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More About Tennessee’s Buprenorphine Guidelines

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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.

 

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Tennessee’s New Guidelines for Office-Based Buprenorphine Prescribing

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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.

Dealing With Disillusionment

 

“You know what? Let’s just switch every patient over to methadone and be done with buprenorphine!” I said angrily during case staffing last week.

This all started several weeks ago, when an angry patient was leaving my office. I don’t recall why he was unhappy with me, but on his way out of my office, he was venting about how he was being treated harshly, compared to patients doing much worse things. He said many patients leave our facility after dosing with buprenorphine with much of the medication packed between their teeth and lips. He said some people sold it, and some injected it, and that we were too stupid to see it.

I didn’t think much about it, but later that day at case staffing, we discussed asking patients to show us the area between teeth and lips, just to see if diversion in this manner was occurring.

I need to explain why we don’t want patients to leave with buprenorphine still in their mouths. Because we are administering this medication at an opioid treatment program, we must abide by different rules than an office-based buprenorphine practice. While physicians in office-based practices can prescribe as many days’ supply of medication as they see fit, different rules apply to opioid treatment programs.

In my state, buprenorphine patients still have to meet time in treatment requirements, same as methadone patients, before they can get any take home doses. Fortunately, our State Opioid Treatment Authority (SOTA) leaders are intelligent and reasonable people, and allow us to ask for take home exceptions early, at the four to six-week mark, for patients on buprenorphine who are doing well and have a couple of drug screens showing only the prescribed medications. This is because buprenorphine is so much safer than methadone.

But when patients first start, or if they’re still using other illicit drugs, or if their lives are unstable in some other way, they must do daily observed dosing with us.

Observed dosing means that they stay on premises while the medication is consumed. With methadone, it’s a quick swallow, and the patient says goodbye, and it’s done. With sublingual buprenorphine, our patients sit in a designated and monitored area until their medication is fully dissolved. We’ve had some patients walk out of the building with buprenorphine still in their mouths, and inject that buprenorphine. Because of that, we ask the patients to show a nurse under their tongue that the med has dissolved before they leave our facility.

But this idea that some patients may be packed medication between their teeth and lip was new. The nurses picked one day to ask all patients to show them their whole mouth – all around teeth, under tongue, after dissolving.

They discovered a handful of patients who had packed medication into a cheek, clearly with the intent of taking that buprenorphine outside the premises.

What did they intend to do with it? I don’t know. Maybe they planned to give part of their dose to a loved one. Maybe they planned to take it later, or maybe they planned to inject it. Maybe they sell the buprenorphine. I have no idea, but I have clear evidence that the patient isn’t taking the medication I’m prescribing.

I have an obligation to prevent diversion of medication I prescribe into the black market. If I know a patient is engaging in behavior that’s suspicious for diversion, I can’t in good conscience continue to prescribe that medication.

We could enter a discussion about how diverted buprenorphine is really a harm reduction method, by providing a safer opioid to the people in the community with opioid use disorders. But opioid treatment programs, called “methadone clinics” in the past, have long histories of stigma. Law enforcement types and regulatory inspectors do not want to hear about harm reduction. Some of these people barely tolerate our existence as it is. I support harm reduction, but I must deal with the world as it is now.

Diversion from an opioid treatment program can get that facility shut down.

When the nurse called me with a list of names of people engaged in diversion of buprenorphine, I had to tell her I will not prescribe any further buprenorphine for those patients. They must either switch to methadone or seek treatment elsewhere.

About half chose to leave and the other half chose to start methadone.

We felt like we had to start checking patients’ entire mouths every day, and found more patients who were diverting their medication. All in all, about ten patients were found to be attempting to divert.

I did not react well. I was furious.

Before you write a comment to me saying how unruly behavior is often a symptom of the disease of opioid use disorder, and that I shouldn’t take such things personally, and that the majority of patients were dosing correctly and that’s what I should concentrate on…yes, I know all of that.

But I had to go through a process to get there, and maybe writing about it is my way of dealing with these feelings.

I get particularly upset when a patient does something that threatens my view of myself as an effective helper. When it starts to look like I’m making it easier for some patients to inject themselves with buprenorphine, I feel anger initially, but underneath that emotion is a whole lot of fear.

I fear I’m not really making any differences in the lives of these people, and that they all look at treatment as a joke. I’m afraid I’ve been deluding myself that medication-assisted treatment helps patients. I wonder if I should go back to primary care practice, where nothing I ever said or did seemed to make a bit of difference in the lives of people with chronic illnesses. I fear that the MAT detractors are right, and that I’ll end my days by regretting the action and advocacy I’ve taken over the past decades.

I feel disillusionment.

As you can see, my strong negative emotions sometimes trigger a runaway train in my mind. Thankfully, as I age and mature, the train slows much faster than it used to.

I’m better now. Thankfully, I can go back to the information that lead me to this field in the first place…the decades of scientific information that show beyond a reasonable doubt that while individual patients may fail to improve with MAT, overall it saves lives. Then I can look at the smiling faces of patients who have completely changed their lives while in treatment.

When I get to the point I can look at reality uncolored by emotion, I see the vast majority of patients at the opioid treatment program are doing very well. Nearly all have improved in some way, some more than others, of course. Some of them do have rocky starts, but can do well if we address the issues and get them to stay in treatment.

Early into the New Year, I’ve re-learned a lesson about disillusionment, fear, and the process of working through all of that to a more reasonable view.

I suspect many people in the helping professions deal with this process over and over. It can be challenging, but such jobs are rewarding as well.

Bad Weather Take Home Doses for Opioid Treatment Program Patients

We’ve had some snowy days in my area, and this means administrators at our opioid treatment program must decide if we should provide extra take home doses to patients for the days when travel will be treacherous.

Because take home doses are closely regulated at opioid treatment programs, both for methadone and buprenorphine, we must get special permission from state and federal regulatory agencies to give extra take home doses. We do this by submitting what’s called an “exception request.” This is an online form where we describe why we are requesting an extra take home, and for whom it will apply. Part of our job is assuring the authorities we won’t give extra take homes to patients who can’t manage them safely.

Ultimately, it’s up to me, the medical director, to decide the risk level of each patient. Which is more dangerous, driving on snowy roads to get to the opioid treatment program to dose, or having an extra take home bottle of medication? I need input from the staff to make the best decisions, so this can be time consuming.

Admittedly, my program failed our patients this last week.

The trouble is, we must decide when to submit a request for extra take homes about 48 hours in advance. It may take a day to submit online and get the medical director’s signature, the state opioid treatment authority signature, and the federal agency signature. Then we must give out the extra take home one day before the harsh weather is predicted.

Sometimes it’s hard to forecast bad weather. Early this month, we got an extra take home exception for a day when ice was predicted. In our area, a few degrees can make the difference between ice and rain. As it turned out, no ice fell and it was a perfectly normal day for driving.

I think that over-reaction was in our minds when we were monitoring the weather last week. At first, weather was expected for late Tuesday night. We were expected to get 1-2inches. We discussed if we should submit an exception, and finally did so late Monday night. I signed it, and it was approved by state and federal authorities, but we chose not to enact the exception Tuesday morning, based on updated forecasts.

It was not the right decision.

Tuesday night, it began to snow during the wee hours. By early morning, we had 3-4 inches and it kept snowing until afternoon. Somehow the forecasted 1-2 inches turned into 8 inches, at least on my side of the Brushy Mountains.

I live in the Brushy Mountains, and have a very steep driveway. Really, really steep. Imagine the steepest paved road you’ve ever driven on, and crank that up a few more degrees and you have my driveway. Plus, it has two curves in it. The only way I can get my small Toyota down the driveway would be to ride it like a luge sled, so it stays in the garage during bad weather.

My fiancé has a four-wheel drive vehicle, so he takes me to work, or I call a co-worker to come get me and I walk down my driveway to the road.

A group of physicians who work at opioid treatment programs were discussing this issue of severe weather take home exceptions on our monthly conference call last week. We pondered the factors that help us decide:

  1. Since buprenorphine has a greater margin of safety than methadone, I’m willing to grant bad weather take home doses for buprenorphine patients, unless there are other concerns to be considered.
  2. Patients in the induction phase of treatment, the riskiest time in treatment for methadone patients, shouldn’t get extra take homes.
  3. Patients who already receive take home doses for Sundays and holidays are likely OK for bad weather days, too.
  4. Patients using alcohol or benzodiazepines are at higher risk, and may not be appropriate for extra take home doses.
  5. Patients who live in a home with other people with active substance use disorders may not be able safely to store their medication, and may not be appropriate for the extra take home.
  6. Patients who have had recent episodes of suspected diversion won’t get extra take homes.
  7. Patients who live around the corner, are healthy, and can easily walk to the opioid treatment program don’t need extra take homes.
  8. Patients who live in more treacherous terrain or longer driving distance may need take homes. Our opioid treatment program is in the foothills of the mountains, but some patients live in a spur off the Appalachian Mountains called the Brushy Mountains. We have some steep and winding roads.

That’s a rough idea of most of the factors that go into deciding who should get take homes and who shouldn’t.

Then there are transportation issues. I mistakenly thought Medicaid-funded patients, who ride a transportation service that contracts with Medicaid to provide transportation to medical appointments, could get their usual ride to the opioid treatment program. Later I found out they have only a few four-wheeled vehicles. On one of our worst snow days, they only transported dialysis patients and others with “life-threatening illnesses.” My patients weren’t transported.

So, now I know that I cannot count on this agency to get patients to treatment on bad weather days.

As a group, OTP physicians are re-evaluating criteria for extra take homes in these bad weather situations, along with some help from our SOTA (State Opioid Treatment Authority). I feel fortunate to live and work in a state with an active SOTA. These remarkable people are tireless in their quest to continually improve the quality of care for patients at opioid treatment programs. They are valuable allies for physicians.

Because that’s the bottom line: we all want the best and safest care possible for our patients.

Buprenorphine Monthly Injection: Sublocade

 

 

 

 

 

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

The STOP Act of North Carolina

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In mid-2017, North Carolina Governor Roy Cooper signed the STOP (Strengthen Opioids Misuse Prevention) Act into law, and as of January 1, 2018, additional portions of the Act became effective.

The STOP Act has several parts, all of which are intended to reduce the epidemic of opioid use disorder by limiting excessive and inappropriate opioid prescribing.

Beginning last July, the STOP Act required physician extenders (nurse practitioners and physician assistants) working for pain management practices to consult with their physician supervisors prior to issuing any Schedule II or III opioids. Then, they must also consult with their physicians every three months while the opioid prescriptions continue.

Prior to this law, extenders had no requirements to consult with physicians prior to issuing these opioids or continuing them. Still, defining the meaning of the word “consult” is a little fuzzy…does it mean a face-to-face conversation, a phone conversation, or email communication? The NC medical board website doesn’t offer much concrete guidance about this.

Beginning last July, the STOP Act also said hospice organizations were to start telling families of patients who passed away while on strong opioids where the leftover medications could be disposed safely. The STOP Act also encouraged the distribution of naloxone kits for opioid overdose reversal, and streamlined the process by which prescribers could enroll delegates to query our state’s prescription monitoring program more easily.

By September 1, 2017, pharmacies were supposed to be reporting all controlled substance medications that they dispensed by the end of the business day. I don’t know if there are any penalties for not meeting that requirement, but I think we still have a way to go towards meeting this standard. Pharmacies also need to correct data quickly if they confirm it’s been entered in error.

This requirement pleases me a great deal, given my interactions with pharmacies over the years. On numerous occasions, when I’ve called about a goofy-looking entry for one of my office-based buprenorphine patients on the North Carolina Controlled Substances Reporting System (NC CSRS, our state’s prescription monitoring program), I’ve been told by pharmacists (usually a CVS) that the error can’t be corrected because it’s a system glitch. Now I can tell them they are required to fix the error!

But one of the most debated portions of the STOP Act took effect January 1, 2018. This was a provision that limits prescriptions for opioids for acute pain conditions to no more than a five-day supply. For post-operative pain, opioid prescriptions can be for up to seven days.

This doesn’t mean a physician can’t write a second prescription when needed. It only means the physician must see the patient again and carefully consider whether to write a second prescription, rather than OK more opioids with little thought.

Many people fear this law, worried they won’t get adequate pain control. However, it’s important to understand that this requirement will not apply to hospice patients and those in palliative care. This requirement is only for acute pain episodes: kidney stones, acute injuries, broken bones, and the like.

This portion of the STOP Act doesn’t apply to chronic pain conditions, either. Patients who are being prescribed opioids as part of an existing program to treat chronic non-cancer pain won’t fall under the five- and seven-day provisions.

However, parts of the STOP will eventually require prescribers to query the NC prescription monitoring program before starting opioids to treat chronic pain. Prescribers will need to review the patient’s prescriptions for at least the preceding twelve months. After beginning an opioid prescription, the physician will need to query the NC CSRS at least every three months., though there’s no deadline to start doing this yet.

Then in January 1, 2020, electronic prescriptions will be required for all targeted controlled substance prescriptions (Schedule II and III opioids).

Some people think the STOP Act is too severe, and will put patients at risk for under-treatment of pain. When medical practice is limited by legislation, opponents of the Act say, physicians are less able to use their clinical judgment and patients are all treated the same.

But this legislation is based on some crucial information.

In 2016, the Centers of Disease Control and Prevention (CDC) issued the CDC Guideline for Prescribing Opioids for Chronic Pain. This document, among other recommendations, stated that opioids are not the ideal way to treat chronic pain conditions, and that non-opioid treatments are preferred. Those guidelines also recommended that if opioids are used, reasonable goals should be set, and patients need to be informed about the risks of opioids. The Guidelines also gave specific recommendations for how to start opioid at a low dose, with short-acting agents, and ways to monitor patients to make this prescribing safer. [1]

Then last year, the CDC released information showing the risk of developing opioid use disorder increases with increased duration of opioid prescribing. This article, “Characteristics of Initial Prescription Episodes and Likelihood of Longer Term Opioid Use – United States, 2006-2015.” Shows us thought-provoking data based on a very large population study.

This interesting data showed that the risk of long-term opioid use increases sharply after the first five days of treatment, and again after the first thirty days of treatment. Therefore, limiting that first prescription to five days, as North Carolina legislature has done, makes good sense. This law is science-based, which isn’t always seen in legislation.

Treatment initiation with a long-acting opioid was associated with higher probability of remaining on opioids for longer than a year, underlining the importance of using short-acting opioids for acute pain situations.

More interesting, using tramadol initially to treat acute pain was associated with a significantly higher risk of remaining on opioid long-term. We need more studies to help clarify this, since many physicians perceive tramadol to be a lower-risk drug than simple opioid agonists like oxycodone or hydrocodone.

The authors of this article also looked at the cumulative dose of opioids given, and noted an increase in the likelihood a patient would remain on opioids long-term once they had consumed more than 700 morphine milligram equivalents.

This study was well-done. It was a random sampling of over a million patients over age 18 on a commercially insured health plan who were prescribed at least one opioid prescription between 2006 and 2015. Cancer patients, patients with a history of substance use disorder, and patients starting buprenorphine were excluded from the study.

Critics may ask how this data is relevant. They may say, for example, that just because a patient remains on opioids for more than a year doesn’t necessarily mean that person will develop opioid use disorder, and that’s true.

But at a population level, more opioid prescribes means more overdose deaths. Over the past fifteen years, the number of milligrams of opioids prescribed quadrupled. Mirroring that rate closely, our nation’s opioid overdose death rate quadrupled right along too.

Less available prescription opioids will mean less available to fall into the wrong hands. We know from NSDUH data that more than fifty percent of the time, the first opioids a youngster takes for experimentation are obtained from a friend or relative.

I support this law, and I’m hopeful the law will mean fewer medicine cabinets have leftover opioids lying about. I’m hopeful this will reduce youthful experimentation, which will reduce the risk for opioid use disorder.

Let’s stop making new patients, as we help established patients along their road to recovery

  1. https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm