[e-drug] WHO DG finally approves 14th WHO Essential Model List (2)

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: WHO DG finally approves 14th WHO Essential Model List (2)
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The previous message gave the wrong URL for the EML Committee report.

The (unedited) EML Committee meeting report is available at:
http://www.who.int/medicines/organization/par/edl/expcom14/14Expcom_ReportFinal-unedited_040705.pdf

The 58 page report contains many interesting issues. I am just reproducing here the summary recommendations (see below).

WHO/EDM and the EML Committee should be commended for the transparency of the process!

E-drug is open for further debate on these changes!

Wilbert
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Wilbert Bannenberg, E-drug moderator
Email: wjb@planet.nl

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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."

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