The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914: 3. The new procedures for updating and disseminating the Model List: 3.3 Review of the new procedures: 3.3.3 Selection criteria

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)

3.3.3 Selection criteria

During the open session, a number of participants commented on the criteria used to select medicines for inclusion in the Model List, in particular, with regard to fixed-dose combination products. It was noted that fixed-dose combinations offer certain advantages; they facilitate adherence to treatment regimens and they can delay the emergence of antimicrobial resistance. It was also noted that many illogical and ad hoc combinations of various medicines are currently being marketed in a number of countries. Any proposal to include fixed-dose combinations in the Model List should be backed by adequate proof of pharmaceutical compatibility and bioavailability.

In light of these comments, the Committee recognized that its selection criteria with regard to fixed-dose combination products were in need of review and recommended that they be modified as follows:

Most essential medicines should be formulated as single compounds. Fixed-dose combination products should be selected only when the combination has a proven advantage in therapeutic effect, safety, adherence or in decreasing the emergence of drug resistance in malaria, tuberculosis and HIV/AIDS.