FDA Unveils Safety Measures for Opioid Painkillers
Drugmakers that market powerful painkiller medications will be required to fund training programs to help U.S. doctors and other health professionals safely prescribe the drugs, which are blamed for thousands of fatal overdoses each year.
The safety plan released by the Food and Drug Administration on Monday is designed to reduce misuse and abuse of long-acting opioid pain relievers, which include forms of morphine, methadone and oxycodone. The agency's plan mainly involves educating doctors and patients about appropriate use of the drugs.
The FDA has issued a number of warnings on prescription pain relievers in recent years but with little effect. Inappropriate use of the drugs caused nearly 425,000 emergency department visits in 2009, according to government figures. The drugs were blamed for 15,600 deaths that year, up from 14,800 in 2008.
The FDA said companies that sell the drugs must offer two to three hours of training to prescribers, either for free or for a small fee. The courses will be designed by companies that provide continuing medical education for health professionals, not by the drugmakers themselves.
The agency wants companies to provide training to least 60 percent of the 320,000 U.S. prescribers of the drugs within three years of launching the programs. The programs, which will be vetted by FDA regulators, must be available by March 2013.