White House, FDA act to reduce opioid misuse and abuse

The Obama administration recently unveiled a multiagency plan to reduce the “epidemic” of prescription drug abuse in the United States. It will include an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.

“The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating,” said Gil Kerlikowske, director of the White House Office of National Drug Control Policy. “We share a responsibility to protect our communities from the damage done by prescription drug abuse.”

FDA estimates that more than 33 million Americans aged 12 and older misused extended-release and long-acting opioids during 2007, up from 29 million just 5 years earlier. In 2006, nearly 50,000 emergency department visits were related to opioids. FDA experts say medications including OxyContin, Avinza, Dolophine, and Duragesic are extensively misprescribed, misused, and abused, leading to overdoses, addiction, and even deaths.

Key elements of the plan-called Epidemic: Responding to America’s Prescription Drug Abuse Crisis-include:

• expansion of state-based prescription monitoring programs;

• recommending convenient and environmentally responsible ways to remove unused medications from homes;

• supporting education for patients and healthcare providers;

• and reducing through law enforcement the number of “pill mills” and doctor-shopping.

In a related action, FDA announced a new risk reduction program-Risk Evaluation and Mitigation Strategy (REMS)-for all extended-release and long-acting opioid medications. The program focuses on educating doctors about proper pain management, patient selection, and other requirements, and improving patient awareness on how to use the drugs safely. FDA wants manufacturers to provide patients with education materials, including a consumer-friendly medication guide that explains safe drug use and disposal. 

FDA is now notifying opioid manufacturers that they must propose a REMS plan within 120 days. Doctor training, patient counseling, and other risk reduction measures developed by the opioid manufacturers as part of the REMS are expected to become effective by early 2012.  These efforts will be required for various drugs including hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine.

“The prescriber education component of this opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks,” said FDA Commissioner Margaret A. Hamburg, MD.