A Risk Evaluation and Mitigation Strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.
The FDA has required a REMS for opioid analgesics.
Under the conditions specified in this REMS, providers of opioid analgesics and HCPs that provide care to patients and their caregivers are strongly encouraged to do all of the following:
For additional information about the Opioid Analgesic REMS, call 800-503-0784.
Patient Counseling GuideUPDATED