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I think the FDA made a number of errors, the first one by not including pharmacists in the overall REMS process and by limiting the REMS guidelines to ONLY extended released opiates. I haven't viewed IMS data lately but I bet the usage of Oxycontin is still trending downward since the formulation change 2.5 years ago. I would also bet the usage of OXYcodone IR 30 mg tablets in particular, is trending upward since the change.
Most Oxycontin abusers are looking to convert the extended release properties of the drug into an immediate release formulation. The FDA did not include IR Oxycodone products in the REMS guidelines. The addicts are still dying from opiate overdoses and the FDA chose not to address the formulation of Oxycodone that's doing it. They actually made it easier because many abusers ask their physician for Oxycodone IR 30 mg in place of the extended release Oxycontin. All the FDA needed to do was ask a community pharmacist.
I enjoyed your article and thanks for your insight.
Dan Long, R.Ph.
Cherry Hill, NJ
Back to The FDA’s REMS Misstep »
Nicely done. A tragic event but as you said, perhaps awareness and education will prove to be lifesavers.
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