The Food and Drug Administration has announced new safety measures for a class of opioid medication used to treat moderate to severe chronic pain.
Opioids are powerful - patients who suffer from chronic pain say the medications can do wonders. But if they fall into the wrong hands or are used for recreational purposes, these meds can cause serious harm, including overdose and death.
"Although many Americans don't realize it, prescription drug abuse is our swiftest growing drug problem. Many of those abuses involve opioids," said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration. "In 2008, nearly 15,000 Americans died where opioids were involved. In 2009, that number went up to 16,000."
In order to cut down on abuse but still get these medications to the people who really need them, the FDA has provided a blueprint to more than 20 companies that manufacture opioid analgesics on how best to educate physicians who prescribe them.
The education guidelines will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs.
In addition, the education will include information on how to recognize evidence of, and the potential of, any opioid misuse, abuse and addiction. Manufacturers will also be asked to provide an "easier to read" information sheet for patients, explaining the ways to use the drugs, what the dangers are and the best way to discard the drugs if they are no longer being used.
"The number of opioid overdoses in the U.S. is higher than heroin and cocaine overdoses combined," said Gil Kerlikowske, director of the Office of National Drug Control Policy. "People need to know how to use the drugs, and what happens if they get in the wrong hands."
The FDA expects manufacturers to meet their obligations by giving educational grants to drug education providers, who will develop and deliver the training for physicians and heath care workers, as they do with other drugs.
The plan, known as a risk evaluation and mitigation strategy or REMS, is part of the government's initiative to address the prescription drug abuse epidemic in the U.S. The FDA hopes that manufacturers will have their continuing opioid education plans in place by March of next year.