White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system.

OBJECTIVE: To convene a group of expert stakeholders to develop recommendations for standardizing systems for the implementation of risk evaluation and mitigation strategies (REMS). DATA SOURCES: 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.
SUMMARY: 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, pilot testing, outcomes monitoring, and quality of care.
CONCLUSION: Several strategies to streamline the development and implementation of a REMS system are feasible. Incorporating such strategies is necessary to manage the rapidly growing number of individual and diverse REMS programs that patients and health care providers must navigate. Furthermore, a standardized REMS system could be used to improve quality of care and support patient education and empowerment.