Source: New York Times
Date: 10 February 2009

F.D.A. to Put New Restrictions on Narcotics


WASHINGTON — Many doctors may lose their ability to prescribe 24 popular narcotic medicines as part of a new effort to reduce the deaths and injuries that result from these medicines’ inappropriate use, federal drug officials announced Monday.

A new control program will result in new restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

These products are classified as schedule II narcotics and already are restricted according to rules jointly administered by the F.D.A. and the Drug Enforcement Agency. But the current restrictions have failed to “fully meet the goals we want to achieve,” said Dr. John Jenkins, director of the F.D.A.’s new drug center.

“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” Dr. Jenkins said in a news conference Monday.

Hundreds of patients die and thousands are injured every year in the United States because they were prescribed drugs like OxyContin or Duragesic inappropriately or they took the medicines when they should not have.

The toll has worsened in recent years, with the blame shared among doctors who prescribe poorly, patients who pay little attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally.

The F.D.A. this year will hold a series of meeting with manufacturers, patient and consumer advocates, and the public to discuss the outlines of the new control program, officials announced.

The 24 medicines under review had 21 million prescriptions written for them in 2007, to 3.7 million patients, Dr. Jenkins said. They are extremely effective in reducing pain, which many medical studies suggest is widely undertreated in patients suffering serious illness.

But many doctors prescribe the drugs far too cavalierly, Dr. Jenkins said. For instance, most are intended for use only in patients suffering severe illness — like end-stage cancer — who have already become so acclimated to opioid therapy that they still are in pain.

The F.D.A. has received reports, however, of patients suffering from something as simple as a sprained ankle being prescribed such medicines, Dr. Jenkins said. In such patients, the medicines can be dangerous.

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