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Safety and the Precautionary Principle Public Health vs. Profit Lessons from the Past - Ongoing Risks
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Women and Adverse Drug Reactions: Reporting in the Canadian Context Colleen Fuller, PharmaWatch and Women and Health Protection
An effective system of reporting and monitoring adverse drug reactions (ADRs) is vital to any strategy designed to support and improve women’s health. The first study of the Canadian system, by Women and Health Protection, concludes that reporting arrangements within Canada’s health protection system are weak, underfunded, and inadequately supported at the political level within Health Canada. Highlights from the report, Women and Adverse Drug Reactions: Reporting in the Canadian Context (2002), are described in summary form here. In the 1960s the modern women’s health movement arose out of a feminist critique of the medical industry as an institution of social control over women. Women began to organize and demand changes in the way medicine was practised, arguing that physicians, in particular, ignored problems that were experienced mainly or exclusively by women. A case in point was DES (diethylstilbestrol), a synthetic hormone developed in 1938 and prescribed to an estimated 200,000 to 400,000 Canadian women to prevent miscarriage. Thirty years later, DES was linked to a number of health problems in daughters exposed to the drug in the womb, including reduced fertility, complications in pregnancy, and a rare form of vaginal cancer.[1] While the inadequacies in the drug safety and post-market surveillance systems affect all communities, women’s experiences with DES—as well as thalidomide in the 1960s, the Dalkon Shield and the Meme breast implant in the late 1980s—underscored the link between sex and gender and the safety of drugs and medical devices. These disasters also contributed to a growing interest in health protection and prescription medicines on the part of the general public and health advocates. It was apparent that the gender biases in the health sector, already identified by women and many consumer advocates, were also undermining the ability of Canada’s system of health protection to serve the needs and interests of women and girls. What is the significance of this bias for the current system of reporting adverse drug reactions? Evidence is mounting that women are at greater risk than men are for adverse drug reactions that take place in both community and hospital settings.[2] Female patients are estimated to have a 1.5 to 1.7- fold greater risk of developing an adverse reaction to drugs compared with male patients.[3] The reasons are not wholly understood, but the differences cannot be attributed solely to patterns of use, for example, higher rates of prescription drug use or multiple drug therapy.[4] According to a recent report of the US General Accounting Office (GAO), 8 of the 10 prescription drugs withdrawn between 1997 and 2001 posed greater health risks for women than for men.[5] One reason may have been due to a higher level of prescription drug use among women. But the GAO concluded that a significant number of the drugs that were withdrawn may have posed greater health risks for women because of "physiological differences that make women differentially more susceptible to some drug-related health risks".[6] A number of strong, positive initiatives have taken place within Health Canada to support strategies that enhance women’s health—including the Women’s Health Bureau, the implementation of a gender-based analysis, and the federal government’s "Plan for Gender Equality". But in the area of drug-related health risks to women, these efforts are undermined by a system of post-market drug safety that is inadequately funded and supported. Canada’s System of ADR Reporting At the end of the 1980s and throughout the 1990s a series of crises and scandals, including those related to the Dalkon Shield, the Meme breast implant, and tainted blood, made it clear to most Canadians that the health protection system was in need of major reform. Indeed, no other part of Health Canada has come under such intense public scrutiny as the health protection system. In April 2002 a new branch—the Marketed Health Products Directorate (MHPD)—was established as part of a massive reorganization of the health protection system. The MHPD has a much broader range of responsibilities than any of its predecessors, with a mandate to monitor pharmaceuticals, biologicals, vaccines, medical devices, natural health products, radiopharmaceuticals (medicinal products that are radioactive when used in patients), and veterinary drug products. The MHPD is charged with monitoring and collecting adverse reaction and medication incident data, reviewing and analyzing product safety data, conducting risk/benefit assessments of marketed health products, communicating product related risks, and monitoring regulated advertising activities. Yet the MHPD was provided an initial allocation of only 35 scientific staff, 15 support staff, and a budget of only $10 million annually.[7] Health Canada has established a toll-free consumer ADR reporting line and the Canadian ADR Monitoring Program publishes a newsletter available on-line to the public. While these efforts are welcome—and are contributing to increased reporting—much more is needed to increase awareness about Canada’s system of reporting adverse drug reactions. There are few incentives to enhance reporting by physicians, pharmacists, and manufacturers, and consumers and patient advocacy groups face significant barriers to reporting, beginning with, for example, the lack of promotional efforts to support the use of the toll-free consumer reporting line. Education is needed, not only of the public, but of health professionals, about the contribution they can make to the safer use of prescription drugs. Without an adequately staffed and funded mechanism to systematically collect, investigate, analyze, and interpret data on adverse reactions that may be associated with drug therapy or medical devices, efforts to develop an effective public health policy for women are inevitably undermined. Of equal importance is a political commitment by Health Canada to design a system of adverse drug reaction reporting that will fully serve the health needs of women. We urge Health Canada to consult with the women’s health community to develop a comprehensive strategy for postmarket surveillance of women’s experiences with prescription drugs. Reform in this area must embrace the fundamental principle of the right of Canadians to be warned and informed about the medicines they use. For a copy of the full report, Women and Adverse Drug Reactions: Reporting in the Canadian Context, contact: Women and Health Protection PharmaWatch NOTES [1] See http://www.web.net/~desact. [2] Heinrich J. Director Health Care-Public Health Issues. US General Accounting Office. Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women. GAO-01-286R (The GAO did not look at over-the-counter drugs or vaccines.); Rademaker M. Do women have more adverse drug reactions? American Journal of Clinical Dermatology 2001;2(6):349-51. [4] Catherine White, PhD, Gender Effects on Pharmacotherapy. Department of Pharmaceutical and Biomedical Sciences, University of Georgia. Paper presented to the Conference on Biologic and Molecular Mechanisms for Sex Differences in Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics, Athens, Georgia, May 5, 1999. [7] HPFB announces a new organization: Marketed Health Products Directorate (MHPD). Health Canada, Ottawa, April 1, 2002. |
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