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Guest Dosing at Opioid Treatment Programs

 

 

 

 

“Guest dose unto others as you would have others guest dose unto you.”

I think all opioid treatment program physicians should follow this twist on the Golden Rule.

That is to say, when OTP physicians are contemplating the appropriateness of approving one of our patients to be guest dosed at another OTP, we need to consider whether we would want to be on the receiving end of a similar patient.

First, let me explain what guest dosing is for my readers who may be unfamiliar with it.

Patients of opioid treatment programs have to dose daily on their medication, unless they meet criteria for take home doses. For buprenorphine (formerly known as Suboxone or Subutex) regulations have loosened in many states, so that take home doses are granted much earlier. (The federal regulations have completely dropped the time in treatment requirement for take home doses of buprenorphine.)

But for methadone, patients have to dose at the facility each day for at least the first ninety days, and after that, if doing well, they can get up to three take homes per week for the next ninety days, then up to four per week after a half of a year, and so on.

What happens if the patient needs to go out of town before they are eligible for these take homes?

There are three options: leave treatment, the worst option, because of the increased risk of death for patients who leave treatment; special take home doses, often risky if the patient isn’t able to take them as prescribed; and guest dosing.

Guest dosing means a patient of one treatment program can be dosed at another program if that patient travels to another area. All opioid treatment programs send their patients for guest dosing and allow guest dosing for patients of other facilities. It should be a smooth and simple process, under ideal circumstances.

But sometimes circumstances get complicated.

Most difficult are the last-minute guest dosing requests. These tend to come at particularly stressful times for the patient, because often a patient’s family member is sick, or just passed away. The patient needs to be with his family.

Setting up guest dosing at the last minute is more difficult for the referring clinic, the accepting clinic, and the patient. Most clinics ask for 24-48 hours advance notice for guest dosing, but some situation don’t allow that much time. We do the best we can, try to explain circumstances to the receiving clinic, and usually are able to work out something.

Guest dosing requires good communication between clinics. Usually the home clinic needs to fax a form with the patient’s picture, their dose, and any take home doses to be dispensed. Most receiving clinics like to see at least the last three drug screen results. Some receiving clinics ask for a doctor’s signature to assure the physician is aware of the guest dosing request. Then when the guest dosing patient arrives at the receiving program, the nurse calls to verbally confirm all of the info on the guest dosing request.

Some opioid treatment programs charge steep guest dosing fees, affecting the patients’ ability to pay for guest dosing. Some clinics charge a one-time fee to set up guest dosing, and after that pays the same as any other patient dosing at that clinic. Some programs charge elevated fees every day the patient guest-doses.

As the medical director, I am consulted any time one of our patients wants to guest dose at another clinic, and any time a patient from another clinic wants to guest dose. We have general guidelines for guest dosing, but often have to consider other factors.

For example, at both of the treatment centers where I work, we prefer not to guest dose patients during induction. Induction is the riskiest time of treatment, and usually lasts at least thirty days. But each request must be considered and the risk/benefit analyzed. What about if a patient admitted three weeks ago finds out a close relative is dying, and wants to be with them? I might agree with guest dosing such a patient, if she is doing well, isn’t actively using benzodiazepines or alcohol, and won’t be gone for many days.

Some clinics won’t allow guest dosing for any patient with positive drug screens. Generally I would agree with that, but for me it depends on what the drug is, and why the patient needs to go out of town, and for how long. For example, if a patient is stable on his dose, but is still smoking marijuana with every drug screen positive for THC, I’d still support guest dosing if this patient needs to work out of town. I’m not OK with continued illicit marijuana use, but the problems caused by missing a work opportunity may be greater than problems caused by marijuana use. If that same patient were using benzodiazepines or alcohol, I probably wouldn’t agree with guest dosing, due to the much higher risk of methadone when combined with these drugs. If the marijuana-smoking patient wanted to guest dose out of town in order to attend a friend’s bachelor party…I’d be hesitant, as I’ve heard rumors that these events tend to involve heavy drinking of alcohol. I’d have to talk to the patient.

Guest dosing in patients on buprenorphine used to be difficult, since so many OTPs weren’t using buprenorphine. Now, most OTPs do offer both buprenorphine and methadone to their patients in treatment, so they can accept guest dosing for both.

But since buprenorphine is such a safer medication than methadone, usually we can get permission for take home doses, if the patient doesn’t already qualify for them. Even though federal regulations dropped the time-in-treatment requirements for take homes in buprenorphine patients, my state still requires time in treatment, unless we ask for an exception, which is usually granted.

So who should not be approved for guest dosing? As above, patient in induction shouldn’t be guest dosed unless there are extreme extenuating circumstances – death in the family, personal medical crisis, or other extraordinary circumstance.

Sometimes I get frustrated not with patient of other treatment programs, but with the people who work at other treatment programs.

For example, last weekend we had a patient show up on a Saturday for guest dosing with no advance notice. Ordinarily, we ask for 48 hours’ notice to make sure guest dosing goes smoothly. Since it was a Saturday, our nurse had to stop dosing our own patients, call me for permission to guest dose her, and then call her home clinic for needed information.

We had already guest dosed this patient a few times within the past few months, so we kind of knew her. Otherwise, I’d have been tempted to say no, because it’s an inconvenience to our waiting patients and a hassle for our nurse. But it seemed harsh to deny her due to her clinic’s ineptitude.

If we had sent a patient to another OTP with no advance notice, I can almost guarantee they would say no, too bad, your counselor should have set this up days ago.

The whole goal of treatment is to help drug addicts regain their ability to live a normal life. Opioid treatment programs should make every effort to remove obstacles to travel during treatment, while still following state and federal regulations. And of course, the freedom to travel and guest dose must be balanced with patient safety. Ideally, the decisions regarding guest dosing should be made by the physician, who is informed by the input of the treatment team, so that the best possible decisions can be made.

Oh, and please, OTP counselors everywhere… it is “guest” dosing, not “guess dosing.” I cringe every time I see that written in any records from any program. We do not guess a dose. We do guest dose patients.

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Diagnostic Overshadowing

Perspective

 

 

I was trying to get through a pile of non-Addiction Medicine journals when I came across an article titled “The Ethics of Behavioral Health Information Technology: Frequent Flyer Icons and Implicit Bias,” in the October 18th, 2016, issue of the Journal of the American Medical Association.

According to the authors, Michelle Joy M.D. et al, at least one electronic medical record (EMR) system provides a way to display an icon shaped like an airplane, as a way to inform treating physicians that the patient is a “frequent flyer.” This term has long been used to describe patients who repeatedly come to emergency departments or other providers on a regular basis.

This term has been used for decades. I’ve used it myself in the past. It’s a short-hand phrase that usually means, “This patient is a pain in the ass because he/she keeps coming back for inappropriate reasons.” More elegantly and succinctly, the authors of this article say the term frequent flier is short-hand for “problem patient.”

This article points out the ethical harms of stigmatizing patients in this manner, and presents the term “diagnostic overshadowing.” This means a physician’s attitude towards a patient can be skewed by the idea that the patient is seeking care for inappropriate reasons. The article goes on to cite studies showing patients with mental health conditions are less likely to get appropriate medical care compared to patients without mental health issues, likely due to this diagnostic overshadowing.

I see this every week in my patients with opioid use disorder. Even my patients who are in recovery and doing well say they are treated differently when they go to our local hospital emergency departments, or even to their primary care doctors. After they reveal they’re on buprenorphine or methadone to treat opioid use disorder, they detect changes in the attitudes of their care providers.

Often, the patient will say, “I know I’ve tried to score drugs from him before, but this time I didn’t get a chance to say anything before the doctor accused me of being a drug seeker.” The doctor, reading the past records, jumped to the conclusions that this person is only in the emergency department to get pain pills. The doctor shuts down further communication because of his diagnostic overshadowing. The patient doesn’t get a chance to receive appropriate care. Maybe just as bad, that patient is given the message that they don’t deserve respect, due to their diagnosis of opioid use disorder.

If this happens to patients years after they’ve been in recovery, just think about what happens to people in active opioid use disorder. They are pre-judged as drug seekers, and the emergency department doctors sometimes decide, before gathering information, that the addicted person has no valid medical problems. The doctor starts with an assumption that the patient is a bad person, rather than a sick person.

This attitude leads to medical disasters. Patients with current intravenous drug use are more likely, not less likely, to have serious medical problems.

I’ve seen two patients who had serious infectious medical emergencies that were missed by local emergency room doctors. Both patients were seen multiple times at two local hospital emergency departments. Both said they were treated with distain by personnel. One was seen a total of four times before she went, on her own, to the emergency department of a nearby teaching hospital, where she was immediately diagnosed, and taken for emergency surgery.

I believe these two patients encountered doctors who experienced the diagnostic overshadowing described in the JAMA article, because they had opioid use disorders. Their doctors assumed they only wanted pain pill prescriptions and weren’t all that sick.

What do we do about diagnostic overshadowing?

We must educate physicians more completely about addiction and mental health disorders. I’ve written in previous blog posts about the lack of training, at least in the past, for physicians about substance use disorders. Specific training in medication-assisted treatment of opioid use disorders wasn’t taught at all. This is slowly changing, and medical schools now teach students about these vital medical problems. This will help younger physicians, who are getting their training now.

What about older doctors, already in practice? I think all of us working in substance use disorder and mental health disorder fields have an obligation to educate our peers. I know I held significant bias against methadone before I knew anything about it. One doctor friend encouraged me to read and learn. When I did, I found piles of information supporting this evidence-based treatment.

Now I try to pass along what I’ve learned. Sometimes I’m successful, sometimes not. I’ve talked to doctors in my community, with a wide range of results. Some physicians have become allies, supportive of the patients we share. Others have not been willing to listen or learn about MAT. One doctor told me if I prescribe MAT for one of his patients, he will dismiss that patient from their practice.

The only difference between this doctor and me was in our willingness to learn. Had I not agreed to read some of the tons of studies showing that methadone helps patients with opioid use disorder, I’d still be opposed to methadone, as he continues to be. It’s a reminder to remain teachable.

It’s easy to become frustrated with my colleagues. For example, I can’t remember even one patient being referred to our opioid treatment program by the local hospital’s emergency department physicians. I have not been successful at educating these doctors.

Up until last year, we didn’t get referrals from our local substance abuse and mental health treatment provider for the county. One patient specifically asked them to refer her to a methadone clinic, and was told, “We don’t do that.” Fortunately, she had friends who told her where to find our treatment center.

Our program manager, nurse manager, and I met with the treatment program’s supervisors, who said they had no idea their facility was trying to prevent patients from accessing opioid treatment programs. They promised to fix the situation, and we now get referrals from this program.

So things do change, but not quickly. All of us advocating for MAT need to be patient, yet persistent. Maybe then we can eliminate diagnostic overshadowing for our patient populations.

 

 

Physicians’ Decisions to Start Buprenorphine: The Key Factors

Just a little “If cats were doctors” humor.

 

 

 

 

Physicians are less likely to prescribe buprenorphine for patients who use illicit benzodiazepines or drink excessive alcohol, who have a spouse with a drug use disorder, or who have Medicaid as their form of payment.

This information comes from an article in the most recent issue of the Journal of Addiction Medicine (Jan/Feb, 2018). Knudsen et al. describe the findings from their investigation about the decision-making process of buprenorphine prescribers.

The authors sent surveys to 3553 physicians, selected at random from all fifty states and the District of Columbia, who were eligible to prescribe buprenorphine and had at least one patient for whom they prescribed buprenorphine. Of this group, 1174 (about a third) of those physicians responded.

These surveys contained twenty patient vignettes describing the various attributes of a prospective patient, then asked about the physicians’ willingness to prescribe buprenorphine for the patient. This study is based on conjoint analysis, which is a way to quantify the contributions of several factors in a decision-making process.

I read all about this method, and following the statistical analysis process was challenging. I wish I could explain it to my readers, but I can’t.

Seven patient attributes were described in the case vignettes, and were the basis upon which the physicians answered whether they would or would not prescribe buprenorphine from their office. The seven attributes were: type of opioid and route of administration, treatment history, risky substance use (benzodiazepine or alcohol use), co-occurring infections (HIV and Hepatitis C), spousal involvement in treatment and whether the spouse was also a drug user, employment status, and method of payment for the office visits.

Of those seven factors, the use of benzodiazepines (or alcohol) had the largest relative importance for the physicians in deciding if they would prescribe buprenorphine or not. In other words, out of all those seven factors, doctors were more influenced not to prescribe buprenorphine if the patient is also using sedative-type drugs.

That makes sense, and I was relieved to see this sample of physicians recognized the risks of this population of patients with opioid use disorders. We know that alcohol and benzodiazepines do increase the risk of mortality and of relapse in patients on medication-assisted treatment with buprenorphine or methadone.

Maybe the physicians felt the risk of treating such patients with buprenorphine is still less than no treatment at all, but that opioid treatment programs are safer settings to start these patients than an office-based setting. At opioid treatment programs, patients can be dosed with buprenorphine, but watched more closely. They can be evaluated for impairment every day when they come to the facility to get that day’s dose. Office-based physicians should be able to refer to local opioid treatment programs easily, and form close working relationships with these facilities.

The next most important factor determining the physicians’ willingness to prescribe buprenorphine was method of payment. Patients with Medicaid were less likely to be started on buprenorphine in the setting of office-based practices.

This did not surprise me.

Medicaid doesn’t pay physicians well for office visits. Medicaid pays much better for surgeries or procedures…that is, “doing” something…. but not well for thinking and patient management in the office setting.

Recently I tried to see how much Medicaid pays for an office visit for a patient being monitored on buprenorphine. It varies by area, but the going rate seems to be $40 to $45. Considering the visit takes about 15-20 minutes, which doesn’t count time spent coordinating care or meeting Medicaid paperwork requirements, that’s not great reimbursement. I don’t know if a practice could break even if they saw only Medicaid patients, unless they saw a high volume, and that’s no fun for patient or doctor.

This study underlines the importance of raising payments to physicians for seeing Medicaid patients, if you want primary care physicians to prescribe buprenorphine from an office setting.

Also, something must be done about eliminating the byzantine Medicaid requirements. It’s altogether too hard to become certified to accept Medicaid, so some doctors don’t bother with it.

The third most important factor was whether a prospective patient’s spouse was going to be involved in the patient’s care, and whether that spouse had an addiction issue too.

I completely get that idea. When I’m admitting a patient and they tell me they live with a significant other who is still using illicit opioids, I worry. Not only could the S.O.’s use of drugs be a trigger for relapse for my new patient, but also that might be at temptation to give some of his dose to the S.O.

We know from research that social contacts influence whether people take drugs or not. Having a stable, non-drug using spouse is a good prognostic sign.

The four other factors didn’t seem to affect whether this group of buprenorphine physicians would start buprenorphine or not.

HIV or Hep C status didn’t matter, and that’s a good thing. Patients with these infections should be able to access treatment.

Surprisingly, the type of opioid used and the route of administration didn’t matter very much. I would have thought that physicians may have considered heroin users higher risk patients than prescription opioid users, but that wasn’t the case. I was surprised that a history of intravenous use didn’t make prescribers hesitate.

In an office-based setting, I think the physician (or physician extender) should ask specifically if the prospective patient has ever injected buprenorphine. If the answer is “yes,” an opioid treatment program, with observed daily dosing until stable, is probably a safer and better choice for these patients. I ask my new patients, and most people who use intravenously have also injected buprenorphine.

Previous treatment episodes didn’t influence physicians’ decisions to prescribe buprenorphine, and neither did employment status.

I would have though physicians would be a little less inclined to start prescribing for a patient who is unemployed, but that wasn’t the case in this study.

I thought this was an interesting article, and showed some insight into how physicians who prescribe buprenorphine decide for whom they will start treatment, and which factors are deterrents to starting a new patient in treatment.

 

Buprenorphine Regulations

Map is from vox.com

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.

https://www.asam.org/docs/default-source/public-policy-statements/statement-on-regulation-of-obot.pdf?sfvrsn=df8540c2_2

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.

More About Tennessee’s Buprenorphine Guidelines

Funding Information

 

 

 

 

Last week I was contacted by Dr. Tom Reach, one of the premier Addiction Medicine physicians in Tennessee, about last week’s blog entry. He supplied background information about the development of Tennessee’s office-based buprenorphine prescribing guidelines.

Dr. Reach contacted state Representative Matthew Hill about a proposed requirement for office-based buprenorphine providers that would have set treatment in that state back into the dark ages. The state legislation nearly approved legislation that would have required that all buprenorphine physicians apply for a certificate of need.

I know what you’re thinking. How could anyone in Tennessee, a state with one of the highest opioid overdose death rates in the whole U.S., even question the need for treatment? By now, surely even the slowest-witted people in the state know there’s a desperate need for opioid use disorder treatment.

This legislation wasn’t proposed because there were too many treatment facilities. It was proposed because bad treatment facilities were located in the areas of powerful legislators. It was also proposed because some areas of Tennessee have many office-based providers, while other areas have few. This legislation was proposed to control the quality and location of office-based buprenorphine prescribers.

Powerful legislators were sick of poorly run clinics, basically pill mills for buprenorphine, and these legislators believed a certificate of need process would weed out the bad providers. They hadn’t considered it would also limit the number of good providers, who probably couldn’t or wouldn’t want to go through an onerous certificate of need process.

Dr. Reach found out this bill was coming up for vote immediately. He flew into action immediately, educating Representative Hill about opioid addiction, its treatment with buprenorphine, and how treatment is best done. Then he quickly moved on to educated what sound like every member of the subcommittee voting on the certificate of need proposal.

It was a nail-biter.

Initially, only one out of the ten committee members opposed this idea to require certificate of need for OBOT treatment. After much conversation, half were still in favor of the requirement, but the other half had begun to believe it might not be good for the state. After more discussion, the committee eventually voted to table this discussion, and allow a panel of experts to gather more information and form a recommendation.

A coalition of stakeholders in the state was formed, but few members were physicians with experience treating opioid use disorder. Eventually, Dr. Reach was able to influence other members.

It turns out that the final document, about which I blogged last Sunday, was the result of a compromise between people with extremely different views about how medication-assisted treatment should be done.

While I think the guidelines are too restrictive…it could have been so much worse, had Dr. Reach not persisted in his efforts to educate other committee members. Also, the requirements initially ran to 78 pages, so the final 50 page document is comparatively brief.

Dr. Reach informed me that some buprenorphine providers in Tennessee have tainted public opinion about this medication and this form of treatment. He and other physicians, dedicated to providing quality care, are lumped together with prescribers running buprenorphine mills.

He says there are buprenorphine programs that get “patients” from West Virginia and Kentucky who drive to Tennessee, get prescriptions for the buprenorphine monoproduct, and sell them for $60 per 8mg tablet in their home states. These Tennessee programs have huge lines and run patients in and out, providing only prescriptions for medication and no counseling. No time is taken to get to know the patient and find out what’s going on with them, or how they are progressing in their recovery. Some programs don’t even do drug testing.

I commiserate with Dr. Reach. Bad programs damage the reputations of physicians dedicated to doing the right thing for their patients.

I still think there’s room in this conversation for harm reduction approach, which might say the more buprenorphine reaches the hands of people with opioid use disorder, the fewer people might die from opioid overdose. But Tennessee’s no Canada, and I doubt anyone could convince the law-and-order types that diverted buprenorphine could reduce heroin overdose deaths.

I am indebted to Dr. Reach, for his willingness to give background information about this whole issue in Tennessee. Thanks to his efforts, and the open-mindedness of committee members willing to be educated, patients with opioid use disorder in Tennessee have dodged a bullet. Yes, there are restrictions, but it could have been so much worse.

North Carolina legislators can learn from Tennessee’s experience. We can watch to see if these relatively restrictive Tennessee buprenorphine guidelines improve the quality of care in the state. And we also need to watch their numbers of opioid overdose deaths.

 

Tennessee’s New Guidelines for Office-Based Buprenorphine Prescribing

Advertisement for Buprenorphine Physician

I’ve spent a great deal of time puzzling through a document titled “Tennessee Nonresidential Buprenorphine Treatment Guide,” released early this year. This document was created, as it says on page 2 of the document, because of the “growing prevalence of individuals who have an opioid use disorder, an increased number of individuals using medication-assisted treatment with buprenorphine, and diversion issues associated with buprenorphine.”

I’ll give my readers a warning – this blog entry is dense with the finer points of Tennessee’s document, and it’s not light reading.

This document outlines the standards of care that Tennessee’s office-based buprenorphine prescribers will be asked to follow. The physicians’ licensing board, the Tennessee Board of Medicine, will use this document to assess the quality of care OBOT physicians provide.

It was written with the help of many experts: doctors from Tennessee’s psychological and psychiatric associations, doctors from the Board of Pharmacy, from Tennessee’s Department of Mental Health and Substance Abuse Services, from Tennessee Department of Public Health, from drug courts, law enforcement personnel, specialists from Vanderbilt University, the state medical association, nurses’ associations, physicians from the medical society and physicians actively practicing addiction medicine. The document is fifty pages long, probably because more than forty people helped write it.

This document acknowledges that buprenorphine can be a valuable tool to treat patients with opioid use disorder, when used appropriately. The guideline describes the consolidated opinion of these experts as to what constitutes appropriate use.

Moving on to the actual guidelines, the document first outlines what must be done before the patient enters treatment.

The physician must:

  • Make sure the patient has opioid use disorder, and determine the length, severity, and consequences of use, including all prior treatments, if any, and the results of those treatments
  • Must document other substances used, and the extent they are used, and how treatment for these substances will be incorporated into the treatment plan
  • Must assess “process” addictions and decide how they can affect substance use disorders. This means assessing the patient for compulsive gambling, sexual practices, spending, or other impulsive and out of control behaviors.
  • Must assess the patient’s other mental health and physical health conditions, and determine how, when, where these problems will be treated
  • Must assess the patient’s social supports, employment status, housing situation, financial status and legal issues
  • Determine the patient’s readiness for treatment
  • Determine the patient’s wishes regarding pregnancy, if she is capable to becoming pregnant. She should be referred for long-acting birth control if she does not wish to become pregnant.
  • The physician must check the state’s prescription monitoring website before initial prescription and before each office visit
  • Must obtain an observed drug screen and document the results, prior to the start of treatment
  • Must do proper patient selection, which means the patent is told about all options for treatment, the patient is willing to start this treatment, and that there are no reasons not to start the patient in treatment
  • Signed agreement to start treatment must be obtained
  • The physician must complete required elements about consent to treatment dealing specifically with pregnancy and NAS prevention

I say physician and not provider, because Tennessee won’t allow physician extenders like nurse practitioners and physician assistants prescribe buprenorphine, despite the changed federal rule that does allow extenders to prescribe. In other states, extenders first need to take a 24-hour course about opioid use disorder and its treatment with buprenorphine, compared to the 8-hr course physicians take. But Tennessee prohibits extenders from prescribing buprenorphine.

Anyway, Tennessee is recommending a thorough assessment of the patient prior to office-based treatment with buprenorphine. In fact, what they describe above is much like what’s called a diagnostic assessment in the substance abuse treatment world. It’s a full evaluation of the patient’s bio-psycho-social needs.

I don’t do this in my office-based practice. Right now, I schedule an hour’s visit with a new patient, enough time for me to do a standard history and physical exam, as I would for any other new primary care patients. I certainly do get a full history of the opioid use disorder, and other substance use, along with psychiatric and medical issues. I get a drug screen prior to treatment, and I always check the prescription monitoring program. But I don’t delve into process addictions, support systems, or figure out how all other issues will be treated. All of this can’t be done in an hour. But as I get to know my patients over the next few weeks, we talk about all of this, albeit in a more casual way.

However, this data doesn’t necessarily need to be collected by a physician. A trained and licensed therapist could go through much of the background information gathering, and pass this along to the physician prescribing buprenorphine. Plus, physician extenders can help the physician gather information about the patient; they just can’t prescribe the buprenorphine.

At the opioid treatment program where I work, counselors gather the data and compose a bio-psycho-social evaluation or diagnostic assessment. This is built into the system, and it’s done before the patient sees me. This whole intake process takes us about two to three hours, but is required at OTPs.

Next comes a section on how to provide care after the patient enters treatment:

  • Women of childbearing age must do an observed urine screen for pregnancy upon admission, and then once per month. The woman must be asked about the possibility of pregnancy at each visit.
  • All patients should be prescribed the combination product buprenorphine/naloxone, unless the patient is pregnant, nursing, or has a documented adverse reaction to naloxone. A physician can prescribe the buprenorphine monoproduct to no more than 5% of his total patients. Going over this limit will subject the prescriber to scrutiny by Tennessee’s medical board, the guidelines say.
  • Under a section titled, “General dosing guidelines,” there is the statement, “Target buprenorphine dose range should be 6-12mg (or equivalent) per day.”

That requirement of monthly pregnancy screens sounds a bit…twitchy…to me. Of course, we want to know when a woman is pregnant as soon as possible, to get prenatal care started. But other medications, some of which actually cause birth defects during pregnancy, carry no requirements of monthly pregnancy testing (ACE inhibitors come to mind).

I worry Tennessee is allowing some of that “criminally pregnant” mindset into their guidelines. It feels like authorities in Tennessee strongly disapprove of women on medication-assisted treatments becoming pregnant. All things being equal, I think it would be best if they could delay pregnancy until off medication, but often that’s unrealistic. It should be the woman’s choice when she wants to start a family, and she shouldn’t be judged for getting pregnant while on medication-assisted treatment.

As for the prohibition of the buprenorphine monoproduct: the authors of this guideline appear to doubt the truthfulness of the many patients who say they feel better on the monoproduct buprenorphine than on the combination product buprenorphine/naloxone. I remain convinced that some patients do absorb some of the naloxone, leading to unpleasant symptoms of nausea, headache, and muscle aches.

Clearly, I hold a minority opinion. However, I’ve found some interesting data about the urine drug screens of patients on the combination product, all testing positive for naloxone. But I digress. That could be a whole other blog.

Why do these dosing guidelines say the target dose should beget dose of 6-12mg per day? The FDA has approved doses up to 24mg per day.

Again, it’s that “less is better” mindset. It’s as if Tennessee health officials have been forced to recognize medication-assisted treatment is necessary, but to show their underlying disapproval, they want physicians to be stingy with dosing.

We saw that same attitude with methadone in the past, too, before we had conclusive data showing better outcomes with adequate dosing.

Tennessee state law already says that any physician who prescribes more than 16mg per day for more than 30 days must document in the record why that dose is needed. I don’t know how that law is helpful, since the only reason to go above 16mg per day is that a lower dose didn’t suppress withdrawal signs and symptoms.

A buprenorphine prescriber who has a patient on more than 16mg per day for more than 30 days must either obtain consultation from an addiction medicine specialist or turn that patient over to such a specialist.

Next, this document gave very specific guidelines about benzodiazepine prescribing in patients on buprenorphine:

  • Benzodiazepines should not be initiated in a patient with opioid use disorder if that patient has never been on them before, or if that patient has misused them in the past.
  • Patients with a longstanding benzodiazepine prescription for a legitimate medical condition may be prescribed buprenorphine, but only with careful coordination of care with the prescriber, which must be documented
  • The buprenorphine provider may take over prescribing the benzodiazepine if the patient is willing to start a taper
  • If the patient with opioid use disorder also has a clear history of benzodiazepine use disorder, the duration and extent of that use must be clearly documented, and the patient may be switched to a long-acting benzodiazepine like clonazepam to taper the dose.
  • Doses of benzodiazepines that are at, or higher, than the equivalent of clonazepam 2mg per day are considered to be on a “high dose.” Reasons for such a high dose must be documented, and these patients should be tapered as rapidly as possible to below that benzo equivalence.
  • Patients on high dose benzodiazepine therapy for more than six weeks shall be managed by a physician who is board-certified in addiction medicine, or by a physician who has obtained a formal consult from such a specialist.

I’m going to refrain from commenting on this section, since I’m more rabidly opposed to benzodiazepines than many physicians.

OK, one comment.

Benzos are not first-line medications for anxiety disorders, and there are few indications for long-term (more than three months) benzo prescriptions, except possibly for end-of-life care. Besides, benzos have long-term side effects like increased incidence of dementia, falls, and the like.

Then the document shifts again to tasks that need to be completed upon admission:

  • Each patient must get a mandatory infectious disease screening, to include, at a minimum, HIV and Hepatitis B and C, tuberculosis, and sexually transmitted diseases. This doesn’t have to be done in the physicians’ office; patients may be referred to the local health department.
  • Each patient must be screened for the need for trauma-informed care, including an ACE (Adverse Childhood Event) score.
  • Before initiating treatment, the patient must sign an individualized treatment plan, to be documented in the patient’s record.

Tennessee’s Health Department must be able to do all this infectious disease testing, which is great. In North Carolina, Health Departments do all except Hepatitis C testing, due to its expense.

After patients needing trauma-informed care are identified, does Tennessee have enough counselors trained to provide Trauma-focused therapy?

At our opioid treatment program, more than 70% of the females entering treatment need this care, but there are few places that provide it, and long wait times to get it. Is Tennessee better equipped? Where are these patients going to get this treatment?

After this section, we get down to the nitty gritty of actual treatment. The guidelines divide treatment into three phases: induction, stabilization, and maintenance. Here are the guidelines:

  • During induction and stabilization phases, patients should have weekly office visits, one observed drug screen per week, counseling sessions every two weeks, at a minimum, and receive weekly case management services
  • For patients in the maintenance phase for less than one year, they must have office visits every 2-4 weeks, counseling sessions at least monthly, have 12 random and observed drug screens per year, and receive case management at least monthly
  • For patients on maintenance for more than one year, they must have office visits at least every two months, receive counseling monthly, get 8 random observed drug screens per year, and receive at least monthly case management services.
  • The prescriber needs to document which stage of treatment the patient is in.

Finally, I think these guidelines, for the most part, are good. There’s nothing wrong with establishing a mandatory minimum of services to be given to patients with opioid use disorder. It’s just that in so many aspects, this guideline for office-based care is almost exactly what is required of care given at opioid treatment programs, even down to the number of required counseling sessions for each patient.

That’s kind of ironic, considering how viciously Tennessee fought to keep OTPs out of their state. After all, the first OTP in Eastern Tennessee, an area with one of the highest overdose death rates in the world, just got their first OTP in August of 2017.

Now, almost comically, we have Tennessee advocating for the type of care OTPs have been providing for decades.

We need to consider the intent of the DATA 2000 law. It was enacted to give patients with opioid use disorder a different treatment option with less restrictive requirements than those found at OTPs. Tennessee’s new guidelines don’t provide a less restrictive option for patients and their physicians in Tennessee.

I worked in primary care for about a decade before switching to addiction medicine. Primary care doctors, faced with Tennessee’s guidelines, well-intentioned as they are, won’t want the headache and responsibility of trying to meet this standard of care. Buprenorphine treatment will remain in the hands of specialists. I’m not saying this is good or bad – just that it may not be Tennessee’s intention. Time will tell.

Perhaps DATA 2000 was overly hopeful. Maybe all patients, or at least patients new to treatment, need tighter guidelines like Tennessee’s.

Or maybe (as I have come to believe) all these patients need to start treatment at an OTP, then transfer to office-based setting after they are stable for a year or so, where they can be treated with fewer restrictions and more flexibility, as DATA 2000 physicians could to do before these new guidelines were passed.

Here’s another important consideration: who will pay for this treatment? Who pays for the therapists, counselors, observed drug screening and pregnancy testing? Who pays for the complete bio-psycho-social work up and the treatment plan development and updates? There was no mention of this in the guidelines.

I know it sounds like I’m critical of Tennessee’s efforts, and I am, a little. But it’s an exceptional accomplishment to get all the people and organizations together who are interested in this problem, get them talking, and get them to agree on a set of guidelines. All participants are to be commended, because that’s not easy work.

Hopefully, the experts can be flexible enough to try something, re-assess, change things that don’t work well, and keep things that do work well.

Concerned people in North Carolina also will be watching and hopefully learning from Tennessee’s efforts.

Canadian Vending Machine To Dispense Hydromorphone

 

 

 

 

Last month the Washington Post newspaper reported that British Columbia officials plan to set up three vending machines to dispense hydromorphone to people with opioid use disorder.

Canada has struggled with opioid overdose deaths just like the U.S., and they declared their opioid use disorder public health emergency in 2016. Projected data from 2017 estimates four thousand Canadians died from opioid use disorder that year. (In the U.S., an estimated sixty-four thousand people died from overdoses in 2016.) The extremely potent drug fentanyl has been detected in around 83% of the Canadian overdoses.

In British Columbia, overdose death rates last year were estimated at 30 per 100,000 people, which is roughly the same as in Rhode Island. (Our highest state, West Virginia, had around 52 per 100,000).

I’ve blogged before about Vancouver’s heroin-assisted therapy (HAT). In a blog in 2013, I described results of trials in Vancouver and Montreal where pharmaceutical-grade heroin was provided, in specialized facilities, to people with opioid use disorder. Medical personnel were on site at the facilities in case of overdose, and new needles and equipment were provided to participants.

Vancouver’s results showed better retention in treatment with heroin-maintenance therapy (HAT) than patients enrolled in traditional medication-assisted treatment with methadone. Participants had lower rates of use for other illicit drugs, and lower rates of participation in criminal activities than patients not in any treatment. Overall, these programs reached a subset of people with opioid use disorder who would not consider more traditional treatments with methadone or buprenorphine.

These HAT programs work in urban settings, where people can come to a centralized facility manned with trained personnel. Logistically, this sort of facility is more difficult in more rural areas. Plus, since there’s no drug company manufacturing heroin, scientists had the idea of vending machines pre-set to deliver doses of pharmaceutical-grade, immediate release hydromorphone tablets. This medication would not be as hard to obtain for patients in the treatment program.

These machines will be set up to release two or three hydromorphone pills three times per day. The cost per patient would be around $3 per day.

This idea was based on a study published in 2016 in the Journal of the American Medical Association Psychiatry by Oviedo-Jones et al., that showed supervised injection of hydromorphone was non-inferior to supervised injection of heroin.

Pharmaceutical-grade hydromorphone reduces the risk of fatal overdose death from heroin, which is often cut with substances that can be lethal, like fentanyl. Plus, non-drug substances are frequently added to heroin to make the product go farther, exposing users to all sorts of contaminants.

Canada already has vending machines to dispense clean needles to drug users, so this idea takes the concept a step farther. I didn’t realize it, but while researching this article, I found that some cities in the U.S. also have clean needle vending machines. I think this is a wonderful idea, based on science that shows access to clean needles reduces spread of infectious diseases.

Of course, hydromorphone vending machines raised concerns. Law enforcement worried that the machines could be tampered with, and the hydromorphone stolen. Other people worry this medication could be sold on the black market. But the machines are supposedly difficult to break, more like ATMs than typical vending machines, and the small amounts dispensed each day per person are thought to make it less likely to sell these pills.

In Canada, harm reduction ideas do not cause the pearl-clutching outrage we tend to have in the U.S. Can you imagine a proposal in some state legislature for a vending machine to dispense hydromorphone? It probably would not be given a hearing.

In fact, we’ve taken the opposite route in the U.S. The pharmaceutical opioid oxymorphone, in the brand formulation Opana ER, was taken off the market because so many people were injecting it. In my area, six month ago, most new patients I admitted into treatment were using Opana as their main opioid drug. Over the past month, that has changed. Now, most patients are using heroin.

This has happened all over the U.S. – declining availability of prescription opioids fueled the sharp increase in heroin use, and with it, heroin overdose deaths.

I suspect Canada will see fewer heroin overdose deaths in areas with hydromorphone vending machines, but I’m not fully sold on their idea. I worry the medication dispensed by these machines may be diverted to new users, creating new cases of opioid use disorder. In the U.S., the increased access and availability of opioids starting twenty years ago was associated with increased rates of opioid use disorder, and got us into our present mess. Before I endorse the vending machine idea, I need research showing it won’t cause unintended harm.

I’m sure British Columbia health officials will track data that will show if this vending machine concept will work to reduce deaths. It’s an interesting concept, and we have a front row seat to watch what happens with our neighbors to the north.