Archive for the ‘Buprenorphine’ Category

Medical Board Action Against Telemedicine Buprenorphine Physician

Telemedicine

 

 

 

Telemedicine is all the rage these days. For medically underserved areas, telemedicine could help reduce physician shortages and provide care to people without medical specialists in their area.

As appealing as the idea may be, physicians must be careful to conform to their states’ medical board regulations.

Of course, buprenorphine can now be prescribed in the office setting to treat opioid use disorders. Even with the increased prescribing capacity DATA 2000 gave us, less than a quarter of people who need treatment for opioid use disorder receive it. In fact, modifications to DATA 2000, passed last year, allow buprenorphine prescribers to have up to 275 patients at a time, if they fulfil various criteria. Also, physician extenders can now get certification to prescribe buprenorphine after taking proper training.

But what about telemedicine? Can it be used to meet the demand for opioid use disorder treatment in underserved areas? We now have clearer guidance, thanks to a recent ruling by the NC Medical Board.

Here’s the condensed story:

A physician, who lived and practiced in the middle of the state, also prescribed Suboxone via telemedicine for patients in the Western part of the state. The medical board was displeased this physician didn’t examine his patients in this second location in person, prior to initiating the Suboxone. The physician stated he felt buprenorphine could be prescribed safely without an in-person exam, but the board didn’t agree.

The medical board faulted the physician for not giving adequate attention to patients’ use of other drugs, and their mental health history. The board said patients were not examined for track marks or withdrawal signs, and that the physician accelerated their doses too quickly. Patients were seen every four weeks from the start, and the medical board opined that was not frequent enough in early treatment.

In other words, there were clearly other issues besides the lack of initial face-to-face contact, but this lack was cited as a departure from the standard of care.

I’ve been contacted by at least a half dozen mental health agencies who wanted to hire me to start treating patients with opioid use disorder with buprenorphine, using telemedicine. I’ve turned them all down, mainly because it wasn’t good medical care, and also because I didn’t want to do anything to violate medical board’s telemedicine policy. They have had published guidelines surrounding telemedicine since 2010, and update it periodically. You can read it here: http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-position-statements/position-statements/telemedicine

You will note that the policy says “This evaluation need not be in-person if the licensee employs technology sufficient to accurately diagnose and treat the patient…”

So it is a little confusing, in view of their recent ruling against a doctor prescribing buprenorphine.

In September of 2016, another Addiction Medicine physician got a public letter of concern from the NC Medical Board, for using the telephone to stay in contact with a patient who had moved out of state. I only know the circumstances of the case from what the medical board listed in their public letter of concern, but I do know the physician. He is well-trained, cautious, and has excellent judgment.

His patient of over three years moved out of state and couldn’t find a new buprenorphine prescriber. So his NC doctor agreed to continue to prescribe for him, and did phone sessions with this patient every two weeks for thirty minutes at a time. He issued buprenorphine prescriptions for only two weeks at a time. This happened over several years without a face-to-face visit. Apparently the physician enlisted the aid of a local pharmacist to do medication counts, and the medical board opined this was “insufficient.”

Wow. This ruling should give every physician a reason to avoid telemedicine. Because I think that doctor did a good thing. Every patient should have such a doctor, willing to go the extra mile to help. I don’t think the physician’s actions were “insufficient” in any regard, though I’ll admit I’m probably not what our NC medical board considers an expert.

I’ve used pharmacists to do pill counts for me if the patient says he is out of town when called for a pill count. Sounds like I’m going to have to stop doing that, given the medical board’s statement.

At least once at an opioid treatment program, I was pressured to admit patients using telemedicine.

Several years ago, I had surgery for a broken leg. At the time, I worked for two opioid treatment programs. One was located an hour away, and the other was two hours away. Driving was going to be cumbersome, of course.

As soon as I was able, I called the program managers of each to let them know I might be out of work for the next week or two. At the first OTP, the program manager said I should take all the time I needed, and intakes could be postponed. Obviously, this is not an ideal situation, since we want to admit patients as soon as possible, but this was one of those things that were out of our control. I was still available by phone, of course.

At the second, the program manager said being out of work for several weeks was “not acceptable.” The program manager pushed me to admit patients via Skype or other technology. I refused, citing quality of care issues. In retrospect, I made the right decision.

I hear about “Doctor on Demand,” advertised by Dr. Phil on his show, and I wonder how these doctors get around this telemedicine issue. These doctors aren’t examining patients face to face on the first visit. Also, to practice medicine in NC, you must have a NC license, and surely all these doctors don’t have NC licenses.

I sent an email to Doctor on Demand asking about these issues. They sent me an email back, saying someone would be in contact with me. This was about four weeks ago and I haven’t heard anything else. I’ll let you know what they say in the unlikely event that they do contact me.

In the meantime, I think all physicians, and specifically buprenorphine prescribers, need to be very careful with telemedicine. Given these two recent rulings by the NC Medical Board, we could be cited for improper medical practice. Telemedicine seems like it could be a wonderful way to get care to people with opioid use disorders who live in remote places, but physicians need to protect their medical licenses first, or we won’t be able to prescribe anything to anybody.

 

 

Suboxone Manufacturer Sued for Anticompetitive Practices

Pharma Lies

 

 

 

I read a brief news item online about the drug manufacturer getting sued, but I didn’t get detailed information until I read last week’s issue of Alcoholism and Drug Abuse Weekly (ADAW).

Here’s the scoop: the Attorneys General for thirty-six states are suing Reckitt-Benckiser (RB, now called Indivior), because the company attempted to block generics from entering the market after RB’s patent for sublingual buprenorphine products expired.

Reckitt-Benckiser manufactured Suboxone and Subutex, which were the initial buprenorphine products that came to market in 2002, after the DATA 2000 law was passed.

As a reminder, before DATA 2000 was passed, it was illegal to treat opioid use disorder in an office setting with an opioid prescription. Doctors have gone to jail for this. Before DATA 2000, opioid treatment programs (OTP) were the only setting where prescribing (methadone was the only approved medication) for opioid addiction was permitted, and these OTPs have always been strictly regulated by multiple governmental agencies.

The FDA has approved only one medication, buprenorphine, to be used under DATA 2000, and only the sublingual form was approved. Then earlier this year, a second form of buprenorphine was approved to treat opioid addiction: the six-month, sustained release implantable rods impregnated with buprenorphine, known as Probuphine.

Buprenorphine taken by other routes of administration aren’t covered by DATA 2000, and therefore can’t be used to treat opioid addiction. These forms include the name brands Butrans patch, Belbucca oral film, and IV/IM buprenorphine used for pain control.

Reckitt-Benckiser’s patent for sublingual buprenorphine tablets was set to expire around 2008. Years before that, RB worked on finding a different delivery system, and the film version of Suboxone came out in mid-2010. This new form had its own patent, so that RB was the only company that could manufacture and sell that form of their medication.

However, since their sublingual tablet had come off patient, other drug companies could make generics, which would bring down the price to consumers of this life-saving medication.

But the Attorneys General allege RB tried to block the release of the generic tablets. RB told their drug salespeople to tell doctors that children were dying from ingesting buprenorphine tablets, and that the risk of prescribing this form of treatment was too great. They said the safest way to treat patients was with the film, which comes individually wrapped in a foil packet. And remember, only RB manufactured this film.

On May 12, 2012, I blogged about Reckitt-Benckiser’s attempt to persuade me to prescribe only the film. In that blog post, I describe how the drug representative told me that sublingual tablets were now suddenly too dangerous to prescribe, due to pediatric overdoses. She also told me it was much better for patients to be prescribed the film, since people addicted to pills could be triggered by tablets.

Her credibility took a big hit that day, because she’d promoted the hell out of her company’s tablet form of Suboxone and Subutex to me for years. I called her out on the inconsistency and disingenuousness of her statements, promulgated by her company, and I blogged about it.

At her next visit, she told me she was “disappointed that I chose such a public forum to describe our conversation.”

It was the first time someone chastised me for something I wrote on my blog, and I was elated. I felt like a real journalist!

She hasn’t visited my office since, and I haven’t missed her. She’s a nice lady, which is the only reason I put up with her in the first place. Right or wrong, I‘ve always found drug reps to be tedious.

I harbor no illusions about what drug reps do. Their job is to sell their product. When I worked in primary care, I was lied to on a regular basis by drug reps. For example, when the drug rep for a company that sold Prempro told me that estrogen replacement therapy reduced the risk of breast cancer. I remember being shocked into silence as I frowned at him, wondering if he thought I was really, really stupid.

Back to the point of this blog. So in 2012, R-B tried to prevent the generic from coming onto the market by saying the pediatric overdose problem was so bad that only the films (still under patent with R-B) should be prescribed

The lawsuit alleges consumers had to pay higher prices due to RB’s efforts to block generic tablets. These states want Indivior, formerly Reckitt-Benckiser, to pay back billions of dollars of profit obtained through unfair practices.

The lawsuit alleges the company manufactured claims of pediatric safety as a way to manipulate doctors into switching their patients over to the film, instead of continuing to prescribe the tablet form of the medication, which would have generic versions coming onto the market soon.

The drug company, as well as the company that developed the film technology, both say they did nothing wrong, and that their product has saved countless lives.

So…what is the price difference for different forms of buprenorphine? I did some current comparisons for my area on www.goodrx.com, recording the lowest price on the site for people with no insurance. Here are the results:

Generic buprenorphine: dose of 16mg per day, #60 tabs: $133

Generic combination product, buprenorphine/naloxone, dose of 16mg per day, #60 tabs: $243

Name brand Suboxone Film, same dose of 16mg per day, #60 films: $455

Name brand Zubsolv, dose of 5.7mg, two per day, #60 tabs: $455

Name brand Bunavail buccal film, 4.2mg, two per day (highest recommended maintenance dose) #60 films: $455

I’m sure readers find it remarkable, as I do, that all three of the name brand forms are the same price. It’s also interesting that the cheapest form, generic buprenorphine monoproduct, is only 28% of what the name brands all cost.

Here’s something more fascinating – BlueCross/Blue Shield of NC requires prior authorization for every one of their covered patients who are prescribed buprenorphine. For years, this insurance company will ONLY authorize payment for the name brand Suboxone in film form. They refuse to pay for the cheaper generic, either mono or combination forms.

I don’t know why BC/BS decided to only cover the name brand Suboxone films.

I could understand if they wouldn’t pay for the monoproduct, due to concerns that it’s more desirable on the black market, and the insurance company may not want to contribute to this problem. But why do they object to the generic combo product? Perhaps they worked out a special, cheaper deal, or perhaps they were swayed by drug manufacturer patter.

It’s hard for me to see that Reckitt-Benckiser/Indivior did anything different than what other drug companies do routinely. Of course their drug salespeople exaggerated the danger of pediatric exposure to buprenorphine tablets in an effort to influence doctors to prescribe only the films. But their claims were so weak and transparent that it would be a gullible doctor indeed who fell for the company line.

And since when do doctors accept what a drug company salesperson tells them at face value? I’m not saying outright lying by drug company representatives should ever be OK, but…it happens.

The drug companies make big bucks, but they counter by saying they spend so much money in research and development of new drugs, and if it weren’t for their work, we wouldn’t have all these new medications that we have that are extending peoples’ lives.

That’s somewhat of a legitimate point, but at what point do we say the drug companies are making adequate profits or excessive profits? And at what point does an exaggeration about a medication become a lie?

 

To Taper or Not To Taper…

aaaaaaaaaaajudgy cat

 

Below is a comment responding to my last blog post, and my answer to it. I thought this aspect of buprenorphine treatment was so important that it’s worth a blog of its own.

While I wholeheartedly disagree with a decision not to stock any buprenorphine products at a pharmacy, I understand what led to it. The area has a troubling pattern of buprenorphine use to maintain dependence instead of being tapered to actually treat the dependence and help the patient. A pharmacist should be able to refuse prescriptions that are being prescribed and/or used inappropriately without having to fall back on a blanket “we no longer stock it” statement. Ensuring that patients who are being gradually tapered to treat dependence or bring treated for pain have a harder time getting their medication is not an acceptable way to lessen the abuse.

         Posted by janaburson on July 28, 2016 at 8:56 pm  edit

Aha!! You may be on to something. Maybe these pharmacists think, like you do, that buprenorphine should be tapered, instead of being used as a maintenance medication. When it first came out, I think many of us hoped we could taper people off of it quickly. However, more & more studies are showing that the patients who stay on buprenorphine do the best. By best, I mean not dying, no illicit opioid use, can hold down a job, finish school, be a good parent, etc.
People who taper have a high relapse rate. Relapses can be deadly. Our opioid overdose death rate is already too too high. Let’s not make it worse by insisting opioid use disorder be treated like a short-term illness, rather than the chronic disease that it is.
Having said that, patients are different, and taper may be appropriate in selected patients. But it’s not a quick process and it takes time to get the counseling and make life changes.
Would you tell a diabetic, who is not eating right or exercising, that they should taper off metformin, since if they changed their behavior, they would not need medication?

I forget there are still people who think buprenorphine should only be used temporarily, as a detoxification medication. I’m not saying that’s always wrong. A minority of patients may do well with only a taper, but most patients with opioid use disorder do better if they stay on buprenorphine long-term.

Does that mean these patients should never taper off buprenorphine? I’m not willing to say that either. We don’t have enough information from good studies to show us how long is long enough.

We do have studies now that tell us tapering off buprenorphine after a few months of stabilization isn’t going to produce best outcomes for most patients.[1, 2, 3]

We also know active opioid use disorder is associated with a high mortality risk.

Some people do misuse buprenorphine, and shouldn’t be kept on this treatment. Those patients will do better with another form of treatment, perhaps methadone.

Let’s take what we know about opioid use disorder and its treatment with buprenorphine, and apply it to an imaginary disease that has no moral judgment attached. Let’s call our disease “Syndrome X.”

We know Syndrome X causes a great deal of emotional, physical, and spiritual suffering. It can occur in anyone, and has a high mortality rate. It can be effectively treated with a medication that is relatively safe, and does not cause euphoria when used correctly. However, the medication can cause some withdrawal if it’s stopped suddenly.

While on medication, patients with Syndrome X feel normal, unlike how they feel off medication. On medication, these patients are more likely to be in better physical health, mental health, and are more likely to be employed. They are more likely to be productive members of their families and their communities.

The studies of patients with Syndrome X show pronounced reduction of death rates while patients are on medication, as well as lower rates of infectious diseases. We also know from studies that if patients with Syndrome X are tapered off their medication, their death rates increase anywhere from three times to sixteen times compared to if they stayed on their medication.

Who in their right mind would ever recommend tapering the medication? Who would say to their loved one, “You’ve got to get off of that stuff. You just need to be strong.” Or, “Isn’t it time you stop using that crutch?”

It’s only because of the stigma this country has against people with substance use disorders that tapering off a life-saving medication is even an issue. If we were talking about any other chronic illness, there would be a loud clamor for every person to be able to get on and stay on that medication. In fact, doctors not prescribing a medication with as much benefit as buprenorphine has for opioid use disorder would be accused of malpractice.

I don’t push my patients to taper off buprenorphine. If that is their desire, I’ll do everything I can do to help them. I tell them what I’ve seen work in my other patients, work with them on relapse prevention, and encourage them to go slowly, to give their brain time to adjust as their dose comes down.

I’ve had many patients taper successfully, and most of them did this after at least a few years of stability on buprenorphine. When I see new patients, I tell them this isn’t (usually) a quick fix that they can do in a few months and be cured forever. A few lucky patients are able to taper quickly but I think we now have studies showing this isn’t the situation for most people with opioid use disorder.

How about this: leave the timing of the taper up to the patient and their doctor.

If you aren’t one of these two people, maybe you don’t get to have an opinion on when or even if a taper should be attempted.

1.Fiellin et al, See comment in PubMed Commons belowJAMA Intern Med. 2014 Dec;174(12):1947-54.

This study concluded “Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care.” The taper arm of the study was started after six weeks of stabilization, with a three week taper. Patients on the taper were offered medication to help withdrawal symptoms and also offered naltrexone treatment. Patients who tapered were significantly more likely to have opioid-positive drug screens compared to the patients who remained on buprenorphine maintanence. Patients on maintenance were significantly more likely to remain in treatment for addiction counseling that the patients were tapered.

2.Marsch et al,  See comment in PubMed Commons belowAddiction. 2016 Aug;111(8):1406-15.

This study of fifty-three young people aged 16 to 23 were enrolled in a double-blind, placebo-conrolled trial. Subjects enrolled in the arm of the study where buprenorphine was tapered over fifty-six days were signigicantly more likely to have opioid-negative drug screens and continued participation in treatment compared to subjects given twenty-eight day tapers

3.Weiss et al, Prescription Opioid Addiction Trial

“Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence: A 2-Phase Randomized Controlled Trial.”  Archives of General Psychiatry 2011.

This study of prescription pain pill users found that taper off buprenorphine after stabilization shows a high relapse rate.

Local Walmart Rolls Back Buprenorphine Decision

aaaawal

 

Great news! After my blog on Sunday, the pharmacy in the North Wilkesboro, NC Walmart decided to stock buprenorphine products again.

I am grateful to my faithful readers. I suspect some of you know people, or are people, with enough clout to get Walmart’s attention. I know the Alcoholism and Drug Abuse Weekly journal is planning a story about pharmacies refusing to stock buprenorphine, and talked with Walmart officials. Other readers contacted people they knew, and raised awareness about this issue.

All day yesterday I got email from people who were outraged about my local Walmart’s decision not to stock buprenorphine. By now, it’s clear that it was a regional decision and not a dictate from corporate Walmart.

The head of media relations called me yesterday afternoon, saying “the problem was fixed,” and that everything was fine. I wanted details, but she didn’t have any for me. I told her blog readers in other parts of the country said their local Walmarts were not stocking buprenorphine products. I feared she didn’t recognize the extent of the problem, but she kept saying the problem was fixed and she thanked me for bringing to Walmart’s attention.

I wanted to make sure, so I called my local Walmart again yesterday evening. I reached the pharmacist on duty, and asked him if it was true that Walmart was going to stock buprenorphine products again. He said yes, they had to, and that they had a “big long meeting today” about this issue. To make sure I understood, I asked, “So if I write a prescription for a buprenorphine product, and my patient brings it to Walmart pharmacy, will you fill it?”

“Yes,” he said. “Send him right over.”

This is the best possible outcome. I’m happy this issue is resolved, and I glad I won’t have to boycott Walmart (they have great pies).

However, I’m still curious about why the original decision was made not to stock the product, and why it was reversed.

I’m eager to see the article in Alcoholism and Drug Abuse Weekly.  http://www.alcoholismdrugabuseweekly.com/

Access to Buprenorphine Will Expand; News About CARA

aaaaaaaaaaa

 

 

 

Last week, the Department of Health and Human Services (HHS) announced it was raising the limit on the number of patients each doctor can treat for opioid use disorder with buprenorphine, from the present cap of 100 patients to 275 patients. However, each doctor must first meet criteria and complete an application procedure to be approved for this higher limit.

Initially, HHS wanted to increase the limit to 200 but for some reason ended up with 275. It’s still an arbitrary number, and opioid use disorder remains the only disease to have patient enrollment limits legislated for physicians.

HHS still wants physicians to meet extra requirements before they are approved to accept 275 patients, as I blogged about in my May 8, 2016 post:

  • Have professional coverage for after-hours emergencies.
  • Provide case management services
  • Use electronic medical records
  • Must use that practitioner’s state prescription monitoring program
  • Accept third-party insurance
  • Have a plan to address possible diversion of prescribed buprenorphine medication
  • Re-apply for permission to treat up to 275 patients every three years
  • Supply yearly reports about their practice and their buprenorphine patients

For some of the reasons I names in my May 8th blog, at this time I’m not planning to request permission to treat more than 100 patients.

This measure by HHS is a good and positive thing, and will help more desperate people get treatment. Just because I have a few objections to several HSS’s requirements doesn’t mean other doctors will feel the same way. I expect many physicians treating opioid use disorder will undergo the procedure to expand their patient limit.

 

Meanwhile, both the House of Representatives and the Senate passed the Comprehensive Addiction and Recovery Act (CARA) as of last week, and the bill is going before the President for his signature.

This bill, considered weak by some members of the House, contained only a fraction of the requested money to treat addiction. However, other advocates for addiction treatment say even a weak bill is better than none.

CARA’s content addresses the following:

Expand availability of naloxone to law enforcement and first responders, in order to quickly reverse opioid overdoses and prevent deaths. I think our own Project Lazarus helped get this ball rolling many years ago, and I’m so grateful my OTP has had support from them to give our patients naloxone kits!

Expand education and prevention efforts toward teens, parents, and aging people to prevent drug abuse and promote treatment and recovery.

Encourage states to improve their prescription monitoring systems. I hope some of that money will be directed to interoperability, meaning it will be easier to access a neighboring state’s prescription monitoring program. I also hope the Veteran’s administration will start reporting their data about prescribed controlled substances, too.

Prohibit the Department of Education from rejecting financial aid for people who have had past drug offences. I didn’t know people with drug offences on their record were denied governmental financial aid. If we want people to improve themselves and their life situations, why would we deny help for them? So this measure in CARA is great.

Expand resources to identify and treat incarcerated people with substance use disorders using evidence-based treatments.

Great idea, about forty years late.

Expand drug disposal sites to keep leftover meds out of the hands of children.

Just a question I’ve always had…Of all the tons of medication which have been collected at these disposal sites, has anyone ever studied how much controlled substances are collected?

Launch a “medication assisted treatment and intervention demonstration program.”

Not sure exactly what this will look like, but good luck with all of that.

I feel like I’ve beaten my head against the brick wall of prejudice and stigma against MAT in my community for four years. All I have is a headache…and resentment towards the medical community. I’d be very happy if someone else wants to take over for a while.

Launch a program to promote evidence-based treatment of opioid use disorder.

Well, yeah. it needs to happen. Actually it needed to happen about fifteen years ago, but whatever.

Director money towards law enforcement, to get people with substance use disorders help, rather than incarceration. CARA wants law enforcement to be able to work with addiction treatment services.

I indulged a private snicker at that last one. What a change from only a few years ago.

About six years ago, I was trying to educate people about medication-assisted treatment of opioid addiction. I thought I could help educate law enforcement personnel about addiction treatment, since they encounter it so much. I used the internet to find a journal for law enforcement.

I wrote to the editor, offering to write an educational article for their publication about opioid addiction treatment. My hopes weren’t especially high, but I wanted to give it a shot.

I was surprised when the journal’s editor took the time to call me in person. I was so excited!

Then the editor started talking to me like I was a naughty child. He asked what made me think it was appropriate to waste his time with such a query letter. He said I should have known better than to think any of his readers would be interested in the kind of thing I was offering to write, and he was calling to see what kind of person would be so unwise as to think otherwise.

I was stunned. I regret my reaction to him. I was so taken aback that I started apologizing to him, and said I was so sorry for bothering him and wasting his time.

In reality, he behaved like an asshole. If he didn’t want to waste time, he could have passed on the urge to call me to tell me how stupid he thought I was.

I wish I would have stuck up for myself in that conversation. I like to think I would handle it differently today.

Anyway, now, six years later, the government earmarked money to help law enforcement learn about opioid use disorder treatment.

While writing this article, I’ve come to realize I have bitterness towards people in law enforcement, medical fields, judicial, etc…when they denigrated my efforts to educate them about medication-assisted treatment for opioid use disorder.

I don’t want this bitterness. It’s too hard on me. It’s a weight that interferes with my enjoyment of life, and I’m going to release it.

The tide has begun to turn. We have legislation addressing the terrible opioid addiction problem we have, and money earmarked to help the problem. I want to be able to work with people who may have said bad things about medication-assisted treatment of opioid use disorders in the past. I want to work with those people without feeling resentment and without indulging in sarcasm.

Probuphine Implants: Impractical?

Probuphine

The more I learn about Probuphine, the less I think it will be practical for use in the average office-based opioid use disorder treatment setting. I predict it will be a specialty medication implanted by a few practitioners who take referrals from other doctors.

Braeburn Pharmaceuticals is sponsoring conferences for doctors to learn how to insert Probuphine, the form of buprenorphine that’s implanted under the skin like Norplant, the birth control medication. This medication is marketed by Titan Pharmaceuticals. Probuphine consists of four slender rods that are inserted just under the skin at the upper arm. These rods release buprenorphine over six months, when they have to be removed, and new rods implanted.

I wasn’t sure I wanted to do Probuphine implants, but I liked the idea of being able to do it, so I asked to attend one of their conferences to learn the procedure.

Alas, the company says only doctors who have performed minor surgical procedures over the past ninety days are eligible to learn to be an implanter of Probuphine. I can still prescribe it if I take the course, their letter says, but I’d have to refer to someone else to implant Probuphine.

Huh? I thought I could prescribe it already, since I have an “X” number. Maybe not.

If I can prescribe it but I can’t administer it, why would the patient see me at all? Why not just go directly to the doctor who can prescribe and implant?

I looked around the room during my recent addiction medicine conference and tried to imagine how many of these specialists had done surgical procedures over the past three months. There was one surgeon, and a few obstetricians, so I decided three out of sixty or so of the doctors who presently prescribe buprenorphine.

Even if the FDA approves Probuphine in May, I have a hard time imagining how Probuphine could be used in a typical office-based buprenorphine practice.

Because besides the implantation conundrum, who pays for it? Drug company representatives were unable to answer questions about the cost.

And how does the implant, the implanting physician, and the patient all arrive at the appointment time? Is the doctor expected to order the implant, store it in her office, and hope the patient shows up for the implantation? Surely we couldn’t give a prescription to the patient to take to a pharmacy for the implant, so I’m not sure how that’s going to work.

Won’t this medication need prior approval? Representatives from the drug’s manufacturer say “no,” but I have a hard time believing that.

I picture one or two sites in North Carolina that will have the resources to do the implants and probably keep them in stock, perhaps at a hospital pharmacy. Maybe the teaching hospitals will have the resources to do this.

Also, the Probuphine delivers drug levels equivalent to six to eight milligrams of sublingual buprenorphine, so patients at higher probably won’t be considered.

I’m starting to doubt the practicality of Probuphine at an average addiction medicine physician’s office.

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.