White House Targets Painkiller Abuse


The advisory committee of drug, addiction, and pain experts had said it would be inappropriate for drugmakers to tell physicians how to prescribe the drugs.

Woodcock told MedPage Today that the FDA will go through the pharmaceutical company's educational material with a fine-toothed comb to make sure it's scientifically sound and accurately portrays the risks of such drugs.

While the FDA will require drug companies to establish training programs, the REMS will not require physicians to participate in such programs, and it's unclear how many busy physicians will voluntarily take such classes. To add some incentive, expert medical faculty would review the training courses in order to certify them for continuing medical education (CME) credits, Woodcock said.

The REMS would be the most "far-reaching and impactful" imposed by the agency, affecting up to 700,000 physicians who prescribe the drugs, Woodcock said.

But it wouldn't be the most restrictive REMS. In order to prescribe the addiction-treatment drug buprenorphine (Suboxone), physicians must go through an eight-hour training class, and in order to prescribe the acne treatment isotretinoin (Accutane), physicians must obtain negative pregnancy test results from their female patients.

Physicians and nurse practitioners who prescribe certain opioids already have to register with the Drug Enforcement Agency (DEA), and some panelists at the July meeting favored linking that registration to completion of a training program.

However, that approach is out of the FDA's reach and would require an act of Congress. And that's where the hypothetical bill that the officials touted would come in.

The bill would give the DEA authority to require that providers registering with the DEA prove they have undergone training. The training would include specifics on which pain patients need extended-release opioids, how much they need, and when it's a better idea to prescribe a immediate-release opioid or a less potent medication such as a non-steroidal anti-inflammatory drug (NSAID).

That congressionally mandated training would still originate from drug companies, Woodcock said. It would have a large focus on what doctors should tell their patients when they prescribe long-acting narcotics, and include clear explanations of what the drug does, what happens if a patient takes too much, and the importance of locking up the prescription in a secure place.

Kolodny said he worries that even this mandatory education would be a very "watered down" program -- one that pales in comparison to the 8-hour class required for buprenorphine prescribing.

Drugmakers "don't want any kind of system that would limit access" to their product, he said, adding that the buprenorphine course has helped to deter prescribing of the drug.

Seven in 10 people who abuse prescription painkillers got them from a friend or relative, according to a survey from the Substance Abuse and Mental Health Services Administration.

Kerlikowske said the DEA also would crack down on doctors who run so-called "pill mills," illegally doling out narcotics for money.

"Although it's a very small number of doctors who abuse their prescribing privileges, they are responsible for an immense amount of the suffering and death," he said.

Another strategy is to increase the number of state prescription drug monitoring programs (PDMPs).

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