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    Peer Reviewed

    Regulatory actions to enhance appropriate drug use: the case of antidiarrhoeal drugs.

    Haak H; Claeson ME

    Social Science and Medicine. 1996 Apr; 42(7):1011-9.

    Inappropriate drug use is a major problem in the control of diarrheal diseases. Addressing the problem, the World Health Organization's (WHO) Program for the Control of Diarrheal Diseases reviewed the literature on the most commonly used antidiarrheal agents, and distributed the resulting document widely in 1990. Individual and group campaigns against the registration and use of antidiarrheal drugs also brought considerable attention to the issue in the popular media. This article evaluates the actions taken against antidiarrheal drugs by national drug regulators during and after these events, January 1989 through December 1993. Information on regulatory actions was requested from countries and extracted from published and unpublished sources. 16 countries reported regulatory actions on 21 occasions during the period of study, with the majority of actions taken against antimotility drugs. Few were against adsorbents, antidiarrheal drugs containing antimicrobials, or adult formulae. Six countries took action against large and heterogenous groups of antidiarrheal drugs, with most actions occurring within two years of the distribution of the WHO review and the attention in the media. Many more antidiarrheal drugs may lose their register in the future through a passive deregistration process. The deregistration of inappropriate drugs, however, will probably take quite a while, with widespread deregistrations unlikely. Moreover, regulatory actions alone are probably not enough to achieve a more appropriate use of drugs. Greater effect can be expected from simultaneous regulatory, managerial, and educational interventions directed at providers, combined with communication to the general public.
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