The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914: 8. Recommendations: 8.4 Additions and changes to the Model List

The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914
(2003; 132 pages)

Table of Contents

WHO Expert Committee on the Selection and Use of Essential Medicines
1. Introduction
2. Open session
3. The new procedures for updating and disseminating the Model List
	3.1 Background
	3.2 Key features of the new procedures
	3.3 Review of the new procedures
		3.3.1 Applications for additions
		3.3.2 Applications for deletions
		3.3.3 Selection criteria
	3.4 The WHO model formulary
	3.5 The WHO Essential Medicines Library
4. Other outstanding technical issues
	4.1 Change of name of the Expert Committee
	4.2 Description of essential medicines
	4.3 Role of treatment costs in relation to the Model List
	4.4 Inclusion of additional items in the Model List
5. Format and presentation of the 12th Model List
	5.1 Section headings
	5.2 The core and complementary lists
	5.3 The “square box” symbol
6. Changes made in revising the Model List
	6.1 Applications for additions
		6.1.1 Antiretroviral medicines
		6.1.2 Artemether + lumefantrine (fixed-dose combination)
		6.1.3 α/β-Arteether
		6.1.4 Artemotil (β-arteether)
		6.1.5 Amodiaquine
		6.1.6 Insecticide-treated bednets
		6.1.7 Miconazole nitrate buccal tablets
	6.2 Applications for deletions
	6.3 Other changes
		6.3.1 Meglumine antimoniate
		6.3.2 Antineoplastic and immunosuppressive medicines
		6.3.3 Reserve list medicines
7. Future reviews of sections of the Model List
	7.1 Update on the review of medicines for the treatment of hypertension
	7.2 Review of the core and complementary lists
	7.3 Review of the use of the “square box” symbol
	7.4 Review of injectable medicines
	7.5 Priorities for further systematic reviews
8. Recommendations
	8.1 Procedures for updating and disseminating the Model List of Essential Medicines¹
	8.2 Description of essential medicines
	8.3 Presentation of the 12th Model List
	8.4 Additions and changes to the Model List
	8.5 Deferred applications
	8.6 Rejected applications
	8.7 Priorities for future reviews of sections of the Model List
	8.8 Change of name of the Expert Committee
	8.9 Other recommendations
Acknowledgements
References
Annex 1 The 12th WHO Model List of Essential Medicines
Annex 2 Additional notes on the medicines recommended for inclusion in the 12th WHO Model List of Essential Medicines
Annex 3 The Anatomical Therapeutic Chemical (ATC) classification system¹
Alphabetical list of essential medicinces (with ATC classification codes)

8.4 Additions and changes to the Model List

1. The following medicines should be added to the core list of essential medicines under section 6.4.2 (Antiretroviral medicines):

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

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

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

The following footnotes should also be added:

The antiretroviral medicines do not cure the HIV infection, they only temporarily suppress viral replication and improve symptoms. They have various adverse effects and patients receiving these medicines 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 medicines to the Model List. Adequate resources and trained health professionals are a prerequisite for the introduction of this class of medicines. Effective therapy requires commencement of three or four medicines 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-medicine combinations as specifically recommended in the WHO clinical 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.

Selection of two or three protease inhibitors from the Model List will need to be determined by each country after consideration of local clinical guidelines and experience, as well as the comparative costs of available products. Ritonavir is recommended for use in combination with indinavir, lopinavir and saquinavir as a booster, and not as a medicine in its own right.

2. Artemether + lumefantrine (fixed-dose combination) should be added to the core list of essential medicines under section 6.5.3a (Antimalarial medicines - for curative treatment).

3. The dosage of meglumine antimoniate should be changed from “approximately 8.5%” to “approximately 8.1%”.