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The Selection and Use of Essential Medicines Report of the 19Th WHO Expert Committee The Selection and Use of Essential Medicines Report of the 19th WHO Expert Committee WHO Technical Report Series UNEDITED VERSION (October 2013) The Selection and Use of Essential Medicines Report of the WHO Expert Committee, 2013 (including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicines for Children) 1 (Version 07Oct2013) The Selection and Use of Essential Medicines Report of the 19th WHO Expert Committee © World Health Organization 2013 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 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. 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. 2 (Version 07Oct2013) The Selection and Use of Essential Medicines Report of the 19th WHO Expert Committee Table of contents Executive Summary ............................................................................................................................ 8 List of participants of the 19th Expert Committee on the Selection and Use of Essential Medicines ........................................................................................................................................... 12 Members .......................................................................................................................................... 12 Declaration of interests of Members of the 19th Expert Committee on the Selection and Use of Essential Medicines ............................................................................................................. 16 Members reported the following interests: ................................................................................ 16 The temporary advisers present declared the following interests: ......................................... 17 1. Introduction ............................................................................................................................... 18 2. Open Session ............................................................................................................................. 19 3. General items ............................................................................................................................. 21 3.1 Defining public health relevance ........................................................................................... 21 3.2 Medicines Information as a Global Public Good ................................................................. 22 3.3 Section 6 ‐ Ivermectin .............................................................................................................. 23 3.4 Other .......................................................................................................................................... 24 4. Applications only for paediatric medicines ......................................................................... 25 Section 1: Anaesthetics ......................................................................................................... 25 Anaesthetics (Review) ‐‐ Children ................................................................................... 25 Section 2: NSAIMs and DMARDs ..................................................................................... 26 2.2: Opioid analgesics ................................................................................................... 26 Hydromorphone (Addition) – Children Oxycodone (Addition) ‐‐ Children ............ 26 Morphine (New formulation) ‐‐ Children ...................................................................... 27 6.2: Antibacterials 6.2.4: Antituberculosis medicines ............................................. 27 Second‐line antituberculosis medicines (Review) ‐‐ Children ..................................... 27 Streptomycin injections (To be moved to complementary list) ‐‐ Children .............. 31 6.4.2: Antiretrovirals...................................................................................................... 31 Abacavir (New formulation); Abacavir + lamivudine (Addition); Efavirenz (New formulation); Lamivudine + nevirapine + zidovudine (New formulation); Lamivudine + stavudine (New formulation; Lamivudine + zidovudine (New formulation); Nevirapine (New formulation) ................................................................ 31 6.5.5: Antitrypanosomal medicines 6.5.5.1: African trypanosomiasis ................. 32 Nifurtimox tablets (Addition) ‐‐ Children ...................................................................... 32 6.5.5: Antitrypanosomal medicines 6.5.5.2: American trypanosomiasis ............. 33 Benznidazole tablets (New formulation) ‐‐ Children ................................................... 33 Section 8: Antineoplastic ..................................................................................................... 34 3 (Version 07Oct2013) The Selection and Use of Essential Medicines Report of the 19th WHO Expert Committee 8.4: Medicines used in palliative care ........................................................................ 34 Palliative care (New section) ‐‐ Children ........................................................................ 34 Section 11: Blood products and Plasma Substitutes ....................................................... 34 11.1: Plasma substitutes ................................................................................................ 34 Colloids (Review) ‐‐ Children .......................................................................................... 34 Section 12: Cardiovascular medicines ............................................................................... 36 12.2: Antiarrhythmic medicines ............................................................................................... 36 Antiarrhythmics (Review) ‐‐ Children ............................................................................ 36 12.6: Lipid‐lowering agents ......................................................................................... 37 Statins (Review) ‐‐ Children ............................................................................................. 37 Section 15: Disinfectants ...................................................................................................... 38 15.1: Antiseptics .......................................................................................................... 38 Chlorhexidine (New formulation) ‐‐ Children ............................................................... 38 Section 24: Psychotherapeutic medicines ......................................................................... 39 24.1: Medicines used in psychotic disorders ............................................................ 39 Chlorpromazine and haloperidol (Deletion) ‐‐ Children only .................................... 39 24.2: Medicines used in mood disorders 24.2.1: Medicines used in depressive disorders ......................................................................................................................... 40 Fluoxetine (Change to age restriction/Deletion from EMLc) ‐‐ Adults and Children .............................................................................................................................................. 40 Section 28: Ear, nose and throat medicines ...................................................................... 40 Montelukast (Addition) ‐‐ Children ................................................................................ 40 Section 29: Specific medicines for neonatal care ............................................................ 41 Dexamethasone (New indication) ‐‐ Children ............................................................... 41 5. Applications for the 18th Model List and the 4th EMLc ................................................... 42 Section 2: NSAIMs and DMARDs
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