Class-wide REMS for extended-release and long-acting opioids: potential impact on pharmacies

Abstract

Objectives: To provide an update on the recently approved class-wide risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids and to discuss the potential impact on pharmacy practice.

Data sources: In mid-2011, the Food and Drug Administration notified drug manufacturers that a single, class-wide REMS would be required for ER and LA opioids. This regulation was the result of a multiyear process that incorporated input from government, drug manufacturers, medical associations, and other stakeholders.

Summary: The goal of the class-wide REMS for ER/LA opioids is to reduce addiction, unintentional overdose, and death resulting from inappropriate prescribing, misuse, and abuse. To accomplish these goals, this REMS focuses on physician education on safe and appropriate prescribing and patient counseling on the risks of opioids. Although voluntary, a movement to require physician education to obtain or renew Drug Enforcement Administration licensing is occurring. Pharmacists are not included in the class-wide REMS per se. Pharmacists play an important role in overall risk reduction and are critical to the success of the class-wide REMS.

Conclusion: Although the changing requirements for prescribing ER/LA opioids will not have a direct effect on pharmacist workflow, the pharmacist-patient interaction remains critical for overall risk reduction with this class of medication.