Federal government must find alternatives to rescheduling hydrocodone combination drugs

FDA intends to recommend CII scheduling for drugs like Vicodin in December

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

The desire to combat abuse and misuse of prescription drugs — now a worse problem in the United States than cocaine or heroin — is laudable, but unlike those two drugs, hydrocodone has a legitimate use as a painkiller, and it's the people who are using it properly and legally who will end up losing.

Most opioid painkillers are already Schedule II drugs, including Purdue Pharma's OxyContin (oxycodone) extended-release tablets and Johnson & Johnson's Duragesic (fentanyl) patch, as well as single-entity hydrocodone products like Zogenix's recently approved drug Zohydro ER. But some drugs that combine a low-dose opioid with another analgesic, including AbbVie's Vicodin (hydrocodone; acetaminophen) and J&J's Tylenol with Codeine, are still Schedule III.

For the Drug Enforcement Administration's purposes, the distinction between CII and CIII is that the former indicates a much higher potential for abuse and dependence than the latter. But for patients who need those drugs, it's an even bigger difference. Under federal law, a prescription for a CIII drug is good for up to six months or five refills, whichever occurs first. But a CII drug cannot be refilled; instead, the physician must write multiple prescriptions to be filled sequentially over a period of up to 90 days.

For patients who suffer from chronic pain, it should be obvious why rescheduling such drugs as Vicodin could be a problem. It would also represent a change from the FDA's previous resistance to rescheduling hydrocodone combination drugs, in contrast with the DEA's push for it.

The DEA has a point. According to the National Institute on Drug Abuse, part of the National Institutes on Health, Vicodin was the most-abused drug among 12th graders after marijuana. But if the interest is in preventing abuse and misuse, there are alternatives to stricter laws. The National Community Pharmacists Association had a better idea when it suggested electronic prescription drug monitoring and tracking systems. Tamper-resistant features similar to the ones now on OxyContin and Opana ER would also help to discourage abuse.


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