BC-FDA-PAINKILLERS-RESTRICTIONS-ART-1STLD-WRITETHRU-NYT

Published on NewsOK Modified: January 25, 2013 at 5:34 pm •  Published: January 25, 2013
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Trying to stem the scourge of prescription drug abuse in the United States, an advisory panel of experts to the Food and Drug Administration voted Friday to toughen restrictions on Vicodin and other hydrocodone products, the most widely used narcotic painkillers in the country.

The panel voted 19-10 in favor of the recommendation, which the FDA will likely follow, which would limit access to the drugs by making them harder to prescribe, a major policy change that advocates said could help ease the growing problem of addiction to painkillers.

The change would have sweeping consequences for doctors, pharmacists and patients. Under the new rules, refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed and pharmacists and distributors would be required to store the drugs in special vaults. The vote comes after similar legislation in Congress failed last year, after intense lobbying by pharmacists and drugstores.

Prescription drugs account for about three-quarters of all U.S. drug overdoses, with the number of deaths more than tripling since 1999, according to federal data. Since 2008, deaths from overdoses have outpaced deaths from car accidents.

The FDA convened the panel, made up of scientists and other experts, after a request by the Drug Enforcement Administration, which contends that the drugs are among the most frequently abused painkillers in the country.

''This is the federal government saying, 'We need to tighten the reins on this drug,'" said Scott R. Drab, associate professor of pharmacy and therapeutics at the University of Pittsburgh's School of Pharmacy. "Pulling in the rope is a way to rein in abuse, and consequently, addiction."

At a two-day hearing at FDA headquarters in Silver Spring, Md., many speakers opposed the change, including advocates for nursing home patients, who said older, frail residents needing pain medication would now be required to make the arduous trip to a doctor's office to continue using hydrocodone products. Other experts questioned how effective the change would be. Oxycodone, another highly abused painkiller, and the active ingredient in OxyContin, has been in the more restrictive category since it came on the market, but the limited access does not seem to have stemmed abuse, they said.

But others including parents who had lost their children to prescription drug abuse, as well as doctors and pharmacists, testified, in favor of the proposed restrictions, sometimes emotionally. Sen. Joe Manchin, D-W. Va., made an impassioned plea.

''When I go back to West Virginia, I hear how easy it is for anybody to get their hands on hydrocodone drugs," Manchin said Friday. "For underage children, these drugs are easier to get than beer or cigarettes."

He added that the less restrictive status was fueling the prescription drug epidemic today."

Dr. James P. Rathmell, chief of the division of pain medicine at Massachusetts General Hospital, said hydrocodone products had similar biological effects as oxycodone products and should unquestionably be in the same category of restrictiveness.

''Knowing what we know today, it was a mistake," Rathmell said, referring to hydrocodone products being placed in the looser category when they came on the market. "It should be corrected."

Dr. Timothy Deer, a pain management specialist at the Center for Pain Relief in Charleston, W.Va., said he feared for older patients, particularly in rural areas, who would now have farther to drive to get their prescriptions renewed. But, because hydrocodone products have been by far the most widely prescribed painkiller, toughening the restrictions on them is a worthy trade-off, he said, particularly in a hard-hit state like West Virginia.

''At the end of the day, the benefits of reducing abuse will outweigh the harm to legitimate pain patients," Deer said. "This will likely reduce the amount of drug falling into the wrong hands."



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