Kingdom Saudi Arabia National Action Plan on Combating Antimicrobial Resistance

1 | P a g e KINGDOM SAUDI ARABIA NATIONAL ACTION PLAN ON combating ANTIMICROBIAL RESISTANCE January 2017 2 | P a g e Table of content Abbreviations and acronyms 3 Foreword 4 Executive summary 5 Introduction 6 Situation analyses and Assessment 7 Country Response 9 Strategic plan 10 Operational plan and budget 18 Monitoring and evaluation plan 35 References 42 3 | P a g e Abbreviations and acronym AMR Antimicrobial Resistance C-DIFF Clostridium Difficile CLSI The Clinical and Laboratory Standards Institute CRE Carbapenem-Resistant Enterobacteriaceae DDD Defined Daily Dose DOT Days of therapy ESBL Extended-Spectrum Beta-Lactamases EUCAST European Committee for Antimicrobial Susceptibility Testing FAO The Food and Agriculture Organization of the United Nations GLASS Global Antimicrobial Resistance Surveillance System GCC-I-C Gulf Cooperation Council- Center of infection control GDIPC General Directorate of Infection Prevention and Control GHSA Global Health Security Agenda GNB Gram-negative bacteria HCAIs Healthcare-Associated Infections HESN Healthcare Electronic Surveillance Network IPC Infection Prevention Control KFMC King Fahd Medical City KSA Kingdom of Saudi Arabia MOH Ministry of Health MOE Ministry of Education MEWA Ministry of environment, water, and agriculture MDROs Multi-Drug Resistant Organisms MRSA Methicillin Resistant Staph Aureus NGHA National Guard Health Affairs NHSN National Healthcare Safety Network OIE World Organization for Animal Health Saudi FDA Saudi Food and Drug Administration US-CDC United States Center for Disease Control and Prevention Vet. Clinics Veterinary Clinics VRE Vancomycin-Resistant Enterococci WHO World Health Organization 4 | P a g e Foreword Antimicrobial resistance threatens the advancement in medicine and the ability to respond to the threat of infectious diseases. The complexity of management and care of patients require effective antimicrobial drugs to prevent and treat associated infections with various conditions and especially those with surgeries and receiving chemotherapy. Misuse and overuse of antimicrobials in human medicine and food production have put every nation at risk, and the Kingdom of Saudi Arabia is not an exception. Few replacement products are in the pipeline. Therefore, an immediate action on a global scale is required before we lose such essential agents. Without such action, we are heading towards a post-antibiotic era in which common infections could once again kill. It is suggested that without policies to stop the worrying spread of AMR, today's already large 700,000 deaths every year would become an extremely disturbing 10 million every year, more people than currently die from cancer. Indeed, even at the current rates, it is fair to assume that over one million people will have died from AMR since he started this Review in the summer of 2014. AMR also has a very real economic cost, which will continue to grow if resistance is not tackled. The cost regarding lost global production between now and 2050 would be an enormous 100 trillion USD if we do not act. Alert to this crisis, the May 2015 World Health Assembly adopted a global action plan on antimicrobial resistance, which outlines five objectives: ��To improve awareness and understanding of antimicrobial resistance through effective communication, education, and training ��To strengthen the knowledge and evidence base through surveillance and research; to reduce the incidence of infection through effective sanitation, hygiene and transmission prevention measures ��To optimize the use of antimicrobial medicines in human and animal health ��To develop the economic case for sustainable investment that takes account of the needs of all countries and to increase investment in new drugs, diagnostic tools, vaccines and other interventions. This action plan for the Kingdom Saudi Arabia to combat antimicrobial resistance has been formulated in the line of the WHO five objectives. It addresses the need for effective “one health” approach involving coordination among numerous national sectors and actors, including human and veterinary medicine, agriculture, finance, environment, and well-informed consumers. Therefore, a large committee of all stakeholders was formed with five technical subcommittees were established to addresses every aspect to contain antimicrobial resistance in the country. Hail M. Al-Abdely, MD Head, AMR National Committee 5 | P a g e Executive summary World Health Assembly adopted a global action plan in May 2015 on antimicrobial resistance, which outlines five objectives, so, Kingdom Saudi Arabia conjoined National Committee for tackling the antimicrobial resistance representing members from different national organizations and formulated five technical committees to implement the WHO AMR objectives.1 The Kingdom Saudi Arabia AMR national action plan highlights the need for effective “one health” approach including human and animal health. The core component of the KSA AMR national action plan consists of: 1.�Strategic plan (goal and objectives, priories and intervention) 2.�operational plan (activities, implementation arrangements, time table, responsible entities, detailed budgeting and costing 3.�Monitoring and evaluation plan (performance indicators, targets and timelines, and data collection and reporting methods) 4.�The objectives of the plan will be achieved by implementing the following Strategic activities 4.3�Improvement the awareness of antimicrobial resistance and promote behavioral change 4.4�Studying the pattern of antimicrobial resistance 4.5�Implementing Infection control programs 4.6�Implementing an antibiotic stewardship program 4.7�Study the Economic burden of AMR in human and animal health 6 | P a g e Introduction Antimicrobial resistance (AMR) in bacteria is emerging and spreading rapidly worldwide. This phenomenon is nowadays affecting public and animal health dramatically on a global level. Unfortunately, the current dependence on antibiotics - whether to treat, prevent, or stimulate food animal growths - have exponentially increased this resistance. When antibiotics are used, selective pressure is created, and possibly forcing the exposed bacteria to mutate or acquire pieces of DNA to become antibiotic resistant. The selection pressure resulting from the overwhelming use and misuse of antibiotics is exponentially supporting the AMR phenomenon. The multidrug-resistant (MDR) pathogens are spreading rapidly in many parts of the world causing severe medical and economic consequences. It is estimated that at least every 10 minutes a patient dies in the USA or Europe because of fatal infections caused by antibiotic-resistant bacteria 1 The Goal of the WHO Global action plan is to ensure, for if possible, continuity of successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them. In May 2015 World Health Assembly adopted a global action plan on antimicrobial resistance with five objectives 1,2 Objective 1: Improve awareness and understanding of antimicrobial resistance through effective communication, education, and training� Objective 2: Strengthen the knowledge and evidence base through surveillance and research � Objective 3: Reduce the incidence of infection through effective sanitation, hygiene and infection prevention measures � Objective 4: Optimize the use of antimicrobial medicines in human and animal health� Objective 5: Develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions The kingdom Saudi Arabia AMR action plan underscores the need for effective “one health” approach involving coordination among numerous international sectors and actors, including human and veterinary medicine, agriculture, finance, environment, and well-informed consumers. The action plan recognizes and addresses both the variable resources nations must combat antimicrobial resistance and the economic factors that discourage the development of replacement products by the pharmaceutical industry. The objectives of WHO were also adopted by The Kingdom of Saudi Arabia. 7 | P a g e Situational Analysis and Assessment A literature review of MDR in Gram-negative bacilli (GNB) showed a substantial increase in the rate of carbapenem-resistant GNB in Saudi Arabia over the last decade in comparison with the rates of the 1990s3. It also documented the increasing prevalence of extended spectrum beta-lactamase (ESBL) producing isolates from Saudi Arabia, where some institutions had 29% ESBL rates among Escherichia coli (E. coli) and 65% ESBL rates among Klebsiella pneumoniae (K. pneumoniae). Thus, these increasing rates have been associated with many reported outbreaks and mortality that ranged between 11-40% 3 Recent region-wide surveillance studies reported that most of carbapenem-resistant Enterobacteriaceae (CRE) from the Gulf Cooperation Council States (GCC) had been found to harbor the carbapenemase encoding genes blaOXA-48-type, and blaNDM-1.4 Carbapenem-resistant Acinetobacter baumannii (A. baumannii) (CRAB) from Saudi Arabia have also increased dramatically over the years. A recent study from Riyadh5 showed that the susceptibilities of A. baumannii to meropenem and imipenem in 2006 ranged between 64-81.2%, while the susceptibility in 2012 ranged between 8.3-11%. Molecular investigation on different CRAB isolates obtained from all the GCC states revealed that many isolates, from different countries, have clustered together, suggesting clonality.6 The colistin resistant and even pan-drug resistant GNB have already been reported. A Saudi national surveillance on Gram-positive cocci demonstrated that 32% of Staphylococcus aureus (S. aureus) are methicillin-resistant (MRSA), and 33% of Streptococcus pneumoniae are resistant penicillin G and 26% are resistant to erythromycin.7 Several factors are associated with the increasing emergence and spread of MDR bacteria in Saudi Arabia. It is evident that the unoptimized use of antibiotics is a major factor for AMR development. A hospital in Riyadh has well demonstrated the overuse of antimicrobial agents from 4 adult ICUs in 2010, where the highest use was meropenem (33.2 defined daily doses [DDD] per 100 bed-days), followed by piperacillin tazobactam (16.0 DDD/100 bed-days). On the other hand, the DDD/100 bed-days in 37 ICUs in the United States was 3.75 for carbapenems and 7.08 for antipseudomonal penicillins.3 Over-the-counter antibiotics without prescription in Saudi community pharmacies is another issue that is driving the improper use of antibiotics. Only one out of 88 pharmacists in Eastern province refused to sell antibiotics without a prescription, and 77.6% of the pharmacies in Riyadh dispensed antibiotics without a prescription3 Heavy international travel activities are occurring due to the large population of expatriates and to pilgrimage the Holy cities. A recent study showed that returned travelers from Hajj had acquired MDR A. baumannii and NDM-producing E. coli during the Hajj event. Previous data from 2 major hospitals in Makkah showed that ceftazidime resistance is evident in 24.6% of E. coli, 34.4% of K. pneumoniae, and 52.7% of P. aeruginosa.8 Another issue that can contribute to the spread of AMR is the challenges related to the adherence of infection control practices. The hand hygiene compliance rate in a hospital in Makkah in 2011 was 50.3%. 8 | P a g e The effectiveness of hand hygiene compliance was well demonstrated in controlling a nosocomial outbreak caused by carbapenem-resistant K. pneumoniae in Riyadh3. There hasn’t been a structured national plan on laboratory surveillance and preventive measures to circumvent the ongoing surge in microbial resistance. A survey of 20 MOH laboratories survey done in 2015 has shown that 18 out 20 hospitals reported antibiograms with current CLSI reference. They have AMR policy and quality assurance, it was found that 60% of staph aureus were resistant to oxacillin, and 50% of E Coli were resistant to 3rd generation cephalosporins,60% of Acinetobacter resistant to Amikacin AND Colistin 40%). Although detection and reporting happen at the institutional level, but coordination between health institutions was not established. No data exist on incidence, mortality and economic impact. Now through the National AMR program, a systematic approach toward the problem is established in guidance with WHO and GHSA action package.9 9 | P a g e Country Response Governance A conjoined National Committee for Tackling the problem of AMR signed with the highest authority (His Excellency the Minister of Health) has been formed with representatives from the following bodies: Ministry of Health 1.�National CDC 2.�Assistant deputy ministry for preventive medicine (The General Directorate of Infection prevention and control, The General Directorate for Infectious Diseases, Field Epidemiology program) 3. The General Directorate of Laboratories and Blood Banks 4. National Health Laboratory 5.�The General Directorate of Pharmaceutical Affairs 6.�The General Directorate for Hospitals 7.�The General Directorate for Media and general affairs 8.�Medical Cities 9.�The Directorate of Medical Licensing Governmental non-MOH 1. Ministry of Environment, Water, and Agriculture 2. Ministry of Education 3. Ministry of Defense- Health Affairs 4. Ministry of Interior – Health Affairs 5. Ministry of National Guard - Health Affairs 6. Ministry of Culture and Information 7. King Saud University 8. King Abdul Aziz City for Science and Technology (KACST) 9. King Saud Bin Abdul Aziz University for Health Sciences 10. King Faisal Specialist Hospital and Research Center 11. Saudi Food and Drug Authority 12. Gulf Cooperation Council - Centre for Infection Control 13. Central Board for Accreditation of Healthcare Institutions (CBAHI) 14. Saudi Commission for Health Specialties Non-Governmental organizations (NGOS) 1.�The Saudi Society for Medical Microbiology and Infectious Diseases 2.�The Saudi Society for Pediatric infectious diseases 3.�The Saudi Society for Sterilization and Infection control 10 | P a g e Part I: Strategic Plan 11 | P a g e KSA AMR Strategic Plan Global action plan strategic objective 1: Improve awareness and understanding of antimicrobial resistance through effective communication, education, and training Objective 1. Increase National Awareness about AMR Strategic interventions Activities Milestone 1.1.�Establish an evidence-based communication program targeting the public for both human and animal health 1.1.1�Assess public awareness about AMR and o� Survey on public awareness of use and misuse of antibiotics. Assign a research team to conduct qualitative (focus group) and quantitative (surveys) data collection. o� Survey on knowledge and attitude toward use and misuse of Antibiotics in Livestock 1.1.2.�Production of Media related materials including documentary on AMR 1.1.3.� Awareness campaign during Antimicrobial Awareness Week (November 2016) in response to WHO World Antibiotic Awareness Week from 14- 20 November 2016 with the theme this year "Antibiotics: Handle with Care." The activities include: - Preparation of awareness materials and brochures, Short awareness messages for broadcasting on Twitter and snap chat, Awareness Video " History of war between bacteria and antibiotics" on YouTube, Broadcasting on TV channel and national newspapers to sensitize society about antimicrobial resistance and rationalizing antibiotic use, Attraction of famous players in Saudi teams to participate in sending the awareness messages, survey study to assess community awareness of antibiotic use. 1.1.4.�Mainstream media engagement 1.1.5.�Applying the tailored interventions 1.1.5.1.�Universities carry out direct public engagement campaigns. Oct 2017 12 | P a g e 1.1.5.2.�Award university clubs. 1.1.5.3.�Work with MOH and launch the Public Health Champion program. 1.1.5.4.�Work with MOE on national curriculum to include the AMR topic. 1.2.�Establish an evidence-based public communication program targeting the healthcare providers for both human and animal health 1.2.1�Awareness program will be prepared for health care providers for both in human and animal health Oct 2017 Objective 2. Improve knowledge of AMR and related topics 2.1.�Include AMR and related topics as a core component of professional education, training, certification and development 2.1.1.�AMR and related topics in undergraduate curricula for human health professionals, animal health professionals and food industry and agriculture professionals. 2.1.2.� AMR E-Learning educational program 2.1.3.�AMR revised and approved educational programs in health care facilities Oct 2017 Global action plan Strategic Objective 2: Strengthen the knowledge evidence base through surveillance and Research Objective 3. Set up a national surveillance system for antimicrobial resistance 3.1.� Establish a national coordination structure for surveillance of AMR. 3.1.1.�National coordinating committee with appropriate mandate and terms of reference and a focal point (Lab surveillance technical committee, Dr. Ali Alsomaily) Jan 2017 3.2.� Designate and develop reference microbiology laboratory facilities to coordinate an effective epidemiologically surveillance of antimicrobial resistance 3.2.1.�Seven CAP accredited. Laboratories were designated to collect the antimicrobial resistance data for the last five years. Riyadh: (KAMC-Riyadh, King Faisal Specialist Hospital & Research Center, KFMC, and King Khaled University Hospital); Eastern Province: King Fahd University hospital in Khobar; Western Province: King Abdulaziz University Hospital. 3.2.2.�Twenty-four MOH laboratories Antibiogram from various regions of the kingdom. June 2017 13 | P a g e 3.2.3.�Determination of KPIs needed from each of the sentinel sites. 3.2.4.�Utilizing Point of care testing 3.3.�AMR surveillance Sentinel sites in human 3.3.1.�12 AMR surveillance Sentinel sites from different regions are selected ��KAMC-Riyadh, King Faisal Specialist Hospital & Research Center, KFMC, and King Khaled University Hospital); Eastern Province: King Fahd University hospital in Khobar; Western Province: King Abdulaziz University Hospital. ��King Abdulaziz – Jeddah ��King Fahd Hospital – Jeddah ��Dammam Medical Complex - Eastern Region ��Assir Central Hospitals Assir ��King Khaled Hospital – Tabouk March 2017 3.4�AMR Sentinel sites in animal 3.4.1.�Six Sentinel sites for surveillance of infections caused by AMR pathogens: ��Riyadh. ��Al-Hassa, ��Al-Dammam ��Jeddah ��Assir ��Al-Kharj 3.4.2.�Surveillance for detection of salmonella, campylobacter and total bacterial count in poultry in all regions of Kingdom (2016). JAN 2017 3.5.�Determine the country priority microorganisms with mechanisms of resistance for AMR surveillance and adapt and apply WHO model systems for antimicrobial resistance surveillance (GLASS) 3.5.1.�WHO priority pathogens including (S. aureus, E. coli, K. pneumoniae plus added pathogens of national priority as VRE, Non-Fermentative GNB. Acinetobacter, Pseudomonas) 3.5.2.�GLASS protocol was endorsed to laboratories during a workshop (10 Labs) and includes age and sites in the upcoming data. June 2017 3.6.�Establishment of systems IT for 3.6.1.�Working on software to link Designated sentinel to 14 | P a g e monitoring antimicrobial and link all sentinel sites to the national center for analysis and reporting. national lab to improve reporting analysis June 2017 Objective 4. Build laboratory capacity to produce high-quality microbiological data for patient management and support surveillance activities in both human and animal sectors 4.1. Designate a national reference laboratory for AMR surveillance 4.1.1. The National lab will assume responsibility for AMR lab in the future. Currently, the AMR Sentinel sites labs will perform required AMR testing and reporting June 2017 4.2. training workshops for microbiologist and laboratory technicians 4.2.1. Plan for series training, workshops will be formulated for Microbiology doctors and lab technicians for all hospitals> 150 beds June 2017 Global action plan strategic Objective 3: Reduce the incidence of infection through effective sanitation, hygiene and prevention measures Objective 5. Establish a national infection prevention and control program 5.1. Create a formal organizational structure to ensure proper development and use of infection prevention and control policies and strategies 5.1.1.�IC Organizational structure has been established 5.1.2.�Core component has been established and distributed 5.1.3.�Infection control national manual distributed to all health care regions 5.1.4.�IC Auditing tool program 5.1.5.�Hand hygiene campaign 2017 Objective 6. Introduce infection prevention and control program in veterinary settings and animal husbandry 6.1. Create a formal organizational structure to ensure proper development and use of infection prevention and control policies and strategies 6.1.1. Write and approve Infection Control Guideline in animal health by KSA MEWA June 2017 6.2. Include hygiene and infection prevention and control as core 6.2.1. MEWA plans for Infection control training June 2017 15 | P a g e (mandatory) content in training and education of veterinary professionals Objective 7 Limit the development and spread of AMR outside health settings by infection prevention and control 7.1. Promote personal hygiene by social mobilization and behavioral change activities 7.1.1. Estimate knowledge of personal hygiene in different social groups as a basis for the social mobilization campaigns June 2017 Global action plan strategic Objective 4: Optimize the use of antimicrobial medicines in human and animal health Objective 8. Ensure uninterrupted access to high-quality antimicrobial medicines 8.1. Strengthen the pharmaceutical supply chain, including the procurement, supply, and management system. 8.1.1. Establish a quality management system for the supply of medicines, covering storage, transport, expiry date, etc. June 2017 Objective 9. Improve and measure appropriate use of antimicrobial agents in health care 9.1.�Create formal antimicrobial stewardship programs in health care facilities 9.1.1.�Plan for series training, antimicrobial stewardship programs workshops will be formulated in all healthcare facilities > 150 beds Dec 2017 9.2.�Awareness and Education on stewardship for Healthcare facilities & veterinary practice � 9.2.1.�Target selected hospitals based on bed capacity from each region of the kingdom: 1- Antibiotic Awareness week 2- Workshops, seminars, case studies, grand rounds, etc. 3-Booklets, brochures, posters, &pocket cards 4- Teleconference or phone consults to hospitals with no ID or Clinical pharmacists to perform ASP 5- Increase awareness of public pharmacist on ASP 9.2.2.�To consider standardized educational material or electronic tool June 2017 9.3.�Guidelines and order sets 4.7.1�Development, awareness & Implementation of empiric antimicrobial guidelines for treatment of community & healthcare associated infection to 20 MOH hospitals. June 2017 16 | P a g e 4.7.2�Integrating those guidelines into electronic health records whenever possible. 4.7.3�Standardizing Surgical Antibiotic Prophylaxis through preset order sheets in 20 selected MOH hospitals. 9.4.� Clinical Care Standards "bundle" implementation 9.4.1.�Medium sized (>150 beds) hospitals should apply "MOH approved" stewardship bundles/ best practices to optimize prescribing practices Dec 2017 9.5.� Mandating Stewardship implementation in all JCI/ CBAHI accredited hospitals 9.5.1.�Communicate with CBAHI to include ASP in the requirements for accreditation/ reaccreditation." June 2017 9.6.�Requesting Stewardship Program KPIs on process and outcome 9.6.1.�5 Antibiotics, 5 MDROs: 1- DOT per 1000 patient days 2- Duration of empiric antibiotics therapy more than seven days 3- Prevalence and trend of CDI April 2017 9.7.�Postgraduate education: enrollment requirement for national residency training programs 9.7.1.�Communication with Saudi Commission for Health Specialties to add to Infection control module Stewardship component; it can be an online module as a prerequisite for enrollment in all medical, nursing, paramedical, and Pharmacy residency programs." Jan 2018 9.8.�Building Capacity: Training Clinical Pharmacists and ID Fellows 9.8.1.�Antimicrobial Stewardship training programs Jan 2018 9.9.�Train the Trainers once a group of certified trained personnel is available 9.9.1.�Setting up a training center/ academy in MOH to train trainers in Principles and Practice of Implementation of ASP in Healthcare Settings Jan 2018 9.10.�Antimicrobial Stewardship Research 9.10.1.�-National Point Prevalence Survey on antimicrobial consumption & resistance in line with Global PPS Multicenter study on the impact of implementation of stewardship on length of stay & cost saving June 2017 Objective 10. Ensure prudent use of antimicrobial agents in terrestrial and aquatic animals and agriculture 10.1. Restrict use of critically important antimicrobials for human medicine in food production animals 10.1�Ongoing surveillance of antibiotics consumed in food production animals and avoiding the following antimicrobial classes: Quinolones, 3rd and 4th generation cephalosporin antibiotics, macrolides, Jan 2018 17 | P a g e ketolides, and glycopeptides Global action plan strategic objective 5: Develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions Objective 11. Identify gaps in research and prepare the economic case for utilization of new medicines, diagnostic tools, vaccines and other interventions 11.1. Economic impact assessment and burden of antimicrobial resistance 11.1.1. Study the cost and economic burden of AMR in Humans. 11.1.2. Study the cost and economic burden of AMR in animals. June 2017 Oct 2017 18 | P a g e Part II: Operational plan and budget 19 | P a g e Operational plan and budget Activity Unit Quantity Date Location Responsible entity Cost (SAR) Source of funding Indicator Strategic intervention 1.1. Establish an evidence-based communication program targeting the public for both human and animal health 1.1.1. Assess public awareness about AMR through: o� Survey on public awareness of use and misuse of antibiotics. Assign a research team to conduct qualitative (focus group) and quantitative (surveys) data collection. o�Survey on knowledge and attitude toward use and misuse of Antibiotics in livestock. Public Awareness Survey Public Awareness Survey 1 1 NOV 2017 NOV 2017 Nationwide Nationwide AMR awareness technical committee AMR awareness technical committee 100,000 MOH MEWA Increases level of awareness 1.1.2� Production of Media related materials including documentary on AMR AMR website 1 NOV 2017 Network AMR awareness technical committee 70,000 MOH Number of documentari es produced 1.1.3� Annual awareness campaign during Antimicrobial in response to WHO World Antibiotic Awareness Week awareness campaign 1 NOV 2017 Nationwide AMR awareness technical committee 200,000 MOH Number of participating sectors 1.1.4� Mainstream media engagement awareness campaign 2 NOV 2017 Nationwide AMR awareness technical committee MOH Number of participating TV channels 20 | P a g e 1.1.5� Applying the tailored interventions: 1.1.5.2�Award university clubs. 1.1.5.3�Work with MOH and launch the Public Health Champion program. 1.1.5.4�Work with MOE on national curriculum to include the AMR topic. awareness campaign awareness campaign awareness campaign 5 2 1 NOV 2017 NOV 2017 NOV 2017 Nationwide Nationwide Nationwide AMR awareness technical committee AMR awareness technical committee AMR awareness technical committee 25,000 10,000 20,000 MOH MOH MOE Number of participating universities increased awareness of AMR among school students Strategic intervention 1.2. Establish an evidence-based public communication program targeting the healthcare providers for both human and animal health. 1.2.1�Awareness program will be prepared for healthcare providers for both in human and animal health awareness program 1 NOV 2017 Nationwide National AMR awareness technical committee 200,000 MOH + MEWA Number of participating healthcare providers for both in human and animal health Strategic intervention 2.1. AMR and related topics as core components of professional education, training, certification and development 2.1.1�AMR and related topics in undergraduate curricula for human health professionals, animal health professionals and food industry and agriculture professionals. AMR curricula 1 NOV 2017 Nationwide National AMR (Stewardship & technical committee) 0 MOH Prepared by committees and approved curriculum by Saudi Commission 21 | P a g e 2.1.2� AMR E – Learning educational program Program 1 Jan 2018 Nationwide GDIPC 300,000 SCFHS Prepared by committees and approved by Saudi Commission 2.1.3� AMR revised and approved educational programs in health care facilities Program 1 Nov. 2017 Nationwide National AMR (Stewardship & technical committee) 210,000 MOH Prepared by MOH Strategic intervention 3.1. Establish a national coordination structure for surveillance of AMR 3.1.1�National coordinating committee with appropriate mandate and terms of reference and a focal point National coordinatin g committee 1 JAN201 7 Nationwide Lab surveillance technical committee. - Committee formation Strategic intervention 3.2. Designate and develop reference microbiology laboratory facilities to coordinate effective epidemiologically surveillance of antimicrobial resistance 3.2.1�Seven CAP accredited. Laboratories were designated to collect the antimicrobial resistance data for the last five years. Riyadh: (KAMC-Riyadh, King Faisal Specialist Hospital & Research Center, KFMC, and King Khaled University Hospital); Eastern Province: King Fahd University hospital in Khobar; Western Province: King Abdulaziz University Hospital. Seven CAP accredited hospital Retrospe ctive 5 years Antibiogr am report Nov 2017 Assigned CAP accredited labs Lab surveillance technical committee. - Percentage of resistant organisms 22 | P a g e 3.2.2�Twenty-four MOH laboratories Antibiogram from various regions of the kingdom. 24 MOH labs Biannual Antibiogr am reports March 2017 MOH labs Lab surveillance technical committee. MOH Percentage of resistant organisms 3.2.3�Utilizing Point of care tests National Lab 3 DEC 2017 Nationwide Lab surveillance technical committee 2,000,000 MOH total number of centers UTILIZING point of care tests Strategic intervention 3.3. AMR surveillance Sentinel sites in human 3.3.1. AMR surveillance Sentinel sites from different regions are selected • KAMC-Riyadh, King Faisal Specialist Hospital & Research Center, KFMC, and King Khaled University Hospital); Eastern Province: King Fahd University hospital in Khobar; Western Province: King Abdulaziz University Hospital. • King Abdulaziz – Jeddah • King Fahd Hospital – Jeddah • Dammam Medical Complex - eastern region • Assir Central Hospital National Lab 12 June 2017 Nationwide Lab surveillance technical committee 225,000 MOH Percentage of AMR priority pathogens resistance 23 | P a g e Assir • King Khaled Hospital – Tabouk Strategic intervention 3.4. AMR surveillance Sentinel Sites in animal 3.4.1� Six Sentinel sites for surveillance of infections caused by AMR pathogens: ��Riyadh. ��Al-ahssa ��Al-Dammam ��Jeddah ��Assir ��Al-Kharj AMR animal sentinel sites 6 June 2017 Nationwide Lab surveillance technical committee 100,000 MEWA Percentage of resistance of priority pathogens in animals 3.4.2. Surveillance for detection of salmonella, campylobacter and total bacterial count in poultry in all regions of Kingdom MEWA report 1 Dec. 2017 Nationwide Lab surveillance technical committee 100,000 MEWA Percentage of resistance Strategic intervention 3.5. Determine the country priority microorganisms with mechanisms of resistance for AMR surveillance and adapt and apply WHO model systems for antimicrobial resistance surveillance (GLASS) 3.5.1� WHO priority pathogens including (S. aureus, E. coli, K. pneumoniae MRSA, VRE, Non Fermentative GNB Acinetobacter, and pseudomonas) Number of isolated priority pathogens Number of isolates for each pathogen Dec. 2017 Human sentinel sites Lab surveillance technical committee MOH Percentage of resistance of each pathogen 3.5.2 GLASS protocol was endorsed to laboratories during a workshop (10 Labs) and includes age and sites in Number of labs endorsed in GLASS 10 March 2017 MOH labs Lab surveillance technical committee 70,000 MOH Number of labs implementing 24 | P a g e the upcoming data. GLASS protocol Strategic intervention 3.6. Establishment of systems IT for monitoring antimicrobial and link all sentinel sites to the national center for analysis and reporting. 3.6.1 Working on software to link Designated sentinel to national lab to improve reporting analysis Number of labs linked to software 20 MOH Oct 2017 Sentinel sites Lab surveillance technical committee 225.000 MOH Number of labs reporting through the software Strategic intervention 4.1. Designate a national reference laboratory for AMR surveillance 4.1.1� The National lab will assume responsibility for AMR lab in future. Currently, AMR sentinel sites labs will perform required AMR testing and reporting National Lab 1 DEC 2017 NATIONAL LAB NATIONAL LAB 1,500,000 � MOH percentage of referral of isolates of AMR to national AMR lab Strategic intervention 4.2. Training workshops for microbiologist and laboratory technicians 4.2.1� Plan for series training, workshops will be formulated for Microbiology doctors and lab technicians for all hospitals> 150 beds Training course 5 NOV 2017 Nationwide Lab surveillance technical committee 70,000 MOH Number of trained staff Strategic intervention 5.1. Create a formal organizational structure to ensure proper development and use of infection prevention and control policies and strategies 5.1.1. IPC Organizational structure has been established Organizatio nal structure 1 2017 Nationwide IPC technical committee 0 MOH Number of hospitals have IPC organizational structure 5.1.2. Core component has been established and distributed Core component 1 2017 Nationwide IPC technical committee 60,000 MOH Number of hospitals implementing 25 | P a g e core component 5.1.3. Infection control national manual distributed to all health care regions IPC manual 1 2017 Nationwide IPC technical committee 60,000 MOH Number of hospitals implementing IPC manual 5.1.4. IC Auditing tool program Auditing tool 1 2017 Nationwide IPC technical committee 60,000 MOH Auditing tool Scoring 5.1.5. Hand hygiene campaign HH campaign 1 2017 Nationwide IPC technical committee 200,000 MOH Number of participating sectors Strategic intervention 6.1. Create a formal organizational structure to ensure proper development and use of infection prevention and control policies and strategies (in veterinary and animal husbandry) 6.1.1. Write and approve Infection Control Guideline in animal health by KSA MEWA IPC Guideline 1 June 2017 Nationwide IC technical committee 60,000 MEWA Number of Vet Clinics implementing guidelines Strategic intervention 6.2. Include hygiene and infection prevention and control as core (mandatory) content in training and education of veterinary professionals 6.2.1. MEWA plans for Infection control training Training program 1 June 2017 Nationwide IPC technical committee 100,000 MEWA Number of trained staff Strategic intervention7.1. Promote personal hygiene by social mobilization and behavioral change activities 7.1.1. Estimate knowledge of personal hygiene in different social groups as a basis for the social mobilization campaigns Awareness social hygiene campaigns 1 June 2017 Nationwide GDIPC 200,000 MOH Increased level of public awareness about personal hygiene Strategic intervention 8.1. Strengthen the pharmaceutical supply chain, including the procurement, supply and management system 8.1.1. Establish a quality management system for the supply of medicines, covering storage, transport, expiry date, etc. Chain of supply 1 June 2017 Nationwide Drug economy and technical research committee 50,000,000� SFDA no of implemented system 26 | P a g e Strategic intervention 9.1. Create formal antimicrobial stewardship programs in health care facilities. 9.1.1. Plan for series training, antimicrobial stewardship programs workshops will be formulated in all healthcare facilities > 150 beds Training program 3 DEC 2017 Nationwide MOH 210,000 MOH Number of trained staff Strategic intervention 9.2. Awareness and Education on stewardship for Healthcare facilities & veterinary practice 9.2.1. Target selected hospitals based on bed capacity from each region of the kingdom: 1- Antibiotic Awareness week 2-Training Activities in ASP educationa l activities 5 Nov 2017 Nationwide Stewardship technical committee 350,000 MOH Number of implemented activities 9.2.2 To consider standardized educational material or electronic tool standardize d educationa l tool 1 June 2017 Nationwide Stewardship technical committee 100,000 MOH Number of staff using electronic tool Strategic intervention 9.3. Guidelines and order sets 9.3.1. Development, awareness & Implementation of empiric antimicrobial guidelines for treatment of community & healthcare associated infection to 20 MOH hospitals. Guidelines 1 June 2017 Nationwide Stewardship technical committee 60,000 MOH Number of hospitals implementing guidelines 9.3.2 Integrating those guidelines into electronic health records whenever possible. Electronic Guidelines 1 June 2017 Nationwide Stewardship technical committee 100,000 MOH Number of hospitals linked to electronic guidelines 9.3.3 Standardizing Surgical Antibiotic Prophylaxis through preset order sheets in 20 selected MOH hospitals. Antibiotic surgical prophylaxis Guidelines 1 June 2017 Nationwide Stewardship technical committee 60,000 MOH Number of hospitals implementing surgical prophylaxis 27 | P a g e Strategic intervention 9.4. Clinical Care Standards "bundle" implementation 9.4.1. hospitals (>150 beds should apply "MOH approved" stewardship bundles/ best practices to optimize prescribing practices Steward ship bundles 1 Dec 2017 Nationwide Stewardship technical committee 100,000 MOH Number of MOH hospitals applying stewardship bundles Strategic intervention 9.5. Mandating Stewardship implementation in all JCI/ CBAHI accredited hospitals 9.5.1. Communicate with CBAHI to include ASP in the requirements for accreditation/ reaccreditation." June 2017 Nationwide Stewardship technical committee CBAHI Strategic intervention 9.6. Requesting Stewardship Program KPIs on process and outcome 9.6.1. 5 Antibiotics, 5 MDROs DOT per 1000 patient days Duration of empiric antibiotics therapy more than seven days Prevalence and trend of CDI 1 April 2017 Nationwide Stewardship technical committee MOH DOT per 1000 patient days Duration of empiric antibiotics therapy more than seven days Prevalence and trend of CDI Strategic intervention 9.7. Postgraduate education: enrollment requirement for national residency training programs 9.7.1 Communication with Saudi Commission for Health Specialties to add to Infection control module Stewardship component; it can be an online module as a prerequisite for enrollment in all medical, Online IC module stewardshi p 1 Jan 2018 Nationwide GDIPC 100,000 SCFHS Number of staff linked to Online IC module stewardship 28 | P a g e nursing, paramedical, and Pharmacy residency programs." Strategic intervention 9.8. Building Capacity: Training Clinical Pharmacists and ID Fellows 9.8.1 Antimicrobial Stewardship training programs training program 1 Jan 2018 Nationwide Stewardship technical committee 500,000 SCFSH number of candidates joining the asp training program Strategic intervention 9.10. Antimicrobial Stewardship Research 9.10.1. -National Point Prevalence Survey on antimicrobial consumption & resistance in line with Global PPS Multicenter study on the impact of implementation of stewardship on length of stay & cost saving PPS study 1 June 2017 Nationwide Stewardship technical committee 250,000 MOH Antimicrobial consumption rate Strategic intervention 10.1. Restrict use of critically important antimicrobials for human medicine in food production animals 10.1.1. Ongoing surveillance of antibiotics consumed in food production animals and avoiding the following antimicrobial classes: Quinolones, 3rd and 4th generation cephalosporins, macrolides, ketolides, and glycopeptides Surveillance program 1 Jan 2018 Nationwide Stewardship technical committee 250,000 MEWA Antibiotic consumption in food production Strategic intervention Economic 11.1. impact assessment and burden of antimicrobial resistance 11.1.1. Study the cost and economic burden of AMR in Humans Research study in human 1 June201 7 Nationwide Drug Economy and technical research committee 250,000 MOH Percentage of AMR and cost of antibiotics 11.1.2. Study the cost and economic burden of AMR in animals. Research study in human 1 Oct 2017 Nationwide Drug economy and research technical committee 250,000 MEWA Percentage of AMR and cost of antibiotics 29 | P a g e Part III: Monitoring and evaluation plan 30 | P a g e Monitoring and evaluation plan Planning element (activity linked to the strategic plan) Indicator Purpose Calculation Frequency of data collection Data source Method Baseline 1.1.1� Assess public awareness about AMR through: o�Survey on public awareness of use and misuse of antibiotics. Assign a research team to conduct qualitative (focus group) and quantitative (surveys) data collection. Increases level of awareness M&E of input No. of participating in the survey / total No. groups to target Annually AMR awareness committee Baseline survey and What measured in baseline survey 2.1.1. Include AMR and related topics in undergraduate curricula for professionals in human and animal health, the food industry and agriculture professionals. 2.1.2. AMR E – Learning educational program number of approved curricula available for undergraduate approved PROGRAM by Saudi Commission M&E of input M&E input No. of curricula / No. undergraduate groups to target of No., of curricula / No. undergraduate groups to target input Annually Annually MOE GDIPC Baseline survey and post interventio n survey SCHF What measured in baseline survey Number of trained staff 31 | P a g e 3.2.1.�Seven CAP accredited. Laboratories were designated to collect the antimicrobial resistance data for the last five years. Riyadh: (KAMC-Riyadh, King Faisal Specialist Hospital & Research Center, KFMC, and King Khaled University Hospital); Eastern Province: King Fahd University hospital in Khobar; Western Province: King Abdulaziz University Hospital. Percentage of retrospective AMR in hospitals M&E of input and Output No. of AMR isolates / Total No of isolates target Annually Lab surveillance technical committee. Lab surveillance technical committee report. Total no of isolates 3.2.6. Utilizing “Point of care tests total number of centers utilizing point of care tests M&E of input No of centers utilizing point of care tests / total no of targeted centers Lab surveillance technical committee. Lab surveillance technical committee report. Centers utilizing point of care testing currently 3.3.1 AMR surveillance Sentinel sites from different regions are selected • KAMC-Riyadh, King Faisal Specialist Hospital & Research Center, KFMC, and King Khaled University Hospital); Eastern Province: King Fahd University hospital in Khobar; Western Province: King Abdulaziz University Hospital. • King Abdulaziz – Jeddah • King Fahd Hospital – Jeddah Percentage of resistance of priority pathogens in animals M&E of input And output No of AMR Isolate /Total No of isolates of priority pathogens Annually AMR lab surveillance committee AMR surveillance program implementa tion report Total No of AMR isolates 32 | P a g e • Dammam Medical Complex - eastern region • Assir Central hospitals Assir • King Khaled Hospital – Tabouk 3..4.1 Six Sentinel sites for surveillance of infections caused by AMR pathogens: �� Riyadh. �� Al-Ahssa �� Al-Dammam �� Jeddah �� Assir �� Al-Kharj Percentage of resistance of priority pathogens in animals M&E of input And output No of AMR Isolate /Total No of isolates of priority pathogens Annually AMR lab surveillance committee AMR surveillance program implement ation report Total number of AMR isolates 4.2.1. Plan for series training, workshops will be formulated for Microbiology doctors and lab technicians for all hospitals> 150 beds Number of trained staff M&E of input No of trained staff/total No of target staff Annually AMR lab surveillance committee AMR surveillance program implement ation report Current number of trained staff of target group 5.1.4. IC Auditing tool program Auditing tool Scoring M&E of input and output No. of hospitals /total no. Health care organizations Annually IPC technical committee IPC technical committee report Number of participating health care organization 5.1.5. Hand hygiene campaign Number of participating M&E of input No. of participating organization Annually IPC technical committee IPC technical committee Number of participating 33 | P a g e health care organization /total no. Health care organizations report report health care organization 6.1.1. Write and approve Infection Control Guideline in animal health by KSA MEWA Number of Vet Clinics implementing Guidelines M&E of input No. of Number of vet clinics participating /total no. VET clinics Annually IPC technical committee report IPC technical committee report Number of participating vet clinics 6.2.1. MEWA plans for Infection control training Number of trained staff M&E of input Some trained staff/no. Of target group Annually IPC technical committee IPC technical committee report Number trained staff of target group 7.1.1. Estimate knowledge of personal hygiene in different social groups as a basis for the social mobilization campaigns Increased level of public awareness about personal hygiene monitori ng and evaluatio n of outcome Awareness scores stratified by target group (composite) Annually Baseline survey report the post interventi on survey report Awareness survey report Baseline survey report 8.1.1. Establish a quality management system for the supply of medicines, covering storage, transport, expiry date, etc. No. of implemented system M&E of output No. of implemented system/ NO health care of organization Annually Drug economy and technical research committee supply chain report NA 9.1.1. Plan for series training, antimicrobial stewardship programs workshops will be formulated in all healthcare facilities > 150 beds Number of trained staff M&E of input No of trained staff/total NO of targeted staff Annually Stewardshi p technical committee Stewardshi p technical committee report No. training staff 34 | P a g e 9.2.1. Target selected hospitals based on bed capacity from each region of the kingdom: 1- Antibiotic Awareness week 2- training actives in ASP Number of implemented activities M&E of input No of trained staff/total NO of targeted staff Annually Stewardshi p technical committee Stewardshi p technical committee report No training staff 9.3.1. Development, awareness & Implementation of empiric antimicrobial guidelines for treatment of community & healthcare associated infection to 20 MOH hospitals. Number of hospitals implementing guidelines M&E of input Number of hospitals implementing guidelines/ total no. of target hospitals Annually Stewardshi p technical committee report. Stewardshi p technical committee’ s survey. No hospitals implementing guidelines in the baseline survey 9.3.3 Standardizing Surgical Antibiotic Prophylaxis through preset order sheets in 20 selected MOH hospitals. Number of hospitals implementing surgical prophylaxis guideline M&E of input Number of hospitals implementing guidelines/ total no. of target hospitals Annually Stewardshi p technical committee report. Stewardshi p technical committee survey No standardized surgical antibiotic prophylaxis preset order sheets 9.10.1. National Point Prevalence Survey on antimicrobial consumption & resistance in line with Global PPS Multicenter study on the impact of implementation of stewardship on length of stay & cost saving Antimicrobial utilization rate M&E of input and output 1- DOT per 1000 patient days 2- Duration of empiric antibiotics therapy more than seven days Annually stewardshi p technical committee survey Stewardshi p technical committee. Survey antimicrobial utilization report 11.1.1. Study the cost and economic burden of AMR in Humans. The cost of management M&E of output Composite annually Drug economy Drug economy No previous research 35 | P a g e of AMR patient committee report. committee report. 11.1.2. Study the cost and economic burden of AMR in the animal. The cost of AMR in animals M&E of output Composite annually drug economy committee report. Drug economy committee report. No previous research 36 | P a g e References 1. World Health Organization. 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Molecular epidemiology of carbapenem-resistant Acinetobacter baumannii isolates in the Gulf Cooperation Council States: dominance of OXA-23-type producers. J Clin Microbiol. 2015;53:896–903. 7. Shibl AM, Memish ZA, Kambal AM, Ohaly YA, Ishaq A, Senok AC, et al. National surveillance of antimicrobial resistance among Gram-positive bacteria in Saudi Arabia. J Chemother. 2014;26:13– 18 8. Leangapichart T, Gautret P, Griffiths K, Belhouchat K, Memish Z, Raoult D, et al. Acquisition of a high diversity of bacteria during Hajj pilgrimage, including Acinetobacter baumannii with blaOXA 72, and Escherichia coli with blaNDM-5 carbapenemases. Antimicrob Agents Chemother. 2016 pii: AAC.00669-16 9- Antibiogram report 2015, GDIPC, MOH, KSA http://www.who.int/drugresistance/global action plan/en/