The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA.

A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS

The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA.

On September 28, 2017 the U.S. Food and Drug Administration (FDA) made available a report titled “A Framework for Benefit-Risk Counseling of Patients Taking Drugs with REMS.” This report is designed to support health care providers who are counseling patients about drugs that require a Risk Evaluations and Mitigation Strategy (REMS). Development of the framework was guided by input from stakeholders and experts, who provided insights into the current state of patient counseling and risk communication. The framework outlines principles, best practices, and examples that help underscore the importance of taking an individualized and collaborative counseling approach when prescribing drugs with REMS, one that engages the patient, helps ensure a balanced conversation about both potential benefits and risks of a drug, and reinforces the patient’s role in mitigating the risks when using such drugs. To learn more, please visit: A Framework fro Benefit-Risk Counseling to Patients About Drugs with a REMS.