WHO Technical Report Series 958 THE SELECTION AND USE OF ESSENTIAL MEDICINES This report presents the recommendations of the WHO Expert THE SELECTION AND USE Committee responsible for updating the WHO Model List of Essential Medicines. The fi rst part contains a review of the OF ESSENTIAL MEDICINES report of the meeting of the Expert Subcommittee on the Selection and Use of Essential Medicines, held in October 2008. It also provides details of new applications for paediatric medicines and summarizes the Committee’s considerations and justifi cations for additions and changes to the Model List, including its recommendations. Part Two of the publication is the report of the second meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines. Annexes include the revised version of the WHO Model List of Essential Medicines (the 16th) and the revised version of the WHO Model List of Report of the WHO Expert Committee, 2009 Essential Medicines for Children (the 2nd). In addition there is a list of all the items on the Model List sorted according to their (including the 16th WHO Model List of Essential Medicines Anatomical Therapeutic Chemical (ATC) classifi cation codes. and the 2nd WHO Model List of Essential Medicines for Children) WHO Technical Report Series — 958 WHO Technical ISBN 978-92-4-120958-8 Geneva TTRS958cover.inddRS958cover.indd 1 110.06.100.06.10 008:328:32 The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for SELECTED WHO PUBLICATIONS OF RELATED INTEREST international health matters and public health. One of WHO’s constitutional functions is to provide objective and reliable information and advice in the fi eld of human health, a responsibility that it fulfi ls in part through its extensive The selection and use of essential medicines. programme of publications. The Organization seeks through its publications to Report of the WHO Expert Committee support national health strategies and address the most pressing public health (including the WHO Model List of Essential Medicines for Children) concerns of populations around the world. To respond to the needs of Member WHO Technical Report Series, No. 950, 2008 (184 pages) States at all levels of development, WHO publishes practical manuals, handbooks and training material for specifi c categories of health workers; internationally Pocket book of hospital care for children. applicable guidelines and standards; reviews and analyses of health policies, 2005 (378 pages) programmes and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision-makers. These books The international pharmacopoeia, fourth edition. are closely tied to the Organization’s priority activities, encompassing disease Volume 1: general notices; monographs for pharmaceutical substances (A–O) prevention and control, the development of equitable health systems based Volume 2: monographs for pharmaceutical substances (P–Z); monographs for dosage on primary health care, and health promotion for individuals and communities. 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Further information on these and other WHO publications can be obtained from WHO Press, World Health Organization, 1211 Geneva 27, Switzerland (tel. +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]; order on line: http://www.who.int/bookorders) TTRS958cover.inddRS958cover.indd 2 110.06.100.06.10 008:328:32 This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the World Health Organization WHO Technical Report Series 958 THE SELECTION AND USE OF ESSENTIAL MEDICINES Report of the WHO Expert Committee, 2009 (including the 16th WHO Model List of Essential Medicines and the 2nd WHO Model List of Essential Medicines for Children) Geneva 2007 WHO Library Cataloguing-in-Publication DataPublications of the World Health Organization enjoy copyright protection in accordance with the TTRS958.inddRS958.indd i 110.06.100.06.10 008:308:30 WHO Library Cataloguing-in-Publication Data The selection and use of essential medicines: report of the WHO Expert Committee, March 2009 (including the 16th WHO model list of essential medicines and the 2nd WHO model list of essential medicines for children). (WHO technical report series; 958) 1. Essential drugs - administration and dosage. 2. Drug information services. 3. Drug utilization. 4. Child. I. World Health Organization. II. Series. ISBN 978 92 4 120958 8 (NLM Classifi cation: QV 55) ISSN 0512-3054 © World Health Organization 2009 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications — whether for sale or for noncommercial distribution — should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). 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 specifi c 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. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization. Typeset in Switzerland Printed in Switzerland ii TTRS958.inddRS958.indd iiii 110.06.100.06.10 008:308:30 Contents PART ONE: 17th Expert Committee on the Selection and Use of Essential Medicines vii Declaration of interests of Members of the 17th Expert Committee on the Selection and Use of Essential Medicines xi 1. Introduction 1 2. Open session 1 3. Proposal for revision of listing of pharmaceutical products 5 4. Review of other matters 6 5. Review of missing essential medicines for HIV 8 6. Review of the report of the Second Subcommittee and of the provisional Second List of Essential Medicines for Children 9 7. New applications for paediatric medicines 13 Section 6. Anti-infective medicines 13 Section 6.2. Antibacterials 13 Procaine benzylpenicillin (review) – (EMLc) 13 Section 6.2.4. Antituberculosis medicines (review, EMLc) 15 Section 6.3. Antifungal medicines 16 Liposomal amphotericin B (inclusion in the EMLc) 16 Section 6.5. Antiprotozoal medicines 17 Section 6.5.3. Antimalarial medicines 17 Artemether + lumefantrine (inclusion in the EMLc) 17 Section 7. Antimigraine medicines 18 Ibuprofen (inclusion in the EMLc) 18 Section 12. Cardiovascular medicines 18 Section 12.4. Medicines used in heart failure 18 Captopril (inclusion in the EMLc) 18 Carvedilol (Inclusion in the EMLc) 19 Section 17.