Hydrocodone Put Up For Reclassification By FDA In CrackdownBy: Amanda Crum - October 25, 2013
Hydrocodone has long been on the DEA’s list of drugs that they’d like to see reclassified, which would make it harder to obtain; now, the FDA has agreed, after a ten-year battle by the DEA, to recommend Vicodin and other hydrocodone-based drugs as a Schedule II substance.
“While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” Janet Woodcock of the FDA said.
What does that mean, exactly? For starters, prescription refills will be limited to a 90-day supply rather than the previous five refills within six months, and in some states only a doctor can write a prescription rather than a nurse practitioner. Many doctors are loathe to give a patient a Schedule II drug because of the potential for addiction. That, according to Edward Michna–an assistant professor at Harvard Medical School–will make things harder for patients who genuinely need the pain medication.
“You have to consider the secondary, unintended consequences: patients who are legitimate users who may lose access, or be restricted,” Michna said. “It’s all a balance.”
However, the FDA has seen the widespread, devastating effects that prescription drug addiction can have, and said in a statement that in some states, it has become an epidemic. The group is recommending the classification change by the end of the year.
“By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II. 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 on the appropriate scheduling of these products,” Woodcock said.
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