Rescheduling Hydrocodone

Oct. 19, 2011— -- About 12 years ago, the Drug Enforcement Administration (DEA) took under consideration a public petition to reclassify hydrocodone combination products (Vicodin, Lortab, and Norco, for example) from schedule III to schedule II drugs -- attempting to put them in a more tightly regulated category that's already home to almost all other opioid painkillers, including oxycodone (OxyContin) and morphine.

Today, the DEA and the Department of Health and Human Services -- via the FDA -- are still reviewing that request.

It's not clear why the process has gone on so long, but researchers close to the situation say the FDA has been slow to complete its part of the review.

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Some speculate that could be attributable to the agency's ties to pain advocacy groups like the American Pain Foundation. The agency said it is taking into account the potential for unintended consequences of rescheduling, such as decreased access to pain medication, as it makes its final recommendation to DEA.

"Areas of mutual concern [between the DEA and FDA] are the negative effects that additional controls will have on patients in acquiring this essential medicine, and whether hydrocodone's contribution to the problem of prescription drug abuse can be meaningfully reduced by restricting patient ease of access," FDA spokesperson Shelly Burgess said in an email.

But Dr. Andrew Kolodny, chair of the psychiatry department at Maimonides Medical Center in Brooklyn, N.Y., said the criteria for determining scheduling set forth in the Controlled Substances Act relate only to abuse potential and other biochemical properties.

"Access issues are not part of the Controlled Substances Act," Kolodny said. "The decision should be based purely on qualities inherent in the drug."

Multiple studies have shown that hydrocodone is just as addictive as its opiate cousins oxycodone, heroin, and morphine.

At the same time, national data have revealed that hydrocodone-related emergency room visits have been on the rise, and the latest figures from the Substance Abuse and Mental Health Services Administration show a clear trend in first-time use: Far more people report having their first opioid encounters with hydrocodone than with oxycodone -- effectively making it the "gateway" drug into potential opioid addiction.

Researchers say that's probably because it's much easier to obtain, given its lax scheduling.

"Obviously not everyone [who uses hydrocodone recreationally] is going to become addicted," Kolodny said. "But if you want to get the opioid epidemic under control, start by [diminishing the pool]."

Still, the FDA maintains that "abuse indicators show that hydrocodone product abuse is not at the same level as oxycodone, fentanyl, methadone, and other Schedule II drugs," Burgess said.

Several groups have launched efforts to push the re-scheduling along. Last month, the American Society of Addiction Medicine sent a letter to FDA commissioner Dr. Margaret Hamburg urging the agency to up-schedule hydrocodone products -- though the group has not yet received a response.

Around the same time, New York state senator Kemp Hannon introduced a bill to move hydrocodone combo products to a schedule II drug in that state.

The actions came on the heels of a massacre at a Long Island, N.Y., drugstore in which four people were killed as the perpetrator ran off with thousands of hydrocodone pills.

Ultimately, up-scheduling would impose harsher punishment for possession, and would toughen restrictions on prescribing. Currently, hydrocodone combo products are lumped in with agents such as anesthetics and anabolic steroids, and prescriptions can even be called in over the phone.

Hydrocodone alone is a schedule II drug, but it almost always appears in combination with acetaminophen, as the well-known Vicodin, Norco, and Lortab. Researchers say that 40 years ago, the DEA put the drug into the lower class because it figured patients wouldn't want to use too much and risk liver injury, an established side effect of acetaminophen -- but they say that hasn't been the case.

There's currently no time frame for the official re-scheduling of hydrocodone products; some question whether another 12 years will go by before any action is taken.