Drug information sheets Various types of information are needed by prescribers and
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.
(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
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
- Journal and newsletter editors/publishers;
- The Monitor, and enclose a copy of the offending advertisement