Drug information sheets Various types of information are needed by prescribers and consumers to ensure the safe and effective use of drugs. The following list is a sample that should be adjusted to meet the needs and abilities of the prescriber.

(1) International Nonproprietary Name (INN) of each active substance.

(2) Pharmacological data: a brief description of pharmacological effects 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 increased or reduced dosage.

(c) Contra-indications.

(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).

(g) Overdosage:

* brief clinical description of symptoms;

* non-drug treatment and supportive therapy;

* specific antidotes.

(4) Pharmaceutical information:

(a) Dosage forms.

(b) Strength of dosage form.

(c) Excipients.

(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).

Copies of the WHO Criteria for Medicinal Drug Promotion are available in English, French, Spanish, Russian, Chinese and Arabic from: World Health Organization, Distribution and Sales, 1211 Geneva 27, Switzerland. Price: Sw.fr.8.-/US$7.20 and in developing countries Sw.fr.5.60. If you have concerns about medicinal drug promotion in your country contact:

- the national drug regulatory authority;

- Medical Lobby for Appropriate Marketing (MaLAM);

- National/international consumer organizations;

- International Federation of Pharmaceutical Manufacturers' Association (IFPMA) and local industry associations, if you consider that the promotion conflicts with the international or any national industry code of marketing;

- Journal and newsletter editors/publishers;

- The Monitor, and enclose a copy of the offending advertisement