Healthy Skepticism Library item: 6792

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lexchin J.
The relationship between pharmaceutical regulation and inappropriate prescribing: the case of psychotropic drugs in Canada during the 1960s and early 1970s
International Journal of Risk & Safety in Medicine 1998; 11:49-59

Abstract:

The outcome of the drug approval process plays a major role in determining how drugs will be prescribed in Canada. The objective of this paper is to examine the nature of the regulatory approval process, its decisions, how these are expressed in pharmaceutical promotion and the ultimate impact of these factors on the prescribing of psychotropic drugs in general and particularly with regard to the benzodiazepines. There is strong circumstantial evidence that the benzodiazepines were approved on the basis of inadequate clinical trials resulting in these drugs being indicated for conditions for which they were not useful and significant safety issues being ignored. These deficiencies in the regulatory process were magnified in the advertising of these products to physicians thus contributing to inappropriate prescribing in four areas: prescribing for psychosocial problems, overprescribing for somatic complaints, overprescribing to women and overprescribing for anxiety disorders. Problems in the approval process continue to exist and these will manifest themselves in ongoing inappropriate prescribing of psychotropic and other medications.

Keywords:
*analysis/Canada/regulatory authorities/trial design/reporting of results/quality of information/journal advertisements/psychotropic drugs/quality of prescribing/women/commercial compendia/Compendium of Pharmaceuticals and Specialties/Health Protection Branch/regulation of promotion/Pharmaceutical Manufacturers Association of Canada/EVALUATION OF PROMOTION: COMMERCIAL DRUG COMPENDIA/EVALUATION OF PROMOTION: JOURNAL ADVERTISEMENTS/IMAGES IN PROMOTION: WOMEN/INFLUENCE OF PROMOTION: PRESCRIBING, DRUG USE/INFORMATION FROM INDUSTRY: REGULATORY AUTHORITIES/PROMOTION IN SPECIFIC THERAPEUTIC AREAS: PSYCHIATRIC DISEASES/REGULATION, CODES, GUIDELINES: INDUSTRY SELF-REGULATION