Contingency Management

Lately I’ve been thinking about contingency management.

I listened to some sessions about contingency management (CM) during several of the national Addiction Medicine conferences this year. That reminded me our opioid treatment program had been talking about using contingency management to improve attendance at our intensive outpatient group just before COVID hit. But after COVID…*POOF* …no more groups.

Now that COVID is on the decline, it’s time to consider re-establishing our intensive outpatient group.

For those who don’t know what contingency management is, or who are a little foggy about what it means, I can tell you I had to look it up again too. I know what it is…but putting it into words is difficult.

In short, CM is a type of behavioral therapy which rewards progress towards a set goal. Patients are rewarded in some way for positive behaviors.

CM can take all kinds of shapes. For example, during one of the sessions at the American Society of Addiction Medicine conference, presenters described how they rewarded patients with small gifts as they met treatment goals. All patients got a pen and a blank journal upon admission. As patients produced negative urine drug screens, they were rewarded with draws from a fishbowl for vouchers for various prizes. The prizes ranged from positive affirmations (“You did a good job”) to polished stones with affirmations on them to gift cards for up to $25.

This program saw impressive results with these small rewards. Their patients had better attendance and more negative drug screens.

Scientific literature shows that contingency management is effective, if it is used in ways that adhere to several basic concepts. The targeted behavior should be an observable and treatment-adherent behavior. In other words, CM should target a patient behavior that is in harmony with substance use treatment goals. Then CM program should give an immediate and tangible reinforcer to the patient when the desired behavior is exhibited. If the desired behavior is not exhibited, the reinforcer is withheld.

CM is not new; at least two-hundred studies of CM techniques have shown that it works to produce desired behaviors in substance use disorder treatments. CM usually shows at least a medium effect size. This means isn’t the next great thing to fix everyone with substance use disorders, but it does provide reliable improvements for patients.

CM has been used in diverse patient populations and appears to be effective for all different socioeconomic groups.

Strangely, despite producing reliably positive results, CM hasn’t been used as much as one would think.

Some people object to the idea of contingency management. For example, an obstacle to implementing CM in substance abuse treatment cropped up last summer. The Trump administration set a cap of $75 per year per patient on CM programs. That is, whether prizes or rewards are donated by local businesses or bought by the treatment program, these programs can’t reward patients with any more than $75 per year, for fear that money would entice patients to come to one treatment program over another. The U.S. Office of the Inspector General (OIG) said such methods of paying patients to participate in treatment might violate the Anti-Kickback Statute. In other words, it’s illegal to pay patients to come to your treatment program. This could be a type of fraud, particularly if the treatment program bills Medicaid/Medicare for treatment.

Last year, the American Society of Addiction Medicine (ASAM) sent a letter to Alex Azar, the then-Secretary of Health and Human Services, asking that contingency management treatment techniques to be exempt from the Anti-Kickback Statute. The ASAM president, Dr.William Haning, pointed out in the letter that safeguards could be applied to prevent fraud, waste, or abuse when using CM techniques in counseling people with substance use disorders.

Some people feel it’s unethical to pay patients for doing what they “ought” to be doing anyway. Other people say it’s manipulative to induce patients to behave in ways decided upon by authority figures. This may be true, but patients still have the choice of participating or not participating in reward programs.

For example, let’s say a patient comes for treatment of her opioid use disorder at an opioid treatment program. That program gives CM rewards for negative urine drugs screens. Perhaps the patient wants to quit using opioids, but she doesn’t see any need to quit using cocaine. She can continue to use cocaine, and have positive drug screens, meaning she won’t get the small rewards of the CM program. She’s not out anything by her decision, and still gets treatment for opioid use disorder.

Salespeople have been using CM for decades. Many advertisers use CM to shape consumer behavior. For example, look at the BOGO sales. The sales staff want to sell more product, so they advertise “BOGO” in large letters. This means if the consumer buys one, the second one – of whatever it is – is free. The consumer is being tempted to a certain behavior – buying something – by an offer from the seller.

By the way, there’s nothing more irritating than seeing a “BOGO” sale advertised, only to read the fine print that the deal is buy one and get some percentage off the second one. That’s not a real BOGO. That’s what I call a faux BOGO. Don’t even bother me with a faux BOGO.

But I digress.

Other contingency management sales techniques might be the reward of a free sub sandwich after you buy five regularly priced subs.

The point is, we participate in CM deals all the time, but usually the behavior desired of us is buying products or services. For treatment of substance use disorders, the desired behaviors might be attending counseling sessions or ceasing drug use to produce negative drug screens. Progress towards those goals are rewarded in some way with CM.

I’d like to start our groups again, and for every three-hour session attended, each person gets a draw from a fishbowl. The fishbowl might contain any number of rewards: gas card for $10, coupon for a sandwich at a local restaurant, a card with positive affirmations, or something similar. The possibilities are endless. Perhaps local businesses could donate goods or services in exchange for some free advertising, or just to do something nice for people who are trying to achieve recovery from substance use disorders.

Twelve-step meetings have been using a type of CM for decades: group members get chips or key tags for achieving days in recovery: they have these for one day, thirty days, sixty days, ninety days, six months, nine months, and one year and multiple of years. The chips or tags themselves are worth very little, but the value of being recognized for achievement in recovery can be important, especially when the recognition is given by people who understand how difficult recovery is.

Some of our patients don’t get the recognition they should for their achievements in recovery from friends or family. Maybe CM is a great way to acknowledge that achieving little goals is a big deal.

Mobile Opioid Treatment Programs

Opioid overdoses killed 47,600 people in the United States in 2017.

Last spring, just before COVID demanded all our attention, a friend at our state opioid treatment authority emailed me a link to document titled, “Registration Requirements for Narcotic Treatment Programs with Mobile Components,” and asked what I thought of it. This was a new document – at that time – posted on the DEA’s website, under the Diversion Control Unit. The document described new rules for mobile opioid treatment programs (they call them NTPs, for Narcotic Treatment Programs).

The intention of the new proposal was to make it easier for treatment providers to meet demand in rural areas.

Sometimes I have an opinion about an issue before I get all the information, and the idea of a mobile OTP seemed dangerous and ill-advised. But after reading the DEA document, I’m convinced mobile opioid treatment programs could be great options, if done with proper care.

The DEA stated that it recognized the extent of the financial burden needed to open a brick-and-mortar opioid treatment program. Because of all the regulations, a new facility owner must pay rent on a building for a very long time before all the permissions and inspections are done by all regulatory bodies. That often ends up being more than a year. That’s a considerable outlay of time and money for new programs, and rural areas with few prospective patients are financially unattractive sites for new OTPs.

Mobile units are a way to fill the void.

This new proposal means mobile units can be operated as a “coincident activity” based out of a brick-and-mortar treatment program. The new rule proposes doing away with the present requirement that mobile unit need their own licensing and registration. This change makes it much cheaper to operate a mobile unit.

There are several caveats involved in creating a mobile OTP unit. For example, trailers won’t qualify. The unit must be a “conveyance,” that is, able to move on its own power. This conveyance would be subject to inspection just as brick-and-mortar opioid treatment programs are.

Medication must be stored securely, of course. Medications must be stored in a safe that is bolted to the floor or side of the vehicle and must be accessible only from inside the vehicle. Medication can’t be accessed from outside of this van or vehicle. Patients should not be able to step into the portion of the vehicle containing the safe with medications in it, so there must be some sort of door dividing the portions of the conveyance.

There must be an alarm system on the unit.

Records may be kept in paper or electronic forms while the mobile OTP is in service but must be stored inside the brick-and-mortar structure overnight.

Analysis of the proposed system indicated that opioid treatment programs will save money because of the reduction in start-up costs for mobile units that are under the auspices of existing brick-and-mortar programs. Mobile vans could reduce healthcare costs and reduce time lost from work for patients.

 At first, I thought the idea was a little goofy, but then I thought of all the ways such mobile units could be creatively used.

Incarcerated patients: Patients already on methadone or buprenorphine products could have their medications delivered and dispensed by the mobile OTP. Jail and prison staff wouldn’t have the headaches of storing and administering these medications, and inmates would be evaluated each day as usual. Or, depending on the stability of the patient and the willingness of jail staff, the patient could be dosed by staff on the mobile OTP, and enough daily doses left until the mobile OTP needs to return. With that method, jail staff would still have to store, track, and administer some doses.

The biggest benefit would be reduction of illness from enforced withdrawal from life-saving medication, and reduced risk of death after the patient is dismissed from jail, assuming the patient remains in treatment.

Rural patients: In areas too small to support a traditional opioid treatment program, mobile units would be able to treat patients more efficiently. I could imagine that arrangements could be made for the mobile unit to be at “X” location in a small community at a set time daily, for treatment of patients living in that area. Then the unit could be scheduled for another location in that rural area for later in the day. Patients would have to make sure they arrived at set times, but they would have far less distance to travel to a more traditional program. This would save them time and money, particularly in areas too rural for public transportation.

Outreach: Some communities are less likely to participate in treatment; for example, a minority community might hold negative opinions about medications for treatment of opioid use disorder. But if a mobile unit repeatedly traveled to that community, both treating patients and educating citizens, hopefully their concerns could be addressed. Healthcare workers could dispel misinformation and reluctance. Or perhaps immigrant communities with suspicions about treatment could be addressed in similar ways.

 A report released last fall described Massachusetts General Hospital’s success using mobile opioid use disorder treatment to reach vulnerable homeless populations in Boston, where overdose death rates were high. This program was called Community Care in Reach. This mobile unit reached homeless populations in the city who have special difficulties accessing healthcare.

Studies showed the homeless die of opioid overdose at a rate approximately twenty times the general population, proving the need for outreach to that population.

The mobile unit wasn’t an opioid treatment program, but it was staffed with primary care providers who diagnosed and treated patients with sublingual buprenorphine products. At the same time, the program dispensed naloxone kits to reverse opioid overdoses, and provided clean needles to people who were injecting drugs. This program, which started in 2018, logged nearly ten thousand patient contacts by late 2019. [1]

As I scoured the internet for information about established mobile OTPs, I found much more information about mobile units that provide buprenorphine treatment. I found less information about true opioid treatment programs on wheels, which provided both methadone and buprenorphine.

I found an article describing how mobile services for methadone maintenance tend to retain patients in treatment longer than typical fixed-site programs.  In this article from 1996 by Greenfield et al., mobile program patients were retained in treatment an average of 15 months, compared to around 4 months for traditional patients. [2]

This study was done in Baltimore, in the inner city. I wonder how much better retention would be for rural areas that have very little public transportation compared to cities.

I want owners of our opioid treatment program to invest in a mobile unit. We have rural counties to our north that have no opioid treatment programs within their borders. They have several office-based programs which prescribe buprenorphine products, but not every patient responds to this medication. Patients who need methadone for stabilization drive an hour or more to our program or drive over the border into Virginia for help. I think a mobile OTP could reach many patients in that area.

However, our nation’s system of healthcare as a business means the mobile OTP would have to make a profit, or at least break even. I have no idea if it would be financially attractive, but I know that with the revision of the DEA rules, it is less costly than in the past.

The whole aim of encouraging development of mobile dosing units is to increase access to treatment in this time of opioid epidemic, while still using appropriate controls to reduce diversion.

  1. https://www.frontiersin.org/articles/10.3389/fpubh.2020.00501/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Public_Health&id=573744
  2. https://pubmed.ncbi.nlm.nih.gov/8889411/

Grand Jury Indicts Buprenorphine Physician

I am not an apologist for any physician who breaks the law. The government should prosecute true criminal offenses. I just would prefer those offenses be actual crimes and not part of generally accepted medical practice.

I’m not going to name names. I don’t want to bring any additional grief to the parties involved. My purpose in writing this blog is to point out some disturbing portions of the grand jury indictments against this provider, and to ask my audience how they feel about specific details of the indictments, like “…buprenorphine doses were often not appropriately tapered.”

I am writing this from the point of view of a physician, of course. I am not a lawyer, despite having watched all “Law and Order” episodes so often that I can quote large chunks of dialog. Sometimes my husband will ask me if recognize the episode from the opening scene. Often, without looking up, I’ll say something like “Bad uncle up in Yonkers,” or “People ain’t just one thing,” or – my favorite – “You heard my husband. He’s not a perfect man. He’s made some mistakes.” That last one is said with grim satisfaction by a wife who successfully set up her husband to take the fall for the murder of his mistress.

I digress. My point is I don’t know law. I’m giving you my reactions and opinions and asking for yours.

This all started nearly three years ago when this physician, who owned a chain of office-based buprenorphine facilities in Eastern Tennessee, Virginia, and North Carolina had his offices raided by federal agents. They took banking records, patient records, billing records, and other things. This put the physician out of business and disrupted the treatment of patients with opioid use disorder who were being treated by physicians working in those offices.

The grand jury indictment was just made public this spring, nearly three years later.

The indictment contains multiple charges, and is a little hard to read, but primarily accuses this doctor, and other providers working in his programs, of prescribing buprenorphine without legitimate medical purpose.

Thus far there is only one FDA-approved reason to prescribe sublingual buprenorphine products: opioid use disorder. Did this doctor prescribe for another reason? Since his practices were described as opioid use disorder treatment programs, this charge puzzles me.

I suppose he could have prescribed sublingual buprenorphine for pain, both because it works and because it’s less likely to be misused. I know the DEA frowns upon this and prefers patients with only pain and no opioid use disorder be prescribed the transdermal products, but I doubt this would be an offense that federal prosecutors would pursue. Besides, separating patients into “pain only” and “opioid use only” groups isn’t practical because of the large overlap.

Among the many complaints, the indictment said the medical records of patients were “superficial” and used cut- and -paste from prior notes.

I’ve blogged about this before. Many of the office-based notes I get from other providers contain obvious cut-and-paste documentation. It’s very common. It’s irritating to get pages and pages of notes on a patient, only to realize there’s very little information there, only repetition. It’s poor documentation and unethical. I am reminded of the notes I got from a local buprenorphine provider that described the patient as having “abdomen consistent with 8-month pregnancy,” for over a year.

Physicians do this because it saves them time and allows “upbilling.” Insurance companies and Medicaid pay on the intensity of the office visit, and if the doctor includes extensive history and physical exam components at each visit, they get paid more. Rather than take the time of doing an extensive review of systems and exam each visit, unethical providers will cut and paste from prior visits. Of course, if the doctors don’t perform what they’ve documented, it’s insurance fraud.

But these practices didn’t accept insurance or Medicaid, which brings me to the next part of the indictment: that the doctor had a “cash only” practice. That is, patients paid for their visits with cash, check, debit/credit cards even if they had insurance or Medicaid. So, these practices couldn’t commit insurance fraud, if they didn’t even participate in insurance programs.

The government can’t force physicians to accept Medicaid or Medicare payment for medical services. Physicians have the right not to participate in these programs. However, as I understand it, providers need to submit something to Medicaid saying they opt out of that program for three years. If you do that, it is perfectly legal to ask patients who have Medicaid insurance to pay whatever cash price you decide to charge. Patients with Medicaid are free, of course, to select a provider who does accept Medicaid.

That’s difficult to do since Medicaid doesn’t reimburse physicians very well for their time. Medicaid pays much better for procedures and surgeries. It’s hard to find buprenorphine prescribers who are willing to accept what Medicaid pays for their time, and in rural areas may be impossible to find.

So, as I understand it at least, it isn’t illegal to refuse to accept Medicaid. You just can’t accept Medicaid from some patients and refuse to accept for other Medicaid patients.

The indictment says Medicaid patients took their prescriptions to their pharmacies, where Medicaid paid for them. I don’t know how that violates the law unless the physician owns the pharmacy.

Then we come to the part of the indictment that describes laboratory shenanigans. Sadly, these also are all too common in our field and give good providers a bad name. (You can also read about this in a past blog of mine, January 23, 2019) As I understand it, this is how it usually works:

A laboratory organization makes an office-based physician a seemingly fantastic offer. They will provide urine drug screens testing for a hundred or so drugs, with the most accurate system that there is. This is usually something involving gas chromatography or mass spectrophotometry. This type of test is more specific and provides fewer false positives than the cheaper immunoassays usually used. And that’s not all – the laboratory company might provide an employee to the doctor’s office to collect and package all those drug screens. This frees the physicians’ employees to do other chores and saves money. The lab company promises to do free testing for patients without insurance, which sounds altruistic, but they will bill patients with insurance, including Medicaid.

And they really bill private insurers and Medicaid. Labs charge hundreds and even thousands for a single urine drug screen testing for a hundred or so substances. The physician feels like he’s able to do better lab tests, the patients without insurance don’t pay at all, so it seems superficially like a good thing. But private insurers and Medicaid get soaked and the laboratory company makes a juicy profit.

For this to work, the physician must provide a statement that all these tests are medically necessary. It’s not true, of course. All the rest of us physicians get by nicely with drug panels testing for seven to twenty specific drugs. We must decide which patients need more extensive testing and which ones don’t, to keep costs reined in.

The indictment describes this sort of lab arrangement and implies it’s illegal. To me, it appears to be insurance fraud. However, the primary beneficiary to this arrangement is the laboratory. The doctor’s office does get an employee to collect drug screens that he doesn’t have to pay for, but that’s hardly a bonanza. This indictment opines that the money that patients saved on drug testing was channeled to the doctor, to pay for office visits. That’s fuzzy reasoning.

The indictment also said the test results were not available at the time the patient was seen and that no “appropriate actions” were taken regarding abnormal findings. I wonder what prosecutors think that “appropriate action” would be.

Any unexpected drug screen result should result in a conversation between patient and provider, but should not result in termination of treatment, except for extraordinary circumstances. I worry that prosecutors imagine that the physicians at these programs should have stopped treatment for patients with unexpected drug screen results, when the opposite is true. Ongoing drug use means patients need more treatment, not less. In fact, stopping or tapering buprenorphine increases the risk of overdose death by at least three-fold, so that would be the worst option.

The indictment also complained that the drug screens weren’t random, and they were done at the time of the patient’s visit.

Uh oh. That’s exactly what I do, except in unusual situations. Once in a great while, I’ll call a patient and ask them to go to a Labcorp facility for a random urine drug screen, if I’m worried about them. Random drug screens probably are the best option, but logistically it’s difficult. Most of my patients work, and it’s hard enough for them to get time off to see me each month.

The next part of the indictment made me giggle with delight. It said providers at the facilities had inappropriately co-prescribed benzodiazepines with buprenorphine products.

I’ve said in the past, jokingly, that it should be illegal to prescribe benzodiazepines to patients on buprenorphine. But it isn’t. Or at least, it isn’t in places other than this corner of the world. Elsewhere, it’s a matter of physician judgement, or it should be. I’m the most anti-benzo physician I know, and I still have a few patients on benzodiazepines while also on buprenorphine. Patient circumstances vary widely, and providers must be allowed to use our best judgment.

Then there was a confusing section where the indictment said patients were prescribed inappropriately high, but they didn’t say what dose they considered to be too high. Instead, the indictment had odd little tables of appointment dates and how many doses were filled per unidentified patients.

I could not understand what these tables were supposed to demonstrate, but I’m going to guess the prosecutors allege that doses above 16mg per day are excessive. Five or so years ago, some experts in the field said no patient should ever need more than 16mg sublingually per day. That’s been debunked, and current teaching is that doses up to 24mg per day might work better for some patients and retain them in treatment. You can read more about this in my blog of October 8, 2017, because this is not new information.

It feels to me like these prosecutors got way down in the weeds with these indictments, trying to decide what appropriate medical treatment should be. I don’t think prosecutors should try to decide what a patient’s dose of buprenorphine should be. I don’t think they should be the ones to decide how often the patient gets drug screened or when – or ever if – the buprenorphine dose should be tapered.

Maybe it’s typical of grand jury indictments to throw everything that could remotely be criminal action into their document, just to see what sticks. But to me, that weakens the overall announcement that the individual who was indicted committed crimes. The real issues get diluted by non-issues, inducing me to think that maybe there are no real issues.

More will be revealed as time goes on and I’ll keep readers updated.

New Ideas and Common Themes at Addiction Medicine Conferences

This blog is about some of the common themes covered at the three recent Addiction Medicine conferences.

Overdose drug deaths:

All three conferences presented general statistics about how the rates of drug overdose deaths increased during 2020, coinciding with the COVID pandemic. Most overdose deaths are polysubstance; that is, decedents are found to have opioids and some other class of drug in their systems at the time of death. Many of these overdose deaths have opioids such as fentanyl and stimulants, either cocaine or methamphetamines.

We think of overdose as being a process associated with sedation and gradually slowed breathing until respiratory arrest occurs, with eventual cardiac arrest. However, the stimulants kill more often by causing cardiovascular events: strokes, heart attacks, or fatal cardiac arrythmias, even in young people without previous medical problems.

We know that stress is a common trigger for drug use, and the statistics show increased consumption for all types of drugs, including alcohol, during the COVID 19 pandemic.

Medications for opioid use disorder during incarceration:

All three addiction medicine conferences had sessions on this topic. In the past, prisons and jails have refused to allow patients to continue their medications to treat opioid use disorder. However, with recent successful lawsuits brought by inmates demanding appropriate medical care, jails and prisons are being forced to re-think their procedures. I sense that jail and prison medical staffs see the writing on the wall and are starting to consider changing their usual anti-methadone/buprenorphine protocols.

There are several ways to get treatment to patients who are incarcerated.

During the ASAM conference, I went to a session where the speaker, a provider of medical care in a prison facility, described how their facility got certified as an opioid treatment program. She outlined all the steps required of her facility and said it was a tremendously difficult process. Though SAMHSA and national agencies have asked jails and prisons to be able to treat patients with opioid use disorder with medications, she said it is those very institutions that make it so difficult to get the approvals needed to become an opioid treatment program.

I heard other sessions about how a mobile clinic, based out of a brick-and-mortar existing opioid treatment program, can be a novel way to dose incarcerated patients. Other people at the conferences talked about having OTP staff transport medication to a jail facility and leave it with medical staff there, using a chain-of-custody form to document in the approved fashion.

There are many possibilities and opportunities to get creative about how to provide methadone or buprenorphine to existing patients and to start these treatments for new patients.

Oh, and by the way…jails should NOT refer to clonidine and clonazepam and other comfort medications that they give for opioid withdrawal as “medication-assisted treatment.” That’s not medication assisted treatment, though it can be of some value to some patients.

Micro-dosing of buprenorphine:

Some providers are interested in a process intended to make it easier to transition patients from full opioids to buprenorphine. This would be helpful because it would eliminate the need for patients to go into withdrawal before buprenorphine could be started. For most short-acting opioids, twelve to twenty-four hours of abstinence from opioids are required to be in enough withdrawal to start buprenorphine. If buprenorphine is started too soon after a full opioid it can cause precipitated withdrawal.

This year at the conferences, lectures and discussions about a procedure known as “micro-dosing” was discussed to achieve transition more easily.

This involves starting buprenorphine at small doses and gradually increasing until the patient it at a full dose of buprenorphine, at which point the patient can stop using other opioids. I’ve read about several difference “recipes” for micro-dosing, but most schedules involve giving .25 to .5mg on day one, then increasing to .5 to 1 milligrams on day 2, and so on, slowly increasing the dose over the next five or so days until the patient is at the 12mg range. Supposedly the patient won’t feel precipitated withdrawal if buprenorphine is started in this way.

Providers also want to try using micro-dosing to help patients get off methadone and on to buprenorphine in an easier manner. Traditional methods of transition require patience and planning. For example, a patient on methadone 100mg per day would be reduced by 5mg per week until he is on 40mg, stay on that for a week, miss two days of dosing, and start buprenorphine on the third day if COWS  (Clinical opioid withdrawal scale) score is at least a 12. I’ve transitioned many patients this way over the past ten or so years.

But micro-dosing is reportedly a faster way to achieve transition. That may be appealing to certain patients who are facing situations where they need to transition quickly.

Micro-dosing appeals to some office-based buprenorphine prescribers who want to accept patients on methadone from opioid treatment programs. It’s possible this could be used, but the office-based physician still must coordinate care with the medical director of the opioid treatment program.  I’ve heard a few office-based practitioners talk dismissively about getting the OTP involved, saying the providers are hard to reach. That might be true in a few cases, but all OTPs are mandated to have 24-hour telephone accessibility. This number is recited on the voicemail options. Usually when a provider says he or she couldn’t reach me on the phone, it’s because they never tried, assuming I could not be reached.

I’m open to the idea of micro-dosing. But I also wonder about the practicality of this quicker procedure. How well does it really work? The initial studies say it works well, but why take the risk of precipitating withdrawal when we already have reliable methods of transitioning from methadone to buprenorphine? I do understand that sometimes patients are inpatient and want the transition to go more quickly than with the traditional method.

Also, what about the nuts and bolts details of micro-dosing? The lowest commercially available sublingual films or tablets are 2mg dose units. The manufacturers counsel against cutting their products because they’ve never done studies to show the active ingredient is evenly distributed over the entire film/tablet. Of course, our patients cut both the films and the tablets all the time. However, what might be fine for a patient already on a stable buprenorphine dose might not be OK for a patient doing a micro-dosing induction, where more precision is desired.

One of the papers I read about micro-dosing said they had a pharmacy with a sharp cutting device cut the tablet form of medication into .25 and .5mg doses.

I’m going to wait for more studies before I undertake any micro-dosing.

Racial inequities in medical care including addiction medicine care:

Minority populations have worse health outcomes than the general population, and substance use disorders are no different. The ASAM national conference had one whole morning plenary session dedicated to racial inequalities in healthcare.

The AATOD conference had sessions discussing racial disparities in the course of illness in minority patients with substance use disorders compared to non-minority patients with the same.

At one session, a psychiatrist presented data collected 2013-2015 that overdose deaths among blacks showed the highest rate of increase in overdose deaths than any other group. This increase was largely driven by increases in metropolitan deaths. A more recent study by Furr-Holden et. Al., published in March of 2021 in Addiction, showed the steepest rate of increase in opioid overdose deaths was greater for African Americans than any other ethnic group, from 2013 -2018. Preliminary data shows even worse data through the COVID pandemic.

Outcome data shows that access to life-saving treatment medication improves survival in patients with opioid use disorder, but access is limited by various factors among African American patients. These factors could include location of the closest treatment facility, transportation problems, affordability, and the like. In other words, if treatment is available geographically but other obstacles get in the way, the patient may still not be able to access treatment.

All of this was good information and it prompted me to have a discussion with our OTP’ program director about how much we are doing to reach minority communities in our area, and what possible obstacles to treatment might exist that we haven’t considered. We decided the best way to determine what obstacles exist was to ask our existing minority patients. We plan a confidential survey, asking their opinions about how are doing and what we could do better to reach and engage minority communities.

We’ve got a few things in our favor. We have reasonably diverse staff, with a wide range of ages and prior work experiences. Five of our twelve counselors are members of minority groups. Nursing staff has less diversity, with no racial minorities and only one male.

Next week: I will write about the extent of law enforcement interference with buprenorphine prescribing in Tennessee, using a recent case as an example.

Conference Season

Each spring we have several addiction medicine conferences. This year was the same; we had our regional North Carolina Society of Addiction Medicine Conference, followed closely by the national AATOD (American Association of Treatment for Opioid Dependence) meeting. Next week is the national ASAM (American Society of Addiction Medicine) conference.

This year, all of them were/are virtual.

I learned a great deal from the first two conferences and look forward to the third as well.

For a regional meeting, this year’s NC spring Addiction Medicine conference was impressive. I wasn’t expecting too much from the virtual meeting, so I was surprised at the ease of access to the sessions, and the graphics for the conference. This conference is supported by the NC Governor’s Institute on Drug Abuse, along with the state’s Department of Health and Human Services. They have been able to get speakers of prominence from the state and national levels. For example, Dr. Paul Earley, current president of ASAM, gave one of the opening keynote addresses.

Federal and state updates on various topics were given, and I particularly enjoyed several talks given by our state’s public health experts on overdose data in our state. We had excellent presentations by several of the most prominent psychiatrists in our state, which is always informative. Dr. Anthony Dekker, renowned for his work with Native American populations, gave interesting updates on the populations he treats.

Every other year, this conference recognizes outstanding work in the field of Addiction Medicine at the state level by giving the Frederick B. Glaser award. It’s awarded to people who have shown ongoing commitment and effort in our field in the areas of treatment, education, research, and leadership.

I (probably along with many other people) nominated Dr. Eric Morse, and was pleased that he won, in addition to Dr. Blake Fagan

I’ve worked most with Dr. Morse, who is tireless at providing advice and guidance to physicians and others working in our field. He chairs our regular OTP physicians meeting, among other activities.

We’ve had teleconference monthly meetings starting around 2008. This last year, due to COVID uncertainties and physicians’ demands, the meeting was held weekly. Dr. Morse moderated all of them. That’s a big commitment of time, especially in the middle of a workday. I find these sessions very helpful, but some weeks I’m too busy with patients to attend. Some weeks I tune in for at least a half hour. Anyway, I really appreciate Dr. Morse’s consistent efforts.

He also started a handful of opioid treatment programs in our state. Many people won’t recognize what a financial challenge this is. With all the regulations around the operation of an opioid treatment program, it usually takes more than a year to get through the approval process to open. Most physicians don’t have the capital to make this happen, but somehow Dr. Morse has been smart and savvy enough to open a handful of OTPs.

This means his OTPs are truly run by a physician, instead of a corporation.

Don’t get me wrong. I work for a for-profit corporation, and the state is fortunate to have these OTPs, because otherwise we couldn’t come close to meeting the needs of patients with opioid use disorders. But I really like the idea of a physician-owned & operated opioid treatment program.

But I digress.

I don’t know Dr. Blake Fagan quite as well, since he doesn’t work at an opioid treatment program but rather as a family physician in the Mountain Area Health Education Center (MAHEC) in Asheville, NC. He is a professor in the Department of Family Medicine at the University of North Carolina and has taught many residents in primary care fields about opioid use disorder and its treatment with medications. This is so important, because it ensures a fresh army of medical workers to help with the opioid use epidemic. He’s educated new providers about how to treat patients in office-based settings with buprenorphine products.

Both physicians richly deserved the award and I’m happy they both won.

The AATOD conference was a little different. I found it to be more difficult to navigate the online meetings; it was a little daunting for me, but I’m not very tech-savvy. It took me some time to figure out how the sessions worked; sessions were pre-recorded, and participants needed to view these presentations, then join a live question and answer session with the presenters. I also had to account for the three-hour time difference, but I made it to all of the plenary sessions in the mornings, and a fair number of the pre-recorded sessions in the afternoons (evenings for those of us on the east coast).

The AATOD plenary sessions are by their nature more about the big picture of opioid use disorder, and AATOD had some great speakers. I was interested in the talk given by Anja Busse, from the United Nations Office on Drugs and Crime. We can sometimes forget that the opioid epidemic taking place in the U.S. isn’t the only thing going on in the world of substance use disorders.

The AATOD meeting had speakers talk about the intersection of the justice system and opioid use disorder treatment, which appears to be a hot topic at present. They had a Justice from the Nevada supreme court and Nevada’s governor Steve Sisolak spoke as well.

With the attention now focused on inmate health, I am hopeful that soon we’ll see incarcerated patients have access to treatment medications for opioid use disorders.

The individual sessions were interesting. I particularly loved being inspired by Dr. Loretta Finnigan, who did the pioneering work on treatment for pregnant women with opioid use disorders, about the compassionate and effective treatment of women with opioid use disorder, followed by Dr. Mishka Terplan, with focused information. I’ve heard them both speak before, and always find it rewarding to hear them.

One of the most interesting sessions was about the changes in the privacy standards for patients getting care at opioid treatment programs. There’s been many people pushing to allow opioid treatment programs enter data about their patients to their state’s prescription monitoring program. Indeed, I’ve blogged about this before (see my blog on September 2, 2020). Presenters made great points. Their best argument against easing confidentiality standards was that prospective patients may be discouraged from seeking help for opioid use disorder if they know their information will be made available to anyone with access to the prescription monitoring program. In some states, law enforcement can access this data, and some states have loose controls around this. The potential for misuse of that information is worrisome.

Next week is the national ASAM meeting, and I’m anticipating it too.

Virtual meetings are great in some ways, not so great is other ways. I appreciate the convenience and cost savings of virtual meetings, aside from reducing the risk of COVID transmission. And I can work on my craft projects while listening to presenters. But a great deal of the “feeling” (for lack of a better word), is lost. I miss that sense of comradery and common purpose I get sitting in a room of my peers, all dedicated to improving our knowledge and skills to better treat our patients. That feeling isn’t reproduced virtually, for me.

I believe that next year we will be back to actual meetings, and I vow not to take that for granted.

Blog Anniversary and…. I Win an Award

Eleven years ago, I started this blog to provide a dependable source of information for people seeking to learn more about opioid use disorder and its treatment with medication. Back in 2010, there wasn’t as much talk about the festering opioid use disorder epidemic in our country. Back then, pain pill mills still flourished in some parts of the country, pouring fuel on the fires of this illness.

Not many people outside the field of Addiction Medicine endorsed the use of buprenorphine products or methadone as a treatment choice back then, and I felt aggrieved by that. Here was this treatment with more evidence to support its benefits than practically anything else in all of medicine, yet there was much misinformation and stigma against it.

“If people just knew of the benefits,” I thought, “If they just knew and understood, they would feel differently about these medications and this treatment.”

I set out to educate as much of the world as I could.

My blog didn’t always get it right. When I read early blog posts now, I sometimes cringe. I use more person-centered language now, and I like to think I’ve become less judgmental towards critics. Trading insults doesn’t really help anyone and perpetuates bad feelings.

I’m an odd person to be writing such a blog. I did my medical residency in Internal Medicine. I didn’t get any training in Addiction Medicine during my residency, though I did learn about 12-step recovery in medical school. At The Ohio State University, every medical student was required to attend at least one Alcoholics Anonymous meeting.

After residency, I worked for seven years in primary care before I developed my own substance use disorder. I took time off work to seek treatment. Like most physicians, I was lucky to receive high-quality treatment with prolonged monitoring after acute treatment. As part of that treatment, I was asked to participate in 12-step recovery.

For me, it worked well. It filled a void in my life by forcing me to re-connect with people without the title of “physician.” During 12-step meetings, I was like all the others seeking help.

I found a great deal of benefit from the Twelve Steps and Twelve Traditions, and from my sponsor, who remains a dear friend these nearly twenty-three years later. I grew as a person and re-connected with a neglected spirituality.

After my treatment, I went back to work in primary care, and found it just as distasteful as before. I was looking for something different when a doctor friend asked me to work for him at a treatment center while he went on vacation.

I thought I’d be doing admission physicals on patients entering their inpatient (abstinence-based) program, which sounded like fun. I did NOT know I’d be seeing patients on methadone and starting patients on methadone. By the time I found this out, I’d already made a commitment to my friend so I couldn’t back out.

I felt like this methadone thing was shady, a “fringe” area of medicine, and decided that when my friend returned, I’d tell him I didn’t “believe” in putting addicts on drugs like methadone. My opinions were based on mistaken preconceptions, certainly not on science.

The patients I saw started my education process. They told me how methadone (buprenorphine was not yet available) had changed their lives for the better and helped them stabilize into the person they were always meant to be. “How can this be true?” I thought. What the patients were saying, and the positive changes I was seeing with my own eyes, contradicted what I thought I knew about treatment and recovery.

Intrigued, I started reading about opioid use disorders, called “opioid addiction” at that time. I went to local addiction medicine conferences and eventually joined the national American Society of Addiction Medicine and our state chapter. I discovered a ton of data clearly proving the benefits of methadone in the treatment of opioid use disorder. I was amazed to read that starting methadone dramatically reduces the risk of patient death.

Not dying…that alone makes this medication worthwhile.  How could I not have heard about this before? As we know now, medical school and residencies paid little attention to addiction and its treatment, so no wonder I had not learned about the use of medications for opioid use disorder.

I gradually transitioned from primary care to addiction medicine, and by 2004, I was working exclusively at opioid treatment programs.

Meanwhile in my own recovery, I continued to go to 12-step meetings. Of course I never spoke about my work at meetings, knowing how most people there felt. But gossip exists in those rooms as it does in every human organization. A few times I was approached after a meeting and told what I was doing professionally was wrong, and against the policies of that 12-step group. Fortunately, by then I knew no person could speak for the entire organization. I also knew these misguided people didn’t have all the facts. They were like I had been, which was uninformed.They didn’t know the science behind treatment. They were relying on opinion and not fact, so their opinions didn’t matter too much to me.

I knew what the science said, and I leaned on that. I also talked to other people in recovery who worked at opioid treatment programs. They also went to 12-step meetings and worked with patients being treated with methadone. They didn’t see any conflict. Those wise people didn’t see one form of treatment opposing another. They felt different treatments should be complementary. That is, rather than an “either/or” approach, recovery could be “both/and.”

That’s what I think now. I hear abstinence-only proponents criticize medications for opioid use disorder, and I think to myself, “If you only knew how much some people benefit from methadone/buprenorphine, you would change your mind.” When I hear people who support medications for opioid use disorder talk badly about 12-step recovery, I think the same thing. If you could only see the great benefits some people get from these recovery meetings, you wouldn’t be so harsh. Meetings aren’t perfect, and the people who attend them certainly aren’t, either, but they can be so helpful.

This year, I have the honor of receiving the Holden/Lane award for Patient Advocacy from the American Association for the Treatment of Opioid Dependence. I believe it is mostly for my efforts writing this blog, and for some other advocacy things I’ve done at a local level for my own patients.

I am thrilled to receive this honor, and a little embarrassed, too. I feel like there are hundreds of people like me working in our field, toiling to do our best job for the patient sitting in front of us, day after day, week after week, etc. My efforts seem puny when compared to professionals who lobby congress and work on changing laws in our nation.

But I do feel a fire to defend and promote adequate treatment for all patients with opioid use disorder, and it’s turned into kind of an obsession for me. I understand how medical professionals lack education about opioid use disorders. And when I offer information to other people including professionals, I expect them to care about the science. When they don’t…I can write snarky things about them in my blog, which is still kind of fun.

I get angry when my patients, mostly all nice people who happen to have a bad disease, are treated poorly. When they endue prejudice and stigma, I get a little obsessed with correcting mistaken impressions and assumptions. I’ve written letters and made phone calls to all sorts of medical and dental professionals, to judges and lawyers, and to law enforcement personnel.

I’ve given many talks locally and around my state about opioid use disorder and its treatment with medications. I’ve talked to probation and parole officers, to EMS workers, and other members of the community. I’ve spoken at churches, university conferences, to community groups, and with DSS workers. I’ve talked to groups of doctors and to nurses. I hate talking in front of people, but after I get started, I lose myself in trying to communicate the important message that medications used to treatment opioid use disorder do work.

I am deeply grateful to be chosen for this distinguished award. The winners in previous years are most impressive people, so these are big shoes to fill.

I plan to continue to advocate as I can, by letter writing, giving talks when asked, and…by continuing this blog.

Primary Care Difficult to Find for OTP Patients

This area where I now live is odd in some ways. It’s beautiful country, but odd. Around here, people must “apply” to become patients of local medical practices. This isn’t because of COVID; it was like this before too.

Many of my patients tell me they keep getting turned down when they apply to be patients at local practices. Some of these patients have no insurance, some have Medicaid, and some have private insurance. Sometimes they wonder aloud to me if they were turned down because they truthfully revealed they had opioid use disorder and were being treated with either methadone or buprenorphine.

There’s just no way to know. It would be illegal, of course, for practitioners to turn down a patient for primary care because they have opioid use disorder, whether they are in or out of treatment. But usually these patients aren’t given an exact reason why they are being turned down for care. They are usually told something vague, like, “Our providers don’t have the expertise to treat your medical conditions.”

I’d love to do a little undercover investigation of this situation, but just don’t have the time.

But last week, I saw a new patient seeking treatment for her opioid use disorder. She had other medical issues that had long been neglected. This is not unusual, because active substance use disorders often push other health issues into the background of a patient’s attention. However, this patient told me she had gone to a local medical clinic for help, both for her drug use and for other medical issues. She was turned away without being seen. She was told she had to get help with her drug use first.

She went to an FQHC, an abbreviation for Federally Qualified Health Clinic.

It isn’t easy for a medical clinic to get FQHC designation. These clinics need to meet certain standards, including making medical care easier to obtain by using a sliding scale for payment. That is, the less money a patient has, the less they are charged for care. The benefit of being an FQHC is that they get paid more for Medicaid and Medicare patients, because they are providing affordable care for low-income people.

But my patient got no care.

As she told it, at her first visit she disclosed her regular illicit opioid and methamphetamine use and asked for help with those problems along with other medical problems. She had severe joint pains of her hands and a few other common medical symptoms. She says she was told she could not receive care until she got her addiction under control. The patient sensed this wasn’t right, and asked to talk to the office manager, who told her the provider didn’t feel comfortable treating any of her medical problems because her drug use would interfere. Again, she was told she could return when she got her addiction “under control.”

She says she received no referral for treatment of her addiction.

I asked the patient if she wanted me to call this office to tell them she’s now in treatment, and she said yes, but please wait until she could see if our treatment was going to work. I agreed.

On her seventh day of treatment, she looked and felt much better. She felt stable on her dose of buprenorphine 16mg per day and she had no cravings for opioids or opioid withdrawal. She had not used any heroin since admission, though she did smoke a small amount of methamphetamine on her fifth day of treatment. This is not unusual, and she was talking to her counselor about her triggers for methamphetamine use.

I asked again if she wanted me to call the FQHC, for her to get her needed primary medical care done there. She said yes, she had to go there, since they were the only care available for low-income patients near her home.

So I called them. I was angry for the way she had been treated, and truth be told, spoiling for a verbal fight. Fortunately, I had a pharmacy student shadowing me that day.

As an aside, pharmacy students who rotate through our local hospital for part of their training have asked to come one day a week to shadow me, to learn about opioid use disorder and its treatment with medication. I’ve been delighted to be given a chance to blather on about my favorite topic. I always make sure to have a few willing patients tell the students their stories of recovery, and about how treatment benefitted them. The students are always amazed, and a few have asked if there’s any place for pharmacists at opioid treatment programs. I say yes, some programs do use pharmacists, though currently ours does not. I’ve been happy with their enthusiasm and willingness to learn.

Anyway, a student was with me that day, and I tend to be better behaved when people are watching me. As I made the phone call, I kept repeating to myself, “Be collaborative, be collaborative…”

I got the receptionist, and described who I was, and which patient I was calling about. Immediately I was put on hold and the office manager came on the line. As I remember, our conversation went something like this:

“Hi, I’m Dr. Burson and I’m seeing Mrs. X.  I understand she was seeking medical care at your office and was told she needed to get help with her addiction issues prior to seeing a provider there. I’m calling to let you know she is getting care with us and has made a great deal of progress with…”

“We absolutely did not refuse to provide care for her. I remember her very well. She was hollerin’ in our lobby about us denying her care. We only told her that we couldn’t treat any of her medical problems until she got off the drugs. That’s not unreasonable. That’s all we told her. We did NOT deny her care.”

“Yes, that’s why I’m calling,” I said, smooth and unruffled as silk, “She found help for her opioid use disorder and stimulant use disorder, so I was wondering if I can tell her to make another appointment with your provider. And by the way, anytime you have a patient with opioid use disorder, please refer them to us. We want them. We can help them.”

A bit of a pause ensued. I sensed – or perhaps imagined –  she didn’t really want my patient in that practice but was smart enough to know she’d be breaking the law if she refused.

“Of course. Tell her to call today, we’ll be happy to see her.”

“Thank you so much for your help. I’ll tell her.”

The student, having heard the whole conversation, said something to the effect of how is that not denying care? I said I thought it was the same thing too, but didn’t want to argue or offend, since I get more cooperation with politeness and cooperation.

The Americans With Disabilities Act, known as the ADA, makes it illegal to discriminate against someone due to their medical conditions. It is illegal to refuse to provide medical care to a person only because they have substance use disorder.

How should this FQHC have handled my patient? Of course, drug use can influence other medical problems. But the answer isn’t turning the patient away. The answer is to see the patient, form a therapeutic alliance with the patient, and assess her needs. Start treatment of medical problems and include referral for treatment of substance use disorders, while also addressing her other medical problems.

Instead, it feels to me – and her – like they said to her, “You’ll have to take your nasty bad habit somewhere else and stop your bad behavior before you are allowed to see our providers.”

They absolutely bungled it.

Out of curiosity, and to try to see who their medical director was, I went to their web page. Ironically, splashed in large letters over their home page was this statement: “We promise not to deny services based on a person’s race, color, sex, national origin, disability, religion, sexual orientation, or ability to pay.”

Well OK.

One nurse practitioner was listed as a provider, but I didn’t see a medical director listed. I plan to call this nurse practitioner soon, when I am calm and cheerful, in the hopes of doing some gentle education.

I’ll let her know about our opioid treatment program, and that we are happy to receive referrals for patients with opioid use disorder, and that she can refer them any weekday. (Just as COVID hit, we started doing admissions five days per week). I also hope to convince her to refer patients with substance use disorders for treatment, just as she would for any other illness, and to give her my cell number to call if she ever has any questions about what to do for a certain patient with substance abuse, even if they don’t have opioid use disorder.

Treatment of Opioid Use Disorder During Incarceration

Change is coming, but slowly.

In the past, many county jails and state prisons refused to allow patients prescribed methadone or buprenorphine to remain on their medication during incarceration. Most experts felt this was denying medical treatment to inmates, something which – we thought – was not allowed in the United States. But due to the stigma against opioid use disorder and the medications commonly used to treat it, our patients were denied treatment repeatedly.

Now there’s hope on the horizon.

Last month, a patient with opioid use disorder, successfully being treated with methadone, was sentenced to thirty days in jail in DuPage County, Illinois. The Chicago Tribune covered the story, but you can also read pertinent details on the website of the Legal Action Center (LAC). [1]

This patient, instead of resigning herself to a miserable thirty days of methadone withdrawal, decided to petition the court system to allow her to be able to take her prescribed medication as usual. I probably don’t have to point out to my regular readers that methadone treatment for opioid use disorder reduces the risk of death by at least three- fold. Remaining on her usual medication would prevent relapse once she’s released from jail, commonly a time for overdose death. And of course, continuing her medication would prevent agonizing withdrawal syndrome.

This patient had been in treatment for her opioid use disorder since 2019 but got a DUI back in 2016. It took five years for her to be sentenced to jail time for her DUI. In her lawsuit, the patient asked a federal judge to make sure she was allowed to take her usual medication as prescribed. The complaint stated that depriving inmates of needed medical treatment for opioid use disorder is cruel and unusual punishment and violates the Americans with Disabilities Act. The complaint correctly stated that the refusal to continue the patient’s treatment placed her in grave and immediate danger.

She brought her lawsuit with the help of the LAC, working with the American Civil Liberties Union. DuPage County, where she would serve her sentence, was alleged to have an unwritten policy of prohibiting people from dosing with methadone or buprenorphine, even when prescribed by a physician. The county denied this, saying that each patient’s needs were evaluated on a case-by-case basis after a physical exam. However, no non-pregnant inmate was ever allowed to remain on methadone or buprenorphine in the jail’s history.

Based on that last fact, it strains credulity to believe this patient would have received her methadone as usual had she not brought her case.

From what I understand by reading internet reports, the federal judge said this patient had not yet been denied her medication, so she needed to wait until it was denied before she could bring her lawsuit to court.

County jail officials, likely sensing the shitstorm that would descend upon them if they denied this patient her medication after attention her lawsuit had received, finally decided to do the right thing, and give the patient her medication.

County officials made some sort of laughable statement that a “headline-grabbing lawsuit” wasn’t needed for this patient to get proper care, and that they would have done the right thing without a lawsuit…but I doubt that. I am judging DuPage County’s attitudes and actions by the ones I’ve encountered at rural North Carolina’s county jails.

In May of 2019, a federal judge ruled that a patient in Maine, sentenced to forty days in jail, must be allowed to remain on her usual daily dose of Suboxone. She was in recovery on this medication for five years before she was sentenced to this term. The judge said that denial of medication-assisted treatment would cause serious and irreparable harm to the patient, and that denial would violate the Americans with Disabilities Act. The patient asked Maine’s division of the ACLU to assist her attorneys in bringing her suit against the county jail.

Attorneys for the county jail had argued that medical personnel at the jail are able to manage opioid withdrawal symptoms, apparently meaning withdrawal could be managed without Suboxone. But they lost the case, and the patient remained on Suboxone during incarceration.

I was very happy with the outcome of this case, and a few others like it, scattered around the country these last two years.

In my state of North Carolina, there are now around five counties that will allow patients in treatment for opioid use disorder to remain in treatment. These counties are to be congratulated for their progress. However, in my county, patients prescribed methadone or buprenorphine products for opioid use disorder are NOT ALLOWED to dose in our county’s jail while incarcerated. The jail medical personnel have some sort of a detox protocol that involves clonidine (which may help a little) and clonazepam. The latter medication, of course, serves to place inmates at even higher risk of death if they relapse back to opioid use once they leave jail.

Use of clonazepam is not part of any legitimate opioid withdrawal protocol that I’m aware of. Plus, it is a controlled substance. If the jail is willing to dose controlled substances, why not just dose the patient with the evidence-based, life-saving medication that the patient is already on?

I have tried talking to county jail medical personnel. The nurses who work there are sympathetic, for the most part, but medical policy about patients on methadone or buprenorphine seems to be set in stone by someone above them. I once talked via phone to the jail doctor, but it went very badly. He was like other doctors of a certain age, who feel they must talk much, much more than they listen. I had to interrupt to get any time to speak at all, and he then became derisive towards medication-assisted treatment in general and dismissive toward me personally. So much for my attempt at gentle education in the name of cooperation. Not everyone remains teachable throughout life.

I’ve been trying to get patients at our opioid treatment program to reach out to our state’s ACLU branch when it’s obvious they will be sentenced to a jail term and denied their usual medication for opioid use disorder. So far, none have taken this step. I’ve tried to call the ACLU for them, but was told I don’t have standing, and it must be the patient who calls to ask for their help.

Understandably, many patients worry that filing a lawsuit to be able to get their usual medications may backfire. If they don’t win, they fear angering the prosecutor or judge. They worry they may face more severe punishment if they attempt to advocate for themselves.

I understand their fears, and I can’t tell them it’s unfounded. If they bring a suit and lose, perhaps they would be treated more harshly. The law enforcement and judicial system in this county is not as forward-thinking as I would prefer, though it is improving.

Our opioid treatment program participated in a three-year grant that paid for treatment for patients involved with the criminal justice system. This grant just ended last August. Our staff worked with local probation and parole officers, who got to see first-hand the dramatic improvements in patients’ lives when evidence-based treatment with medication for opioid use disorder is available. Some of those officers still refer their clients to us, even after the grant ended. But other officers remain cool towards our treatment program, though at least they have stopped telling our patients they must get off of methadone or buprenorphine to remain on probation. Small victories.

Many jail systems, large and small, say they can’t allow methadone or buprenorphine dosing of inmates already prescribed these medications because of diversion risks. Staff say such medications would be diverted from the patient for whom it is prescribed, presenting overdose risks to other inmates.

That argument suggests that jail personnel are unfamiliar with observed dosing protocols that OTPs use every day. We could teach jail staff these simple techniques. And again, if the jail is already giving out doses of clonazepam, what steps are they now using to make sure the dose goes to the patient for whom it is intended?

And from what I see and hear from patients who have been incarcerated, plenty of drugs are already circulating in some jails and prisons. Availability seems to vary a great deal at different facilities, for whatever reason, but these places don’t allow methadone or buprenorphine through approved channels.

It’s possible to find creative solutions to all the issues that make methadone and buprenorphine administration difficult for incarcerated patients.

Jail systems say they don’t have the manpower to bring each patient to the opioid treatment program to be dosed each day. However, that would not be required in every case.

Most patients could be issued take home doses for whatever time frame the medical director feels in appropriate. For example, a relatively stable patients could be brought to our OTP for observed dosing every two weeks, with daily take -home doses issued for the thirteen days in between visits. These doses could be given, via chain of custody forms, to jail personnel to be taken to the county jail and stored in a locked container. Chain of custody is a method where there is documentation of which personnel are in possession of the medication each step of the way. When a dose if given to the patient, jail personnel watch to make sure it is consumed and can document this.

Or perhaps OTP staff could bring the medication to the local jail and do observed dosing there, then, when appropriate, leave daily doses of medication in the care of medical personnel to be stored in a locked safe until the next dose is due.

For patients on sublingual buprenorphine products prescribed by office-based providers, the methods could be much simpler. The patient could bring in their bottle or box of medication with them when they report for incarceration, and the medication can be stored under lock and key. It can be dosed daily, with jail personnel watching to make sure the medication dissolves and no residue remains under the tongue or in the mouth, to prevent diversion.

Sublocade could be an excellent option for buprenorphine patients. This is an injection that can be given once monthly, so that the jail personnel would only need to bring that patient from the jail to the provider once per month for their injection, instead of worrying about daily dosing. And with the injection, diversion of medication would not be an issue. Soon, we may have weekly injections available, also eliminating fears of medication diversion.

My point is that I believe we can work together to find solutions to every possible problem raised by continuing patients on life-saving methadone and buprenorphine, if only we have the will to do so.

These half-assed, county jail “detox protocols” must stop. They are insufficient to prevent withdrawal, not evidence-based, and they place patients at unnecessary risk of overdose death once the patient is released. They interrupt a legitimate medical treatment that has more evidence to support it than nearly anything else we do in the field of medicine.

Medically fragile patients can die from improperly treated opioid withdrawal during incarceration. I’ve blogged about this before. Who can forget the case of David Stojcevski, who died from benzodiazepine and methadone withdrawal, sixteen days into his incarceration? He lost forty-four pounds and suffered from hallucinations and seizures during his time in this county jail. The family brought lawsuits against the county jail, which still has not been resolved. The county jail employees pointed their fingers to Correct Care Solutions, a company that was supposed to have provided medical care to their inmates. Of course, Correct Care Solutions pointed their fingers at county jail employees. Since all this happened, Correct Care Solutions was bought by another company and merged into Wellpath LLC. This new company is also plagued with lawsuits alleging improper care of inmates. [2]

I’m going to continue to tell my patients facing incarceration about recent lawsuits, and I’m going to continue to point them towards the Legal Action Center in New York, and our state’s chapter of the ACLU. I’d love for one of my patients to make a little history in the cause of patients’ rights.

And I’ll testify for my patients for free, with pleasure, if I am asked.

  1. https://www.lac.org/news/dupage-county-sheriff-sued-for-access-to-life-saving-medication-to-treat-opioid-use-disorder
  2. https://www.metrotimes.com/news-hits/archives/2020/03/12/lawsuit-targets-billion-dollar-company-making-life-and-death-medical-decisions-in-michigan-jails

The Future of COVID Take Home Doses

This may be a controversial blog post. I’ve been mulling over the ideas I’m presenting in this blog for many weeks and have changed my mind several times. So don’t get too upset with what you read, because I may have changed my mind again by the time you read it.

The events of this past year have given us experiences and information, and it seems prudent to learn what we can from them.

In the spring of last year, state and federal authorities moved quickly to allow patients enrolled in opioid treatment programs to receive more take homes doses than usual. They did this to reduce the risk of patients’ exposure to the COVID virus. Most opioid treatment programs were able to give many more take home doses of buprenorphine or methadone than ever before. This cut down the number of patients physically present at OTPs at any one time, thus creating more social distancing than ever before.

Now patients – and providers – are wondering what will happen after our country no longer has a high risk of COVID transmission in crowds. Will the previous regulations snap back into place? Will patients receiving extended take home doses now be asked to come more frequently and give up the convenience of extra take home doses?

In my state of North Carolina, as I understand it, once the state is no longer under a “state of emergency” declaration, the permission to give extra take homes to patients will no longer exist.

I’m not sure what state and federal authorities will advise, but I have some thoughts.

As I see it, we have two sets of questions. The first is what to do about patients presently receiving extra take homes. The second is deciding if information from events of the past year should cause us to change regulations about methadone take home doses.

At my opioid treatment program, we have about half our patients dosing of buprenorphine and half on methadone. Because of its better safety profile, buprenorphine patients already get take homes more quickly than methadone patients. So, my next paragraphs will be about patients being prescribed methadone at opioid treatment programs.

Let’s take the first question: what shall we do about patients who are getting extra take homes now? This has been an unusual time in history – I hope – and we have a cohort of patients who were suddenly given many more take homes than they were accustomed to getting.

Some patients had problems with those extra take homes. They came back to the opioid treatment program early, saying they didn’t know what had happened to the extra doses, or that the nurse hadn’t given them extra doses, or that some other person stole their medication. These problems almost always came to light within the first few months. Those patients were not ready – at that time – for extended take homes, though they may be able to do so in the future.

However, most patients with extra methadone take home doses did well. We’ve done bottle recalls (like pill counts done at pain management clinics) and most patients brought their bottles back in with the correct number of bottles untouched, with the appropriate amount of medication contained in them. This reassures us that these patients can take only one dose per day and are able to store it safely where it won’t be stolen or tampered with. Most of these patients have been reachable by their counselors for weekly in-person or telehealth meetings, showing further evidence of stability.

For patients who have proven their ability to manage their take home doses, it seems counterproductive to reduce the number of take- home doses again after the COVID emergency passes. Why would we want to do this? So long as patients have been making appropriate contact with their counselors at their programs and are doing well, I will advocate for them to stay at their advanced take homes. I might have to submit an exception to get permission for this from state and federal authorities, but that’s easy to do, and would seem a reasonable request.

Then comes the question of what to do with these patients if they have drug screens positive for illicit drugs. Should these patients move back to daily dosing? What if the only illicit drug they use is THC? Before the extra COVID take homes, our state said patients who remained positive for THC couldn’t advance past a level 1, which means they had to come every day but Sundays. In the past, I agreed with this policy. I reasoned that people using THC weren’t as stable as those not using it.

Now I have changed my mind.

Don’t misunderstand. I am no fan of marijuana. I think it can hold patients back in some insidious ways. It’s not harmless, as some people think, but neither is it a toxic substance, like alcohol is. Some day we may have beneficial medications derived from the marijuana plant, but at present, lighting the plant on fire to inhale the smoke isn’t a medically safe way to ingest those chemicals. We know marijuana use affects adolescent brains adversely, but even in adults, it can shave off IQ points, and may interfere with motivation to make life changes.

However, regular marijuana doesn’t cause the chaos that other illicit drugs cause.

 Since COVID, I’ve seen many patients, long-term smokers of marijuana, managing their additional take-home doses quite well. They appear as stable as non-smokers of THC. I don’t see that it would help anyone to revoke those take-home doses, and it may benefit some of these patients to be able to give even more take homes. At present I am more open to such ideas than I ever have been in the past.

Patients using alcohol and other sedatives are not getting extra take homes at the opioid treatment program where I work, due to the dangers of mixing methadone with sedatives. I have not changed my mind about that.

What about stimulant use? We’ve seen an uptick in methamphetamine use over the past several years, and some of those patients are getting extra take homes now. Some are not, depending on an assessment of each patient’s overall stability. I have not been consistent with decisions about take home doses for such patients, because stimulant-using patients can differ widely.

For example, one patient has tested positive for methamphetamines for about a year, but she has a job, a stable relationship, and no apparent clinical decline, at least thus far. But another patient tested positive for methamphetamines for two months. Since then, his family committed him once to a mental institution for a few days, for auditory hallucinations related to drug use. He’s lost twenty pounds in two months and is twitchy and easily distracted when I try to talk to him.

I was generous with take homes for the first patient and denied take homes to the second one. Of course, the second patient feels like this is unfair towards him. After the COVID take-home exceptions end, should both patients be moved back to daily dosing?

Let’s move on to the idea of changing existing take home regulations. There are eight criteria that patients ordinarily need to meet to get take home doses of medication. In an abbreviated form, these are:

  1. No ongoing drug or alcohol use
  2. Regular attendance
  3. No serious behavioral problems at the OTP
  4. No recent criminal activity
  5. Stable home environment
  6. Ability to store medication safely
  7. Benefits of take homes outweigh risks of diversion
  8. Time in treatment

I agree with all these requirements, except perhaps the last one, which I feel is the most restrictive. Federal and state authorities have firm regulations about how soon a patient, doing very well otherwise, can be granted take home doses, based only on how long that patient has been in treatment. New patients can receive up to one take home dose per week for the first three month, then if all is going well, can get three take home doses per week for the next three months, then four doses per week for three months, etc. At the one-year mark, even an extremely stable patient will need to come once per week for a year.

That’s a long time, and perhaps unduly restrictive for many patients.

Before readers criticize me for risking lives due to putting methadone at risk for diversion, let me explain that I do know how much harm methadone take homes can cause in the wrong hands. I can tell you horror stories about diverted methadone, but I won’t do that now.

But on the other side, more patients thrive with extra take- home doses, able to feel less stress about getting to their OTP in time to get dosed and get to work on time. They can spend more time with their families in the morning hours. That’s worth quite a lot.

If we decide to revisit our present methadone take home schedule regulations and ultimately relax them a bit, it will fall to treatment center staff and ultimately the medical director to decide if a given patient is stable enough for take homes. That means the medical director will need to know her patients well. This requires time at the opioid treatment program and involvement with the patients. That should already be happening, but I know that’s not always the case.

Here are a few of the warning signs we’ve seen that can indicate problems forming: coming in a day or two early to dose, even when the patient should already have take-home doses; being unable or unwilling to give urine drug screens; giving falsified urine drug screens; counselors being unable to reach the patient for telehealth counseling sessions; poor attendance or repeatedly coming at the last minute to dose; new mental health issues or new physical health issues, and unexplained change in appearance or affect.

Since the medical director is ultimately responsible for the consequences of methadone take-home doses, the medical director needs to be made aware of any warning signs seen in patients, aside from positive urine drug screens. The medical director needs to know the patients well, and have input from counselors, nursing, and even front office staff when making these important decisions. Therefore, time for case staffing, sometimes also called treatment team meetings, is so important.

At the OTP where I work, we usually have case staffing twice per week, and it includes medical and counseling staff. We make decisions about take home doses at these meetings. Sometimes we disagree, and that’s good. It means differing opinions are being voiced. Sometimes emotions run high, a reflection of the importance of our decisions to patients. It’s often a difficult process.

But because of the importance to patients, perhaps take-home regulations should be re-evaluated at national and state levels, in the light shed by our recent experiences with the extra COVID 19 take home doses.

Never mind….

You know that blog I posted a few weeks ago, about DHHS’s decision to allow any physician with a DEA license to prescribe buprenorphine products for their patients with opioid use disorder? That idea has been nixed. SAMHSA said HHS’s decision to announce the change of regulations to have been “premature.”

I have no idea what political machinations were behind all of this, but Medscape’s webpage said loosening the restrictions was an idea put forward by Trump’s administration, and Biden’s administration cancelled that plan.

Many addiction medicine specialists were wary about the idea of loosening restrictions, fearful of the consequences if any physician could prescribe buprenorphine without the mandatory training course. That eight-hour course teaches providers about opioid use disorder in general and specifically about how to prescribe buprenorphine products from an office-based practice to treat that disorder. They say prescribers need this education, since for decades it was illegal to treat opioid use disorder from an office setting. Consequently, most physicians don’t know much about treating addiction, and may mistakenly think it’s the same thing as treating pain.

On the other hand, eliminating the need to take this course could encourage more doctors to prescribe buprenorphine products to treat opioid use disorders, thus expanding access to treatment.

I’m not sure what I think.

 On the one hand, I’ve seen providers with no training or “X” number prescribing all sorts of buprenorphine products for years, and not always with the diligence I would hope for.

For example, several months ago I reviewed a new patient’s data from the North Carolina prescription monitoring program. I saw the local pain clinic had been prescribing an extended- release full opioid agonist, along with a short-acting full agonist for breakthrough pain for many months. Then I saw the Butrans patch (contains buprenorphine) was added to this regime of medication.

I asked the patient what happened when they started the Butrans patch.

“Oh I found out I was allergic to it. It made me very sick. I felt like I was back in withdrawal. I can’t take that medication.”

Of course, that was no allergic reaction. That was precipitated withdrawal, predictable to providers familiar to the pharmacology of buprenorphine. But now this patient is convinced that buprenorphine in any form will make her sick under any circumstance. She was started on methadone and has done very well, but it is a shame she had to be put through that nightmare.

However, another prescriber, this one who took the eight-hour course and who has a DEA “X” number, starts all patients at a dose of buprenorphine/naloxone 32/8mg per day (four of the 8/2mg tablets) and tapers down over a period of several months until the patient is off the medication completely. Apparently this prescriber wasn’t paying attention to instructions given at the 8-hour training course about how to do induction. Or how to do maintenance. Or that most patients need much longer than several months on the medication to remain in recovery, and few need any higher dose than 16 to 24mg per day.

Then there’s another prescriber in town, also with her DEA “X” number, who accepts methadone patients from our opioid treatment program and starts them on buprenorphine without asking for any data from us. We only find out about the patient’s medical misadventures when their counselor calls them, to find out why they’ve missed days of treatment with us. The patient says he told the prescriber what dose of methadone he was currently on, and but prescriber asked the patient to miss one or two days of methadone before she started a sublingual buprenorphine product.

If they patient was on a dose of 40mg or less for at least a week, everything will go well. But if the patient’s been dosing at 110mg per day, per example, and missed a few days…things usually don’t go well. The patient ends up in precipitated withdrawal, which is completely predictable. If we are lucky, we can get them back into treatment right away.

At our opioid treatment program, we switch patients all of the time, though much more slowly. My usual “recipe” for switching involves tapering by 5mg per week, down to 40mg, where they dose for at least a week. Then the patient misses two days and sees me on the third day. If they are in sufficient withdrawal, with a COWS greater than 12, I feel safe starting them on buprenorphine. I usually end up dosing them with between 4 to 8mg on that first day.

Anyway, my point is that most of these prescribers, who took the eight- hour course, don’t necessarily do things as I would hope they learned in the course. But perhaps it would be worse if buprenorphine prescribers took no course.

My opinion about this issue rockets from one side to the other faster than a tennis ball at Wimbledon.

I can’t decide what I think. I read opinions from leaders in the field that say untrained prescribers could lead to disasters, and I know they are correct. Then I read from other leaders in the field that increasing access will save lives and I know that’s right, too.

I have no conclusion for this blog post. I’m just acknowledging uncertainty.