[e-farmacos] Nueva Lista Modelo de la OMS en la web

["Hogerzeil, Hans" <hogerzeilh@who.int>]

E-farmacos: Nueva Lista Modelo de la OMS en la web
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Apreciados co-listeros,

La 13a Lista Modelo de Medicamentos Esenciales de la OMS se ha colgado en la 
pagina web WHO/Medicines, junto con el reporte no editado del 13 Expert
Committee on the Selection and Use of Essential Medicines (2003), y el 
resumen de sus recomendaciones. Todos los materiales pueden encontrarse en el 
sitio web:
www.who.int/medicines

en la seccion : "latest" y, luego, en  "Expert Commitee on the Selection and 
Use of Essential Medicines". 

La direccion directa es:
http://www.who.int/medicines/organization/par/edl/expertcomm.shtml

Mas abajo se resumen las principales recomendaciones del Comite de Expertos 
para la 13a Lista. Las evidencias cientificas que las apoyan, se encuentran 
en los documentos originales del Comite.

Estamos trabajando para tener la traduccion a las cinco lenguas y para 
adaptar el WHO Model Formulary en su edicion de 2003.

Cordialmente,

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. 
[NOTA: Mensaje sin acentos ni caracteres especiales.]
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