FDA Looks to Crack Down on Misuse of Opioid
TUESDAY, April 19 (HealthDay News) -- U.S. health officials
unveiled Tuesday a new plan to try to curb misuse of
extended-release and long-acting opioid pain killers such as
OxyContin, morphine and methadone.
The new Risk Evaluation and Mitigation Strategy (REMS) is part
of a larger multi-agency initiative announced Tuesday by the White
House to reduce overall prescription drug abuse in the United
"This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain," said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, the agency that launched the new program.
For now, the initiative will be limited to extended-release and
long-acting products, which, Woodcock said, "have a much greater
risk than immediate-release because they contain more
She did not rule out the possibility that the approach could be
expanded to include immediate-release drugs in the future.
Right now, the action affects 16 companies that make both
branded and generic products. The products affected are known under
their generic names as hydromorphone, methadone, morphine,
oxycodone, oxymorphone, transdermal fentanyl and transdermal
According to Woodcock, about 23 million prescriptions are
dispensed each year for extended-release and long-acting opioids,
which represented about 10 percent of the opioid market in
But, abuse and misuse is also extensive, with the FDA estimating
that 33 million Americans aged 12 and older used such a drug for
non-medical purposes in 2007, up from 29 million people in
Some 50,000 emergency room visits in 2006 were related to
opioids, officials said.
"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
"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."
The U.S. National Institute on Drug Abuse has more on
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