Buprenorphine: Current Practices

NCSAM

I just got back from the NC Society of Addiction Medicine annual conference. (Yes, I’ve been to several conferences lately.) One of the sessions I attended was a lively discussion of the current practices in office-based prescribing of buprenorphine, for opioid addiction.

The session was run by two experienced, knowledgeable addictionologists, who mediated topics and shepherded the dialogue. One physician works in North Carolina and the other in Tennessee. The room was packed with at least fifty people, most of us doctors who prescribe buprenorphine for addiction.

Deliberations were collegial but we didn’t agree on all issues, of course. Dissenting opinions were respected and debated.

The first topic I can recall was about how often buprenorphine patients need to be seen. Most practitioners agreed that new patients needed to be seen at least weekly initially. As stability develops, we gradually extend the time between visits to one month. One doctor opined that no patient should be allowed to go any more than one month between physician visits. When the moderator asked if anyone disagreed, I raised my hand, and the moderator asked me to explain.

With some trepidation, I told the audience that I had a super-stable group of patients in my practice. I inherited most of them from another physician who was one of the first in the area to prescribe buprenorphine. This group of patients all have over five years of stable and relapse-free recovery. A few have been in stable recovery for nearly ten years. These people work, and have happy and productive lives.

So yes, I do allow these patients to go two months between visits.

No one booed or hissed me, but I got the feeling I’m doing something with my patients outside the realm of normal for most doctors prescribing buprenorphine. Thankfully, the moderator made the point that we should use our clinical judgment and adjust treatment to best fit each situation, which made me feel better.

I was mulling this over later, and maybe I do have an unusual group of patients, who have been stable on MAT for so long. Some of these patients elected to stay on sublingual buprenorphine because they are doing so well on it, and they fear relapse if they taper off of it. Others plan to stay on buprenorphine because they developed addiction as a complication of chronic pain treatment. Happily, the buprenorphine works as well for their pain as it does for their addiction, so we get the two birds with the one stone.

There’s another unusual thing about these super-stable patients: almost all of them are deeply involved in 12-step recovery. Many were in Alcoholics Anonymous prior to their opioid addiction. They developed addiction to opioid pain pills after receiving prescription opioids for an acute or chronic pain condition. Once they started on buprenorphine to treat the opioid addiction, they continued going to Alcoholics Anonymous (a few go to Narcotics Anonymous).. Other patients didn’t start going to AA until after they entered MAT on buprenorphine.

I’ve had many people write comments to my blog, furious when I even mention 12-step recovery and MAT in the same sentence. But I have living proof in my practice of multiple patients on medication-assisted treatment of opioid addiction who have been able to make 12-step programs work for them.

Getting back to the conference…we spent much time discussing the monoproduct buprenorphine versus the combination product buprenorphine/naloxone. All of us agreed there’s a need for caution with prospective patients who insist they can take only the monoproduct (this is the equivalent of the brand name Subutex), because it does have a higher street value than the combination product.

Of course, there are people who inject the combination product (Suboxone film, Zubsolv, etc.), but overall, people seeking to inject buprenorphine are much more likely to prefer plain buprenorphine. Black market prices are higher for the monoproduct than the combination product, underscoring the preference for monoproduct.

One outspoken doctor said the monoproduct should rarely if ever be prescribed. Another doctor echoed my feelings on the matter when he said something to the effect that some patients really do have a bad reaction to the naloxone in the combination products, and if we are cautious, we can prescribe the monoproduct. However, the general opinion was that financial reasons weren’t sufficient to take the risk of prescribing the monoproduct.

I disagree with that, but kept quiet, already feeling like maybe I’m a bit too liberal.

I have had patients, stable on a buprenorphine combination product (usually brand name Suboxone films), who suddenly lost their health insurance. If such patients had negative drug screens for years, and no history of intravenous use, I switched them to the generic monoproduct because it’s the cheapest buprenorphine product on the market. These patients could not have stayed in treatment if I’d made them stay on the much more expensive brand names. Most of those patients prefer the films, and when they got new insurance, asked to switch back to the films.

I did not suspect these patients would sell their medication for profit. You have to know them, but these patients had stable jobs and no leanings toward criminality. And I am by no means a gullible person.

Since then, a generic combination product came onto the market. Still more expensive than the monoproduct, it’s less expensive than all the name brands.

Next we discussed how to deal with patients who say they are allergic to naloxone, and thus can’t take the combination product (Suboxone, Zubsolv) but only the monoproduct (Subutex).. Patients usually don’t mean an actual allergy, but rather intolerance to naloxone. These patients report headache, nausea, etc. when they ask their physician to prescribe the monoproduct. Of course, this raises suspicion with physicians that such patients plan to misuse the medication by injecting or snorting.

Should physicians just accept what patients say at face value, or should we say sorry, I only prescribe buprenorphine in combination with naloxone? After all, there’s no way to “prove” a headache or nausea. There’s no test we can order that will give any useful information. One doctor said he sent such patients to a neurologist for evaluation of the headache, or to a gastroenterologist to decide the cause of nausea. He says most patients fail to follow through, and so he weeds such prospective patients out of his practice that way.

An audience member suitably questioned this habit, asking how could a specialist be expected to determine if a medication caused headache or nausea? I think it’s kind of a sneaky way to get rid of patients who want buprenorphine monoproduct.

I have the same fears when fielding new calls from prospective patients. I’ve instructed my patient contact representative (who is also my office’s licensed professional counselor, after-hours contact person, pharmacy liaison, licensed clinical addiction specialist, prior approval wrangler, and fiancé) to tell these people that I do not prescribe the monoproduct to new patients. I have no problems saying “no” upfront to these patients, and try to explain why I’ve made this decision for my private practice (even though, as above, I have prescribed it for patients I know very well).

I use the monoproduct in the opioid treatment program where I work, because those patients dose with us every day until they have a period of stability. The dosing nurses roughly chop the tablets, to minimize diversion, and patients stay on-premises until the medication has dissolved, also to make diversion more difficult. These patients don’t get any take home doses until we feel they have stabilized.

We also discussed how long to keep patients on buprenorphine. The bottom line is that no one knows. Best outcomes are seen in patients who stay on buprenorphine, since there’s still a high relapse rate back to opioids in patients who stop buprenorphine. I ask my patients periodically if they wish to start a slow taper, if they’ve been stable for over a year. I don’t push them to taper if they’re not ready, but if they are, I recommend they taper slowly. From the discussion at this meeting, it sounds like most of my colleagues do the same.

We discussed the maximum daily dose of buprenorphine. According to studies, a daily dose of 16mg saturates most of a patient’s opioid receptors, and increasing the dose to 24mg only gives about a 4% increase in the number of covered opioid receptors. Some doctors say this shows buprenorphine should never be dosed more than 16mg per day.

However, about a third of the doctors in the room raised their hands when the moderator asked if they had any patients who seemed to require 24mg per day to stabilize.

I didn’t interject anything into the discussion, but I just went to a session at the national ASAM meeting where this same topic was discussed. While it’s true that basic pharmacology would indicate 16mg is probably the just as effective as 24mg in most patients, several studies have shown better patient retention in treatment when higher doses (24-32mg per day) are used.

It’s possible this isn’t a physiologic effect, but more of a mental process. We can’t be sure. But for whatever reason, if my patient does best at 24mg, I’ll allow her to stay on that dose.

For patients on higher doses, we need to make sure they aren’t diverting some of their medication. Patients sometimes ask for a higher dose than they need, in order to get enough medication to treat a friend, family member, or significant other. Some doctors call this “piggy-backing.” Even though it means a suffering addict is getting treatment, the piggy-backer won’t get any counseling. Also, law enforcement types use examples of diversion to demonstrate that buprenorphine is a bad street drug, contributing to the stigma against patients doing well in their treatment. Diversion threatens the whole concept of office-based treatment program.

All in all, we had two hours of lively interaction on the finer points of office-based prescribing of buprenorphine. I don’t think all doctors will agree about everything, but it’s nice to hear what other physicians are doing, to make sure I am not too far out of line with the standard of care.

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10 responses to this post.

  1. I wish that our experience with physicians, affiliated with inpatient treatment facilities, were as open to buprenorphine maintenance as you and the rest of your colleagues appeared to be. I tried to find an inpatient program, that would accept buprenorphine for an open ended period and discovered that no one wanted to use MAT beyond a 3-5 day detox. I was able to make a referral to Betty Ford Center, but the acceptance of maintenance for pain management patients or recreational users, is, primarily, limited to individual practice Docs and and outpatient programs. We, too, have had tremendous success with chronic pain patients and, as you relate, most stabilize at 16 mgs. sometimes after a period of getting used to various symptoms. Virtually all, eventually find that their lives are greatly enhanced, our retention and patient focus are all increased greatly. Having been using MAT for ten years, we have the same situation that you describe, with a percentage of patients choosing to stay on the buprenorphine, often after a great deal of skepticism from the patient themselves and family. Once they see how much better the patient is functioning, they are just happy to not expect that call from the morgue.
    Interestingly, the AA meetings, in our area, are full of people with long term sobriety, who are on MAT but fail to share out of a sense of fear of judgment. The NA mtgs. refuse to allow patients on bupe to share, greet, make the cake or participate in any way as they are, still, defined as “not clean”. It’s a younger crowd and they have a tendency to have shorter sobriety and have, apparently, missed some of the tenets of humility and acceptance. Encouragingly, many of the sober livings are beginning to allow patients to be admitted with buprenorphine.
    With time and the mandates that are coming down in the future, I suspect that we will see more programs begin to accept science as an adjunct to recovery and not the enemy.
    Our biggest problem, is patient brokering, selling urine to toxicology labs, call centers staffed with untrained people and the ultimate oxymoron—NON-MEDICAL DETOX or social model detox. Patients are dying and experiencing life threatening events, on a regular basis as the state lacks the resources to mandate that these facilities don’t use medications or treat patients that need psychiatric, medical or withdrawal medical care.

    Reply

  2. Posted by Andrew angelos on April 25, 2016 at 10:27 am

    It’s uplifting to know that medical professionals are having these discussions. Personally I believe that bupe is the key ingredient here. I’m my personal case, I’m unable to get treatment from doctors because of the health care situation here in California. I buy my subs from other people that are in programs now and have for over a year. This has forced me to taper to a dose that is within my financial reach. I pay about 25 dollars per 8 mg strip. “(About 4 mg a day. )”this brings my cost to about 12.50 a day which is about what I spend on tobacco and caffeine. I have no professional medical treatment on bupe yet I’m stable I have a job just got a much better job in fact. The stress of not knowing if I’ll be able to get more is sometimes almost unbearable. I go to psychotherapy monthly and my therapist knows about my situation. She’s actually the therapist from my old sub program. I’d prefer to be under medical observation but honestly the weekly and monthly visits wouldn’t work with my work schedule anyway and id be hard pressed to find a doctor that would be willing to do every other month. To me bupe is a wonder drug for people who have outgrown their addiction to opiates. There’s so many people out there that wish the could quit but physically can’t and mentally won’t. That said I wouldn’t doubt if in twenty years there will be a new drug that’s meant to get us off suboxone.

    Reply

  3. As always, I appreciate all your input on MAT and what other practitioners are doing…Has there been any talk about raising the limit to 200 patients instead of 100 patients and who will be able to qualify for this increase? The thing that bothers me about more restrictions to treatment is that when I received my Suboxone DEA number back in 2003, it was meant so that PCP’s could treat patients in their office. Now it seems that the increase in numbers may be restricted to only certain health professionals regardless of the number of years and experience they have treating these patients. Any feedback on this issue?? In my community young people are dying daily from heroin addiction and I have a full Suboxone panel. Treatment does save lives so what are we waiting for?

    Reply

    • Yes. There is a proposed rule to allow some physicians to increase to 200 patients, but it comes with some conditions. For example, the physician must take third party insurance, must refer for counseling, must have electronic medical records, must re-apply periodically, must have a 100 patient limit for one year before going to 200patients, and other requirements.

      Reply

      • When did CIGNA say the 10 year rule became effective? Since buprenorphine treatment is medication assisted recovery and is used for maintenance how can they cut you off? Something does not seem right here…I would fight it.

      • I think that you are right on with Reckitt-Benckiser’s motives and the circumstances that demanded a new formulation and/or structure. No need to reiterate your comments, as they were well expressed. I have chosen to stay on buprenorphine only (subutex) due to some studies that indicate the possibility of long term use of naloxone being linked to stressed livers. Already put this one through enough trauma.
        I can speak to the film and found it extremely easy to end up on my teeth, tongue or nose. Not the best absorption. Plain old generic buprenorphine has worked for the last 7 of 10 yrs. I am not a physician and don’t have any opinions about formularies and their superiority but I do run an outpatient clinic and we have found that patients do just as well on subutex. The DEA may not agree but I think that you may be right, they’ve all been sold a bill of goods.
        Regarding my problems with Cigna, I find that they just have very little knowledge, at the appeal level, about MAT, in general. Their written letter, to me, clearly stated that buprenorphine was only to be used as a detox med. for 3-5 days. Obviously, since I was at the appeals level, I was, already complaining about their stringent oversight. Later, they made the same statement, but referred to the medication as suboxone. I think that it comes down to a lack of understanding and an attempt to get their arms around detox in general. Unfortunately MAT and detox, are really different clinical efforts. With our patients, we are focusing on stabilization and recovery. I am in recovery, attending my meetings because I’ve found the ones that I love.
        Ironically, I got a survey asking some good questions of me as a provider, so I shouldn’t be picking on Cigna as they are the only ones that have actively partnered with us in thirty years. At least, they are trying to find out and they have sued Sky Toxicology, at least twice, for fraudulent billing. Maybe some more of the insurers ought to go get their money back from out of network billers.
        Thanks Jana for a fantastic blog.

      • Posted by Rocky Hill on April 30, 2016 at 12:18 am

        I hit the reply button and went to your site. My fingers just lost control and I left another post. Sorry for being so prolific.

        It wasn’t so much a ten year rule, that is just how long I have been taking one of the buprenorphine formularies. It may be that because I take subutex, it triggered some issue but their letter made no sense. In my many conversations, I reminded them that buprenorphine was designed as a maintenance medication and that the folks who were using it for 3-5 days to do detox, were not working within the directives of the FDA. I could tell that none of them had any idea. I tried to appeal to their sense of compassion, by saying that if I was a desperate heroin patient trying to get my prescription filled, I would have been sick for five days, while I messed around with them. That one hung up on me. There is such ignorance in the insurance industry. We have casemanagers, who we try to get authorizations from, that have no knowledge about addiction and if we go doc to doc, it doesn’t matter if we read from their own manual, the answer is NO. Keep up the good work. I know that you try to keep things positive, but we are having a hell of a time with out of network billings, patient brokering and non medical detox that uses Salvation army graduates to dispense medications from a “house supply” of serax, trazadone, codeine and suboxone. Haven’t shared that on the blog, as they sued me for working with DOJ, Senate office of oversight and outcomes (Rogue Rehabs-author John Hill) and three wrongful death cases. They lost, appealed and lost again, so it just cost them $152,000 in attorney’s fees. I’m sure you’ve read of the murder charges filed by a Grand jury and elder abuse. Unfortunately, the judge threw out the murder charges without reading what the jury took two weeks to review. She let the elder abuse stand so they may still do 5-9 yrs. Rocky Hill

      • Thank you for your input on the 200 patient limit…I will keep my eyes open for the changes.

  4. Cigna just denied my ten year script for buprenorphine, stating that it is only intended for 3-5 day detox. It took a week of my physician’s time and three hours of mine, with five Cigna staff, (including supervisors). Trying to explain that their policies are just not the law.
    Where could they have gotten that concept of 3-5 day detox. Not from the Dept. of Health and Human Services, Mike Boticelli or SAMSHA. Maybe, it came from their inpatient providers who are terrified of empty beds, if buprenorphine is widely accepted and integrated into mainstream medicine.
    fortunately, their SIU staff are just beginning to litigate, with a few of the toxicology labs and treatment programs that have been financially raping them with fraudulent drug testing. It’s a start, but there are thousands more between the labs, unethical programs and sober living homes that are out of network but they keep on paying.
    Organizations like NAATP, need to come out and truly endorse MAT as more than medically assisted treatment and embrace the maintenance use of buprenorphine before it is mandated on their members.
    A huge step forward is embodied in Addiction medicine becoming a medical specialty,just like cardiology, psychiatry or OB/GYNs etc. We are making progress, it just comes at such a high price. How may more families will have to lose their loved ones, as we bicker about the only drug that has a cap on how many patients a physician can treat. The absurdity is mind-boggling and would be humorous if we were not in the midst of an epidemic and would rather talk about “Donald’s” latest gaffe, than this problem. At least, Hillary and Bernie, and our President realize that we face an unparalleled catastrophe in this nation.

    Reply

  5. Posted by Brian Griffin on April 29, 2016 at 7:52 am

    Hello, I just recently discovered your blog. I will be reading it regularly, as I am currently taking Suboxone. I just wanted to briefly comment on this current post. When it comes to the idea of a “monoproduct” vs. buprenorphine/noloxone, I firmly believe that a fair amount of people are misinformed about the pharmacology of buprenorphine. This includes both physicians and lay people. Reckitt- Benckiser has unfortunately, perhaps deliberately, led people to believe that noloxone is a sufficient deterrent to abuse (I.V., oral, etc.). This, of course, is just my opinion, but we are all well aware of the financial motives behind pharmaceutical companies. Post marketing studies have demonstrated that it is bupreborphine alone, that precipitates w/d in opiate dependant individuals. Buprenorphine has a higher (Ki) affinity for the mu-receptor than noloxone. Obviously, this translates to the fact that buprenorphine sufficiently saturates receptors, and “blocks” any effect that the noloxone would have. In my experience, I have unfortunately witnessed the lack of knowledge in this area. As I mentioned, I believe that RB has been successful in their approach to sell this idea. Forgive me if this appears to be off topic regarding this specific blog entry, but I am very interested in your opinion on this. Also, I am curious as to your view on Suboxone being re-formulated into the current “dissolvable film” form, if you have one. When I first discovered that RB had done this several years ago, I couldn’t help but feel that this was an obvious attempt at patent extension and/or “evergreening”. Again, I apologize if I maybe drifted off topic. Thank You!

    Reply

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