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TRS958.Indd I 12.04.10 16:01 WHO Library Cataloguing-In-Publication Data 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 The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for 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 programme of publications. The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specifi c categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision-makers. These books are closely tied to the Organization’s priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHO’s Member countries and the collaboration of world leaders in public health and the biomedical sciences. To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publications and encourages their translation and adaptation. By helping to promote and protect health and prevent and control disease throughout the world, WHO’s books contribute to achieving the Organization’s principal objective — the attainment by all people of the highest possible level of health. The WHO Technical Report Series makes available the fi ndings of various international groups of experts that provide WHO with the latest scientifi c and technical advice on a broad range of medical and public health sub- jects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily refl ect the decisions or the stated policy of WHO. An annual subscription to this series, comprising about six such reports, costs CHF 168.00/US$ 151.00 (CHF 128.40/US$ 115.00 in developing countries). For further information, please contact: 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]; order on line: http://www.who.int/bookorders). 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 TRS958.indd i 12.04.10 16:01 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 TRS958.indd ii 12.04.10 16:01 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. Gastrointestinal medicines 19 Section 17.2. Antiemetic medicines (Inclusion of ondansetron in the EMLc) 19 Section 18. Hormones 20 Section 18.5. Insulins and other antidiabetic agents 20 Access to essential diabetes medicines for children in the developing world 20 8. Review of the comments on the Report of the Informal Expert Meeting on Dosage Forms of Medicines for Children 20 9. Applications for the 16th WHO Model List of Essential Medicines 22 Section 4. Antidotes and other substances used in poisonings 22 Section 4.2. Specifi c 22 Pralidoxime (inclusion) 22 Section 5. Anticonvulsants/antiepileptics 23 Lamotrigine (inclusion) 23 iii TRS958.indd iii 12.04.10 16:01 Addition of lorazepam and midazolam 24 Lorazepam (inclusion) 24 Midazolam (inclusion) 24 Section 6. Anti-infective medicines 25 Section 6.2. Antibacterials 25 Section 6.2.4. Antituberculosis medicines 25 Rifabutin (inclusion) 25 Section 6.4. Antiviral medicines 26 Section 6.4.2. Antiretrovirals 26 Atazanavir (inclusion) 26 Protease inhibitors (review) 27 Fixed-dose combinations 29 Zidovudine + lamivudine + abacavir (AZT/3TC/ABC) (inclusion) 29 Section 6.4.3. Other antivirals 31 Amantadine and rimantadine, oseltamivir, zanamivir (inclusion) 31 Section 6.5. Antiprotozoal medicines 32 Section 6.5.5. Antitrypanosomal medicines 32 Nifurtimox + efl ornithine (inclusion) 32 Section 7. Antimigraine medicines 33 Sumatriptan (inclusion) 33 Section 8. Antineoplastic, immunosuppressives and medicines used in palliative care 34 Section 8.2. Cytotoxic medicines 34 Carboplatin (inclusion) 34 Hydroxycarbamide (inclusion) 35 Ifosfamide (inclusion) 36 Mesna (inclusion) 37 Section 10. Medicines affecting the blood 38 Tranexamic acid (inclusion) 38 Section 12. Cardiovascular medicines 38 Section 12.2. Antiarrhythmic medicines 38 Amiodarone (inclusion) 38 Section 12.4. Medicines used in heart failure 39 Hydrochlorothiazide (new formulations) 39 Quinidine (deletion) 40 Section 17. Gastrointestinal medicines 41 Section 17.1. Antacids and other antiulcer medicines 41 Omeprazole (inclusion) 41 Section 17.5. Medicines used in diarrhoea 42 Endar (inclusion) 42 Oral rehydration salts (inclusion) 42 Section 22. Oxytocics and antioxytocics 43 Misoprostol
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