Pubdate: Mon, 16 Feb 2004
Source: Lexington Herald-Leader (KY)
Copyright: 2004 Lexington Herald-Leader
Contact:  http://www.kentucky.com/mld/heraldleader/
Details: http://www.mapinc.org/media/240
Author: Marc Kaufman, The Washington Post

TIGHTER CONTROLS LIKELY ON PAINKILLER

Hydrocodone Is Widely Prescribed, Widely Abused

WASHINGTON - The Drug Enforcement Administration is working to make one of 
the nation's most widely prescribed medications more difficult for patients 
to obtain as part of its stepped-up offensive against the diversion and 
abuse of prescription painkillers.

Top DEA officials confirm that the agency is eager to change the official 
listing of the narcotic hydrocodone -- which was prescribed more than 100 
million times last year -- to the highly restricted Schedule II category of 
the Controlled Substances Act. A painkiller and cough suppressant sold as 
Lortab, Vicodin and 200 generic brands, hydrocodone combined with other 
medications has long been available under the less-stringent rules of 
Schedule III.

The DEA effort is part of a broad campaign to address the problem of 
prescription-drug abuse, which the agency says is growing quickly around 
the nation and has been a longtime problem in Eastern Kentucky. But the 
initiative has repeatedly pitted the agency against doctors, pharmacists 
and pain sufferers, and it is doing so again with the hydrocodone proposal.

Pain specialists and pharmacy representatives say the new restrictions 
would be a burden on the millions of Americans who need the drug to treat 
serious pain from arthritis, AIDS, cancer and chronic injuries, and that 
many sufferers are likely to be prescribed other, less-effective drugs as a 
result.

If the change is made, millions of patients, doctors and pharmacists will 
be affected, some substantially. Patients, for instance, would have to 
visit their doctors more often for hydrocodone prescriptions, because they 
could not be refilled; doctors could no longer phone in prescriptions; and 
pharmacists would have to fill out significantly more paperwork and keep 
the drugs in a safe. Improper prescribing would carry potentially greater 
penalties.

The DEA said the change is necessary because hydro-codone is being widely 
misused -- with a 48 percent increase in emergency-room reports of 
hydrocodone abuse from 1998 to 2001. The drug, a semisynthetic chemical 
cousin of opium, produces a morphine-like euphoria if taken without a 
medical purpose but generally does not produce a similar "high" in patients 
with severe or chronic pain. Last year, radio talk-show host Rush Limbaugh 
acknowledged that he was addicted to several prescription painkillers, 
including hydrocodone.

"Hydrocodone is one of the most-abused drugs in the nation," said Christine 
Sannerud, deputy chief of the drug and chemical evaluation section of the 
DEA. "The agency thinks it would be wise to move it to Schedule II, because 
that would help a lot in terms of reducing abuse and trafficking."

DEA officials would not say when they might begin the process of changing 
the schedule, but other federal officials said the DEA appears to want to 
act soon.

Under the federal Controlled Substances Act of 1970, the DEA places all 
narcotic or mind-altering drugs into one of five "schedules," and the 
medications are more or less available based on the potential dangers they 
pose and benefits they provide. Morphine-based hydrocodone, when combined 
with aspirin, acetaminophen or other common analgesics, has been a Schedule 
III drug since the act went into effect.

The DEA effort comes as the agency is already embroiled in a dispute with 
many pain specialists over the use -- and alleged overprescribing -- of 
another powerful painkiller, OxyContin. Scores of doctors have been 
arrested on felony charges of conspiracy, drug trafficking and even murder 
in connection with their prescribing.

Susan Winkler of the American Pharmacists Association said her organization 
is concerned that the "ripple effects" would be substantial and negative.

"Our members and doctors would have increased liability if (hydrocodones) 
are rescheduled, and that will inevitably reduce prescribing," she said. 
"We urge the DEA to make sure their decision is based on science and will 
make the situation better, not worse."

Reflecting the complexity of the issue, the Florida legislature tightened 
rules on hydrocodone in 2000. At the request of state enforcement 
officials, lawmakers made the same change that the DEA wants. But in 2001, 
after patients and health care providers protested loudly, Florida repealed it.

The process of changing the classification of a controlled drug is 
cumbersome and time-consuming, and it involves a formal review by the Food 
and Drug Administration, a listing in the Federal Register and a public 
comment period. The DEA, however, has the final authority.
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MAP posted-by: Beth Wehrman