For immediate release: July 11, 2012
Contact: Chuck Weber – 262.473.3018

REMS Statement

The following statement was issued by the American Pain Society in response to the July 9 announcement by the FDA of its extended-release, long-acting opioid REMS decision.

GLENVIEW, Ill., July 11, 2012 — The FDA’s Risk Evaluation and Mitigation Strategies (REMS) for extended release/long-acting (ER/LA) opioids, announced on July 9, is consistent with the American Pain Society’s strong belief that competency-based educational programs will benefit both primary care and specialty prescribers of ER/LA opioids and ultimately improve patient safety and decrease diversion while still assuring access to these medications for patients who need them.

Professional and consumer education programs can achieve significant benefits for improving awareness and reducing behaviors that contribute to opioid abuse. For example, the FDA’s mandate that simplified medication guides and information sheets for ER/LA opioids be made available for patients will hopefully lead to improved knowledge concerning proper use, storage and disposal of these drugs and result in less intentional and unintentional diversion of these medicines.

The educational opportunities for prescribers and dispensers mandated by the REMS should be offered through a variety of channels. APS and other professional societies can play a vital role in helping to develop educational modules as part of the REMS programs implemented by FDA and drug manufacturers. Clinician training programs should be evidence-based, and designed to develop and improve clinical skills such as patient assessment, communication and recognition of risks for abuse as the basis for developing integrated treatment plans, revising treatment plans, and making referrals to pain specialists as necessary.

Despite our appreciation for the ER/LA REMS as announced, APS continues to disagree with FDA’s decision to limit REMS to extended-release, long-acting opioids only. All opioids must be used, stored and disposed of in similar ways for maximum safety.