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Drug-N-Therapeutics-Committee.Pdf Irrational use of medicines is a widespread problem at all levels of health care, but especially GUIDE DRUG AND THERAPEUTICS COMMITTEES: A PRATICAL in hospitals. This is particularly worrying as resources are generally scarce and prescribers in communities often copy hospital prescribing practices. Use of medicines can be greatly improved and wastage reduced if some simple principles of drug management are followed. But it is difficult to implement these principles because staff from many different disciplines are involved, often with no forum for bringing them together to develop and implement appropriate medicines policies. A drug and therapeutics committee (DTC) provides such a forum, allowing all the relevant people to work together to improve health care delivery, whether in hospitals or other health facilities. In many developed countries a well functioning DTC has been shown to be very effective in addressing drug use problems. However, in many developing countries DTCs do not exist and in others they do not function optimally, often due to lack of local expertise or a lack of incentives. Drug and Therapeutics Committees: A Practical Guide provides guidance to doctors, pharmacists, hospital managers and other professionals who may be serving on DTCs and/or who are concerned with how to improve the quality and cost efficiency of therapeutic care. It is relevant for all kinds of DTCs - whether in public or private hospitals and whether at district or tertiary referral level. This comprehensive manual covers a committee’s functions and structure, the medicines formulary process, and how to assess new medicines. The chapters on tools to investigate drug use and strategies to promote rational use are followed by a discussion of antimicrobial resistance and infection control. The publication concludes by explaining in detail how to start a committee or improve the effectiveness of an existing one. The manual has been developed by the WHO Department of Essential Drugs and Medicines Policy, in collaboration with the Rational Pharmaceutical Management Plus Program of Management Sciences for Health. WHO/EDM/PAR/2004.1 Drug and therapeutics committees A practical guide World Health Organization Department of Essential Drugs and Medicines Policy Geneva, Switzerland In collaboration with Management Sciences for Health Center for Pharmaceutical Management Rational Pharmaceutical Management Program Arlington, Virginia, USA Authors Kathleen Holloway1 (Editor) Terry Green2 with contributions from: Edelisa Carandang,1 Hans Hogerzeil,1 Richard Laing,3 David Lee,2 The text was reviewed by: John Chalker,2 Mary Couper,1 Andrew Creese,1 Marthe Everard,1 Anna Paula di Felici,4 Chris Forshaw,5 David Henry,6 Yvan Hutin,7 Sabine Kopp,1 Souly Phanouvong,8 Clive Ondari,1 Lembit Rago,1 Marcus Reidenberg,9 Budiono Santoso,10 Anthony Savelli2 and Rosamund Williams.4 1 Department of Essential Drugs and Medicines Policy (EDM), World Health Organization, Geneva, Switzerland 2 Management Sciences for Health (MSH), Washington DC, USA* 3 Department of International Health, Boston University, Boston, Massachusetts, USA 4 Department of Communicable Disease Surveillance and Response, World Health Organization, Geneva, Switzerland 5 Uganda Health Sector Programme Support, Danida, Kampala, Uganda 6 Department of Clinical Pharmacology, University of Newcastle, New South Wales, Australia 7 Safe Injection Global Network, Department of Blood Safety and Clinical Technology, World Health Organization, Geneva, Switzerland 8 Global Assistance Initiatives, United States Pharmacopeia, Maryland, USA 9 Division of Clinical Pharmacology, Weill Medical College of Cornell University, New York, USA 10Regional Office for the Western Pacific, World Health Organization, Manila, the Philippines *The MSH Rational Pharmaceutical Management Plus Program is supported by the U.S. Agency for International Development, under the terms of cooperative agreement number HRN-A-00-00-00016-00. © World Health Organization 2003 All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. Designed by minimum graphics Printed in France 9. GETTING STARTED Contents Acronyms and abbreviations v Preface vii 1 Introduction 1 1.1 Why are drug and therapeutics committees (DTCs) needed? 1 1.2 Goals and objectives of the DTC 2 1.3 Functions of the DTC 2 1.4 Role of the DTC in the drug management cycle 5 2 Structure and organization of a DTC 6 2.1 Principles in setting up a DTC 6 2.2 Steps in setting up and managing the DTC 7 Annex 2.1 Example of a declaration of interest form 12 Annex 2.2 Model terms of reference for a DTC in Zimbabwe 13 Annex 2.3 Example of a mandate for a DTC: excerpts from the Zimbabwe National Drug Policy 1998 14 3 Managing the formulary process 15 3.1 The formulary process 15 3.2 The formulary list (essential medicines list) 16 3.3 The formulary manual 22 3.4 Standard treatment guidelines (STGs) 23 Annex 3.1 Application forms to be filled in by applicants when applying for a new drug to be added to the hospital formulary list 28 Annex 3.2 Drug information included in a comprehensive formulary 34 4Assessing new medicines 35 4.1 The need for critical assessment of new medicines 35 4.2 Sources of information to assess new medicines 36 4.3 Assessing the efficacy and safety of new medicines from the literature 36 4.4 Measuring and comparing clinical treatment outcomes 38 4.5 Measuring and comparing drug costs 39 Annex 4.1 Sources of information 46 Annex 4.2 Checklist to detect common problems encountered in articles 48 iii DRUG AND THERAPEUTICS COMMITTEES – A PRACTICAL GUIDE 5 Ensuring medicine safety and quality 51 5.1 The need for ensuring medicine safety and quality 51 5.2 Monitoring and addressing medication errors 51 5.3 Monitoring and ensuring medicine quality 54 5.4 Safety of medicines 58 Annex 5.1 Basic analytical medicine tests 65 Annex 5.2 Examples of adverse drug reaction reporting (ADR) reporting forms 66 Annex 5.3 Naranjo algorithm for assessing the causality of an ADR 70 6Tools to investigate the use of medicines 71 6.1 Stepwise approach to investigating the use of medicines 71 6.2 Analysis of aggregate medicine use data 72 6.3 WHO/INRUD drug use indicators for health facilities 81 6.4 Qualitative methods to investigate causes of problems of medicine use 81 6.5 Drug use evaluation (DUE) (drug utilization review) 85 Annex 6.1 Defined daily doses (DDD) of some common medicines 91 Annex 6.2 DUE criteria on data collection form for amikacin 94 7Promoting the rational use of medicines 95 7.1 Changing a medicine use problem 95 7.2 Educational strategies 96 7.3 Managerial strategies 99 7.4 Regulatory strategies 102 7.5 Choosing an intervention 103 7.6 Evaluating interventions 103 Annex 7.1 Examples of structured order forms from a hospital in Nepal 106 8 Antimicrobials and injections 108 8.1 Antimicrobials, resistance and infection control 108 8.2 Safe and appropriate use of injections 115 9 Getting started 122 9.1 Addressing the problem 122 9.2 Stepwise approach to starting a DTC where none exists 123 9.3 Revitalizing non-functioning DTCs 126 9.4 Using this manual to solve problems 126 Glossary 130 References 136 Further reading 139 Useful addresses and websites 140 iv 9. GETTING STARTED Acronyms and abbreviations ABC ABC analysis ADR adverse drug reaction AGREE Appraisal of Guidelines for Research and Evaluation in Europe AHFS American Hospital Formulary Service AMR antimicrobial resistance ARR absolute risk reduction ASHP American Society of Health-System Pharmacists DALYs disability-adjusted life years DDD defined daily dose DTCdrug and therapeutics committee DUE drug use evaluation DUR drug utilization review EDL essential drugs list EML essential medicines list EDLIZ Essential Drug List of Zimbabwe GMP good manufacturing practices IM intramuscular INN International Nonproprietary Name INRUD International Network for Rational Use of Drugs IV intravenous MCAZ Medicines Control Authority of Zimbabwe MI myocardial infarction MoH Ministry of Health MSHManagement Sciences for Health MUE medication use evaluation NDTPAC National Drug and Therapeutics Policy Advisory Committee NNT numbers needed to treat QALYsquality-adjusted life years RCT randomized controlled trial RPM Rational Pharmaceutical Management Project RR relative risk v DRUG AND THERAPEUTICS COMMITTEES – A PRACTICAL GUIDE RRR relative risk reduction SC subcutaneous SIGN Scottish Intercollegiate Guidelines Network SK streptokinase STG standard treatment guideline TB tuberculosis TPA tissue plasminogen activator UNFPA United Nations Population Fund UNICEF United Nations Children’s Fund VEN analysis vital, essential and non-essential analysis WHO World Health Organization vi 9. GETTING STARTED Preface Inefficient and irrational use of medicines is a widespread problem at all levels of health care (Hogerzeil 1995). Per capita wastage from inefficiencies and irrational use tends to be greatest in hospitals; this is particularly worrisome since resources are scarce and prescribers in communities often copy hospital prescribers. Many of these sources of wastage could be reduced if some simple principles of drug management and use were followed.
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