FDA Introduces New Safety Measures For Opioids

Whether it be on the street, or at a pain management doctor, if you need a strong pain pill, they are not very difficult to find.  And, today in a society where it is ridiculously easy to access some very strong pain pills, called opioids, the federal government is beginning to worry about the effects they are having on the population that use them.  Therefore the US Food & Drug Administration has just approved a program that seeks to educate and inform about the abuse of opioids.

The FDA has approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, the highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

The REMS is part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic. 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,” said FDA Commissioner Margaret A. Hamburg, M.D.  “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.”

Key components of the ER/LA opioid analgesics REMS include: training for providers, an updated guide and patient counseling document and assessment and auditing procedures.

The new ER/LA opioid REMS will affect more than 20 companies that manufacture these opioid analgesics. Under the new REMS, 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 (CE) 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.

ER/LA opioid analgesics are associated with serious 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.

“We commend the FDA for taking action to save lives by increasing access to prescriber education,” said Gil Kerlikowske, director of the Office of National Drug Control Policy.

“Misuse and abuse of prescription opioids is a complex problem and demands a holistic response,” said John Jenkins, M.D., director of CDER’s Office of New Drugs. “The new REMS program is one component of a multi-agency, national strategy to address this important public health issue.”