New FDA Safety Measures for Opioid Medications

The FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids. These safety measures are part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic. Opioids are highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER and LA opioids, while ensuring access to needed medications for patients in pain. Key points include:

  • Training for prescribers – Companies will be required to make educational programs available for prescribers of ER/LA opioids with information on risks and benefits of opioid therapy, choosing, managing, monitoring, and counseling patients on the safe use of these drugs. Also, it will include information on how to recognize opioid misuse, abuse, and addiction.
  • Updated Medication Guide and patient counseling document – Companies must make available FDA-approved patient education material on the safe use, storage and disposal of ER and LA opioid analgesics; signs of overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure.
  • Assessment/auditing – Companies will be expected to achieve certain FDA-established goals for the percentage of prescribers of ER and LA opioids who complete the training, as well as assess prescribers' understanding of important risk information over time.

It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013.

For more information call (888) INFO-FDA or visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310870.htm.