Abstract
To convene a group of expert stakeholders to develop recommendations for standardizing systems for the implementation of risk evaluation and mitigation strategies (REMS). On July 15, 2009, the American Pharmacists Association convened an expert panel of stakeholders to explore standardized solutions to REMS development and implementation. Meeting participants included pharmacists from various practice settings, physicians, researchers, patient advocates, and a nursing delegate, and the meeting was observed by a U.S. Food and Drug Administration representative. The stakeholders' recommendations were combined with themes arising from discussion of their experiences with existing REMS, and a review of the literature on REMS and risk management was performed by the author. A systematic, standardized REMS process that balances the need to control the risks of medications with the need to minimize the impact on patient access is required. A standardized REMS system could address various aspects of development and implementation, including the creation of specific REMS "levels," centralized systems for data management and program structure, public education, individualized patient education, provider education, access to medications, ...Continue Reading
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