Emerging antimicrobial resistance reporting framework: August 2018

0 Emerging antimicrobial resistance reporting framework August 2018 0 1 Emerging antimicrobial resistance reporting framework August 2018 2 Emerging antimicrobial resistance reporting framework ISBN 978-92-4-151459-0 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. 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Printed in Switzerland 3 Table of Contents Abbreviations .......................................................................................................................................... 4 Acknowledgements ................................................................................................................................. 5 1 Introduction .................................................................................................................................... 7 2 The purpose and scope of the emerging AMR reporting component of GLASS ............................ 8 3 Detection and reporting of emerging resistance ............................................................................ 9 3.1 Detection of emerging AMR and reporting at national level ................................................. 9 3.1.1 Collection of raw data ..................................................................................................... 9 3.1.2 Triage of relevant data .................................................................................................. 10 3.1.3 Verification of unusual resistance ................................................................................. 10 3.1.4 National reporting and initial assessment .................................................................... 10 3.2 Reporting emerging AMR to GLASS ...................................................................................... 11 3.2.1 Provisional watch list .................................................................................................... 11 3.2.2 Submission of emerging AMR data ............................................................................... 11 3.3 Data sharing .......................................................................................................................... 13 3.3.1 Data security ................................................................................................................. 13 3.3.2 Sharing of genetic sequence data ................................................................................. 14 3.4 WHO risk assessment and communication of newly detected AMR.................................... 14 Annex 1. Example list of critical resistance phenotypes ....................................................................... 15 Annex 2. Proposed generic data set for reporting emerging AMR ....................................................... 16 4 Abbreviations AMR antimicrobial resistance CLSI Clinical and Laboratory Standards Institute GLASS-EAR GLASS Emerging Antimicrobial Resistance Reporting EUCAST European Committee on Antimicrobial Susceptibility Testing FAO Food and Agriculture Organization of the United Nations GLASS Global Antimicrobial Resistance Surveillance System MIC minimum inhibitory concentration NRL national reference laboratory OIE World Organisation for Animal Health WHO World Health Organization 5 Acknowledgements WHO would like to express its sincere appreciation and gratitude to all those who have supported and contributed to the development of this document. Developer group Muna Abu Sin, Rene Hendriksen, Roman Kozlov, Jean Patel, Diamantis Plachouras, Pilar Ramon Pardo, Neil Woodford, Takuya Yamagishi Review group Olov Aspevall, Tim Eckmanns, Jonas Fuks, Shoaib Hassan, Danilo Lo Fo Wong, Sonja Löfmark, Babatunde Olowokure, Sirenda Vong Executive group Sergey Eremin, Martina Escher, Carmem Pessoa da Silva Financial Support US Centers for Disease Control and Prevention Cooperative Agreement 6 7 Emerging AMR reporting and risk assessment 1 Introduction The goal of the Global Antimicrobial Resistance Surveillance System (GLASS) is to enable standardized, comparable and validated data on antimicrobial resistance (AMR) to be collected, analysed and shared with countries, in order to inform decision-making, drive local, regional and national action and provide the evidence base for action and advocacy. Standards and methodologies for global AMR surveillance, as well as requirements of necessary systems and capacities, were developed and described in the GLASS manual1 and supporting documents, but the processes for reporting the emergence and detection of new (or previously unrecognised) AMR mechanisms and associated public health events were not defined. At the 1st meeting of the GLASS Collaboration Platform in Copenhagen in October 20152, participants agreed that there is an urgent need to develop a system for early detection and reporting that would signal emerging AMR mechanisms and map their global spread. It has been decided to establish a working group to provide guidance on timely detection, reporting, risk assessment, and monitoring of emerging resistance and to support development of tools and capacity building activities. The working group members contributed to the development of the emerging resistance reporting component via the GLASS communication platform and face-to-face meetings. Review and discussion of the first draft of the emerging AMR reporting and risk assessment framework document at the 2nd meeting of the GLASS Collaborative Platform in Geneva in December 2016 informed further development of the framework3. In the technical consultation with Member States in April 20174 countries agreed to advancement of the framework and emphasized that implementation of GLASS-EAR requires strong political support and, ideally, should be included in national action plans on AMR. To increase awareness of GLASS- EAR, validate the processes in its workflow, and identify strengths and areas for improvement, a simulation exercise was conducted from 16-30 November 20175. The exercise brought together a geographically diverse group of stakeholders who agreed that the GLASS-EAR module is ready to deploy. Senior public health professionals responsible for developing and coordinating national surveillance of AMR, including national GLASS focal points in enrolled countries, constitute the main target audience of this document. The document is also intended for senior staff at ministries of health and public health agencies coordinating national public health surveillance, regional surveillance networks and other AMR surveillance initiatives (e.g., private or academic), and staff of WHO 1 Global Antimicrobial Resistance Surveillance System: Manual for Early Implementation. World Health Organization (2015) available at http://www.who.int/antimicrobial-resistance/publications/surveillance-system-manual/en/ 2 Global Antimicrobial Resistance Surveillance System: report of the technical meeting on the early implementation phase, 22-23 October 2015, Copenhagen, Denmark available at http://www.who.int/antimicrobial-resistance/events/GLASSmeeting/en/ 3 Report of the 2nd Meeting of the Global Antimicrobial Resistance Surveillance System (GLASS) Collaborative Platform, 15-16 December 2016, Geneva, Switzerland available at http://www.who.int/antimicrobial-resistance/events/2nd-GLASS-collaborative-platform- meeting/en/. 4 Report of the 2nd High Level Technical Meeting on Surveillance of Antimicrobial Resistance for Local and Global Action, 27-28 April 2017, Stockholm, Sweden available at http://www.who.int/antimicrobial-resistance/events/2nd-technical-mtg-on-surveillance-AMR/en/. 5 GLASS-EAR Simulation Exercise Report, 16-30 November 2017. Geneva: World Health Organization; 2018 8 Collaborating Centres supporting AMR surveillance. It may also be useful for other sectors engaged in surveillance of AMR (animal health, agriculture, environment etc.). 2 The purpose and scope of the emerging AMR reporting component of GLASS The purpose of the GLASS Emerging Antimicrobial Resistance Reporting (GLASS-EAR) component is defined as timely communication of any newly detected antimicrobial resistance findings that may influence surveillance and control practices. Examples of such newly detected antimicrobial resistance include: 1) exceptional phenotypes that have not previously been reported or are very rare; and 2) novel resistance genotypes that are associated with mechanisms of resistance that may have a high public health impact (i.e. high potential for spread and health impact) or pose serious challenges in laboratory detection and surveillance. The system will target both new types of phenotypic resistance and new genetic determinants of AMR in bacteria and fungi6 causing acute infections in humans. The system will accept also signals arising from surveillance in animals, the food chain and environment, with relevance to human health. The scope of the GLASS-EAR component includes mapping global spread of new types of AMR. While active tracking of the cross-border spread of novel or otherwise epidemiologically and/or clinically important resistant pathogens, resistance genes, and AMR threats labelled "international epidemic clones" and "high-risk clones" (such as e.g. E. coli ST131, K. pneumoniae ST258 etc.) is not currently included, this will be addressed in the future. Some emerging AMR events may represent a significant international public health risk, and the Annex 2 decision instrument of the IHR (2005)7 should be used by the States Parties to decide whether the AMR event requires formal notification to WHO via IHR channels. Articles 6 to 11 of the IHR (2005) are intended to encourage States Parties to share information with WHO before a public health emergency of international concern (PHEIC) is declared. When the emerging AMR is reported via IHR, the GLASS-EAR will receive an appropriate signal from a WHO IHR focal point. At the same time, many new AMR findings would only represent “important to know” findings prompting domestic response only or for which no immediate public health response would be required. Ideally, the information should come from the national AMR surveillance systems with the developed early warning, risk assessment and alert capabilities, clearly defined protocols for reporting unusual AMR events with established systems to verify the initial claim of an unusual event in order to avoid action based on erroneous laboratory results. Considering the nature of GLASS, with its primary goal of fostering creation and further development of national AMR surveillance systems, an important responsibility of GLASS will be to support development of detection, early warning, risk assessment, rapid alert and response capacities of the national AMR surveillance programmes. At the same time, many countries still need to develop such capacities (which could take several years), and the global system is needed now. The proposed solution is to develop and 6 Currently the GLASS-EAR targets Candida auris only 7 International Health Regulations (2005), 3rd edition. World Health Organization, 2016. Available at http://www.who.int/ihr/publications/9789241580496/en/ 9 implement a system to allow the exchange of information at a technical peer-to-peer level, quickly following discovery of new AMR mechanisms, and preceding academic journal publication. This includes both National Coordinating Centres for AMR surveillance,8 but also WHO Collaborating Centres, AMR surveillance networks, and research institutions producing quality AMR data. Ideally, the reporting system would not only include public health, but also all constituencies that might discover new types of AMR. The emerging AMR detection and reporting to WHO (GLASS) based on an initial assessment, in certain circumstances may need be followed by a structured public health risk assessment, both to inform risk management and provide additional information to GLASS if needed. WHO will provide assistance to countries for risk assessment and management upon request and will work on developing comprehensive guidance for risk assessment of emerging AMR and associated public health events. 3 Detection and reporting of emerging resistance 3.1 Detection of emerging AMR and reporting at national level Ideally, national AMR surveillance systems should include an early warning, risk assessment and alert component. Clearly defined protocols for detecting, verifying, and reporting unusual AMR events should be developed and disseminated as part of national AMR surveillance programmes. The detection of emerging antimicrobial resistance at the local and national level can be organized into three main phases:  Collection of raw data  Triage of relevant data  Verification of unusual resistance Every verified unusual AMR finding should be reported at the national level where an initial evaluation will guide necessary actions. 3.1.1 Collection of raw data Results of pathogen identification and antimicrobial susceptibility testing could be accompanied by detection of specific antimicrobial resistance mechanisms of clinical and /or epidemiological importance where capacities exist. The isolates could be obtained from routine clinical samples but also from active screening, special surveys and other activities: it is important to distinguish the sources during the assessment stage. The microbiological data should be accompanied by clinical, demographical and other epidemiological data in accordance with locally/nationally defined minimal data sets (the proposed minimal data sets for GLASS-EAR reporting are available in the Annex 3). These data will be needed to inform initial assessment at the triage stage and subsequent public health risk assessment. 8 The National Coordinating Centre (NCC) is an institution that has been designated by the national authorities to oversee the development and functioning of the national AMR surveillance system. For full description and sample terms of reference see National antimicrobial resistance surveillance systems and participation in the Global Antimicrobial Resistance Surveillance System (GLASS): A guide to planning, implementation, and monitoring and evaluation. World Health Organization (2016). available at http://www.who.int/antimicrobial-resistance/global-action-plan/surveillance/supporting-documents-tools/en/ 10 3.1.2 Triage of relevant data The data collection site should be able to detect unlikely, unusual, and clinically and/or epidemiologically important findings. These could be deviations from expected resistance in specific bug-drug combinations9, resistance patterns not previously reported or only rarely reported to date, and predefined “exceptional phenotypes” in accordance with expert rules. Several international guidance documents are available to inform the detection of unusual phenotypes, including CLSI document M100 Appendix A10, Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance by Magiorakos A-P et al.11, and EUCAST Expert rules, intrinsic resistance and exceptional phenotypes12. It is often helpful if the appropriate alerts are included as ‘flags’ in laboratory and/or hospital information systems. This can serve to remind laboratory personnel that an exceptional result should be validated carefully, and reported if confirmed. For example, WHONET software has about two hundred pre-defined expert rules for alerting of unusual AMR findings, which may be supplemented locally by user-defined alerts. 3.1.3 Verification of unusual resistance The unusual findings need to be verified in a designated expert laboratory that provides confirmatory testing, where such capacity exists within countries. Ideally, criteria and indications for sending isolates for confirmation should be developed and disseminated as part of national AMR surveillance programmes. In countries with developed national AMR surveillance systems the confirmatory testing of isolates with rare and unusual resistance patterns and resistance mechanisms should be performed by designated National Reference Laboratories (NRL)13. Ideally, the NRLs should have the capacity to perform or have access to specialized tests such as molecular detection of resistance mechanisms. The confirmation methods should be based on international standards such as e.g. the EUCAST guideline for detection of resistance mechanisms and specific resistances of clinical and/or public health importance 14 . In countries where no laboratory capacity currently exists, regional collaboration may be an option whereby a neighbouring country’s NRL or a WHO Collaborating Centre can fulfil this role. 3.1.4 National reporting and initial assessment The unusual findings detected during surveillance of AMR (as well as reported from surveys, special studies etc.) and verified, should ideally be reported to a designated public health authority. There an initial assessment should be conducted to categorize the event and to decide, in particular, whether a formal public health risk assessment is required at the national level to inform a proper 9 Reporting the exceptional susceptibility is not required by GLASS-EAR, but detecting and verifying an unusual susceptible isolate of a species that should have intrinsic resistance to the same drug is important for quality assurance. 10 CLSI Document M100 Appendix A. Suggestions for Confirmation of Resistant (R), Intermediate (I), or Nonsusceptible (NS) Antimicrobial Susceptibility Test Results and Organism Identification. Available at http://clsi.org/m100/ 11 Magiorakos A-P, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, et al. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect [Internet]. 2012 Mar [cited 2013 Apr 3];18(3):268–81. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21793988 12 EUCAST Expert rules, intrinsic resistance and exceptional phenotypes v 3.1 (Sept 27, 2016) available at http://www.eucast.org/expert_rules_and_intrinsic_resistance/ 13 See National antimicrobial resistance surveillance systems and participation in the Global Antimicrobial Resistance Surveillance System (GLASS): A guide to planning, implementation, and monitoring and evaluation. World Health Organization (2016). available at http://www.who.int/antimicrobial-resistance/global-action-plan/surveillance/supporting-documents-tools/en/ 14 EUCAST guideline for detection of resistance mechanisms and specific resistances of clinical and/or public health importance v 2.0 (July 2017) available at http://www.eucast.org/resistance_mechanisms/ 11 response, whether the event meets the criteria for reporting to GLASS-EAR, and/or whether the event requires formal notification to WHO via IHR channels. 3.2 Reporting emerging AMR to GLASS 3.2.1 Provisional watch list The following data are expected to be reported by countries:  Pan-drug resistant (PDR)15 phenotypes and, wherever available, responsible genes16  Pre-defined17 critical resistance phenotypes (see Annex 1) and, wherever available, responsible genes  Extensively drug-resistant (XDR)18 phenotypes which were not previously detected in a country and, wherever available, responsible genes  Novel (not previously reported globally) genetic determinants of resistance No formal list of AMR events could be used unequivocally to monitor emerging resistance: a specific resistant phenotype/genotype may be emerging in one place, and already endemic in another. Other pre-existing multidrug-resistant (MDR) 19 and extensively drug-resistant (XDR) phenotypes could be reported to the GLASS-EAR system in accordance with national risk assessment. This is expected, for example, when a sudden, “dramatic” change (not just a trend) occurs in epidemiology of a specific resistant pathogen. Examples could be a shift from predominantly healthcare-associated infections to a significant proportion of community-associated infections or an increase of life- threatening infections caused by the resistant pathogen. However, it should be noted that a number of important MDR and XDR phenotypes are included in the “routine” GLASS surveillance data set for regular reporting. It should be also noted that pan-drug resistance is difficult to standardise internationally. Definition locally or nationally will be influenced by drugs licensed within country. If a drug class is not licensed, it may not be tested, and so PDR in country A may “only” be considered XDR in country B. 3.2.2 Submission of emerging AMR data Member States, regardless their enrolment status in GLASS, through their National AMR Surveillance Coordinating Centres and other GLASS-EAR member20 institutions, including WHO Collaborating Centres, AMR surveillance networks, and research institutions producing quality AMR data, can provide data on emerging AMR via the GLASS-EAR IT module in a rapid, systematic and timely manner. The proposed data flow and feedback are presented in the Figure 1 below. The proposed data set for GLASS-EAR reporting is available in the Annex 2. 15 Non-susceptibility to all agents in all antimicrobial categories (see Magiorakos A-P, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, et al. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect [Internet]. 2012 Mar; 18(3):268–81. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21793988) 16 Defining the genotypic basis for novel PDR would require whole genome sequencing. 17 Based on application of several criteria including clinical significance of the pathogen , its potential for spread, potential to affect treatment options, laboratory and surveillance implications etc. 18 Non-susceptibility to at least one agent in all but two or fewer antimicrobial categories (see Magiorakos A-P et al., 2012) 19 Non-susceptibility to at least one agent in three or more antimicrobial categories (see Magiorakos A-P et al., 2012) 20 As defined in Emerging antimicrobial resistance reporting. Guide for emerging AMR event sharing. Geneva: World Health Organization; 2018 12 Figure 1. Emerging AMR reporting The GLASS-EAR will accept reports on emerging resistance in humans, food, animals, crops, and the environment (with relevance to human health), linking to and ensuring information exchange with other existing rapid alert systems maintained by FAO and OIE. 3.2.2.1 Time frame for reporting to GLASS There are several features that make AMR challenging to detect and confirm in a timely manner and consequently make very tight timeframes for reporting difficult to keep or less meaningful. The potential to spread undetected through asymptomatic carriers may lead to considerable spread of resistance already when detected. However, AMR does not usually spread as fast as, for example, respiratory viruses. Detection of novel AMR could also be confounded by the fact that not all drugs are tested universally as panels of drugs tested vary by specimen type, lab to lab, and within and between countries. In the context of GLASS-EAR the initial information is expected to be reported within two weeks of verifying new resistance, with subsequent submissions of additional information when it becomes available. Within any particular country, this will depend on where resistance is discovered and whether confirmation is sought. 3.2.2.2 IT platform for reporting to GLASS-EAR WHO has developed a web-based IT module as part of its GLASS IT platform, allowing novel AMR discoveries to be shared in a rapid and secure manner. The GLASS-EAR IT module provides a space where experts can share information regarding emerging AMR events (as defined in this document) to assess their importance, facilitate early information sharing, and stimulate epidemiological and microbiological discussion for coordinated actions. Launched in 2018, the GLASS-EAR IT module is open to those in charge of national AMR surveillance systems and constituencies that might discover new types of AMR in bacteria and fungi with potential relevance to public health. The module is administered by WHO, with organized 13 distribution of the access rights, including guest users with contributions to be confirmed by the GLASS IT platform administrators. In addition to maintaining a secure database available to registered users representing national AMR surveillance programmes, existing partner regional reporting systems, and contributing institutions, the module will inform also reports to be shared openly with professionals and the general public as needed. A detailed description of the GLASS- EAR IT module and a user manual are available in a separate document21. 3.3 Data sharing While antimicrobial resistance in general is an ongoing, persisting threat, the detection of novel resistance mechanisms warrants the application of best practices for risk assessment, international reporting and data sharing in order to limit any potential public health implications. Member States are strongly encouraged to share data and reports of emerging antimicrobial resistance internationally. Systematic data sharing will facilitate global tracking and monitoring of AMR trends and impact. This will help to inform Member States of the location and occurrence of emerging AMR mechanisms and related public health events. Such information can be of great value to national health authorities for planning their response and for resource allocation purposes. Globally, data reported to WHO are used to produce regularly updated global reports on the current AMR situation, available for the Member States and the public in general, and also shared through a dedicated IT platform. WHO has recently developed policy on the use and sharing of data collected by WHO in Member States outside the context of public health emergencies22. The policy was introduced on 1 January 2018 and is being monitored to be evaluated over a 12-month transition period. WHO seeks a paradigm shift in the current approach to information sharing in emergencies, from one limited by embargoes set for publication timelines, to open sharing using modern fit-for- purpose pre-publication platforms23. The ICMJE recommendation that “in the event of a public health emergency (as defined by public health officials), information with immediate implications for public health should be disseminated without concern that this will preclude subsequent consideration for publication in a journal” is encouraging24. Understanding that most emerging AMR events are not public health emergencies, researchers, journals and funders will need to realize the serious public health implications of emerging AMR and use a similar approach to sharing information on emerging antimicrobial resistance25. WHO will be working on several additional options to facilitate the data sharing, including making GLASS-EAR reports a citable event. National engagement needs to be actively encouraged to overcome inertia and concerns and ensure that discoveries are communicated rapidly. 3.3.1 Data security WHO has a formal and comprehensive policy for securely managing all databases and information sources hosted by the Organization. The policy includes information security, technical and physical 21 Emerging antimicrobial resistance reporting. Guide for emerging AMR event sharing. Geneva: World Health Organization; 2018 22 WHO Data Policy. Available at http://www.who.int/publishing/datapolicy/en/. 23 See Policy statement on data sharing by WHO in the context of public health emergencies (as of 13 April 2016),Weekly epidemiological record, No 18, 2016, 91, 237–248 available at 24 http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/overlapping-publications.html 25 Recognition of an isolate with a novel AMR mechanisms could rarely be formally recognized as a public health emergency per se. Also, many researchers are placed outside public health reporting systems and do not usually participate in public health risk assessment. 14 data security, data access and retention procedures, and confidentiality agreements. As international civil servants, all WHO staff are required to adhere to the policy and its procedures (detailed under Staff Regulations), including with full respect to Article 45 of the IHR. 3.3.2 Sharing of genetic sequence data WHO will advocate that pathogen genome sequence data should be made publicly available as rapidly as possible through relevant databases such as e.g. European Bioinformatics Institute (EMBL- EBI), Genbank (National Center for Biotechnology information – NCBI) etc., and that benefits arising from the utilization of those data should be shared equitably with the country from where the pathogen genome sequence originates17. 3.4 WHO risk assessment and communication of newly detected AMR After triage and verification of incoming emerging AMR reports, both via the GLASS-EAR IT module and other formal and informal channels, WHO will perform an initial assessment to categorize the event, to guide quick communication with the reporting country, and inform next steps which may involve, when necessary, rapid risk assessment using the risk questions described below and in accordance with internal protocols defining, in particular, representative composition of risk assessment teams. WHO will also assist countries in performing risk assessment when requested by countries and will update the global assessment according to national assessments as/if needed. Emerging AMR reports received both through the GLASS-EAR IT module and other formal and informal channels, after confirmation with the source country will be communicated with Member States and the international community. The communication means, depending on the nature of the information and its sensitivity, will include EIS26 postings, GLASS-EAR webpage and Disease Outbreak News on the WHO website, information notes, analytical reports, and other means in accordance with WHO publications and other relevant policies and procedures. While AMR risk management is not covered here, it should be noted that when the emerging AMR event represents a significant and immediate public health risk, further field investigations or control measures may be needed to interrupt spread of AMR. This may require e.g. deployment of partners and/or WHO staff, mobilisation and deployment of resources etc. 26 WHO Event Information Site for IHR National Focal Points 15 Annex 1. Example list of critical resistance phenotypes Table 1. Critical resistance phenotypes (R=resistant, NS=non-susceptible) Organism or organism group Resistance phenotype Shigella spp. Extended-spectrum cephalosporin-R OR Carbapenem-NS Salmonella spp. Fluoroquinolone-NS AND third generation cephalosporin-NS AND azithromycin-NS OR Carbapenem-NS Neisseria gonorrhoeae Ceftriaxone-NS OR high-level azithromycin-R Neisseria meningitidis Ampicillin- or penicillin-R OR Extended-spectrum cephalosporin-NS OR Meropenem- NS OR Minocycline-NS OR Fluoroquinolone-NS Haemophilus influenzae Extended-spectrum cephalosporin-NS OR Carbapenem-NS Enterobacteriaceae XDR including Colistin-R Non-fermenting bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter spp.) XDR including Colistin-R Enterococcus spp. VRE daptomycin-NS OR linezolid-R OR telavancin, dalbavancin, oritavancin NS Staphylococcus aureus Vancomycin-R OR Telavancin-NS OR Dalbavancin-NS OR Oritavancin-NS OR Tigecycline-NS OR daptomycin-NS OR Linezolid-R Staphylococcus, coagulase-negative Vancomycin-R Telavancin-NS OR Dalbavancin-NS OR Oritavancin-NS OR daptomycin-NS OR Linezolid-R Streptococcus pneumoniae Linezolid-R OR Vancomycin-NS Streptococcus, β-haemolytic group Ampicillin- or penicillin-NS OR Extended-spectrum cephalosporin-NS OR Daptomycin-NS OR Carbapenem-NS OR Linezolid-R OR Vancomycin-NS Clostridium difficile Vancomycin-R Metronidazole-R Bacteroides spp. Metronidazole-R Carbapenem-R Candida auris This list is a tentative list and it is not exhaustive. It will be updated on a regular basis in accordance with continuing global risk assessment. Countries may wish to develop contextualized lists, adapting and expanding the global one. 16 Annex 2. Proposed generic data set for reporting emerging AMR Event title Title of the event (includes microorganism(s); resistance pattern/resistance mechanism; country involved; year) Reporting country Reporting person Name and contact details Date of first reporting to GLASS Date(s) of update (s) If any Short description of event, including reason for reporting It should include clinical and epidemiological data when available (e.g. demographic data such as age, gender; community vs hospital origin, previous antimicrobial treatment etc.) Report to respective national body/authority Yes/No; if yes, date of first report Confirmation by (national/regional) reference laboratory Yes/No; if yes, specify (name of reference laboratory, date of confirmation, confirmatory testing) International reporting (other than to GLASS) Yes/No; if yes, specify (to whom, legal framework, date of reporting) Microorgansim(s) Phenotypic R (Antibiogram) Including original MICs or zone diameters Genotypic R (Molecular mechanism(s)) Source of sample(s) List all, e.g. human (clinical/screening; specify specimen), animal, food, environmental, etc. Reason for sampling Routine, study, survey, etc. Date of sampling Potential source of microorganism(s) acquisition Action taken Risk assessment If available 17 18