Promoting Rational Use of Medicines: Core Components - WHO Policy Perspectives on Medicines, No. 005, September 2002: Core policies to promote more rational use of medicines: 11. Appropriate and enforced regulation

Promoting Rational Use of Medicines: Core Components - WHO Policy Perspectives on Medicines, No. 005, September 2002
(2002; 6 pages) [French] [Spanish]

Table of Contents

	Definition of rational use of medicines
	The problem of irrational use
	Assessing the problem of irrational use
	Working towards rational use of medicines
	Core policies to promote more rational use of medicines
		1. A mandated multi-disciplinary national body to coordinate medicine use policies
		2. Clinical guidelines
		3. Essential medicines list based on treatments of choice
		4. Drugs and therapeutics committees in districts and hospitals
		5. Problem-based training in pharmacotherapy in undergraduate curricula
		6. Continuing in-service medical education as a licensure requirement
		7. Supervision, audit and feedback
		8. Independent medicine information
		9. Public education about medicines
		10. Avoidance of perverse financial incentives
		11. Appropriate and enforced regulation
		12. Sufficient government expenditure to ensure availability of medicines and staff
	Key documents
	Contacts at WHO Headquarters

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.