Opioid REMS

For Healthcare Professionals

ER/LA Opioid Analgesics REMS

Two important but opposing factors—undertreatment of pain and opioid misuse and abuse—have emerged as major barriers to successful pain care. One effort to address the misuse and abuse of opioids is the Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics.

A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to help ensure that a drug’s benefits outweigh its risks. FDA has required a REMS for all extended-release and long-acting 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 ER/LA opioid analgesics. Unlike most REMS programs, which cover only one prescription drug, the shared REMS for ER/LA opioid analgesics applies to more than 40 opioid pain medications from several companies.

  • This shared REMS for ER/LA opioid analgesics include both brand name and generic products with extended-release and long-acting formulations of an opioid (e.g., morphine, methadone, buprenorphine, fentanyl, oxycodone, oxymorphone, tapentadol, hydrocodone, or hydromorphone)
  • Purdue strongly supports the FDA REMS program, which serves an important role ensuring that the benefits of ER/LA opioid analgesics continue to outweigh their risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate prescribing, abuse, and misuse.

Under the conditions specified in this REMS, prescribers of ER/LA opioid analgesics are strongly encouraged to

  • Train (educate yourself)—Complete a REMS-compliant CME/CE program offered by an accredited provider of continuing education for your discipline
    • This education program for prescribers (e.g.,physicians, nurse practitioners, physician assistants) is the central component of the shared REMS for ER/LA 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 ER/LA opioid analgesics 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 ER/LA opioid is dispensed to them
  • Consider using other tools—In addition to the Patient Counseling Document, there are other publicly available tools to improve patient, household, and community safety. There are also practice tools to improve compliance with conditions of treatment (e.g., patient–prescriber agreements and risk assessment instruments)

For More Information on REMS

Go to ER-LA-opioidREMS.com to download materials for healthcare professionals and materials for your patients, including a list of frequently asked questions.

Learn more at the FDA ER/LA Opioid Analgesics REMS page and the FDA REMS page.