WHO Technical Report Series -- UNEDITED PREPUBLICATION REPORT OF THE WHO EXPERT COMMITTEE ON THE SELECTION AND USE OF ESSENTIAL MEDICINES Geneva, 19-23 March 2007 Unedited prepublication WHO Technical Report Series -- UNEDITED PREPUBLICATION © World Health Organization 2007 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]). 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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. Printed in (for external printing) Printed by the WHO Document Production Services, Geneva, Switzerland WHO Technical Report Series -- UNEDITED PREPUBLICATION Table of contents 1. Introduction.............................................................................................................................................. 1 2. Open session ............................................................................................................................................ 1 3. Update on current activities .................................................................................................................. 4 3.1 Procedure to update and disseminate the Model List .......................................................... 4 3.1.2 Procedure for between‐meeting decisions ............................................................... 4 3.2 Proposal for sub‐committee on essential medicines for children........................................ 5 3.3 Proposal on listing FDCs for infectious diseases................................................................... 7 3.4 Report from the Advisory Committee on Safety of Medicinal Products (ACSoMP) ....... 8 3.5 Update of dosage forms and strengths for products on the EML....................................... 9 3.6 Rare diseases proposal ............................................................................................................ 10 3.7 Procedure for updating the content of the Interagency Emergency Health Kit.............. 11 3.8 Late agenda item on medicines for acute care ..................................................................... 12 3.9 Report on WHO Model Formulary ....................................................................................... 12 3.10 Report on Drug Bulletin manual ........................................................................................... 13 3.11 Review of critically important antibiotic proposal.............................................................. 13 3.12 Advice on draft resolution on rational use of medicines ................................................... 14 4. Changes made in revising the Model List ‐ by section .................................................................. 15 Medicines for all populations......................................................................................................................... 15 4.1 Section 2: addition of prolonged release morphine............................................................. 15 4.2 Section 6.1: deletion of levamisole as anthelminthic........................................................... 16 4.3 Section 6.2.1: Beta lactam: addition of cefazolin/cefalexin ................................................. 18 4.4 Section 6.2.4: Antituberculosis medicines............................................................................. 19 4.4.1 Addition of rifampicin + isoniazid + ethambutol.................................................. 19 4.4.2 Section 6.2.4: Review of quinolones for multi‐drug resistant TB ........................ 20 4.5 Section 6.4.2: Antiretrovirals .................................................................................................. 21 4.5.1 Section 6.4.2.1: Nucleoside reverse transcriptase inhibitors: Addition of emtricitabine............................................................................................................... 21 4.5.2 Section 6.4.2.1: NRTI: addition of tenofovir disoproxil fumarate ....................... 22 4.5.3 Section 6.4.2: Antiretrovirals .................................................................................... 23 Section 6.4.2.2: Non‐nucleoside reverse transcriptase inhibitors: addition of new strength of efavirenz ................................................................................................. 23 Section 6.4.2.3: Protease inhibitors......................................................................................... 24 4.5.4 Fixed‐dose combinations of antiretrovirals ........................................................... 24 4.5.4.1 Addition of lamivudine/zidovudine....................................................................... 24 4.5.4.2 Addition of lamivudine/zidovudine/nevirapine................................................... 26 4.5.4.3 Addition of lamivudine/stavudine/nevirapine ..................................................... 27 4.5.4.4 Addition of emtricitabine and tenofovir disoproxil fumarate fixed‐dose combination................................................................................................................ 28 4.5.4.5 Addition of efavirenz, emtricitabine and tenofovir disoproxil fumarate FDC tablet ............................................................................................................................ 29 4.6 New section under 6.4.3: Addition of new section and medicine ribavirin..................... 30 4.7 Late item: antiviral medicines for pandemic influenza ...................................................... 30 4.8 Section 6.5.2: Antileishmaniasis: addition of paromomycin.............................................. 31 4.9 Section 6.5.3: Antimalarial medicines ................................................................................... 32 4.9.1 Review of section 6.5.3: Antimalarial medicines................................................... 32 4.9.2 Addition of artesunate (injectable and suppositories).......................................... 33 4.10 Review of section 6.5.5: Antitrypanosomal medicines ....................................................... 35 4.11 Section 7: Antimigraine medicines ........................................................................................ 37 4.11.1 Addition of sumatriptan........................................................................................... 37 WHO Technical Report Series -- UNEDITED PREPUBLICATION 4.11.2 Deletion of paracetamol............................................................................................ 37 4.12 Section 8.2: Cytotoxic drugs ................................................................................................... 38 4.12.1 Section 8.2: Cytotoxic medicines.............................................................................. 38 4.12.2 Deletion of chlormethine .......................................................................................... 38 4.12.3 Deletion of levamisole as an anticancer medicine................................................. 39 4.13 Review of section 8.4: Medicines used in palliative care.................................................... 39 4.14 Section 12.6: Lipid‐lowering drugs: addition of simvastatin............................................. 40 4.15 Section 18.3: Contraceptives ................................................................................................... 42 4.14.1 Review of section 18.03.00.00: Contraceptives....................................................... 42 4.14.2 Addition of levonorgestrel implants....................................................................... 43 4.14.3 Addition of medroxyprogesterone acetate plus estradiol cypionate ................. 44 4.15 Section 19.2: Sera and immunoglobulins.............................................................................. 45 4.15.1 Application for antivenom serum: equine immunoglobuline