FDA Announces Final REMS for Extended-Release and Long-Acting Opioids

On July 9, FDA announced the approval of a final risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids (ER/LA Opioid Analgesic REMS).  The REMS introduces new safety measures to reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain.  It will impact nearly 20 companies and over 30 products.  

Notable components of the ER/LA Opioid Analgesic REMS include:

  • Prescriber education: manufacturers are required to make education programs available to prescribers based on an FDA Blueprint of information to be covered in the programs. Completion of the program is voluntary.
  • Patient education:
    • Manufacturers are required to make available to prescribers a patient counseling document to to voluntarily at point of prescribing. 
    • Manufacturers are required to provide to pharmacies an updated, one-page consumer friendly MedGuide to be dispensed with the medication.
      • The new MedGuide format serves as a starting point for FDA’s ongoing efforts to improve MedGuides.
      • The patient document and MedGuide will be available online.
  • Assessment and audits:  REMS assessment will include CE completion, audits of CE material covered, knowledge assessment, and impact on patient access.
  • The ER/LA REMS is part of the overall federal effort to address prescription drug abuse, misuse, and overdose being coordinated through the White House Office of National Drug Control Policy (ONDCP). In addition to prescriber education through the REMS, the National Prescription Drug Abuse Plan  also addresses medication disposal, prescription drug monitoring programs, and enforcement.

Pharmacists will be required to dispense the updated MedGuide.  In addition, pharmacists may be interested in using the patient counseling document in addition to the MedGuide when talking to patient and/or participate in CE programming. APhA has expressed its appreciation to FDA on its time and commitment in considering APhA's comments on REMS programs.  The opioid REMs discussion has served as a valuable vehicle for APhA to discuss with FDA, manufacturers, and other stakeholders the need to improve and standardize REMS programs to make them less burdensome on pharmacists and more effective for patients. 

Visit the FDA REMS for ER/LA Opioids Web page for additional information, including the FDA press release, CE Blueprint, FAQ, MedGuide template, patient counseling document, and Consumer Health Information Update.

July 11, 2012