FDA-Required Opioid Analgesic REMS for Serious Drug Risks

Encourage Education and Use of Patient Counseling Guide

April 18, 2019

The U.S. Food and Drug Administration (FDA) has released Risk Evaluation Mitigation Strategy (REMS) information for opioid analgesic drug products used in the outpatient setting. They are also providing two helpful resources that are part of the Opioid Analgesic REMS.

Healthcare providers are strongly encouraged to:

  • Complete a REMS-compliant education program.
  • Counsel patients and/or their caregivers with every prescription on the safe use, serious risks and proper storage and disposal of these products using the Opioid Analgesic REMS Patient Counseling Guide and the specific drug’s Medication Guide.
  • Consider other tools to improve patient, household and community safety.

REMS-compliant training focuses on pain management and creating a pain treatment plan. FDA offers specific core messages in the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain” (FDA Blueprint), as well as a list of available REMS-compliant training. AAPA also offers an FDA REMS compliant course.

Find the Opioid Analgesic REMS Patient Counseling Guide here. Or order a copy by calling the REMS Call Center at 1-800-503-0784.

To report all suspected adverse reactions associated with the use of opioid analgesics, contact the FDA MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch/report.htm.