FDA Targets Prescription Drug Abuse with New REMS

On April 19, the Obama Administration introduced a plan to address the national prescription drug abuse epidemic and announced new Federal requirements aimed at educating health care providers on proper prescribing practices.

The plan—which involves the Office of National Drug Control Policy, the US Department of Health and Human Services, FDA, and DEA—will support the expansion of state-based prescription drug monitoring programs, recommend more convenient and environmentally responsible disposal methods to remove unused medications from the home, support education for patients and health care providers, and reduce the prevalence of pill mills and doctor-shopping through enforcement efforts.

In support of the plan, the FDA announced an Opioids Risk Evaluation and Mitigation Strategy (REMS) that will require manufacturers of long-acting and extended-release opioids to provide educational programs for prescribers and materials they can use when counseling patients about the risks and benefits of opioid use.

Prescription drug abuse is the Nation's fastest-growing drug problem. According to the Office of National Drug Control Policy, prescription drugs are the second most abused category of drugs after marijuana. In 2007, approximately 27,000 people died from unintentional drug overdoses, driven mostly by prescription drugs. Additionally, the Substance Abuse and Mental Health Services Administration reports that number of Americans in 2009 aged 12 and older currently abusing pain relievers has increased by 20% since 2002.

In light of these statistics, the FDA is calling for drug makers to work together to develop a single system for implementing the REMS strategies and propose a plan within 120 days.

The aim of the initiative is to improve pain management while preserving patient access to these needed medications, according to Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “This will be an important step toward addressing what has become a critical public health problem,” she said in a statement.

Physician training, patient counseling, and other risk reduction measures developed by opioid makers as part of the REMS are expected to become effective by early 2012. They will be required for various brand name products known under the generic names hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine.

“Long-acting and extended-release opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly, with serious negative consequences for individuals, families, and communities,” said FDA Commissioner Margaret A. Hamburg, MD. “The prescriber education component of this Opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks.”

Although physician training is not mandatory under the REMS plan, other federal agencies are working to get Congress to link mandatory physician training to the already required Drug Enforcement Administration registration number that doctors must have to prescribe controlled substances.

The FDA will also require the risk management plan to include a way to determine if the education programs are helping to reduce problems associated with long-acting and extended-release opioids, as well as allowing patients who need opioids to get them.

For more information:

• Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)
• List of Long-Acting and Extended-Release Opioid Products Required to have an Opioid REMS
• Video: The New REMS Era