Archive for the ‘Buprenorphine’ Category

Buprenorphine Regulations

Map is from

In response to the rise of opioid use disorders in this country, lawmakers in heavily affected states are passing laws they hope will help. But well-intentioned laws may have unintended consequences, requiring re-evaluation of those laws.

Nearly one year ago, The Virginia legislature asked the Virginia Board of Medicine to regulate prescribing of buprenorphine. Legislators were worried about the diversion of prescribed monoproduct buprenorphine to the streets. You can read about this in more detail in my blog entry dated February 24, 2017.

It’s been a year since that blog entry, and I have a little bit of data regarding some of the consequences of Virginia’s new rules.

Initially, the new Virginia Board of Medicine (VBOM) regulations said the buprenorphine monoproduct could only be prescribed for pregnant ladies and nursing mothers. They did this because the monoproduct, containing only buprenorphine and no naloxone, has a higher street value and is more likely to be injected and misused than the combination product.

The VBOM received so many complaint letters that they finally changed the regulations to say that each buprenorphine physician could prescribe buprenorphine monoproduct to up to three percent of their patients. Each of these patients must have documentation of their intolerance in their chart.

It was hoped that this compromise would limit the amount of buprenorphine monoproduct being prescribed, while still making allowances for some patents with intolerance to naloxone in the combination product.

The VBOM didn’t stop there. They passed regulations about care at opioid treatment programs (OTPs), which are already the most heavily regulated medical providers in the nation. The VBOM said if buprenorphine monoproduct was used, the patient had to consume it on site, with observed dosing, and that no take home doses could be allowed for the monoproduct.

To clarify, this meant that OTP patients dosing with buprenorphine monoproduct had to either switch to the combination product, buprenorphine/naloxone, to get their usual take homes, or dose daily at the OTP on the monoproduct and forfeit all the take homes they had earned.

Or they could switch to methadone, where take homes are still allowed, following standard guidelines.

This is the irony – methadone is a heavier and stronger opioid than buprenorphine, and more likely to cause overdose death if taken illicitly or diverted. Virginia patients can get methadone take home doses, after they have a period of stability and meet the guidelines which have been in place for decades.

OTPs must follow both state and federal guidelines, and must obey the stricter of the two. The federal guidelines dropped the time in treatment requirement for buprenorphine, meaning the federal agency decided to allow the admitting physician to decide how many take home doses were appropriate, from day one, for a buprenorphine patient.

Essentially, Virginia went the opposite direction, and eliminated take homes, at least for the monoproduct.

At the time the new regulations were implemented, there were 600 Virginia patients on buprenorphine at OTPs. Monoproduct was used because was about half the price of the combination product, and kept treatment more affordable for patients. Also, because OTPs already followed stricter regulations than office-based programs, the risk of diversion was felt to be lower than at office-based programs.

Of those 600 patients, 384 patients attended one of the four OTPs owned by Acadia Healthcare in Virginia. They collected data on what happened to their Virginia patients after these new regulations were implemented. Since I work for Acadia, that data was released to me for an upcoming presentation, but I’ll give my readers an early view.

Of those 384 patients, 260 made the switch to the combination product so that they could continue to get take home doses. In other words, two-thirds of the patients switched, and one-third did not.

The cost of medication doubled, but rather than pass this on to the patients, Acadia Healthcare absorbed all the extra cost. The patients paid the same as if they were getting the cheaper monoproduct. This was fortunate, since an overnight doubling of costs could have caused hundreds of patients to leave treatment.

To some lawmakers, an extra couple of hundred dollars per month might not seem like much. But to many patients, it’s the difference between being able to stay in treatment or having to leave and go back to illicit drug use.

So, what happened to the patients who didn’t make the switch?

  • 15 switched to methadone, and will be able to get take home doses once they meet criteria. It’s takes a while, but at least they can get take homes eventually.
  • 21 transferred to out-of-state opioid treatment programs because they had an intolerance to the combination product.
  • 24 (6%) patients dropped out of treatment.
  • 58 remained on the monoproduct and accepted that they will have to dose every single day that they are in treatment. Since all these clinics are in rural areas of Southwestern Virginia, I suspect some of these people are driving long distances daily, and incurring extra expenses for that travel.
  • 6 patients were lost to follow up, and couldn’t be contacted to see what happened.

Studies show the risk of death increases as much as eight-fold for patients who leave treatment, so those 24 people are at high risk. I suspect the 6 people who couldn’t be found are also in that risk group.

I have a little bit of data about what’s happened on the receiving end with patients on buprenorphine at Virginia OTPs. One OTP located in Boone, NC, received 12 patients in transfer from Virginia. Those patients could have been OTP patients or office-based patients; I don’t have that data.

I have my own office-based buprenorphine practice in the Lake Normal area of North Carolina, which is 73 miles from the North Carolina-Virginia border. My practice got around twenty phone calls last year, just after Virginia’s law changed. These patients were willing to drive from Virginia to my office if I would prescribe buprenorphine monoproduct. I declined to accept any of those patients, both because it is unworkable in the long run to come from such a distance, and because I was concerned about regulatory scrutiny in my own state.

You can draw your own conclusions based on this limited data. It appears that roughly two-thirds of patients, if forced to switch to the combination product, can do so and remain in treatment.

But remember, costs weren’t increased for those patients enrolled at Acadia OTPs.

That would not have been the case for office-based self-pay patients, who would have paid roughly double each month for their prescriptions for combo products at the pharmacy. Community pharmacies would not have absorbed the extra cost.

I combed the internet, trying to discover data on what happened to office-based patients in Virginia on the monoproduct. If data is out there, I haven’t found it. Or perhaps it’s still being collected and analyzed. I also looked to see if overdose death data changed much in 2017, but it’s likely too early for this.

The American Society of Addiction Medicine has written a public policy statement addressing regulations on office-based buprenorphine policy. This document outlines the most reasonable approach to assure appropriate care for patients while limiting onerous regulations for providers. State legislators would do well to read this policy and abide by its specific recommendations.

I’m tempted to give a summary of ASAM’s statement, but ASAM warns against this, at least without their permission. They don’t want people to use just a section of their policy to justify a position; they want their statement to be read in full.

I think that’s smart of ASAM. I encourage interested readers to check it out.


Buprenorphine Monthly Injection: Sublocade












Late last year the FDA approved Sublocade, the brand name of a monthly buprenorphine injection, marketed by Indivior, the same company that sells Suboxone brand sublingual films. Sublocade is expected to be commercially available by February or March of this year.

This medication is indicated for patients with moderate to severe opioid use disorder who have stabilized on transmucosal buprenorphine products for at least seven days. Sublocade comes in a pre-filled syringe, and is injected into the subcutaneous tissue over the abdomen. This viscous liquid forms a solid deposit containing buprenorphine, and the medication is released over a month, giving therapeutic plasma levels of buprenorphine.

Thus far, we have two studies, one a randomized controlled trial and another that was an open-label study, that both show Sublocade, compared with placebo, was significantly more likely to result in fewer positive drug screens for illicit opioids and in fewer self-reports of illicit opioid use.

Of note, the manufacturer warns against attempts to inject this preparation intravenously, because the solid mass that forms can block a blood vessel, or travel in the vessel to the lungs, possibly causing death from a pulmonary embolus. To reduce the risk of this bad outcome, the medication will only be distributed to healthcare professionals, and not to patients.

Sublocade comes in two doses; a 300mg dose and 100mg dose. Patients should receive 300mg per month for the first two months, then drop to 100mg per month. This is the indicated dose for patients on the equivalent of sublingual buprenorphine 8 to 24mg per day. If patients have inadequate response after dropping to 100mg, the dose may be increased to 300mg in some patients, if the physician feels this is indicated. At the manufacturers website, they say Sublocade delivers a dose adequate to block opioid receptors to the degree that if other opioids are used, they will have no effect.

Steady state is established after 4-6 months of treatment. Steady state is a term describing the pharmacokinetic state where the drug’s intake is in dynamic equilibrium with the drug’s elimination from the body. Usually this occurs after four to five times the drug’s half-life. After steady-state has been achieved, buprenorphine may be detected in patients for up to 12 months after dosing stops. It is unknown how long buprenorphine will remain detectable in urine testing.

After this medication is stopped, the patient should be monitored for opioid withdrawal symptoms for several months, since blood levels will drop slowly.

Indivior recommend checking liver function tests at baseline, then monthly.

Because of the possible harm of intravenous use of this product, Indivior created a REMS (Risk Evaluation and Management Strategy) protocol. Healthcare settings seeking to dose Sublocade and pharmacies wishing to dispense Sublocade must be certified by the REMS program for this medication.

I tried to go to the website mentioned on the Indivior website regarding the REMS requirements, but the link wasn’t working for me.

I’m excited about this new option because it can reduce diversion of buprenorphine products. At the opioid treatment program, we have a fair number of patients who attempt to divert or misuse sublingual forms. At present, if I have unmistakable evidence a patient is trying to divert medication, I can no longer prescribe it. I can offer to switch the patient to methadone, but that’s unattractive for several reasons to many patients. But if we can administer subcutaneous buprenorphine, it gives us another option. It would be difficult to divert, and it isn’t as complicated to administer as the Probuphine implants.

I do have some concerns. First, how do the financial aspects work? Since it can only be dispensed to the healthcare provider for administration to the patient, I suspect the facility or physician owner of the practice will need to buy the medication and pay up front. What if a patient’s insurance company refuses to pay? What if a patient refuses to pay, or only pays part of the drug cost? Could the physician lose money treating patients if this happens?

Currently, with sublingual buprenorphine products, the physician isn’t in the middle. The patient pays the pharmacy directly.

I was thrilled to learn that North Carolina’s Medicaid program will pay for this medication, without even requiring a prior authorization. That’s wonderful, but many private buprenorphine practices don’t treat Medicaid patients, due to low reimbursement rates. But this will be good for facilities who do accept Medicaid as payment.

I’m amazed our state can afford this. Perhaps they got a much better deal from the drug company, Indivior, than the quoted priced of $1500 to $1800 per month. One month’s worth of generic monoproduct buprenorphine, dosed at 16mg per day, costs about $105 per month at the cheapest retail pharmacy, according to That means this new subcutaneous injectable formulation costs fourteen times more than the cheapest form of buprenorphine on the market.

That’s quite a difference. I’m assuming the state’s willingness to pay this expense is based on expectation of a marked decrease in diversion of this medication. Apparently, the lump of buprenorphine can be cut out if it’s done within the first 14 days, but that seems an unlikely extreme for patients. In other words, with the monthly injection, the medication will reach the patient for whom it is prescribed.

At this point we could launch into a discussion about whether diversion of buprenorphine – possibly the safest opioid available – is a good or bad thing. Law enforcement types see diversion as bad, but arguing a pure harm reduction viewpoint, one could say that diverted, black market buprenorphine might be saving lives by giving people with untreated opioid use disorder a safer option. Note that I said safer, not safe. But that whole debate is an entire blog post so I’ll keep the focus on this new way of delivering buprenorphine.

About half of my office-based patients are self-pay, with no Medicaid or private insurance. They pay out of their own pocket for my office charges, and pay for their medication at their pharmacy. I think Sublocade’s price will make it an unworkable alternative for these people. About half my patient have private insurance, and most have Blue Cross/Blue Shield. I plan to make some phone calls, to get information about their payment policy for Sublocade.

I’m eager to try this new preparation at the opioid treatment program. It sounds like this will be workable for Medicaid patients.

But that brings up my second concern: how can I get patients to come for weekly counseling sessions if they only get medication once per month? I was pondering this idea in a group Email yesterday when I was informed (by someone who knows these things) that soon, a competitor of Indivior will be releasing a weekly injection form of buprenorphine. He envisioned weekly injections for new patients, with gradual decreasing of frequency of visits as the patient stabilizes, eventually moving to monthly treatment and counseling sessions, when clinically appropriate.

I like this idea. This sounds workable. And as I emailed him…let’s hope there’s a price war, with both companies lowering their prices to attract patients.

I’m happy about any new options for patients, and I’m eager to use this product. I just hope cost won’t be a deal-breaker for patients and their insurers.


Subcutaneous Buprenorphine Injections for Treatment of Opioid Use Disorders






I’ve blogged in the past about studies conducted on CAM2038, a new preparation of buprenorphine that can be given in a subcutaneous injection weekly or monthly. I think this delivery system holds great promise for the treatment of opioid use disorder.

Earlier this year, pharmacokinetic data from healthy volunteers showed that blood levels with the subcutaneous injections equaled the levels provided by sublingual means. This data supports the idea that the injections should provide therapeutic levels in patients with opioid use disorder. [1]

Later this year, a Phase II study was published in JAMA Psychiatry. Weekly subcutaneous preparation of buprenorphine was administered to 47 subjects with opioid use disorder. These patients were not seeking treatment, but had agreed to take part in this study, and all were diagnosed with opioid use disorder, either moderate or severe.

These subjects were given dose of either 24mg or 32mg one week apart, and had complete suppression of opioid withdrawal at both doses. The subjects were then challenged with varying doses of hydromorphone, and had sustained blockade of response to the hydromorphone. [2]

The six-month implant, brand name Probuphine, hasn’t been widely prescribed. As I predicted, the confusion over cost, insurance coverage, and implantation regulations have so complicated Probuphine’s use that mainstream medical providers aren’t considering its use. Also, it’s only indicated for patients on 8mg or less of sublingual buprenorphine, and patients have concerns about what will happen if it doesn’t work well. They ask if their insurance companies would pay for supplemental buprenorphine if the implant doesn’t work as well for them. I don’t know for sure, but I’m guessing they would not pay for supplemental medication.                                                                                                                                                                                                                                                                                                                                                                                                                 My biggest concern with Probuphine was that patients may be less inclined to come for counseling sessions if they have had a six-month implant that keeps them feeling normal. They have no monthly incentive to see their physicians. Many physicians require counseling as a condition for ongoing monthly prescription for sublingual buprenorphine.

I like the idea of injections for weekly or monthly buprenorphine. If it works as well or better than sublingual buprenorphine, it could be the solution to some difficult problems.

  • It would save time for my patients on buprenorphine at the opioid treatment program. One of the complaints we hear is of the regulations surrounding treatment in our setting. Unlike in the office-based setting, buprenorphine prescribing at the opioid treatment program demands we follow the sometimes onerous rules of both state and federal laws governing opioid treatment programs.
  • It would resolve our diversion dilemma.But injections can’t be diverted, so far as I’m aware.
  • Because buprenorphine has a high street value in my community, patients are sometimes tempted to spit out their medication to sell it, or even to inject it into themselves. We don’t want this, given the high rates of complications with intravenous use. We don’t want patients to sell medication because it hurts our reputation in the community. We don’t want to be known as suppliers of illicit buprenorphine.
  • It would be a godsend for patients who have to go to jail unexpectedly.
  • Most of the time, jails won’t bring incarcerated patients to the OTP for their daily dose of buprenorphine (or methadone), so they suffer opioid withdrawal and are at risk for relapse upon being released, with increased risk of overdose death. But if we can give them a monthly or even weekly shot, it will keep them feeling better, and serve as a blocker if they do leave jail and use illicit opioids like Opana or oxycodone or heroin.
  • Patients wouldn’t have to think about taking medication each day; with the injections they wouldn’t have to take a dose of anything each day, just show up for weekly or monthly injections given to them by a medical professional
  • Subcutaneous injections are much less complicated to administer than Probuphine, with rods that require a minor surgical procedure to implant, then explant six months later.The FDA plans to discuss this new preparation of buprenorphine at their advisory committee meeting November 1, 2017. Several days prior to this meeting, data to be discussed at this meeting should be available online for interested readers. [3]If this new option is approved by the FDA, it can give us yet another tool with which to treat patients, always a good thing.
  • 1. Albayaty et al., Advanced Therapeutics, 2017, Feb; 34 (2)


  • 2.Walsh et al., JAMA Psychiatry, 2017;74(9):894-902.


Maximum Daily Dose of Buprenorphine

Hser et al., 2014, Addiction






I’d like to thank my readers for their patience during my recent break from blogging. Now that I’m rested, it’s time to start barbequing some sacred cows.

First on my list: limiting the dose of sublingual buprenorphine to 16mg per day.

Recently I’ve heard from physicians who have been told 16mg of sublingual buprenorphine is the highest daily dose that should be prescribed, because studies show that opioid receptors in a human brain are saturated at that dose in most people. While this is true, limiting all patients to 16mg or less neglects research from real life patients.

Some governmental agencies have gone as far as forbidding daily doses higher than 16mg. For example, the Virginia Board of Medicine passed a regulation earlier this year that the highest dose that physicians could prescribe was 16mg per day. In Tennessee, patients can’t go above 16mg per day unless they are seen by an addiction specialist physician.

However, the FDA has approved doses up to 24mg SL per day. Who is right? Did the FDA get it wrong? Are patients who want to go higher than 16mg all drug seekers? Or do all such patients plan to sell their excess medication?

If you read the REMS document created by the manufacturer of Suboxone film, it says the target dose should be no higher than 16mg per day, and that doses higher than 24mg haven’t been shown to provide additional benefit. That leaves a question mark about dosing between 16 and 24mg.

The American Society of Addiction Medicine (ASAM) issued a statement addressing the tendency of state prescription monitoring programs to assign MME (morphine milligram equivalents) values to buprenorphine doses. In that statement, issued earlier in 2017, they said, “The US Food and Drug Administration (FDA) approves dosing to a limit of 24 mg per day. There is some evidence regarding the relative efficacy of higher doses.” [1]

If ASAM says 24mg is OK for some patients, and the FDA has already approved that dose, that’s good enough for me…assuming the patient truly needs a higher dose.

Some patients do better on a dose of 24mg than on 16mg. I work at an opioid treatment program where we observe the patients taking their doses on site, and we pay close attention to any attempt at diversion of the dose. Therefore, we have no question about whether a patient is taking less than the dose I’m prescribing.

When I see new patients within a week or two of admission, I ask how they are feeling. Some patients dosing at 16mg per day of buprenorphine describe symptoms consistent with opioid withdrawal by late evening. I increase their dose above 16mg when I also see physical signs of withdrawal, like large pupils, sweaty palms, and the like. Many patients feel improvement to the point we don’t have to consider switching to methadone.

I increase these patients’ doses because I am sure they are getting their full dose each day, and because I see signs of withdrawal with my own eyes. I know experts say a dose of 16mg is “supposed” to block all the opioid receptors according to studies of this drug, and I believe that is true for many patients. I also think there are patients for whom increasing the dose above 16mg provides benefit, and can eliminate the need to switch to methadone.

Not that there’s nothing wrong with methadone. It has a proven track record, but it does have more medication interactions than buprenorphine, and is more dangerous with certain medical problems.

Methadone patients were under-dosed for years, when physicians had the misperception that no patient needed more than 70mg per day to treat withdrawal. With further studies and information, we know that’s not true, and best evidence shows most patients need between 80-120mg, and sometimes much more than that.

I think in years to come, we will see that by limiting patient doses to 16mg, we are under-dosing some buprenorphine patients.

Why are so many agencies trying to keep buprenorphine doses low?

First, the U.S. has a “less is more” attitude regarding medication-assisted treatments for opioid use disorder. Given the existing bias against these medications, of course some peoples’ attitudes will be grudging acceptance of the medications, but trying to limit the doses to be as low as possible.

Second, there’s the very real concern about diversion of buprenorphine. The more buprenorphine that’s being prescribed and dispensed, the more that may end up being diverted to the black market. I know this is true.

However, opinions can differ regarding the potential harm of providing more buprenorphine to the black market. Some experts might think since buprenorphine is one of the safest opioids manufactured, increased black market access could help save lives. Though many more people embrace harm reduction now than ten years ago, we are not yet in a place where the law-and- order types would allow a serious conversation about this.

Third, I’m worried that some decisions about dose maximums for buprenorphine may be driven by cost. In a state where many patients prescribed buprenorphine products are on Medicaid, higher doses would cost the state more. The same would be true for managed care organizations and the insurance companies and the like. I hate to sound cynical, but financial concerns often drive medical decisions.

By now you know my opinion; if a patient dosing with buprenorphine 16mg SL per day reports withdrawal symptoms and has physical signs that match these symptoms, I’m willing to increase the dose to 20 to 24mg per day. We have a pretty good study, by Hser et al., 2014, that shows higher treatment retention rates with higher doses. Plus, the FDA has already approved doses up to 24mg per day. [2]

I’m cautious about take home dose in patients at the opioid treatment program. If the patient has a history of injecting drugs, I’d like them to have more time in stable recovery before granting take homes. For patients on 24mg per day, I may do more frequent pill counts and bottle recalls, as a precaution against drug diversion. But I’m not sure a patient on 16mg is any less likely to sell part of her prescription than a patient dosing at 24mg.

  2. Hser et al., “Treatment Retention among Patients Randomized to Buprenorphine/naloxone Compared to Methadone in a Multi-site Trial,” Addiction, 2014, Jan; 109(1) 78-87.


Buprenorphine in the Primary Care Setting






I was asked to participate in a project to help primary care doctors provide buprenorphine in office-based settings. This grant, awarded to some very smart people at the University of North Carolina, uses the ECHO model to help physicians in the community become more comfortable with treating patients with opioid use disorder in their offices.

This ECHO model, originally conceptualized at the University of New Mexico, uses a hub-and-spoke model to connect experts at UNC and other locations with primary care doctors at their North Carolina locations. The ECHO model can help not only the physicians and physician extenders, but also nurses, social workers and other staff members who are a part of patients’ treatments, using teleconferencing.

Other hub-and-spoke models have placed physicians and the hub and patients at the spokes, so this is a little different. It’s also different from telemedicine, since the participants at the hub and spoke are all care providers, not providers and patients.

It’s a great program, and gives free continuing medical education hours to the physicians who participate, at the same time they get help with problematic situations in their practice.

Our group is prepared. We’ve done practice sessions and we’ve gotten comfortable with the technology (no small achievement for me!).

Now all we need are providers to participate.

We’ve had some interest, but of course would like to reach as many providers as possible. We had some brainstorming sessions about how to get more participants. We would like to reach primary care providers who have a waiver to prescribe buprenorphine, or who may be interested in prescribing.

As it turns out, many physicians who get the waiver to prescribe buprenorphine don’t end up prescribing, or only prescribe to a few patients. These providers could see more patients with opioid use disorder, and help our nation’s situation with the treatment gap.

This treatment gap is the number of people who need treatment compared to the number of people who are able to receive it. At present, experts estimate that only about 20% of people who need treatment for opioid use disorder actually get it. Of course, some of the remaining 80% aren’t yet interested in treatment, but many are desperate for help, and can’t access it.

Due to changes in the DATA 2000 law, physician extenders like nurse practitioners and physicians assistants will be allowed to prescribe buprenorphine to treat opioid use disorder, after they take a 24-hour course. Of course…many extenders in my area have been prescribing buprenorphine for years, off-label “for pain” with a wink and a nod, but the new law will allow them to be legitimate prescribers. This may expand the number of prescribers a great deal, and help to close the treatment gap.

So why do providers, after getting the training to be able to prescribe buprenorphine, not end up prescribing?

A study done by Walley et al., published in the Journal of Internal Medicine, 2008, surveyed all 356 physicians in Massachusetts who were waivered to prescribe buprenorphine. The study was done in 2005, so that was relatively early in the history of office-based treatment. Out of that total, 235 responded to the survey. Of the 235 that answered the survey, 66% had prescribed at least once, and 34% had never prescribed buprenorphine.

Of the non-prescribers, around half said they would prescribe if some barriers were removed. Nearly a third of these doctors felt like they had insufficient office support. Other barriers, in rank of descending importance, were insufficient nursing support, lack of institutional support, insufficient staff knowledge, low demand for services, and payment issues. So this study showed physicians didn’t feel like they had the support staff that they needed.

Of the physicians who were already prescribing buprenorphine in their office-based practices, the biggest barriers, in descending order of importance, were payment issues, insufficient nursing support, insufficient office support, insufficient institutional support, and pharmacy issues.

Some additional tidbits of data emerged from this study. For example, psychiatrists were less likely to prescribe buprenorphine than were primary care physicians, and physicians in solo practice were more likely to prescribe than those in group practices.

I suspect it’s easier to implement changes to medical practice when you are the boss and the lone provider. In groups of physicians, it’s probably harder to change the status quo to take on new projects and ideas, even when more support staff are presumably available.

This trend, where many of the physicians waivered to prescribe buprenorphine don’t end up prescribing, or prescribe for very few patients, has continued through the last fifteen years.

A study from 2014 by Hutchinson et al., published in the Annals of Family Medicine, looked at 120 physicians in Washington State who received training in 2010 and 2011, to prescribe buprenorphine for opioid use disorder. Out of the 120 providers trained, 92 participated in the post-training survey. Of those providers, some were excluded because they were still in their residencies, or were prescribing buprenorphine before they took the course, leaving 78 physicians newly qualified to receive a waiver to start prescribing buprenorphine for opioid use disorder

Of these 78 physicians, only 64% actually applied for the waiver. Of these 50 physicians, only 22 actually ended up treating at least one patient with buprenorphine. In other words, only about a fourth of physicians who could start prescribing to treat opioid use disorder actually did so. Of these 22 physicians, half prescribed for only three or fewer patients.

Physicians in a practice where there was already another physician prescribing buprenorphine were significantly more likely to actually start prescribing than physician in practices where no other physicians prescribed. Younger physicians were more likely to prescribe buprenorphine than older physicians. Fewer than half of these physicians were willing to have their names listed on SAMHSA’s buprenorphine treatment locator site. (

Another study by DeFlavio et al., Rural Remote Health, 2015, was done with an anonymous survey of all of Vermont’s primary care doctors. As it turns out, 10% were buprenorphine prescribers, while 80% said they saw patients addicted to opioids. The barriers that these physicians saw for buprenorphine treatment were inadequately trained staff, insufficient time, insufficient office space, and cumbersome regulations.

Interestingly, Vermont also used a “hub and spoke” model, where experts at the hub stabilize patients newly starting buprenorphine, and after stabilization they transfer to the “spokes” which are primary care providers who continue the prescribing for these patients. This model seemed to work well for the patients and physicians who participated.

As of today, SAMHSA’s website ( accessed 6/6/17) says there are almost 38,000 physicians with waivers to prescribe buprenorphine from an office setting to treat opioid use disorder. Around 3200 have permission to treat up to 275 patients; nearly 9000 can treat up to 100 patients, and around 26,000 can treat up to thirty patients.

In other words, if all of these physicians were prescribing to their maximum, and were located in areas with the highest rates of opioid use disorder, we’d have enough manpower to treat all patients who wanted help.

But these providers aren’t at their maximum.

How can we convince these doctors to prescribe for more people? How can we recruit new providers, who will follow through with a commitment to treat people with opioid use disorder? How can we remove the barriers, which largely appear to fall under the category of insufficient support to give good care?

Some smart people have been working on this for some time, and we now have several models available to assist buprenorphine providers help patients with opioid use disorders.

“Collaborative Care Model,” also known as the Massachusetts model, uses nurse care managers to expand access to treatment. This model is based on how patients with other difficult chronic diseases are managed, such as diabetes and HIV infection. In other chronic illnesses, nurse care managers help the patient with day-to-day care management. This helps the physician know what is going on with the patient and gives the doctor much-needed support to manage the health of these patients.

Studies done on this model showed that patients did as well or better than patients managed only by physicians. This program expanded into community health centers, and the numbers of waivered physicians participating increased by 375%, though this was at a time when buprenorphine was first taking off anyway. The patients treated under this model also had significantly fewer hospital stays.

In this model, nurse managers were doing much of the medical management: doing inductions, doing follow-up on patients, and troubleshooting any problems the patients were having. Providers participating in the model mentioned that RNs can’t charge as much for the care they provide as physician extenders or physicians, so that’s a possible problem.

This year at the American Society of Addiction Medicine’s annual conference, Dr. Andrew Saxon spoke during a session which addressed how to engage practitioners to treat opioid use disorders. He treats patients in the Veterans Administration system, and describing an intriguing method that he called “academic detailing” that they use at the VA.

He said that pharmaceutical companies have already found a model that works, when it comes to getting doctors to prescribe new medications. These companies hire charming people to go to doctors’ offices to spend time talking with the physicians and physician extenders, explaining the new medication and giving them brochures with information.

Dr. Saxon started doing the same thing with VA doctors. Experienced providers make an appointment to speak with a doctor, and bring him or her information, perhaps bring lunch, and generally talk about the process and pleasures of treating opioid use disorders in an office setting. This one-on-one approach appears to work well, and the VA increased treatment availability a great deal using this approach.

The VA made a slick brochure, called “Opioid Use Disorder Provider Guide” which is a pretty good summary of information needed by providers starting to prescribe buprenorphine. Since it’s in the public domain, you can access this document at:

I think this academic detailing idea is a winner. It makes sense – pharmaceutical companies wouldn’t have used this method for years if it didn’t work.

To veer off-topic for a moment…it strikes me that I’ve been trying to “detail” local providers for five years, not to get them to prescribe, but just to get them to stop telling patients to get off buprenorphine and methadone. It would be a huge relief if local doctors encouraged these patients, rather than belittling them.

I exaggerate, of course. There are many physicians in my area who are great to work with, but I guess the more difficult doctors tend to stand out in my mind.

Maybe local doctors need detailing from a physician with credentials and/or clout. Perhaps I lack the credibility or personal charisma that makes other doctors listen to me. I’d like to enlist that kind of doctor to “detail” in my area.

Back to the topic at hand.

The VA isn’t the only agency that’s created guidelines.

The American Society of Addiction Medicine (ASAM) has had a similar document, composed by experts as a guide for prescribers:

There’s also information published by SAMSHA (Substance Abuse and Mental Health Services Administration):

However, the last time I tried to download this one, there seemed to be a glitch.

So there’s plenty of information available for new prescribers, and there’s a nationwide support network called PCSS MAT, for Providers’ Clinical Support System. It’s an organization dedicated to training and mentoring medical providers in the treatment of opioid use disorders with medication-assisted therapies.

If you go to their website, ( you can access archived trainings about various topics relating to MAT. They have online modules, podcasts, and basic information. It’s possible to be connected with a one-on-one mentor with experience treating the disease. This helps the provider feel connected and supported, particularly with difficult issues that often arise.

So currently, there’s a ton of data and support for providers who want to treat patients with opioid use disorders, more than there’s ever been before.

With our ECHO UNC launch, providers can get specific recommendations for managing complex patients (with patient privacy protected, of course). Their staff can learn how to support the prescriber, and it’s all free, paid for under grant money. The prescriber can even earn continuing education credit hours, so it’s a win-win-win prospect for them.

I’ll keep my readers updated about how it’s going.

If you are a provider or know a provider who’d like to take advantage of this opportunity to learn, get help with issues that are vexing you, and get free credit hours for doing so, send me an email so I can connect you with the ECHO UNC hub. The technology is free and easy to use.

New Way to Dose Buprenorphine

FluidCrystal technology



We all know that Probuphine in now available. It’s a depot preparation of buprenorphine that can be implanted beneath the skin to release buprenorphine for six months. It finally came to market last year, and we are awaiting news of how well it is working.

Soon we may have another choice: weekly and monthly depot injections of buprenorphine. I blogged about this in an entry posted July 30, 2013.

In essence, this new subcutaneous injection of buprenorphine was invented by Camarus Pharmaceuticals, a small Swedish company that invented a nanoscale drug delivery system, as they say on their website. This “Fluidcrystal” injection containing buprenorphine comes in preparations of varying doses, and can be dosed once per week or once per month, depending on the preparation.

The liquid substance containing buprenorphine is injected subcutaneously (under the skin), where it forms a gel. Then a capsule-type substance surrounds it, allowing buprenorphine to be released into the body over time. Started weekly, the dose can be adjusted to meet patient needs. Eventually, the patient can move to once-monthly injections. The matrix of material is biodegradable, and eventually completely absorbed by the body.

This subcutaneous injection of medication has a very low viscosity, meaning it can be given with small needles that cause less pain to the patient. The medication is already pre-mixed, making it convenient for medical providers, and it is stable at room temperature for up to three years.

Initial trials of this medication have been intriguing; they show a fast delivery of medication, giving rapid onset and a steady blood level over one week or one month, depending on the preparation given. Safety data was pretty good; other than some headache and a low rate of inflammation at the injection site, it was well-tolerated. Because of the Fluidcrystal technology, if an addict attempts to inject this substance into a vein, it will form a deposit at the injection site, blocking the vein.

I’m excited by this medication. First, with daily buprenorphine dosed sublingually, some patients relapse. They may decide to stop taking the buprenorphine for a few days so that they can use their opioid of choice and get high again. True, they have to do a little more planning to relapse than if they were not on buprenorphine, but relapse rates are still too high. The depot forms make relapse less likely, I think, because compliance is assured once the medication is injected.

Second, with the depot forms of buprenorphine, the patients don’t have to think about taking something to treat their addiction. They don’t have to think about their medication at all, and their addiction doesn’t have the chance to urge them to take more of their medication than prescribed. Thankfully with buprenorphine there is a ceiling to its opioid effect, so that patients already on a blocking dose of sublingual buprenorphine won’t usually feel any intoxication from taking more of their medication.

Third, we’ve seen increases in the amount of buprenorphine being diverted to the black market, as the total amount prescribed has increased. Politically, this diversion threatens buprenorphine availability. One only need to look at regulations like what was passed by Virginia’s medical board to see the limits being placed on this life-saving medication, due to concerns about diversion. Law enforcement officials and politicians believe buprenorphine is a desirable street drug. Of course, research shows most people using illicit buprenorphine are trying to prevent withdrawal, and not using it to get high.

With this subcutaneous injection, I think it’s highly unlikely to be diverted, or at least much less likely that film or tablet to be diverted.

Because the dosing interval is every one week to every one month, medical providers can still see the patient once per month, and can provide counseling as a condition of continued treatment. With the six-month depot placement of Probuphine, it’s unlikely the patient will voluntarily return monthly for counseling visits, once they get the medication implanted. The more frequent and simpler administration of this form of buprenorphine appears ideal to me.

According to the Drug Addiction Treatment Act of 2000, the FDA must give approval to any form of buprenorphine that’s to be used to treat opioid addiction. At present, the sublingual form of buprenorphine and the implantable form of buprenorphine known as Probuphine have FDA approval. Other forms of buprenorphine in patch (Butrans) or injectable form are illegal for a doctor to prescribe to treat opioid addiction. this new subcutaneous injection of buprenorphine therefor must be approved by the FDA before it can be legally used to treat patients with opioid use disorder.

According to the manufacturer’s website, Phase 3 trials are concluded. According to a company press release, a double-blind, double dummy controlled trial of the weekly and monthly injections were found to be “non-inferior” to sublingual buprenorphine. That phrase is something drug manufacturers have to prove before a new drug is allowed to be approved by the FDA. The new drug must show it’s at least as good as the old drug. Additional data is rumored to show that it’s superior to sublingual buprenorphine, though I haven’t been able to find and read the original data yet.

This is a medication I would be excited to use in my practice. Instead of a surgical procedure, all I would need to do would be give a subcutaneous injection of this new product. How easy! My patient could see me as often as needed, and could see her counselor the same day she gets the injection, thus remaining established in a counseling program, too.

I am eager for the FDA to review this drugs study and approve it, if appropriate.

Medical Board Action Against Telemedicine Buprenorphine Physician





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:

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.