News You Can Use

 

 

 

 

 

 

 

 

 

 

 

 

 

Tidbits From the latest issue of Journal of Addiction Medicine

Don’t Forget the Family

I finished reading the latest issue of the Journal of Addiction Medicine this weekend, and as usual there’s much good stuff in it. One article that captured my interest was about family involvement in substance use disorder treatment.

Family members of patients with substance use disorder can powerfully influence the course of treatment of their loved ones.

I’ve known about the studies that support this for years, yet I must admit I haven’t gone out of my way to involve family members unless my patients request this.

The journal article reminded me we have research that shows family members can help prevent substance use disorder, can halt the development of these disorders, and can affect the prognosis once a substance use disorder is established. This article, by Ventura et al., reminds readers that involving family members in evidence-based interventions can improve health outcomes for the entire family.

That is, not only do these interventions improve the health of the person affected with substance use disorder, but also improve the health of all family members. Family members of affected patients show decreased healthcare expenditures as the patient’s treatment outcome improves.

It’s not fair to blame family members for actions which may worsen the substance use disorder of the affected person. They aren’t professionals. They are trying their best to deal with the insanity brought into the home with substance use disorders. They may not know the best way to support their affected loved one. Instead of judging these family members for their actions, better outcomes are seen when we educate them, and help them get care for themselves.

It’s tough to include families. Sometimes, our patients refuse us to include family in their treatment, and that is their right, and must be honored. Sometimes family members have their own substance use disorder that needs treatment. It’s also time consuming to involve family members, and many treatment professionals already feel their time is stretched. Some families are hostile to medication-assisted treatment of opioid use disorder. Explaining the reason why MAT is not just “substituting one drug for another” takes time and patience.

But if we can overcome these obstacles, involving the family in treatment can make a substantial difference in the lives of all family members, and not just the affected person.

 

Ondansetron for opioid withdrawal:

An article by Chu et al. described a study that looked to see if ondansetron (often known better under its brand name Zofran) could lessen withdrawal in patients on chronic opioid therapy. Because of previous studies that show some symptoms of opioid withdrawal may be mediated through the serotonin system, the authors hypothesized that ondansetron, as a serotonin receptor antagonist, could reduce opioid withdrawal.

This was a small study, with only 33 subjects, who participated in this double-blind, randomized crossover study. The subjects all had chronic back pain, and were changed from whatever opioid they were on to sustained-release morphine prior to the study. Then precipitated withdrawal was induced in these subjects with intravenous naloxone. Subjects’ withdrawals were treated with either placebo or ondansetron, and then both objective signs and subjective symptoms were measured.

The study showed no difference in withdrawal symptoms when ondansetron was given, compared to placebo.

That’s disappointing, but important to know.

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Media Maintains Methadone is Menacing Mountains

 

NEWS CAT

Last week, a colleague of mine directed my attention to local news coverage of the opioid use disorder epidemic. It’s a four-part series titled “Paths to Recovery.”

Anytime the press covers opioid use disorder and its treatments, I feel hope and dread. I hope the report will be fair and unbiased, and give the public much-needed information. And I dread the more likely stigmatization and perpetuation of tired stereotypes about methadone as a treatment for opioid use disorder.

Overall, the four segments of this news report had some good parts, and some biased parts. It was not a particularly well-done series, and could have benefitted from better editing. It was disjointed and contained non-sequiturs, which I suspect confused viewers.

In the introduction to the first segment, the report says their investigators have spent months digging into treatment options in the area. Their conclusion: there’s a variety of options and treatment is not one-size-fits-all. The report goes on to give statistics about how bad the opioid use disorder situation has become, and they interviewed a treatment worker who says we’re two years in to this, and the community doesn’t grasp the seriousness of the situation. They also interviewed some harm reduction workers, and discussed naloxone rescue for overdoses and needle exchange.

So far, so good, except that of course we are more like two decades into the opioid crisis, not two years.

Part two of this series was “Mountain methadone clinics.” As soon as I saw the dreadful alliteration, I cringed, fearing the content of the segment.

This report didn’t say good things about methadone. In fact, one physician, supposedly the medical director of a new opioid treatment program in the area, says on camera, “Methadone is very dangerous. It has some effects on the heart. The rhythm of the heart, it has some drug interactions.” He went on to say that at the right dose, people could feel normal, and that it replaced the endorphins that were lacking, but I worry people will remember only that a doctor said methadone was a very dangerous drug.

Methadone can be dangerous, if you don’t know how to prescribe it, or if you give a person with opioid use disorder unfettered access to methadone. But in the hands of a skilled and experienced physician, at an opioid treatment program with observed dosing, methadone can be life-saving.

The news report outlined the failings of existing methadone programs in the area, saying staff had inadequate training, and failed to provide enough counseling for patients. It said one program made a dosing error and killed a patient, while another program had excessive lab errors.

All of that sounds very bad.

No positive aspects were presented as a counterpoint to that bleak picture. I felt myself yearning for an interview with a patient on methadone who has gotten his family back, works every day, and is leading a happy and productive life. Of course, those people are hard to find, since they are at work and harder to find by the media, even reporters who have supposedly been “working for months” on this story.

And then…of course they interviewed patients who had misused methadone. One person criticized his opioid treatment program because they allowed him to increase his dose to 160mg per day, and he said “…that’s a lot. I didn’t need that much…” and goes on to admitting to selling his take home medication. Another patient said the methadone made him “sleep all the time.” Another patient said methadone made him “high all the time.”

There will always be such patients…ready to lie to treatment providers to get more medication than needed, break the law by selling that medication, and then blame it all on the people trying to help them. Unable to see their own errors, they blame it all on someone else, or on the evil drug methadone.

Every program has such patients. But these people can also be helped, if they can safely be retained in treatment long enough, and get enough counseling.

Even though these patients are few, they get far more media attention compared to the many patients who want help and are willing to abide by the multitude of rules and regulations laid on opioid treatment programs by state and federal authorities. These latter patients are why I love my job. I see them get their lives back while on methadone. They become the moms and dads that they want to be. They go back to school. They get good jobs and they live normal lives. They don’t “sleep all the time,” as the patients on this report said.

But not one such patient was interviewed for this report.

As I watched this segment, I thought back to an interview the A. T. Forum did with Dr. Vincent Dole, one of the original researchers to study methadone for the treatment of opioid use disorders. This was in 1996, before our present opioid crisis gained momentum.

A.T. FORUM: It seems that, over the years, methadone has been more thoroughly researched and written about than almost any other medication; yet, it’s still not completely accepted. How do you feel about that?

  1. VINCENT DOLE:It’s an extraordinary phenomenon and it has come to me as a surprise. From the beginning of our research with methadone we were able to rehabilitate otherwise hopeless addicts that had been through all of the other treatments available. I expected methadone would be taken up very carefully by the addiction treatment community, but with some enthusiasm. Instead of that, we’ve had endless moral and other types of objections which are really irrelevant to the scientific data.

I was surprised, because my background in research had led me to expect that the medical community was a very critical but nonetheless objective group that would respond to solid, reproducible data. Instead I find that we still get the anti-methadone argument of substituting one addictive drug for another.

This is ignoring the scientific data showing that, as a result of methadone treatment, people who have been hopelessly addicted and anti-social and excluded from any normal life or family, are in a wonderful way becoming responsive to social rehabilitation and today constitute a very large number of people who are living normal lives. The fact that people, especially medical practitioners, would dismiss that as unimportant simply staggers me!

[http://atforum.com/interview-dr-vincent-dole-methadone-next-30-years ]

 

What would Dr. Dole think now, twenty more years later, during a terrible wave of death from opioid use disorders, about the continued stigmatization of methadone?

Then next segment was about buprenorphine, and how it can be prescribed in a doctor’s office, making it a better choice for patients. It wasn’t a bad segment, and contained some useful information. Physicians who were interviewed had nothing but good things to say about buprenorphine.

Or rather, they had good things to say about Suboxone.

The brand Suboxone was heavily promoted by this piece. Not once did the reporter use the drug’s generic name, buprenorphine. Every time, the medication was called by its brand name, Suboxone, and every picture of the medication was of Suboxone film. No mention was made of the other brands: Zubsolv, Bunavail, Probuphine, or even that there are generic combination buprenorphine/naloxone equivalents for Suboxone film, for less than half the price.

I know buprenorphine is kind of a mouthful for non-medical reporters, but still, I thought it was odd to use only the name of one brand: Suboxone. It’s as if this was a commercial for that drug company. Indivior, the manufacturer of Suboxone, must be delighted with this coverage. To me, it felt like an advertisement rather than journalism.

Another segment was about sober recovery homes. The investigative reporter talked to owners of sober recovery houses and the tenants at those homes. She said NC has no regulations or standards for recovery homes. She talked on screen to a patient advocate who says patient brokering is going on in Asheville, as well as lab scams at recovery homes where the patients’ best interests aren’t at the heart of the way these homes function.

She talked to Josh Stein, NC Attorney General, about passing laws to better regulate these sober homes, and he agreed that if these laws were needed, they should be passed.

No controversy with that one.

There was a segment about how there’s not enough beds in residential facilities for patients with opioid use disorder who want help. I agree, though I’m not sure this is breaking news for anyone. I don’t think there’s ever been enough beds to meet the treatment need.

Overall, I was left with a bitter taste after this reportage. The news program missed an opportunity to educate viewers about all evidence-based treatments for opioid use disorder, but ended up doing an advertisement for Suboxone and denigrating methadone.

Buprenorphine and methadone both work under the same principle: they are long-acting opioids which, when dosed properly, prevent withdrawal and craving while also blocking illicit opioids. While buprenorphine is a safer drug with fewer drug interactions, it isn’t strong enough for everyone. Methadone has countless studies to support its use to treat opioid use disorder, showing it reduces death, increases employment, decreases crime… but why go on, since facts don’t seem to matter as much as sound bites.

In my opinion, WLOS bungled an opportunity.

Depraved Indifference or Reckless Disregard?

 

 

 

 

 

I have a weird affinity for old “Law and Order” reruns. I’m not talking the lesser “Law and Order” spin offs like Criminal Intent and SVU…I prefer the originals. With a total of twenty seasons, there’s almost always an episode being broadcast on one channel or another.

I recently watched – for perhaps the third or fourth time – an episode about a man with serious mental illness who killed a woman by hitting her on the head with a rock. This man had auditory hallucinations due to schizophrenia. As he described it, his “bad uncle up in Yonkers” told him to kill people. Of course, he wasn’t guilty, by reason of insanity.

But the show rambled on, and detectives discovered this person was recently released from jail at Riker’s Island, where he hadn’t received much in the way of medical care. He hadn’t been properly treated for his schizophrenia, due to cost containment strategies of the company that provided medical care for prisoners. After he served his sentence, this sick man was dropped off with no medication and no plans for follow up medical care.

Jack McCoy, indignant and outraged (as he so often is on “Law and Order”), decided to charge the owner of the healthcare company with manslaughter. The physician assigned to treat the schizophrenic man was initially investigated, but he was able to prove he was threatened with being fired if he used expensive drugs or sent patients to the hospital. So then the owner of the company became the focus of Jack’s ire.

I don’t remember the exact count he was charged with, but the jury found him guilty, and he was sentenced to about a year’s incarceration. – in the very jail that his company contracted with to provide healthcare. The chief District Attorney, Nora Lewin, jokes that his immune system had better be good, because prisoners there don’t receive good health care.

I was thinking again about numerous news reports of patients with substance use disorders who die in jail, and it made me wish we had a few Jack McCoys in various locations.

Do you remember the case of David Stojcevski? I blogged about this horrible case on 10/20/2015, and again 2/25/2016. As a reminder, David was sentenced to thirty days in jail for non-payment of traffic tickets. He died on the seventeenth day of his sentence from what the autopsy said was “Acute withdrawal from chronic benzodiazepine, methadone, and opiate medication.” He had been on physician-prescribed methadone, clonazepam, and alprazolam, but was denied all of these medications during his incarceration. He was also not treated for the predictable withdrawal from these medications.

The family released videotape of his immense suffering (he had been moved to a “monitored” cell when he began to exhibit delirium) and are suing Macomb County, Michigan, where this jail was located. They are also suing Correct Care Solutions, the healthcare provider contracted to attend to the health of inmates.

The Justice Department investigated to see if criminal charges should be levied against the people who allowed David to die by denying him medical care. They investigated the charge of “deliberate indifference” on the part of jail staff and Correct Care Solutions personnel. Last year, the U.S. Attorney for that area announced they couldn’t find evidence for criminal intent on the part of jail workers and Correct Care Solutions that met the standard of beyond a reasonable doubt, so criminal charges were not brought.

Several days ago. the FBI was forced to release part of the documents regarding their investigation.

From the little that was released, the FBI discovered David had no intake of food during the last five days of his life, and that there were no medical visits from medical staff for the last 48 hours of his life. One guard said he got the impression from medical staff that they believed he was “faking” withdrawal symptoms.

The physician employed by Correct Care Solutions, after observing David, said he was not having seizures, and that he was faking those symptoms. An FBI physician said David should have been started on a withdrawal protocol, and that his fifty-pound weight loss and dehydration should have raised alarms. His opinion was that David died because of deliberate indifference to his medical needs.

The FBI’s records on their investigation showed there were medical visits that weren’t documented, or had poor documentation. Other news reports say 12 people have died in that county jail since 2012.

Even though there will be no criminal charges against the people who should have prevented David’s death by providing routine medical care, and the family’s civil case will proceed – at a snail’s pace.

I don’t understand the decision of the Justice Department. How can jails and prisons legally deny medical care to inmates? Isn’t that against the law? And if an inmate dies from lack of medical care from a completely preventable cause, shouldn’t that be illegal? Doesn’t this violate the 8th Amendment?

There’s a phrase I learned from “Law and Order.” It is res ipsa loquitor, and means “the thing speaks for itself.”

Surely the death of David Stojcevski from a treatable condition speaks for itself.

My question is this: how much louder do similar tragedies need to speak before changes are made to the disgraceful way inmates are treated?

Trump’s Opioid Speech

 

 

 

 

 

 

At least five or six people asked me what I thought about the President’s address in which he declared the opioid crisis a public health emergency. I didn’t watch his address, but I did read a transcript of his speech.

When people insert the comment, “Believe me,” into what they are saying, I tend not to believe them. Perhaps it’s an occupational hazard, but that’s what I consider a “tell.” Just like the phrase, “I’m not gonna lie to you,” my brain assumes there’s a whooper of a lie headed my way.

However, the “believe me” phrase could be just a verbal tic on President Trump’s part, like the word “very” which he said eighteen times in his speech. Yes, I counted. I don’t know why that annoys me so much, except maybe I expect a more diverse vocabulary from the President. It’s very, very, very annoying.

I applaud his effort. He said some good things, and the overall message of his speech was that the U.S. has a problem, we need to do something about it, and here’s what I’m going to do to help. I could nitpick about the accuracy of some of the things he said, but I think he’s sincere in his desire to help people overcome substance use disorders.

But isn’t it disingenuous to tell people you plan to get approvals for treatment at the same time you are ending Obamacare? People need insurance to pay for medical care, so how will the 10 million or so who had insurance under Obamacare pay for treatment?

It was also disingenuous for him to say he’s “directing all executive agencies to use every appropriate emergency authority to fight the opioid crisis,” and that we should expect to see “Approvals that will unlock treatment for people in need and those approvals will come very, very fast…”

Money is being released quickly, from the 21st Century CURES Act, passed by Obama in December of 2016 and made available to states by April of this year. That is fast, for government money. I didn’t like Trump taking credit for legislation passed before he became president.

But those are trivial irritations compared to what’s important. Perhaps President Trump will pass legislation that gives people access to treatment for opioid use disorder. I hope that access will be for evidence-based treatment, and not for a “just don’t start” sort of campaign. We already endured the “Just say no” of Nancy Reagan. It’s not bad as far as it goes, and might prevent people from experimentation with drugs, but it’s of little use once opioid use disorder develops.

After President Trump’s speech, I am cautiously optimistic. I’ll have to see details before I get too excited, though. With so much at stake, I do hope the President allows experts to guide his policies. If we shoot a missile at opioid use disorder, let’s be sure it’s pointing in the right direction.

 

Temporary Grace: the CURES Act

 

 

 

 

 

 

The 21st Century Cures Act, signed into law by President Obama late in his presidency, provided money to help people with opioid use disorder get treatment. In April of this year, states got this money, in the form of STR (state targeted response to the opioid crisis) grants. Eighty percent of this money is to be spent for treatment, meaning more people with opioid use disorder should be able to access treatment.

And this is happening.

In North Carolina, the money was allotted to LME/MCO organizations. These organizations also manage our Medicaid dollars in various regions of the state. As I understand it, these organizations help to decide which treatment programs receive CURES dollars.

Our opioid treatment program (OTP) immediately applied for access to this money for patients. Since we’ve already gone through the vetting process to be approved to accept Medicaid patients by our LME/MCO agency, it didn’t take long to become approved for CURES dollars.

We’ve admitted around eighty people on the CURES grant who had no other way to pay for treatment. To qualify for CURES, they needed to apply for Medicaid, and then bring in the refusal letter, saying that they didn’t qualify to receive Medicaid. (Being a red state, in North Carolina a person can be making very little money at their job and still not qualify for Medicaid.)

These eighty people, instead of having to pay their daily treatment fee, have it paid for them through the CURES grant.

This is fantastic. This is wonderful. We’ve re-admitted many patients who were in treatment with us in the past, but who dropped out for financial reasons. We’ve admitted patients with long-standing opioid use disorder who have never been able to afford treatment. It is thrilling to see these patients stop using opioids and start to engage in treatment. The great majority of patients admitted under CURES have shown improvement.

It’s not all been roses, though. Some of these patients are extremely ill with long-neglected mental and physical health issues. It’s been a challenge to find places to refer them for primary care. Some patients have burned bridges with many of the primary care doctors in the area. Others with serious health issues refuse to see a doctor. Substance use disorder isn’t the only disease with denial. I sense these patients are often scared to hear a bad diagnosis from a doctor, and prefer to ignore their ailments.

Some people admitted with CURES dollars have severe mental illness, to the point that it can interfere with treatment and affect other patients. We’ve tried to strike a balance between helping patients with serious mental illness, while still maintaining a safe and comfortable treatment program for our patients. Often these patients refuse to be referred to the facility that contracts with our LME to provide mental health care. In other words, their mental illness interferes with their ability to get care for their mental illness. It can be terribly frustrating. I’m not a psychiatrist, and I’m not qualified to help them with these serious conditions.

We’ve admitted a handful of homeless people with opioid use disorder under the CURES grant. Our small town has one facility that will house people for up to two weeks, so at best that’s a very short-term solution. We can refer them to neighboring towns, but they don’t have transportation to dose with us every day, so they must transfer their care for opioid use disorder to another facility approved for CURES money. Some homeless people would rather live outside in a familiar area than move to a different town. With winter coming, it’s a grave concern.

Our patient census shot up relatively quickly, and our OTP has growing pains. We are struggling to hire more personnel, particularly to reduce wait times for dosing. I don’t have time to see every patient as I would like to, so the company I work for is looking for a physician extender to help me.

As is human nature, some people try to take advantage of grant money. I’ve had a few “patients” start on sublingual buprenorphine, only to see them attempt to divert their dose. When I confront them, and tell them I’m no longer willing to prescribe buprenorphine but would be willing to switch them to methadone, they get angry and leave. I believe – but can’t prove – these people intended to get buprenorphine to sell on the black market, where it goes for around $30 for an 8mg tablet.

We also must live with the uncertainty that this grant could be snatched away by a president intent on undoing everything the last president did. I tell patients benefitting from the CURES grant to look at this opportunity as a temporary thing, and that if possible, they need to try to find a way to pay for treatment themselves if the grant falls through. I hope it doesn’t, but the future of healthcare overall is in a period of transition, and opioid use disorder treatment is no exception.

Our whole staff feels more stress, and I try to remind them – and myself – of the larger picture. Experts say only 10-20% of people with opioid use disorder are presently getting help for their illness, and now with CURES, I believe that we are reaching a chunk of those who haven’t had care in the past.

It’s an opportunity that I’ve never seen in the sixteen years I’ve worked treating opioid use disorder. Despite our growing pains, we will continue to do all we can to access treatment dollars for people who can’t afford it otherwise. This CURES program should have this same effect across the country, enabling people with opioid use disorder enter treatment, often for the first time.

 

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.

  1. https://www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2016/10/11/public-policy-statement-on-morphine-equivalent-units-morphine-milligram-equivalents
  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.