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

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.