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FDA Looks to Crack Down on Misuse of Opioid Painkillers
Date:4/20/2011

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"This is a large and growing problem and, despite a number of efforts over the years, it continues to grow," Woodcock said. "It's clear we have a huge problem on our hands."

One of the main components of the new FDA program will be educating doctors and other prescribers on proper ways to prescribe opioids, as well as how to identify appropriate patients for these drugs.

"If a prescriber has a concern that a patient might unintentionally or intentionally misuse the drug, they need to know how to spot these individuals," Woodcock said.

Doctors will also get materials on how to educate their patients, not only on proper use of opioids but also on proper storage and disposal.

Manufacturers will be required to use one central system to provide these educational materials, Woodcock said. And the FDA will monitor company-generated literature to make sure it isn't promotional but is effective, she added.

Companies have 120 days to issue a draft REMS and Woodcock hoped matters will be completed by early 2012.

"In the meantime, doctors should be prescribing opioids as they have been doing and we hope they thoroughly discuss risks and benefits with their patients," Woodcock said. "People taking opioids should continue to take them as directed and, if they have concerns, should consult a health-care professional."

More information

The U.S. National Institute on Drug Abuse has more on opioids.

SOURCE: April 19, 2011, teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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