WHO/EDM/PAR/2004.8 HOW TO DEVELOP A NATIONAL FORMULARY BASED ON THE WHO MODEL FORMULARY A PRACTICAL GUIDE World Health Organization 2004 Authors Richard Laing1 (Editor) Klara Tisocki2 With contributions from: Douglas E. Ball2, Joe Collier3, Dinesh K. Mehta4, Rachel S. M. Ryan4, Andrea Tarr3, The text was reviewed by: Jude Nwokike5, Rachel Ryan4, Khalid H.M. Said6, Wong Wai See7, Robert S. Summers8, Monika Zweygarth8 1 Department of Essential Drugs and Medicines Policy, World Health Organization, Geneva Switzerland 2Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait 3Editorial Committee, British National Formulary, Royal Pharmaceutical Society of Great Britain, London, United Kingdom 4Drug and Therapeutics Bulletin, London, United Kingdom 5Centre for Pharmaceutical Management, Management Sciences for Health, Inc (MSH), Windhoek, Namibia 6Directorate General of Pharmacy, Federal Ministry of Health, Khartoum, Sudan 7Department of Pharmaceutical Services, Ministry of Health, Bandar Seri Begawan, Brunei 8MEDUNSA School of Pharmacy, Pretoria, South Africa © World Health Organization, 2003 All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: [email protected]). 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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. 2 HOW TO DEVELOP A NATIONAL FORMULARY BASED ON THE WHO MODEL FORMULARY A practical guide Contents Abbreviations......................................................................................................................................................... iii 1 INTRODUCTION............................................................................................................ 1 Objectives ............................................................................................................................................................... 1 The need for formularies......................................................................................................................................... 1 What is a formulary?............................................................................................................................................... 1 The essential medicines concept ............................................................................................................................. 1 The WHO model list of essential medicines and the WHO model formulary ........................................................ 2 2 OVERVIEW OF THE NATIONAL FORMULARY PROCESS.............................. 3 Organization of the national formulary committee ................................................................................................. 3 The editorial team .............................................................................................................................................. 3 The advisory group............................................................................................................................................. 3 Agreement on purpose, content, structure and format ............................................................................................ 3 Financing ................................................................................................................................................................ 4 Selection of medicines to be included in the national formulary ............................................................................ 4 Development of the draft ........................................................................................................................................ 4 Reviewing and finalizing content............................................................................................................................ 5 Production, dissemination and implementation ...................................................................................................... 5 Evaluation and review............................................................................................................................................. 5 3 DEVELOPING THE PRELIMINARY INFORMATION SECTION....................... 7 Developing locally relevant introductory information............................................................................................ 7 General entries at the front of a national formulary ................................................................................................ 7 Acknowledgements ............................................................................................................................................. 7 Introduction or preface ...................................................................................................................................... 7 Table of contents ................................................................................................................................................ 7 Abbreviations ..................................................................................................................................................... 8 Units of measurement......................................................................................................................................... 8 Additional information at the front of the national formulary ................................................................................ 8 Instructions on how to use the formulary........................................................................................................... 8 Glossary ............................................................................................................................................................. 8 Policies and procedures of the national formulary and national formulary committee..................................... 8 National policies and regulations ...................................................................................................................... 8 List of changes.................................................................................................................................................... 9 Adapting the “General advice to prescribers” section of the WHO model formulary ............................................ 9 4 DEVELOPMENT OF THERAPEUTIC INFORMATION AND MONOGRAPHS USING THE WHO MODEL FORMULARY....................................................................... 10 Adapting the therapeutic classification system of the WHO model formulary..................................................... 11 Options for adapting information from the WHO model formulary in the national formulary ............................ 11 Addition of locally important, specific information to the WHO model formulary text....................................... 14 Introductory text of therapeutic sections.......................................................................................................... 14 Monographs ..................................................................................................................................................... 14 Brand name(s).................................................................................................................................................. 14 Price................................................................................................................................................................. 15 Writing new material for the national formulary .................................................................................................. 15 Language, style and presentation .......................................................................................................................... 16 Technical copy-editing.......................................................................................................................................... 16 i 5 ADDITIONAL SOURCES OF INFORMATION....................................................... 18 The evidence-based approach in formulary development..................................................................................... 18 Information retrieval ............................................................................................................................................