From Our Perspective
Risk Evaluation and Mitigation Strategies (REMS)
Part 2 - Implementation: Challenges and Opportunities
By: Claudia Manzo, Director, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, Centers for Drug Evaluation and Research
Risk Evaluation and Mitigation Strategy (REMS) programs focus on preventing, monitoring, and/or managing a specific serious risk(s) associated with certain drugs by informing, educating, and/or reinforcing actions to reduce the frequency and/or severity of a particular adverse event(s). As discussed in Part 1, there are several key participants who play important roles in the medication use process for drugs that are subject to REMS.