12th Expert Committee on the Selection and Use of Essential Medicines Meeting

15-19 April 2002

 

** Summary of Recommendations by the Expert Committee on the Selection and Use of Essential Medicines, Geneva, 15-19 April 2002

Introduction by the WHO Secretariat 

The Expert Committee on the Selection and Use of Essential Medicines met in Geneva from 15 to 19 April 2002. On 15 April 2002 from 10 a.m. till 5 p.m. an open session was held; other sessions of the meeting were private. The Agenda and Meeting Documents are available elsewhere on this web site. The full report of the Expert Committee will be issued as soon as possible. A summary of the recommendations of the Expert Committee is given below.

Recommendations

Procedures for updating and disseminating the Model List of Essential Medicines1 

1. Applications for inclusion, change or deletion should be submitted to the Secretary of the Expert Committee not only by the relevant diseases department within WHO but also by any individual or organization. 

2. The standard review procedure as summarized in Box 2 of the revised procedures should be revised, according to the new box in the full report of the Expert Committee. 

3. Specific procedures for deleting an item from the Model List should be developed, with possibilities for either a simplified consultation procedure or a systematic review. In both cases the evidence for deletion should be carefully recorded. 

4. Paragraph 7 on the selection criteria should be amended as follows: "Most essential medicines should be formulated as single compounds. Fixed dose combination products are selected only when the combination has a proven advantage in therapeutic effect, safety, adherence or in delaying the development of drug resistance in malaria, tuberculosis and HIV/AIDS." 

5. The draft Model Formulary should be updated to include the recommended changes in the Model List of 2002 and be published as soon as possible. 

6. Applications for inclusion, change or deletion should be maintained on the Essential Medicines Library as part of the presentation of underlying evidence for items on the Model List. Archival files should be created for all items which have been considered by successive Expert Committees. 

7. Important sections of the Essential Medicines Library should be made available in languages other than English. In this regard, WHO should consider the benefit and feasibility of creating hot-links to reliable information sites in other languages, and to the web sites of well-established drug regulatory agencies. 

8. Additional resources and capacity should be made available to the WHO Secretariat and relevant disease departments to ensure the full implementation of new procedures. 

9. Experiences with the new procedures should be carefully reviewed; this includes those aspects of the procedures which could not yet be implemented in full. When appropriate, the procedures should be further refined. 

10. A separate mechanism with appropriate procedures should be created to assess and identify essential medical devices and health technologies. 

11. The open session was useful to the work of the Committee, and a similar meeting should be included in the agenda of the next meeting.

Description of essential drugs 

12. The Committee recommended to replace the wording of "prevalence of disease" by "public health relevance" in the section on selection criteria; add "implementation of" and "with adequate information" to the section on purpose.

Presentation of the Model List 

13. The Model List should maintain its current system of section numbering. However, in addition to its usual presentation the printed version of the Model Lists should also be presented in the 5-level Anatomical Therapeutic Chemical (ATC) classification. 

14. WHO should actively pursue ways and means to put the relevant information on the ATC classification in the public domain. 

15. The core and complementary list should be maintained, but the two lists should be presented separately (see also recommendation 28). 

16. The WHO Vaccines and Biologicals Department should synthesize its current recommendations on vaccines into a format compatible with the Model List of Essential Medicines, and present this summary with supporting evidence to the Expert Committee for consideration as part of the Model List. The EPI vaccines and vaccine combinations should also be included in this systematic review.

Additions, changes and deletions from the Model List 

The following items should be added to the core list: 

Antiretroviral medicines:

17. Nucleoside reverse transcriptase inhibitors: abacavir (ABC), didanosine (ddI), lamivudine (3TC), stavudine (d4T) and zidovudine (ZDV or AZT) 

18. Non-nucleoside reverse transcriptase inhibitors: efavirenz (EFV or EFZ), nevirapine (NVP) 

19. Protease inhibitors: indinavir (IDV), lopinavir/low dose ritonavir (LPV/r), nelfinavir (NFV), ritonavir (r), and saquinavir (SQV). 

20. The following footnotes should be added: "The antiretroviral drugs do not cure the HIV infection, they only temporarily suppress viral replication and improve symptoms. They have various adverse effects and patients receiving these drugs require careful monitoring by adequately trained health professionals. For these reasons, continued rigorous promotion of measures to prevent new infections is essential and the need for this has not been diminished in any way by the addition of antiretroviral drugs to the Model List. Adequate resources and trained health professionals are a prerequisite for the introduction of this class of drugs. Effective therapy requires commencement of three or four drugs simultaneously, and alternative regimens are necessary to meet specific requirements at start-up, to substitute for first-line regimens in the case of toxicity, or to replace failing regimens. The Committee strongly recommends the use of three- or four-drug combinations as specifically recommended in the WHO treatment guidelines. The use of fixed dose preparations for these combinations is also recommended, with assured pharmaceutical quality and interchangeability with the single products as approved by the relevant drug regulatory authority" and "Selection of two or three protease inhibitors from the Model List will need to be determined by each country after consideration of local treatment guidelines and experience, as well as the comparative costs of available products. Ritonavir is recommended for use in combination with indinavir, lopinavir and ritonavir as a booster, and not as a drug in its own right." 

Antimalarial medicines: 

21. Artemether/lumefantrine

Deferred applications 

22. The application of amodiaquine was deferred pending the receipt of more detailed information on its safety when used for curative purposes in resource poor settings. 

23. The application of insecticide-treated bednets was deferred pending the receipt of evidence on the use and effectiveness of long-acting products.

Rejected applications 

24. Artemotil, a/ߍ arteether, miconazole nitrate buccal tablets.

Changes 

25. Meglumine antimoniate: change from "approx. 8,5%" to "approx. 8,1%".

Priorities for future review 

26. The section on antihypertensive drugs should be reviewed as soon as the new WHO/ISH treatment guidelines are available. In the light of this review other medicines on the Model List such as reserpine, methyldopa, hydralazine and nifedipine should also be reviewed. 

27. A full review of other categories of cardiovascular drugs should be initiated. 

28. In view of the new definition of medicines in the complementary list and the need for consistency, a full review of the placement of all items on the core or complementary lists should be undertaken before a recommendation is made by the next Expert Committee whether to maintain the two lists. 

29. The use of the square box symbol should become more restricted. To this end a review should be undertaken by the next Expert Committee. 

30. All injectable medicines on the Model List should be reviewed. 

31. A full inventory should be made of all other suggestions for deletions and/or review of sections, and an electronic consultation should be held among members of the Committee and other experts to identify the most urgent items or sections for future review through one of the two processes as recommended in Recommendation No.3 above. 

32. The glossary which was contained in previous reports of the Committee should be updated by the next Committee.

Change of name of the Expert Committee 

33. The name of the Expert Committee on the Use of Essential Drugs should be changed into "Expert Committee on the Selection and Use of Essential Medicines".

Other recommendations 

34. The development of appropriate paediatric dosage forms of essential medicines should be encouraged. 

35. Tariffs and taxes on essential medicines, medical devices and health technologies create a considerable burden for equitable access to these items. This issue should be addressed by the World Health Organization.


1 Document EB109/8 (Annex)

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