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Restricting Vicodin is the wrong Rx

Reclassifying it and other such drugs could make it hard for those with chronic pain to get relief.

January 21, 2013
(Robert Neubecker / For Time…)

More than 1 million Americans visit an emergency room each year because of prescription drug abuse, and the toll has been rising steadily since 2004. The U.S. Drug Enforcement Administration thinks it has an idea that will help: Reclassify the pain reliever Vicodin and other medications containing hydrocodone as Schedule II drugs, the most restrictive category for pharmaceuticals with accepted medical uses.

The suggestion was turned down by the U.S. Food and Drug Administration in 2008, but DEA officials believe that the signs of increasing abuse call for another look. In 2004, close to 38,000 people landed in the emergency room after overdosing on hydrocodone. By 2008, the number had risen to about 89,000, and in 2010, it reached 115,739, according to the Substance Abuse and Mental Health Services Administration.

Frightening numbers indeed. But as an FDA advisory committee deliberates on the matter this week, it must also take into consideration the tens of millions of people who receive Vicodin and similar prescriptions each year without becoming emergency room patients, and the problems they would have obtaining medication that provides welcome relief from moderate to severe pain. The benefits of having hydrocodone more readily available to those who need it appear for now to outweigh the toll of its misuse. Though that picture might change if hydrocodone abuse continues to increase, for now the FDA should continue to classify it as a less tightly restricted Schedule III drug.

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Oxycodone, another widely abused narcotic painkiller, is classified as a Schedule II drug. Hydrocodone is considered to be about as addictive, but it is far less likely to be abused. According to the FDA, about 47 million people obtain hydrocodone prescriptions each year, more than three times the number who use oxycodone. Yet tens of thousands more emergency room visits are made by those using oxycodone, and the number of such visits has been rising much more quickly than for hydrocodone overdoses.

Meanwhile, according to an FDA report, the regulations involved in reclassifying hydrocodone as Schedule II would make it harder for patients in pain to receive the medication they need. The rules vary from state to state, but in some states prescriptions for Schedule II drugs may be written only by a physician, while a nurse practitioner or physician's assistant could prescribe a Schedule III drug. (In California, the rules about who can prescribe are the same for both categories.) Because of restrictions on how a Schedule II drug may be prescribed, patients seeking refills must visit the doctor twice as often. Some pharmacies don't carry Schedule II drugs.

Those restrictions could create serious obstacles for people in chronic pain. Also, regulations covering record-keeping and storage of Schedule II drugs by manufacturers and distributors are far more extensive, which might result in higher prices.

A reclassification might prompt doctors to switch to drugs that are less appropriate for their patients, the FDA report says. They might choose medications that cannot control the pain or that can have more serious side effects for certain people. Or they might write more prescriptions for other Schedule II drugs, such as oxycodone, with higher chances of abuse.

The FDA report said there was little if any evidence that moving Vicodin and related painkillers to the more restrictive category would lead to less abuse. That makes sense; oxycodone's classification as a Schedule II drug hasn't kept abuse from escalating at an even faster clip.

There appear to be more effective ways to curb narcotic painkiller abuse. As the Los Angeles Times' investigative series "Dying for Relief" pointed out, California has an underutilized database that tracks prescriptions for frequently abused drugs, including both hydrocodone and oxycodone. It can be used to find addicts who go from doctor to doctor to obtain multiple prescriptions and the doctors who regularly prescribe questionable amounts of addictive drugs. For now, a better solution would be more effective enforcement using the tools that government already has, rather than placing more restrictions on a popular and useful painkiller.

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