2. Guidelines for establishing a national programme for essential drugs

In order to ensure that an essential drugs programme is adequately instituted at national level, several steps are recommended:

1. A national drug regulatory authority should be established along the lines recommended in the guiding principles for small national drug regulatory authorities presented in Annex 1 of the fifth report of the Expert Committee (12). The authority should interact with other interested bodies, including organizations responsible for drug procurement in the public and private sectors and the committee referred to in item 2.

2. A national drug and therapeutics committee of health care professionals should be appointed to give technical advice to the national programme. The committee should include individuals competent in the fields of medicine, clinical pharmacology, pharmacy and clinical microbiology, as well as other appropriate health care workers. Where individuals with adequate training are not available within the country, cooperation from WHO could be sought until such individuals can be trained. The first task of the committee should be to recommend a list of essential drugs for the national programme. The committee should remain a part of the national programme for essential drugs, continually advising on matters of technical importance.

3. The international nonproprietary (generic) names for drugs or pharmaceutical substances (14) should be used whenever available, and prescribers should be provided with a cross-index of nonproprietary and proprietary names.

4. Concise, accurate and comprehensive drug information should be prepared to accompany the list of essential drugs, in the form of a prescriber’s formulary to serve as a pocket guide to rational drug use. More detailed information about drugs should be made available at drug and poison information centres, pharmacies and all educational institutes concerned with training health professionals.

5. The quality of all products, including stability and bioavailability, should be assured through a product registration process, with additional laboratory testing where appropriate for imported products. Assurance of quality can also be obtained through the use of WHO’S Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (section 5.1) and is particularly important where resources for regulation of medicines are severely limited.

6. Competent health authorities should decide on the level of expertise required to prescribe individual drugs or a group of drugs in a therapeutic category. Consideration should be given, in particular, to the competence of the personnel to make a correct diagnosis. In some instances, while individuals with advanced training are necessary to prescribe initial therapy, individuals with less training could be responsible for maintenance therapy.

7. The success of the essential drugs programme is dependent upon the efficient administration of supply, storage and distribution at every point from the manufacturer to the end-user. Government intervention may be necessary to ensure the availability of some drugs in the formulations listed, and special arrangements may need to be instituted for the storage and distribution of drugs that have a short shelf-life or require refrigeration.

8. Efficient management of stocks is necessary to eliminate waste and to ensure continuity of supplies. Procurement policy should be based upon detailed records of turnover. In many instances, drug utilization studies will contribute to a better understanding of true requirements.

9. Research, both clinical and pharmaceutical, is sometimes required to settle the choice of a particular drug product under local conditions. Facilities and trained personnel for such research must be provided. Clinical trials of pharmaceutical products should follow the WHO Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products presented in Annex 3 of the sixth report of the Expert Committee (13).