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[e-med] La nouvelle liste OMS des médicaments essentiels sur le web

E-MED: La nouvelle liste OMS des médicaments essentiels sur le web
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[Modérateur : traduction partielle d'un message de e-drug. CB]

Chers tous,

La 13ème Liste Modèle de l'OMS sur les Médicaments Essentiels a été publiée
sur le site web de OMS/EDM, avec le raport du 13ème Comité d'Experts sur la
Sénection et l'Usage des Médicaments Essentiels (2003), et le résumé de
leurs recommandations. Tous les documents peuvent être trouvé à cette
adresse www.who.int/medicines sous la rubrique "latest" et ensuite "Expert
Commitee on the Selection and Use of Essential Medicines". L'addresse direct
est
http://www.who.int/medicines/organization/par/edl/expertcomm.shtml

Les recommandations les plus importantes du Comité d'expert et les
changements au niveau de la 13ème Liste Modèle sont résumées ci-dessous.

Nous sommes en train de travailler dur pour traduire dans les 5 langues la
liste et pour adapter le Formulaire Modèle de l'OMS pour l'édition 2003.

Hans V. Hogerzeil, MD, PhD, FRCP Edin
Coordinator for policy, access and rational use
Department of Essential Drugs and Medicines Policy
World Health Organisation, 1211 Geneva
Tel +41-22-7913528
Fax +41-22-7914167
<hogerzeilh@who.int>

-----Message d'origine-----
De : owner-e-drug@healthnet.org [mailto:owner-e-drug@healthnet.org]De la
part de Hans Hogerzeil
Envoyé : mardi 13 mai 2003 00:07
À : e-drug@healthnet.org
Objet : [e-drug] New WHO Model List on the web


E-drug: New WHO Model List on the web
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Dear all,

The 13th WHO Model List of Essential Medicines has been posted on
the WHO/Medicines web site, together with the unedited report of the
13th Expert Committee on the Selection and Use of Essential
Medicines (2003), and the summary of their recommendations. All
materials can be found at the www.who.int/medicines website under
"latest" and then "Expert Commitee on the Selection and Use of
Essential Medicines". The direct address is
http://www.who.int/medicines/organization/par/edl/expertcomm.shtml

The main recommendations of the Expert Committee and changes in
the 13th Model List are summarized below. For the underlying
evidence and the reasoning of the Committee, please see the original
applications and the report of the Committee.

We are working hard to get the other five language translations of the
Model Iist on the web; and to adapt the WHO Model Formulary
accordingly for the 2003 edition.

With best regards,

Hans V. Hogerzeil, MD, PhD, FRCP Edin
Coordinator for policy, access and rational use
Department of Essential Drugs and Medicines Policy
World Health Organisation, 1211 Geneva
Tel +41-22-7913528
Fax +41-22-7914167
<hogerzeilh@who.int>

----
Summary of recommendations of the Expert Committee and changes
in the 13th Model List of Essential Medicines

Added:
- amodiaquine tablet, 153 mg or 200 mg (base);
- azithromycin 250 or 500mg capsule, and suspension 200mg/5ml.
- 1.5 mg single levonorgestrel (new dosage form)

Rejected: paediatric ibuprofen, porcine insulin suspension (insulin
semilente), miconazole buccal tablets, misoprostol and valaciclovir.

Deleted:
- ethinylestradiol + levonorgestrel tablet, 50 micrograms + 250
micrograms (pack of four)
- nonoxinol and spermicides with condoms and diaphragms
- chloral hydrate
- dextromethorphan
- fludrocortisone
- folic acid injection
- ipecacuanha syrup
- human immunoglobulin
- pethidine
- cyclophosphamide in section 2.4
- trimethoprim injection
- iron dextran injection
- prazosin
- hydralazine
- reserpine
- desmopressin

Changed:
- ORS: to 75 mEq/l sodium (sodium chloride 2.6 g/liter) and 75 mmol/l (13.5
g/liter) glucose
- streptokinase: dosage changed to powder for injection 1.5 million IU in
vial.

The Committee decided to define the criteria for core and complementary
lists, as follows:
The core list presents a list of minimum medicine needs for a basic health
care system, listing the most efficacious, safe and cost effective medicine
for priority conditions. Priority conditions are selected on the basis of
current and estimated future public health relevance, and potential for safe
and cost-effective treatment.
The complementary list presents essential medicines for priority diseases,
for which specialized diagnostic or monitoring facilities, and/or specialist
medical care, and/or specialist training are needed.
In case of doubt medicines may also be listed as complementary on the basis
of consistent higher costs or less attractive cost-effectiveness in a
variety of settings.

The Committee recommended that the core and complementary list be combined
as one, with medicines on the complementary list printed in italics or
otherwise identified.

Moved from the core list to the complementary list:
amphotericin-B, aminophylline, azathioprine, clomifene, diethylcarbamazine,
dopamine, ethosuximide, hydrocortisone rectal preparations, intraperitoneal
dialysis solution, methotrexate, penicillamine, pentamidine, pyridostigmine,
sulfadiazine and sulfasalazine.

Moved from the complementary list to the core list:
amoxicillin/clavulanic acid, chloramphenicol oily solution, epinephrine
(adrenaline) injection, levonorgestrel, mannitol and norethisterone
enantate.

The Committee agreed to use the square box symbol on the basis of the
following description:
"The square box symbol is primarily intended to indicate similar clinical
performance within a pharmacological class. The listed medicine should be
the example of the class for which there is the best evidence for
effectiveness and safety. In some cases, this may be the first medicine that
is licensed for marketing; in other instances, subsequently licensed
compounds may be safer or more effective.
Where there is no difference in terms of efficacy and safety data, the
listed medicine should be the one that is generally available at the lowest
price, based on international drug price information sources.
Therapeutic equivalence is only indicated on the basis of reviews of
efficacy and safety and when consistent with WHO clinical guidelines.
National lists should not use a similar symbol and should be specific in
their final selection, which would depend on local availability and price."

Square box symbol removed:
amiloride, amoxicillin, amoxicillin/clavulinic acid, antitetanus
immunoglobulin, azathioprine, chloramphenicol, chloroquine, ciclosporin,
clomifene, charcoal activated, codeine, cycloserine, dexamethasone,
diloxanide, DL-methionine, doxorubicin, doxycycline, epinephrine/adrenaline,
ethionamide, hydrocortisone, glibenclamide, ibuprofen, mannitol, morphine,
neostigmine, promethazine, quinine, sodium nitroprusside, retinol,
sulfadiazine, sulfadoxine/pyrimethamine, sulfamethoxazole/trimethoprim and
verapamil.

Square box symbol retained but listed medicine changed:
- cloxacillin to be replaced by dicloxacillin
- captopril to be replaced by enalapril
- cimetidine to be replaced by ranitidine

Review of corticosteroids:
Core list: section 3:
- prednisolone tablets 5mg and 25mg with square box
- dexamethasone, injection 4mg dexamethasone phosphate (as disodium salt) in
1ml
- hydrocortisone, powder for injection, 100mg (as sodium succinate) in vial
both
Complementary list, section 8.3: same items listed
Section 18.1: all corticosteroids deleted

Review of antihypertensive drugs:
Deleted: reserpine, hydralazine and prazosin
Captopril be replaced by enalapril with square box
Critical review to be carried out of the justification of the use of
dihydropyridine calcium channel blockers as first-line treatment for
hypertension.
Methyldopa kept on core list, but only for use in pregnancy
In summary, the Committee recommended that boxed atenolol tablet 50mg,
100mg; enalapril tablet 25mg; boxed hydrochlorothiazide scored tablet 25mg;
methyldopa tablet 250mg and boxed nifedipine be listed on the core list of
section 12.3; and that sodium nitroprusside, powder for infusion, 50mg in
ampoule be listed on the complementary list.

Proposals for fast-track deletion in 2004
Ether, codeine, colchicine, clonazepam, niclosamide, pyrantel,
triclabendazole, oxamniquine, imipenem/cilastatin, nalidixic
acid,spectinomycin, levofloxacin, thioacetazone/isoniazid, diethyltoluamide,
ergotamine, polygeline, Factors VIII and IX, isoprenaline, procainamide,
quinidine, nifedepine, topical sun protection agent, local
anaesthetic/astringent ointment, atropine in section 17.4,
medroxyprogesterone acetate, silver nitrate eye solution, ergometrine,
salbutamol in section 22.2.2, aminophylline, cromoglicic acid, calcium
gluconate and sodium fluoride. The Committee recommended that these items be
marked in the list with the following footnote: "The public health relevance
and/or efficacy and/or safety of this item has been questioned and its
continued inclusion on the list will be reviewed at the next meeting of the
Expert Committee.

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