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Opioid Crisis: Easy Fix

11/02/2017

If too liberal prescribing of opioid drugs, usually oxycodone and hydrocodone, for pain contributed to the opioid crisis, what prevents us from encouraging substitution of safer, and maybe less addictive, buprenorphine? Government over-regulation, that's what.

Most patients taking high doses of bupe for maintenance (MAT) report little effect or "high" from use of the drug. FDA approved the parenteral Buprenex brand decades ago for treatment of pain. The patch form can only be prescribed for chronic pain, not for addiction, and is not an appropriate dose form for acute pain.

European physicians have prescribed the drug for years for acute, post-operative pain, like after a dental procedure, but the lowest dose available here, 2 mg., is too high for that indication. Although physicians can legally prescribe it off label to non-addicts in the U.S. many remain fearful of DEA scruitny, and we would have to cut a 2 mg. Suboxone or Subutex film into about 4-6 pieces to get the appropriate dose.

What stops a pharmaceutical company from making the drug in, say, 0.5 mg. tablets? Regulations. As far as I know a pharmaceutical company would have to start from scratch, spending $millions to obtain approval.

Mr. Trump, if you want to address this emergency, tell your FDA to suspend this requirement and encourage pharma to produce the drug in a dose form suitable for acute post-op pain. Even if it leads to addiction for some, the drug would rarely contribute to an overdose death.