Saturday, May 15, 2010

Opioid Prescribing FDA REMS

Well, it is happening. Because of our failure as physicians to reign in bad prescribing practices someone is going to do it for us. The United States Food and Drug Administration (FDA) is getting ready to implement risk evaluation and mitigation strategies (REMS) for opioid prescribing. Basically they are going to supervise us.

I have written a lot about the problems of opioid abuse and recently about the dilemma of adequately treating chronic pain without causing addiction. The opioids which include Vicodin, Lortabs, hydrocodone, oxycodone, Oxycontin, and morphine are commonly used to treat chronic pain but there clearly has been a pattern of over prescribing. Prescription pill abuse is now the number one drug used by adolescents and those in their early twenties (excluding alcohol and tobacco). Drug overdose deaths have increased five fold since 1990, most of them opioids. And someone has written a prescription of all these drugs that are being abused. Something has to change and the FDA is making sure that is going to happen.

Mandatory training is what is doing to happen. It should. Many doctors are caught between treating pain and avoiding addiction with little knowledge of or help from guidelines. It is a good thing that specific training will be required. Currently there is one opioid, buprenorphine, that can only be prescribed by physicians who have had a required 8 hours of training. Buprenorphine is used as a medication to treat opioid dependent patients long term to reduce risks of hepatitis C, HIV, tuberculosis and other infections and to reduce crime and allow for stable employment in those who are addicted to heroin.

Some people are concerned that any additional requirements by the FDA or the DEA will make it more difficult for pain patients to have access to these opioid medications but I do not think it will be a widespread problem. My biggest concern is precedent. We are doing a poor job now of over prescribing antipsychotic mood stabilizers for children and adolescents. I am very concerned that if we as physicians don't police ourselves here that the FDA might decide to. And that could make it very difficult for many patients to have access to these medications who truly do need them. There is a large number of people who don't want any psychiatric medications prescribed for children. I do not want physicians regulated by non clinicians in the realm of child and adolescent psychiatry but I can see this coming if we don't clean our own house.

Thought for the day

Negotiation with a higher power

"I will demonstrate my immediate obedience provided you comply with my demand for a more satisfying assignment".

Thomas John Carlisle

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