FDA Releases REMS for Extended-Release/Long-Acting Opioids

August 28, 2012
Posted by: 
Tamar Hosansky

On July 9, the US Food and Drug Administration (FDA) released its Risk Evaluation and Mitigation Strategy or REMS for extended-release and long-acting (ER/LA) opioid analgesics.

The centerpiece of the ER/LA Opioid Analgesic REMS is a prescriber education program about the risks of opioid medications as well as safe prescribing and safe use practices. The FDA developed and issued a blueprint, which contains the core educational messages. The education will be controlled, designed, and delivered by accredited continuing health care education providers, based on the blueprint. The first page of the blueprint says that "accrediting bodies and CE providers will ensure that the CE activities developed under this REMS will be in compliance with the standards of the ACCME or another CE accrediting body."

The education will be funded by a consortium of opioid manufacturers, the REMS Program Companies (RPC), through educational grants to accredited CE providers, so that it is available free of charge or at nominal cost to prescribers.

"We appreciate that the FDA recognizes the value of accredited education and chose to leverage the CE system to carry out this important public health initiative," said Murray Kopelow, MD, ACCME President and CEO, in an audio commentary. "Accredited CME providers can base their activities on the blueprint and be in compliance with the ACCME Standards for Commercial Support.”

For more information about the ER/LA Opioid Analgesic REMS and the issue of opioid abuse, please see the following resources:

FDA Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids: This FDA information page includes links to the ER/LA Opioid Analgesic REMS blueprint, Q&A, news release, and other resources.

ER/LA Opioid Analgesics REMS: This REMS Program Companies Web site includes information for CE providers, including the request for grant applications.

ACCME Audio Commentary: Murray Kopelow, MD, ACCME President and CEO, discusses the role of accredited CME and the ACCME in supporting the ER/LA Opioid Analgesic REMS.

Ask ACCME Q&A about the ER/LA Opioid Analgesic REMS.

Johns Hopkins MedBiquitous Project Supports FDA REMS Initiative Addressing ER/LA Opioid Abuse: A new project by the MedBiquitous Consortium will permit data about REMS-compliant CE programs from across the health professions to be successfully aggregated into a single data set describing the entire nation’s accredited CE efforts in support of the FDA’s REMS initiative.

Office of National Drug Control Policy: This White House Web site features information and resources about prescription drug abuse and a link to the 2011 Prescription Drug Abuse Prevention Plan. The plan includes the role of continuing health care education in addressing the national prescription drug problem.

Joint Commission Issues New Sentinel Event Alert: Safe Use of Opioids in Hospitals: The recommendations include education and training for clinicians and staff who care for patients, identifying gaps, and developing improvement strategies.