. "4 Consumer Involvement in Reporting Adverse Events." Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary. Washington, DC: The National Academies Press, 2007.
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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary
ate candidates for nonsteroidal anti-inflammatory drugs are especially relevant (Goulding, 2004). The issue of over- or underprescribing medications for the elderly requires greater scrutiny in order to prevent potential adverse events and to promote better health and appropriate utilization of health-care resources.
POTENTIAL SOLUTIONS AND NEXT STEPS
Solutions to reporting issues may not necessarily have to be high tech and can build upon existing mechanisms for reporting. Ms. Rein suggested looking to successful reporting programs, such as the United Kingdom’s yellow card system, for models of how to provide consumers with multiple avenues for reporting. Ms. Rein believed that the MedWatch system needs to be improved but is still a valuable surveillance tool. “We need to work to improve visibility of MedWatch by integrating reporting into the health-care delivery system,” she said. Ms. Rein suggested public service announcements and direct-to-consumer advertising as possible ways to increase MedWatch visibility, as well as distributing the form (and/or access information) to patients in relevant clinical care settings. User accessibility could be improved by establishing separate web and telephone interfaces to provide consumers with multiple avenues for reporting events. Beyond MedWatch, Ms. Rein indicated that adverse event reporting should be a central element in electronic prescribing and medication management systems. Other avenues include technical support for training in ADE recognition and reporting and reimbursement policies that create incentives for ADE reporting; communication channels between doctors and patients and between patients and the FDA could be enhanced. Electronic resources could be further developed for disseminating safety and reporting information.
Dr. Lipman suggested next steps that would benefit consumers. The first is the formation of a drug safety oversight board with its own regulatory power, comprising consumer representatives and scientists with no industry ties or involvement in the approval process. Second, a clinical trials registry should be established and monitored. Both positive and negative trial results should be posted in a public forum. Third, DTC ads could be regulated with respect to content and subject to a two- to three-year moratorium after a drug is marketed. “To counter pharmaceutical ads, the FDA itself could launch a program of public service advertisements about drug safety, adverse drug reaction reporting, and the importance of postmarketing surveillance,” said Dr. Lipman.