The U.S. Food and Drug Administration has approved a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids.

The REMS is part of a federal initiative to address the prescription drug abuse, misuse and overdose epidemic, according to an FDA news release. The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain.

"Misprescribing, misuse and abuse of extended-release and long-acting opioids are a critical and growing public health challenge," FDA Commissioner Margaret A. Hamburg, MD, said in the news release. "The FDA’s goal with this REMS approval is to ensure that healthcare professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs."

The new ER/LA opioid REMS affects more than 20 companies that manufacture opioid analgesics. Under the new REMS, companies will be required to make education programs available to prescribers based on FDA guidelines. It is expected that companies will meet this obligation by providing educational grants to continuing education providers, who will develop and deliver the training.

The REMS also requires companies to make available FDA-approved patient education materials on the safe use of these drugs.

ER/LA opioid analgesics are widely prescribed medicines with an estimated 22.9 million prescriptions dispensed in 2011, according to IMS Health, which provides services and information to the healthcare and pharmaceutical industries. The medications are associated with serious risks of overuse, abuse, misuse and death — according to the Centers for Disease Control and Prevention, 15,597 Americans died from complications involving these medications in 2009. That total was quadruple the number in 1999.

"Misuse and abuse of prescription opioids is a complex problem and demands a holistic response," said John Jenkins, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. "The new REMS program is one component of a multi-agency, national strategy to address this important public health issue."

Key components of the ER/LA opioid analgesics REMS include:

• Training for prescribers. Based on an FDA Blueprint, developed with input from stakeholders, educational programs for prescribers of ER/LA opioids will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients and counseling patients on the safe use of these drugs. The education also will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse and addiction, and general and specific drug information for ER/LA opioid analgesics.

• An updated medication guide and patient counseling document. These materials contain consumer-friendly information on the safe use, storage and disposal of ER/ LA opioid analgesics. Included are instructions to consult one’s physician or other prescribing healthcare professional before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.

• Assessment/auditing. Companies will be expected to achieve certain FDA-established goals for the percentage of prescribers of ER/LA opioids who complete the training, as well as assess prescribers’ understanding of important risk information over time. The assessments also cover whether the REMS adversely affects patient access to necessary pain medications, which manufacturers must report to FDA as part of periodic required assessments.

It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013. Prescribers face no requirement to take the training and no precondition for prescribing ER/LA opioids to patients.

However, the Obama administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011 as part of its comprehensive plan to address the epidemic of prescription drug abuse. The program, which would be linked to DEA registration by providers, would require legislative changes that are being pursued by the administration.

The FDA continues to support this approach, but absent the needed legislation, plans to exercise its authority to require mandatory elements for companies and voluntary elements for prescribers. It said these steps are important and necessary to help curb the misuse and abuse of ER/LA opioid analgesics without being overly burdensome.

For more information on the REMS, visit http://1.usa.gov/MbDBFT.