[india-drug] 13th WHO Model List of Essential Medicines

["Dr. Hogerzeil" <hogerzeilh@who.int>]

13th WHO Model List of Essential Medicines
------------------------------------------

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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