Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioid Analgesics

Extended-release/long-acting (ER/LA) opioid analgesics are powerful medications approved to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The ER/LA Opioid Analgesic REMS, approved on July 9, 2012, is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths due to prescription opioid analgesics.

As part of the FDA’s Opioid Action Plan, the agency intends to update the ER/LA Opioid Analgesic REMS after having evaluated existing requirements and considered recommendations from the joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee on May 3-4, 2016, including:

• Expanding the FDA Blueprint to incorporate pain management and extending training to other health care professionals involved in the management of patients with pain
• Expanding the REMS requirements to include the immediate-release opioid analgesic drug manufacturers
• Evaluating the best approach to implementing mandatory prescriber education on pain management

Additional Resources

• Opioid Medications
• Accredited Opioid REMS CE: Free or Nominal Charge
• FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (PDF - 580KB)

Meetings with Industry and Stakeholders 

• Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics: Exploring the Path Forward - May 9-10, 2017
• Industry Meeting on Modifying ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) –
  January 25, 2017
• May 3-4, 2016 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee

Background and Historical Information

• Safety Measures for Extended-release and Long-acting Opioids
• Historical Information on ER/LA Opioid Analgesic REMS