Medicines in Health Care Delivery Thailand
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MEDICINES IN HEALTH CARE DELIVERY THAILAND Situational Analysis: 23 November – 4 December 2015 Report prepared using the WHO/SEARO workbook tool for undertaking a situational analysis of medicines in health care delivery in low and middle income countries February 2016 World Health Organization, Regional Office for South East Asia, New Delhi, India. 1 CONTENTS Page 1. Abbreviations 5 2. Executive Summary 2.1 Introduction ..8 2.2 Medicines Supply ..9 2.3 Medicines Selection 10 2.4 Medicines Use 10 2.5 Medicines Regulation 12 2.6 Medicines Policy 13 3. Programme 15 4. Medicine Supply 16 4.1 Responsible Agents/Departments 17 4.2 Drug availability 17 4.3 Annual aggregate data of medicines distribution/consumption 19 4.4 Drug procurement 25 4.5 Allocation of Budget for medicines in the public sector 26 4.6 Drug quantification in the public sector 26 4.7 Drug Distribution in the public sector 27 4.8 Patient Flow in the Health Facilities 29 4.9 Insurance 30 4.10 Drug Manufacturing 31 4.11 Drug management in the private sector 32 4.12 Summary status in medicines supply since last situational analysis 33 4.13 Medicines Supply: Recommendations 33 5. Medicines Selection 35 5.1 National Essential Medicines List (EML) 36 5.2 Other Medicine Lists 37 5.3 Development / updating of national EML 38 5.4 Implementation of the EML 39 5.5 Summary status in medicines selection since last situational analysis 41 5.6 Drug Selection: Recommendations 41 Contents 2 6. Medicines Use 42 6.1 Responsible Agents / Departments 43 6.2 Past prescription surveys of medicines use done in the last 10 years 44 6.3 Current prescribing practices 45 6.4 Dispensing Practices 49 6.5 Policies to promote rational use of medicines 50 6.5.1 Monitoring and supervision of prescribing / dispensing 51 6.5.2 Standard Treatment Guidelines (STGs) 51 6.5.3 National Formulary 52 6.5.4 Drug Information Centre 53 6.5.5 Independent drug information 53 6.5.6 Drug and Therapeutics Committees 53 6.5.7 Undergraduate education on medicine use 55 6.5.8 Continuing Medical Education and medicines use 56 6.5.9 Public Education on the safe and prudent use of medicines 56 6.5.10 Generic Policies 57 6.6 Summary status in medicine use since last situational analysis 58 6.7 Medicines Use: Recommendations 58 7. Medicines Regulation 60 7.1 Responsible Agents/Departments 61 7.2 Pharmaceutical sector 61 7.3 Current Medicines Legislation (key documentation) 62 7.4 National Regulatory Authority for medical products 64 7.5 Drug Schedules 67 7.6 Regulation and inspection of drug outlets 68 7.7 Drug Registration 68 7.8 Pharmacovigilance 69 7.9 Drug Promotion 70 7.10 Drug Price Controls 70 7.11 Drug Testing Laboratories 71 7.12 Drug Recall 72 7.13 Clinical Trial Oversight 72 7.14 Licensing and Accreditation of Health Professionals 73 7.15 Licensing and Accreditation of Health Facilities and Pharmacies 75 7.16 Summary status in drug regulation since last situational analysis 76 7.17 Medicines regulation: Recommendations 77 Contents 3 8. Medicines Policy and Coordination 78 8.1 National Medicines Policy Documents 79 8.2 Summary of medicines policies in place to promote rational use of medicines 81 8.3 Coordination of medicines-related policies within Ministry of Health 82 8.4 Coordination beyond the Ministry of Public Health 84 8.5 Summary status in medicines policy since last situational analysis 87 8.6 Medicines Policy & Coordination: Recommendations 87 9. References 89 10. Persons met during the situational analysis 92 11. Participants of the Stakeholder Workshop 96 12. Workshop Slide Presentation 98 Contents 4 1. ABBREVIATIONS ABC ABC analysis – method for measuring drug consumption ADR Adverse Drug Reaction AMR Antimicrobial Resistance ASEAN Association of Southeast Asian Nations ASU Antibiotics Smart Use project BHA Bureau of Health Administration CME Continuing Medical Education CPD Continuing Professional Development CSMBS Civil Servant Medical Benefits Scheme DHO District Health Office DIC Drug Information Centre DPHO District Public Health Office DMSIC Drug and Medical Supply Information Centre DRA Drug Regulatory Authority DRG Disease-related Group Costing (for inpatient treatment) DTC Drug and Therapeutics Committee GDP Good Dispensing Practice EML Essential Medicines List EMIT Emergency Medical Institute of Thailand EDL Essential Drug List EML Essential Medicines List FDA Food and Drug Administration FEFO First Expired First Out FIFO First in First out GCP Good Clinical Practice Abbreviations 5 GLP Good Laboratory Practice GMP Good Manufacturing Practice GPO Government Pharmaceutical organization GPP Good Pharmacy Practice HC Health Centre IPD Inpatient Department MO Medical Officer MOF Ministry of Finance MOH Ministry of Health MOL Ministry of Labour MOPH Ministry of Public health NDP National Drug Policy NF National Formulary NGO Non-Governmental Organisation NHC National Health Committee NHSO National Health Security Office NDP National Drug Policy NEML National Essential Medicine List NHP National Health Policy NLED National List of Essential Medicines NMP National Medicines Policy OPD Outpatient Department OPS Office of the Permanent Secretary OTC Over-the-Counter PV Pharmacovigilance PHO Provincial Health Office Abbreviations 6 PLEASE Project focusing on Pharmacy andTherapeutics Committee, Labelling and leaflet, Essential RUD tools, Awareness of RUD among prescribers and patients, Special population care, and Ethics in Promotion PM Prime Minister PTC Pharmacy and Therapeutics Committee QA Quality Assurance RDU/RUD Rational Drug Use/Rational Use of Drugs RUM Rational Use of Medicines SOP Standard Operating Procedures SSO Social Security Office SSS Social Security Scheme STG Standard Treatment Guidelines TOR Terms of Reference TRM Traditional Medicines UHCS Universal Health Care Coverage Scheme URTI Upper Respiratory Tract Infection VEN Vital, Essential, Non-essential – method for classifying drug importance VMI Electronic management information system run by the GPO for the drugs and vaccines that they supply WHO World Health Organization Abbreviations 7 2. EXECUTIVE SUMMARY 2.1. Introduction A situational analysis was conducted in Thailand during 23 November – 4 December 2015. The Terms of Reference were to examine medicines in health care delivery with respect to medicines supply, selection, use, regulation and policy. It was agreed that the WHO/SEARO workbook tool would be used and that a team of government officials, led by the [name of government department], facilitated by WHO/SEARO, would conduct the situational analysis. The team members consisted of: WHO/SEARO: Dr Kathleen Holloway, Dr Anita Kotwani, Dr Budiono Santoso WHO/Thailand: Dr Nima Asgari Pharmacy Section, BHA, MOPH: Ms Pornpimon ChantrakunaparsMs Voranadda Srisuphan, , Dr Araya Sripairoj, IHPP, MOPH: Dr Chutima Akaleephan NHSO Chiang Mai: Mrs Siriporn Wohbah Thai FDA, MOPH: Ms Worasuda Yoongthong, Mrs Naphaphorn Puripunyavanich, Ms Kakanang Tosanguan, Ms Lalittanan Moolasart, Ms Juthathip Martro, Mr Kitti Sukantho, Mr Thanakrit Mongkolchaipak , Mr Sataporn Lumpaiboonsuk, Mr Yuthana Duangjai The programme involved meetings with all the major government departments and other stakeholders involved in the management of medicines and visits to health facilities in two regions. A detailed program can be seen in section 3. During the visits to public health facilities and private pharmacies, drug stores were visited to collect data on stock availability for 40 selected essential drugs and drug management, outpatient dispensaries were visited to do a prescription audit, wards were visited to review in-patient drug management, and staff were interviewed to identify health and health care factors affecting drug management. A one-day national stakeholder workshop was held on 4 December 2015 where findings were discussed and recommendations developed. Fifty-five participants attended the workshop and the list of participants can be seen in section 12. The findings were presented on behalf of the team by Dr Holloway, WHO/SEARO. Group work was done by participants to develop recommendations in the areas of medicines supply, selection, use, regulation and policy. The words “medicine” and “drug” are used interchangeably in this report. Executive Summary 8 2.2. Medicines Supply Thailand has a remarkable health delivery system where almost all patients are covered by insurance for their health services, including medicines. There is a well-functioning medicines public supply system as part of their health services delivery for the universal health coverage policy. Most of the needed essential medicines, over 90 %, are available in public hospitals with very small levels of stock out. The drug distribution is decentralized where the needed medicines are directly supplied to hospitals. The supplies for public health centers are taken care by the community hospitals. The availability of essential medicines in public health center facilities (even those classified for use at health centres) is less as compared to hospitals, possibly because some health centres are not using a substantial number of the medicines that are classified for use at that level in the national EML. A substantial proportion of hospital expenditures has been accounted for by medicines not listed in the National Essential Medicines list, and most hospitals have their own hospital formularies serving as basis medicines supply. There is a need to promote the compliance with the national Essential Medicines List. The pharmaceutical services and management in hospitals