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The DEA proposal to move hydrocodone combination products from Schedule III to Schedule II could have a major impact on pharmacies.
The Drug Enforcement Administration’s (DEA) proposal to move hydrocodone combination products from Schedule III to Schedule II late last week could have a major impact on pharmacies.
The DEA is asking for public comments on its proposed rule to reschedule hydrocodone combination products, as recommended by the Department of Health and Human Services and “as supported by the DEA’s own evaluation of relevant data”.
“The analysis by HHS and the DEA shows hydrocodone combination products have a high potential for abuse, and abuse may lead to severe psychological or physical dependence,” the DEA wrote in a statement announcing the proposed rule. “Data and surveys from multiple federal and non-federal agencies show the extent of abuse of hydrocodone combination products.”
To demonstrate abuse involved with these products, the DEA pointed out that Monitoring the Future surveys from 2002 through 2011 found that twice as many high school seniors used Vicodin, an hydrocodone combination product, non-medically, as those who used OxyContin, a Schedule II drug that is more tightly controlled.
In addition, abuse of hydrocodone combination products was linked to 82,479 emergency department admissions in 2011, according to the Drug Abuse Warning Network (DAWN). While nationwide estimates of overdose deaths due to hydrocodone combination products cannot be quantified, data from five states shows an increase of 63% in deaths related to hydrocodone combination products from 2004 through 2010, according to the DEA.
The rescheduling of hydrocodone combination products was initiated by a petition from a physician in 1999. The DEA submitted a request to HHS for a scientific and medical evaluation of these products and a scheduling recommendation. In 2013, FDA held a public Advisory Committee meeting on the issue, and the committee voted to recommend rescheduling hydrocodone combination products from Schedule III to Schedule II by a vote of 19 to 10.
Electronic comments must be submitted, or written comments postmarked, on the rescheduling by 11:59 p.m. Eastern Time on April 27. Requests for hearings must be submitted by March 31, the DEA said. To submit electronic or written comments on the proposed rule, visit www.regulations.gov.