E-DRUG: 7-11 March: next WHO Essential Medicines Committee meeting
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[After 2 years, the next WHO EML Committee meeting will be held 7-11 March 2005 in Geneva.
A lot of proposals to add/delete/reintroduce are downloadable on the WHO website.
- 17 additions
- 1 new formulation
- 34 deletions
- 2 reinstatements
A list is below; all comments are publicly available as well (deadline for comments has now passed). Some products are getting alot of debate/attention, whereas others are getting no response.
There is a public day on 7 March; the rest is in camera. Maybe WHO should reconsider this?
All data available at:
www.who.int/medicines/organization/par/edl/expcom14/expcom05agenda.shtml
WB]
PROPOSED ADDITIONS:
buprenorphine
Letter: International Association for Pain and Chemical Dependency (30kb pdf)
Letter: South Eastern European Addiction Treatment Network (79kb pdf)
Letter: International AIDS Society (67kb pdf)
Rejoinder: Expert Committee Member (14kb pdf)
Comment: Director, Mental Health, MOH, Islamic Republic of Iran (41KB pdf)
Letter: WHO/Mental Health and Substance Abuse & HIV/AIDS (14 January 2005) (24KB pdf)
Letter: Ministry of Health, Kyrgyz Republic (11 January 2005) (71KB pdf)
Letter: British Columbia Centre for Excellence in HIV/AIDS (245KB pdf)
Letter: Central and Eastern European Harm Reduction Network, European AIDS Treatment Group and International Harm Reduction Association 114KB pdf)
Letter: Alcohol and other Drugs Council of Australia (47KB pdf)
Preliminary response: Expert Committee Member (30 Nov 2004) (10KB pdf)
Letter: American Psychological Association (18KB pdf)
Letter: Colonial Management Group, LP, USA (71KB pdf)
Letter: Virginia Commonwealth University, USA (535KB pdf)
Letter: College on Problems of Drug Dependence, Inc. USA (23KB pdf)
Application: WHO/Mental Health and Substance Abuse & HIV/AIDS (418KB pdf)
Letter to Director-General WHO (44KB pdf)
caffeine
Application: Royal Children's Hospital & University of Melbourne (135kb pdf)
Review: Application of caffeine, 05 January 2005 (22kb pdf)
Memorandum: WHO Child and Adolescent Health and Development, 14th December 2004 (17kb pdf)
cefixime
Review: Expert Committee Member (19kb pdf)
Application: WHO/RHR (138kb pdf)
emtricitabine
Review: Expert Committee Member (48kb pdf)
Report: WHO Advisory Committee on Safety of Medicinal Products (26kb pdf)
Message: Gilead Sciences Inc, USA (03 Nov 2004) (23kb pdf)
Application: Gilead Sciences Inc, USA (28 Oct 2004) (289kb pdf)
emtricitabine +tenofovir (fixed dose combination)
Review: WHO Expert Committee Member (48kb pdf)
Report: WHO Advisory Committee on Safety of Medicinal Products (25kb pdf)
Message: Gilead Sciences Inc, USA (03 Nov 2004) (23kb pdf)
Application: Gilead Sciences Inc, USA (28 Oct 2004) (659kb pdf)
etonogestrel releasing implant
Application: WHO Department of Reproductive Health and Research (85KB pdf)
ibuprofen suspension
Comment: WHO Child and Adolescent Health and Development (41kb pdf)
Comment: Cochrane Pain and Palliative Care Group (16kb pdf)
Application: International Ibuprofen Foundation (2592kb pdf)
Review: Application of ibuprofen pediatric suspension, 20 December 2004 (137kb pdf)
levonorgestrel releasing implant
Application: WHO Department of Reproductive Health and Research (85KB pdf)
levonorgestrel-releasing IUD for contraception
Review: WHO Expert Committee Member (80kb pdf)
Application: WHO/RHR (289kb pdf)
medroxyprogesterone acetate + estradiol enantate
Application: WHO Department of Reproductive Health and Research (90KB pdf)
methadone
Letter: International Association for Pain and Chemical Dependency (30kb pdf)
Letter: South Eastern European Addiction Treatment Network (79kb pdf)
Letter: International AIDS Society (67kb pdf)
Rejoinder: Expert Committee Member (14kb pdf)
Comment: Director, Mental Health, MOH, Islamic Republic of Iran (41KB pdf)
Letter: WHO/Mental Health and Substance Abuse & HIV/AIDS (14 January 2005) (24KB pdf)
Letter: Ministry of Health, Kyrgyz Republic (11 January 2005) (71KB pdf)
Letter: Alcohol and other Drugs Council of Australia (47KB pdf)
Letter: Central and Eastern European Harm Reduction Network, European AIDS Treatment Group and International Harm Reduction Association (114KB pdf)
Preliminary response: Expert Committee Member (30 Nov 2004) (10KB pdf)
Letter: American Psychological Association (18KB pdf)
Letter: Colonial Management Group, LP, USA (71KB pdf)
Letter: Virginia Commonwealth University, USA (535KB pdf)
Letter: College on Problems of Drug Dependence, Inc. USA (23KB pdf)
Application: WHO/Mental Health and Substance Abuse & HIV/AIDS (281KB pdf)
Letter to Director-General WHO (on rescheduling buprenorphine: methadone mentioned) (44KB pdf)
Media Alert February 2004 (26KB pdf)
Letter to Director-General WHO (on inclusion of drug users into 3by5 initiative: methadone mentioned) (178KB pdf)
methoxyflurane
Application: Medical Developments International Limited (177kb pdf)
mifepristone combined with misoprostol
Review: WHO Expert Committee Member (142kb pdf)
Application: WHO/RHR (75kb pdf)
miltefosine
Letter: WHO Department of Control, <prevention, and Eradication (CPE) (27 pdf)
Message: Dr J Berman, NIH/NCCAM (USA) (10KB pdf)
Message: Midecins Sans Frontihres (16KB pdf)
Application: Zentaris GmbH (418kb pdf)
Memorandum: WHO Communicable Diseases (10 December 2004) (20kb pdf)
Message: Prof. Dr. Juergen Engel, Zentaris GmbH
Message: Prof. Dr. Juergen Engel, Zentaris GmbH (24KB pdf)
Attachment 1 (27kb pdf)
Attachment 2 (19kb pdf)
Attachment 3 (60kb pdf)
Review: application of miltefosine, 30 December 2004 (26KB pdf)
Message: Prof. Dr. Jamie Soto, MD, Columbia (15KB pdf)
norethisterone enantate +estradiol valerate
Application: WHO Department of Reproductive Health and Research (85KB pdf)
tenofovir
Review: Expert Committee Member (48kb pdf)
Report: WHO Advisory Committee on Safety of Medicinal Products (23kb pdf)
Message: Gilead Sciences Inc, USA (03 Nov 2004) (23kb pdf)
Application: Gilead Sciences Inc, USA (28 Oct 2004) (934kb pdf)
Public statement: European Agency for Evaluation of Medicinal Products (22 October 2003)
(146kb pdf)
Public statement: European Agency for Evaluation of Medicinal Products (30 July 2003)
(129kb pdf)
zinc sulfate
(no data!?)
ADDITIONAL FORMULATION
ceftriaxone 1g
Application: WHO/ERI Epidemic Readiness & Interventions (124KB pdf)
Review: Application of ceftriaxone 1g, 20 December 2004 (21KB pdf)
SECTION REVIEWS
Section 1 & 20: Anaesthetics and muscle relexants
Review: International Society of Drug Bulletins (618KB pdf)
Letter: Dr M Dobson, World Federation of Societies of Anaesthesiologists (618KB pdf)
Review: Dr M Dobson, World Federation of Societies of Anaesthesiologists (618KB pdf)
Section 6.2.1: Cefalosporins and imipenem+cilastatin
Review: International Society of Drug Bulletins (177KB pdf)
Annex to ISDB review: comparative costs of ceftazidime, ceftriaxone, imipenem/cilastatin and gentamicin sulfate (22KB pdf)
Section 21: Ophthalmological preparations (177KB pdf)
Secretariat note (7KB pdf)
Review: International Society of Drug Bulletins (177KB pdf)
POSSIBLE DELETIONS
aminophylline
Review: external (109KB pdf)
Review: International Society of Drug Bulletins (36KB pdf)
Application: WHO/CRA (Chronic Respiratory Diseases and Arthritis) (1346KB pdf)
Statement: Midecins Sans Frontihres [update 26 January 2005] (17KB pdf)
atropine (antispasmodic)
Review: International Society of Drug Bulletins (33KB pdf)
calcium gluconate (mineral)
Review: International Society of Drug Bulletins (45KB pdf)
clonazepam
Review: International Society of Drug Bulletins (26KB pdf)
codeine (antidiarrhoeal)
Review: International Society of Drug Bulletins (20KB pdf)
colchicine
Review: International Society of Drug Bulletins (75KB pdf)
cromoglicic acid
Message: Non-Profit Organization "Japan Institute of Pharmacovigilance" (62KB pdf)
Review: International Society of Drug Bulletins (29KB pdf)
Application: WHO/CRA (Chronic Respiratory Diseases and Arthritis) (556KB pdf)
diethyltoluamide
Memorandum: WHO Roll Back Malaria (26 Nov 2004) (18KB pdf)
Statement: Midecins Sans Frontihres (11KB pdf)
ergometrine
Comment: WHO Reproductive Health and Research (112KB pdf)
ergotamine
Review: International Society of Drug Bulletins (75KB pdf)
ether
Ether supply 1999-2004
Review: International Society of Drug Bulletins (48KB pdf)
factor VIII and factor IX
Letter: Associagco Portuguesa dos Hemofilicos (54KB pdf)
Submission: European Plasma Fractionation Association (116KB pdf)
Letter: Haemophilia Association of Sri Lanka (598KB jpg)
Letter: National Hemophilia Foundation, USA (100KB pdf)
Letter: Finnish Hemophilia Society (15KB pdf)
Letter: Plasma Protein Therapeutics Association (99KB pdf)
Application: Plasma Protein Therapeutics Association (138KB pdf)
Letter: Cork University Hospital, Ireland (22KB pdf)
Letter: Australian Haemophilia Centre Directors' Organization (31KB pdf)
Letter: National Hemophilia Patients Associations (1961KB pdf)
Message: Marta Ferro, Argentina (24KB word)
Submission: World Federation of Hemophilia (317KB pdf)
Comment: WHO/HGN (Human Genetics) (252KB pdf)
Message: Dr Jing Sun, Guangzhou, China (23KB word)
Message: Dra Rosa Nieves, Santo Domingo, Repzblica Dominica (22KB word)
Message: Maria Joao Diniz, Lisbon, Portugal (21KB word)
Message: Dr R Anburajan, Tirunelveli, India (22KB word)
Letter: Association Suisse des Himophiles (23KB pdf)
Letter: The Haemophilia Society, United Kingdom (30KB pdf)
imipenem + cilastatin
Letter: Prof. B. Barsic, Croatia (20KB pdf)
Letter: Prof. J. Vukadinov, Serbia (29KB pdf)
Letter: Prof. V. Vlahov, Bulgaria (29KB pdf)
Letter: Prof. A. Streinu-Cercel, Romania (22KB pdf)
Letter: Prof. L.S. Stratchounski, Russia (41KB pdf)
Letter: Merck & Co Inc. (412KB pdf)
Review: International Society of Drug Bulletins (74KB pdf)
Annex to ISDB review: comparative costs of imipenem/cilastatin, ceftazidime, ceftriaxone and gentamicin sulfate (22KB pdf)
E-mail from Prof.Dr. Marcus M|ller (12KB pdf)
Letter from Prof. S. Ragnar Norrby (18KB pdf)
EDM reply to Prof. S. Ragnar Norrby (11KB pdf)
Message to representative of Merck & Co., Inc (10KB pdf)
isoprenaline
Message: Non-Profit Organization "Japan Institute of Pharmacovigilance" (40KB pdf)
Review: International Society of Drug Bulletins (74KB pdf)
levofloxacin
Memorandum: WHO Stop TB Department (32KB pdf)
local anaesthetic/astringent ointment (for haemorrhoids)
Review: International Society of Drug Bulletins (19KB pdf)
medroxyprogesterone acetate depot injection
Comment: WHO/RHR memorandum (29KB pdf)
Comment: MSF (17KB pdf)
medroxyprogesterone acetate tablet
Review:Expert Committee Member (50KB pdf)
nalidixic acid
Memorandum: WHO Child and Adolescent Health and Development (CAH) (18KB pdf)
Weekly Epidemiological Record No.39, 24 September 2004 (pages 355-6) (590KB pdf)
Review: International Society of Drug Bulletins (22KB pdf)
Statement: Midecins Sans Frontihres [update 26 January 2005] (17KB pdf)
niclosamide
Comments: WHO/CDS (17KB pdf)
nifedipine
Review: WHO Collaborating Centre (96KB pdf)
Table: WHO Collaborating Centre review (47KB pdf)
Statement: Midecins Sans Frontihres (13KB pdf)
oxamniquine
Comments: WHO/CDS (17KB pdf)
polygeline
Review: International Society of Drug Bulletins (74KB pdf)
Statement: Midecins Sans Frontihres (12KB pdf)
procainamide
Review: International Society of Drug Bulletins (32KB pdf)
pyrantel
Comments: WHO/CDS (17KB pdf)
quinidine
Review: International Society of Drug Bulletins (32KB pdf)
salbutamol (obstetric use)
Review: British Medical Journal - Clinical Evidence & WHO/RHR (171KB pdf)
Statement: Midecins Sans Frontihres (15KB pdf)
silver nitrate eye solution
Review: International Society of Drug Bulletins (21KB pdf)
Comment: WHO/CPM (Chronic Diseases Prevention and Management (47KB pdf)
sodium fluoride
Review: International Society of Drug Bulletins (130KB pdf)
Annex: International Society of Drug Bulletins Review (34KB xls)
Submission: Dr Junji Kato, Japan (33KB pdf)
Submission: Fluoride Action Network, USA (26KB pdf)
WHO Oral Health Programme statement (47KB pdf)
Expert Panel Member comment (10KB pdf)
Letter from FDI World Dental Federation (220KB pdf)
spectinomycin
Review: International Society of Drug Bulletins (21KB pdf)
Comment: Midecins Sans Frontihres (15KB pdf)
Statement: WHO/RHR/STI (10KB pdf)
theophylline
Review: external (154pdf)
Review: International Society of Drug Bulletins (42KB pdf)
Application: WHO/CRA (Chronic Respiratory Diseases and Arthritis) (1219KB pdf)
thioacetazone/isoniazid (TH)
Statement: WHO Stop TB Department (231KB pdf)
Statement: Midecins Sans Frontihres (14KB pdf)
topical sun protection agent
Review: International Society of Drug Bulletins (32KB pdf)
triclabendazole
Statement: Midecins Sans Frontihres (MSF) (17KB pdf)
Comments: WHO/CDS (17KB pdf)
APPLICATIONS FOR REINSTATEMENT
immunoglobulin human:
Submission: European Plasma Fractionation Association (106KB pdf)
Letter: Prof. Hughes, UK (42KB pdf)
Letter: Plasma Protein Therapeutics Association (99KB pdf)
Application: Plasma Protein Therapeutics Association (126KB pdf)
Immune Deficiency Foundation (329KB pdf)
International Union of Immunological Societies (IUIS) (41KB pdf)
UK Primary Immunodeficiency Network (32KB pdf)
International Patient Organisation for Primary Immunodeficiencies (IPOPI) (20KB pdf)
Organizations supporting reinstatement (14KB pdf)
fludrocortisone:
(no data!?)
OTHER MATTERS
Letter: Midecins Sans Frontihres, text change to section 6.4.2, Antiretroviral medicines (37KB pdf)
Statement: summary of evidence, oxytocin for post-partum haemorrhage, PATH, USA (47KB pdf)
Statement: critical path to commercial availability of oxytocin in UNIject: PATH, USA (37KB pdf)
Secretariat comment: oxytocin & UNIject statements from PATH, USA (12KB pdf)
Review: labetalol for the treatment of hypertension in pregnancy, WHO/RHR, 15 December 2004 (57KB pdf)
Review: nifedipine as tocolytic in late pregnancy (71KB pdf)
Review: prostaglandins in the management of portpartum haemorrhage (106KB pdf)
Comments on 13th Model list: British National Formulary (Summary) (23KB pdf)
Priorities for future reviews: extract from TRS920 (2004) (23KB pdf)