Prescription Drugs Subject to a Risk Evaluation and Mitigation Strategy: Patient Perspectives on Risk Communication and the Value of Educational Materials

In a survey of patients and caregivers with experience navigating FDA risk evaluation and mitigation strategy (REMS) programs, most respondents reported feeling well-informed about the safety risks of their medications, yet their understanding of REMS requirements the value of REMS educational materials varied. These findings highlight the need for clearer, more tailored educational resources and greater provider involvement to improve patient knowledge and adherence to REMS programs.