The relationship between pharmaceutical regulation and inappropriate prescribing: the case of psychotropic drugs in Canada during the 1960s and early 1970s

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.