FDA prescribes new safety measures for opioid painkillers
The Food and Drug Administration unveiled a new safety plan to reduce misuse and abuse of prescription painkillers. The measures focus on training doctors prescribing the drugs and educating patients who take them.
The Associated Press
WASHINGTON — Drugmakers that market powerful painkiller medications will be required to train U.S. doctors, nurses and other health professionals in the safe use of the drugs, which are blamed for thousands of fatal overdoses each year.
The plan released by the Food and Drug Administration (FDA) on Monday is designed to reduce misuse of long-acting opioid pain relievers, which include forms of morphine, methadone and oxycodone. The plan involves educating doctors and patients about appropriate use of the drugs.
The FDA issued warnings on prescription pain relievers in recent years, with little effect. Inappropriate use of the drugs caused nearly 342,000 emergency-department visits in 2009, according to government figures. The drugs were blamed for 16,000 deaths that year, up from 14,800 in 2008.
The FDA said drug companies must provide two to three hours of training to prescribers, either for free or for a small fee. The agency wants companies to train at least 60 percent of the 320,000 U.S. prescribers of the drugs within three years of launching the education programs.
Drugmakers will be required to distribute brochures to patients explaining risks of the drugs and instructions to seek emergency care in case of overdose.
The plan covers about 30 opioid drugs.