RISK EVALUATION AND MITIGATION STRATEGY (REMS)

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) - Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) for your discipline

  • Counsel Your Patients - Discuss the safe use, serious risks, storage, and disposal of ER/LA opioid analgesics with patients and/or their caregivers every time you prescribe these medicines. Click here for the Patient Counseling Document (PCD)

  • Emphasize Patient and Caregiver Understanding of the Medication Guide - Stress to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an ER/LA opioid is dispensed to them

  • Consider Using Other Tools - In addition to the PCD, there are other publicly available tools to improve patient, household and community safety, as well as compliance with conditions of treatment, including Patient-Prescriber Agreement (PPA) and risk assessment instruments

For additional information about the ER/LA Opioid REMS Program, call 800-503-0784.