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FDA/DEA Consider Changing Hydrocodone Products to Schedule II

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The FDA and DEA are considering whether to change products like Vicodin containing hydrocodone from Schedule III to Schedule II as a means of deterring diversion and drug abuse.

A report from the NACDS on January 24, 2013 states:

"An FDA advisory panel will meet Jan. 24 and 25 to discuss regulation of certain painkillers that contain the opioid hydrocodone. Topics considered will include whether to reclassify some of these drugs, such as Vicodin (hydrocodone plus acetaminophen), into a higher category of danger for misuse or abuse. Other opioid painkillers including Oxycontin and Percocet are already classified in the higher category. The DEA requested that an FDA advisory panel undertake the review and would like the painkillers to be moved to the more tightly controlled Schedule II designation from its current Schedule III designation. An FDA spokesman stated the advisory panel would most likely vote on the issue Jan. 25. At press time, NACDS was prepared to testify against reclassification, emphasizing the need for a zero-tolerance for drug abuse and diversion and a 100-percent commitment to maintaining access to pain medications for legitimate patient-care needs."

The whole story is at: http://consumer.healthday.com/Article.asp?AID=672792.

Is this a necessary step or overkill? What do you think?

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joegreiner's picturePharmacistjoegreinerJoined: Feb, 2013
Location: New Buffalo, MI
Posts: 1

There are 13 yr olds in rehab for vicodin addiction. Why is there so much of this so readily available?

jessevivian's picturePharmacistjessevivianJoined: Jul, 2011
Location: Detroit, MI
Posts: 25

Here's another take on this story that appeared in the 1/25/2013 edition of the FDA SmartBrief:

"An FDA panel was set to this week to consider reclassifying hydrocodone-containing products from Schedule III to Schedule II drugs. "Even if we change hydrocodone-containing products from Schedule III to Schedule II, it in no way jeopardizes access. What this means is that patients who might be able to go to their doctor every six months would now have to see their doctor every three months [to get a prescription]," said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing.

It seems inconsistent to say that access will not even be affected if hydrocodone products are changed from Schedule III to Schedule II given that Schedule II drugs cannot be refilled whereas Schedule III drugs may be refilled up to five times within 6 months from the date a prescription is issued. As one reader pointed out, oxycodone is already a Schedule II drug and the abuse of it is also rampant. Will a simple change in scheduling bring about any desirable difference or simply make access more inconvenient for those patients who have legitimate need for pain medication?

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katrph91's picturePharmacistkatrph91Joined: Oct, 2012
Location: Ann Arbor, MI
Posts: 83

Overkill and an exercise in futility. Oxycodone is schedule II, yet the misuse and overprescribing of this drug is rampant.

Regarding hydrocodone products, they may consider reducing the time frame that the prescription remains valid after it is issued, but even that likely would not have a major impact on the problem at hand.