FDA endorses safety measures for long-acting opioid painkillers

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Companies that manufacture opioid painkillers must underwrite training and educational programs for the physicians who prescribe them, according to a new federal safety measures announced Monday.

The Food and Drug Administration stopped short of making special training for physicians who prescribe extended-release and long-acting opioid painkillers mandatory — against the advice of an expert panel. Instead, the FDA is requiring the makers of such medications to underwrite voluntary physician training programs as part of their risk evaluation and mitigation strategy (REMS) program.

As the numbers of new prescriptions for these powerful narcotics have risen in recent years, so too have the number of adverse events associated with the drugs. They have been linked to an increase in falls and fractures in the elderly, drug abuse and overdose-related deaths.

According to the agency, REMS has three key components, including: education and training for prescribers; a newly updated medication guide and patient counseling document; and an auditing and assessment process.

Long-term care groups have been lobbying to loosen regulations over how opioid painkillers are dispensed in nursing homes. In a Senate hearing in mid-June, lawmakers pressed Attorney General Eric H. Holder about pending legislation that would allow designated nursing home staff to administer controlled substances to residents while acting on a physician's verbal orders. Holder said he hoped to reach a solution with the Drug Enforcement Agency by the end of 2012.


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