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.