The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 920
(2003; 137 pages) View the PDF document
Table of Contents
View the document1. Introduction
View the document2. Open session
Open this folder and view contents3. Update on current activities
Open this folder and view contents4. Changes made in revising the Model List
Close this folder5. Reviews of sections of the Model List
View the document5.1 "Fast-track" procedure for deleting items from the Model List
View the document5.2 Review of core versus complementary listing of medicines
View the document5.3 Review of the use of the square box symbol (including a review of the corticosteroids)
View the document5.4 Review of the antihypertensive medicines
View the document6. Priorities for future reviews
Open this folder and view contents7. Recommendations
View the documentReferences
View the documentAnnex 1 The 13th WHO Model List of Essential Medicines
View the documentAnnex 2 The Anatomical Therapeutic Chemical (ATC) classification system1
View the documentAlphabetical list of essential medicines (with ATC classification code numbers)
View the documentSelected WHO Publications of Related Interest
 

5.2 Review of core versus complementary listing of medicines

The 12th Model List of Essential Medicines (revised April 2002) is presented as two separate lists: a "core" list and a "complementary" list, which are described 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 medicines 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 which are efficacious, safe and cost-effective but not necessarily affordable, or for which specialized health care facilities or services may be needed.


At the meeting of the Committee in 2002, there was considerable debate about whether the system of two lists should be retained or whether they should be combined into a single list. This discussion was prompted in part by the observation that the existing criteria for core or complementary listing had become blurred and had been misapplied to those medicines that are for priority conditions but are thought to be expensive. Moreover, as the prices of pharmaceuticals are variable and changing, it did not seem reasonable to use "cost-effective but not necessarily affordable" as the main criterion for the placement of an item on the complementary list (2).

During the course of 2002, and in the wake of this debate, the designation of all medicines on the 12th Model List as "core" or "complementary" was reviewed according to the following general principles:

1. All essential medicines should be placed on the core list, unless there is a specific reason for them to be on the complementary list.

2. If there is uncertainty about the classification, the medicine should be put on the core list.


The following criteria were used for putting items on the complementary list:

Primary criterion. Use of the medicine requires specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training.

Secondary criterion (to be used only in cases of doubt). Consistently higher cost or less attractive cost-effectiveness in a variety of settings.


Seventy-nine (or 24%) of the total 325 medicines included in the 12th Model List are listed as complementary; some appear on both the core and the complementary list. For each of these medicines the indications and specifications for use as described in the WHO model formulary were evaluated: if, according to the WHO model formulary, there is always a need for specialist medical care or facilities for use of a medicine for a given indication, the medicine was classified as "complementary" for that indication; where there was uncertainty, evidence of consistently higher cost or less attractive cost-effectiveness in most settings was used as the secondary criterion for putting the medicine on the complementary list. In cases where there was still doubt, the medicine was classified as a core list medicine.

At its present meeting, the Committee agreed to define the criteria for core and complementary listing 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 medicines 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 cases of doubt, medicines may also be listed as complementary on the basis of consistently higher costs or less attractive cost-effectiveness in a variety of settings.


The Committee recommended that core and complementary medicines, previously presented in two separate lists, be combined into one list, with the complementary medicines printed in italics or otherwise identified (see Annex 1).

In reviewing the proposals for changes to the classification of medicines as "core" or "complementary", the Committee decided not to make recommendations for changes to items in those sections of the Model List which were also recommended for systematic review; changes of this nature would be recommended as part of such reviews (e.g. see section 5.4 Review of the antihypertensive medicines (section 12.3 of the Model List)).

The Committee recommended that the following medicines be moved from the core list to the complementary list:

- aminophylline (section 25.1 Antiasthmatic medicines);

- amphotericin B (section 6.3 Antifungal medicines);

- azathioprine (in section 2.4 Disease-modifying agents used in rheumatoid disorders);

- clomifene (section 18.6 Ovulation inducers);

- diethylcarbamazine (section 6.1.2 Antifilarials);

- dopamine (section 12.4 Medicines used in heart failure);

- ethosuximide (section 5 Anticonvulsants/antiepileptics);

- hydrocortisone (rectal preparations in section 17.4 Gastrointestinal anti-inflammatory medicines);

- intraperitoneal dialysis solution (section 23 Peritoneal dialysis solution);

- methotrexate (in section 2.4 Disease-modifying agents used in rheumatoid disorders);

- penicillamine (in section 2.4 Disease-modifying agents used in rheumatoid disorders),

- pentamidine (in section 6.5.2 Anti-leishmaniasis medicines, in section 6.5.4 Antipneumocystosis and antitoxoplasmosis medicines and in section 6.5.5a Antitrypanosomal medicines - African trypanosomiasis),

- pyridostigmine (section 20 Muscle relaxants (peripherally-acting) and cholinesterase inhibitors);

- sulfadiazine (section 6.2.2 Other antibacterials);

- sulfasalazine (in section 2.4 Disease-modifying agents used in rheumatoid disorders).


The Committee recommended that the following medicines be moved from the complementary list to the core list:

- amoxicillin + clavulanic acid (section 6.2.1 β-lactam medicines);
- chloramphenicol (oily suspension for injection in section 6.2.2 Other antibacterials);
- epinephrine (adrenaline) (in section 12.2 Antiarrhythmic medicines);
- levonorgestrel (30mg tablets in section 18.3.1 Hormonal contraceptives);
- mannitol (section 16 Diuretics);
- norethisterone enantate (section 18.3.1 Hormonal contraceptives).


The Committee also recommended that the following items be deleted from the Model List for the reason(s) stated:

Cyclophosphamide (section 2.4 Disease-modifying agent in rheumatoid arthritis). The Committee noted the findings of a recent Cochrane Review (34) on the efficacy and safety of cyclophosphamide as a disease-modifying agent in rheumatoid arthritis, and recommended that this item be deleted for this particular indication.

Desmopressin (section 10.2 Medicines affecting coagulation). The Committee recommended the deletion of this item on the grounds of the rarity of the indication.

Iron dextran (section 10.1 Antanaemia medicines). The Committee recommended the deletion of this item on the basis of its unfavourable benefit-risk ratio.

Pethidine (section 2.2 Opioid analgesics). The Committee noted that pethidine was listed on 19 out of 25 national essential medicine lists; that pethidine was considered inferior to morphine due to its toxicity on the central nervous system; and that it is generally more expensive than morphine. The Committee concluded that there was insufficient justification to keep pethidine on the Model List and recommended that it be deleted. The Committee stressed that all national programmes should ensure that sufficient quantities of morphine are always available for those who need it.

Trimethoprim (injection in section 6.2.2 Other antibacterials). The Committee recommended that the injectable form of trimethoprim be deleted because of the lack of need of this particular administration route for this medicine.

 

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