Subutex?

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DLY303

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Hello PharmD's...

This is a question that has come up in class and a place I am shadowing at. Can something like Subutex be prescribed off-label for pain without the additional DEA designation required when it is used for opiate withdrawal?

What are the limits, if any, of prescribing drugs like this off-label? With this particular drug, none of the practitioners in the office knew the answer.
 
Not sure if they can legally or not. I can tell you this pharmacist won't fill it whether it's legal or not. I won't fill for more than a 14 day supply and it's gotta have the correct documentation (DEA correct, I document I checked the website).

With all of the pain meds to choose from, why would someone choose subutex for pain?
 
DLY303 said:
Hello PharmD's...

This is a question that has come up in class and a place I am shadowing at. Can something like Subutex be prescribed off-label for pain without the additional DEA designation required when it is used for opiate withdrawal?

What are the limits, if any, of prescribing drugs like this off-label? With this particular drug, none of the practitioners in the office knew the answer.
Click to expand...

Yes it can


Can Subutex® or Suboxone® be prescribed for conditions other than opioid addiction, e.g., pain control?

Subutex® and Suboxone® have received FDA approval only for the treatment of opioid addiction. However, once approved, a drug product may be prescribed by a licensed physician for any use that, based on the physician's professional opinion, is deemed to be appropriate. Neither the FDA nor the Federal government regulates the practice of medicine. Any approved product may be used by a licensed practitioner for uses other than those stated in the product label. Off-label use is not illegal, but it means that the data to support that use has not been independently reviewed by the FDA. Information on FDA policy regarding off-label use of pharmaceuticals is available on the FDA Web site, http://www.fda.gov/cder/cancer/tour.htm, or http://www.fda.gov/cder/present/diamontreal/regappr/index.htm
​
http://buprenorphine.samhsa.gov/faq.html#A21
 
they told us the physician only needed to be registered with the dea if it was for addiction treatment. I mean, have the special X dea number and all.
 
Shamelessly stolen from my opioid lecture...
sbj01v.jpg

So who knows why they prescribe it for other things, seems like it's **** to me for anything useful. But I'm not on the wards or in a pain clinic so what the hell do I know, why not ask the pain medicine dudes?
 
I think they still need the waiver from the feds to prescribe buprenorphine though, ie an X DEA#. But they can prescribe it for whatever they want once they have the authority.
 
Thanks! You guys are great. I was just curious because off-label prescribing came up in class and then this unique issue at the clinic with this particular drug. I'm sure we will see more of this drug in the future. I had never even heard of it before though.
 
meister said:
I think they still need the waiver from the feds to prescribe buprenorphine though, ie an X DEA#. But they can prescribe it for whatever they want once they have the authority.
Click to expand...

This. In my understanding, it doesn't matter what it's being prescribed for, it's the DRUG that requires the special registration/waiver/DEA, not the INDICATION.

Anyone know for sure?
 
The extra registration ID is for treatment of opioid addiction, not for subutex or suboxone itself.

"DATA 2000 permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act to treat opioid addiction with Schedule III, IV, and V opioid medications or combinations of such medications that have been specifically approved by the Food and Drug Administration (FDA) for that indication. Such medications may be prescribed and dispensed."

If the prescription is written for treatment of addiction, it must have the X-------- number on it. If it is written for pain, it does not need the number. I've seen two Rx's where the physician wrote "for pain" on the hardcopy. The whole purpose of the program is to make sure that physicians are trained in the treatment of addiction before they start handing out drugs. They have to have special certifications and attend additional training to get the number in the first place.
 
Well, they order Buprenex like water at my little joint for pain. They love it up in labor/delivery...and the orthopods use it for post op...

Why? Hell if I know. I always thought it was bizarre...with...you know...actual agonists available. I swear to God that one of the family docs who graduated back in like 1947 rounds with a little stamp that reads "Buprenex™ 1/2-3/4 CC IV q3h PRN PAIN"...wtf is that all about?

But they let anyone use it...of course this is inpatient...a mystical world where physicians can do anything they want that makes no sense...
 
WVUPharm2007 said:
Well, they order Buprenex like water at my little joint for pain. They love it up in labor/delivery...and the orthopods use it for post op...

Why? Hell if I know. I always thought it was bizarre...with...you know...actual agonists available. I swear to God that one of the family docs who graduated back in like 1947 rounds with a little stamp that reads "Buprenex™ 1/2-3/4 CC IV q3h PRN PAIN"...wtf is that all about?

But they let anyone use it...of course this is inpatient...a mystical world where physicians can do anything they want that makes no sense...
Click to expand...

Well according to my chart that was created by some pharmacologist it doesn't really do jacksh*t, and maybe that's the point
 
I think one of the main points is the supposed low potential for abuse.
 
Maybe I just follow the "cookbook" too much, but that treatment sure isn't in the pain management guidelines.

I don't think anybody could convince me that Subutex is appropriate for pain management, I'm still not sure about using it on an outpatient basis at all.
 
Rebel78 said:
Maybe I just follow the "cookbook" too much, but that treatment sure isn't in the pain management guidelines.

I don't think anybody could convince me that Subutex is appropriate for pain management, I'm still not sure about using it on an outpatient basis at all.
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yeah what is its halflife again?? im sure something with a 37 hour half life is easy to dose and self administer for stable concentrations 🙄
 
type b pharmD said:
yeah what is its halflife again?? im sure something with a 37 hour half life is easy to dose and self administer for stable concentrations 🙄
Click to expand...

Check into the success rates of outpatient narcotic addiction treatment, especially outpatient induction. It ain't good. Subutex doesn't correct the main reason someone is hooked on heroin, and you sure can't fix it at home. A stable concentration ain't gonna make somebody get off of heroin addiction.
 
Rebel78 said:
Check into the success rates of outpatient narcotic addiction treatment, especially outpatient induction. It ain't good. Subutex doesn't correct the main reason someone is hooked on heroin, and you sure can't fix it at home. A stable concentration ain't gonna make somebody get off of heroin addiction.
Click to expand...

yeah i was kidding. hence the rolling eyes face.

I know a guy who died from a methadone overdose.. Apparently the respiratory depression effect outlasts the analgesic effect (leading people to take more) I was thinking maybe buprenorphine would cause something similar . Long lasting pain meds (greater than 12 hours) seem inherantly risky to me, since there's such a high potential for people to ignore the directions for use. Wouldnt patients and doctors have an easier time titrating their dose and achieving stable levels with maybe a once or twice daily med?
 
Oh, and y'all don't start with telling me about the form the MD sends in to SAMSHA saying they referred to outpatient counseling when they start a patient on Subutex, doesn't mean a thing. If the MD doesn't followup, it doesn't happen.

We had a 20 year old girl at our store that was on Suboxone for over a year, and I found out she was getting oxycodone at another chain during that time, and who knows what else from off the street. We quit filling for her, and a good friend of mine from the other chain told me she died last year.

Ever wonder why they charge so much for those meds? What is cheaper, an expensive outpatient med, or inpatient induction treatment with long-term counseling? Which would you think is more successful?
 
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