Use of IM Buprenex

Buprenorphine Post
sdaviss
Posts: 49

Postby sdaviss » Tue Mar 16, 2004 4:40 am

I talked with the head of Pharmacy at our hospital, who did some research and spoke with a friend of his at DEA.

He initially said:
<<The CFR 1307.40 (at home now or I'd cite the exact section) clearly states that as long as the detox is SECONDARY to another medical problem then the institution may treat the patient with appropriate pharmacotherapy for detox. The doses must be given out by the pharmacy one day at a time and the total dose for that day only. NO outpatient prescriptions given to take home. >>

My response:
<<This is all true. However, I believe that the regs state that if one is admitted for some primary reason, and the need for detox is secondary, that the opiates used to detox are NOT limited to only those which are INDICATED for detox, but can be ANY narcotic. Thus, it does not have to be only methadone or SUBLINGUAL buprenorphine, but can also be other opiates, including INTRAMUSCULAR buprenorphine.>>

And finally from him again:
<<Steve, I spoke to my friend at DEA, they now reference 21CFR1300-1310 (dated 1 April 2003) and 21USC829 Section 301-309,353...and little change from what I told you EXCEPT that the reg discusses narcotics in general and therefore Buprenex could be used... The main point, DETOX must be secondary....and may be done as long as patient is in the hospital. (with some other primary diagnosis). No outpatient Rx's permitted for detox. Must coordinate admission to detox program somewhere...>>

I added the links to the codes for those who want to check it out. Some seems to apply more for manufacturers:
[url="http://www.deadiversion.usdoj.gov/21cfr/cfr/2100cfrt.htm"]21 CFR 1300[/url] DEFINITIONS
[url="http://www.deadiversion.usdoj.gov/21cfr/cfr/2104cfrt.htm"]21 CFR 1304[/url] RECORDS & REPORTS
[url="http://www.deadiversion.usdoj.gov/21cfr/cfr/2106cfrt.htm"]21 CFR 1306[/url] PRESCRIPTIONS
[url="http://www.deadiversion.usdoj.gov/21cfr/cfr/2107cfrt.htm"]21 CFR 1307[/url] MISCELLANEOUS
[url="http://www.deadiversion.usdoj.gov/21cfr/cfr/2116cfrt.htm"]21 CFR 1316[/url] ADMINISTRATIVE PROCEDURES
[url="http://www.deadiversion.usdoj.gov/21cfr/21usc/829.htm"]21USC 829[/url] CONTROLLED SUBSTANCE ACT (I couldn't figure out what Section 301-309, 353 was)

BOTTOM LINE (needs to be confirmed): i.m. bup should be OK for detox in hospital setting *if* one documents a primary admitting diagnosis different from "detox" and refere for follow-up care. I don't know if "vomiting", "dehydration", or "hypertension" are acceptable in this situation, but have not heard or seen otherwise.

=Steve Daviss MD
=Baltimore

mgh63
Posts: 29

Postby mgh63 » Tue Mar 16, 2004 4:40 am

PS: We did stop using it(IM Buprenex) at Md Gen'l Hosp in Balto as that hospital did not need any more trouble at this time. I am furious about this turn of events as as soon as JCAHO is over I intend to pursue the issue. Makes no sense whatsoever. MGH

mgh63
Posts: 29

Postby mgh63 » Tue Mar 16, 2004 4:40 am

Idmcrook's experience is absolutely chilling. Everyone in Baltimore from Hopkins to Univ of Md and several of the rest of us have used IM Buprenex for in patient withdrawal for a number of years. I knew that there were some precautionary words at some of the trainings but had no idea that they would go after us if we were not in danger of playing some role in diversion. There have been and probably still are some practitioners who have written prescriptions for Buprenex (and had them filled) some of those written well intended and others with fraud in mind. It is not a wise or safe practice. I intend to find out why the feds especially CESAT would be upset about the use of Buprenex in hospital settings. While I did use it in the ambulatory detox setting for a long time and initially when no other product was available I now use only Suboxone. I changed for clinical reasons not for worry or fear of the DEA. Are we going to return to the 1920's? Sad and scary state of affairs. And you wonder why more MD's aren't flocking to treat drug dependent patients!

ldmcrook
Posts: 23

Postby ldmcrook » Tue Mar 16, 2004 4:40 am

In my case the concern was inpatient since none of my colleagues are doing any outpatient detox. Most of their patients are admitted to our psych unit with a primary diagnosis other than opiate dependence. As I understand it, opiate dependent patients admitted to a hospital for any other reason can be treated with an approved drug while in the hospital. Now that LAAM is off the market the only approved drugs are methadone and sl buprenorphine. My advice would be to contact a DEA field office and ask.

sdaviss
Posts: 49

Postby sdaviss » Tue Mar 16, 2004 4:40 am

Did the DEA seem to be concerned only with *outpatient* i.m. bup, or was it also inpatient? The standard of care in our area has become to use i.m. bup for pts needing detox who are admitted to medical units for medical problems. If the DEA is concerned about this, there needs to be a larger discussion of the nature of their concerns.

=Steve Daviss MD

ldmcrook
Posts: 23

Postby ldmcrook » Tue Mar 16, 2004 4:40 am

I had the experience of having an unannounced inspection from the DEA this past week. It seems there has been a directive to start checking on buprenorphine providers. One of the questions was whether anybody here (psychiatric dept in a tertiary hospital) was using any IM Buprenex. I/we don't, but the agent said that if anybody is using it for detox or maintenance they should stop immediately "or they will lose their license". Doesn't seem worth the risk now that Suboxone/Subutex is available.


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