The US Food and Drug
Administration has recommended tighter controls on prescriptions for painkillers
such as Vicodin and Lortab that contain the powerful narcotic hydrocodone.
The change will cut in half
the number of refills that patients can get before seeing their doctor to get a
new prescription, the agency said.
Patients also will have to
take a prescription to their pharmacy to have it filled, rather than have a
doctor call it in.
The FDA announced that it
will also ask in mid-December that all prescription medications containing
hydrocodone be reclassified as "Schedule II" medications.
As Schedule II drugs, these
painkillers will be subject to the same type of strict control as other
narcotics with the highest potential for abuse, including OxyContin, methadone,
fentanyl, Adderall and Ritalin.
The FDA has been spurred to
action by epidemic levels of prescription drug abuse in the United States, said
Dr Janet Woodcock, director of the agency's Centre for Drug Evaluation and
The agency struggled over
the impact that the change might have on patients, she said, but decided that
public health concerns have become paramount.
"These are very
difficult tradeoffs that our society has to make," Woodcock told The
New York Times. "The reason we approve these drugs is for people in
pain. But we can't ignore the epidemic on the other side."
One out of every five
Americans has used prescription drugs for non-medical purposes at some time,
according to the US National Institutes of Health. Some 22 million Americans
have misused prescription painkillers since 2002.
About 131 million
prescriptions for medications containing hydrocodone were issued to an
estimated 47 million patients in 2011. According to government estimates,
that's equivalent to about 5 billion pills, the Times reported.
Dr Lynn Webster, president
of the American Academy of Pain Medicine, said: "This decision will mean
there will be far less hydrocodone prescribed, and far less of it diverted [for
abuse]. There will be an increase in health care costs due to more frequent
office visits and co-pays, but it will take a bite out of the prescription drug
crisis. We can't have status quo. We can't be doing what we have been doing for
the last two decades."
The new regulations could
take effect as early as next year, Woodcock said. The U.S. Department of Health
and Human Services must approve the recommendation before it can be adopted by
the U.S. Drug Enforcement Administration, which has been pushing for tougher
regulation of hydrocodone medications.
Patients currently can
refill a prescription for a drug containing hydrocodone five times during a
six-month period before having to return to their doctor for a new
The new regulations would
cut that period down to three months before a new prescription is required.
"There's no question
that these are important changes in the right direction," said Dr. G.
Caleb Alexander, co-director of the Centre for Drug Safety and Effectiveness at
Johns Hopkins School of Public Health in Baltimore. "The FDA plays a
critical role in helping to reduce the toll that this epidemic has taken. The
clinical community and public health community will welcome these
However, Alexander said
doctors and regulators need to keep an eye on problems for patients that result
from the tighter control.
"The bottom line is
these kind of complex policies are often hard to predict," he said.
"They can have both intended or unintended consequences."
Earlier this year, an FDA
advisory panel voted 19 to 10 in favour of reclassifying hydrocodone-based
painkillers as Schedule II drugs.
There's more on the dangers
of prescription painkiller abuse at the US Centres
for Disease Control and Prevention.