FDA Recommending Schedule II Reclassification for Hydrocodone Combination Products

October 25, 2013 04:25 pm Matt Brown

The FDA has announced it will recommend(www.fda.gov) to HHS that hydrocodone combination products be reclassified as Schedule II drugs. These products currently are classified as Schedule III medications. The agency said it will submit a formal recommendation package to HHS by early December.

"We anticipate that the National Institute on Drug Abuse will concur with our recommendation," said the FDA in its announcement. "This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products."

According to Alan Schwartzstein, M.D., of Oregon, Wis., chair of the AAFP Commission on Health of the Public and Science, although the change could be viewed as a burden to prescribers and patients -- requiring that prescriptions be written for no more than 90 days without an option for refill -- the benefits outweigh any potential negatives.

"The AAFP is very concerned about the problem of opiate misuse and pain management, and we are working actively within our organization with the FDA and other organizations to minimize opiate misuse and maximize the treatment of pain relief for our patients," Schwartzstein told AAFP News Now. "We recognize that the lack of ability to write for refills more than 90 days will require that our members more frequently write these prescriptions, but we understand and accept that this is necessary to achieve our goals."

Story highlights
  • The FDA has announced it plans, by early December, to submit a formal recommendation package to HHS to reclassify hydrocodone combination products as Schedule II drugs.
  • Under the reclassification, hydrocodone prescribers will be able to write prescriptions for no more than 90 days without an option for refill.
  • The AAFP is working with the FDA and other organizations to minimize opiate misuse and maximize the treatment of pain relief for patients.

Schwartzstein said the FDA move complements the conclusions published in the Academy's 2012 position paper on the subject of opioid abuse and pain management.

"We want to work with other organizations and with our members to make sure that students and physicians are kept up-to-date on appropriate prescribing of immediate- and long-acting opiates," he said. "It is also important that (physicians) are using (opiates) in the most effective way to manage pain without contributing to misuse of the substances."

According to the National Safety Council(www.nsc.org) (NSC), 45 U.S. citizens die each day from an unintentional overdose of prescription pain medication, and one in every 20 Americans age 12 or older reported using prescription painkillers recreationally in the past year.

Moreover, in its latest report on prescription drug abuse(www.nsc.org), the NSC says only three states adequately address the issue.

Meanwhile, the Trust for America's Health (TFAH) reported in its recent publication Prescription Drug Abuse: Strategies to Stop the Epidemic(healthyamericans.org) that prescription drug-related deaths now outnumber those from heroin and cocaine combined, and drug overdose deaths exceed motor vehicle-related deaths in 29 states and Washington, D.C.

"Misuse and abuse of prescription drugs costs the country an estimated $53.4 billion a year in lost productivity, medical costs and criminal justice costs, and, currently, only one in 10 Americans with a substance abuse disorder receives treatment," TFAH said in the report.

In an interview with AAFP News Now, NSC medical adviser and family physician Donald Teater, M.D., of Clyde, N.C., said he applauds the FDA move and is pleased with the AAFP's affirmative stance on the issue.

"(The schedule change) may present some hardships for a few people, but I think that those should be minor," said Teater. "When you are looking at the overall picture -- where greater than 16,000 people are dying every year from prescription pain medications -- something has to be done. And, because hydrocodone is the most commonly prescribed opioid, it just makes sense to put more controls on it to prevent those accidental deaths."

Teater said he believes the FDA's move will help address the prescription drug misuse issue somewhat, but added that more needs to be done.

"(The proposed schedule change) is certainly not a magic bullet, but it will make some difference," he said. "In the whole area of prescription drug abuse and overdose, there's just not going to be one magic solution, but a whole bunch of small steps like this.

"I think we need to be pleased with every positive step and keep going forward."

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