Pubdate: Sun, 15 Feb 2004
Source: Washington Post (DC)
Copyright: 2004 The Washington Post Company
Page: A03
Contact:  http://www.washingtonpost.com/
Details: http://www.mapinc.org/media/491
Author: Marc Kaufman, Washington Post Staff Writer
Cited: American Pain Society http://www.ampainsoc.org/
Cited: American Pharmacists Association http://www.aphanet.org/
Cited: National Association of Drug Diversion Investigators 
http://www.naddi.org/
Bookmark: http://www.mapinc.org/topics/hydrocodone
Bookmark: http://www.mapinc.org/find?232 ( Chronic Pain )

U.S. IS WORKING TO MAKE PAINKILLERS HARDER TO OBTAIN

Patients May Suffer as DEA Battles Abuse

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. 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 that 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 says the change is necessary because hydrocodone 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. Hydrocodone was one of
several prescription painkillers that radio talk show host Rush
Limbaugh acknowledged last year that he was addicted to.

"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 they
understand that the DEA wants 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.

Although the agency says the prosecutions are needed to shut down
"pill mills" and stop unscrupulous doctors, many pain specialists say
that the agency has become overzealous and that some doctors are
refusing to prescribe needed painkillers because they fear DEA
investigation.

"Rescheduling the drug will bring more hoops and barriers to getting
access to the drugs, and it may prevent some minimal amount of abuse,"
said Richard Payne, president of the American Pain Society. "But my
concern is that it will come at the cost of denying access to
thousands of patients."

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 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.

The DEA's Sannerud said hydrocodones have become an increasing problem
as the number of Americans taking the drug skyrockets. According to
statistics from IMS Health, which collects information about
prescription drugs, the number of hydrocodone prescriptions rose from
about 80 million in 1999 to 100 million in 2002. That is about four
times as many prescriptions as are written annually for oxycodone, the
active narcotic in the high-profile drug OxyContin.

Hydrocodone has been made for decades but, because most brands are
less profitable off-patent drugs, it is generally not heavily
marketed. Two generic versions, distributed by Tyco
Healthcare/Mallinckrodt and Watson Pharmaceuticals Inc., were listed
by IMS Health as the third and sixth most prescribed drugs in the
nation last year.

Sannerud said the DEA has contacted several companies that make
hydrocodone and not heard any strong opposition to a schedule change.
Several of the larger manufacturers, however, said in interviews they
were not aware of DEA's plans.

Sannerud said her agency took up the issue because of a citizen's
petition filed by a doctor in Upstate New York, Ronald Dougherty.

The doctor, who runs an inpatient drug recovery center outside
Syracuse, said he had sent letters for years urging the rescheduling
annually.

"With all the focus on OxyContin, the abuse of hydrocodones has been
very underappreciated," said Dougherty, who remarked that almost a
quarter of his patients are addicted it.

Charles Cichon, president of the National Association of Drug
Diversion Investigators Inc., representing both law enforcement and
prosecutors, said his group has urged rescheduling for years.

"This is widely accepted to be the nation's most abused prescription
drug, and a big reason why is that it's Schedule III and can be called
in by a doctor," he said. "That opens the door to a lot of abuse."

But John T. Farrar, a pain specialist at the University of
Pennsylvania and a consultant to the FDA advisory panel on analgesics,
said taking away a doctor's ability to call in a hydrocodone
prescription would have serious consequences for patient care.

"There's really no substitute that doctors would be allowed to call
in," Farrar said. "That means many patients would probably be getting
other Schedule III drugs that are less effective for their pain, while
drug abusers will just find another source." 
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MAP posted-by: Richard Lake