Posted Monday, July 9, 2012
The U.S. Food and Drug Administration today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids — highly potent drugs approved for moderate to severe pain.
The REMS is part of a federal initiative to address the U.S. prescription drug abuse, misuse and overdose epidemic. New safety measures that will be introduced are 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, M.D., says in a media release. “The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”
The new ER/LA opioid strategy will affect more than 20 companies that manufacture the medications. Under the new strategy, companies will be required to make education programs available to prescribers based on an FDA Blueprint. 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 will require companies to make available FDA-approved patient education materials on the safe use of these drugs. The companies will be required to perform periodic assessments of the implementation of the REMS and the success of the program in meeting its goals. The FDA will review these assessments and may require additional elements to achieve the goals of the program.
“We commend the FDA for taking action to save lives by increasing access to prescriber education,” Gil Kerlikowske, director of the Office of National Drug Control Policy, says. “Since day one, the Obama Administration has been laser focused on addressing the prescription drug abuse epidemic and today’s action is an important contribution to this comprehensive effort.”
ER/LA opioid analgesics are associated with risks of overuse, abuse, misuse and death, and the numbers continue to rise. According to the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications – nearly four times as many deaths compared to 1999.
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