(2002; 6 pages) [French] [Spanish]
11. Appropriate and enforced regulation
Regulation of the activities of all actors involved in the use of medicines is critical to ensuring rational use (Box 6). If regulations are to have any effect, they must be enforced, and the regulatory authority must be sufficiently funded and backed up by the judiciary.
Box 6 Regulatory measures to support rational use
• registration of medicines to ensure that only safe efficacious medicines of good quality are available in the market and that unsafe non-efficacious medicines are banned;
• limiting prescription of medicines by level of prescriber; this includes limiting certain medicines to being available only with a prescription and not available over-the-counter;
• setting educational standards for health professionals and developing and enforcing codes of conduct; this requires the cooperation of the professional societies and universities;
• licensing of health professionals - doctors, nurses, paramedics - to ensure that all practitioners have the necessary competence with regard to diagnosis, prescribing and dispensing;
• licensing of medicine outlets - retail shops, wholesalers - to ensure that all supply outlets maintain the necessary stocking and dispensing standards;
• monitoring and regulating medicine promotion to ensure that it is ethical and unbiased. All promotional claims should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. WHO's ethical guidelines (1988) may be used as a basis for developing control measures.