UNEDITED DRAFT REPORT OF THE 17th EXPERT COMMITTEE P P ON THE SELECTION AND USE OF ESSENTIAL MEDICINES 23 to 27 March 2009 Version: 18 May 2009 UNEDITED WHO Technical Report Series (18 May 2009) © 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 HU UH 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. 2 UNEDITED WHO Technical Report Series (18 May 2009) Contents PART ONE 17th Expert Committee on the Selection and Use of Essential Medicines...........9 TU UPU UPU UT List of participants........................................................................................................................................11 TU Declaration of interests................................................................................................................................14 U 1. Introduction...............................................................................................................................16 U U U U 2. Open session..............................................................................................................................16 U U U U 3. Proposal for revision of listing pharmaceutical products.................................................19 U U U U 4. Review of other matters...........................................................................................................20 U U U U 5. Review of missing essential medicines for HIV................................................................22 U U U U 6. Review of the report of the Second Subcommittee and U U U of the provisional Second List of Essential Medicines for Children..............................23 U 7. New applications for paediatric medicines.........................................................................26 U U U U Section 6: Anti‐infective medicines.....................................................................................................26 U U U U Section 6.2: Antibacterials...................................................................................................................26 U U U U Procaine benzylpenicillin (Review) ‐‐ (EMLc).................................................................................................26 U U Section 6.2.4: Antituberculosis medicines (Review, EMLc).............................................................27 U U U U Section 6.3: Antifungal medicines.....................................................................................................29 U U U U Liposomal amphotericin B (Inclusion in the EMLc).......................................................................................29 U U Section 6.5: Antiprotozoal medicines................................................................................................30 U U U U Section 6.5.3: Antimalarial medicines..................................................................................................30 U U U U Artemether + lumefantrine (Inclusion in the EMLc)......................................................................................30 U U Section 7: Antimigraine medicines......................................................................................................30 U U U U Ibuprofen (Inclusion in the EMLc)....................................................................................................................30 U U Section 12: Cardiovascular medicines..............................................................................................31 U U U U Section 12.4: Medicines used in heart failure....................................................................................31 U U U U Captopril (Inclusion in the EMLc)....................................................................................................................31 U U Carvedilol (Inclusion in the EMLc)...................................................................................................................31 U U Section 17: Gastrointestinal medicines.................................................................................................32 U U U U Section 17.2: Antiemetic medicines (Inclusion of odansetron in the EMLc)................................32 U U U U Section 18: Hormones...............................................................................................................................32 U U U U Section 18.5: Insulins and other antidiabetic agents.........................................................................32 U U U U Access to Essential Diabetes Medicines for Children in the Developing World........................................32 U U 8. Review of the comments on the Report of the Informal Expert Meeting on Dosage U U U Forms of Medicines for Children..........................................................................................33 U U 3 UNEDITED WHO Technical Report Series (18 May 2009) 9................................................................................Applications for the 16th Model list ......................................................................................................................................................34 U Section 4: Antidotes and other substances used in poisonings......................................................34 U U U U Section 4.2: Specific..............................................................................................................................34 U U U U Pralidoxime (Inclusion)......................................................................................................................................34 U U Section 5: Anticonvulsants/antiepileptics..........................................................................................34 U U U U Lamotrigine (Inclusion)......................................................................................................................................34 U U Addition of lorazepam and midazolam...........................................................................................................35 U U Lorazepam (Inclusion).......................................................................................................................................36 U U Midazolam (Inclusion).......................................................................................................................................36 U U Section 6: Anti‐infective medicines.....................................................................................................37 U U U U Section 6.2: Antibacterials...................................................................................................................37 U U U U Section 6.2.4: Antituberculosis medicines...........................................................................................37 U U U U Rifabutin (Inclusion)...........................................................................................................................................37 U U Section 6.4: Antiviral medicines.........................................................................................................38 U U U U Section 6.4.2: Antiretrovirals.......................................................................................................................38 U U Atazanavir (Inclusion)........................................................................................................................................38 U U Protease inhibitors (Review)..............................................................................................................................39 U U Fixed‐dose combinations.............................................................................................................................41 U U Zidovudine + lamivudine + abacavir (Inclusion) (AZT/3TC/ABC).............................................................41 U U Section 6.4.3: Other antivirals.....................................................................................................................42 U U Amantadine and rimantadine, oseltamivir, zanamivir (Inclusion)..............................................................42 U U Section 6.5: Antiprotozoal medicines................................................................................................43 U U U U Section 6.5.5: Antitrypanosomal medicines.............................................................................................43 U U Nifurtimox + eflornithine (Inclusion)...............................................................................................................43 U U Section 7: Antimigraine medicines............................................................................................................44 U U Sumatriptan (Inclusion).....................................................................................................................................44 U U Section 8: Antineoplastic, immunosuppressives and medicines used in palliative care..........45 U U U U Section 8.2: Cytotoxic medicines........................................................................................................45 U U U U Carboplatin (Inclusion)......................................................................................................................................45 U U Hydroxycarbamide (Inclusion).........................................................................................................................45 U U Ifosfamide (Inclusion).........................................................................................................................................46 U U Mesna (Inclusion)................................................................................................................................................47 U U Section 10: Medicines affecting the blood.......................................................................................47 U U U U Tranexamic acid (Inclusion)..............................................................................................................................47 U U Section 12: Cardiovascular medicines..............................................................................................48 U U U U Section 12.2: Antiarrhythmic medicines.............................................................................................48 U U U U Amiodarone (Inclusion).....................................................................................................................................48 U U Section 12.4: Medicines used in Heart Failure........................................................................................49 U U Hydrochlorothiazide (New formulations).......................................................................................................49 U U Quinidine (Deletion)...........................................................................................................................................49 U U U 4 UNEDITED WHO Technical Report Series (18 May 2009) Section 17: Gastrointestinal medicines............................................................................................50 U Section 17.1: Antiacids and other antiulcer medicines.....................................................................50 U U U U Omeprazole (Inclusion)......................................................................................................................................50 U U Section 17.5: Medicines used in diarrhoea.........................................................................................51 U U U U Endar (Inclusion).................................................................................................................................................51 U U Oral rehydration salts (Inclusion).....................................................................................................................51 U U Section 22: Oxytocics and antioxytocics...........................................................................................52 U U U U Misoprostol (Inclusion)......................................................................................................................................52 U U Section 24: Psychotherapeutic medicines........................................................................................53 U U U U Section 24.1: Medicines used in psychotic disorders........................................................................53 U U U U Clozapine, olanzapine, risperidone, quetiapine, aripiprazole and ziprasidone (inclusion).....................53 U U Section 24.2: Medicines used in mood disorders..............................................................................54 U U U U Section 24.2.1: Medicines used in depressive disorders.................................................................54 U U U U Fluoxetine, paroxetine and sertraline (Inclusion)...........................................................................................54 U U Section 24.3: Medicines used in generalized anxiety and sleep disorders...................................55 U U U U Addition of a selective‐serotonin reuptake inhibitor (escitalopram, paroxetine and sertraline)..............55 U U Section 24.5: Medicines used in substance dependence programmes..........................................56 U U U U Nicotine Replacement Therapy (NRT) (Inclusion).........................................................................................56 U U Section 25: Medicines acting on the respiratory tract...........................................................56 U U U U Section 25.1: Antiasthmatic and medicines for chronic obstructive pulmonary disease...........56 U U U U Beclometasone (New formulation)...................................................................................................................56 U U Cromoglicic acid (Re‐instatement)...................................................................................................................57 U U Summary of recommendations.......................................................................................................58 U U Additions, changes and deletions to the Model List..................................................................58 U U Additions, changes and deletions to the EMLc...........................................................................................61 U U Appendix 1: Proposed lists of priority essential medicines for HIV.......................................63 U U Appendix 2: Report of the Informal Expert Meeting on Dosage Forms of U Medicines for Children...........................................................................................................67 U ANNEX 1: 16th Essential Medicines List........................................................................................79 U UPU UPU U ANNEX 2: Second EMLc..................................................................................................................81 U U ANNEX 3:The Anatomical Therapeutic Chemical (ATC) classification system...................83 U U ANNEX 4: Alphabetical list of essential medicines U (with ATC classification code numbers)..............................................................................85 U PART TWO Second Meeting of the Subcommittee of the Expert Committee on the U Selection and Use of Essential Medicines...........................................................................87 U 1. Introduction...............................................................................................................................91 U U U U 2. Open session..............................................................................................................................91 U U U U 3. Review of terms of reference..................................................................................................92 U U U U U 5 UNEDITED WHO Technical Report Series (18 May 2009) 4. .....................The WHO Model List of Essential Medicines for Children – by section ....................................................................................................................................................100 U Section 4. Antidotes and other substances used in poisonings....................................................100 U U U U Section 4.1 Non‐specific.........................................................................................................................100 U U U U Charcoal, activated (review)............................................................................................................................100 U U Section 4.2 Specific.................................................................................................................................101 U U U U Acetylcysteine (review)....................................................................................................................................101 U U Pralidoxime (inclusion)....................................................................................................................................101 U U Section 6. Anti‐infective medicines...................................................................................................102 U U U U Section 6.2 Antibacterials......................................................................................................................102 U U U U Section 6.2.1 Beta‐lactam medicines..................................................................................................102 U U U U Cefalexin (inclusion).........................................................................................................................................102 U U Procaine benzylpenicillin (review).................................................................................................................103 U U Ceftazidime (review)........................................................................................................................................104 U U Ceftriaxone ...................................................................................................................................................105 U U Carbapenems (review).....................................................................................................................................106 U U Section 6.2.2 Other antibacterials.......................................................................................................107 U U U U Fluoroquinolones (review)..............................................................................................................................109 U U Tetracycline (review)........................................................................................................................................111 U U Gentamicin (review).........................................................................................................................................112 U U Sulfadiazine (review)........................................................................................................................................113 U U Section 6.2.4 Antituberculosis medicines (review).........................................................................113 U U U U Section 6.4.2 Antiretrovirals (new formulations)............................................................................114 U U U U Section 6.5: Antiprotozoal medicines..............................................................................................116 U U U U Section 6.5.2: Antileishmaniasis medicines......................................................................................116 U U U U Liposomal amphotericin B (inclusion)...........................................................................................................116 U U Section 8: Antineoplastic, immunosuppressives and medicines used in palliative care........117 U U U U Section 8.2: Cytotoxic medicines (review)......................................................................................117 U U U U Section 8.4: Medicines used in palliative care (inclusion)...........................................................118 U U U U Section 12: Cardiovascular medicines.................................................................................................121 U U U U Quinidine (review)............................................................................................................................................121 U U Rheumatic fever and rheumatic heart disease (review)...............................................................................121 U U Section 13: Dermatological medicines (topical)................................................................................122 U U U U Dermatological medicines (review)................................................................................................................122 U U Section 15: Disinfectants and antiseptics...........................................................................................124 U U U U Chlorhexidine (new formulation)...................................................................................................................124 U U Section 17: Gastrointestinal medicines...............................................................................................124 U U U U Pancreatic enzymes (inclusion).......................................................................................................................124 U U Section 17.2: Antiemetic medicines (review)...................................................................................125 U U U U Section 18: Hormones, other endocrine medicines and contraceptives........................................126 U U U U Hydrocortisone and fludrocortisone (inclusion)..........................................................................................126 U U 6 UNEDITED WHO Technical Report Series (18 May 2009) Section 24: Psychotherapeutic medicines (review)...........................................................................126 U U U U Section 25: Medicines acting on the respiratory tract.......................................................................127 U U U U Salbutamol (review)..........................................................................................................................................127 U U Section 27: Vitamins and minerals......................................................................................................128 U U U U Retinol ...................................................................................................................................................128 U U New Section 28: Ear, nose and throat conditions in children.........................................................129 U U U U New Section 29: Essential medicines for neonates...........................................................................130 U U U U 5. Summary of recommendations............................................................................................132 U U U U References of the Second Report of the Subcommittee...........................................................136 U U Appendix A: Declaration of interests of Subcommittee members........................................141 U U Appendix B: Essential medicines that can be used in neonates.............................................143 U U References.........................................................................................................................................147 U U 7 UNEDITED WHO Technical Report Series (18 May 2009) 8 UNEDITED WHO Technical Report Series (18 May 2009) PART ONE th 17 Expert Committee on the Selection and Use P P of Essential Medicines 9 UNEDITED WHO Technical Report Series (18 May 2009) 10
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