FDA Finalizes REMS for Long-Acting and Extended-Release Opioids Adopting Many ASA Recommendations

On July 9, the Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy (REMS) for all long-acting and extended-release (LA/ER) opioids.  The REMS is part of the federal government’s 2011 Prescription Drug Abuse Prevention Plan to combat abuse and diversion of opioids.  The central component of the LA/ER REMS is a voluntary prescriber education program.  Accredited continuing education (CE) providers will offer the education programs and must cover the content of a blueprint developed by FDA. 

As part of the final blueprint, FDA adopted many of the recommendations submitted by ASA.  The FDA expects that sponsors of LA/ER opioids will provide educational grants to CE providers to offer training to prescribers at no or nominal cost.  The prescriber education will be approximately three hours, and will include drug information on LA/ER opioids; information on assessing patients for treatment; initiating therapy, modifying dosing, and discontinuing use of LA/ER opioids; managing therapy; and counseling patients and caregivers about the safe use of these drugs.  Additionally, prescribers will learn how to recognize evidence of and potential for opioid misuse, abuse, and addiction.

It is expected that the first CE activities under the REMS will be offered to prescribers by March 1, 2013.  There are approximately 320,000 prescribers of LA/ER opioids, and FDA expects companies to train 60 percent of these prescribers within three years of the start of training.

The REMS for LA/ER opioids will also include a Medication Guide and a patient counseling document for prescribers to give to patients. 

According to the FDA, REMS is a "risk management plan that FDA can require a drug company to develop and implement to manage serious risks associated with a drug."  Under the FDA Amendments Act of 2007, the FDA may require a manufacturer to develop and implement REMS when the FDA finds it is necessary to ensure that the benefits of a drug outweigh its risks. 

Go to the FDA’s webpage on REMS for LA/ER opioids.

Read ASA’s comment letter on the draft blueprint for prescriber education.

Go to ASA’s Pain Medicine advocacy webpage to learn what federal policymakers are doing to combat prescription drug abuse.