FDA might tighten reins on Vicodin

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.

The agency 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.

A 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.

For 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 prescription.

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 request.

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.

The DEA counters that abuse, trafficking and diversion of the drug have grown since its first request, causing a "devastating effect" on public health.

"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 abuse.

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 doctor.

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 security.

"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 problem."

Ed Michna, an assistant professor at Harvard Medical School who is board-certified in anesthesia, pain and palliative care, 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.

"The 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

Doctors, 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.

Last 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.

The 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.

Though 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 evaluation."