F.D.A. Rejects Mandatory Training in Painkillers for Doctors

by EMSBLOG Editor July 9, 2012

The Food and Drug Administration, overriding the advice of an expert panel, said Monday that it would not require doctors to have special training before they could prescribe long-acting narcotic painkillers that can lead to addiction.

But the agency said companies that make the drugs, like OxyContin, fentanyl and methadone, would be required to underwrite the cost of voluntary programs aimed at teaching doctors how to best use them.

The F.D.A. announcement came after several years of deliberations by the agency into the growing problem of prescription painkiller abuse and misuse. In 2010, a panel of outside experts assembled by the F.D.A. overwhelmingly rejected the agency’s proposal that physician training be voluntary.

Instead, that panel said that mandatory training was essential both to reduce the abuse of strong painkillers, or opioids and to make sure that pain patients were treated appropriately with them.

In introducing the plan on Monday, both Dr. Margaret A. Hamburg, the F.D.A. commissioner, and R. Gil Kerlikowske, President Obama’s top drug policy adviser, said they were hopeful that Congress would eventually enact mandatory physician training.

But the Obama administration has yet to draft legislation, despite voicing support for more than a year.

Major doctors groups like the American Medical Association have fought the idea of mandatory training, saying that the programs would be burdensome and could reduce the number of physicians who treat pain patients.

Over the last decade, overdose deaths related to the abuse and misuse of long-acting narcotics have reached epidemic proportions.

There are also growing concerns that long-term use of the drugs can cause a variety of problems, such as sharply reduced hormone production, sleep apnea and increased falls and fractures in people over 70.

Dr. Scott M. Fishman, a pain specialist, said he believed that the public health issues surrounding opioid use had reached a point at which doctor training was essential.

“The problem of prescription drug abuse has become so severe, I believe that the time has come to make that training mandatory,” said Dr. Fishman, a professor at the University of California, Davis.

More.

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