Patient Perceptions of and Experiences with Risk Evaluation and Mitigation Strategies

In interviews with patients and caregivers using seven drugs subject to FDA risk evaluation and mitigation strategy (REMS) programs, participants were found to be generally knowledgeable about REMS-related drug risks, but some encountered challenges finding prescribers, navigating testing requirements, and managing the administrative burdens of these programs. REMS programs are effective in educating patients about drug risks, but better integration of REMS into clinical workflows can improve medication access and adherence.