (e.g. national action plans on AMR); • information on quantities and types of consumed antimicrobials for policy-makers and prescribers; • a common methodology to the countries for collecting, analysing and reporting national antimicrobial consumption data; • reliable and comparable national consumption data over time and between countries; • a methodology for collecting global antimicrobial consumption data as part of GLASS; • comparable consumption data with animal and agricultural consumption data. 2.3. Three-level structure of surveillance of national AMC The surveillance of AMC involves actors at three levels – national, regional and global – as outlined below. 2.3.1. National level Countries are responsible for collecting, analysing and reporting on AMC at national level on a routine basis, and should use this information on AMC to take actions to improve the use of antimicrobials. For this, countries would need to set up a national surveillance system to monitor antimicrobial consumption at national level as part of their AMR national action plans and its implementation. Countries should also develop a strategy for AMC surveillance at national level, that defines the objectives of the surveillance, and designates an AMC national team or group that is responsible for establishing and managing the AMC surveillance system. The national team is thus responsible for identifying data sources, collecting and validating the consumption data with the data providers, sharing the information at country level for further policy actions and finally reporting the consumption data to WHO via the GLASS platform. The team should also facilitate linkages with AMC surveillance across human health, animal health and environmental sectors in the country. To operate and have support from the national authorities, the AMC team should be placed under the authority of the ministry of health, or other national health authority mandated by the ministry of health (e.g. national regulatory authority). All Member States are invited to participate in the global surveillance and share their national AMC data with WHO at the GLASS platform (GLASS-AMC). Participation involves formal enrolment in GLASS- AMC, establishment of a national coordinating team or group and nomination of a GLASS-AMC national focal point for communication with WHO GLASS. 2.3.2. Regional level At regional level, WHO is responsible for supporting countries in implementing their national surveillance system on AMC and for coordinating the WHO surveillance programme. In terms of support, WHO regional offices assist countries in their capacity- building efforts for AMC surveillance at national level. In terms of coordination, the regional offices ensure that information and expertise on AMC in the region is shared among the countries, and that countries report their national data to WHO. WHO analyses consumption data, provides regular reports on AMC in the regions, and supports country efforts for optimal use of antimicrobials. Also, the GLASS-AMC platform facilitates coordination between countries and their respective WHO Regional Offices. 2.3.3. Global level At global level, WHO is responsible for providing standardized methodologies, tools and technical expertise (in coordination and consultation with the other levels), and for coordinating global surveillance of AMC in line with regional specificities. At global level, WHO also collates national consumption data submitted by the countries into GLASS-AMC, analyses these data and provides regular global reports on AMC; WHO makes these data available to the other levels for further analysis and production of reports. 6GLASS Methodology for surveillance of national antimicrobial consumption 2.4. Setting up a national surveillance system for AMC The tasks required to set up a national system for surveillance of antimicrobial consumption can be grouped into six main steps, as outlined below. Step 1: Structures and governance • Identify the government agency, unit or participants who will lead the national programme under the supervision of the national authorities. • Establish a multidisciplinary AMC national team with clear terms of reference, and ensure that the team has, as a minimum, the core set of skills in pharmaceutical supply chain systems and data management needed to run the surveillance system. • Establish a technical working group on surveillance of AMC to support the AMC national team; the working group should be linked to, or be part of, the national AMR committee. • Identify the different actors involved in the surveillance activities and their roles. • Appoint a national focal point to liaise with WHO. To ensure good integration of the surveillance of AMC with other national activities related to antimicrobial use and AMR, it is important that the AMC national team collaborates with other AMR programmes (e.g. for surveillance of AMR as part of the “One Health” approach, and for surveillance of antimicrobial use and AMR in the animal and agricultural sectors). Where there are multiple data providers, including from the private sector, it may be necessary to put contracts in place or develop legal tools to ease the release of data by these providers. Step 2: Objectives and methodology • Define the objectives and outputs of the national programme on AMC. • Become familiar with the WHO methodology on AMC monitoring, including the Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/ DDD) classification system. Step 3: Data sources • Identify possible data sources for monitoring AMC and select the most suitable data sources, given the objectives and resources available. • If applicable, meet with the data providers to inform them about the purpose of the surveillance programme and how the requested data will be used. If necessary, organize a workshop with the data providers to train them on how to report. • Agree with the data providers on the data submission process and legal considerations related to data ownership, sharing and dissemination. Step 4: Data collection and validation • Set up tools for data collection, starting with simple tools. • Initiate data collection. • Work with data providers to validate data. Step 5: Data analyses • Develop a data analysis plan that outlines the results to be generated according to objectives and target audience. • Clean and analyse the data according to the data analysis plan. • Report and publish results on AMC to inform national strategies to optimize antimicrobial use and to combat AMR. • Submit national data to the WHO through the GLASS platform on an annual basis. Step 6: Sustainability and long-term plans • Develop IT tools for data collection. Consider setting up electronic support systems to facilitate data extraction. Automate data collection as much as possible to reduce manual work; automation decreases the risk of data errors and promotes sustainability. Consider how representative the data are, and whether the data quality and coverage can be improved. If it is not possible to obtain complete coverage initially, simply start small, validate data quality and scale up over time. • Consider how to ensure sustainability of the AMC surveillance programme (e.g. funding, capacity- building and structures). • Consider how to collaborate with other relevant surveillance programmes (e.g. AMR, and AMC in the agriculture sector). Methodology 7 S E C T I O N 03 8GLASS Methodology for surveillance of national antimicrobial consumption Table 3.1. Definitions of the ATC levels LEVEL 1 Level 1 indicates the anatomical main group and consists of one letter. There are 14 main groups. The group most relevant to work on antimicrobials is group J Antiinfectives for systemic use. However, some antimicrobials are classified in other main groups; for example, antibiotics used as intestinal antiinfectives are in ATC main group A Alimentary tract and metabolism, while some oral and rectal anti-protozoal agents are in ATC main group P Antiparasitic products, insectides and repellants. LEVEL 2 Level 2 indicates pharmacological and therapeutic subgroups; for example, J01 is Antibacterials for systemic use, J02 Antimycotics and J04 Antimycobacterials. LEVEL 3 Level 3 indicates chemical or pharmacological subgroups; for example, J01C is Beta-lactam antibacterials, penicillins. LEVEL 4 Level 4 indicates the pharmacological subgroup; for example, J01CA is Penicillins with extended spectrum. LEVEL 5 Level 5 indicates the chemical substance; for example, J01CA01 is ampicillin and J01CA04 is amoxicillin. ATC: Anatomical Therapeutic Chemical. 3. Methodology 3.1. Definitions For the purpose of the protocol presented, the following definitions apply: • Antimicrobial consumption (AMC) data refer to estimates derived from aggregated data sources such as import or wholesaler data, or aggregated health insurance data, which provide no information available on the patients who receive the medicines or why the antimicrobials are being used. These data sources provide a proxy estimate of use of antimicrobials. Consumption data may be presented as total consumption for a country or may be disaggregated by health care setting (community or hospital, and public or private sectors). • Antimicrobial use data refer to estimates derived from patient-level data. These data may allow disaggregation based on patient characteristics (e.g. gender and age), or indication for which the medicine is being used. Depending on the source of information, it may be possible to determine the patients’ symptoms, physician diagnoses and medications ordered. This will facilitate assessment of clinical practice against agreed protocols and treatment guidelines. Measuring consumption data is an important starting point for countries with limited experience in data collection. With experience and as data sources become more sophisticated (e.g. e-prescribing records), it is expected that there will be more emphasis on measuring antimicrobial use. 3.2. Measurement issues There is a need for a common system of classification and standard metrics to facilitate comparisons of AMC between health facilities, between countries and between regions. The most commonly used classification system is the ATC classification system. The most commonly used measurement metric is the number of DDDs. These are discussed in more detail in the following section and in Annex A. 3.3. The ATC/DDD system 3.3.1. The ATC classification The ATC classification system is the most commonly used method for aggregation of medicines data, and it allows flexibility in reporting by medicine or groups of medicines. In this system, the active substances are divided into different groups according to the organ or system on which they act, and their therapeutic, pharmacological and chemical properties. Methodology 9 Medicines are classified in groups at five different levels, as shown in Table 3.1. More information on the ATC system is provided in Annex A, and the full list of assigned ATC codes is available online.3 3.3.2. Unit of measurement (DDD) The most commonly used measurement statistic is the number of DDDs. The DDD is the assumed average maintenance dose per day for a medicine used for its main indication in adults. A DDD is only assigned for drugs that already have an ATC code. The DDD, however, is only a technical unit of use; it does not necessarily reflect the recommended or average prescribed dose. The DDDs for the antiinfectives are generally based on use in infections of moderate severity. However, some antiinfectives are only used in severe infections and their DDDs are assigned accordingly. There are no separate DDDs for children, which makes the DDD estimates for paediatric formulations more difficult to interpret. The number of DDDs is calculated as follows: Number of DDDs = Total grams used DDD value in grams Where the total amount of the medicine used (in grams) is determined by summing the amounts of active ingredient across the various formulations (e.g. different strengths of tablets or capsules, syrup formulations or injections) and pack sizes. The number of DDDs provides a measure of extent of use; however, for comparative purposes these data are usually adjusted for population size or population group, depending on the medicines of interest and the level of data disaggregation that is possible. For most antimicrobials, the DDDs/1000 inhabitants/day (DID) will be calculated for the total population, including all age and gender groups. It may also be possible to stratify the national estimates by age group, gender and health care sectors (community and hospital, public and private). Where there is stratification there needs to be careful consideration of the appropriate estimate for the denominator (e.g. DDDs/1000 children <5 years/day or DDDs/1000 women/day). 3.4. Antimicrobials The WHO surveillance focuses only on antimicrobials for systemic use; topical antimicrobials are excluded. WHO has defined a core set of antimicrobials that all countries should include in their surveillance programme, as shown below: ANTIBACTERIALS J01 ANTIBIOTICS FOR ALIMENTARY TRACT A07AA NITROIMIDAZOLE DERIVATIVES FOR PROTOZOAL DISEASES P01AB In addition, the WHO surveillance programme includes an optional list of antimicrobials that countries may include in their surveillance programme according to local needs and resources, as shown below: ANTIFUNGALS J02 ANTIMYCOTICS D01BA ANTIVIRALS J05 ANTIMYCOBACTERIALS FOR TREATMENT OF TUBERCULOSIS J04A ANTIMALARIALS P01B Finally, countries may include in their national surveillance programme extra antimicrobial agents that are not in the core or optional lists. In such cases, countries should collect and report the results of these additional analyses separately at national level. Countries should liaise with their Regional AMC team regarding reporting of any additional analyses at regional level. For example, there may be interest in reporting consumption of tuberculosis (TB) medicines in regions where there are several countries with large populations of patients requiring treatment. A list of medicines and ATC codes is provided in Annex B. 3 See http://www.whocc.no/atc_ddd_index/ 10 GLASS Methodology for surveillance of national antimicrobial consumption 3.5. Health care sectors and levels The surveillance methodology considers two health care sectors (public and private) and two health care levels (hospital and community). It is possible to collect data for both sectors or for only one sector if data for the other sector are not available. When collecting data for both sectors, it is possible to collect the data separately (i.e. public and private) or as a whole (i.e. global sector). In a similar way, data can be collected for both levels or for only one level if data for the second level are not available. Again, data can be disaggregated (i.e. community and hospital) or not (i.e. total level). The combination of reporting health care sectors and levels is summarized in Table 3.2. The ability to collect disaggregated data depends on the capacity and experience of data providers to capture the consumption data and on the types and structure of the surveillance databases. As the national surveillance systems mature over time, countries are gradually moving from aggregated to disaggregated data collection. 3.5.1. The community health care level The community health care level corresponds to primary care and may also include outpatient hospital care; it is sometimes referred to as ambulatory care. Primary care is care provided, for example, by general practitioners (GPs), family doctors, nurses, physician assistants, pharmacists, dentists and clinical officers. Residential care (e.g. nursing homes, day care centres) is also typically considered to belong to the community sector. In many countries, antimicrobials reported in the community sector are usually prescribed by GPs, community nurses or health workers. Antimicrobials are dispensed or supplied to the patients in pharmacies or licensed drug stores. In other countries, people are more likely to seek primary care from hospital outpatient or emergency departments – antimicrobials dispensed by the hospitals for outpatient care should be included in the community health care level. It might not be possible to split inpatient and outpatient AMC in the databases of the data providers, and this often results in outpatient consumption being wrongly reported as hospital consumption. In such cases, this limitation should be noted as a deviation from the standard methodology, because it can influence the overall consumption figures and impede comparisons with other countries. 3.5.2. The hospital health care level The hospital sector corresponds to care provided to inpatients (admitted patients) in health care facilities. These can include general and district hospitals, as well as secondary and tertiary care hospitals and other specialist health clinics. In many countries, antimicrobials reported in the hospital sector are usually prescribed by hospital doctors and administered to the patients directly by the health professionals in those facilities. In other countries, antimicrobials for inpatients might be purchased from community pharmacies, and this can result in hospital consumption being wrongly reported as community consumption. If this scenario occurs frequently, leading to an overestimate of the consumption of some hospital medicines at the community level, this should be noted when reporting consumption data. 3.5.3. Public and private health care sectors Disaggregation of AMC data for the public and private health care sectors is facilitated by the fact that the actors, flow and channels of medicines are often clearly differentiated between the two health care sectors. It may be more difficult to collect data from the private health care sector. In that case, regulations or laws may need to be altered to make reporting of data on AMC mandatory for private actors. Table 3.2. Combinations of health care sectors and levels LEVEL / SECTOR PUBLIC PRIVATE GLOBAL Community Hospital Total Methodology 11 3.6. Data sources for consumption estimates 3.6.1. Flow of antimicrobials Procurement and supply of antimicrobial agents at the country level may be complex. In its simplest and “idealized” form, for a country without domestic manufacturing capacity, antimicrobials are first imported (as licensed imports with customs records); then supplied and distributed by licensed wholesalers and distributors to public and private hospitals, community health facilities and community pharmacies; and finally dispensed to patients based on prescriptions written by appropriately registered health care professionals. In some countries, these medicines will be reimbursed by health insurance programmes, with or without the imposition of patient co-payments. The reality in many countries (with manufacturing capacity) is quite different. Antimicrobials may be sourced from both international and domestic producers. Imports may be subject to re-export to other countries, and domestic producers may export part of their production. Orders may be placed with wholesalers or directly with manufacturers. Imported products may be used in the veterinary and agriculture sectors as well as for human use. Health care professionals and patients may be able to import products directly. Antimicrobials may be purchased over-the-counter as well as with a prescription. Borders may be “porous”, with illegal imports and exports. Patients may buy products in neighbouring countries where products are cheaper or more available. Thus, the flow of antimicrobials can be complex and initial mapping is required to identify the relevant data sources for national AMC data. 3.6.2. Potential sources of information on AMC Information on the AMC can be obtained from five levels of the value chain of medicines as shown in Fig. 3.1. The levels are: • procurement and supply • distribution • prescribing • dispensing • patient use. There are several potential sources of information on AMC at each level: • procurement and supply level – import data (using data from customs records and declaration forms) – production records of domestic manufacturers (excluding any exports of products) Fig. 3.1. Value chain of medicines Research and development Regulation Marketing authorization Import Manufacturers Procurement and supply Imports Manufacturers Distribution Wholesalers Central medical stores Doctors Prescribing of medicines Primary health acare Hospitals Dispensing Pharmacies Insurances Hospitals Post-market surveillance Pharmaco- vigilance Substandard and falsified medicines Use Selection 12 GLASS Methodology for surveillance of national antimicrobial consumption • distribution level – wholesaler and distributor data – this could be data on procurement by wholesalers, or records of sales by the wholesalers to health care facilities and pharmacies – public sector procurement records – these exist where there is both centralized and decentralized purchasing of medicines for the public sector – donations or programmes – this may relate to particular international health programmes (e.g. for HIV, TB or malaria), or for special populations such as migrants and refugees where medicines would be provided by nongovernmental organizations (NGOs) • dispensing level – records from community and hospital pharmacies, and licensed drug stores – data from health insurance programmes • prescribing level – prescribing records of doctors and dispensing records of pharmacists – patient use level – information on antimicrobial use from patients themselves. These sources provide information with differing levels of detail on the consumption and use of antimicrobials. It is important to understand the nature, scope and limitations of the data collection from each of these sources, to avoid under- or over-estimation of AMC. Table 3.3. summarizes some of the strengths and weaknesses of each of these data sources. The sources also differ in terms of difficulty of gathering information. For example, there may be a single import authority in the public sector that retains records of all authorized importation, a complex array of local and multinational manufacturers, multiple wholesalers in the public and private sectors, an insurance authority that covers only some sectors of the population, and private health care providers (e.g. hospitals, clinics and health care professionals) that may be reluctant to provide information. It will be up to governments in Member States to decide whether data collection is voluntary or mandatory across all providers and all sectors. Changes in regulation or laws might be necessary to oblige the data providers to deliver the requested information. Data sources that are close to the patient will provide the most reliable estimates of AMC, and will be more likely to provide data on age and gender of the patient, provider details and indication for the antimicrobial prescription. However, these sources will also be the most sophisticated and most expensive. The WHO methodology allows for flexibility in the choice of data sources, ranging from import and production records to patient data, enabling countries with limited resources to use pre-existing data sources to build sustainable programmes for the surveillance of AMC. It is important to correctly identify the data sources that are used to collect AMC data in the country and, if more than one data source is used, to be aware of the overlaps in the information provided. If the sources are treated as separate estimates and summed to provide “total consumption”, this may overestimate actual AMC. According to the WHO methodology, data are collected from official channels without capturing antimicrobials sold on the informal (illegal) market. For countries with a significant informal market, other types of monitoring (e.g. surveys) may be more suitable for capturing these data. Each country should at least try to estimate or approximate the share held by the informal market in order to interpret AMC data. Methodology 13 Table 3.3. Strengths and limitations of data sources for AMC DATA SOURCE STRENGTHS LIMITATIONS Import data • Import permits issued by government • Centralized records • Standardized reporting for customs declaration forms, including product type (generic or branded), volume, port of origin, country of manufacture, batch number and expiry date • Includes OTC medicines • Documentation may be incomplete • May include parallel trade stock movements • May not account for smuggled goods or illegal entry of products • Volumes match import cycles rather than consumption patterns • Are administrative records and thus are not formatted for research and analysis Domestic manufacturers • Local licensed producers should be easily identified • Can separate product volumes for local use and for export • Can request data in format suitable for analysis • Private companies may be unwilling to provide data • Volumes reflect production rather than consumption patterns Public sector procurement • Likely to have reasonable documentation of purchases • Possible to disaggregate distribution data to facility types (community and hospital) and geographical location • May be single (or limited number) of procurement agencies • Only provides data for public sector • May not reflect total public sector consumption if other procurement is undertaken by hospitals and health facilities • May include stock procured but never supplied Wholesalers • Only legal entity able to import medicines for distribution • Can provide purchase and supply data • Supply data may be disaggregated (e.g. by community or hospital, regions or facility type) • Data collection easier where numbers of wholesalers are limited • Distribution and supply data are likely to be closer to actual consumption than purchase data • In some countries, medical, dental, veterinary practitioners and pharmacists can also import medicines • May be difficult to get data from private sector • Many wholesalers in some settings • May supply other smaller wholesalers not “end users” • Wholesalers may provide agriculture and veterinary sectors as well as for human use Donations and programmes • May represent a significant proportion of antimicrobials dispensed for specific clinical programmes or specific populations • May be difficult to differentiate donations for local population and special populations (e.g. migrants and refugees) 14 GLASS Methodology for surveillance of national antimicrobial consumption DATA SOURCE STRENGTHS LIMITATIONS Community and hospital pharmacies, drug stores dispensing data • Sales from pharmacies or drug stores are closer to the actual use of antimicrobials by the patients • Can separate community and hospital sectors • Potentially can separate public and private sectors • May include some OTC medicines • Large number of facilities makes data collection resource intensive • May be difficult to collect data where only manual records exist • May be difficult to get information from private sector • Does not take into account compliance with therapy Health insurance data • Patient-level consumption data • May be disaggregated by patient demographic characteristics • Geographical data may be available • Possible to disaggregate to community and hospital sectors • Often limited number of data providers • Data more accessible if public sector agencies • May be difficult to get information from private sector • Only reimbursed antimicrobials reported • Selected populations covered by health insurance, may not be representative of whole population • Administrative records may not include all the variables of interest Prescribing records of (health professionals or databases) • May have patient characteristics, diagnosis, dose, duration, co-prescribed medicines • Prescribed medicines may not be dispensed • Samples of prescribers may not be representative and therefore may not reflect national data Community, household survey data • Patient-level data will be available • Most closely reflects actual consumption • Repeat surveys can provide longitudinal data • Time-consuming and labour-intensive to collect the data • Issues of representativeness of the data collected Commercial data sources (e.g. IQVIA – previously IMS Health) • Standardized data collection • Capacity to combine data from multiple sources, including manufacturer records, hospital and pharmacy data • Data must be purchased • Data collection may be limited in some countries • May not be able to examine data at regional, local, facility or prescriber level • EphMRA/PBIRG classification is used rather than ATC codes, so information at the pharmacological or chemical subgroup level may be limited AMC: antimicrobial consumption; ATC: Anatomical Therapeutic Chemical; EphMRA: European Pharmaceutical Market Research Association; OTC: over the counter; PBIRG: Pharmaceutical Business Intelligence and Research Group. Data collection for AMC 15 S E C T I O N 04 16 GLASS Methodology for surveillance of national antimicrobial consumption 4. Data collection for AMC AMC is defined as quantities of antimicrobials used by a population in a specific setting (e.g. community or hospital health care levels) during a specific period of time (e.g. days, months and year). For global reporting, national estimates of consumption are reported for the calendar year (i.e. January to December). For national reporting, and for better understanding of the dynamics of the consumption of antimicrobials, it is advised to collect and report data: • on a quarterly or monthly basis – to take into account seasonal variations often linked with different disease patterns; or • at subnational level – to take into account geographical variability and socioeconomic determinants of the use of antimicrobials. In terms of methodology, the ATC/DDD classification system standardizes the data collection, calculation and reporting of AMC. 4.1. Elements of data collection There are three elements to the data collection: AMC data, denominator data, and descriptive or contextual information that is relevant for interpreting the consumption estimates calculated (see Fig. 4.1). 4.2. AMC data WHO accepts two different types of AMC data: • product level data • substance level data Product level data are the standard, default data expected by WHO. However, where product level data are not available, countries could submit substance level data. The two types of AMC data are discussed below. Fig. 4.1. Elements of data collection Antimicrobial consumption data Contextual information related to antimicrobial consumption Denominator data • Product level data • Consumed packages at product level (aggregated packages) • May be stratified by health care levels and sectors • Data source information; for example, national reference data (total) or health care sector (community or hospital) • Which antimicrobials are included in surveillance • Specific exclusions of health care institutions (e.g. nursing homes, day care centres, psychiatric facilities and private sector) • Population under surveillance to which data apply • May be stratified by health care sectors Data collection for AMC 17 4.2.1. Product level data Register The first step requires identification of all the products for the antimicrobial agents registered (i.e. with marketing authorization) in the country; that is, a valid and complete national register of products. The register corresponds to the list of all antimicrobial medicinal products covered by the surveillance system. It contains detailed information about the medicinal products, divided into three areas: identifying the product, calculating consumption and breaking down consumption into more fine-grained details for further analyses. The set of standard variables for the register is described in Annex C. The register is used to link each medicinal product with its corresponding ATC substance code. Depending on the capacities of the national pharmaceutical system of the country, the link with the ATC substance code may or may not have already been made during the authorization or registration procedure. In the case of registration, the link with the code will need to be done specifically for the national surveillance programme. Owing to the authorization or withdrawal of new products and the annual updates of the ATC/DDD system, it is mandatory to update the register file at least once a year in order to integrate these changes. Package data Consumption is expressed as the total number of packages for each product listed in the register that are consumed by the population in the defined setting during the defined period of time. In some countries, the consumed products may be counted not by package but by item (e.g. as number of tablets or number of vials). In such cases, the product package size should be set to 1 and the reported number of packages will actually be the number of items. Consumption data The consumption expressed in DDD is calculated by multiplying the content of active substances in each product by the number of packages of that product, and dividing it by the corresponding DDD. The product content and the DDD must be expressed in the same units. Number of DDDPi = Product contentPi x Number of consumed packagesPi DDDPi Finally, the consumption of DDD for each product is aggregated to be reported by the ATC substance code. 4.2.2. Substance level data At substance level, consumption is expressed in terms of the ATC substance. For each ATC substance, the consumption expressed in DDD is obtained by dividing the total quantities of active substances by the DDD of the corresponding ATC. The total consumed quantities and the DDD must be expressed in the same units. Number of DDDATCi = Total consumed quantitiesATCi DDDATCi Where the total consumed quantities of the medicines are determined by summing the amounts of active ingredient across the various formulations (e.g. different strengths of tablets or capsules, or syrup formulations) and pack sizes. 4.3. Denominator data The total numbers of DDDs derived as consumption estimates should be adjusted for the population to which the data apply. 4.3.1. Global reporting For global reporting, WHO use United Nations (UN) population statistics as standardized population estimates for all Member States. When the surveillance system does not include the whole population, countries can provide – as part of the AMC data questionnaire (Annex D) – the percentage of total population covered by the surveillance system. 18 GLASS Methodology for surveillance of national antimicrobial consumption WHO will correct the UN population according to the figures provided by countries, and will then report consumption per population. 4.3.2. National reporting Countries should use the best estimates of the population covered by the surveillance system. This is important when the surveillance system includes specific populations not normally counted in national statistics (e.g. refugees). 4.4. Reporting metrics The standard reporting metric used by WHO for national estimates is DDD/1000 inhabitants/day (DID). Another relevant metric for national estimates is DDD/ inhabitant/day. Using these metrics, it is possible to estimate the average number of people treated on a day or the average number of days of treatment per person in one year period, based on the assumption that one DDD equals one day of treatment. This measure needs to be interpreted carefully. When data are provided at product level, if the package size of each product is known, it is possible to estimate consumption in number of units (e.g. tablets, vials or bottles of syrup). However, when data are provided at substance level, such estimation is not possible. 4.5. Contextual information relating to data collection It is important to report the sources of data used, the health care levels and sectors involved, the antimicrobial agents included in the surveillance, and whether any specific groups of patients or facility types have been excluded from the calculations (e.g. nursing homes, day care centres, psychiatric facilities or rehabilitation units). When countries report to WHO, they should fill in the AMC data questionnaire (Annex D), which includes this type of information. Using the contextual information will facilitate the validation and proper reporting by WHO of the data shared by countries. Data management 19 S E C T I O N 05 20 GLASS Methodology for surveillance of national antimicrobial consumption 5. Data management 5.1. Data flow between countries and WHO Within the framework of a global WHO programme on surveillance of AMC, countries submit data to WHO through the GLASS IT platform. The three levels of WHO (country, regional and global) interact with countries through the GLASS IT platform for data submission, validation, analysis and finally for reporting (Fig.5.1). 5.2. Data collection 5.2.1. Collection of AMC data Collection of data on AMC, population and contextual information (collected through the questionnaire) is the responsibility of the country and its surveillance programme’s AMC national team. At country level, protocols, forms and related documents provided by WHO might be translated into national language. If necessary, extra documents such as training materials may be produced by countries to facilitate the national data collection. To ensure a reliable data collection process, the national data providers may need training on which data to collect and how to report those data to the AMC national team. The data collection is annual and involves different stakeholders; the collection is coordinated by the national AMC team (Fig. 5.2). At national level, the data collection process can be split into different tasks as suggested below: 1. For the initial data collection, the national team develops protocols and trains the data providers to report AMC to the team. 2. Every year, the national team sends a call for AMC data to the data providers. 3. The data providers deliver the requested information to the national team in the agreed format. 4. The national team checks and validates the data delivered by the data provider. If there are issues with the data or if clarifications are needed, the national team contacts the data providers. 5. Once the data have been validated, the national team prepares the data for submission to WHO. The interaction with WHO can be initiated before the data are validated, to smooth the process of data submission and validation between the country and WHO. 6. The national team analyses and reports the data at national level. Some countries may prefer to submit data to WHO at this step. 7. The national team analyses the data collection process and results, and makes changes to the protocol for the next annual data collection. Fig. 5.1. Flow of data between countries and WHO GLASS Country WHO global level WHO regional level WHO country level Data flow Data validation WHO coordination Data management 21 Fig. 5.2. Annual data collection Prepare & set up Antimicrobial consumption surveillance National team Interactions with data providers Interactions with WHO As se ss & Im pro ve Collect Validate A naly ze & R ep or t 5.2.2. WHO template for data collection Aims of template WHO has developed an Excel file, the AMC Excel template, to help national AMC teams to manage their country’s data.4 Countries can use this file to enter their register of antimicrobial medicines; enter consumption per year, per health care sector and per level; produce simple consumption figures; and generate the data file for submission into GLASS-AMC. The Excel template includes some macros that automatically validate the data or make calculations. Nevertheless, countries should check their data to assess their relevance before sharing the results produced by the Excel template. Structure of template The WHO AMC Excel template has multiple worksheets for entering: • data for the main ATC groups and health care sectors and levels per year • population per year • consumption data at product level including: – the list of products – the consumed number of packages per year, and the health care sectors and levels. Using the AMC Excel template, countries can export data that matches the GLASS-AMC specifications, into a file that can be submitted to the GLASS IT platform. A manual for AMC data management4 includes a detailed description of the template, and explains how to use it and how to produce simple descriptive statistics on AMC. 5.3. Data submission Data submission involves the country and WHO. Data submission is done through the GLASS IT platform and its GLASS-AMC module (which are only accessible to the registered national AMC teams and to WHO staff). Each country only has access to its own data. The data submission process is separated into the following steps: 1. The AMC national team submits nationally validated consumption data, population data and questionnaire responses in the GLASS-AMC module. 4 See https://www.who.int/activities/facilitating-global-surveillance-of-antimicrobial-resistance 22 GLASS Methodology for surveillance of national antimicrobial consumption 2. The AMC national team validates and approves the submitted data in the GLASS-AMC module. 3. WHO checks the approved data for coherence. 4. WHO publishes the data. WHO may identify errors in data submitted by countries or may request clarifications before approving the data. These may require national AMC teams to contact data providers to obtain the correct figures or additional information (Fig. 5.3). WHO will only publish data that has been approved by countries. At any time, if there are errors, countries can request withdrawal of data that have been previously approved and published, and can re-submit data with the correct figures. The validation of data by WHO should be done at the WHO regional level with the support of the WHO global level. 5.4. Data analysis Analysis of the consumption data is a key step in the surveillance programme. The analysis serves to: • generate metrics or indicators of AMC that will be understandable by relevant health professionals and stakeholders – mainly through calculating consumption by classes of antimicrobials (expressed in DDD per population) but also breaking down the consumption by groups of interests (e.g. using the AWaRe [Access, Watch, Reserve] classification, by period of time or settings or population if available); and • identify changes over time or between settings, and formulate a hypothesis to explain the difference that could be discussed with relevant experts. Where analysis of the consumption data identifies inappropriate use of these medicines, it should lead to further action. It is important that countries develop their own capacity to undertake the analyses of AMC data, by training the staff in charge of surveillance but also by using resources in the academic sector. WHO should provide technical support to countries to ensure these data are used in a proper manner at country level. WHO will also provide analyses and reports at regional and global level, for global policy-makers. 5.5. Dissemination of data Although there is Member State agreement for reporting of AMC estimates to WHO for regional and global reporting, the data are useful primarily at country level. Countries should share findings with all stakeholders through various communication channels; for example, through national reports, public websites, scientific publications and dissemination workshops. Fig. 5.3. GLASS submission and validation processes National teamWHO International National Data provider Subm ission Su bm is si onValidationVa lid at io n GLASS-AMC IT platform 23 S E C T I O N 06 24 GLASS Methodology for surveillance of national antimicrobial consumption 6. GLASS-AMC IT platform The GLASS IT platform5 for global surveillance on AMR, AMC and AMU, launched by WHO in 2016, is a common environment for sharing data between Member States and WHO. The platform hosts IT elements for GLASS technical components. The GLASS-AMC IT platform allows: • countries to submit and validate their national AMC data to WHO; • the three levels of WHO to access data submitted by countries; • countries to produce their national AMC reports; and • WHO to generate a global database on AMC. The GLASS-AMC platform accepts consumption data from countries in two formats: product level data and substance level data. The platform calculates consumption metrics (as DDD) using the latest version of the ATC/DDD that is available in the platform, and reports consumption per population using the UN population figures and coverage figures provided by countries. When a new ATC/DDD index is added into the platform, it recalculates all consumption metrics accordingly. 6.1. Users When a country enrols with GLASS-AMC, the nominated national focal point (NFP) is registered as such in the GLASS-AMC IT platform. If alternates have been nominated, they will be also registered into the platform. In addition, the NFP has viewer access to the other GLASS components. When a previously nominated NFP is no longer active, the country needs to inform WHO so that the NFP’s access can be removed. 6.2. Data submission The GLASS-AMC provides various functions for countries submitting their data: • upload of data file; • validation and revocation of submitted data; • download of submitted data and consumption metrics; and • access to auto-generated analysis reports. 6.2.1. Data upload The GLASS-AMC platform allows countries to upload data as: • product level data, or • substance level data. Both formats are expected to be uploaded as tabbed files. Depending on the language, users should specify the format of the decimal character used in the data file (i.e. either dot or comma). When new data are uploaded, the GLASS-AMC platform calculates consumption metrics at substance level. Product level data By default, GLASS-AMC accepts the product level data, as defined in Annex E. Using this format, countries have information on consumption, but also important information on the antimicrobial products and market shaping, which allows additional analysis. WHO will not publish any consumption data that includes product names. Compared with substance level data, the product level format allows better validation of the data by countries and WHO. 5 See https://extranet.who.int/glass/portal/ GLASS-AMC IT platform 25 Substance level data When a country cannot report product level data, they can report substance level data, as defined in Annex F. In contrast to product level data, reporting data at substance level will not allow additional information on market shaping and has limited validation options. 6.3. AMC data questionnaire On the GLASS IT platform, the AMC national team submits the AMC data questionnaire responses, in addition to the validated consumption data. Responses to the questionnaire provide general information on the uploaded data and should accompany each new submission of consumption data (one questionnaire per year). The questionnaire addresses five areas: • ATC classes reported; • data sources used (e.g. importation, central drug store and pharmacies); • proportion of the population covered by the data; • level of care (community versus hospital) and health care sectors (public versus private) covered by the data; and • shortage of antimicrobials. The AMC national team can share a different set of information for each ATC class (see Annex D for details).

Annexes 27 A N N E X E S GLASS Methodology for surveillance of national antimicrobial consumption 28 Annex 1 Introduction to ATC and DDD methodology Categorization of medicines The Anatomical Therapeutic Chemical (ATC) classification system is the most commonly used method for aggregation of medicines data; it allows flexibility in reporting by medicine or groups of medicines. The classification of a substance in the ATC/Defined Daily Dose (DDD) system is not a recommendation for use, nor does it imply any judgements about efficacy or relative efficacy of drugs and groups of drugs. The first level of the code indicates the anatomical main group and comprises one letter. There are 14 main groups as shown here: ATC main groups A Alimentary tract and metabolism B Blood and blood forming organs C Cardiovascular D Dermatologicals G Genito-urinary system and sex hormones H Systemic hormonal preparations, excluding sex hormones and insulin J Antiinfectives for systemic use L Antineoplastic and immunomodulating agents M Musculo-skeletal system N Nervous system P Anti-parasitic products, insecticides and repellants R Respiratory system S Sensory organs V Various Annexes 29 The structure and nomenclature used in the ATC classification system is illustrated for metformin (used in the treatment of diabetes) in Box A1. There are a number of challenges with the use of the ATC system. In some cases, a medicine can be used for different indications, and this is not always reflected in the ATC code. In some cases, medicines will have several different ATC codes depending on the use of the product (e.g. for systemic use or topical use). Medicinal products containing two or more active ingredients are considered as combinations in the ATC system and have a different ATC code to the single components. In addition, there are regular revisions of the ATC code to deal with new drugs and changes in use of products. When interpreting trends over time, it is important to be aware of changes in ATC codes that may have occurred over time. The WHO Collaborating Centre for Drug Statistics Methodology has developed coding rules for all medicines. In relation to antimicrobials, the 2016 guidelines6 state the following: Box A1. The ATC classification system In the ATC classification system, active substances are divided into different groups according to the organ or system on which they act, and their therapeutic, pharmacological and chemical properties. Drugs are classified in groups at five different levels. The drugs are divided into 14 main groups (1st level), with pharmacological/therapeutic subgroups (2nd level). The 3rd and 4th levels are chemical/pharmacological/ therapeutic subgroups, and the 5th level is the chemical substance. The 2nd, 3rd and 4th levels are often used to identify pharmacological subgroups when that is considered more appropriate than therapeutic or chemical subgroups. The complete classification of metformin is shown here to illustrate the structure of the code: A Alimentary tract and metabolism (1st level, anatomical main group) A10 Drugs used in diabetes (2nd level, therapeutic subgroup) A10B Blood glucose lowering drugs, excl insulins (3rd level, pharmacological subgroup) A10BA Biguanides (4th level, chemical subgroup) A10BA02 Metformin (5th level, chemical substance) Thus, in the ATC system, all plain metformin preparations are given the code A10BA02. Nomenclature International nonproprietary names (INN) are preferred. If an INN name has not been assigned, a United States Adopted Name (USAN) or British Approved Name (BAN) is usually chosen. J01 ANTIBACTERIALS FOR SYSTEMIC USE This group comprises antibacterials for systemic use, except antimycobacterials, which are classified in J04. The antibacterials are classified according to their mode of action and chemistry. Combinations of two or more systemic antibacterials from different third levels are classified in J01R, except combinations of sulfonamides and trimethoprim, which are classified at a separate 4th level, J01EE. Combinations of antibacterials with other drugs, including local anesthetics or vitamins, are classified at separate 5th levels in the respective antibacterial group by using the 50-series. Common cold preparations containing minimal amounts of antibacterials are classified in R05X. Inhaled antiinfectives are classified here based on the fact that preparations for inhalation cannot be separated from preparations for injection. 6 See https://www.whocc.no/atc_ddd_index/?code=J01 GLASS Methodology for surveillance of national antimicrobial consumption 30 Application of the ATC classification system The antiinfective agents for systemic use are classified under ATC main group J (level 1). Level 1 (Main group): ATC main group J (Antiinfective for systemic use) Level 2 (pharmacological/therapeutic subgroups): J ANTIINFECTIVES FOR SYSTEMIC USE J01 Antibacterials for systemic use J02 Antimycotics for systemic use J04 Antimycobacterials J05 Antivirals for systemic use J06 Immune sera and immunoglobulins J07 Vaccines Level 3 (chemical/pharmacological/therapeutic subgroups): J01 ANTIBACTERIALS FOR SYSTEMIC USE J01A Tetracyclines J01B Amphenicols J01C Beta-lactam antibacterials, penicillins J01D Other beta-lactam antibacterials J01E Sulfonamides and trimethoprim J01F Macrolides, lincosamides and streptogramins J01G Aminoglycoside antibacterials J01M Quinolone antibacterials J01R Combinations of antibacterials J01X Other antibacterials Level 4 (chemical/pharmacological/therapeutic subgroups): J01C BETA-LACTAM ANTIBACTERIALS, PENICILLINS J01CA Penicillins with extended spectrum J01CE Beta-lactamase sensitive penicillins J01CF Beta-lactamase resistant penicillins J01CG Beta-lactamase inhibitors J01CR Combinations of penicillins, J01CR Combinations of penicillins, incl. beta-lactamase inhibitors Level 5 (chemical substance): J01CA PENICILLINS WITH EXTENDED SPECTRUM ATC CODE NAME J01CA01 ampicillin J01CA02 pivampicillin J01CA03 carbenicillin J01CA04 amoxicillin J01CA05 carindacillin J01CA06 bacampicillin J01CA07 epicillin J01CA08 pivmecillinam J01CA09 azlocillin J01CA10 mezlocillin J01CA11 mecillinam J01CA12 piperacillin J01CA13 ticarcillin J01CA14 metampicillin J01CA15 talampicillin J01CA16 sulbenicillin J01CA17 temocillin J01CA18 hetacillin J01CA19 aspoxicillin J01CA20 combinations J01CA51 ampicillin, combinations Annexes 31 Some examples of ATC codes 1. Amoxicillin is J01CA04 and is classified as follows: J ANTIINFECTIVES FOR SYSTEMIC USE (Level 1) J01 ANTIBACTERIALS FOR SYSTEMIC USE (Level 2) J01C BETA-LACTAM ANTIBACTERIALS, PENICILLINS (Level 3) J01CA Penicillins with extended spectrum (Level 4) J01CA04 Amoxicillin (Level 5) Note: J01CA04 applies to amoxicillin in all its formulations (e.g. oral, parenteral and syrup formulations for children). 2. Ceftriaxone is J01DD04 and is classified as follows: J ANTIINFECTIVES FOR SYSTEMIC USE (Level 1) J01 ANTIBACTERIALS FOR SYSTEMIC USE (Level 2) J01D OTHER BETA-LACTAM ANTIBACTERIALS (Level 3) J01DD Third-generation cephalosporins (Level 4) J01DD04 Ceftriaxone (Level 5) 3. Amoxicillin + clavulanic acid is J01CR02 and is classified as follows: J ANTIINFECTIVES FOR SYSTEMIC USE (Level 1) J01 ANTIBACTERIALS FOR SYSTEMIC USE (Level 2) J01C BETA-LACTAM ANTIBACTERIALS, PENICILLINS (Level 3) J01CR Combinations of penicillins including beta-lactamase inhibitors (Level 4) J01CR02 Amoxicillin and enzyme inhibitor (Level 5) Changes of ATC codes and new codes ATC codes can change over time as more experience is gained with the medicine and more products become available. The WHO ATC/DDD website7 provides information on alterations to ATC codes between 2005 and 2020. New ATC codes can also be found on the website.8 Antimicrobials with multiple ATC codes Some antimicrobials are classified under more than one ATC code (e.g. metronidazole and vancomycin), reflecting their use in different clinical situations. Metronidazole A01AB17 Alimentary tract and metabolism, Antiinfectives and antiseptics for local oral treatment D06BX01 Dermatologicals, Other chemotherapeutics G01AF01 Genitourinary system and sex hormones, Imidazole derivatives J01XD01 Antiinfectives for systemic use, Imidazole derivatives P01AB01 Antiparasitic products, insecticides and repellants, Nitroimidazole derivatives P01AB51 Antiparasitic products, insecticides and repellants, Nitroimidazole derivatives, metronidazole combinations Vancomycin A07AA09 Alimentary tract and metabolism, Intestinal antiinfectives J01XA01 Antiinfectives for systemic use, Other antibacterials, Glycopepeptide antibacterials To determine the total use of each of these antimicrobials, it will be necessary to include all the relevant ATC codes. However, for metronidazole, the WHO methodology indicates that only J01XD01 and P01AB01 are to be used, because the other codes refer to metronidazole for local or topical use. 7 See http://www.whocc.no/atc_ddd_alterations__cumulative/atc_alterations/ 8 See http://www.whocc.no/atc/lists_of_new_atc_ddds_and_altera/new_atc/ GLASS Methodology for surveillance of national antimicrobial consumption 32 Defined Daily Dose (DDD) The most commonly used measure for reporting of drug utilization is number of DDDs, where the DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. A DDD is only assigned for drugs that already have an ATC code. Converting aggregate quantities to DDDs allows a rough estimation of the potential treatment days for which the pharmaceutical is procured or consumed. The DDD, however, is only a technical unit of use; it does not necessarily reflect the recommended or average prescribed dose. The DDDs for the antiinfectives are generally based on use in infections of moderate severity. However, some antiinfectives are only used in severe infections, and their DDDs are assigned accordingly. Generally, DDDs assigned are based on daily treatment. However, in the case of antimicrobial agents, there are rules to guide calculation of the DDD based on the duration of the treatment. For antiinfectives given in a high initially starting dose followed by a lower daily “maintenance” dose, the DDDs are based on the “maintenance” dose if the total duration of the treatment course is more than 1 week. However, if the treatment course is 7 days or less, the DDDs are assigned according to the average daily dose (i.e. the total course dose divided by the number of treatment days). The DDD is a technical unit of measurement, and it does not necessarily reflect the doses that are prescribed and used in practice. The prescribed daily dose (PDD) is the average daily dose prescribed; it is obtained from a representative sample of prescriptions. The DDD remains a useful metric because it is a standardized measure and can be applied to all data. When interpreting the results of the analysis, it is important to think about possible differences with prescribed daily doses. Example of calculation of DDD for antimicrobial agent Substance M: 1000 mg on the first day, then 500 mg daily. Duration of therapy: 14 days DDD is 500 mg (maintenance dose as total duration of the treatment course is more than 1 week) Substance M: 1000 mg on the first day, then 500 mg daily. Duration of therapy: 5 days DDD is 600 mg ((1000 + 4x500)/5 = 600 mg) Annexes 33 Returning J01CA Penicillins with extended spectrum, the assigned DDD values are as shown here: Note: There are three DDD values for ampicillin, and two each for amoxicillin, epicillin and metampicillin. For epicillin and metampicillin, the DDDs remain the same for oral and parenteral administration, but this is not the case for all antimicrobials. ATC CODE NAME DDD UNIT OF DDD ADMINISTRATION ROUTE J01CA01 ampicillin 2 g O 6 g P 2 g R J01CA02 pivampicillin 1.05 g O J01CA03 carbenicillin 12 g P J01CA04 amoxicillin 3 g P 1,5 g O J01CA05 carindacillin 4 g O J01CA06 bacampicillin 1.2 g O J01CA07 epicillin 2 g O 2 g P J01CA08 pivmecillinam 0.6 g O J01CA09 azlocillin 12 g P J01CA10 mezlocillin 6 g P J01CA11 mecillinam 1.2 g P J01CA12 piperacillin 14 g P J01CA13 ticarcillin 15 g P J01CA14 metampicillin 1.5 g O 1.5 g P J01CA15 talampicillin 2 g O J01CA16 sulbenicillin 15 g P J01CA17 temocillin 2 g P J01CA18 hetacillin 2 g O J01CA19 aspoxicillin 4 g P J01CA20 combinations J01CA251 ampicillin, combinations DDD: defined daily dose; g: gram; O: oral; P: parenteral. GLASS Methodology for surveillance of national antimicrobial consumption 34 Some examples of where the DDD changes according to the formulation are shown here: Notes: 1. The DDD for amoxicillin and enzyme inhibitor is the same as the DDD for amoxicillin alone. The DDD for the combination is based on the main active ingredient. 2. Erythromycin ethylsuccinate has a special code for salt (ESUC) in the data collection template to ensure that the correct DDD is applied. 3. The different DDD values for ciprofloxacin, tobramycin and metronidazole are assigned in the template according to whether the product is for oral, parenteral, inhalation or rectal administration. 4. In the case of metronidazole, J01 only includes the forms for parenteral administration. For total use of metronidazole, it will be necessary to use all the relevant ATC codes for systemic use. Data for P01AB01 are included in the AMC template. If there is no ATC code available or there is no DDD assigned for product, contact the GLASS-AMC team at glass-amc@who.int for advice. ATC CODE NAME DDD UNIT OF DDD ADMINISTRATION ROUTE J01CR02 amoxicillin and enzyme inhibitor 1.5 g O 3 g P J01FA01 erythromycin 1 g O erthyromycin ethylsuccinate 2 g O 1 g P J01MA02 ciprofloxacin 1 g O 0.5 g P J01GB01 tobramycin 0.112 g Inhal. powder 0.3 g Inhal. Solution 0.24 g P P01AB01 metronidazole 2 g O P01AB01 metronidazole 2 g R J01XD01 metronidazole 1.5 g P DDD: defined daily dose; g: gram; inhal: inhalation; O: oral; P: parenteral; R: rectal. Annexes 35 Annex 2 List of ATC subgroups under surveillance CODE NAME CORE SET A07AA Antibiotics Mandatory D01BA Antifungals for systemic use Optional J01AA Tetracyclines Mandatory J01BA Amphenicols Mandatory J01CA Penicillins with extended spectrum Mandatory J01CE Beta-lactamase sensitive penicillins Mandatory J01CF Beta-lactamase resistant penicillins Mandatory J01CG Beta-lactamase inhibitors Mandatory J01CR Combinations of penicillins, incl. beta-lactamase inhibitors Mandatory J01DB First-generation cephalosporins Mandatory J01DC Second-generation cephalosporins Mandatory J01DD Third-generation cephalosporins Mandatory J01DE Fourth-generation cephalosporins Mandatory J01DF Monobactams Mandatory J01DH Carbapenems Mandatory J01DI Other cephalosporins and penems Mandatory J01EA Trimethoprim and derivatives Mandatory J01EB Short-acting sulfonamides Mandatory J01EC Intermediate-acting sulfonamides Mandatory J01ED Long-acting sulfonamides Mandatory J01EE Combinations of sulfonamides and trimethoprim, incl. derivatives Mandatory J01FA Macrolides Mandatory J01FF Lincosamides Mandatory J01FG Streptogramins Mandatory J01GA Streptomycins Mandatory J01GB Other aminoglycosides Mandatory J01MA Fluoroquinolones Mandatory J01MB Other quinolones Mandatory J01RA Combinations of antibacterials Mandatory J01XA Glycopeptide antibacterials Mandatory J01XB Polymyxins Mandatory J01XC Steroid antibacterials Mandatory J01XD Imidazole derivatives Mandatory J01XE Nitrofuran derivatives Mandatory J01XX Other antibacterials Mandatory GLASS Methodology for surveillance of national antimicrobial consumption 36 CODE NAME CORE SET J02AA Antibiotics Optional J02AB Imidazole derivatives Optional J02AC Triazole derivatives Optional J02AX Other antimycotics for systemic use Optional J04AA Aminosalicylic acid and derivatives Optional J04AB Antibiotics Optional J04AC Hydrazides Optional J04AD Thiocarbamide derivatives Optional J04AK Other drugs for treatment of tuberculosis Optional J04AM Combinations of drugs for treatment of tuberculosis Optional J04BA Drugs for treatment of lepra Optional J05AA Thiosemicarbazones Optional J05AB Nucleosides and nucleotides excl. reverse transcriptase inhibitors Optional J05AC Cyclic amines Optional J05AD Phosphonic acid derivatives Optional J05AE Protease inhibitors Optional J05AF Nucleoside and nucleotide reverse transcriptase inhibitors Optional J05AG Non-nucleoside reverse transcriptase inhibitors Optional J05AH Neuraminidase inhibitors Optional J05AR Antivirals for treatment of HIV infections, combinations Optional J05AX Other antivirals Optional P01AB Nitroimidazole derivatives Optional P01BA Aminoquinolines Optional P01BB Biguanides Optional P01BC Methanolquinolines Optional P01BD Diaminopyrimidines Optional P01BE Artemisinin and derivatives, plain Optional P01BF Artemisinin and derivatives, combinations Optional P01BX Other antimalarials Optional N04BB Adamantane derivatives Optional Annexes 37 Annex 3 Definition of variables for AMC surveillance The variables for AMC surveillance are split into three groups of data: • product information • consumption information • population information The tables show the variables for each of these three groups. Variables for ‘Product information’ VARIABLE COUNTRY Description Three-letter code uniquely identifying the reporting country. Data type Coded value Variable type Mandatory Information List of country codes based on the ISO3166 alpha-3 country codes list (ref: https://en.wikipedia.org/wiki/ISO_3166-1_alpha-3) VARIABLE PRODUCT_ID Description The national code of the medicinal product. The code that uniquely identifies the medicinal product for the country. Data type Text Variable type Mandatory Information In theory, it is important that the Product_ID should not change over time. When a product is no longer available on the market or is no longer registered, its Product_ID should not be attributed to another product; this makes it possible to identify the old product for historical purposes (prescription history). In practice, when no formal code exists for a product, the country should provide one arbitrary code that should uniquely identify the product for a specific year. VARIABLE LABEL Description The label of the medicinal product. If possible, the label should contain the name of the medicinal product, package size, strength and pharmaceutical form. Data type Text Variable type Mandatory Information The label is an important variable because it is the only information that allows an external reviewer to cross check the medicinal product package. GLASS Methodology for surveillance of national antimicrobial consumption 38 VARIABLE PACKSIZE Description The package size of the medicinal product. The size of the product should be reported as the number of pieces in the package, except for syrup where it should be reported as the number of mL. Data type Number Variable type Mandatory Information For products that are administrated as liquid form (i.e. syrup), the package size should be reported as mL of final reconstituted product. For all other pharmaceutical forms, the package size must be reported as the number of pieces. For instance, for vials, the package size must be reported as a number of vials in the package and not as the volume of reconstituted product. VARIABLE PACKSIZE_UNIT Description The unit of the package size of the medicinal product. Data type Coded value Variable type Mandatory Information The measurement unit in which the package size of the medicines is expressed. See Measurement unit list (Annex G) for coded values. VARIABLE ROUTE_ADMIN Description The route of administration of the medicinal product. Data type Coded value Variable type Mandatory Information The route of administration is used to attribute a DDD to the product and to report consumption according to the route of administration. See Administration route list (Annex H) for coded values. VARIABLE STRENGTH Description The strength of the active substance of each item, as defined by PACKSIZE. For multi- ingredient products, this field should contain the strength in which the DDD is expressed. Data type Number Variable type Mandatory Information For some specific substances used in combination with others, the WHO Collaborating Centre (CC) has defined some rules; for example, to only take into account the antimicrobial substance and not the combined substance (e.g. amoxicillin/clavulanic acid). For products with multiple antimicrobial substances, the WHO CC has defined DDD for combined products. In such cases, the strength should be reported in the same unit as the DDD for the corresponding combined product. Annexes 39 VARIABLE STRENGTH_UNIT Description The unit of the strength of the medicinal product. Data type Coded value Variable type Mandatory Information The measurement unit in which the strength of the product is expressed. See Measurement unit list (Annex G) for the coded values. VARIABLE INBASQ Description The basic ingredient quantity (INBASQ) used for describing concentration of fluids (e.g. 200 mg/10 mL) such as syrups. In syrups and solutions, INBASQ describes the denominator part of the strength. In all other cases (including perfusion fluids or ampullas), the INBASQ should be set to 1. Data type Number Variable type Mandatory Information The default value is 1 when the package size is not expressed in mL VARIABLE INBASQ_UNIT Description The unit of the INBASQ of the medicinal product. Data type Coded value Variable type Mandatory Information The measurement unit in which the basic ingredient quantity of the product is expressed. See Measurement unit list (Annex G) for the coded values. VARIABLE ATC5 Description The WHO ATC code at substance level (ATC 5th level) of the medicinal product Data type Coded value Variable type Mandatory Information Each ATC code is linked to its product main therapeutic use. The ATC5 variable is used to attribute a DDD to the medicinal product package (MPP) and to report antimicrobial consumption according to the ATC classification. See ATC classification (Annex A). VARIABLE SALT Description The code of the salt associated to the active substance. Data type Coded value Variable type Optional Information It is only valid for methenamin (J01XX05) and erythromycin (J01FA01); for all other substances, the salt should not be specified. This is because the WHO CC has defined DDD depending on the salt for only these two substances. See the Salt list (Annex I) for the coded values. GLASS Methodology for surveillance of national antimicrobial consumption 40 VARIABLE COMBINATION Description The code of the combined product of the medicinal product Data type Coded value Variable type Optional Information If the product is a combined product with a corresponding entry in the combined product list, the variable must be set in order to attribute the correct DDD to the product. In addition, if the variable is set, the strength unit should be reported in Unit Doses. See the combined product list (Annex J) for the coded values. VARIABLE PAEDIATRIC_PRODUCT Description The product is a paediatric medicinal product. Data type YES/NO Variable type Optional Information The product is a paediatric product or not. VARIABLE FORM Description The pharmaceutical form of the medicinal product. Data type Text Variable type Optional Information VARIABLE PRODUCT_NAME Description The name of the medicinal product. Data type Text Variable type Optional Information The name of the product. The name should be common to all products with different formulation of the same product. VARIABLE INGREDIENTS Description The name of the ingredients in the medicinal product. Data type Text Variable type Optional Information INN names should be used to report the ingredients. Any other non-active substances should be reported in addition to the antimicrobial substances. VARIABLE PRODUCT_ORIGIN Description The source of the product. Data type Coded value Variable type Optional Information The source of the product can be import, donation or locally produced. See the Product origin list (Annex K) for the coded values. Annexes 41 VARIABLE MANUFACTURER_COUNTRY Description Three-letter code uniquely identifying the country of manufacturing. Data type Coded value Variable type Optional Information See COUNTRY variable VARIABLE MARKET_AUTH_HOLDER Description The name or code of marketing authorization holder. Data type Text Variable type Optional Information VARIABLE GENERICS Description The medicinal product is a generic. Data type YES/NO Variable type Optional Information VARIABLE YEAR_AUTHORIZATION Description Year of marketing authorization granted Data type Number Variable type Optional Information The year should be reported as a four-digit number YYYY VARIABLE YEAR_WITHDRAWAL Description Year of marketing authorization withdrawn Data type Number Variable type Optional Information The year should be reported as a four-digit number YYYY VARIABLE CONV_FACTOR Description The conversion factor to transform strength expressed in international units (IU) into strength expressed in grams (G). Data type Number Variable type Mandatory Information If there is no need to convert from IU to G, the CONV_FACTOR must be set to 1. If strength is expressed in IU and DDD in G, and no conversion factor exists, no DDD per MPP will be calculated and no consumption for this MPP will be reported. See the Conversion factor list (Annex L). GLASS Methodology for surveillance of national antimicrobial consumption 42 VARIABLE PACKCONTENT Description The content of active substance in the medicinal product. Data type Number Variable type Mandatory Information The package content of the product is calculated by multiplying the package size by the strength, dividing by the INBASQ and multiplying by the CONV_FACTOR. VARIABLE PACKCONTENT_UNIT Description The unit of the package content of the medicinal product. Data type Coded value Variable type Mandatory Information The measurement unit in which the package content of the product is expressed. See Measurement unit list (Annex G) for coded values. VARIABLE WHO_DDD Description The official WHO DDD of the medicinal product. Data type Number Variable type Mandatory Information The WHO DDD is assigned according to the ATC5, ROUTE_ADMIN, COMBINATION and SALT variables. Some products will not have a corresponding WHO DDD, either because no ATC5 code has been assigned for the product or because no DDD has been defined for the ATC5. In the latter case, no DDD will be calculated and no consumption for this product will be reported. VARIABLE WHO_DDD_UNIT Description The unit of the WHO DDD of the medicinal product. Data type Coded value Variable type Mandatory Information The measurement unit in which the WHO DDD of the product is expressed. See Measurement unit list (Annex G) for coded values. VARIABLE DPP Description The number of calculated DDD in the package for the medicinal product. Data type Number Variable type Mandatory Information The number of DPP is calculated by dividing the PACK_CONTENT by the WHO_DDD. Annexes 43 Variables for the ‘Consumption information’ VARIABLE COUNTRY Description Three-letter code uniquely identifying the reporting country. Data type Coded value Variable type Mandatory Information List of country codes based on the ISO3166 alpha-3 country codes list (ref: https://en.wikipedia.org/wiki/ISO_3166-1_alpha-3) VARIABLE YEAR Description The year of the reported consumption data Data type Number as YYYY Variable type Mandatory Information The year of the reported consumption (as a four-digit number), not the year when data are reported. For instance, if 2018 data are reported into 2020, the YEAR variable should be set to 2018. VARIABLE PRODUCT_ID Description The national code of the medicinal product. The code that uniquely identifies the medicinal product for the country. Data type Text Variable type Mandatory Information See the Product information table above. VARIABLE HEALTH CARE_SECTOR Description The health care sector to which consumption data are reported. Data type Coded value Variable type Mandatory Information The health care sector (either public, private or both) aggregated as global. See the Health care sector list (Annex M) for the coded values. VARIABLE HEALTH CARE_LEVEL Description The health care level to which consumption data are reported. Data type Coded value Variable type Mandatory Information The health care level (either community, hospital or both) aggregated as total. See the Health care level list (Annex N) for the coded values. VARIABLE PACKAGES Description The number of packages of the medicinal product Data type Number Variable type Mandatory Information The number of packages of the medicinal product consumed for the specified year, health care sector and health care level. GLASS Methodology for surveillance of national antimicrobial consumption 44 Variables for the ‘Population information’ VARIABLE COUNTRY Description Three-letter code uniquely identifying the reporting country. Data type Coded value Variable type Mandatory Information List of country codes based on the ISO3166 alpha-3 country codes list (ref: https://en.wikipedia.org/wiki/ISO_3166-1_alpha-3) VARIABLE YEAR Description The year of the reported consumption data. Data type Number as YYYY Variable type Mandatory Information The year of the reported consumption (as a four-digit number), not the year when data are reported. For instance, if 2018 data are reported into 2020, the YEAR variable should be set to 2018. VARIABLE HEALTH CARE_SECTOR Description The health care sector to which consumption data are reported. Data type Coded value Variable type Mandatory Information The health care sector (either public, private or both) aggregated as global. See the Health care sector list (Annex M) for the coded values. VARIABLE HEALTH CARE_LEVEL Description The health care level to which consumption data are reported. Data type Coded value Variable type Mandatory Information The health care level (either community, hospital or both) aggregated as total. See the Health care level list (Annex N) for the coded values. VARIABLE POPULATION Description The population covered by the surveillance programme. Data type Number Variable type Mandatory Information The population covered by the surveillance programme for the specified year, health care sector and health care level. Annexes 45 Annex 4 AMC data questionnaire The antimicrobial consumption (AMC) data questionnaire aims to provide contextual information on the submitted data. It is an online questionnaire that is part of the GLASS-AMC platform. The questionnaire should be filled per year of data submitted, irrespective of the number of times data for a specific year have been submitted. However, each time data for a specific year is re-submitted, the relevant questionnaire should be updated if necessary (even for retrospective correction). Note: The questions are given here ONLY for the use of the reader. If you wish to take the questionnaire, please submit your responses ONLINE. Note: An asterisk indicates that a question is mandatory to answer. Country*: Year*: 1. Introduction Which ATC classes have been reported?* (Specify which ATC classes you have reported data for) A07AA D01BA J01 J02 J04A J04B J05A P01B All classes Is the same data source(s) used to report consumption data for all substances? (Specify if the data source(s) and sectors (public/ private, community/hospital) from where consumption data was collected were the same for all reported ATC classes) Yes No 2. ATC class information Sectors from where data is reported Please select the sectors from where data is reported: SECTOR PUBLIC PRIVATE GLOBAL Community Hospital Total Comments on the sectors reported: Population coverage using United Nations population as reference Do the reported data cover the same population for all reported sectors? Yes No (If “Yes” to the above question) Provide the percentage (as a number between 0 and 100) of the population covered (all population=100) % (If “No” to the above question) Provide the percentage (as a number between 0 and 100) of the population covered (all population=100) for each sector: SECTOR PUBLIC PRIVATE GLOBAL Community Hospital Total Have the related consumption data been extrapolated to the whole population? Yes No GLASS Methodology for surveillance of national antimicrobial consumption 46 Comments on the reported population coverage: Public/Private sectors market share Have you reported data for both public and private sectors? Yes No (Skip if “No” to the above question) Have you provided data grouped together (global)? Yes No Provide the estimated percentage (as a number between 0 and 100) of the national market share for antimicrobials covered by the public sector (all market=100) % Comments on the distribution of consumption between the public and private sectors: Data sources Did you use the same data source to collect public sector data? Yes No (If “Yes” to the above question) Provide the data source used to collect public sector data Import Production for domestic market Nongovernmental organization International programmes Central drug store Wholesalers Insurance data Hospitals Pharmacies Market research companies (If “No” to the above question, please answer the next two questions) If you reported data for community care in the public sector, provide the data source Import Production for domestic market Nongovernmental organization International programmes Central drug store Wholesalers Insurance data Hospitals Pharmacies Market research companies If you reported data for hospital care in the public sector, provide the data source Import Production for domestic market Nongovernmental organization International programmes Central drug store Wholesalers Insurance data Hospitals Pharmacies Market research companies Did you use the same data source to collect private sector data? Yes No Annexes 47 (If “Yes” to the above question) Provide the data source used to collect private sector data Import Production for domestic market Nongovernmental organization International programmes Central drug store Wholesalers Insurance data Hospitals Pharmacies Market research companies (If “No” to the above question, please answer the next two questions) If you reported data for community care in the public sector, provide the data source Import Production for domestic market Nongovernmental organization International programmes Central drug store Wholesalers Insurance data Hospitals Pharmacies Market research companies If you reported data for hospital care in the public sector, provide the data source Import Production for domestic market Nongovernmental organization International programmes Central drug store Wholesalers Insurance data Hospitals Pharmacies Market research companies Comments on the data sources: 3. Shortages Did you have shortage at national level of antimicrobial substances during the year of reporting? Yes No (If “Yes” to the above question, please answer the next two questions) Please list all substances for which at least one shortage event has occurred during the year of reporting in public sector Please list all substances for which at least one shortage event has occurred during the year of reporting in private sector Comments on shortage 4. General Overall comments on reported data GLASS Methodology for surveillance of national antimicrobial consumption 48 Annex 5 Specification of the GLASS-AMC product level data file The GLASS-AMC Product Level Data file contains variables related to: • product information • consumption information The format of GLASS-AMC is tab separated, and it contains the variables shown below. Users should not modify the order and names of variables because modification will cause the file to be rejected by the GLASS-AMC platform. Variables for the ‘Product Level data’ GLASS-AMC file VARIABLE COUNTRY Description Three-letter code uniquely identifying the reporting country. Data type Coded value Variable type Mandatory Information See Annex C VARIABLE YEAR Description The year of the reported consumption data. Data type Number as YYYY Variable type Mandatory Information See Annex C VARIABLE PRODUCT_ID Description The national code of the medicinal product. Data type Text Variable type Mandatory Information See Annex C VARIABLE LABEL Description The label of the medicinal product. Data type Text Variable type Mandatory Information See Annex C VARIABLE PACKSIZE Description The package size of the medicinal product. Data type Number Variable type Mandatory Information See Annex C VARIABLE PACKSIZE_UNIT Description The unit of the package size of the medicinal product. Data type Coded value Variable type Mandatory Information See Annex C Annexes 49 VARIABLE ROUTE_ADMIN Description The route of administration of the medicinal product. Data type Coded value Variable type Mandatory Information See Annex C VARIABLE STRENGTH Description The strength of the active substance of each item as defined by PACKSIZE. Data type Number Variable type Mandatory Information See Annex C VARIABLE STRENGTH_UNIT Description The unit of the strength of the medicinal product. Data type Coded value Variable type Mandatory Information See Annex C VARIABLE INBASQ Description The basic ingredient quantity (INBASQ) used for describing concentration of fluids. Data type Number Variable type Mandatory Information See Annex C VARIABLE INBASQ_UNIT Description The unit of the INBASQ of the medicinal product. Data type Coded value Variable type Mandatory Information See Annex C VARIABLE ATC5 Description The WHO ATC code at substance level (ATC 5th level) of the medicinal product Data type Coded value Variable type Mandatory Information See Annex C VARIABLE SALT Description The code of the salt associated with the active substance. Data type Coded value Variable type Optional Information See Annex C VARIABLE COMBINATION Description The code of the combined product of the medicinal product Data type Coded value Variable type Optional Information See Annex C GLASS Methodology for surveillance of national antimicrobial consumption 50 VARIABLE COMBINATION Description The code of the combined product of the medicinal product Data type Coded value Variable type Optional Information See Annex C VARIABLE PAEDIATRIC_PRODUCT Description The product is a paediatric medicinal product Data type YES/NO Variable type Optional Information See Annex C VARIABLE FORM Description The pharmaceutical form of the medicinal product. Data type Text Variable type Optional Information See Annex C VARIABLE PRODUCT_NAME Description The name of the medicinal product. Data type Text Variable type Optional Information See Annex C VARIABLE INGREDIENTS Description The name of the ingredients in the medicinal product. Data type Text Variable type Optional Information See Annex C VARIABLE PRODUCT_ORIGIN Description The source of the product. Data type Coded value Variable type Optional Information See Annex C VARIABLE MANUFACTURER_COUNTRY Description Three-letter code uniquely identifying the country of manufacturing. Data type Coded value Variable type Optional Information See Annex C VARIABLE MARKET_AUTH_HOLDER Description The name or code of marketing authorization holder. Data type Text Variable type Optional Information See Annex C Annexes 51 VARIABLE GENERICS Description The medicinal product is a generic. Data type YES/NO Variable type Optional Information See Annex C VARIABLE YEAR_AUTHORIZATION Description Year of marketing authorization granted. Data type Number Variable type Optional Information See Annex C VARIABLE YEAR_WITHDRAWAL Description Year of marketing authorization withdrawn. Data type Number Variable type Optional Information See Annex C VARIABLE GLO_TOTAL_PACKAGES Description The number of consumed packages for the global health care sector and total health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for aggregated health care sectors and levels as one figure, they should be reported in that variable. VARIABLE GLO_COMMUNITY_PACKAGES Description The number of consumed packages for the global health care sector and community health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for aggregated health care sectors and community level, they should be reported in that variable. VARIABLE GLO_HOSPITAL_PACKAGES Description The number of consumed packages for the global health care sector and hospital health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for aggregated health care sectors and community level, they should be reported in that variable. VARIABLE PUB_TOTAL_PACKAGES Description The number of consumed packages for the public health care sector and total health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for public health care sector and aggregated health care levels, they should be reported in that variable. GLASS Methodology for surveillance of national antimicrobial consumption 52 VARIABLE PUB_COMMUNITY_PACKAGES Description The number of consumed packages for the public health care sector and community health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for public health care sector and community health care level, they should be reported in that variable. VARIABLE PUB_HOSPITAL_PACKAGES Description The number of consumed packages for the public health care sector and hospital health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for public health care sector and hospital health care level, they should be reported in that variable. VARIABLE PRIV_TOTAL_PACKAGES Description The number of consumed packages for the private health care sector and total health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for private health care sector and aggregate health care levels, they should be reported in that variable. VARIABLE PRIV_COMMUNITY_PACKAGES Description The number of consumed packages for the private health care sector and community health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for private health care sector and community health care level, they should be reported in that variable. VARIABLE PRIV_HOSPITAL_PACKAGES Description The number of consumed packages for the private health care sector and hospital health care level for the specified year and product. Data type Number Variable type Optional Information If consumption data have been reported for private health care sector and hospital health care level, they should be reported in that variable. Annexes 53 Annex 6 Specification of the GLASS-AMC Substance Level Data file The GLASS-AMC substance level data file contains variables related to consumption information. The format of the GLASS-AMC is tab separated, and it contains the variables shown below. Users should not modify the order and names of variables because modification will cause the file to be rejected by the GLASS-AMC platform. Variables for the ‘Substance level data’ GLASS-AMC file VARIABLE COUNTRY Description Three-letter code uniquely identifying the reporting country. Data type Coded value Variable type Mandatory Information See Annex C VARIABLE YEAR Description The year of the reported consumption data. Data type Number as YYYY Variable type Mandatory Information See Annex C VARIABLE ATC5 Description The WHO ATC code at substance level (ATC 5th level) of the medicinal product. Data type Coded value Variable type Mandatory Information See Annex C VARIABLE ROUTE Description The route of administration of the medicinal product. Data type Coded value Variable type Mandatory Information See Annex C VARIABLE SALT Description The code of the salt associated with the active substance. Data type Coded value Variable type Optional Information See Annex C VARIABLE SECTOR Description The code of the health care sector for which data are reported Data type Coded value Variable type Optional Information See Annex C GLASS Methodology for surveillance of national antimicrobial consumption 54 VARIABLE TOTAL_DDD Description The number of DDD for the specified ATC5, ROUTE, SALT and SECTOR for total health care level. Data type Number Variable type Optional Information If consumption data expressed in DDD have been collected for the specified ATC5, ROUTE, SALT and SECTOR and for total health care level, they should be reported under this variable. VARIABLE COMMUNITY_DDD Description The number of DDD for the specified ATC5, ROUTE, SALT and SECTOR for community health care level. Data type Number Variable type Optional Information If consumption data expressed in DDD have been collected for the specified ATC5, ROUTE, SALT and SECTOR and for community health care level, they should be reported under this variable. VARIABLE HOSPITAL_DDD Description The number of DDD for the specified ATC5, ROUTE, SALT and SECTOR for hospital health care level/ Data type Number Variable type Optional Information If consumption data expressed in DDD have been collected for the specified ATC5, ROUTE, SALT and SECTOR and for hospital health care level, they should be reported under this variable. VARIABLE TOTAL_TONS Description The number of metric tons for the specified ATC5, ROUTE, SALT and SECTOR for total health care level. Data type Number Variable type Optional Information If consumption data expressed in metric tons have been collected for the specified ATC5, ROUTE, SALT and SECTOR and for total health care level, they should be reported under this variable. VARIABLE COMMUNITY_TONS Description The number of metric tons for the specified ATC5, ROUTE, SALT and SECTOR for community health care level. Data type Number Variable type Optional Information If consumption data expressed in metric tons have been collected for the specified ATC5, ROUTE, SALT and SECTOR and for community health care level, they should be reported under this variable. VARIABLE HOSPITAL_TONS Description The number of metric tons for the specified ATC5, ROUTE, SALT and SECTOR for hospital health care level. Data type Number Variable type Optional Information If consumption data expressed in metric tons have been collected for the specified ATC5, ROUTE, SALT and SECTOR and for hospital healthcare level, they should be reported under this variable. Annexes 55 Annex 7 Measurement unit list Annex 8 Administration route list Annex 9 Salt list CODE NAME MG Milligram G Gram IU International unit MU Millions of international units UD Unit dose PCS Piece ML Millilitre CODE NAME O Oral P Parenteral R Rectal IP Inhalation powder IS Inhalation solution CODE NAME ESUC Ethylsuccinate erythromycin HIPP Hippurate methenamine MAND Mandalate methenamine GLASS Methodology for surveillance of national antimicrobial consumption 56 Annex 10 List of DDD for combined products The list of Defined Daily Doses (DDDs) for combined products is derived from the Anatomical Therapeutic Chemical (ATC)/DDD list of DDD for combined products. Combination codes (COMB_CODE) are specific codes for the Global Antimicrobial Resistance and Use Surveillance System (GLASS) methodology. The list is updated every year according to the annual release of the ATC/DDD system. The list below is based on the 2020 version of the ATC/ DDD. COMB_CODE ATC5 FORM ROUTE UNIT DOSE (SUBSTANCES+STRENGTH) DDD DDD_INFO J01AA20_1 J01AA20 Tab O tetracycline 115.4 mg/ chlortetracycline 115.4 mg/ demeclocycline 69.2 mg 2 UD 2 UD (=2 tab) J01CA20_1 J01CA20 Tab O pivampicillin 0.25 g/ pivmecillinam 0.2 g 3 UD 3 UD (=3 tab) J01CA20_2 J01CA20 Tab O pivampicillin 0.125 g/ pivmecillinam 0.1 g 6 UD 6 UD (=6 tab) J01CE30_1 J01CE30 Powder for inj P comb. of benzylpenicillin/ procaine-benzylpenicillin/ benzathine benzylpenicillin 3.6 G 3.6 g expressed as benzylpenicillin J01CR50_1 J01CR50 Tab O ampicillin 0.25 g/ cloxacillin 0.25 g 4 UD 4 UD (=4 tab) J01CR50_2 J01CR50 Powder for inj P ampicillin 0.66 g/ oxacillin 0.33 g 2 UD 2 UD (= 2 g) J01CR50_3 J01CR50 Caps O ampicillin 0.125g/ oxacillin 0.125 g 8 UD 8 UD (= 8 caps) J01CR50_4 J01CR50 Tab O ampicillin 0.25 g/ flucloxacillin 0.25 g 4 UD 4 UD (=4 tab) J01CR50_5 J01CR50 Powder for inj P ampicillin 250 mg/ cloxacillin 250 mg 2 UD 2 UD (=2 grams of powder for injection) J01CR50_6 J01CR50 Powder for inj P ampicillin 500 mg/ cloxacillin 500 mg 2 UD 2 UD (=2 grams of powder for injection) J01CR50_7 J01CR50 Tab O ampicillin 125 mg/ cloxacillin 125 mg 8 UD 8 UD (=8 tab) J01EC20_1 J01EC20 Tab O sulfacarbamide 0.167 g/ sulfadiazine 0.167 g/ sulfadimidine 0.167 g 4 UD 4 UD (=4 tab) J01EE01_1 J01EE01 Inf conc P sulfamethoxazole 80 mg/ trimethoprim 16 mg 20 UD 20 UD (=20 ml) J01EE01_2 J01EE01 Mixt O sulfamethoxazole 0.2 g/ trimethoprim 40 mg 8 UD 8 UD (= 40 ml) J01EE01_3 J01EE01 Tab O sulfamethoxazole 0.4 g/ trimethoprim 80 mg 4 UD 4 UD (=4 tab) J01EE02_1 J01EE02 Mixt O sulfadiazine 0.205 g/ trimethoprim 45 mg 4 UD 4 UD (=20 ml) J01EE02_2 J01EE02 Tab O sulfadiazine 0.41 g/ trimethoprim 90 mg 2 UD 2 UD (=2 tab) Annexes 57 COMB_CODE ATC5 FORM ROUTE UNIT DOSE (SUBSTANCES+STRENGTH) DDD DDD_INFO J01EE03_1 J01EE03 Tab O sulfametrole 0.8 g/ trimethoprim 0.16 g 2 UD 2 UD (=2 tab) J01EE03_2 J01EE03 Powder for inj P sulfametrole 0.8 g/ trimethoprim 0.16 g per vial 2 UD 2 UD (defined as 2 vials) J01EE06_1 J01EE06 Tab O sulfadiazine 0.25 g/ tetroxoprim 0.1 g 2 UD 2 UD (=2 tab) J01EE07_1 J01EE07 Tab O sulfamerazine 0.12 g/ trimethoprim 80 mg 4 UD 4 UD (=4 tab) J01RA04_1 J01RA04 Tab O spiramycin 1.5 MU/ metronidazole 250 mg 3 UD 3 UD (=3 tab) J01RA04_2 J01RA04 Tab O spiramycin 0.75 MU/ metronidazole 125 mg 6 UD 6 UD (=6 tab) J01RA05_1 J01RA05 Tab O levofloxacin 250 mg/ ornidazole 500 mg 2 UD 2 UD (=2 tab) J01RA07_1 J01RA07 Tab O azithromycin 1000 mg (1 tab)/ fluconazole 150 mg (1 tab)/ secnidazole 1000 mg (2 tab) (combination package) 4 UD 4 UD (=4 tab) J01RA09_1 J01RA09 Tab O ofloxacin 200 mg/ ornidazole 500 mg 2 UD 2 UD (=2 tab) J01RA10_1 J01RA10 Tab O ciprofloxacin 500 mg/ metronidazole 200 mg 2 UD 2 UD (=2 tab) J01RA11_1 J01RA11 Tab O ciprofloxacin 500 mg/ tinidazole 600 mg 2 UD 2 UD (=2 tab) J01RA11_2 J01RA11 Tab O ciprofloxacin 250 mg/ tinidazole 300 mg 4 UD 4 UD (=4 tab) J01RA12_1 J01RA12 Tab O ciprofloxacin 500 mg/ ornidazole 500 mg 2 UD 2 UD (=2 tab) J01RA13_1 J01RA13 Tab O norfloxacin 400 mg/ tinidazole 600 mg 2 UD 2 UD (=2 tab) J04AM02_1 J04AM02 Tab O rifampicin 0.3 g/ isoniazid 0.15 g 2 UD 2 UD (=2 tab) J04AM02_2 J04AM02 Tab O rifampicin 0.15 g/ isoniazid 0.1 g 4 UD 4 UD (=4 tab) J04AM02_3 J04AM02 Tab O rifampicin 0.15 g/ isoniazid 75 mg 4 UD 4 UD (=4 tab) J04AM05_1 J04AM05 Tab O rifampicin 0.12 g/ pyrazinamide 0.3 g/ isoniazid 50 mg 6 UD 6 UD (=6 tab) J04AM05_2 J04AM05 Tab O rifampicin 0.15 g/ pyrazinamide 0.4 g/ isoniazid 75 mg 4 UD 4 UD (=4 tab) J04AM05_3 J04AM05 Tab O rifampicin 225 mg (1 tab)/ pyrazinamide 750 mg (1 tab)/ isoniazid 150 mg (1 tab) (combination package) 6 UD 6 UD (=6 tab) J04AM05_4 J04AM05 Tab O rifampicin 60 mg/ pyrazinamide 150 mg/ isoniazid 30 mg 10 UD 10 UD (=10 tab) GLASS Methodology for surveillance of national antimicrobial consumption 58 COMB_CODE ATC5 FORM ROUTE UNIT DOSE (SUBSTANCES+STRENGTH) DDD DDD_INFO J04AM06_1 J04AM06 Tab O rifampicin 0.15 g/ pyrazinamide 0.4 g/ ethambutol 0.275 g/ isoniazid 75 mg 4 UD 4 UD (=4 tab) J04AM06_2 J04AM06 Tab O rifampicin 450 mg (1 tab)/ pyrazinamide 750 mg (2 tab)/ ethambutol 800 mg+isoniazid 300 mg (1 tab) (combination package) 4 UD 4 UD (=4 tab) J04AM07_1 J04AM07 Tab O rifampicin 150 mg/ ethambutol 275 mg/ isoniazid 75 mg 4 UD 4 UD (=4 tab) J05AP51_1 J05AP51 Tab O sofosbuvir 400 mg/ ledipasvir 90 mg 1 UD 1 UD (=1 tab) J05AP53_1 J05AP53 Tab O ombitasvir 12.5 mg/ paritaprevir 75 mg/ ritonavir 50 mg 2 UD 2 UD (=2 tab) J05AP54_1 J05AP54 Tab O elbasvir 50 mg/ grazoprevir 100 mg 1 UD 1 UD (=1 tab) J05AP55_1 J05AP55 Tab O sofosbuvir 400 mg/ velpatasvir 100 mg 1 UD 1 UD (=1 tab) J05AP56_1 J05AP56 Tab O sofosbuvir 400 mg/ velpatasvir 100 mg/ voxilaprevir 100 mg 1 UD 1 UD (=1 tab) J05AP57_1 J05AP57 Tab O glecaprevir 100 mg/ pibrentasvir 40 mg 3 UD 3 UD (=3 tab) J05AR01_1 J05AR01 Tab O lamivudine 0.15 g/ zidovudine 0.3 g 2 UD 2 UD (=2 tab) J05AR02_1 J05AR02 Tab O abacavir 0.6 g/ lamivudine 0.3 g 1 UD 1 UD (=1 tab) J05AR03_1 J05AR03 Tab O emtricitabine 0.2 g/ tenofovir disoproxil 0.245 g 1 UD 1 UD (=1 tab) J05AR04_1 J05AR04 Tab O zidovudine 0.3 g/ lamivudine 0.15 g/ abacavir 0.3 g 2 UD 2 UD (=2 tab) J05AR05_1 J05AR05 Tab O lamivudine 150 mg/ nevirapine 200 mg/ zidovudine 300 mg 2 UD 2 UD (=2 tab) J05AR06_1 J05AR06 Tab O emtricitabine 0.2 g/ tenofovir disoproxil 0.245 g/ efavirenz 0.6 g 1 UD 1 UD (=1 tab) J05AR08_1 J05AR08 Tab O emtricitabine 0.2 g/ tenofovir disoproxil 0.245 g/ rilpivirine 0.025 g 1 UD 1 UD (=1 tab) J05AR09_1 J05AR09 Tab O emtricitabine 200 mg/ tenofovir disoproxil 245 mg/ elvitegravir 150 mg/ cobicistat 150 mg 1 UD 1 UD (=1 tab) J05AR11_1 J05AR11 Tab O lamivudine 300 mg/ tenofovir disoproxil 300 mg (fumarate)/ efavirenz 600 mg 1 UD 1 UD (=1 tab) Annexes 59 COMB_CODE ATC5 FORM ROUTE UNIT DOSE (SUBSTANCES+STRENGTH) DDD DDD_INFO J05AR12_1 J05AR12 Tab O lamivudine 300 mg/ tenofovir disoproxil 300 mg (fumarate) 1 UD 1 UD (=1 tab) J05AR13_1 J05AR13 Tab O lamivudine 300 mg/ abacavir 600 mg/ dolutegravir 50 mg 1 UD 1 UD (=1 tab) J05AR14_1 J05AR14 Tab O darunavir 800 mg/ cobicistat 150 1 UD 1 UD (=1 tab) J05AR15_1 J05AR15 Tab O atazanavir 0.3 g/ cobicistat 0.15 g 1 UD 1 UD (=1 tab) J05AR17_1 J05AR17 Tab O emtricitabine 200 mg/ tenofovir alafenamide 10 mg 1 UD 1 UD (=1 tab) J05AR17_2 J05AR17 Tab O emtricitabine 200 mg/ tenofovir alafenamide 25 mg 1 UD 1 UD (=1 tab) J05AR18_1 J05AR18 Tab O emtricitabine 200 mg/ tenofovir alafenamide 10 mg/ elvitegravir 150 mg/ cobicistat 150 mg 1 UD 1 UD (=1 tab) J05AR19_1 J05AR19 Tab O emtricitabine 200 mg/ tenofovir alafenamide 25 mg/ rilpivirine 25 mg 1 UD 1 UD (=1 tab) J05AR20_1 J05AR20 Tab O emtricitabine 200 mg/ tenofovir alafenamide 25 mg/ bictegravir 50 mg 1 UD 1 UD (=1 tab) J05AR21_1 J05AR21 Tab O dolutegravir 50 mg/ rilpivirine 25 mg 1 UD 1 UD (=1 tab) J05AR22_1 J05AR22 Tab O emtricitabine 200 mg/ tenofovir alafenamide 10 mg/ darunavir 800 mg/ cobicistat 150 mg 1 UD 1 UD (=1 tab) J05AR24_1 J05AR24 Tab O lamivudine 300 mg/ tenofovir disoproxil 245 mg/ doravirine 100 mg 1 UD 1 UD (=1 tab) J05AR25_1 J05AR25 Tab O lamivudine 300 mg/ dolutegravir 50 mg 1 UD 1 UD (=1 tab) P01BB51_1 P01BB51 Tab O atovaquone 0.25 g/ proguanil hydrochloride 0.1 g 4 UD 4 UD (=4 tab) P01BB51_2 P01BB51 Tab O atovaquone 62.5 mg/ proguanil hydrochloride 25 mg 16 UD 16 UD (=16 tab) P01BF03_1 P01BF03 Tab O artesunate 25 mg/ amodiaquine 67.5 mg 8 UD 8 UD (=8 tab) P01BF03_2 P01BF03 Tab O artesunate 50 mg/ amodiaquine 0.135 g 4 UD 4 UD (=4 tab) P01BF03_3 P01BF03 Tab O artesunate 0.1 g/ amodiaquine 0.27 g 2 UD 2 UD (=2 tab) P01BF05_1 P01BF05 Tab O artenimol (dihydroartemisinin) 20 mg/ piperaquine 160 mg 6 UD 6 UD (=6 tab) P01BF05_2 P01BF05 Tab O artenimol (dihydroartemisinin) 40 mg/ piperaquine 320 mg 3 UD 3 UD (=3 tab) GLASS Methodology for surveillance of national antimicrobial consumption 60 Annex 11 Product origin list Annex 12 Conversion factor list CODE NAME IMP Imported medicines DON Donations/Programs medicines LOC Locally produced medicines for domestic market ATC5 ADMINISTRATION ROUTE FROM TO FACTOR J01CE01 P MU G 0.6 J01CE02 O MU G 0.625 J01FA02 O MU G 0.3125 J01CE08 P MU G 0.6 J01CE09 P MU G 1 Annex 13 Health care sector list Annex 14 Health care level list CODE NAME GLO Global sector (public+private sectors) PRI Private sector PUB Public sector CODE NAME T Total level (community+hospital levels) C Community level H Hospital level

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