Archive for the ‘Doctors Behaving Badly’ Category

Update on Jail Death Lawsuits

 

 

 

 

Long-time readers of my blog will remember the story of Eric Stojcevski, a young man who died from withdrawal from prescribed medication while in jail in Macomb County, Michigan, for unpaid traffic tickets in 2014.

I blogged about this case on November 3, 2017, February 5, 2016, and October 20, 2015.

I’ve given readers periodic updates because to me, this case is the most extreme example of how poorly sick inmates are treated by jailers. I feel this is one of our country’s biggest moral failings, because it goes on all the time, usually with little to no publicity.

Someone once said we can judge the quality of a society by how we treat the most vulnerable members of that society. Incarcerated people are among the most vulnerable, since they can’t take themselves to a hospital for medical care if they get sick. They are dependent on the jailers to get them care when ill.

This did not happen in the case of David Stojcevski. In June of 2014, he went to jail for failure to pay parking tickets, and it turn into a death sentence. According to news sources, he was being prescribed methadone, clonazepam, and alprazolam by a physician. He was not given any of these prescribed medications when he was in jail.

According to his autopsy, he died from acute drug withdrawal on the seventeenth day of his thirty-day sentence. Despite intense suffering, his pleas for medical attention were ignored. When he exhibited bizarre (withdrawal) behavior, he was sent to a mental health cell, where his last eleven days on earth were videotaped. His family, livid at the lack of medical care that resulted in his death, released the videotape online, where it went viral. The recording showed him naked, having repeated seizures on the jail floor as he died.

His family filed a civil case against jail personnel, and against Correct Care Solutions, the health organization that was contractually obligated to provide medical care to prisoners in the Macomb County jail.

There was a criminal investigation that went nowhere.

The Department of Justice investigated, and said they found no evidence of criminal intent on the part of jail personnel or personnel of Correct Care Solutions. The FBI had to be forced by the family to release its investigation records, and only released part of them.

These records should be helpful to the family’s civil case, and now depositions for this civil case are underway.

According to news reports, [1] Sheriff Wickersham’s sworn testimony revealed that David lost forty pounds in his last seventeen days, spent in the county jail. Over the last three days of his life, he drank almost no water. Of the thirty-three meals served to him over the last eleven days of his life, he ate perhaps three of them.

According to news reports, jail guards thought the medical staff was responsible for deciding when a patient should go to the hospital. Medical staff thought it was the guards’ responsibility to monitor the amount of food and water inmates are consuming.

Sheriff Wickersham admitted he was responsible for the well-being of the inmates, but also admitted he rarely enters the jail. Even though his office is located a few feet from the jail, he enters the jail perhaps once per month. He said he delegated oversight of medical care to another employee, who had no medical training.

News reports didn’t say whether Correct Care Solutions employees had been contacted about the state of health David was in during his last days.

News reports did say that David’s prescribing physician, Dr. Bernard Shelton, was charged with unlawful delivery of controlled substances. [2] This report says he prescribed four million “addictive pills” to Macomb County residents, though it didn’t specify over what period of time or what type of pills they were. From what he prescribed David Stojcevski, it appears to have been opioids and benzodiazepines.

In 2017, according to the state of Michigan’s medical board documentation, Dr. Shelton lost his medical license for inappropriate prescribing of controlled substances that were outside acceptable practice. His charts were reviewed by other physicians, who have the knowledge to judge such things. They said he didn’t check patients on the Michigan prescription monitoring website, he didn’t keep complete records, and lacked essential documentation.

The medical board suspended his medical license for fifteen months, fined him $10,000, and said he wouldn’t be considered for license re-instatement unless he could prove, with clear and convincing evidence, that he had good moral character, the ability to practice medicine with reasonable skill and safety, the ability to follow the guidelines of re-instatement, and for it to be in the public interest that he be licensed again. At present, he does not have a license to practice in Michigan.

Now it appears Dr. Shelton will face criminal charges as well as losing his medical license.

But getting back to David Stojcevski’s case…even if his doctor prescribed opioids recklessly and inappropriately, it doesn’t release the sheriff of his obligation to make sure inmates receive medical care. Watching David suffer on the recordings made by the jail, I can’t help but wonder why no one took any action to help a man obviously in serious need of medical attention.

What if Sheriff Wickersham (or one of his deputies) walked down the street of whatever town is in Macomb County, Michigan, and he came to a man lying on the sidewalk, barely conscious, having a seizure. What would he do? I expect he would squat down beside the sick man, check for a pulse, and summon 911 for help. That’s what most citizens would do, out of common decency and concern for a fellow human.

In other words, it did not take any medical knowledge to know David was in serious need of medical help, yet no one in the whole jail called 911.

You can believe I’ll be watching this case unfold. It has the potential to be a multi-million -dollar case. In other similar cases, awards were in the three-million-dollar range. It’s sad that is takes a large financial award to change the way people do things, but in this case, it appears necessary.

It’s too late for David, but a large settlement or award against Macomb County and against Sheriff Wickersham could be another paving stone on the road of appropriate medical care for vulnerable inmates.

  1. https://www.clickondetroit.com/news/defenders/sheriff-answers-questions-under-oath-about-death-of-inmate-at-macomb-county-jail (accessed 7/4/18)
  2. https://www.clickondetroit.com/news/defenders/doctor-charged-with-distributing-opioids-to-inmate-who-died-from-withdrawal-at-macomb-county-jail (accessed 7/4/18)
Advertisements

Not Dying: A Worthy Goal

 

 

A new study about opioid overdose death and treatment of opioid use disorders was published in the Annals of Internal Medicine this month. [1]

It showed that people who experience a non-fatal overdose have a significantly reduced risk of death if they start on medication-assisted treatment with methadone or buprenorphine. Naltrexone was also examined but limited data prevented conclusions about the use of this medication.

This large cohort study, done in Massachusetts on adults age 18 and older, covered the four years from 2011 and 2015. Subjects were identified as people who experienced at least one non-fatal opioid overdose and survived at least for 30 days afterward. Patients were excluded if they had a diagnosis of cancer.

This turned out to be a huge study, with over seventeen thousand study subjects.

In the year prior to the overdose event, 26% had received at least one medication to treat opioid use disorder. Twenty-two percent received opioid detoxification at least once. Forty-one percent had received an opioid prescription in the preceding year, and 28% received a prescription for a benzodiazepine within the previous year.

For these same patient, in the year after their nonfatal overdose, 30% received at least one medication for opioid use disorder (13% got buprenorphine, 8% got methadone, and 4% got naltrexone. The other 5% received more than one medication.)

People younger than 45 were more likely to received treatment with medication, as were people with diagnoses of anxiety or depressive disorders.

In the year after overdose, 4.6 of the people with a prior non-fatal overdose died, and of those, 2.1% died from opioid-related causes.

For patients treated with medication for opioid use disorder, both the all-cause mortality and opioid mortality rates were significantly reduced; they were cut approximately in half.

Patients who started n methadone after their non-fatal overdose had markedly reduced risks for both all-cause mortality and opioid-related mortality, with the adjusted risk at around half what it was for untreated patients. Results for patients on buprenorphine were nearly the same; they had not quite the degree of risk reduction as with methadone, but still significantly lower risk of death than patients on no medications.

There were no associations between risk of death for patients started on naltrexone, but the authors noted this was a smaller group, so any differences weren’t statistically significant. Of note, most of those patients were only treated for a month or two.

So what does this study tell us?

We have another study that shows medication-assisted treatment with methadone or buprenorphine reduces the risk of death, this time in people with at least one prior non-fatal opioid overdose. In this study, being methadone or buprenorphine reduced deaths from all-cause mortality, as well as opioid-related mortality.

We also see, again, that only a minority of people, 30%, with nonfatal overdose were started on life-saving medication.

I was surprised the percent of people referred for medication-assisted treatment was that high. This study was done in Massachusetts, a state that’s probably at the forefront of opioid use disorder treatment. They have some excellent providers and physician leaders, and better methods to pay for treatment in that state.

I don’t think rural areas in North Carolina come close to a 30% referral rate. I’d be amazed if 2-3% were referred for evidence-based treatment with medication. I suspect most people here who survive near-fatal opioid overdoses aren’t directed, referred, or even informed about medication-assisted treatments. People get referred to OTPs around here by concerned friends and family members, but rarely by physicians.

It has started to change. In our area, of the three OB/GYN groups, we have one practice that refers patients to us. The LME (local management entity, which contracts with the state to see people on Medicaid and those with no insurance) has referred less than a handful of people for treatment. That’s a dramatic improvement from seven years ago when the LME told patients to get off methadone.

But back to the study. So even in one of the most progressive states, only 30% of people got life-saving treatment.

Let’s picture a patient who has a near-fatal episode of a different chronic disorder. Thankfully, the patient survives this episode. There’s a treatment medication for this disorder that will reduce the patient’s risk of dying by half over the next year. What do you think would happen if this patient wasn’t given or referred for that life-saving treatment?

There would be an outcry. There would be wringing of hands and rending of garments, and possibly gnashing of teeth. There would be lawyers…malpractice lawyers, swarms of them.

Yet this exact situation happens over and over, again and again, in emergency departments across this nation.

To be fair, this article doesn’t say why the patients who survived a near-fatal overdose weren’t started on medication. Maybe emergency department personnel offered this medication but the patients refused.

Realistically, there are significant barriers to starting medication-assisted treatment of opioid use disorder. Methadone can only lawfully be prescribed from a properly-licensed opioid treatment program. Maybe emergency department physicians gave referrals to OTPs, but the patients didn’t show up. Maybe they referred to office-based buprenorphine prescribers.

Every time I do an intake on a patient entering treatment with MAT, I ask if there’s been an overdose in their history. Much of the time, the answer if “Yes.” I then ask what kind of recommendation for treatment they got. Most times the patient looks at me blankly. They can’t think of any kind of treatment recommendation or referral. One patients said, “They told me to quit using drugs.”

Telling people to quit using drugs IS NOT treatment for opioid use disorder. It’s sad that I even have to write this, as it should be well-known by all medical personnel.

All of us working in this field need to keep chugging along. We need to put this article in our mental back pocket, ready to talk about if/when the time comes when we hear stale old beliefs about medication-assisted treatments.

This study points to the bottom line: “We are using medications that reduce the risk of dying by half, for people who have had a prior nonfatal overdose.” Not dying is a huge benefit of treatment, perhaps the ultimate benefit.

It is long past time for medical professionals to set aside their personal opinions and what they think they know, in favor of hard data. Methadone and buprenorphine reduce the risk of dying, and patients with opioid use disorder must be informed & encouraged about these treatments. To do otherwise is malpractice.

  1. Larochelle et al., “Medication for Opioid Use Disorder after Nonfatal Opioid Overdose and Association with Mortality: A Cohort Study,” Annals of Internal Medicine, June 19, 2018

Continuum of Care for Opioid Use Disorder

 

 

 

 

 

 

“Continuum of care is a concept involving an integrated system of care that guides and tracks patient over time through a comprehensive array of health services spanning all levels of intensity of care.” (Evashwick, 1989)

Continuum of care isn’t a new concept. It’s a pattern of care that we use to treat patients with all sorts of chronic medical illnesses. For mild forms of a chronic illness, primary care providers manage patients’ illnesses. For more severe forms of the same illness, patients are referred to specialists, with more experience and training in that area of medicine. Ideally these shared patients flow back and forth between specialists and primary care providers as needed based on the severity of illness as it may fluctuate over time.

We ought to apply this same concept for the management of opioid use disorder. It’s a chronic illness which can have exacerbations and remissions over time, just like diabetes and asthma.

I try to follow this concept at the opioid treatment program where I work. Patients new to treatment often are ill, not only from the drug use, but also from neglected physical and mental health issues. They need more intense care. An opioid treatment program offers more structure and supervision than an office-based practice, so it’s a level of care that’s appropriate for such patients.

At the opioid treatment program, we can do daily observed dosing, to make sure patients take the dose I prescribe. We assess the adequacy of the dose by asking about withdrawal symptoms and observing withdrawal physical signs. We can monitor for side effects. We can do frequent drug screens, to provide information about the proper level of counseling needed. Counseling, both group and individual, are built into the system at opioid treatment programs.

At the other end of the spectrum, stable patients with years of recovery in medication-assisted treatment need less care. We still need to monitor for relapses, but they usually don’t need as much counseling, and no longer require observed dosing. They need the freedom that office-based practices provide.

Stable patients on methadone get more take home doses, but opioid treatment programs are their only option for treatment setting. Stable patients on methadone can’t get their treatment in primary care settings. It’s illegal for office-based physicians to prescribe methadone for the purpose of treating opioid use disorder. Primary care doctors can prescribe methadone to treat pain, but not if the patient also has opioid use disorder.

It’s different for patients on buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail). Since 2000, it’s been legal to prescribe this medication from office-based settings for patients with opioid use disorder.

But that doesn’t mean this is the right setting for all patients with opioid use disorder.

I have an advantage, since I see patients in both settings, both opioid treatment program and an office-based practice. I have the luxury of being able to treat new patients in the opioid treatment program, and after they stabilize, talk to them about transitioning to the office-based practice. If a patient encounters a rough patch, I can ask them to return to the opioid treatment program for more intense treatment until they again stabilize.

I can use the same concept as used with other chronic medical illnesses.

Sometimes a new patient can safely be treated in an office-based program. This all depends on individual patient circumstances. One patient may have a fantastic support system at home, while another may have to put up with active drug use in his home. Obviously, the latter patient needs more support from treatment staff.

Sometimes patients on buprenorphine aren’t appropriate for office-based treatment, even after months of treatment.

Unfortunately, most patients with opioid use disorder aren’t placed in a treatment setting based on their needs. Most patients end up in whatever facility they enter for the duration of their treatment, which may not be the best thing for the patients.

It’s rare for an office-based practice to refer their patients who are struggling to opioid treatment programs. Many office-based providers, enthusiastic about treating patients with opioid use disorder, still regard opioid treatment programs with great suspicion. It’s partly due to lack of knowledge about OTPs. It’s also partly due to that old bugaboo that blocks so much of appropriate treatment for people with substance abuse disorders: stigma. Some providers believe all sorts of outlandish things about what takes place at opioid treatment programs.

It’s painful to admit, but some providers’ opinions are formed based on the actions of poorly run opioid treatment programs. Some opioid treatment programs provide little more than daily dosing of medication. In our business, those programs are referred to derisively as “juice bars,” meaning patients get a daily dose of methadone, which looks like red juice, and little more.

These programs taint the reputation of good opioid treatment programs which offer an array of services all meant to help the patient. This is a real shame.

So, what about me? Do I refer stable buprenorphine patients at our opioid treatment program to other office-based buprenorphine practices? Well…not so often.

I know plenty of excellent office-based buprenorphine providers across the state who are diligent and painstaking about the care they deliver. And I know some providers in my area who don’t meet that standard. I’m hesitant to refer to them.

For example, one nearby provider charts extensive patient visits. These notes include everything from history of present illness, complete review of systems, and complete physical exam for each visit. Yet I was troubled about how similar each visit was, and suspected there was a whole lot of “cut and paste” going on, and that the charted care wasn’t actually being delivered.

Recently a patient transferred from this practice back to me, at the opioid treatment program, for purely financial reasons. We requested a copy of her charts, as we do for all patients who have been seeing other practitioners. This is good medical practice, even if it hasn’t been all that helpful with this particular provider in the past.

I was reading the records, and was confused. I read in the exam section of her last visit, “Abdomen consistent with eight month pregnancy.”

How had I missed this, I thought. I’m no obstetrician, but even I should pick up an advanced pregnancy on exam.

I slid my eyes back to the patient, sitting on a chair near the corner of my desk. Her abdomen looked flat.

“Um, so…are you pregnant?”

“No! Why?”

“Well you don’t look pregnant,” I added, not wishing to offend her. “It’s just that this last note says you’re eight months pregnant.”

She sighed and rolled her eyes. “The baby is seventeen months old. I guess they just never changed it in my chart.”

I looked back at each note. Sure enough, the exams for each date all read, “Abdomen consistent with eight month pregnancy.” For many months. Clearly, this was cut and paste charting. It’s not quality care, and may be illegal if the provider charged for services not delivered.

This confirmed my worst suspicions about the level of care provided at that practice, so I don’t think I will be referring patients to them.

In this country, we do have obstacles to providing a continuum of care for patients with opioid use disorders. We have some office-based practices that aren’t well-run and have little oversight. We have substandard opioid treatment programs providing little more than medication dosing, and we have undeserved stigma against opioid treatment programs that have been providing quality care for many years.

In fact, opioid use disorder may have the least organized continuum of care of all chronic diseases.

What’s the answer? Better communication and better education among medical providers.

I’m doing my part.

I go to many conferences, to learn the latest data and standards in my field. I also meet other providers at these conferences, even though by nature I’m a bit of a recluse. I’ve given talks, both to community groups and at medical meetings, to do my part to pass on what I know. I don’t enjoy public speaking, but find that once I get involved in my topic, I lose my fears.

All providers of care for people with opioid use disorders need to do this – we must meet each other, talk to each other, and learn from each other.

Here are a few wonderful opportunities to interact and learn:

ASAM conferences: the American Society of Addiction Medicine holds several conferences per year at the national level, and these are excellent for learning and meeting the leaders in the field. You can read more at their web site: www.asam.org

 

In my state of North Carolina, you can get some valuable information from the Governor’s Institute, at https://governorsinstitute.org/ and also their blog: http://www.sa4docs.org/

You can attend webinars, get clinical tools, and obtain mentoring from the Providers’ Clinical Support System MAT, at https://pcssmat.org/

If you are a provider in North Carolina and want CME hours while you teleconference with peers and mentors, you can participate in the UNC ECHO project. You can read more about that here: https://uncnews.unc.edu/2017/02/15/unc-chapel-hill-initiative-will-combat-opioid-use-disorders-overdose-deaths/

Write to me if you want to participate and I can forward you to the people that can make that happen.

Mismanagement of Opioid Use Disorder

aaaaaa

 

 

 

 

I’m going to give an overview of what happened to one patient with opioid use disorder, changing enough details to keep people from recognizing the person. I’ve changed non-essential data, but not the medical facts as I learned them from the patient. The facts were confirmed by medical records that I obtained from two local hospitals, a local cardiologist, and a teaching hospital. I could not get records from the mental health clinic that is mentioned because none were made. All of this happened a few years ago.

This 31 year-old man had years of opioid use disorder which progressed to intravenous use for a little over a year before he started feeling ill. He went to his local hospital and was correctly diagnosed with endocarditis, which is a serious and life-threatening infection of the delicate valves of the heart. He was transferred to a teaching hospital, had a surgical repair of a heart alve, given six weeks of antibiotics, and sent home.

He says no one mentioned any sort of addiction treatment, but he admits he probably would not have agreed to treatment anyway. He also admits it’s possible he just doesn’t remember and treatment was discussed. His records contain no mention of substance use treatment referral upon his discharge from the hospital.

About a year later, he was re-admitted to our local hospital with fever and suspected endocarditis. His attending physician in the hospital started treatment with appropriate antibiotics but correctly identified he needed to be seen by a specialist too. As his medical record reveals, two teaching hospitals refused to accept this patient in transfer because he had no insurance, no money, and because he didn’t quit using drugs after the first illness. The physicians that could have accepted the patient in transfer said they don’t want to waste resources treating him again.

His admitting physician explained all of this to the patient. Since it appeared he would die without surgery, Hospice care was arranged to ease his remaining days. He was sent home to die. Somehow, qualifying for Hospice care also got him approved for Medicaid.

After his Medicaid came through and he’d been on antibiotics waiting to die for some weeks, he started wondering what would happen if he arranged an appointment with a cardiologist on his own. Since he now had Medicaid, he was able to make an appointment with a local cardiologist. Though he hadn’t died yet, he was very sick, with fluid building in his lungs and backing up into his feet and legs.

I got the cardiologists’ records, and between the lines I could sense he had been as puzzled as I was now– why was this man turned down for medical care? The cardiologist correctly suspected the patient didn’t have a severe endocarditis, since he probably wouldn’t still be alive at that point. He arranged a referral to a cardiologist friend of his at the local teaching hospital, and a more sophisticated evaluation was done. It showed a hole in the patient’s heart. Blood was flowing in the wrong direction, causing heart failure and severe shortness of breath.

The patient was admitted to the hospital and had a procedure to patch this hole. As it turned out, this procedure could be done without open-heart surgery.

All is well, right? Nope. The original problem, opioid use disorder, has still not been comprehensively treated, although this teaching hospital did at least give this patient a few days of buprenorphine during his short hospitalization. He was told to follow up with a Suboxone doctor in his area.

He tried. He called several office-based buprenorphine physicians in his area. But he had Medicaid, and couldn’t find a doctor to accept this form of payment, or else the few that did accept Medicaid didn’t have appointments for many weeks.

He relapsed to intravenous opioid use, and became sick with fever, had trouble breathing, and went to his local hospital’s emergency department. He was given some fluids, some antibiotics for “pneumonia,” and told to go home.

Before he left, he asked if he could be referred for treatment of his addiction, and was told he would have to go to the local mental health provider that contracts with Medicaid in his county.

He went in person to that facility the next day, and asked the receptionist if he could be referred to the local methadone clinic. He was told they didn’t make referrals to the methadone clinic, so he left, discouraged. He never imagined it could be so hard to get treatment for his addiction.

He continued to feel very bad, with fevers, cough, and then developed severe back pain. He went to another local hospital’s emergency department, was again told he had pneumonia, and that he needed different antibiotics. He was sent home from the emergency department, but went back a few days later, when his back pain worsened.

He says he got the feeling the hospital personnel felt he was drug seeking for pain medication. He admits he did want pain medication, but mainly because of severe back pain. He was told to be patient, and give the antibiotics time to work.

The day before he came to our opioid treatment center, he went back to the first local hospital with fever, back pain, and trouble breathing. He was told for a fourth time that he had pneumonia, and was sent home with new antibiotics.

He got the address of our opioid treatment program from one of his friends, and came in person to see if we could help him. Since I wasn’t there that day, we set him up with an intake appointment for the next day, and he arrived bright and early to start the intake process.

When I first laid eyes on this patient, my impression was that he was seriously ill and not stable enough to start treatment with us that day. He looked bad. However, I listened with fascination to his entire story, which he told in short bursts of conversation between gasping breaths.

I didn’t want to start treatment. I wanted to get him to a teaching hospital as quickly as possible. He was sweaty, breathless, wincing in pain and clutching his back, and running a low-grade fever. He did have sounds in his lungs consistent with pneumonia, but at this point he’d been on antibiotics for over a week. Clearly something more than pneumonia was going on.

But I knew I could not turn him away without doing something for him. More as a gesture than as a real treatment, I gave him an induction dose of buprenorphine and sent him to the teaching hospital, located about an hour from us.

I got a call back later that day from the resident physician who admitted this patient. The severe back pain that my patient had reported at four hospital emergency department visits turned out to be osteomyelitis, which is a bacterial bone infection needing antibiotic treatment for several months. He also had an abscess on the spine nearby the infected bone. The bacteria they finally cultured was methicillin-resistant Staph aureus, also known as MRSA.

He spent months in several hospitals. He had to undergo a debridement of the bone to get rid of infected and dead material, and had to be on very heavy intravenous antibiotics for a prolonged time.

Because he had been started on buprenorphine at our opioid treatment program, I convince the residents they could continue that medication, and gave some suggestions for increasing it a little bit.

Finally, he was healthy enough to leave the acute care hospital to go to a physical rehabilitation hospital, where he stayed for about six weeks. Thankfully, since he had already been started on buprenorphine, these providers were also willing to continue his medication. He was re-admitted to our opioid treatment program the day after he was discharged from the physical rehab hospital so that we could continue his treatment.

He had to have strong opioids early in his hospitalization but by the time he came back to our OTP, he was only on buprenorphine 8mg sublingually per day. I did have to increase his dose a little for fine-tuning, and he’s been healthy ever since, with no positive UDS, no illicit drug use.

He looks fantastic. He’s healthy, energetic, and works every day. He’s usually smiling, and he makes me smile too. I don’t think he’s using any illicit opioids for many months.

He asked me a difficult question. He wanted to know how his medical treatment could have been better. I told him that I had the luxury of hindsight and the pile of his medical records, but I did see some mismanagement of his care. I told him these were the things that bothered me about his treatment:

  1. He was turned down for medical care when he came to his local hospital for what they thought was endocarditis. It turned out to be something different, but the small hospital didn’t have the technology to diagnose and manage the problem. They did the right thing by attempting to transfer him to another hospital, but were refused. I don’t know what recourse a physician at a small hospital has if teaching hospitals refuse to accept a patient, and I’m sure this patient was refused because he had drug addiction, and judged as a person not worthy of care.
  2. There was an appalling lack of attention to his underlying medical disease that fueled all of his medical problems. He should have been told about buprenorphine and methadone as treatments for his problem, and referrals should have been made. Ideally, he should have been referred after his endocarditis infection, or by any of the half-dozen doctors who saw him after that. Then even when he specifically asked for referral for that sort of treatment, the mental health facility missed an opportunity to help this man, saying they didn’t refer to the methadone clinic.

Believe me, we notified people who supervise this mental health facility about their failure to act, and what we thought of this failure. We have been assured this will never happen again.

3.This patient sensed an attitude of distain in his caregivers, and I also sensed it in the wording of the documents from the hospital. The emergency department records are sketchy, with little documentation of the medical reasoning of the attending physician. I worry that the physician saw the patient as a bad person seeking drugs, rather than a sick person with a treatable illness. I know I’m sensitized to this issue, so it’s possible I’m jumping to the wrong conclusion.

I’ve tried my best to talk to local physicians. In a few enjoyable exceptions, I’ve had great responses and cooperation. In other cases, I’ve had rude responses. Most responses are neutral, neither rude nor friendly, and I sense a disinterest in the topic.

I wish all of the doctors who treated this patient when he was sick with opioid use disorder could see him now. He’s a happy and productive member of society, and yes, he does plan to stay on buprenorphine indefinitely. I support that decision.

This patient, and hundreds like him, are why I love my job.

What’s a Doctor To Do?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Above, you will see two documents which illustrate the problem.

The second is a letter sent to North Carolina opioid treatment program (OTP) physicians from the preeminent OB/GYN group at the University of Tennessee. The first is a letter sent last month to obstetrical providers and opioid use disorder treatment providers from the Center for Substance Abuse Treatment, an arm of SAMHSA (Substance Abuse and Mental Health Services Administration).

You will note they recommend polar opposite approaches to the management of opioid use disorder in pregnant women. The obstetricians at University of Tennessee recommend that pregnant women with “chronic narcotic use” be offered the option of taper from opioids, to avoid neonatal abstinence syndrome and to avoid microcephaly.

In contrast, the letter to providers from CSAT division of SAMHSA recommends, “Pregnant women with opioid use disorder should be advised that medically supervised withdrawal from opioids is associated with high rates of relapse and is not the recommended course of treatment during pregnancy.”

That mention of microcephaly in the U of T letter baffles me. The resources cited in their letter referred to one study of head circumference in babies with neonatal abstinence syndrome (NAS). There’s no mention whether the moms are on illicit opioids or MAT. The second study looked at head circumference in babies born to moms with polysubstance use. None of the studies looked at head circumference of infants born to moms on MAT and compared them with controls. Using microcephaly as an argument against MAT is a misuse of data.

Why on earth would Tennessee obstetricians send their letter to NC opioid treatment program providers? Because, as I have ranted about so often in the past, there are no opioid treatment programs in Eastern Tennessee. Because that portion of Tennessee still has no methadone programs, patients are forced to drive across the border to get the gold standard of treatment for opioid use disorder. True, there are some buprenorphine prescribers in that area, and that’s a great thing as far as it goes, but as we know, not all patients do well with buprenorphine, and we have around six decades worth of data about methadone in pregnancy.

So not only does Tennessee refuse to allow the most evidence-based treatment for opioid use disorder to exist in that part of their state, but their physicians seek to control the actions of opioid treatment physicians in North Carolina, and ask us to adopt treatment approaches discouraged by all other expert organizations.

The study touted by Dr. Towers in their above letter was published by Bell, Towers, et al. in September 2016 issue of the American Journal of Obstetrics and Gynecology: http://www.ajog.org/article/S0002-9378(16)00477-4/abstract

After reading this study in some detail, I’m surprised by the authors’ conclusions. I find their conclusions to be based on some very thin evidence.

This study was a retrospective analysis of four groups of pregnant women with opioid use disorder. The first group consisted of incarcerated women, allowed to go through opioid withdrawal without the standard of care, buprenorphine or methadone. How this is even legal is beyond me.

The study says that jail programs in east Tennessee have “no ability to provide opiates to prevent or perform an opiate-assisted withdrawal medical withdrawal.” It went on to say that the jail doctor can treat symptoms with anti-nausea meds, clonidine, and anti-diarrheal meds. They also lack the ability to perform fetal monitoring while incarcerated.

Of the 108 women in group 1, two suffered intrauterine fetal death, one at 34 weeks and one at 18 weeks. The authors don’t say what the expected rate of fetal death would be, and I don’t know either. Apparently the authors didn’t consider these two deaths to be outside the range of normal.

Group 2 consisted of 23 pregnant women with opioid use disorder who were sent to inpatient opioid detoxification followed by long-term follow-up behavioral health programs. These women did well, with only 17% relapsing while in treatment. This group had a 17% rate of neonatal abstinence syndrome in the newborns.

I guess that means all of the four women who relapsed had babies with NAS. That’s 100%, much higher than the 50% rate nationwide. That seems odd to me.

Group 3 did the worst. These 77 women had inpatient detoxification but then did not have the long-term treatment that group 2 were given. Of the infants born to these women, 22% needed admission to the neonatal intensive care unit. Of these 77 women, 74% relapsed, and NAS was present in 70% of those infants. Again, this gives a NAS rate of 95%, which is a great deal higher than most other studies of NAS in babies born to moms using opioids of any kind. Even with methadone, studies give estimates of 50% to 80% at the highest.

Group 4 consisted of 93 women on buprenorphine prescribed by office-based physicians who agreed to taper the women’s doses during pregnancy. The rate of relapse in this group was noted to be 22%, and 17% of all the babies had NAS. Again, this gives a relatively higher NAS rate than has been found in other studies. In this Bell study, NAS occurred in 76% of the women who relapsed, up from 50% of women on buprenorphine in the MOTHER trial who were not tapered.

A little sentence in the articles table of demographics and outcomes gives the clue to why their NAS rates were so high. The way this study determined relapse was by drug screen at the time of admission to the hospital for delivery, or an admission by the pregnant woman, or positive meconium screen, or treatment of NAS in the newborn.

I think relapses could have gone undetected very easily, so that only the women with a relapse close enough to the time of delivery were detected to have used opioids.

Other problems with this study have been pointed out by much smarter people than me. Dr. Hendree Jones, author of the landmark MOTHER trial comparing methadone and buprenorphine during pregnancy, commented in the Journal of Addiction Medicine in the March/April 2017 issue: Her conclusions after a review of the Bell article plus a handful of other similar studies is: “Evidence of fetal safety to support the equivalence of medically assisted withdrawal to opioid agonist pharmacotherapy is insufficient.”

Of course, pregnant patients have one big concern: “What can I do to keep my baby from having withdrawal?” and that’s what they focus on. They are willing to do anything, including coming off methadone or buprenorphine or other opioids, if it will keep their baby from withdrawal. As Doctor Jones cogently points out in the above referenced article, there’s lack of data to show medically-supervised withdrawal from opioids results in less risk of NAS.

In other words, if prevention of NAS is our only goal, there’s not enough evidence to show that reducing opioids during pregnancy will achieve this. In part, that’s due to the high risk of relapse in the mother, and in part due to other factors.

This is the state of the situation right now. Things could change in the future. We do need new studies, done with closer attention to fetal monitoring and drug testing throughout pregnancy to help us determine the ideal treatment of pregnant women with opioid use disorder.

But for right now, maintenance on buprenorphine or methadone is still the treatment of choice.

It’s not only SAMHSA that’s recommending MAT as the treatment of choice for pregnant patients with opioid use disorder. Even the American College of Obstetrics & Gynecology (ACOG), the professional organization of OB/GYNs in the U.S., in a position statement from 2012, says:

  • “The current standard of care for pregnant women with opioid dependence is referral for opioid-assisted therapy with methadone, but emerging evidence suggests that buprenorphine also should be considered.”
  • “Medically supervised tapered doses of opioids during pregnancy often result in relapse to former use.”
  • “The rationale for opioid-assisted therapy during pregnancy is to prevent complications of illicit opioid use and narcotic withdrawal, encourage prenatal care and drug treatment, reduce criminal activity, and avoid risks to the patient of associating with a drug culture.”

The World Health Organization says, in its guidelines from 2014:

  • “Pregnant women dependent on opioids should be encouraged to use opioid maintenance treatment whenever available rather than to attempt opioid detoxification. Opioid maintenance treatment in this context refers to either methadone maintenance treatment or buprenorphine maintenance treatment.”

A new statement from the American Society of Addiction Medicine earlier this year, titled, “Substance Use, Misuse, and Use Disorders During and Following Pregnancy, with an Emphasis on Opioids” said:

  • “For pregnant women with opioid use disorder, opioid agonist pharmacotherapy is the standard of care; the ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use recommends that pregnant women who are physically dependent on opioids receive treatment using methadone or buprenorphine monoproduct rather than withdrawal management to abstinence.

So the experts agree. Medication-assisted treatment is the gold standard for pregnant women with opioid use disorder.

Why are some OB/GYNs in Tennessee and other areas recommending the opposite, based on evidence that most of us consider preliminary at best, and flimsy at worst?

I don’t know for sure, but I think these physicians suffer from the same biases as other non-medical people. I would like for these physicians to base their actions on the best scientific data, but that’s not happening in some areas. I believe these doctors, with the best of intentions, have been swayed by the political climates of their areas. Rather than challenge long-held beliefs about medication-assisted therapies that have been based on ideology rather than fact, they have stayed inside the comfort zone of believing pregnant women shouldn’t be on methadone or buprenorphine.

This leaves addiction medicine physicians in the middle. We know what the standard of care is, but our patients are told we are wrong, and that they should taper off maintenance medication, or not start it in the first place.

I’ve tried, one OB at a time, to educate gently about what I see as the standard of care. I’ve sent studies and position papers and other data to the OBs with whom I share patients. I’ve blogged about the negative experiences I’ve had. In short, many of these obstetricians say something to the effect of: “Who are you to tell me how to care for this pregnant patient?” After all, I’m not an obstetrician. But I do read, and I do keep my fund of knowledge up to date in the field of addiction medicine, which overlaps with obstetrics at times.

I’m terribly frustrated by the situation, and I know my colleagues at other opioid treatment programs feel the same way. I’m fortunate that there is one group of OBs who are somewhat supportive of my pregnant patients on MAT, and I appreciate that. But often these pregnant ladies using opioids are already going to one of the anti-MAT OBs, and that creates real problems.

If it’s difficult for physicians, just think how the pregnant patients feel. They are given polar opposite recommendations by their OB and their physician at the OTP. They sought help in order to do the best thing for their babies, wanting to be good mothers. In most situations, they have tried desperately to quit opioid on their own, and couldn’t. Now the OB is telling them they must taper off their medication during pregnancy, and the OTP physician is recommending they stay on it, even recommending they increase their dose if needed.

At a difficult time in their lives, these mothers-to-be aren’t sure if they are doing the right thing by being in treatment with MAT or not. They second guess themselves, and their families also recommend, with the best of intentions, that they follow the OB’s directions.

I think this won’t change unless professional organizations like ACOG reach out more directly to obstetricians in the field. Perhaps SAMHSA can organize educational lectures, given by obstetricians who know the data and know the best practice recommendations. Perhaps state medical societies or state medical boards can contact these obstetricians with statements of best practices, if more are needed. With WHO, ACOG, SAMHSA, and ASAM all recommending MAT for opioid-dependent pregnant women, you wouldn’t think further statements of best practice would be needed…yet they are.

All I know is that I don’t seem to be making any headway at all. I need help, and my patients need help.

 

 

 

Guest Blogger: Thoughts on Roadside Suboxone Signs

This is not a picture of Daniel Rhodes. But if he were a dog, he might look like this.

 

It is with delight that I present a guest blogger who has volunteered to give his thought on the roadside Suboxone signs that I blogged about several weeks ago.

I’m also delighted that I get to take a week off blogging, and hope all my readers have a great holiday weekend.

Daniel Rhodes is an LCAS-A and LPC-A working in both an OTP and a private Office Based Practice. He had a background in Abstinence-Based treatment models, and has, over the years, come to believe strongly in MAT. He believes in the importance of both approaches and that each has much to learn from the other.

When I first saw a sign on the side of the road advertising Suboxone, I reacted strongly enough to take a picture to show at work and marvel over. I discussed the issue with Dr. Burson, and realized my initial reaction was incomplete.  My gut told me that there was something off about the situation, that there was something unethical or below-board happening, but I could not understand why that might be.  I believe pretty strongly in a Harm-Reduction approach to addiction treatment, first managing the dangers of overdose and disease then trying to help addicts address the issues underlying their disease. I think wider availability of the combination buprenorphine/naloxone product is a good step towards that goal of Harm-Reduction.  In fact, I have been known to argue for the combo product to be available in vending machines. While this is an extreme example and there are many reasons it is not a feasible option, I do think it illustrates a valid principle: Buprenorphine saves lives, prevents the spread of disease, and is a remarkably safe medication. Expanded availability is a good thing.

                So why did this mobile Suboxone van raise my hackles?  Surely, this would increase access to the potentially life-saving medication, and should therefore line up perfectly with my philosophy!  In part, of course, it does; however, I have been able to articulate for myself several ways it does not, several reasons for my misgivings.

                First, as Dr. Burson has said many times, it should be no more expensive for a doctor’s appointment addressing addiction than it is for any other appointment. In the affluent area of Lake Norman, were I to pay out-of-pocket for a routine follow-up visit with my primary care MD (without applying insurance), my cost would be $65. According to their website, the Mobile Suboxone practice charges $175 for an office visit, making their per-appointment charge roughly 270 percent what my primary-care MD charges. While there is certainly nothing wrong with making a profit, I have to wonder if the price differential is warranted, or if it is taking advantage of a relatively desperate population.

                Second, since their website does not identify the person (people?) seeing the patients, there is no way to assess the legitimacy of the practice. In my previous example of buprenorphine in a vending machine, there could be no pretense of legitimate medical practice. However, in a Mobile Suboxone unit, a patient might leave believing he or she had received sound medical advice when this was not the case. There is little on their own website that points to more than a veneer of sound medicine; there are many claims, but paltry sourcing (Wikipedia among them) and seemingly no accountability. As far as I can find, they make reference to a Physician Assistant and “physicians throughout the state,” but attach no names to their practice. In short, even though the practice might expand access to buprenorphine, it seems to be doing so in a way that potentially bills their service as more than it is.

                Third, and following on my point about the medical quasi-legitimacy, the website compares their service to Methadone clinics in a way that I do not believe is fair or even reasonable. They claim that Methadone clinics are too expensive, that they disrupt life too much. While it is certainly true that daily dosing in a clinic can be a burden, particularly if a patient lives far away, a clinic offers a vital component seemingly lacking in the model of the Mobile Suboxone practice: accountability. While they make claims of daily electronic interaction, the daily in-person contact of a Methadone clinic provides a much better picture of a patient’s progress than any electronic communication could. A Methadone clinic mandates and provides counseling for its patients, typically included in the daily fee. The website for the mobile practice offers counseling electronically, the frequency of which is “between you and the counselor,” at a cost of an additional dollar per minute. It seems like an apples-to-oranges comparison: Yes, Methadone might be more expensive than their service, but it comes with much more intense support.

                Finally, that the signs mention “micro-loans” is worrisome. I am not sure how this will work, and I find no mention of the loans on the site. “Micro-loan,” however, evokes images of payday lenders, pawn shops, and other outlets associated with active addiction. It is hard to imagine a scenario in which no one is taking advantage.

I believe the idea of the Mobile Suboxone practice risks losing the ground we have fought so hard to gain in the discussion of the “opioid crisis.” At last, MAT is something being discussed in political circles, and funding is finally opening up to expand access to treatment. Poorly run practices, profiteering, and anything that risks damaging the perceived legitimacy of MAT risks lives. If the practice is not well-run, I fear it might prove an impediment to treatment rather than the expansion it claims to be.

                In conclusion, I may be completely wrong. The Mobile Suboxone practice may be exactly what we need to help more patients get access to life-saving treatment. I sincerely hope my misgivings prove unfounded and that the people behind the roadside signs are creating a new way to combat the disease of addiction. At this point, however, I believe the onus of proof lies on them to show the rest of us how their treatment will work, and that they are not taking advantage of a population that so desperately needs the help offered by well-administered MAT.

 

 

Shady Signs and the Corporate Practice of Medicine

Roadside Suboxone Advertisement

 

The roadsides of rural North Carolina have become littered with these signs advertising access to Suboxone prescriptions.

When I first saw one of these signs, I was appalled. These signs, more commonly used to advertise homes for sale or dating services, exude tackiness, when used to advertise for medical care. They are called “bandit” signs, for their often unauthorized use. As far as I can tell, these particular signs don’t violate any laws, when placed in the public road right-of-way, but they do seem dodgy. Their 1-800 number and the mention of “microloans” smacks of unprofessionalism to a degree rarely seen in medicine, even in these days. It reminds me of the more outrageous signage of the South Florida pain clinic scourge five or ten years ago.

 

South Florida pain management sign

One shady buprenorphine prescriber casts shade on all other prescribers. These signs make me feel embarrassed to be a doctor who prescribes buprenorphine, because the general public will lump all of us together.

I also felt embarrassed for my patients who take this medication for opioid use disorders. In fact, not long after I saw that first sign, one of my long-term patients, in relapse-free recovery for more than eight years, told me she felt mortified when she and her husband saw a similar sign while driving. She has had a spectacularly successful recovery, yet when her husband saw the roadside sign, he started criticizing her again for “still” being on that medication.

Out of curiosity, I went to the website advertised on the sign.

It’s scary.

They advertise a “mobile medical unit” that will “utilize church parking lots as much as possible,” for privacy reasons. The website says the clinic is staffed by a physician assistant and no medications are dispensed on site. Prescriptions for twenty-eight days will be called in and patients seen by telemedicine. (I assume this meant patients could get counseling via telemedicine.) Twenty-eight cities are highlighted on a NC map on the website, so presumably these are the target areas. The price listed for this monthly visit from a mobile medical unit was about twice what I charge my buprenorphine patients for a routine office visit, so it’s not cheap.

I suspect this business is not going to be owned or operated by a physician, though I could be wrong about that. From the way the content on the website is written, I can almost guarantee no one with medical training had a role in its composition.

This may be its downfall, since NC’s corporate practice of medicine act states that non-physicians aren’t allowed to own medical practices or employ physicians. This means that physicians employed by non-physicians are subject to sanction from the NC medical board.

Let us take a moment to go down this interesting rabbit hole known as the Corporate Practice of Medicine Act, or CPOM.

This antiquated law was a bit of legislation passed many decades ago, when lawmakers had the quaint and rather touching idea that physicians should be the only people to own and operate medical services, since they are the only people trained to know what’s best for the patient.

How can this law still exist, you ask, since about half of doctors’ offices are owned by hospital corporations? Because the medical board doesn’t enforce CPOM law for practices owned by non-profit entities, or for practices owned by hospitals. The medical board’s reasoning is that these hospital corporations, many of them for-profit, are likely to have the patient’s best interests at heart and therefore not be likely to make decisions based on profits alone, unlike other for-profit, non-doctor-owned entities. To me, that seems a bit arbitrary, but I’m not privy to their discussions on the matter.

Ten years or so ago, I quit working for a non-profit opioid treatment program to work for a for-profit OTP. Worried about the CPOM law, I called one of the NC medical board’s lawyers, to ask for information about the legalities of doing this. The board lawyer told me that if anyone reported a doctor for working for a for-profit, non-hospital agency, the medical board would “take action.” I tried to ask about specifics, and told him most of the opioid treatment programs in our state and in most states aren’t physician-owned. I asked if all of those programs were in violation. He kept saying that if they were reported, action would be taken.

He recommended I hire a lawyer who could give me specific legal advice, saying that since he worked for the medical board, he couldn’t give specific advice to the people whose licensure is controlled by that board. He gave me the name of a lawyer in private practice who used to work for the medical board and would be knowledgeable about these laws.

I called this lawyer and explained my situation and asked him how much it would cost to have him figure this out for me. To his credit, this lawyer gave me what felt like good information. He said I shouldn’t have to hire a lawyer to figure this out.

He said that since opioid treatment programs are ordered by law to have a physician as medical director, this puts them in direct opposition to the corporate practice of medicine act, and that this was an example of two laws contradicting each other. He said something to the effect that a medical facility that’s so closely regulated by the state can’t be outlawed by the state. This made sense. He said this needed to be figured out at a much higher level than me. He said it was an issue that needed to be worked out between the NC medical board and the state opioid treatment authority.

I liked that answer, since I wasn’t eager to shell out big bucks to hire an attorney. I contacted people at the state opioid treatment authority, and also the board lawyer to tell them what this attorney had said. Then I quit worrying about CPOM since, since this issue was too big for me to take on.

I doubt the issue has been resolved, because I still hear rumblings about how some opioid treatment programs are in violation of the CPOM. All I can say is that this is NOT a new topic, but it is a complicated one.

OK….. let’s pop our head back out of the rabbit hole, and talk about possible positives of having road signs advertising buprenorphine prescriptions.

Maybe the signage I find appalling is a means to harm reduction. We have mobile syringe exchange units, so why not mobile buprenorphine units? Far too many patients are dying of opioid overdose, so maybe roadside advertising is a novel way to reach people at risk for dying from this disease of opioid use disorder. Maybe we need to accept a little tacky advertising in the name of saving lives.

I don’t know – I know I don’t have all the answers. But I question the harm reduction motives of this particular business, based on how much they are charging, and their offer of “microloans.”

I hope somewhere in this business model there’s a conscientious physician tasked with overseeing quality of care. I hope that physician is truly involved, and not just providing a signature on a form every three months.