The government is getting serious about prescription drug abuse, releasing a multi-agency plan aimed at reducing the epidemic. The plan, titled “Epidemic: Responding to America’s Prescription Drug Abuse Crisis” targets the reduction of prescription drug abuse and the diversion of prescription drugs for recreational use through education, state-based drug monitoring programs, drug disposal programs, and reduction in the number of “pill mills” and doctor-shopping through law enforcement.
According to Gil Kerlikowske, director of the White House Office of National Drug Control Policy, “The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating. We share a responsibility to protect our communities from the damage done by prescription drug abuse.”
At the same time, the Food and Drug Administration has developed a Risk Evaluation and Mitigation Strategy (REMS) that zeros-in on reducing the misuse and misprescribing of opioids. Opiods are used in pain control for everything from migraines to sports injuries and in post-surgical situations. They are highly addictive and have become a drug of choice, with oxycontin becoming one of the mostly widely abused in the category (which also includes morphine, fentanyl, oxymorphine and methadone). According to the FDA, more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007—up from 29 million just five years earlier. And in 2006, nearly 50,000 emergency room visits were related to opioids.
"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," says FDA Commissioner Margaret A. Hamburg, M.D.
The REMS is primarily for healthcare professionals and includes further education on proper pain management, including how to increase patient awareness on the addictive effects and safe usage of opiods. Additionally, the FDA wants drug makers to work together to develop a single system for implementing the REMS strategies. Toward that goal, FDA is now notifying opioid makers that they must propose a REMS plan within 120 days.
Doctor 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.