National Multi-sectoral Action Plan on Combatting Antimicrobial Resistance (2017-2020)

1 Appendix 1 to the Joint Ministerial Order of Health and Food, Agriculture and Light Industry N ….dated on May …, 2017 NATIONAL MULTI-SECTORIAL ACTION PLAN ON COMBATTING ANTIMICROBIAL RESISTANCE (2017-2020) 1. CURRENT CONTEXT Microbial infection and infectious disease prevalence among Mongolian population do not decrease and even has tendency to rise. Linked to this situation, antibiotic use in medicine treatment is increasing year by year, several clans of microorganisms are getting resistant to antibiotics, and medical treatment is becoming challenging. In other way, doctors do not take attention on a laboratory validation and do not have an interest to send patients for testing due to poor hospital laboratory settings especially insufficient capacity of microbiological laboratory, poor quality, somehow not reliable results and not available rapid test results. Doctors usually have poor justification for antibiotic prescribing and there is a lack of control on prescribing, dispensing per prescription at pharmacy and use of antibiotics. Moreover knowledge and attitude of people is not sufficient, wrong practice to get antibiotics from pharmacy without any restriction and careless use of it widely spread among the population. Mongolia imports 70 percent of total medicines from foreign countries and about 30 percent of total of the medicines used in treatment are antimicrobials. There are functioning about 35 local manufacturers and five of them producing antibiotics. With the purpose of prevention of AMR, certain actions required to be taken including responsible prescribibg of antimicrobials, promoting distribution of antibiotics with doctor’s prescription; to improve hospital capability for prevention and control of AMR; to improve awareness of patients, consumers and healthcare professionals about consequences of AMR and promoting rational use of medicines. Mongolia has high consumption amount of animal products particularly meat. It has 3 million people and 50 million livestock. Recent years, consumption of imported chicken, sea food and pork is increasing. Today about 700 medicines 2 are registered and commonly used in the agriculture sector and it is vital to take a laboratory test and to ensure quality and safety of animal products consumed. Consumption of animal products with residual antibiotics is causing health risks through food products. 2. BACKGROUND In order to make a proper decision in antibiotic use and emergence of antimicrobial resistance, strategic policy on rational use of antibiotics and antibacterial drugs should be developed in accordance to global strategy as a first step of action. One of the worldwide emerging problems related to hospital quality care is a drug resistance particularly bacterial resistance to antibiotics and inappropriate combat to hospital acquired infections. Results from previous studies indicate that inappropriate use of antimicrobials, consequently the resistance to antimicrobials has been increasing in the last years. According to the latest reports, resistance to third generation cephalosporins was 86/101 (85%) for E coli, 87/99 (88%) for K.Pneumonia, 42/75 (56%) for N.gonorrhoeae, 85/99 (86%) for Methicillin-resistant S.aureus (MRSA); resistance to penicillins was 67/97(69%) for S.pneumonia and resistance to fluorquinolones - 68/91 (75%) for non-typhoid Salmonella and 35/57 (61%) for Shigella spp (Antimicrobial resistance, Global Report on Surveillance, World Health Organization, 2014) Reports produced by the National Centre for Communicable Diseases of Mongolia indicated that out of 1495 isolates resistance to ampicillin was 100% for E.Coli, Citrobacter freundii, 80% for Shigella, 60% for Staphylococcus, 54% for Streptococcus, resistance to oxacillin was 15% for Streptococcus, respectively. (Microbiology laboratory of the National Centre for Communicable Diseases of Mongolia, report, 2014) Therefore, there is an emerging need to develop an antibiotic treatment policy in detail, to take actions in drug treatment, to streamline rational use of antibacterial drugs, and to monitor antimicrobial resistance based on the above mentioned evidences. In addition, improvement of human resource and laboratory capacity of human and animal sector, as well as information exchange at the worldwide level is essential. World Health Organization recommends its member countries to develop a multi sectoral National Action Plan on prevention of AMR and implement corresponding activities. 3 3. GOVERNANCE A working group consisting of non cadre members representing the health, food and agriculture sector will be discussing about antimicrobial resistance. Technical working group will discuss about the process of implementation at the end of year, annually. Terms of reference of working group:  Responsible for implementation of activities in the corresponding sectors and agencies  Meet every six months to review and coordinate implementation  M&E of the implementation of the national action plan  Organize technical meetings on specific issues when needed  Provide technical input on activities 4. MAIN PRINCIPLES The National Action Plan on Combatting Antimicrobial Resistance will be applied for all health-care facilities including public and private health care organizations, as well as veterinary clinics and animal husbandry with main principles of their active participation, open to public and be responsible including: 4.1 approach and improve coordination of AMR at international and national levels; 4.2 to promote prevention first through improved laboratory capacity for AMR surveillance and diagnostics, and infection prevention and control measures; 4.3 to improve monitoring of prescribing and dispensing of antibiotics in all health care facilities and veterinary clinics for consumers, and streamline rational use of antibiotics; 4.4 to ensure access to quality assured antimicrobials through conduct post marketing surveillance of antimicrobial drugs regularly; 4.5 to foster research and development for new tools to combat AMR. 5. OBJECTIVE(S) The goal of the National Action Plan is to promote rational use of antibiotics and prevention of the emergence and spread of AMR, improve surveillance of AMR and diagnostics, treatment of antimicrobial infections, and enhance quality of hospital care and outcomes. The National Action Plan includes activities in accordance with the following six areas: 4 1. Establish a governance and ensure multisectoral role to combat antimicrobial resistance, sustainable investment and functioning 2. Strengthen surveillance and diagnostic capacity for AMR and research 3. Reduce the spread of infections through better infection prevention and control 4. Ensure quality and safety of antimicrobial medicines 5. Optimize the use of antimicrobials in the human and animal sectors 6. Raise awareness and understanding of AMR and rational use of the general public, herdsmen and health professionals 5 6. Operational action plan Activities Year Leading Implementer(s) Participating organization (s) Indicator(s) 2 0 1 7 2 0 1 8 2 0 1 9 2 0 2 0 1. Establish an multisectoral coordinating mechanism to combat AMR, improve legal environment 1.1 Set up a Technical Working Group to coordinate the implementation of the national action plan and discuss every six mounts about the implementation х х х х MoH MoFALI Participating stakeholders Technical Working Group to coordinate the implementation of the national action plan in MoH and MoFALI established 1.2 Sharing information about new registered and rectricted antimicrobials by human and animal drug committties semi annually х х х х Human Drug Council Animal Drug Council MoH MoFALI CHD Mechanism to link the human and animal drug committees with regular information of antimicrobials established. 1.3 Upgrade legal environment in Law on Medicines and Medical Devices regarding to prescription only medicines for human and animal use х х х х MoH MoFALI GASI Legal environment regarding to prescription only medicines for human and animal use upgraded. 1.4 Estimate the annual expenditure of activities in the plan and involve in budget of all participating organizations х х х х Participating organizations MoH MoFALI EFD Annual expenditure of activities estimated in the plan and involved in budget of all participating organizations. . 6 1.5 Overall implementation of the plan to be reviewed jointly by the Ministries х MoH, MoFALI CHD, VABA Overall implementation of the plan reviewed by M&E and internal auditing departments in each Ministry. 1.6 Hold bi-annual National AMR conference to share information including the national AMR surveillance report , determine next steps for the action х x Technical working group (TWG) MoH, MoFALI, WHO, FAO, OIE Bi-annual National AMR conference organized. 1.7 Promote sharing of information from the human animal sector through relevant journals, establish each quarter reporting mechanism to AMR multi sectorial working group, TWG and related stakeholders х х х х NCCD, CHD, VABA, MoH, MoFALI, WHO, FAO, OIE Sharing of information from the human animal sector through relevant journals promoted, reported and disseminate to the AMR multi sectorial working group, TWG and relevant stakeholders quarterly. 1.8 Set up a coordinating mechanism to analyze the national AMR data with dedicated staff with job description х х х NCCD, VABA MoH, MoFALI, SCVL, NVDTCL WHO, FAO, OIE Coordinating mechanism to analyze the national AMR data established at NCCD and VABA with dedicated staff with job description. 7 1.9 Include in Law of animal health issue of control of drug residue in raw materials and products derived animals х MoFALI SCVL, NGOs Issue of control of drug residue in raw materials and products derived animals included in Law of animal health. 1.10 Develop a national program on food safety and quality including the determination of antimicrobial residues in food products and implement the program х х х MoFALI Vet Ins, NGOs Program developed and implemented. 2. Strengthen surveillance and diagnostic capacity for AMR and research 2.1 Develop a national guideline on determination and surveillance of AMR based on international accepted guidelines and the WHO AMR surveillance manual х NCCD, Vet Ins MoH, MoFALI, NZCD, NCPH, CHD, WHO, FAO, OIE National guideline on determination and surveillance of AMR developed. 2.2 Strengthen, update and harmonize microbiology identification SOPs for AST and AMR in human and animal laboratories х х х х NCCD, Vet Ins MNUMS, laboartories of selected II, III hospitals of aimags and districts and animal laboratories, WHO, ADB, FAO Mcrobiology identification SOPs for AST and AMR in human and animal laboratories strengthened and implemented in selected hospitals and animal laboratories. 8 2.3 Prepare training materials, distribute and conduct hands on and e-learning trainings on the use of the AMR surveillance manual and standardized SOPs in all laboratories (human and animal) x х х х NCCD, Vet Ins MoH, MoFALI, GASI, NZCD, VABA, NGOs, AFCCP, Academic Institutions WHO, OIE, FAO Training materials, distribute and conduct hands on and e-learning trainings on the use of the AMR surveillance manual and standardized SOPs in all laboratories (human and animal). . 2.4 Invite WHO expert on AMR in order to enroll into the Global AMR Surveillance System (GLASS) and conduct trainings for human and animal laboratories х MoH NCCD, NCZD, Vet Ins, NCPH, CHD, human and animal laboratories Training conducted. 2.5 Enroll into the Global AMR Surveillance System (GLASS, WHONET) and upload hospital laboratory data regularly in human and animal laboratories x x x x NCCD, Vet Ins Human and animal laboratories, TB lab, NCZD Human and animal laboratories enrolled into the Global AMR Surveillance System (GLASS, WHONET) and uploadad hospital laboratory data regularly. 2.6 Upgrade national WHONET network to aimags, districts, private hospitals laboartories and NZDC х х NCCD, Vet Ins Aimags, district, private hospitals laboartories and NCZD, WHO, OIE,FAO Aimags, districts, private hospitals laboartories and NZDC lab linked to WHONET. 2.7 Identify priority resistant pathogens transmitting from veterinary to human sector based on local and global antimicrobial х NCCD, Vet Ins, NCZD MoH, MoFALI, GASI WHO, OIE,FAO Priority resistant pathogens transmitting from veterinary to human sector identified. 9 surveillance data 2.8 Strengthen infstructure, lab equipments and reagents of microbiological laboratories to meet standard requirements in cascade x х х х Aimags, districts hospitals laboartories MoH, WHO, ADB Infstructure, lab equipments and reagents of selected microbiological laboratories strengthened to meet standard requirements. 2.9 Accredite human and animal laboratories in cascade and set up mechanism to improve proficiency testing х х х х NCCD, Vet Ins, human and animal lab MASM, human and animal lab, NGOs Selected human and animal laboratories accredited and improved proficiency testing. 2.10 Enroll in external quality assurance programme from UKNEQAS or other European providers/networks (e.g. ECDC) х х х х NCCD, Vet Ins, NCZD MoH, MoFALI, WHO, FAO, OIE Human and animal laboratories enrolled in external quality assurance programme from UKNEQAS/ECDC 2.11 Improve capacity of TB reference laboratory in line with AMR surveillance х х TB reference laboratory MoH, Global Fund Capacity of TB reference laboratory improved 2.12 To increase the number of laboratories capable of early and rapid detection of antimicrobial resistance by means of molecular biological level in regards with tuberculosis and rifampicin х х х х RDTC, Hospitals’ DTC, aimags, and districts’ TB laboratories MoH, Global Fund The number of laboratories capable of early and rapid detection of antimicrobial resistance by means of molecular biological level in regards with tuberculosis and rifampicin 2.13 Identify and locate opportunities to introduce rapid detection method for AST x x x FCH, TCH Rapid method for determination of AST introduced. 10 3. Reduce the spread of infections through better infection prevention and control (IPC) 3.1 Undertake assessment of IPC knowledge, attidue, and practice (KAP) among health professionals х х Research organization/ team, NGOs NCPH, CHD, MoH, AFCCP, ADB, WHO Assessment conducted, recommendations disseminated. 3.2 Conduct regular trainings on strengthening IPC among health professionals based on results of the assessment х х х х NCCD, Academic organizations NCPH, CHD, MoH, ADB, WHO Trainings conducted. 3.3 Develop IPC training and communication materials based on results of KAP survey of health professionals, publish and disseminate x x x CHD, NCPH, NGOs MoH, ADB, WHO IPC training and communication materials based on results of KAP survey of health professionals developed, published and disseminated. 3.4 Strengthen guidelines on active surveillance linked to main hospital acquired infections and implement х х NCCD, FiHCDP MoH, ADB Guidelines on active surveillance linked to 4 main hospital acquired infections developed, approved and implemented (in 2017 8, 2018- 11 hospitals) 3.5 Implement active surveillance of hospital acquired infections in aimags’ and districts’ hospitals step by step х х х х NCCD, FiHSDP MoH, HDs of capital city and aimags, ADB, WHO Active surveillance of hospital acquired infections implemented in aimags’ and districts’ hospitals 3.6 Develop job description of hospital epidemiologist and infection disease specialist and get х х NCCD, hospitals MoH, ADB Job description of hospital epidemiologist and infection disease specialist developed and approved. 11 approval 3.7 Create a national surveillance and information system for infectious diseases х х MoH, CHD, NCCD, NCZD Capital city’s HD, aimags’ and capital city’s HDs National surveillance and information system for infectious diseases created. 3.8 Study identification of the antmicrobial resistance x x MoH, NCCD, NCZD Vet Ins Donor organizations Study report. 3.9 Develop and comply with the revised regulations in regards with the prevention, detection and surveillance of resistant isolates x х х NCCD, NCPH MoH, hospitals WHO Regulation procedure approved and implemented. 3.10 Improve the centralized sterilization of hospitals and equipment, tools with high risk of infection (lenses, respiratory apparatus) in compliance with the standards х х х х Hospitals MoH, FiHSDP, АDB, WHO Centralized sterilization of hospitals and equipment, tools with high risk of infection (lenses, respiratory apparatus) improved in compliance with the standards. 3.11 Strengthen the infection prevention and control system in health care facilities, introduce an implementation plan of newest and modest technology of waste management and provide modern sterilization and disinfection х х х NCCD, hospitals MoH, aimags’ and capital city’s HDs Implementation plan of newest and modest technology of waste management introduced and modern sterilization and disinfection equipment provided in healh care facilities. 12 equipment and tools step by step 3.12 To update IPC guidelines for animal husbandry based on international guidelines x x x x Vet Ins MoFALI, FAO, OIE IPC guidelines for animal husbandry based on international guidelines 4. Ensure quality and safety of antimicrobial medicines 4.1 Update, get approval and disseminate Essential Medicines List x x MoH MoH, Profeesional Committee Essential Medicines List updated and disseminated 4.2 Develop and comply with procedures on recalling medicines, bio preparations, medical devices, biologically active compounds and corresponding raw materials, starting materials from market, withdraw, abolish, re-working and re- licensing such products to the market х x x MoH GASI, CHD Legal aspects on recalling medicines, bio preparations, medical devices and biologically active compounds from market established and implemented. 4.3 Set up mechanism that bioequivalence determination should be one the criteria for registration of generic antimicrobials х х x x HDC, CHD MoH, GASI, DCL Bioequivalence determination- one the criteria for registration of generic antimicrobials. 4.4 Develop methodology for determination of bio potency of antibiotics by microbiological х х х х Human pharmacop eia DCL, MNUMS Methodology of determination of bio potency of antibiotics by microbiological method developed. 13 method and conduct test regularly committee 4.5 Conduct post marketing surveillance of antibiotics quality and safety х х Human pharmaco peia committee, Research team GASI, DCL, MNUMS, Drug manufacturers and importers Post marketing surveillance of antibiotics quality and safety conducted. 4.6 Study prevalence of substandard, illegal medicines (including antimicrobilas) in drug market х Research team MoH, ADB, Technical Assistant Project Prevalence of substandard, illegal medicines (including antimicrobilas) in drug market studied. 4.7 Develop national “Antimicrobial guidelines” based on local antibiograms and international guidelines and comply with х x x х FCH, SCH, TCH, NCCD, MNUMS MoH, CHD, WHO “Antimicrobial guidelines” based on local antibiograms developed and complied. 4.8 Disseminate antimicrobial guidelines to all hospitals and hold regular training workshops (hands on and e-learning) on the use of the guidelines with health-care professionals х х х х Hospitals, academic institutions Health care facilities, WHO Hands on and e-learning trainings on the use of the “Antimicrobial guidelines”provided. 4.9 Develop hospital antibiotic resource policy and set up mechanism to register the medicines included in the hospital resource policy х х х SCH, NGO hospital association MoH, CHD, Em Association, WHO Hospital antibiotic resource policy developed and priority antibiotics registered. 4.10 Ensure manufacturing of antimicrobials are compliant with GMP х х х х MoH, drug manufactur ers GASI, Em association Drug manufacturers producing antimicrobials complied with GMP standard. 14 4.11 Develop and implement enforce regulation on prescription only dispensing medicines, including antibiotics х х х х CHD, MoH GASI, hospitals, pharmacies Enforce regulation on prescription only sales medicines, including antibiotics approved and implemented. 4.12 Strengthen capacity of GASI inspectors regarding to enforcement implementation of AMR issue х х х х GASI MoH, MoFALI, Donor organizations Inspectors GASI trained, capacity improved. 5. Optimize the use of antimicrobials in the human and animal sectors 5.1 Revise and update drug registration procedure in human and animal sector х HDC, ADC MoH, MoFALI Drug registration procedure in human and animal sector updated and approved. 5.2 Develop country specific antimicrobial consumption (AMC) methodology and programme for human animal health x MoH, MoFALI CHD, NCPH, VABA, research institutions Country specific antimicrobial consumption (AMC) methodology and programme for human animal health developed. 5.3 Collect AMC data and develop annual report for human and animal health sector x x x MoH, MoFALI WHO, FAO, OIE AMC data collected and annual report for human and animal health sector developed. 5.4 Conduct ongoing awareness raising activities on rational use of antimicrobials and risks of AMR for human and animal sector,health care professioanals, general public and herdsmen within WAAW х х х х MoH, MoAFLI, CHD, VABA, AFCCP, GASI, donor organizations, Professional Assiciasions, NGOs Awareness raising activities on rational use of antimicrobials and risks of AMR conducted. 15 5.5 Expand existing interactive training materials on appropriate use of antimicrobials and AMR for health care professionals х х х MNUMS CHD, hospitals Existing interactive training materials on appropriate use of antimicrobials and AMR expanded and training with credit hour for health care professionals provided. 5.6 Conduct one month campaing on rational use of antibiotics in hospitals according to specific schedule every year х х х х CHD Health care facilities in UB One month campaing on rational use of antibiotics conducted in II and III levels hospitals during a year and reports of activities done. 5.7 Develop and implement a national AMS guideline for selected hospitals х FCH, TCH, hospitals DTCs MoH, MNUMS, WHO National AMS guideline in selected 2 hospitals developed, implemented and disseminated to other hospitals. 5.8 Develop and implement standards on prescription and prescribing of veterinary medicines х х х х Animal Pharmaco peia Committee MoFALI, ADC Standards on prescription and prescribing of veterinary medicines developed and implemented. 5.9 Develop interactive training module on rational use of drugs and AMR in animal sector х Vet Ins, Academic institutions MoFALI, Donor organizations Interactive training module on rational use of drugs and AMR in animal sector developed. 5.10 Provide and evaluate regular training on developed interactive training module on rational use of drugs and AMR in animal sector for vets and specialists of animal sector х х Vet Ins, Academic organiza tions AFCCP, Entities, Professional org, NGOs, vets, veterinary pharmacists Regular training on developed interactive training module on rational use of drugs and AMR in animal sector for vets and specialists of animal sector provided and trainings evaluated. 16 5.11 Assess and strengthen inspection law implementation on enforcement of regulation of prescription only sales of antimicrobials х CHD, VABA MoH, MoFALI, GASI, AFCCP Assessment report, correct actions done. 6.Raise awareness and understanding of AMR and rational use of the general public, herdsmen and health professionals 6.1 Promote activities to expand activities for increasing number of reimbursed prescription antibiotics CHD SIGA, Hospitals, Em association, Association of FGPs, AFCCP Number of reimbursed antibiotics increased. 6.2 Publish all health care facilities prescription form in sufficient number, provide monitoring control of suplly of prescription forms regularly х х х х Health care facilities, CHD Em association, Association of FGPs, AFCCP, GASI All health care facilities prescription form in sufficient number. 6.3 Conduct KAP surveys of the general public and hersdsmen on AMR and rational use drugs х х NCPH CHD, AFCCP, NGOs, Academic Institutions Asssessment reports completed, recommandations done. 6.4 Develop and disseminate via public media IEC materials, posters, short videos ect on AMR and rational use drugs for general public, herdsmen and health professionals х х х х NCPH, CHD, Agriculture Science Academy MoH, MoFALI, GASI, AFCCP, Professional org, NGOs IEC materials, posters, short videos ect on AMR and rational use drugs for general public, herdsmen and health professionals developed, disseminated via public media. 6.5 Comment to introduce rational use х MoH, CHD MoECSS Rationale of introduction of rational use 17 of drugs and risks of AMR module/tool into secondary school curriculum of drugs and risks of AMR module into secondary school curriculum commented. 6.6 Organize actions to involve into awareness raising activities on rational use of drugs and AMR governmental, NGOs, public media tools (TV, FM, facebook, twitter), journalists ect х х х х AFCCP, TWG MoH, MoFALI, NGOs, public media Governmental, non governmental organizations, public media tools, journalists involved into awareness raising activities on rational use of drugs and AMR. 6.7 Information sharing about AMP in human and health sector via professional journals х х х х CHD, Vet Ins, NGOs MoH, MoFALI Information sharing about AMP in human and health sector via professional journals provided. 6.8 Determine the economic burden related to AMR and inform all stekeholders х х NCCD, Vet Ins, NCPH, CHD, MNUMS MoH, MoFALI, WHO, FAO,OIE The economic burden related to AMR determined and informed to relevant stakeholders. 6.9 Develop training material and conduct regular tranings on rational use of medicines, AMR and prescription for FGPs, soums and bags health care spesialists and evaluate trainings х х х х FGPs Association, Acadermic institutions NCPH, CHD Traning materai on rational use of medicines, AMR and prescription for FGPs, soums and bags health care spesialists prepared and the specialist trained. 6.10 Promote to provide specific activities on dispencing prescription only antibiotics for pharmacies х х х х “Em” association, Association of veterinary pharmacists Aimags,districts health departments Specific activities on dispencing prescription only antibi otics for pharmacies organized and all pharmacies complied with. 18 6.11 Translate , publish and disseminate key technical documents to support decision making -Sanford Guide to Antimicrobial Therapy 2016 46th edition х х Professional association SCH MoH, Donor organizations Sanford Guide to Antimicrobial Therapy 2016 46th edition translated, published and distributed.