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Women and Adverse Drug Reactions Reporting in the Canadian Context

There are multifaceted, complex and inter-related issues underlying both of these phenomena. One area that is gaining attention and being increasingly analyzed and acted upon by grassroots women’s organizations is the interplay of women’s access to, control and ownership of land and housing and HIV. Ownership of housing and land are significant components of a woman’s overall well-being and security. Practices that exclude and deny women adequate rights to land and housing have a complex relationship to HIV and AIDS - increasing women’s ability to claim, gain and maintain ownership of land and housing may be central. | Women and Adverse Drug Reactions Reporting in the Canadian Context a discussion paper prepared by Colleen Fuller for Women and Health Protection October 2002 Final Draft Revised August 2003 Introduction Women s health issues have been defined as any matter that affects the health of women exclusively that impacts predominantly on women s health at any age or that affects women s health differently from that of men 1. An effective strategy to support women s health addresses all of these matters including the approval use and regulation of prescription drugs. The purpose of this paper is to provide an overview of how Canada s program for reporting Adverse Drug Reactions ADRs supports - or doesn t support - an effective women s health strategy related to prescription drug use. Women are at greater risk of exposure to unsafe medications and drug interactions2 something that was recognised in 1996 when new guidelines were introduced in Canada requiring the inclusion of women in clinical trials3. The guidelines flowed from Health Canada s commitment to develop and apply a Gender-Based Analysis GBA to programs policies and legislation. However thus far a GBA has not been applied to Health Canada s program of post market surveillance. The paper offers an overview of the current ADR reporting system including the steps taken to improve both the reporting system itself and the flow of ADR information to health providers patients and the public at large. It includes a review of the literature about the public policy environment governing women and prescription medicines specifically the environment in which reports of adverse drug reactions are received analysed and utilised to develop and or improve the national Women s Health Strategy. The paper summarises the various factors that may influence the increased frequency of adverse events associated with women s prescription drug use including direct-to-consumer-advertising DTCA fast-tracked drug approvals deregulation .