Belbuca

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I’ve been seeing a lot of patient on Belbuca for chronic pain.

1. do you guys think belbuca is more efficacious or lower risk than just using conventional opioids for chronic pain.

2. I’ve seen some people prescribing big doses of Belbuca, and concurrently prescribing immediate release oral opioids for breakthrough pain. Am I right in thinking these IR opioids aren’t really doing anything?

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1. Yes, lower risk. Possibly more efficacious due to less OIH and less supratentorial effects but not clear
2. It's unclear. The question is primarily about off-target effects, as my patients report efficacy with IR agents as PRNs. I normally lean more on atypical PRNs such as tramadol/tapentadol so I feel better from a PK/PD perspective. The basic science just suggests Oxy/Hydrocodone/Hydromorphone shouldn't really compete too well with buprenorphine
 
1. Yes, lower risk. Possibly more efficacious due to less OIH and less supratentorial effects but not clear
2. It's unclear. The question is primarily about off-target effects, as my patients report efficacy with IR agents as PRNs. I normally lean more on atypical PRNs such as tramadol/tapentadol so I feel better from a PK/PD perspective. The basic science just suggests Oxy/Hydrocodone/Hydromorphone shouldn't really compete too well with buprenorphine

I get warnings from our EMR for butrans + tramadol. I think seratonin syndrome, agree?
 
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1. Definitely think it is lower risk. Buprenorphine and tapentadol are my first choices if I am using opioids, this is almost always patients coming to me on opioids that I convert.

2. What is big doses? Addiction will often go up to 24mg of buprenorphine via suboxone. Belbuca is dosed in mcg. There is receptor availability for IR opioids even if on bupe, even at higher doses. This is a fairly common scenario post-op for people on suboxone. We add oral dilaudid and it doesn't work as well, but they still notice some benefit.
 
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How do u convert 3 norco 10/325 per day to belbuca?
 
For acute pain I understand adding IR opioids. But how about a chronic pain patient, you have them on Belbuca, up to 900mcg, and now your adding 30 or 60 Percocet or oxycodone or whatever a month for breakthrough pain? I don’t understand the rationale for even using Belbuca in this scenario.
 
The serotonin syndrome risk is a class effect of opioids in general, but Tramadol, Tapentadol, Fentanyl, and Methadone are bigger culprits. Buprenorphine has been implicated but generally more from Suboxone than the buprenorphine doses available for chronic pain.

The anesthesia literature argues that Suboxone 16-24 mg is the point where most full agonists are going to be ineffective, so with the lower doses, you should be able to get some effect. I agree that it does appear efficacious.

I primarily try to use buprenorphine as the sole agent. I've had some patients use it as a PRN but the cost is prohibitive with Belbuca, so I generally use off-label Suboxone.
 
I try to use it as first line whenever I can. It seems to work fairly well for a lot of patients especially with neuropathic pain. Low dose short acting for breakthrough doesn’t seem to be an issue at all. The main issues I have is insurance coverage as well as it not showing up consistently on UDS but that is because it has to be tested at a really low cutoff (around 1-3ng/ml I believe) and a lot of labs don’t offer that. They typically test at cutoff levels expected more in line with someone on suboxone. Many insurances want them to have failed MS Contin, OxyContin, and Fentanyl. Makes absolutely zero sense as it is a schedule 3 but I guess that’s the game we must play like everything else in medicine.
 
I try to use it as first line whenever I can. It seems to work fairly well for a lot of patients especially with neuropathic pain. Low dose short acting for breakthrough doesn’t seem to be an issue at all. The main issues I have is insurance coverage as well as it not showing up consistently on UDS but that is because it has to be tested at a really low cutoff (around 1-3ng/ml I believe) and a lot of labs don’t offer that. They typically test at cutoff levels expected more in line with someone on suboxone. Many insurances want them to have failed MS Contin, OxyContin, and Fentanyl. Makes absolutely zero sense as it is a schedule 3 but I guess that’s the game we must play like everything else in medicine.
As in, your patients don’t need short acting when on Belbuca. Or do you mean those that use short acting opioids seem to get good relief even while I’m Belbuca.
 
As in, your patients don’t need short acting when on Belbuca. Or do you mean those that use short acting opioids seem to get good relief even while I’m Belbuca.

Those that use shorting acting get relief in conjunction with belbuca. But Tramadol and Tylenol #3 is pretty much what I stick to. For "breakthrough" pain....
 
The serotonin syndrome risk is a class effect of opioids in general, but Tramadol, Tapentadol, Fentanyl, and Methadone are bigger culprits. Buprenorphine has been implicated but generally more from Suboxone than the buprenorphine doses available for chronic pain.

The anesthesia literature argues that Suboxone 16-24 mg is the point where most full agonists are going to be ineffective, so with the lower doses, you should be able to get some effect. I agree that it does appear efficacious.

I primarily try to use buprenorphine as the sole agent. I've had some patients use it as a PRN but the cost is prohibitive with Belbuca, so I generally use off-label Suboxone.


Any concerns about the DEA? I would also use suboxone over belbuca due to cost, but concerned re DEA persecution for writing suboxone for pain vs belbuca . (Despite it being the same active molecule)
 
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off topic a bit but CVS/Walmart/walgreens refuse to fill suboxone prescriptions without a DEA-x license.
For several months, they refused to fill belbuca without a DEA-x license as well.

Humana covers belbuca without zero issues or PA.
 
Any concerns about the DEA? I would also use suboxone over belbuca due to cost, but concerned re DEA persecution for writing suboxone for pain vs belbuca . (Despite it being the same active molecule)
This is an issue. A DEA agent once gave a lecture to our pain society stating that suboxone should not be used off-label for pain. In fact, if you have an x- designation on your license, you have to keep your suboxone charts separate and readily accessible to the DEA at all times. The office notes cannot mention anything about treating pain and have to have elements related to opioid dependence like cravings, etc.
 
This is an issue. A DEA agent once gave a lecture to our pain society stating that suboxone should not be used off-label for pain. In fact, if you have an x- designation on your license, you have to keep your suboxone charts separate and readily accessible to the DEA at all times. The office notes cannot mention anything about treating pain and have to have elements related to opioid dependence like cravings, etc.

thank you for the input.

i do think the DEA is going about this all wrong. generic bup should be firstline long acting opioid, before MS Contin, oxy, etc.
 
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This is an issue. A DEA agent once gave a lecture to our pain society stating that suboxone should not be used off-label for pain. In fact, if you have an x- designation on your license, you have to keep your suboxone charts separate and readily accessible to the DEA at all times. The office notes cannot mention anything about treating pain and have to have elements related to opioid dependence like cravings, etc.

Is it the same for bup?
 
you do not need an x waiver for butrans and belbuca buprenorphine rx for chronic pain; its is on their company websites I believe
 
thank you for the input.

i do think the DEA is going about this all wrong. generic bup shOuld be firstline long acting opioid, before MS Contin, oxy, etc.
Agreed. It’s the safest opioid in terms of adverse risk profile.
 
No just suboxone (SL bup)

I'm embarrassed that I don't know this, but you're saying the DEA only has issues with you writing suboxone for pain, but the DEA is okay if you write for just generic buprenorphine specifically for pain only? (not addiction)

X-waiver still required if writing bup for pain only?
 
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I'm embarrassed that I don't know this, but you're saying the DEA only has issues with you writing suboxone for pain, but the DEA is okay if you write for just generic buprenorphine specifically for pain only? (not addiction)

X-waiver still required if writing bup for pain only?
No. They have issues with practitioners writing for SL buprenorphine that is FDA approved for opioid dependence. This applies to long acting injectable (sublocade) and implantable pellet (probuphine) formulations that require an X waiver and are also indicated for MAT. I’m not sure I understand your question as transdermal buprenorphine (Butrans) is also generic and is indicated for chronic pain.
 
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Im an NP; don’t have x license.
When I write for any form of buprenorphine (Belbuca, Suboxone, Butrans, etc) I specify the diagnosis code and add “for pain, not addiction” on the script. No issues, fwiw. Indiana.
 
Im an NP; don’t have x license.
When I write for any form of buprenorphine (Belbuca, Suboxone, Butrans, etc) I specify the diagnosis code and add “for pain, not addiction” on the script. No issues, fwiw. Indiana.
That's the pharmacy letting you get away with writing for the suboxone off label for pain. If the DEA decides to audit your prescriptions for suboxone, they can come into your clinic and ask to see the charts for your suboxone patients. I’m not sure they are going to accept off label use for pain as the rationale to write this. In the end, it’s your license.
 
No. They have issues with practitioners writing for SL buprenorphine that is FDA approved for opioid dependence. This also applies to long acting injectable (sublocade) and implantable pellet (probuphine) formulations that require an X waiver are also indicate for MAT. I’m not sure I understand your question as transdermal buprenorphine (Butrans) is also generic and is indicated for chronic pain.



Regarding your answer. Butrans might be generic but it is still very expensive for most patients. Belbuca is really expensive as well.

I would like to write for generic SL buprenorphine for pain without getting in trouble with the DEA. It is the same molecule as Butrans and Belbuca, but is far less expensive.

I'd prefer to start with SL buprenorphrine when I need to start a patient on a long acting opioid, but not at the cost of getting into trouble with the DEA.

Lately I've been writing for a lot of belbuca.....but only on patients with the right insurance, and only because I don't want any DEA hassles.

I'd prefer to skip belbuca and just start with SL buprenorphine, because once patients have tasted ER morphine/oxycodone it's very difficult to get them to accept buprenorphine.
 
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Usually it is pretty easy for a patient to get a diagnosis of uncomplicated opioid dependence to prescribe the suboxone for if thinking of it more as for pain. This has gotten it covered for me. It would be nice if there wasn't such push back from insurance companies to do full agonist first. I don't know how many times I have sent in that I don't think starting my 80y old patient on methadone/fentanyl/MS contin/Oxycontin first is a good idea.
 
Usually it is pretty easy for a patient to get a diagnosis of uncomplicated opioid dependence to prescribe the suboxone for if thinking of it more as for pain. This has gotten it covered for me. It would be nice if there wasn't such push back from insurance companies to do full agonist first. I don't know how many times I have sent in that I don't think starting my 80y old patient on methadone/fentanyl/MS contin/Oxycontin first is a good idea.


Agree. In those patients you can get it covered (even though in your mind you're writing it mainly for pain).

But that is patients with opioid dependence. I'm looking for ways to start patients on generic SL bup (in patients that haven't been on other opioids chronically), without getting into trouble with the DEA.

I usually start with the same stuff you guys do, tramadol, cymbalta, gaba, lyrica, elavil, etc. I try everything to avoid a true opioid.

For the right patient I will start someone on low dose bid norco, but if they need more coverage than that, I'd rather go from norco to SL bup next, instead of TID/QID norco/percocet, and certainly before writing for oxycontin, MS contin, methadone, fentanyl.
 
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Agree. In those patients you can get it covered (even though in your mind you're writing it mainly for pain).

But that is patients with opioid dependence. I'm looking for ways to start patients on generic SL bup (in patients that haven't been on other opioids chronically), without getting into trouble with the DEA.

I usually start with the same stuff you guys do, tramadol, cymbalta, gaba, lyrica, elavil, etc. I try everything to avoid a true opioid.

For the right patient I will start someone on low dose bid norco, but if they need more coverage than that, I'd rather go from norco to SL bup next, instead of TID/QID norco/percocet, and certainly before writing for oxycontin, MS contin, methadone, fentanyl.

I guess you have to do what you feel comfortable with. I haven't started someone on opioids with the intention to use them chronically for chronic pain that wasn't already on them in a long time. I find it hard to believe that the DEA would crack down on some well meaning pain doctor with a handful of appropriately selected patients on off-label use of suboxone. I actually find it very hard to get covered if there is not some type of opioid dependence diagnosis.
 
I guess you have to do what you feel comfortable with. I haven't started someone on opioids with the intention to use them chronically for chronic pain that wasn't already on them in a long time. I find it hard to believe that the DEA would crack down on some well meaning pain doctor with a handful of appropriately selected patients on off-label use of suboxone. I actually find it very hard to get covered if there is not some type of opioid dependence diagnosis.

Good point. Insurance coverage is always a concern. Though I spoke with a pharmacist who tells me you can get #30 2mg bup tabs for $25 with a discount card, paying in cash. If the patient cuts those in half its like the max dose of the 900mcg belbuca, but for $25 instead of $900. Much easier for the average patient to pay for.

Economically, I think the generic bup tabs make much more sense than butrans/belbucca. Pushback on those from patients is about cost 90% of the time, (if they weren't on standard opioids previously).

This why I pose the question about writing generic bup for pain to the board here. I haven't been doing that, but I'd like to. In my current position, I'm seeing patients early before they get screwed up by other physicians, so I'm trying to limit harm by starting them on generic bup instead of oxycontin/MS contin, fentanyl, etc.

Anyone else think the DEA would hassle me about writing generic bup (not suboxone) off label for pain?
 
Good point. Insurance coverage is always a concern. Though I spoke with a pharmacist who tells me you can get #30 2mg bup tabs for $25 with a discount card, paying in cash. If the patient cuts those in half its like the max dose of the 900mcg belbuca, but for $25 instead of $900. Much easier for the average patient to pay for.

Economically, I think the generic bup tabs make much more sense than butrans/belbucca. Pushback on those from patients is about cost 90% of the time, (if they weren't on standard opioids previously).

This why I pose the question about writing generic bup for pain to the board here. I haven't been doing that, but I'd like to. In my current position, I'm seeing patients early before they get screwed up by other physicians, so I'm trying to limit harm by starting them on generic bup instead of oxycontin/MS contin, fentanyl, etc.

Anyone else think the DEA would hassle me about writing generic bup (not suboxone) off label for pain?

I cannot speak for the DEA, but if reviewing for them, I would not hassle for appropriate pain care using bupe in any form.
 
Regarding your answer. Butrans might be generic but it is still very expensive for most patients. Belbuca is really expensive as well.

I would like to write for generic SL buprenorphine for pain without getting in trouble with the DEA. It is the same molecule as Butrans and Belbuca, but is far less expensive.

I'd prefer to start with SL buprenorphrine when I need to start a patient on a long acting opioid, but not at the cost of getting into trouble with the DEA.

Lately I've been writing for a lot of belbuca.....but only on patients with the right insurance, and only because I don't want any DEA hassles.

I'd prefer to skip belbuca and just start with SL buprenorphine, because once patients have tasted ER morphine/oxycodone it's very difficult to get them to accept buprenorphine.
Regarding your response that I bolded above, yes I am well aware of this. I was just trying to clarify which type of generic buprenorphine you were taking about. SL buprenorphine, while generic, is still off label for chronic pain and is FDA approved for opioid dependence. You will still risk a potential DEA audit if you continue to prescribe this for pain. Granted, the DEA is more likely going to go after large volume prescribers of this drug first, but it is a risk you run.

Some guys I know who do this obtain their X waiver, add the diagnosis of opioid dependence in the patient’s chart, and prescribe it, but are careful not to mention pain or pain scores in the chart. They focus on clinical elements of dependence. Net result is the patient still gets the suboxone and it helps their pain.
 
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Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion (4th paragraph under "Introduction.")

https://www.chcf.org/wp-content/uploads/2019/08/BuprenorphineOverviewClinicians.pdf (page 9, main paragraph on left hand side of page)

Buprenorphine's original intent was as (at first, injectable) analgesic. Its use has fluctuated thru the years, but it always has and always will be indicated for pain separate from OUD….and anyone with a DEA license, X license not utilized, can write for it for pain without cause for worry (as far as I can tell and in my humblest opinion - based on both my reading on this matter as well as personal experience). Making a distinction between its varying forms (buccal vs sublingual vs transdermal) wouldn't mesh with logic should a highly unlikely (but still not worrisome) DEA audit/visit occur..... particularly when, depending on the doses of course, they can work out to equal morphine equivalencies.
 
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Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion (4th paragraph under "Introduction.")

https://www.chcf.org/wp-content/uploads/2019/08/BuprenorphineOverviewClinicians.pdf (page 9, main paragraph on left hand side of page)

Buprenorphine's original intent was as analgesic. Its use has fluctuated thru the years, but apparently it always has and always will be indicated for pain separate from OUD….and anyone with a DEA license, X license not utilized, can write for it for pain without cause for worry, as far as I can tell and in my humblest opinion. Making a distinction between its varying forms (buccal vs sublingual vs transdermal) wouldn't mesh with logic should a highly unlikely (but still not worrisome) DEA audit/visit were to occur..... particularly when, depending on the doses, they can work out to equal morphine equivalencies.
I just clicked on the source link in your second article. Nowhere in the source material does it state you can prescribe SL buprenorphine for chronic pain. It mentions specific instances when you can prescribe it without an X waiver, but it’s mainly limited to an acute setting to prevent withdrawals. The first article is an expert opinion consensus on the use of buprenorphine in chronic pain, but it refers to all formulations of it. Once again, I’m not debating that suboxone doesn’t work for chronic pain. I’m stating the legality behind prescribing it off label.

 
buprenorphine is buprenorphine is buprenorphine.
 

tells these docs too (granted it's a crappy survey)…..regardless, I understand the indication isn't there....but the logic is. 🙂 I'm looking for more proof to provide.
 
I was taught that much like Methadone, off label usage for pain is irrelevant to the DEA-X system. I would be very cautious with using it for OUD as that clearly requires an X and is limited in patient volume. I will have to research this more later
 
I was taught that much like Methadone, off label usage for pain is irrelevant to the DEA-X system. I would be very cautious with using it for OUD as that clearly requires an X and is limited in patient volume. I will have to research this more later
I was taught the same thing. I only changed my prescribing habits after I listened to the lecture given by a DEA agent at our pain society meeting.
 
I was taught the same thing. I only changed my prescribing habits after I listened to the lecture given by a DEA agent at our pain society meeting.
What state was that in?
 
SL buprenorphine, while generic, is still off label for chronic pain and is FDA approved for opioid dependence. You will still risk a potential DEA audit if you continue to prescribe this for pain. Granted, the DEA is more likely going to go after large volume prescribers of this drug first, but it is a risk you run.

Some guys I know who do this obtain their X waiver, add the diagnosis of opioid dependence in the patient’s chart, and prescribe it, but are careful not to mention pain or pain scores in the chart. They focus on clinical elements of dependence. Net result is the patient still gets the suboxone and it helps their pain.
I was taught the same thing. I only changed my prescribing habits after I listened to the lecture given by a DEA agent at our pain society meeting.

These two somewhat different answers are why I worry. I'm not going to lie in a legal medical record just to get a patient cheaper generic bup.

However to your second answer, I would certainly write for cheap inexpensive SL bup (not suboxone) for pain if I was confident I wouldn't get in trouble with the DEA. Much better medically than starting a patient on oxycontin/ms contin, etc. but not if it risks my license.
 
These two somewhat different answers are why I worry. I'm not going to lie in a legal medical record just to get a patient cheaper generic bup.

However to your second answer, I would certainly write for cheap inexpensive SL bup (not suboxone) for pain if I was confident I wouldn't get in trouble with the DEA. Much better medically than starting a patient on oxycontin/ms contin, etc. but not if it risks my license.
I would defend you if it ever came to it. And we would win.
 
Any provider licensed by the Drug Enforcement Administration (DEA) (e.g., physician, nurse practitioner, physician assistant) can prescribe buprenorphine for pain. As a Schedule III drug, buprenorphine can be ordered by phone or fax, and refills can be included on the original prescription.

Any physician with a special "X" number issued by the DEA. The way the law is written, any doctor can prescribe Suboxone for treating pain, however the FDA has not granted approval for Suboxone to be used for pain, so it would be an off-label prescription.

For TN - Prescribers shall not prescribe buprenorphine in the form of oral or sublingual buprenorphine for chronic pain condition.
For TN - Buprenorphine/naloxone combinations shall be avoided for chronic pain
For VT - Prior to prescribing buprenorphine or a drug containing buprenorphine that exceeds the dosage threshold approved by the Vermont Medicaid Drug Utilization Review Board and published in its Preferred Drug List, prescribers must receive prior approval from the Chief Medical Officer or Medical Director of the Department of Vermont Health Access or designate.

This is likely the best response from the DEA to the specific question!
Fourth Clinical Vignette: Can I Use Suboxone®/Subutex® for Analgesia?
The DATA waives the requirement for obtaining a separate DEA registration as a narcotic treatment program for physicians using the approved drugs for maintenance and detoxification; however, it does not apply to physicians using Suboxone® or Subutex® for the treatment of pain.

I am unclear if the DEA agent meant specifically for the disease of addiction or OUD, but it's clear that there are no restrictions for Suboxone unless you're using it for MAT. I am unclear if things have changed since that response but in general it appears that we are moving towards easier access to Suboxone.
 
These two somewhat different answers are why I worry. I'm not going to lie in a legal medical record just to get a patient cheaper generic bup.

However to your second answer, I would certainly write for cheap inexpensive SL bup (not suboxone) for pain if I was confident I wouldn't get in trouble with the DEA. Much better medically than starting a patient on oxycontin/ms contin, etc. but not if it risks my license.

I did find this letter from the DEA from 2003 that supports your argument for the off label use of suboxone. However, this was before the advent of Butrans and Belbucca, which are indicated for chronic pain as opposed to opioid dependence. You guys do what you want with this info, but it won’t change my prescribing habits until I get clarification from a more recent source.
 
I did find this letter from the DEA from 2003 that supports your argument for the off label use of suboxone. However, this was before the advent of Butrans and Belbucca, which are indicated for chronic pain as opposed to opioid dependence. You guys do what you want with this info, but it won’t change my prescribing habits until I get clarification from a more recent source.

Yes, I saw that letter too. It's a topic worth clarifying, certainly.
 
Yes, I saw that letter too. It's a topic worth clarifying, certainly.

I can see if they're taking calls on Monday I guess?

04/2020 update
Guidance on the Clinical Use of Buprenorphine
Approved buprenorphine products have received FDA approval only for the treatment of opioid dependency. However, once approved, a medication may be prescribed by a licensed practitioner for any use that, based on the practitioner’s professional opinion, is deemed appropriate. Neither the FDA nor the federal government regulates the practice of medicine.
A licensed practitioner can use the approved product 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 the off-label use of medications is available on the FDA website.
 
Another question regarding this topic. When I did attempt to write SL buprenorphine for chronic pain in the past, the pharmacist would not fill my prescription because I did not have the X designation even though I stated on the prescription the indication was for chronic pain. Is this also a state-specific thing or is it up to the pharmacist’s discretion?
 
Well I my state they routinely only fill 7 days of medication even though the law explicitly excepts chronic pain and I put chronic pain on the Rx. You can make your own judgement about the intelligence of the pharmacists
 
Well I my state they routinely only fill 7 days of medication even though the law explicitly excepts chronic pain and I put chronic pain on the Rx. You can make your own judgement about the intelligence of the pharmacists
Agreed. Let’s not even mention all the lack of entries or inaccurate entries that routinely pop up on the PMP. The best part is there is little to no repercussion for them while there is plenty for us.
 
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