FDA Wants Hydrocodone Combo Pain Meds Reclassified

Megan Brooks

November 01, 2013

If the US Food and Drug Administration (FDA) has its way, hydrocodone combination products such as Vicodin (AbbVie Inc) will soon be reclassified from Schedule III to Schedule II, further increasing controls on these opioid painkillers, with a potentially huge impact on providers and patients.

"By early December, FDA plans to submit our formal recommendation package to HHS [US Department of Health and Human Services] to reclassify hydrocodone combination products into Schedule II," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement posted on the FDA Web site October 24.

"We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA [Drug Enforcement Administration] on the appropriate scheduling of these products," Dr. Woodcock said.

Timing "Odd"

The same week the announcement was made, the FDA approved the first single-entity extended-release (ER) formulation of hydrocodone bitartrate (Zohydro ER, Zogenix Inc), as reported by Medscape Medical News.

This approval was "more shocking to me than this announcement," Edward Michna, MD, member of the American Pain Society, told Medscape Medical News.

That these 2 events happened back-to-back is "kind of odd," added Dr. Michna, who is director of the Pain Trials Center at Brigham and Women's Hospital and assistant professor at Harvard Medical School, both in Boston, Massachusetts.

"Zohydro is another drug that doesn't have abuse-deterrent technology; so you have another opioid in high dose that is going to be released [in the midst] of pressure on drug companies to develop abuse-deterrent drugs, but then this gets approved," Dr. Michna noted.

The FDA said Zohydro ER is indicated for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate.

"Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA [long-acting] opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain," the FDA said in a release announcing the approval.

Zohydro ER and other Schedule II drugs can be dispensed only by prescription, and no refills are allowed. Stringent record-keeping, reporting, and physical security requirements are also in place for these substances.

Dr. Michna said rescheduling hydrocodone combination products from Schedule III to II is likely to have a huge impact on patients and providers. "It's the most prescribed drug and there are a lot of issues here and we have to be concerned about that," he said.

"The ease of prescribing is a big controversy. People don't want it to be so easily prescribed and you can make an argument for that," Dr. Michna said. "On the other hand, there is the practical world. You have rural areas where it is hard to see a doctor; you have elderly patients who can't ambulate easily to get to the doctor; and you have the added cost of increasing doctor visits if this means they have to come in and the doctor can't just write a script. The e-prescribing of class II narcotics is not available yet so you don't have that option," he said.

FDA Action "Appropriate"

But Charles E. Argoff, MD, a neurologist with the Albany Medical Center in New York, has a different view. "This FDA action is appropriate scientifically as the potency of hydrocodone, an active ingredient of the most commonly prescribed drug (of any type) in the US, is greater than morphine, an opioid that is a Schedule II substance," he told Medscape Medical News.

Still, Dr. Argoff said, "If this action proceeds to full implementation, it will undoubtedly have effects on clinical practice and patient care. However, at a time when we recognize that we are in the midst of a prescription drug abuse/misuse crisis, we need to move forward in a manner that maintains access to treatments that can help the people we take care of while recognizing that steps need to be taken to minimize the potential and actual harm associated with such treatments," Dr. Argoff said.

The American Pharmacists Association (APhA) is against the rescheduling of hydrocodone combination products from Schedule III to Schedule II, Stacie Maass, senior vice president of Pharmacy Practice and Government Affairs for APhA, told Medscape Medical News.

"We are worried about the impact it will have on patients. Patients have legitimate needs for these medications and we are concerned what it will do to patient access and whether it will truly have an impact on abuse," she said. A Schedule II designation also puts a "heavier" burden on pharmacists, she noted.

Every week, we have patients coming from a different practice saying their doctors are not writing for these drugs anymore. Dr. Edward Michna

Dr. Michna told Medscape Medical News that right now around the Boston area some practices are abandoning writing for controlled substances "because it has just become so burdensome. With the risk involved and regulatory requirements, they are just giving up and a lot of these doctors are retiring and their younger partners are saying we aren't going to do this anymore. Every week, we have patients coming from a different practice saying their doctors are not writing for these drugs anymore."

An "opioid phobia" is occurring right now, Dr. Michna added. "Yes, it's important that we tighten up everything and do the right thing, but some people will be really affected by this. It's the 70-year-old with osteoarthritis of the knee (or whatever) that is depending on these drugs to get some functionality, not the addict, that is being dumped in the street too."

In her statement, Dr. Woodcock said, "Going forward, the agency will continue working with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most."

Dr. Michna has disclosed no relevant financial relationships. Dr. Argoff is consultant and/or independent contractor for Collegium Pharmaceutical, Depomed Inc, Endo Pharmaceuticals Inc, Forest Laboratories Inc, Janssen Pharmaceuticals Inc, Lilly USA LLC, and Pfizer Inc. He has received grant/research support for Endo Pharmaceuticals, Forest Laboratories Inc, and Lilly USA LLC and honoraria from Depomed Inc, Endo Pharmaceuticals, Forest Laboratories Inc, and Lilly USA LLC. He is on speakers bureaus for Allergan Inc, Depomed Inc, Endo Pharmaceuticals, and Lilly USA LLC. He is a stock shareholder for Pfizer Inc. Ms. Maass has disclosed no relevant financial relationships.


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