Opioid Analgesic REMS

One effort to address the misuse and abuse of opioids is the Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics.

A REMS is a program to manage known or potential serious risks associated with a drug product and is required by the U.S. Food and Drug Administration (FDA) to help ensure that a drug’s benefits outweigh its risks. The FDA has required a REMS for opioid analgesics.

Purdue Is a Member of the REMS Program Companies

Opioid REMS

This consortium of pharmaceutical companies was formed to implement a single shared REMS for opioid analgesics, which applies to more than 253 opioid pain medications.

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
    • This education program for prescribers (e.g.,physicians, nurse practitioners, physician assistants) is the central component of the shared REMS for opioid analgesics
    • Sponsors of this REMS program make funding available for educational grants to accredited CME/CE providers, so they can offer training programs to prescribers at no or nominal cost
    • Purdue, as a member of the REMS Program Companies consortium, contributes to the fund that supports these CME/CE providers
  • Counsel your patients—Discuss the safe use, serious risks, storage, and disposal of opioid analgesic with patients and/or their caregivers every time you prescribe these medications
  • Emphasize patient and caregiver understanding of the Medication Guide—Stress to patients and their caregivers the importance of reading the Medication Guide that they 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 More Information on REMS

Go to https://opioidanalgesicrems.com/RpcUI/home.u to download materials for healthcare professionals and materials for your patients, including a list of frequently asked questions.

Learn more at the FDA Opioid Analgesic REMS page and the FDA REMS page.