A Risk Evaluation and Mitigation Strategy (REMS) is a strategy 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 extended-release and long-acting (ER/LA) opioid analgesics.
Under the conditions specified in this REMS, prescribers of ER/LA opioid analgesics are strongly encouraged to do all of the following:
- Train (Educate Yourself)
- Counsel Your Patients
- Emphasize Patient and Caregiver Understanding of the Medication Guide
- Consider Using Other Tools