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:

  • Educate Yourself - Complete an FDA REMS-compliant accredited continuing education (CE) program offered by an accredited provider of CE for your discipline
  • Counsel Your Patients - Discuss the safe use, serious risks, storage, and disposal of opioid analgesics with patients and/or their caregivers every time you prescribe these medicines. Click here for the Patient Counseling Guide
  • 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 opioid is dispensed to them
  • Consider Using Other Tools - In addition to the Patient Counseling Guide, there are other publicly available tools to improve patient, household and community safety, including Patient-Provider Agreement (PPA) and risk assessment instruments

For additional information about the Opioid Analgesic REMS, call 800-503-0784.