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Can MD's legally prescribe Subutex "off label" for chronic pain?

I have been on Buprenorphine for almost 8 years (8mg/twice daily/sublingually).  My doctor informed me out of the blue that a "drug rep" informed him that it was illegal for him to be RX'ing this drug without special "addiction" certification.  I have researched this topic for years, and as far as I can tell;  as long as the prescribing doctor is certified to prescribe Schedule III or above narcotics, they may prescribe Buprenorphine for PAIN ONLY provided that they indicate this in their notes as the primary reason for the RX.  My doctor is close to retirement, and it would seem that he is unwilling to further examine the actual laws regarding this "miracle" drug...and I can hardly blame him....if it means he will have to register as someone who prescribes this drug and have heroin junkies flooding his office with calls.  I have had immense success with this drug for long-term extreme chronic pain management, and extremely risky and varying success with the traditional (in US) hard-core opioids.  I want to arm my doctor with CORRECT information regarding his legal right to prescribe this medicine "off label".  I need someone who really knows these laws to answer please.  Thanks!
2 Responses
547368 tn?1440541785
Hello and Welcome,

Please excuse my tardy response. I hear your concern - and the fear that many of our PCP and PMP now face.

I am not an expert on the laws of opiate RX. I know a bit through research and my PMPs educating and opinions. The drug rep is correct. Physicians require additional education to safely RX opiates according to the DEA.

Around 2009, 2010 the FDA approved the Buprenorphine for Chronic Pain use.  Buprenorphine comes in two forms: Subutex, which is composed of only buprenorphine, and Suboxone, which is a combination of Buprenorphine and Naloxone. It's my understanding that a physician requires even more education when ordering either of these drugs than the usual opiate education. The medical documentation required is even more stringent. Indeed it's now even more difficult to find a physician that will order Buprenorphine. The DEA is breathing down their necks.

The following link may help you - though it does talk more about using Buprenorphine for addiction than Chronic Pain. It's my understanding through years of reading and researching this topic - that the same laws apply for RX rather it's for Chronic Pain or Addiction. Here's the link:

http://www.albop.com/Suboxone%20for%20addiction%200714.pdf

This should link you to a PDF file - so if the link doesn't work please let me know.

I understand your PCP concern in ordering Buprenorphine. The regulations are tight - even tighter than they are for most Schedule III drugs. As I'm sure you know the climate in opiate therapy has changed greatly the last several years - for the negative. Many of us have had our opiates reduced or in some instances, discontinued. It's a sad situation and one not likely to be corrected soon.  

It's also my understanding - again after much reading and research and consultation with my current PMP - that physicians that follow the governmental guidelines and prescribe responsibly are really not in serious jeopardy. These responsible physicians rarely are even audited by the DEA and licenses are not lost. It's the physician that fails to keep good records or repeated fails to follow the guidelines are red flagged - and face serious consequences from the government. I could provide you with links to articles if I did a bit of searching for them again. I don't think it would help your situation.

I doubt that your close-to-retirment PCP will be inclined to to seek further education including learning the regulations and documentation requirements to prescribe Buprenorphine. This is not a comfortable position for a physician - especially one that is looking at retirement. I wish I had better answers for you. I don't think there is any information that will change your PCPs position. Why? It's not such an easy task to be approved to prescribe Buprenorphine and follow all the requirements associated with it. Buprenorphine prescribing comes with great responsibility and increased risk over that of other opiates.

That's my opinion. I've been here since 2008 and have heard many similar situations to yours. Sadly many Chronic Pain patients have been forced to change from whats been effective for them -Buprenorphine -  to an untried and sometimes not so effective opiate. My heart goes out to you. I do get it! My opiates were changed drastically.

I hope I've offered something that will be helpful to you. I apologize if I have not been very hopeful. I just have not seen/heard good outcomes in situations similar to yours. I hope you'll be the one that will break the trend. Please let us know how you are doing. I'll look forward to hearing more from you. Please keep in touch - and best of luck.

Take Care,
~Tuck

Avatar universal
Hey there! So this is a late reply, but I just read your post. The above reply is COMPLETELY incorrect.  You are correct. Any doctor with M.D. after their name can prescribe Subutex only, not Suboxone for pain. I am in the same predicament you are in, although I only take 6mg/day. My PCP wanted no part of pain rx and referred me to a Pain Mgmt. Dr. who has prescribed it to me for one year and is now threatening to cut me off because I’ve had no “recent” epidural injections.  This leads me to believe he only cares about how much money he can make off of me. Anyway, I hope you get my msg and reply to let me know what you ended up doing.           Best, A
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