The DEA for nearly a decade has pushed for tighter restrictions on
Vicodin, the nation's most widely prescribed drug. The chronic abuse of
such painkillers, and devastating toll associated with this abuse, has
reached epidemic proportions in the United States.
could get its wish later this month when the Food and Drug
Administration considers the DEA's request to put Vicodin in the same
category as OxyContin and other powerful narcotics.
recommendation from the FDA has proven elusive and is far from certain,
but such a reclassification would allow the Drug Enforcement
Administration to elevate the powerful painkillers from Schedule III to
Schedule II, the most restrictive category of medically accepted drugs.
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the millions of patients across the nation who rely on Vicodin for
relief from severe pain, the new rules could sharply restrict the number
of pills they can get and drastically increase the number of doctor
visits necessary to get them. Many patients who can now get a six-month
supply would need to visit their doctors every 30 days to renew a
The Centers for Disease Control and Prevention calls
prescription painkiller abuse an epidemic. Opioid painkillers, such as
Vicodin and OxyContin, cause 75% of prescription drug overdoses, the CDC
says. In recent years, such overdoses have outpaced cocaine and heroin
deaths combined, the CDC notes.
"This is a real problem for the
country," said Lynn Webster, president-elect of the American Academy of
Pain Medicine and a board-certified anesthesiologist. He will speak
before the FDA committee that meets Jan. 24-25 to consider the DEA's
This is the DEA's second attempt to get the FDA to
elevate the powerful painkillers from Schedule III to Schedule II. In
2008, the FDA rejected the DEA's initial request submitted in 2004. The
reasoning: The hydrocodone combination drugs have less potential for
abuse than the other drugs in Schedule II, including oxycodone.
DEA counters that abuse, trafficking and diversion of the drug have
grown since its first request, causing a "devastating effect" on public
"Schedule III controls are not adequate," DEA Deputy
Assistant Administrator Joseph Rannazzisi wrote Feb. 13, 2009, in a
letter to the FDA requesting a scientific and medical evaluation of the
drug for rescheduling.
Emergency room visits involving hydrocodone
jumped from 37,844 in 2004 to 57,550 in 2006, the DEA says. In 2010,
the most recent year available, the number had doubled from just four
years earlier: 115,739 people were treated.
The FDA committee will
evaluate the DEA's evidence, hear comments from the public and vote on
its recommendation to the FDA commissioner and the Department of Health
and Human Services.
The vexing question during the last review,
and surely this one, is whether changing the classification will stem
the misuse of the drug, or simply inconvenience patients. An analysis
completed last year and submitted by the Department of Health and Human
Services in advance of the meeting concluded the painkillers are "widely
abused," but found no evidence to support that rescheduling would curb
WHAT PATIENTS SEE
Vicodin is a combination of
hydrocodone and acetaminophen, the medicine in Tylenol. As a Schedule
III drug, doctors can authorize up to five refills on one 30-day
prescription, giving patients a six-month supply before they must visit a
Doctors wrote nearly 131 million prescriptions for the
combination hydrocodone painkillers for 47 million patients in 2011, the
FDA found in its analysis. IMS Health, a consulting and research firm,
put the number of prescriptions at 137 million.
If Vicodin and
other hydrocodone combinations, such as Lortab and Vicoprofen, are
elevated to Schedule II, doctors cannot prescribe refills of a 30-day
supply or phone a prescription in to a pharmacy. Rescheduling the
painkillers would add another layer of regulations for manufacturers and
pharmacies, including more extensive record-keeping and tighter
"On the surface, it looks like it might be the right
thing to do," Webster said. "With increasing availability, we've seen
an increase in the amount of harm from the drug, but I'm not sure
rescheduling is going to reduce that harm."
Webster predicts that
a reclassification would change prescribing practices because the
restrictions on such drugs place burdens on physicians who have to do
more paperwork and see patients more frequently. Patients who need the
drug could face higher costs and more co-pays with increased doctor
visits, he said.
"If we're talking about the problem of abuse,
it's not just about the drug," Webster says. "It's also about the person
and the environment. Part of the solution is for us to not focus only
on the drug but also on the risk factors that lead to a substance-abuse
Ed Michna, an assistant professor at Harvard Medical
School who is board-certified in anesthesia, pain and palliative care
physician, says the hydrocodone combinations have the same abuse
potential as oxycodone, so there's no medical or scientific reason why
they are not in the same category.
"It's one of the most abused drugs in the country," Michna said.
But he points out that changing the classification won't end abuse and might cause other problems.
other side of it is there's going to be an impact on patient care,"
Michna said. "Certainly, there will be less Vicodin prescribed. What's
going to happen is that patients who probably deserve to have this as a
treatment option are going to suffer."
A DECADE OF CONCERN
the DEA and the FDA have wrestled with the drug since 1999 when a
physician petitioned the DEA to change the classification, citing
increasing reports of abuse. The DEA, after compiling abuse data, in
2004 asked the FDA's Center for Drug Evaluation and Research for a
scientific and medical evaluation.
On March 6, 2008, the FDA
recommended against changing the classification. A year later, on Feb.
13, 2009, the DEA resubmitted its request with new data.
The January hearing is the final step in the FDA's latest evaluation.
year, the Senate unanimously passed a measure offered by Sen. Joe
Manchin, D-W.Va., to elevate the hydrocodone combinations to Schedule II
as an amendment to the Food and Drug Administration Safety and
Innovation Act, but the House did not include the measure in its bill.
DEA's administrator could issue an emergency order that would
reschedule the drugs for two years, as it did when drugs such as K2 and
Spice, synthetic forms of marijuana, emerged as a problem. The DEA
declined to say Wednesday why it had not issued such an order.
the DEA and experts concerned with painkiller abuse are urging quick
action, FDA spokeswoman Morgan Liscinsky defends the pace, and method,
of the deliberation.
"Because this issue would impact millions of
people, it has to be handled carefully and we have to make sure we are
evaluating all the available data we have and make a really informed