Physician Understanding and Perceptions of Risk Communication Related to Drugs Covered by Risk Evaluation and Mitigation Strategy Programs

Zakoul H, Cosenza C, Lee SB, Tekle W, Freedman A, Belitkar S, Toyserkani GA, Oswell KH, LaCivita C, Dal Pan GJ, Kesselheim AS, Sarpatwari A - Pharmacoepidemiology and Drug Safety

  • Regulation and Clinical Evidence

Summary:

In semi-structured interviews with 50 physicians, most were aware of FDA Risk Evaluation and Mitigation Strategy (REMS) testing requirements for drugs and viewed REMS programs as valuable sources of risk communication. To improve implementation of these programs, physicians reported wanting more information on managing side effects, more accessible information on REMS requirements, integration of REMS programs with electronic medical records, and more timely updates to REMS materials as new safety data emerge.

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