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马尔代夫的法律

National Action Plan for Containment of Antimicrobial Resistance 2017-2022

颁布于 2017 · 文本截至 2026-10-01

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语言
English
类型
policy
国家
马尔代夫
主题
Livestock, Environment, General
关键词
public health, animal health, animal production, animal welfare, animal feed/feedstuffs, drugs, environmental impact assessment (EIA), authorization/permit, inspection, antimicrobial resistance (AMR), One Health approach, hazardous substances, hazardous waste, registration

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  1. 1. Awareness

  2. 2. Surveillance

  3. 3. Infection Prevention and Control and Hygiene

  4. 4. Optimizing Antimicrobial Use

  5. 5. Research and Innovation Each of the TSCs will be responsible for programme planning and budgeting referring to NAP on AMR while focusing on One Health and for coordinating between the different agencies and secretariat. They will assume charge for monitoring and evaluation and based on their interactions and review mechanisms come up with a set of workable recommendations. The 5 TSCs will be mandated by the NACC and will report to their Chairpersons and to the National Focal Point of the NACC. The organisational structure, composition, locus of coordination centre and general terms of reference are listed below. Specific jobs of individual TSCs have been detailed in the Strategic Plan document P a g e 24 | 63 General Terms of references of Technical Sub Committee Technical Sub Committee (TSC) will be multi-sectoral in composition and will report to the NACC. In their respective strategic objective, the TSC will:  Provide strategic direction by identifying intervention and key activities  Conduct situational analyses  Draft detailed sub activity level NAP  Plan and budget for different activities  Monitor and evaluate implementation of strategic interventions and corresponding key activities  Provide technical input  Commission specialised task forces Constituting Specialised Task forces Specialised task forces will be commissioned by the TSCs for delivering on specific tasks in the respective strategic areas. The task forces will work under technical guidance and supervision of respective TSC and will comprise of in-country as well as international experts, including those from WHO/FAO/OIE. The Task forces will be tasked with functions such as evaluation of existing policies, frameworks, interventions and guidelines and the development of guidelines and standards. They will be envisioned for the implementation of the Maldives National Action Plan as mentioned in the Strategic Plan document. P a g e 25 | 63 P a g e 26 | 63 Figure 2: NAP Governance Structure in Maldives, 2017-2022 P a g e 27 | 63 Strategic Plan While developing the NAP-AMR for Maldives, a strategic plan has been formulated, keeping in mind its geographical aspects as also its public health and other socio-cultural and economic status. The NAP AMR has been based on the implementation of five strategic objectives, each of which has its objectives, strategic interventions and key activities. Strategic Objective 1: Awareness The GAP AMR has identified the need to raise awareness of AMR and promote behavioural change through public communication programmes that target different audiences in human health, animal health and agricultural practices as well as a wide range of consumers related to these sectors. The GAP AMR has also focused on making AMR as a core component of the professional education training, certification, continuing education and development in the health and veterinary sectors and agricultural practice. This approach is expected to foster proper understanding and awareness amongst professionals. The Situation Analysis in Maldives revealed that awareness campaigns on AMR have recently been initiated with the support of WHO Country Office. Awareness campaigns that are led by MFDA target different groups including general public and professionals in health sector. Awareness in livestock and fisheries sector including farmers is yet to be planned and conducted. Initial planning is also underway to introduce curricular interventions in schools and allied health services. Continuous professional education for in service professionals in health sector are also being proposed and technical support sought. MoFA is yet to plan similar curricular/continuous professional education level interventions. By 2022, Maldives will carry out nationwide evidence-based awareness campaigns with regular M&E. The aim is also to develop/revise curricula in schools, nurses, allied health and veterinary services, and Continuous Professional Development courses. Revised curricula will be implemented on a limited scale but with regular audits. The Strategic Plan is as follows: P a g e 28 | 63 Objective 1.1: To improve awareness of AMR amongst the general public and professionals Strategic intervention 1.1 Establish an evidence-based public communications programme targeting audiences in policy making, human and animal health practice, the general public and professionals on prudent use of antimicrobials KEY ACTIVITIES Under the technical guidance of TSC (Awareness): Year Activity Description of Activity 2017 Conduct KAP Studies on A task force will conduct KAP Studies on a national scale on AMR, AMU, environmental relationships to AMR, AMU ,(human and assess awareness levels and gaps in knowledge in different target groups. Priority target groups will include animal ) environmental school students and teachers, general public, policy makers, clinicians, pharmacists, nursing staff, farmers relationships in different in poultry/goat/aquaculture farming, pet owners and pet shop owners target groups 2018 Design evidence based MoH and MoFA, in collaboration with MoE, will design evidence based communication campaigns using communication campaigns evidence generated that will include accurate and relevant messages targeting priority groups (school with accurate and relevant students and teachers, general public, policy makers, clinicians, pharmacists, nursing staff, farmers in messages targeting priority poultry/goat/aquaculture farming, pet owners and pet shop owners). Awareness campaigns conducted groups recently by MFDA on AMR and AMU will be reviewed for suitability for inclusion in overall communication strategy 2017-18 Roll out communication MoH and MoFA will identify pilot sites to implement communication campaign for antibiotic awareness campaigns on AMR improvement. Limited scale roll out will be done with support from WHO, FAO and relevant NGOs 2019 Incorporate AMR and AMR and related topics will be incorporated in grade 1-12 school curricula. Limited scale testing of revised related topics in school curriculum along with regular audit of courses will be conducted before planning a nationwide scale up by curricula 2022 P a g e 29 | 63 Evaluate communication Pilot campaigns will be evaluated in 2019. This will be followed by nationwide scale up and scale out of campaigns followed by awareness campaigns in 2019 with regular monitoring and evaluation nationwide implementation Responsible Agency MoH (MFDA, HPA), MoFA, MoE (NIE, School health) Partners and Stakeholders WHO, FAO, OIE, State Trading Organization (STO), Maldives Medical Association, Dentists Association, Nurses Association, Private Hospital‟s Association, Fisheries Association, Pharmacy Association, PSM, Broadcasting Commission, Media council , NGO‟s Illustrative Indicators  Evidence based communication campaigns tailored for specific target groups; and  Increased awareness on AMR and related issues among general public and professionals P a g e 30 | 63 Objective 1.2 Improve knowledge of AMR and related topics in professionals through professional education and training deployed at national scale Strategic intervention 1.2 Include AMR and related topics such as Infection Prevention Control as a core component of professional education, training, certification and development for health care providers in human and animal health and food production industry including aquaculture KEY ACTIVITIES Under the overall supervision of TSC (Awareness): Year Activity Description of Activity 2017-18 Conduct KAP Studies to Task Force commissioned in 1.1 will conduct KAP Studies on a national scale to assess assess gaps in knowledge on awareness levels and gaps in knowledge in professional groups on AMR, AMU, hygiene & IPC, AMR, hygiene & IPC, environmental relationships. Priority professional groups will include: clinicians, pharmacists, environmental relationships nursing staff, medical laboratory technicians, health assistants, public health & primary health in professional groups care professionals, ministry officials of relevant departments and policymakers 2019-20 Revise and roll out MFDA and MoFA Counterpart, under technical guidance of MoE, and in collaboration with professional development WHO Country Office will undertake revision for professional development courses (human courses of human and animal health, animal health, aquaculture and food industry). Proposals submitted by MFDA and MoE health, the food industry and will be reviewed for their suitability for new curricular strategies. Roll out of courses will be agriculture sectors to include done on a limited scale along with concurrent regular audits followed by nationwide scale up. topics on AMR and related issues 2020-22 Revise undergraduate and AMR and related topics will be incorporated in undergraduate and postgraduate curricula postgraduate curricula in including in allied health courses (pharmacists, nursing staff, medical laboratory technicians, human and animal health, health assistants, public health & primary health care professionals). Limited scale testing of P a g e 31 | 63 Food industry and revised curriculum along with regular audit of courses will be conducted before planning a Agriculture sector to include nationwide scale up in next phase of NAP topics on AMR and related issues Responsible Agency MoH (MFDA, HPA), MoFA, MoE (NIE, School health), MNU (Faculty of Health Sciences and Faculty of Science) Partners and Stakeholders WHO, FAO, OIE, NGOs, Maldives Medical Association (MMA), Maldives Dentists Association (MDA), Maldives Nurses Association (MNA) Illustrative Indicators  Revised curricula for undergraduate, postgraduate and Continuous Professional Development courses in human and animal health and food industry; and  Increased knowledge of AMR and related topics among professionals. P a g e 32 | 63 Strategic Objective 2: Surveillance of Amr The GAP AMR identifies the need to establish evidence based surveillance for AMR in the nation and identifies the following critical information/evidence gaps:  Descriptive epidemiology of resistant organisms as they emerge  Understanding how resistance develops and spreads  The ability to rapidly characterise the emergent resistant organisms  Understanding social sciences, behavioural and other research needed for holistic fulfilment of all five strategic objectives  Treatment and prevention of infections, especially in the low resource settings  Basic and translational research to support the development of new treatments, diagnostic tools, vaccines and other interventions  Alternatives to non-therapeutic uses of antimicrobial agents in the context of agriculture, aquaculture and their use in crop protection  Economic research The situation analysis revealed that several elements of systematic AMR surveillance are not in place in different sectors such as surveillance standards/guidelines, laboratory standards, systematic data collection and analysis including electronic reporting, recording and linkage with HAI surveillance. Human health sector is ahead with an institutional level bacterial AST and initial efforts to put quality assurance system in selected laboratories performing AMR testing. However, animal health sector has no AMR surveillance in the emerging food animal production systems of poultry, goat farms and aquaculture. By 2022, Maldives will consolidate its strengths in AMR surveillance and develop a high quality AMR surveillance system on a limited scale that will integrate AMR surveillance in laboratories, hospitals, AMU and surveillance in animal sectors. Sentinel environmental surveillance in high risk settings will be established. By 2022, a national early warning system will be in place to identify early, the emergence of resistance in priority pathogens and to critical antimicrobials. Nationwide expansion will be planned at the end of this phase of NAP in 2022. The Plan will be rolled out as below: P a g e 33 | 63 P a g e 34 | 63 Objective 2.1: Set up a national surveillance system for antimicrobial resistance under the leadership of a National Coordinating Centre. Strategic intervention 2.1 Establish a national coordination structure for surveillance of AMR KEY ACTIVITIES Year Activity Description of Activity 2017 Establish AMR Surveillance The TSC (Surveillance), TSC (IPC) and TSC (AMU) will jointly identify an AMR Coordination Unit, define Surveillance Coordination Unit (ASCU), define its mandates and terms of reference followed mandates, terms of reference by notification by ministerial decree. The ASCU will be located in the MFDA. and identify a focal point 2017-18 Develop a One Health AMR The ASCU, with technical support from WHO, OIE and FAO, will develop guidelines for guidelines and plan for AMR Surveillance including guidelines for data sharing (indicators, triggers, analysis plan, surveillance in humans, animal response plan), incorporating the critical components as outlined in guidance documents and food industry based on (WHO sample templates, GLASS implementation guide, AGISAR technical international standards and recommendations, OIE, Codex Alimentarius, etc.) guidelines ASCU will develop a One Health AMR surveillance plan in human health care settings and food animal production sector including aquaculture (sample selection, number of samples, sample processing, logistics)with identification of surveillance sites 2017-18 Enlist priority pathogens and The ASCU will identify priority pathogens, sample sites and pathogen-antimicrobials antimicrobials for surveillance combinations in humans and food animal production systems, based on the country‟s AMR in human, animal and food situation industry Assess and inventory of ASCU, in collaboration with Environment Protection Agency (EPA) and MoEE, will assess resources for sentinel and inventory resources for monitoring, surveillance and testing sentinel environmental sites environmental surveillance for antimicrobial resistant organisms and antimicrobial agents Conduct trainings on AMR ASCU will be responsible for training of surveillance staff and clinical staff in AMR P a g e 35 | 63 surveillance for surveillance surveillance and lab techniques according to GLASS standards staff Develop an integrated human Under the technical guidance of ASCU, MoH will develop an integrated information system and animal IT platform for to ensure interoperability between AMR surveillance and hospital infection surveillance in AMR surveillance reporting different HCFs. WHONET platform will be implemented for epidemiological and laboratory AMR surveillance data entry, storage and transmission in human clinical and food testing labs 2019-22 Implement National AMR ASCU will implement a national AMR surveillance program that is representative but with Surveillance Program including limited number of operational sites. IGMH, Regional Hospitals and Atoll Hospitals with sentinel environmental existing Bacterial AST facility will be targeted in the pilot phase. Additionally, ADK surveillance of antimicrobial Hospital from private sector will be included as a surveillance site. For animal surveillance resistance organisms and selected poultry commercial, goat farms and aquaculture farms will be recruited and antimicrobial residues specimens submitted to NHL. One tertiary hospital, 1 commercial poultry production unit, 1 hospital waste dumping island will be recruited as sentinel sites for environmental surveillance. Regular data of AMR along with resistance profiles of priority pathogens for humans, animals, aquaculture and environmental sites will be made available to ASCU from these, limited number of sites. Integrated information system will be integral to the AMR surveillance pilot 2021-22 Establish formal linkage of The ASCU will establish formal linkages between national AMR surveillance programme National AMR Surveillance and WHO GLASS. Reporting to GLASS will commence after formal assessment of national Programme and WHO GLASS AMR surveillance program pilots Conduct formal assessment of TSC (Surveillance) will conduct a formal assessment of National AMR surveillance followed National AMR Surveillance by recommendations of nationwide scale up Program Responsible Agency P a g e 36 | 63 MoH (MFDA, HPA), MoFA, MoEE (EPA) Partners and Stakeholders WHO, FAO, OIE Illustrative Indicators  National AMR Surveillance network with focal point; and  Improved surveillance of priority pathogens and pathogen-antimicrobials combinations in humans, animals, environment and food industry Objective 2.2: Build laboratory capacity under the leadership of a National Referral Laboratory (NRL) to produce high-quality microbiological data for patient and food-safety management and support surveillance activities. Strategic intervention 2.2 Establish a quality assured national laboratory surveillance network (for AMR surveillance and action) KEY ACTIVITIES Under the overall technical guidance of TSC (Surveillance): Year Activity Description of Activity 2017 Identify National Reference The Microbiology Laboratory at IGMH will be identified as National Reference Laboratory Laboratory (NRL) for (NRL) for AMR Surveillance in Maldives. IGMH will cater human clinical samples. MFDA‟s AMR Surveillance in National Health Laboratory will support IGMH in testing of food samples, samples from food Maldives with expertise in animal production systems, animal feeds, and environmental samples for presence of methods for confirming and antimicrobial resistant organisms (AROs) and antibiotic residues as part of the overall characterising specific surveillance of AMR & AMU. The IGMH will develop expertise in methods for confirming and pathogens, performing characterising specific pathogens, performing susceptibility testing, organising quality assurance susceptibility testing, and participating in external quality assurance schemes (EQAS). IGMH will continue to P a g e 37 | 63 organising quality participate in Thailand EQAS network for a regular EQAS participation in addition to additional assurance and participating efforts to subscribe to CMC Vellore EQAS program. The IGMH in collaboration with QAD and in external quality MFDA will coordinate a national network of surveillance laboratories to monitor AMR in human assurance schemes (EQAS) clinical, animal, food and environmental samples. A laboratory designated to cater animal samples is needed. Identify participating Laboratories linked with AMR surveillance sites in 2.1 (7) will be identified by IGMH. These laboratories of National surveillance laboratories will be capable of identifying target pathogens and perform AMR Surveillance susceptibility testing as per standard operating procedures (SoP) laid down by IGMH Network that are capable of identifying target pathogens and perform susceptibility testing Develop AMR surveillance The IGMH, in partnership with NHL will develop and share AMR surveillance standards and standards and guidelines, guidelines, including SoPs, incorporating other intergovernmental standards (OIE/WHO GLASS incorporating and AGISAR/Codex) with surveillance labs intergovernmental standards 2018 Train surveillance staff, IGMH and NHL will train surveillance staff, clinical staff, and laboratory personnel in AMR clinical staff, and surveillance, lab techniques and data management according to international standards (WHO laboratory personnel in GLASS and AGISAR, OIE, Codex Alimentarius) AMR surveillance, lab techniques and data management 2018-19 Roll out National AMR Lab surveillance network in support of National AMR surveillance network will be rolled out in Laboratory Surveillance limited number of sites (Sites identified in 2.1 (7) will be targeted in the pilot phase) network 2022 Conduct a formal TSC (Surveillance) will conduct a formal assessment of National AMR surveillance network assessment of National followed by recommendations for a nationwide scale up P a g e 38 | 63 AMR Laboratory Surveillance network Establish linkage with IGMH will expand the network into a nationwide quality assured laboratory AMR surveillance international and global network. IGMH will establish linkages with international and global surveillance and surveillance and internationally relevant initiatives (like GLASS, GFN). Reporting to GLASS will commence from internationally relevant surveillance sites, recruited and operationalized in initial phase initiatives Responsible Agency MoH (MFDA, NHL), IGMH, MoFA, MoEE (EPA), Health Facilities under MoH Partners and Stakeholders WHO, FAO, OIE, private Hospitals and clinics Illustrative Indicators  National laboratory surveillance network with National Reference Laboratory (NRL) and quality assured network of surveillance laboratories; and  Laboratory surveillance of AMR strengthened Objective 2.3: Develop a multi-centric surveillance system on the national scale to provide early warning of emerging resistance and monitoring of secular trends at national and sub-national levels. Strategic intervention 2.3 Establish a systematic, standardized process to collect, assess and share data, maps and trends on AMR hazards; develop communication and dissemination systems to ensure coordination and information exchange and initiate responses to warning triggers KEY ACTIVITIES P a g e 39 | 63 Under the overall technical guidance of TSC (Surveillance) and with technical support from WHO and FAO: Year Activity Description of Activity 2017-19 Establish a network of The ASCU will identify agencies (related to human and animal health, aquaculture, drug control, agencies for AMR hazard environmental health) to be involved in AMR hazard and risk assessment, outline their roles and risk assessment and responsibilities Develop and disseminate The ASCU will frame guidelines and national standards for systematic collection, sharing, and guidelines and national assessment of AMR hazard events framed in keeping with international standards standards for systematic (IHR/WHO/OIE/FAO); includes surveillance manual, investigation/response guidelines, case collection, sharing, and management guidelines and lab guidelines assessment of AMR hazard events Enlist priority pathogens and Lists and definitions of priority events (priority pathogens, specimens, and pathogen- AMAs for AMR hazard risk antimicrobial combinations) will be developed in keeping with country‟s AMR situation assessment Conduct surveys to establish The MFDA will collaborate with MoH, IGMH, QAD and HPA to conduct surveys to establish baseline estimates and trends baseline estimates and trends of AMR to determine risks and establish thresholds for alerts and of AMR to determine risks action systems and establish thresholds for alerts and action systems 2020-21 Establish a central library or A central library or database will be established at the ASCU to store AMR risk information, database on AMR risk and make data available to government agencies, public and international community as information appropriate in future 2021-22 Conduct and communicate Data transmission on AMR alerts will start flowing from initial phase AMR surveillance sites comprehensive real time identified and recruited in 2.1 (7). Processing of information will be initiated in real time or analysis of AMR hazards in close to real time. This will be followed by a comprehensive analysis on AMU in the human and the human, animal, food animal sector and its linkage with the resistance profiles reported in animals and humans by the industry and environment laboratory based in AMR surveillance programme P a g e 40 | 63 sector to inform programme planning and action Responsible Agency MoH (MFDA, NHL), IGMH, MoFA, Ministry of Environment (EPA), Health Facilities under MoH, MoEE Partners and Stakeholders WHO, FAO, OIE, private Hospitals and clinics Illustrative Indicators  National early warning system on AMR hazards with central database on AMR risk information  Thresholds for alerts and action applied for early identification of AMR hazards and risks P a g e 41 | 63 Strategic Objective 3: Hygiene, Infection Prevention And Control (Ipc) Infection prevention and control, especially in the context of hospitals, is an important aspect of a strategic plan to contain AMR since clinical settings represent an ecosystem of high antimicrobial usage. Within this ecosystem exists patients, who may be immunologically impaired. These patients not only represent the population that is vulnerable to serious life-threatening infections and at the same time, they promote the emergence of resistance. On the other hand, better hygiene (WaSH) and Infection prevention control represent methods to cut down on the spread of infections in ambulatory human and animal care facilities, in food production systems and in the community in general. Vaccination in humans and animals and biosecurity in food production systems are specific interventions that if implemented effectively, can result in better health outcomes and reduced risk of emergence of AMR. The Situation Analysis of measures related to hygiene, infection prevention and control in human, animal and related sectors in Maldives reveals frameworks that have been developed. However, in the absence of standardised guidelines, awareness, training and resources, the quality and scale of implementation has been less than optimal. Health Care Quality Standards are platforms that could be capitalised. Other measures such as AMR stewardship programme in healthcare settings or ambulatory settings, in human and animal health and food production sectors and HAI surveillance are yet to be initiated. The Strategic Plan as outlined below aims to roll out a comprehensive multi-sectoral national IPC programme on a limited scale in healthcare facilities in public, private sector and in selected food animal production sector (poultry, goat farms, aquaculture). Similarly, HAI surveillance will be implemented in few public and private healthcare facilities. In community settings, formal campaigns for sanitation and hygiene including biosecurity and animal husbandry practices and food handling practices on a small scale in animal and food animal production sites. Human vaccination programs are well-developed programs that will be further consolidated and animal vaccination strengthened. P a g e 42 | 63 Objective 3.1: To establish a national infection prevention and control programme through full implementation and compliance with the IPC guidelines within healthcare settings, animal husbandry systems, fisheries and the food chain Strategic intervention 3.1 Create a formal organizational structure to ensure proper development , use of infection prevention and control policies and strategies in health care settings, animal rearing facilities and in aquaculture KEY ACTIVITIES Year Activity Description of Activity 2017-18 Evaluate existing IPC, and TSC (IPC) in collaboration with TSC (Surveillance) and TSC (AMU) will commission a Biosecurity guidelines multi-sectoral task force that will evaluate existing IPC, Hygiene, IPC and Biosecurity components of food production systems. Existing guidelines and programmes (such as the Health Care Quality Standards) on patient safety in human hospital services will be reviewed for their strengths and weaknesses including resource constraints and technical capacity. The Task Force will develop a national IPC policy, mandating the creation and harmonization of National IPC Programmes in healthcare facilities and food production systems (poultry, goat farms, aquaculture) Under the overall technical supervision of TSC (IPC): 2017-18 Develop IPC guidelines with The Taskforce on IPC will develop IPC guidelines with implementation and M&E plans implementation for infection covering infection prevention and control in all health care settings (hospital and prevention and control in all ambulatory) in human sector including linking it with hospital accreditation system; health care settings (hospital and IPC/biosecurity in food animal production facilities, vaccination, and biosecurity in the farm ambulatory) in human sector; to fork chain in line with international standards set out by OIE/FAO. Existing guidelines IPC/biosecurity in animal health and program will be reviewed before integration into national guidelines facilities (hospital and ambulatory), vaccination, and biosecurity in the farm to fork P a g e 43 | 63 chain Identify target groups to be The Task Force, in collaboration with WHO, FAO, OIE and ASCU will identify target trained in IPC from different groups to be trained in IPC from different sectors (human health, food production, sectors and at different levels environment) and at different levels (policy makers, programme managers, industry leaders, farmers, etc.) Train target groups in different TSC (IPC) through MFDA and Quality Assurance and Regulation Division (QARD), will sectors in IPC coordinate capacity building at healthcare facilities to create dedicated, trained IPC teams at facilities in selected number of sites including large private hospitals. MFDA and MoFA will conduct training of biosecurity teams to implement and supervise food animal production units Roll out IPC program in human TSC (IPC) through MoH and MoFA will roll out IPC programme on a limited scale, with health, animal health and food dedicated trained teams placed in some public healthcare facilities, private sector and in industry selected food chains 2019-20 Review existing professional QAD and MoFA, in collaboration with MoE, will review existing curricula of professional curricula for content on IPC and courses with respect to content on IPC and develop training modules for incorporation into develop training modules for professional courses their incorporation into professional courses 2022 Assess National IPC Programme TSC will conduct a formal assessment of National IPC Programme, followed by and recommend Nationwide recommendations of nationwide scale up in all human and animal healthcare facilities scale up in human, animal across the nation and across all food production systems. healthcare facilities, food production systems. Responsible Agency MoH (MFDA, NHL, QAD), IGMH, MoFA, MoEE (EPA), Health Facilities under MoH, MoE (School health programme) P a g e 44 | 63 Partners and Stakeholders ADK Hospital, MMA, MDA, MNA, Livestock/ Fisheries Producers‟ Associations, WHO, FAO Illustrative Indicators  A National IPC programme for human, animal health and food industry sector; and  Proportion of human, animal, food industry facilities with functional IPC programme implemented Objective 3.2: Decrease Hospital Acquired Infection (HAI) and associated AMR (Human Health) Strategic intervention 3.2 Implement a healthcare facility-based HAI surveillance system along with related AMR surveillance (human health). KEY ACTIVITIES Year Activity Description of Activity 2017-18 Develop guidelines for The TSC (IPC) will commission a multi-sectoral task force that will, as part of Hospital IPC Hospital Associated Guidelines, develop guidelines for HAI surveillance (objectives, standardised case definitions, Infection (HAI) methods of detecting infections/procedures/exposures and exposed populations, process for analysis Surveillance of data, evaluation of data quality, reporting/communication lines at local level and from local to national facilities, quality assured microbiology capacity, training programme, financial outlays). 2019-22 Implement a pilot scale ASCU will implement on pilot scale a HAI surveillance in select public and private healthcare on HAI surveillance in facilities. HAI surveillance data will be reported centrally from these public and private healthcare select public and private facilities healthcare facilities 2022 Integrate HAI ASCU will carry out a formal assessment of HAI surveillance pilot. Data from HAI surveillance surveillance network into network will be integrated into National AMR surveillance network as outlines in 2.1 (7). Integrated National AMR analysis of surveillance data will form the basis for monitoring and response frameworks, including surveillance network; the identification of priority triggers (priority pathogens or pathogen-drug resistance combination) that P a g e 45 | 63 Conduct formal will be established by ASCU. HAI surveillance will be implemented on a nationwide scale covering assessment of HAI tertiary, regional, Atoll hospitals, health centres in public and sentinel private hospitals Surveillance network for nationwide scale-up Responsible Agency MoH (MFDA, NHL), IGMH, MoFA, MoEE (EPA), Health Facilities under MoH Partners and Stakeholders ADK Hospital, MMA, MDA, MNA, WHO Illustrative Indicators  National HAI surveillance program for priority infections, procedures and exposed populations;  Proportion of health care facilities with functional HAI surveillance programme; and  Reduced HAI and associated AMR in health care facilities Strategic intervention 3.3 Promote sanitation and hygiene by social mobilisation and behavioural change activities KEY ACTIVITIES Objective 3.3: To limit the development and spread of AMR outside health settings Year Activity Description of Activity P a g e 46 | 63 2017 Review and evaluate the existing The TSC (IPC), in collaboration with MoE, will commission a multi-sectoral task force. The national campaigns on water, taskforce will review and evaluate the existing national campaigns, generate new evidence wherever sanitation & hygiene (WaSH), food necessary , modify guidelines suitably to address issue of sanitation and hygiene including, food safety, and vaccination in humans handling practices ,vaccination in humans and animals and animals 2018 Implement formal campaigns for MoH and MoFA will implement formal campaigns for sanitation and hygiene, vaccination and food sanitation and hygiene in human, handling practices among general public; biosecurity and vaccination on a small scale in food animal animal, food animal production production sites sectors Evaluate existing vaccination MoFA will strengthen immunization programmes for preventable infections; MoH and MoFA will programme in human and animal evaluate existing vaccination programme for their effectiveness and coverage sectors for their effectiveness and coverage 2018- Review and revise undergraduate MoH and MoFA in collaboration with MoE will include sanitation and hygiene including food 19 and post graduate curricula to handling practices in the core curricula in secondary and undergraduate education for school and include course content related to college students water, sanitation , hygiene and food handling practices 2019 Evaluate campaigns on hygiene and MoH and MoFA will carry out monitoring ,concurrent evaluation of campaigns on sanitation and sanitation hygiene to inform nationwide scale-up Responsible Agency P a g e 47 | 63 MoH (MFDA), IGMH, MoFA, MoEE (EPA), Health Facilities under MoH, MoE (School health programme) Partners and Stakeholders ADK Hospital, MMA, MDA, MNA, Livestock/ Fisheries Producers‟ Associations, WHO, FAO, OIE, UNFPA, UNICEF Illustrative Indicators  Evidenced based national campaigns on water, sanitation & hygiene (WaSH), food safety, vaccination in humans and animals;  Increased coverage of WaSH related interventions , vaccination in humans, animals and food industry; and  Reduced infections and associated AMR outside health settings P a g e 48 | 63 Strategic Objective 4: Optimise Use Of Antimicrobial Medicines Use of antimicrobials in any form, even when rational and prudent, can precipitate resistance in target microbes. High antibiotic use may reflect over-prescription, easy access through over-the-counter sales, and more recently sales via the Internet which are widespread in many countries. The situation analysis reveals that Maldives has a fully functional National Regulatory Authority that is responsible for regulation and licensing; drug import and pharmacovigilance. Post licensing inspections including for retail pharmacies and OTC sales are carried out on national scale regularly. However, limited human and technical resources as well as the complex challenges of import based system of procurement limit the effectiveness of regulatory activities. Import of AMAs used in food animal production sector including aquaculture is covered by the regulatory framework. The country lacks important instruments and systems such as a National AMR containment policy, AMU surveillance including surveillance of sales of antimicrobial agents. Animal health sector lags on all of the above fronts and is also constrained by lack of regulatory powers. Maldives will establish a robust system for regulation and surveillance of use of antimicrobial agents for control of use of antimicrobial substances in human, animal and food production sectors. Some of the measures taken will include an empowered National Drug Regulatory Authority, import frameworks favourable to regulatory requirements, National AMR Containment and Use Policy and related regulatory frameworks, standard treatment guidelines with special reference to use of antimicrobial agents, National Antimicrobial Stewardship Programme and AMU monitoring programme in human and food animal production systems, ambulatory and community settings and including, residues testing in food products. All of the above systems to optimise use of antimicrobials, however, will be implemented on a limited scale during 2017-2022. Formal assessments will be carried out at the end of this period before nationwide scale up. The Strategic Plan to establish the above is as outlined below: P a g e 49 | 63 Objective 4.1: Establish a national Antimicrobial Stewardship Programme on a national scale to improve and measure the appropriate use of antimicrobials Strategic intervention 4.1 Create a national AMR containment policy for control use of antimicrobials in humans and animals, and implement a comprehensive evidence-based formal antimicrobial stewardship programmes at the national level KEY ACTIVITIES The TSC (AMU) in collaboration with TSC (Surveillance) and TSC (IPC) will commission a task force to develop a National AMR Containment , Use Policy and related regulatory frameworks. Within this policy framework, the task force will: Year Activity Description of Activity 2017-19 Develop a national AMR Develop a national AMR containment policy and propose a formal organisational structure containment policy and responsible for implementation of the National AMR containment policy. The Policy will organizational framework mandate provisions for the five strategic objectives enshrined in GAP and NAP AMR for within the charter of the Maldives Policy Formulate a regulatory MFDA in consultation with stakeholders will develop an essential medicine lists with special framework for control of reference to the use of antimicrobial agents. Antimicrobial agents in the EML will be antimicrobial substances in considered for inclusion based on Maldives‟s situation of current levels of AMR, availability, human, animal sectors and supply chains, financial outlays , international guidelines and standard treatment guidelines in food industry human medicine, veterinary medicine and aquaculture (including antimicrobial growth promoters; AGPs). Existing EML to be reviewed in light of the National AMR Containment Policy Develop standard treatment STGs (including antimicrobials) will be developed by the taskforce for training, supervision guidelines (STGs) for and supporting critical decision-making in antimicrobial use practices, in human and antimicrobial use in human veterinary healthcare and food production. Existing efforts of Quality Assurance and and animal healthcare and Regulation Division will be reviewed for informing STGs for AMAs food industry P a g e 50 | 63 Conduct surveys to Conduct baseline surveys to assess the extent, barriers and enablers of AMSP at institutional characterize institutional levels Antimicrobial Stewardship Programmes (AMSP) Develop evidence based Develop comprehensive, evidence based guidelines for a National Antimicrobial Stewardship guidelines for a National Programme (AMSP) with the aim of improving and measuring the appropriate use of AMSP antimicrobials in human , animal health care, ambulatory and community settings as well as aquaculture. Under the overall supervision of TSC (AMU) 2018-22 Implement AMR MFDA, QAD and MoFA will implement AMR policy for control of human and veterinary containment policy for use of antimicrobial substances, including the preventing introduction/phasing out of AGPs. control of human and Limited scale implementation of the national AMSP in human health settings, ambulatory , veterinary use of community settings and food animal production systems will be done. This will be antimicrobial substances in accompanied by monitoring and concurrent evaluation followed by nationwide human and animal health implementation in the next phase of NAP care, ambulatory and community settings and food industry Responsible Agency IGMH, ADK, MoH (MFDA, QAD) & MoFA Partners and Stakeholders WHO, FAO, OIE, Maldives Medical Association, Maldives Nurses Association, Pharmacy Association, NGOs Illustrative Indicators P a g e 51 | 63  A national AMR containment policy to control the use of antimicrobials in humans, animals and food industry;  Evidence-based National Antimicrobial Stewardship Programmes; and  Proportion of human, animal health and food industry facilities with functional AMSP Objective 4.2: Regulate post-marketing quality of drugs to ensure access to safe and quality antibiotics Strategic intervention 4.2 Strengthening of a competent National Regulatory Authority (NRA) which can enforce quality standards of antimicrobial drugs (veterinary, human, and food production sectors) KEY ACTIVITIES Under the overall supervision of TSC (AMU): Year Activity Description of Activity 2017 Formulate a National Drug MFDA in collaboration with a suitable counterpart in MoFA will review the National Policy with special reference Medicine Policy, Medicine Chapter of Health Services act 2015 , relevant regulations, with to AMAs and AMR special reference to AMAs and AMR. The Policy will be applicable to human , animal health, applicable to human , animal aquaculture and food production sectors. health, and food industry Introduce legislation and regulations on AMAs for veterinary use. 2017- Strengthen existing National MoH will further strengthen MFDA in serving its mandates of drug control, import, quality, 19 Drug Regulatory Authority distribution, pricing, market authorization, advertising, retail sales, inspection, and to and establish additional implement the relevant regulations. Human resource and technical capacity of National regulatory frameworks Health Laboratory of MFDA will be strengthened to establish systematic surveillance of quality of imported drugs and food at points of entry as well as post marketing surveillance of drugs and food. MFDA will cover drugs used in human health , extend similar regulatory framework to import medicines for animal health, aquaculture and food production Establish import Bulk procurement system of drugs including AMAs through the STO will be established to procurement systems ensure import frameworks favourable for regulatory compliance P a g e 52 | 63 favourable to regulatory compliance Establish a system for the NDRAs will establish a system for the coordination and collation of data on drug quality coordination and collation of (including supply, storage, transportation) from different sources or parts of the nation; data on drug quality tracking and reporting suspected product quality and treatment failure. The system will be implemented by designated regional institutions. Special attention will be given to international border areas known for illegal import of drugs 2017- Establish and implement an Within the regulatory frameworks laid down by MFDA, the MoH will review and strengthen 22 institutional network with the the existing institutional network/system of inspection, coordination and collation of data on capacity for quality control drug quality (including supply, storage, transportation) from different sources or parts of the and enforcement of nation; tracking and reporting suspected product quality and treatment failure. System regulatory provisions for strengthening will include building capacity of Public Health Units that support MFDA and antimicrobial agents or APIs are responsible for selected drug regulatory functions such as supply chain, inspection of pharmacies for OTC sales in peripheral parts of the country. Human resources will be adequately provisioned for effective monitoring and enforcement Conduct independent MFDA in collaboration with QAD, HPA and MoFA counterparts will continue to conduct periodic surveys to estimate independent periodic surveys to estimate the extent of OTC ,inappropriate sales of antibiotics the extent of OTC and and the drivers for the same and evaluate the effectiveness of OTC regulations done and inappropriate sales of corrective measures undertaken. Monitoring &evaluation of AMA sale in veterinary sector antibiotics and APIs Responsible Agency MoH (MFDA) & MoFA health Facilities (PHUs) Partners and Stakeholders WHO, FAO, OIE, HPA, QAD, STO P a g e 53 | 63 Illustrative Indicators  National Drug Policy with special reference to AMAs and AMR;  National DRAs with appropriate mandate, TORs, and institutional network; and  Number of sites (islands, atolls and locations.) with strengthened post marketing and drug quality monitoring system Objective 4.3: Establish mechanisms to monitor antimicrobial usage on a national scale to inform interventions to reduce overuse and promote prudent use of antimicrobial substances Strategic intervention 4.3 Monitoring antimicrobial use (AMU) and sales in humans, animals and fisheries; monitor trends of residues of antimicrobials in food chains to inform interventions to promote prudent use of antimicrobials KEY ACTIVITIES Under the overall technical guidance of TSC (AMU), TSC (Surveillance) and TSC (IPC): Year Activity Description of Activity 2017 Establish AMU Surveillance ASCU will establish a subcommittee called AMU Surveillance Committee (AUSC) with coordination structure appropriate mandate, TORs and Focal Point (FP) that links with ASCU 2018 Design an AMU and residue The AUSC will coordinate policies on AMU and monitoring their impact on AMR. AUSC monitoring program in will design an AMU monitoring program in humans and food animal production systems humans, animals and food including, residues testing in food products (guidelines and standards for surveillance design, industry; develop guidelines data type, reporting formats, reporting sites, sources of antimicrobial usage/sales data, list of to implement residue testing indicators). AMU monitoring will include monitoring of sales data in humans as well as animals (sales quantity per kg of slaughtered animal, sales quantity per PCU etc.). Quantity and quality of AMU in different settings will be assessed through point prevalence surveys by QAD, HPA and MFDA. Longitudinal surveillance will be planned in the next phase of NAP In collaboration with NHL, AUSC will also develop guidelines to implement residue testing P a g e 54 | 63 including data sharing 2019-22 Implement AMU AUSC will implement AMU surveillance and residue testing, Healthcare facilities, including surveillance and residue in ambulatory, community settings and parts of food animal production systems will be testing recruited on a limited scale. For residue testing, surveillance sites operationalized for AMR Surveillance in 2.1 (7) will be recruited. AMU surveillance and residue testing will be conducted on limited scale by 2022. Data for the use of antimicrobial substances and sales data in humans, animals, and food production sectors will be available by 2020 Conduct integrated analysis The AUSC will analyse AMU data in linkage with the resistance profiles reported by the of AMU, AMR and residue AMR surveillance programme. Actionable recommendations will be made to modify existing surveillance data to guide local STGs programme planning Responsible Agency MoH (MFDA, QAD, HPA), MoFA, IGMG, MoEE Partners and Stakeholders Ministry of economic development, WHO, FAO, OIE Illustrative Indicators  AMU and residue surveillance and monitoring system; and  AMU, AMR and residue surveillance data analysed to guide programme planning P a g e 55 | 63 Year Activity Description of Activity Strategic Objective 5: (Economic) Case For Sustainable Investments And Increase Investments In New Medicines, Diagnostic Tools, Vaccines And Other Interventions To Reduce Antimicrobial Use The GAP AMR posits that the economic case should reflect the need for capacity building and training in low resource settings, while developing evidence based interventions to reduce infections and combat AMR. The 2001 strategy for AMR containment could not achieve its goals; one of the reasons cited for the same is that there was absence of economic assessments, which evaluated the cost of doing nothing versus the cost/benefits of action at the present. The Situational Analysis in Maldives indicates that research on AMR has not been a priority for both policy makers and research community. Limited evidence exists on the nature and extent of AMR as a public health threat and drivers of AMR and AMU. This calls for policy and program relevant research to support planning and implementation of public health interventions. The phase of development of the health system provides an opportunity to put in place strategic research agenda for public health research and AMR in particular to inform health system responses. The Strategic Plan lays down a roadmap for establishing a strategic research agenda, with systematically prioritised research areas and knowledge gaps related to AMR that will feed into a national policy for research and innovation. By 2022, multi-stakeholder platform and research consortia will be established that will generate program and policy relevant evidence on and compare cost effectiveness of AMR control strategies. The strategic plan also envision collaborations with national and international agencies, for implementation of strategic research agenda. This will be one of the key strategies for Maldives, given its existing nature of AMR threat and limited institutional capacity. Objective 5.1: To promote sustainable investment in new medicines, diagnostic tools, vaccines and other interventions by developing a strategic research agenda and national research policy Strategic intervention 5.1 Generate cost effectiveness and benefit evidence for reducing AMU & AMR; develop a national strategic research agenda KEY ACTIVITIES Under the overall supervision of TSC (Research): P a g e 56 | 63 2017- Create an inventory of relevant In collaboration with National Medical Research Committee (NMRC), Faculty of 18 networks, initiatives, institutions and Health Sciences (FHS) and Faculty of Science (FoS) at MNU will create an inventory experts involved in AMR research of relevant networks, initiatives, institutions and experts involved in AMR research across human and animal health sectors in Maldives. The NMRC will assess existing research, capacities, future plans and funding sources for research and innovations through a landscape analysis Develop a Strategic research agenda, FHS & FoS will develop a Strategic research agenda, with systematically prioritised with systematically prioritised research research areas and knowledge gaps related to research and innovation in the field of areas and knowledge gaps in the field of AMR, and resource needs that are relevant for Maldives (in terms of human resources, AMR materials and funding). Priority research will include:  Research to estimate and characterize burden and risk of AMR and AMU in human, food animal production and environment sectors including prescribing behaviours as well as treatment and care-seeking, barriers and drivers for uptake of prudent antimicrobial use practices. Special focus will be on broader socioeconomic burden of antimicrobial resistance and cost effectiveness and feasibility of interventions to reduce AMR and AMU across different sectors.  Systems and policy research including operational research to understand and improve priority areas such as regulatory frameworks and their enforcement, stakeholder analysis, supply chains, public private partnerships, interoperability between different elements of AMR control plans and sectors, information management systems, AMR and AMU surveillance and use in health care and ambulatory settings across sectors, laboratory support. Priority research to support implementation of NAP will include human resources for implementation of NAP, cost of interventions and mapping of funding sources for implementation 2017- Develop a National AMR Research TSC (Research) will develop a national policy for research and innovation, based on 18 Policy the research agenda P a g e 57 | 63 2018- Establish a multi-stakeholder platform TSC (Research) will establish a multi-stakeholder platform to guide AMR research and 19 to guide AMR research and innovation innovation. The research platforms will develop research collaboration between national agencies and with international partners, for implementation of strategic research agenda 2020- Document and disseminate to different TSC (Research) will make evidence available through research databases, peer 22 stakeholders, evidence on AMR and reviewed publications, policy briefs, policy advocacy dialogues to inform national , related issues for policy and programme local policies and strategic interventions in different strategic objectives to reduce the intervention need for antimicrobial in several settings (health care, animal husbandry, aquaculture and food production) Responsible Agency MoH (NMRC), MoE (FHS, FoS) & MoFA, Ministry of Environment (EPA) Partners and Stakeholders IGMH, National Health Laboratory, HPA, Villa College, WHO, FAO, OIE Illustrative Indicators  Research network and collaborations;  Multi-stakeholder research initiative National Research Policy on AMAs and AMR Research;  Strategic research agenda, with prioritised research areas, resource needs in the field of AMAs and AMR; and  Increased availability of peer reviewed evidence to support sustainable investments for containment of AMR P a g e 58 | 63 Way Forward The National Action Plan for prevention and control of AMR in Maldives covers the period 2017-

  6. 2022. It factors in the expert view of stakeholders from different ministries to come up with a Strategic Plan, outlining a set of operational details. The Plan takes into account both strengths and limitations that are unique to Maldives and consolidates them before formulating a vision of AMR prevention and control. It builds on the government‟s concern to make universal healthcare available to all and to simultaneously ensure animal welfare and food security across the length and breadth of the country. The Plan draws from valuable insights that emerged from a Situation Analysis that was conducted along with one-on-one interviews, guided discussions and participative dialogues that were undertaken with multiple stakeholders from the government, civil society, NGOs and others. Technical support was provided by WHO Country office, WHO SEARO and an independent Consultant. The NAP AMR of Maldives in its existing form provides a constructive opportunity for the government to fine tune it based on its local realities and sensitivities. Further, it presents an affirmative statement of goals, objectives and strategic interventions that will be deployed to achieve the objectives set out clearly in the document. The strategic plan or roadmap outlines collaborations with national and international agencies, for implementation of a strategic research agenda that has potential to serve as a major strategy for the country. Undoubtedly, it will use both evidence to guide programme planning and action. Essential elements of AMR containment which have so far not completely taken off the ground will now see movement as comprehensive awareness programmes are conducted, surveillance of AMR and AMU including laboratory capacity, IPC and AMSP are strengthened and other public health functions are aligned to the new AMR goals. Following submission of the final report to the World Health Assembly, the Government of Maldives will continue with its deliberations and planning process under the leadership of NMSC. Next, the NMSC through its constituent NACC, TSCs and Task Forces will draw up a detailed operational plan in addition to its budget, monitoring and evaluation plan for successful implementation of the activities. Most of these activities will be implemented by the key actors as outlined in the strategic plan that covers the period 2017-22. The successful implementation of the NAP AMR within a stipulated time frame is estimated to bring together all the critical players from the human and animal health and related domains on a common platform. This will inevitably create greater responsibility, ownership and transparency. Working closely with a more sensitized and aware population, Maldives, like other countries in the region, is expected to bring down its levels of AMR. In the months to come it will also institutionalize some of its mechanisms to better manage and arrest the spread of AMR. P a g e 59 | 63 Bibliography

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  25. 19. World Health Organization. Template for a national action plan on antimicrobial resistance. 2016. P a g e 60 | 63 Annexures Annexure 1: Interpretation of phase of AMR prevention and control program implementation Phase of What it means Programme Implementation Phase 1 There are no programmes implemented in a systematic manner in order to conduct AMR prevention and control in the country. However, the process Phase of of designing a program has been initiated, and depending on the progress Exploration made (as seen through the indicators), it may be that one or more of the and Adoption following activities are being undertaken: - Identification of needs, options and resources - Identification of potential barriers to implementation (funding, human resources, system responsiveness, etc.) - Investing in systems to augment their readiness to deploy the programme and overcome the identified barriers in implementation - Identifying structures (both in policy making and implementation frameworks) to aid in the implementation of the programme As the nation gets closer to the end of Phase 1, it is on the verge of implementing (at any scale, even a pilot project) an AMR surveillance programme. Phase 2 The decision to implement a programme has been made and the initial set of activities have been undertaken in order to launch the program. These Phase of may include: Programme Installation - Capacity building - Resource allocation - Establishment of data transmission, security, and sharing protocols - Development of process indicators, standard operation protocols and other guidelines to be adhered to by institutions participating in the programme In course of the second phase, there is more emphasis on development of infrastructure, and allocation of resources in order to implement a programme in a defined context and then scale it up to the national context in the subsequent phases. Phase 3 This is probably the most challenging phase in the stages of early implementation of any programme within the context of developing Phase of Initial P a g e 61 | 63 Implementation nations. In this phase, there is a need to initiate a change or an intervention, which may have patchy uptake or maybe avoided altogether. - In course of this phase, a functional model of the program is identified - All protocols, SOPs, etc. undergo a real world challenge This is a very crucial phase and most programs are likely to find it difficult to come out of this phase. Phase 4 This is the process of scaling up a successful model of the programme that may have been trialled in the previous phase. Phase of Full Operation - The programme is part of accepted practice - There is a nation-wide (or a large scale) adoption of the programme - The programme is functional by generating outputs and outcomes on a regular basis (seek proof of evidence) Phase 5 This is the highest grade of operational efficiency of the programme and indicates that the programme can have long-term survival. Phase of Sustainable - The programme is resilient to changes in funding volume, partner Operation agency support, etc. external factors which were essential for installation and initial implementation of the programme. - Through a functional M&E mechanism, there is systematic improvement of capacity, especially in human resources and system capacity, to enable the programme to function without extensive need to invest in continued capacity building P a g e 62 | 63

National Action Plan for Containment of Antimicrobial Resistance 2017-2022 · Nelum