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:
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