Regulatory actions to enhance appropriate drug use : The case of antidiarrhoeal drugs.
Inappropriate drug use is a serious problem in the control of diarrhoeal diseases.
To address this problem, the World Health Organization's Programme for the Control of Diarrhoeal Diseases reviewed the literature on the most commonly used antidiarrhoeal agents, and distributed the resulting document widely in 1990.
Antidiarrhoeal drugs received simultaneous attention in the popular media as groups and individuals campaigned against their registration and use.
This article evaluates the actions against antidiarrhoeal drugs taken by national drug regulators in the period during and after these events (January 1989 until December 1993).
Information on regulatory actions was requested from countries and extracted from published and unpublished sources.
Sixteen countries reported regulatory actions on 21 occasions during the period of study.
The majority of actions concerned antimotility drugs ; few were against adsorbents. antidiarrhoeal drugs containing antimicrobials, or adult formulae.
Six countries took action against large and heterogenous groups of antidiarrhoeal drugs.
Most actions occurred in the two-year period immediately following the distribution of the WHO review and the attention in the media.
The sequence of distribution of the review, media coverage, and activities of dedicated groups and individuals, followed by a noticeable cluster of regulatory actions suggests a clear relationship.
Further research is necessary to determine the relative rol...
Mots-clés Pascal : Antidiarrhéique, Utilisation, Réglementation, Politique sanitaire, Médicament, Autorisation mise sur marché
Mots-clés Pascal anglais : Antidiarrheal agent, Use, Regulation, Health policy, Drug, Marketing authorization
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 96-0181379
Code Inist : 002B30A01C. Création : 199608.