Introduction

 

Chronic pain is gradually becoming acceptable as an off label indication for the prescription Suboxone.

 How great would it be to have an opiate for the opiate dependent patient that can be used for maintenance in the setting of chronic pain where that opiate is 1000 times less addictive, far less abusable, and far cleaner with regards to the standard opiate side effects like constipation, erectile dysfunction, liver dyscrasias, and obesity, not to mention a myriad of other end organ damaging effects that include even decaying dentition. Such an opiate exists. It’s buprenorphine or Suboxone which is available in 2 and 8 mg doses of sublingual tablets. Approved by the FDA for detoxing from opiates in the settings of misuse and abuse including heroin addiction, it may also be used at smaller doses for chronic pain (among other things; future topics of discussion on this site) in a manner of prescribing that is considered “off label” but allowed by the FDA.

 

Disclaimers

 

  1. This discussion is geared towards patients on traditional opiates like oxycodone that are stable and wish to consider Suboxone as a much safer option. The discussion is also aimed at physicians who would like to prescribe the Suboxone for the traditional opioid patient that is not demonstrating addictive malignant behaviors on their opiate simply because they want to enter a safer world that includes this opiate, Suboxone, that is much less addictive, much less abusable, and has much fewer side effects than any traditional opiate before they get into problems.
  2. The obvious disclaimers that patient should not self prescribe Suboxone or any traditional opiate without a doctor’s a specific written prescription who knows about and who is licensed to prescribe Suboxone (those special DEA license Suboxone prescribing doctors can be found in all major cities).

 

Discussion

 

The whole discussion of when you need Suboxone in terms of requiring it as per federal guidelines, so in other words, acceptable, in label use prescribing versus off label prescribing has become muddy and unclear. So let me start first with approved FDA prescribing about Suboxone. There are folks that really should be on Suboxone. Those would be folks getting their prescribing because they have shown misuse problems with traditional opiates. They’ve shown a problem. And their Suboxone prescribing doctor knows it will stabilize them with their opioid dependence.

 

Then there are the folks that have not shown any problems with their traditional opiate prescribing, but feel that they might eventually, or their doctor feels like they might eventually, or they are escalating on their traditional opiate unnecessarily, without any obvious signs of addiction or dysfunction; yet. Oddly, the circumstance for patients that are not experiencing problems that are on opiates and could benefit from Suboxone, is, unfortunately for them, considered off label prescribing.

 

It’s unfortunate because their insurance may not cover them for the Suboxone since they are showing no need to detox. The FDA considers that prescribing Suboxone for them is off label.

 

However, some insurances are covering that more and more often now. Insurances are gradually realizing that opiate dependency can be treated with Suboxone whether it is dysfunctional opioid dependence or functional opioid dependence. And after all, functional opioid dependence is a ticking time bomb waiting to become dysfunctional. If those folks want to be on Suboxone and have not shown any signs of addiction or problem, they should be entitled to use the Suboxone before the addiction behaviors and problems begin. It’s fortunate then that insurance is starting to favor this.

 

So, the whole discussion of when does opioid dependency move into opioid addiction becomes purely academic. If they are dependent and not putting a gun to a pharmacist’s head or stealing prescription pads, why should they be denied the use of Suboxone instead of oxycodone or methadone or morphine. These folks can respond nicely to Suboxone even though they’ve never had to use it as per federal guidelines. They find that it has much less constipating in fact, affects and destroys erectile function much less, destroy his teeth much less than other opiates, and so forth. Suboxone is a much cleaner opiate. Suboxone is also much harder to abuse. So if they have not had problems yet and they move into the world of Suboxone for maintenance, they can live on Suboxone knowing of course that if they have a breakthrough problem or a surgery or fall out of a burning building, they can return to the world of oxycodone and such as needed. As long as they understand that their pain will always be cared for and that switching to Suboxone is not a “do not use oxycodone anymore” world, they are comfortable to make the switch to Suboxone.

 

Many of them that make the switch know that they have regularly taken a little extra oxycodone here and there and have escalated on traditional opiates. They are happy to be in a world where that is much less likely.

 

Now there are a few chronic pain patients that make the switch to Suboxone that simply never find that the Suboxone works as well as their oxycodone or the like. The explanation is that they had usually been on very high doses of traditional opiates. So a standard 8 mg of buprenorphine provided by a tablet of Suboxone may not tend to their chronic pain. Fortunately, these patients tend to require larger doses of Suboxone simply because of the previous history of high doses of opiates. So adjusting the Suboxone higher in them tends to be indicated before just giving up on Suboxone as an alternative to oxycodone or the like for chronic opiate pain management.

 

Increasing some of these patients to two or three Suboxone 8 mg per morning (single first thing in the morning dosing is this the correct administration of that medication; another online seminar to follow will discuss this in greater detail), unfortunately never allows them to feel benefit from the Suboxone. They want their oxycodone back.

 

If those folks are cooperative with an exhaustive trial of Suboxone that uses higher doses and truly do not get a response in their chronic pain, they should be allowed to go back to the world of oxycodone maintenance if they are responsible with it at conservative doses.

 

In summary, opioid dependent patients maybe divided into two groups. One group that uses their traditional opiates safely. And another group that doesn’t use their opioid medication safely. Both of these groups stand to benefit from changing to Suboxone for maintenance. The latter group that must be changed because of addictive maladaptive behavior is called the approved in-label group in terms of federal guidelines for Suboxone. The previous group that is stable on their traditional opiates and wants to go to the world of Suboxone just for less side effect and also to keep them out of harm because they feel like maladaptive behavior or side effects could come anyway and they might be at risk for them — they should be entitled to the elective use Suboxone before problems start. That is called off-label prescribing, even though Suboxone would be safer than their traditional opiates! Fortunately, insurances are finally covering that more now and even pharmacists are even treating it as acceptable prescribing. Both groups of patients do well on Suboxone, and everyone involved including the patients, their families, the pharmacists, and the insurance companies, are all slowly coming around.

 

It’s important to note that both groups have patients that never do well on Suboxone. There are patients that are doing poorly on traditional opiates showing signs of addictive behavior that must be switched to Suboxone that hate their Suboxone and never grow to like it. And there are patients that never show problems on traditional opiates that want to try Suboxone (the off label group) that never like it, and return to their oxycodone or what not.

 

But those that do well grow to truly appreciate their switching to Suboxone. The approved in label addicts that know they don’t have much choice, so they appreciate that Suboxone keeps them out of trouble and compliant with the law. And the ones that are using Suboxone electively for their chronic pain, knowing they can return to their oxycodone for any exacerbation, elective surgery, nonelective injuries. Both groups tend to be very happy campers.

 

But there are some that never seem to respond to the Suboxone for their chronic pain even when used at high doses. Fortunately, it’s only a small group. Diversion (the term used when selling is suspected) needs to be suspected in that latter group. The feds certainly look at it that way.

 

But I believe that there are some genuine, clear candidates for maintenance on things like oxycodone that have failed the highest safe doses of Suboxone for their chronic pain.They need to be watched closely for evidence of diversion, of course. Genetic testing can be done to see if they might just be rapid metabolizers of opiates. It’s clearly indicated. If this is found to be the case, they should be carefully restarted on their oxycodone at a much lower dose. While they’re switching back to oxycodone, in addition to watching counts more closely, more effort needs to be exerted to lowering their opioid demands, more effort needs to be exerted to document their genuine opioid need. Anesthesiology consults bring a lot to the table because they provide so adjuncts that lower opioid doses. When sending the patient in for an anesthesiology consult, the patient and referring physician need to assertively instruct the anesthesiologist been consulted that they don’t want higher dose of opiates, that they don’t want prescribed opiates at all unless it’s some sort of intrathecal deployment of an opiate. Steroid injections, stem cells — these adjuncts are great to lower opioid demands in the patient that simply refuses to tolerate Suboxone for whatever reason.

 

Case study

 

Patient XY. This young man has a history of nerve damage from a motor vehicle accident that perhaps did initially justify chronic traditional opiate maintenance therapy. As is the current guidelines, he does not have to have an end-of-life situation nor cancer to be maintained on traditional opiates. The feds are OK with this. That’s how he’s been living. He’s always remained stable. If he continues to use oxycodone at conservative doses, and doesn’t show signs of addictive behavior, he should be entitled to his ongoing oxycodone, with occasional consults to anesthesiology or stem cells to lower opioid prescribing. Adjunctive non-opioid prescribing to keep him healthy will also lower opioid dosing. But this is a healthy young man so needs very little of any of that. If he starts showing up to the clinic earlier and earlier for routine refills, the escalation is absolutely not acceptable with further work up. If the behavior becomes more odd (e.g., en route to the pharmacy, he alters the prescription), the doctor documents this as addictive behavior. Immediately, that doctor has to offer Suboxone or referral to a doctor allowed to prescribe it. He has become a candidate for Suboxone, and Suboxone should be started. This is in-label prescribing. If this patient had presented before for tampering with a prescription asking for Suboxone, it would’ve been called off label prescribing. And he should be allowed to get Suboxone.

 

If he follows up with his doctor two weeks later, doing well on Suboxone, excellent vital signs even claiming that he did well, but wants his oxycodone back, and doesn’t state exactly why — suspicion for diversion must occur. Oxycodone and the like should be avoided. The physician should keep him on the Suboxone, optimizing its efficacy for him by tweaking the dose, adding adjunctive therapy, strong arming him into an anesthesiology consult to lower opioid demand, with a plan to continue Suboxone until further notice. If this angers the patient, that’s obviously consistent with divergence. If the patient is agreeable with this, he is less up suspect for that likelihood. Either way, he is maintained on Suboxone until further notice. Patients like this occur all the time. They are clear-cut candidates for Suboxone before Suboxone in an off label setting before Suboxone becomes clearly indicated in an in label, as per federal guidelines setting.

 

Conclusion

 

Belbucca, with maximum doses of less than a milligram of buprenorphine, the prodrug in Suboxone, is now available as a form of buprenorphine approved by the FDA for chronic pain. So pharmacists are aware that Suboxone is entering the world of chronic pain management even though it per se is still off label for it.

 

Stay well,

David Allingham, MD