Le rapport de la réunion du Comité de la liste des médicaments essentiels de
l'OMS est disponible en anglais à cette adresse :
http://www.who.int/medicines/organization/par/edl/expcom14/14Expcom_ReportFinal-unedited_040705.pdf
Les 58 pages contiennent des informations intéressantes et Wilbert
Bannenberg, modérateur de e-drug (le petit frère anglais de e-med), diffuse
le résumé des recomandations en soulignant la transparence du fonctionnement
de ce comité.
Carinne Bruneton
modératrice de e-med
----
summary recommendations
"Additions, changes and deletions on the 14th Model List
1. The Committee recommended to delete the following medicines from the
Model List: (
(1.1) ether;
(2.3) colchicine;
(5) clonazepam;
(6.2.2) nalidixic acid;
(6.2.5) thioacetazone + isoniazid;
(6.6) diethyltoluamide;
(7.1) ergotamine;
(11.1) polygeline;
(12.2) isoprenaline;
(13.7) sun protection agents;
(17.3) local anaesthetics, astringent, anti-inflammatory as
anti-haemorrhoidal;
(17.4) atropine as spasmolytic;
(21.1) silver nitrate eye solution;
(22.1) ergometrine tablet;
(22.2.2) salbutamol as tocolytic;
(25) theophylline, aminophylline, cromoglicic acid.
2. The Committee recommended the following changes be made in items already
on the Model List:
(1.1) halothane: add square box;
(6.1.1) niclosamide: remove footnote on future review;
(6.1.1) oxamniquine: remove footnote on future review; pyrantel: remove
footnote on future review; triclabendazole: remove footnote on future
review;
(6.2.1) ceftriaxone: add 1 g injection;
(6.2.1) imipenem + cilastatin: remove footnote on future review;
(6.2.2) spectinomycin: remove footnote on future review;
(6.4.1) levofloxacin: remove footnote on future review;
(11) factors VIII and IX concentrates: remove footnote on future review;
(11.1) dextran-70:add square box,
(12.2) antiarrythmic medicines: add footnote that section will be reviewed
at next meeting;
(12.3) nifedipine: replace with amlodipine with square box;
(12.4) heart failure: add furosemide (tablet and injection, as under
diuretics);
(17.7) change section name to: "Antidiarrhoeal (symptomatic) medicines for
adults";
(18.3.1) subsection "hormonal" to be divided into two subsections: oral,
injectable; medroxyprogesterone acetate (depot injection): move to core
list, remove footnote on future review;
(18.4) ethinyloestradiol: add footnote on future review;
(18.7) norethisterone: add footnote on future review; medroxyprogesterone
acetate: add footnote on future review;
(20) alcuronium: add footnote that potential alternatives will be reviewed
in 2007;
(27) sodium fluoride: change description to "in any appropriate topical
formulation"; remove square box and remove footnote on future review,
calcium gluconate: remove footnote on future review.
3. The Committee recommended that the following medicines be added to the
14th Model List:
(6.2.1) cefixime tablet 400 mg;
(6.3) clotrimazole 1%, 10% vaginal cream; 100, 500 mg vaginal tablets;
(17.5.2) zinc sulfate tablet or syrup in 10 mg per unit dosage,
(22.1) misoprostol 25 microgram intravaginal tablet on complementary list;
mifepristone 200mg oral tablet - misoprostil 200 microgram vaginal tablet on
the complementary list with the footnote " Requires close medical
supervision": in reviewing the recommendation relating to this combination
of products, the Director-General decided to add a note adjacent to the
combination in the WHO Model List stating "Where permitted under national
law and where culturally acceptable";
(22.2) nifedipine 10 mg capsule as tocolytic;
(24.5) methadone oral solution 5mg/5ml, 10 mg/5ml, or concentrate for oral
solution 5mg/ml, 10 mg/ml on complementary list, with square box to cover
buprenorphine, within a new subsection "Medicines used in substance
dependence programmes" and a footnote that these products should only be
used within an established support programme.
4. The Committee decided to defer its recommendations on the following
medicines on the following items, and requested that more information be
submitted at its next meeting in 2007:
(6.4.2) tenofovir, emtricitabine, tenofovir + emtrictabine;
(25) caffeine citrate.
5. The Committee recommended that the following applications be rejected:
(2.1) ibuprofen paediatric suspension;
(2.1) methoxyflurane;
(6.5.2) miltefosine;
(12.3) labetalol;
(18.3.1) combination injectable contraceptives, etonogestrel releasing
implant, levonorgestrel releasing implant, levonorgestrel releasing IUD;
(19.2) immunoglobulin, human normal.
6. The Committee recommended that full applications for addition of the
following items be submitted to the Committee for consideration at its next
meeting in 2007:
(1) propofol,
(6.2.1) cefalexin, cefazolin;
(6.4.2) emtricitabine + tenofovir;
(7.1) 5 HT1 agonist (triptan(s));
(12.2) amiodarone, sotalol;
(20) atracurium, pancuronium;
(27) oral calcium.
7. The Committee recommended that the following section reviews be prepared
and submitted for discussion at its next meeting in 2007:
Section 4: Antidotes,
Section 6.4: medicines for MDR-TB,
Section 11.1: colloids versus crystalloids,
Section 12.2: anti-arrhythmic medicines;
Section 12.3.: medicines for hypertension in pregnancy and also the
continued use of the square box for amlodipine;
Section 12.4: medicines used for cardiac failure;
Section 17.7.2: antidiarrhoeals in adults;
Section 18.3: contraceptives,
Section 21: ophthalmological preparations.
Methodological issues
1. The Committee recommended that section reviews should, as much as
possible, be performed in the first year after a Committee meeting, so that
full applications for new additions, if suggested by the section review, can
be prepared in time and submitted to the next Committee meeting at the same
time.
2. The Committee recommended that a policy advisory group on rare disease be
established to study the issue of effective medicines for life-threatening
rare diseases.
3. The Committee recommended that the original applications and other
supporting documents for the Expert Committee published on the WHO web site
be maintained on the web site for readers of the report who wish to see
these materials, and that a permanent record be created as well.
Rational medicine use
The Committee recommended that WHO encourages and supports Member States in
developing and implementing effective strategies and national programmes to
improve access to and quality use of medicines; and that WHO urgently
identify potential sources of funding and donor support to develop a work
plan for this key area."