Veterinary Medicine - September 2008 - (Page 486)

Leading Off identify potential participants is limited in size and scope. A centralized veterinary clinical trial Web site that matches investigators, trials, and patients is paramount to the continued growth of evidence-based veterinary medicine. Our profession is too small, funding is too limited, and the need for clinical trials is too great for an otherwise well-designed clinical trial to fail because of a lack of sufﬁcient study participants, particularly if eligible patients exist. Such a Web site, which should provide the service at no or minimal charge, might also include a frequently updated description of ongoing or ﬁnished clinical research studies and, as deemed appropriate by investigators, updated results. more commonly emerge with postmarket surveillance when thousands of patients are receiving the product. This surveillance vitally depends on reporting by practitioners or clients. The only mechanism by which these reports will ﬁnd their way back to the profession is if they are reported to an agency that collects, analyzes, and re-reports the data. This will only happen with practitioner input. Reporting adverse events is a multistep process: accepting that they may occur, knowing what to look for, recognizing the clinical signs, and alerting the client. Finally, the practitioner must take time (perhaps delegate the responsibility) to report the information to the manufacturer or the regulatory agency. ADVERSE EVENT REPORTING Practitioners can further contribute to clinical research by reporting adverse events, which include any undesirable response to a therapeutic or preventive intervention such as a drug, vaccine, FDA- and USDA-regulated products For drugs (animal, human, or compounded) and foods, the appropriate agency for reporting adverse events is the FDA Center for Veterinary Medicine (CVM) A centralized veterinary clinical trial Web site that matches investigators, trials, and patients is paramount. therapeutic procedure, dietary supplement, food, diagnostic test, or medical device. Adverse drug events include medication errors. The term adverse generally implies a serious nature to the event such that the quality or quantity of life is affected. However, less serious side effects also are undesirable. Therapeutic failure (e.g. to compounded products or vaccines) also might be considered an adverse event. It is important to report adverse events because although they might be discovered during the approval process, they (www.fda.gov/cvm/adereporting.htm). For vaccines (and some other biologics), the United States Department of Agriculture (www.aphis.usda.gov) is the appropriate agency. By law, each manufacturer must report the adverse event information to its respective regulatory agency. The ASPCA also sponsors a poison control center. Although the center maintains extensive records regarding any type of adverse event, data collection is generally fee-based (with the intent of providing therapeutic advice), and the information is not accessible to the public. Practitioners often express concern that clients will be less likely to use products if counseled regarding adverse events or that such counseling paves the way for future litigation should an adverse event occur. Yet data from human medicine indicate that patients are more likely to become angry with their caregivers if information is withheld. Informed clients tend to be happier clients. Although reporting adverse events is particularly critical immediately after a new drug, particularly a new drug class, is approved, practitioners should remain diligent and report all adverse events. It is only through continued data collection that more subtle adverse events might emerge, and only then might safety differences among drugs within the same class (e.g. NSAIDs) become evident. Adverse vaccine events reported by practitioners or their clients are analyzed annually and then reported to the profession through veterinary journals. The path for reporting adverse drug events to the profession is less clear and would beneﬁt from practitioner direction. Adverse drug events reported to the FDA-CVM have been posted annually and cumulatively on its Web site. However, because pharmaceutical companies do not provide information regarding the number of units of each drug sold, a popular drug might be interpreted as having a greater incidence of side effects, when, in fact, it is simply more commonly used. Further, the cause and effect between the adverse event and the drug cannot always be conﬁrmed through the reports, and reports are not always accompanied by risk factor information (e.g. overdose, underlying disease). Disconcertingly, the FDA-CVM has recently removed information regarding the incidence of adverse events to products from its Web site (www .fda.gov/cvm/ade_cum.htm), markedly limiting the usefulness of the information to practitioners. Equally important 486 September 2008 VETERINARY MEDICINE http://www.fda.gov/cvm/adereporting.htm http://www.fda.gov/cvm/adereporting.htm http://www.aphis.usda.gov http://www.aphis.usda.gov http://www.fda.gov/cvm/ade_cum.htm http://www.fda.gov/cvm/ade_cum.htm

Table of Contents Feed for the Digital Edition of Veterinary Medicine - September 2008

Veterinary Medicine - September 2008 Contents Leading Off Practical Matters Idea Exchange A Challengin Case: Thymic Cyst and Recurrent Chylothorax in a Cat 10 Life-Threatening Behavior Myths CE Form Advertiser Index Marketplace/Classifieds Mind Over Miller

Veterinary Medicine - September 2008

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