The U.S. Food and Drug Administration has approved a risk management plan that will require drug manufacturers to fund training programs to help doctors and other health care professionals learn how to properly prescribe extended-release and long-acting opioid painkillers, and how to instruct their patients about using them safely. The plan affects more than 20 such manufacturers, including OxyContin maker Purdue Pharma, which issued a statement on the development Monday.
According to the FDA, companies that sell the drugs must provide two to three hours of training to prescribers, either for free or for a small fee. At least 60 percent of the 320,000 U.S. prescribers of the drugs must be trained within three years of launching the programs, which must be available by March 2013, the agency said. Drug makers will also be required to distribute safety brochures to patients explaining the risks of the drugs and instructions to seek emergency care in event of an overdose.
Prescription painkillers are responsible for around 15,000 deaths and 475,000 emergency room visits a year, killing more people than car accidents.