|The use of essential drugs: Eight report of the WHO Expert Committee (WHO, 1998, 84 p.)|
For the safe, effective and prudent use of essential drugs, relevant and reliable drug information should be available. In order to provide this, a series of publications entitled WHO model prescribing information is being prepared. The first five titles in this series, Drugs used in anaesthesia (39), Drugs used in parasitic diseases, second ed. (40), Drugs used in mycobacterial diseases (41), Drugs used in sexually transmitted diseases and HIV infection (42) and Drugs used in skin diseases (43) have already been published. Further titles are in preparation. The Committee supports with great enthusiasm the provision of model prescribing information and considers that the documents published to date are clear, useful and well written.
At its previous meeting, the Committee had urged that a Model Formulary should be developed to complement the Model List of Essential Drugs. The purpose of such a formulary, which could be updated periodically, would be to provide general information and information on prototype drugs in the Model List of Essential Drugs according to the specifications as shown in the sample drug information sheet overleaf. This information could then be adapted by countries according to their own needs and would be a key element in rational drug use. The formulary was not intended to restrict the concept of essential drugs. The Committee was informed of progress in the development of this formulary.
Health care professionals should receive education about the use of drugs not only during their initial professional training but throughout their professional careers. The more highly trained individuals should assume a responsibility to educate those with less training. Pharmacists and other health care workers responsible for dispensing drugs should accept every opportunity to inform consumers about the rational use of these products, including those for self-medication, at the time they are dispensed.
The Committee recommended that comprehensive educational programmes for health care professionals include:
- accurate and understandable drug information and information on all aspects of medical care in which they are involved;
- information about patterns of disease in the community, especially prevailing sensitivity patterns, to aid in the selection of antimicrobial drugs;
- diagnostic and therapeutic guidelines for conditions recognized as important.
Governments, universities and professional associations have a major responsibility to collaborate on improving undergraduate, postgraduate and continuing education in clinical pharmacology, therapeutics and drug information issues.
Appropriate drug information that is well presented is cost-effective in that it ensures that drugs are used properly and decreases inappropriate drug use; drug information activities should be financed from the national budget for the provision of drugs.
Drug information sheets
The following is an example of a format for supplying information to prescribers to facilitate the safe and effective use of drugs. The content should be adjusted to the needs, knowledge and responsibilities of the prescriber.
1. INN of each active substance.
2. Pharmacological data: a brief description of pharmacological properties and mechanism of action.
3. Clinical information:
(a) Indications: whenever appropriate, simple diagnostic criteria should be provided.
(b) Dosage regimen and relevant pharmacokinetic data:
- average and range for adults and children;
- dosing interval;
- average duration of treatment;
- special situations, e.g. renal, hepatic, cardiac or nutritional insufficiencies that require either an increased or a reduced dosage.
(d) Precautions and warnings (reference to pregnancy, lactation, etc.).
(e) Adverse effects (quantify by category, if possible).
(f) Drug interactions (include only if clinically relevant; drugs used for self-medication should be included).
- brief clinical description of symptoms;
- non-drug treatment and supportive therapy;
- specific antidotes.
4. Pharmaceutical information:
(a) Dosage forms.
(b) Strength of dosage form.
(d) Storage conditions and shelf-life (expiry date).
(e) Pack sizes.
(f) Description of the product and package.
(g) Legal category (narcotic or other controlled drug, prescription or non-prescription).
(h) Name and address of manufacturer(s) and importer(s).
The Committee also recognized the need to develop appropriate drug information sheets for consumers.