Archive for the ‘Evidence-based Treatments’ Category

A Bridge to Treatment

 

 

 

 

 

In my last blog, I lamented the lack of communication and cooperation between medical professionals involved in the care of patients with opioid use disorders.

Opinion about medication-assisted treatment has split the field in half. Most old-school, 12-step-based, abstinence-only programs discourage patients with opioid use disorder from seeking treatment with medication like methadone and buprenorphine. Some providers at opioid treatment programs rail against the lack of knowledge and open-mindedness of these programs, yet don’t inform stable patients on buprenorphine about their office-based options, which may be more appropriate and less restrictive (an option usually not available to methadone patients). Office-based providers accept patients from opioid treatment programs without bothering to get records that could give essential information that could make treatment safer.

Hospitals lack information about appropriate referral sources to treat opioid use disorders, and emergency departments let patients leave after a near-fatal overdose with only a list of phone numbers to call for help.

It’s time to break down barriers and put the welfare of patients first.

At the American Society of Addiction Medicine (ASAM) conference this year, I heard a possible solution.

Dr. Sarah Wakeman and Dr. Laura Kehoe, both associated with Harvard Medical School, talked about their Bridge Clinic. This program is set up to be a bridge between acute hospital or emergency department care and long-term primary care for patients with substance use disorders.

This model is “low barrier” or “low threshold” care, which means eliminating obstacles between the patient and appropriate care. The clinic’s mission is to provide on-demand, compassionate care to patients in all stages of addiction.

Most of their patients have opioid use disorder, and around 77% are treated with buprenorphine products. Around 11% are treated with naltrexone. I assume the others are treated for alcohol use disorder or other substance use disorders.

The Bridge Clinic serves as an immediate access clinic for Massachusetts General Hospital patients with substance use disorders who don’t have a primary care provider. This clinic provides both drop- in and scheduled appointments for patients. It’s been in operation for the past several years and has grown quickly, indicating a need for their services. In some cases, patients elect to remain in treatment at this Bridge Clinic rather than go on to primary care, office-based medication-assisted treatment.

This clinic is opened seven days per week, from 9am to 5pm. The physicians who staff this clinic are very aggressive with starting same day pharmacotherapy for substance use disorders, not only MAT for opioid use disorder. They refer to opioid treatment programs when that level of care is most appropriate, or if the patient needs methadone rather than buprenorphine.

They also work with families, and connect patients with other needed services.

The clinic staff includes an addictionologist, family practice physician waivered to prescribe buprenorphine, recovery coach for peer support services, resource specialist who finds other programs to help patients with their needs (food, housing, etc), and administrative assistant and a patient service coordinator. Extended care in the overnight hours can be provided by the colleagues at the emergency department.

Patients are referred from Massachusetts General Hospital, where patients with substance use disorders are offered induction onto medication-assisted treatment while hospitalized.

That’s right. I said that. Patients with opioid use disorder are started on methadone and buprenorphine during hospitalizations for other medical ailments. For example, a patient with endocarditis from IV opioid use disorder can be started on treatment with methadone or buprenorphine before ever leaving the hospital, and the Bridge Clinic can take care of the patient during the gap between hospitalization and arrival at an office-based or opioid treatment program.

This is treatment nirvana!

Patients with near-fatal overdoses can be started on buprenorphine before they even leave the emergency department, and use the Bridge Clinic to link them with care.

This wonderful new idea has substantial evidence to show it works. D’Onofrio et al., [2] published results of a randomized study of patients with previously untreated opioid use disorder who presented to the emergency department. In one arm of the study, patients got treatment as usual, which was referral to treatment facilities. In the second arm, patients received brief intervention counseling and referral to care to an outpatient buprenorphine provider. In the third arm, patients were started on buprenorphine and linked directly with outpatient buprenorphine treatment, with no gap in treatment. In this last group, nearly 80% of patients followed up with buprenorphine treatment and had significantly less opioid use than patients in the other two arms.

For this reason, the Bridge Clinic wanted physicians who worked in the emergency department to get their waivers to prescribe buprenorphine, and accomplished this. When they see patients with opioid use disorder, they either do the induction onto buprenorphine in the ER, or send the patients home to do a home induction by providing a two-day pack of buprenorphine. Since the Bridge Clinic is open seven days a week, such patients can be seen quickly.

This is wonderful, since we know from studies that patients who are started on MAT while in the hospital or emergency department have much higher rates of treatment retention. We also know that higher treatment retention means fewer opioid overdose deaths.

Around half of the patients referred to the Bridge Clinic from the hospital or emergency department are seen within 24 hours of being referred.

The clinic endorses a harm-reduction model, and does not discharge patients for continued drug use. They staff attempt to build trust by offering services without attempting to control the patients’ intake of drugs. The patients are included in the plan of care. They have low no-show rates, and are aggressive at getting patients back in to treatment if they miss appointments.

The Bridge Clinic’s goal is to eventually transition care, after acute stabilization, to somewhere closer to where the patient lives. Sometimes this can be worked out easily, and sometimes there may be problems. Bridge Clinic staff attempt to work out these difficulties.

Some patients need the Bridge Clinic short-term, and others for longer. Their average length of stay is around three months. This program provides help to patients with ongoing drug use, homelessness, pregnancy with substance use disorders, chronic pain patients, and to patients leaving incarceration, eager to find help prior to a relapse.

I was so inspired by the description of this program. It was obvious that these women excelled at gaining the cooperation of their colleagues at their hospital and in the primary care practices. It really sounds like the ideal situation, with everyone working for the good of the patient, no matter what their needs are. There are no waiting lists, and no senseless obstacles for patients to surmount.

Every community needs a bridge clinic, I think. How wonderful that would be, with a warm and friendly place to send patients in crisis, open every day of the week. Patients could be assessed, stabilized, then referred to the best treatment program nearest to where they live.

However, North Carolina isn’t Massachusetts. We have a higher percentage of people with no health insurance, while Massachusetts has expanded Medicaid, which helps pay for this sort of treatment.

But at least we have a model for quick-access, low-barrier care for people in crisis with substance use disorders. If we can ever muster the cooperation and will for such a program, these people can teach us how to do it.

  1. Sordo et al., 2017, British Medical Journal
  2. D’Onofrio et al., Journal of the American Medical Association, 2015, Apr 28; 313(16): 1636-1644.
  3.  
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ACLU Sues to Allow MAT During Incarceration

 

 

 

I was sent a link to this article that made my day:

https://bangordailynews.com/2018/07/26/mainefocus/aclu-lawsuit-demands-maine-man-get-addiction-treatment-in-jail/

This article reports that the ACLU (American Civil Liberties Union) has taken the case of a man in recovery on medication-assisted treatment who must serve a nine-month jail sentence starting in September in Maine. This man, Zachary Smith, has been in recovery on a buprenorphine product for the past five years. Ordinarily, the jail has a policy of NOT continuing medication-assisted treatment to inmates, leading to forced withdrawal from these medications.

Opioid withdrawal doesn’t (usually) kill healthy adults but can be fatal to people in fragile health. Acute withdrawal does cause significant suffering, and it leaves the person at increased risk of death from overdose upon release from incarceration.

The ACLU says there are two reasons why denying this medical care is against the law. First, denying medical treatment to inmates violates our 8th amendment against cruel and unusual punishment. Second, the Americans With Disabilities Act recognizes opioid use disorder as an illness covered by that Act. This means denying appropriate medical treatment for this condition is discrimination.

The ACLU filed a preliminary injunction to speed up a hearing of the case prior to the beginning of the jail sentence. This means the case will be heard – hopefully – before Mr. Smith must show up for his sentence in early September.

I was so happy to see this case. I think it could be a watershed moment for this nation, one way or the other. I have never understood how it could be legal for a person to be denied medical care while incarcerated, yet it happens across this country every day. In most jails, patients in treatment for opioid use disorder with medication-assisted treatment are denied their medication.

I’ve blogged about this before. I’ve even called the NC chapter of the ACLU myself, many years ago, to ask for help, but was told I had no standing, and that it needed to be the patient to contact the ACLU for help. But my patients sentenced to jail are often reluctant to bring an action against their local jail, feeling they might receive retribution of some sort – a very realistic concern, at least in my area.

Can you imagine the uproar if any other group of patients with chronic illness were denied medical treatment? What if patients with heart disease were denied life-sustaining medications during incarceration? What if diabetics were denied their insulin? For all I know, this may be happening. If it is, citizens of this country should not stand for this. We shouldn’t stand for it for people with substance use disorders, either.

Since all of this is happening in Maine, I was curious if North Carolina has any similar cases pending. I went to the website of the North Carolina chapter of the ACLU and found nothing advocating for inmates to be continued on medication-assisted treatment for opioid use disorder.

However, I did find that our state chapter of the ACLU filed a federal class action lawsuit against North Carolina’s Department of Public Safety’s policy of denying treatment for Hepatitis C to incarcerated people with the virus. The current class action suit was filed on behalf of all people incarcerated in NC with Hepatitis C.

https://www.acluofnorthcarolina.org/en/press-releases/aclu-incarcerated-people-sue-nc-failure-provide-life-saving-treatment

Current expert recommendations are that all incarcerated people receive Hep C testing, since according to data from the Center for Disease Control, around one-third of all prisoners are infected with Hepatitis C.

In the past, recommendations were to wait until the person with the Hep C virus developed liver damage before treating. Those expert recommendations have changed. The current recommendation is that all people with active Hep C infection should be treated. Experts now also recommend treatment even if the patient has not stopped illicit drug use.

The NC Department of Public Safety’s present policy is that incarcerated people with Hep C infection that’s caught early, when at its most treatable, are forbidden to receive treatment while incarcerated.

This article says there’s no law for universal testing of prisoners for Hep C, and the decision to test is left up to personnel at each jail site.

Both issues are important, though to me, continuing access to medication-assisted treatment appears more pressing, and could prevent more deaths in the short term.

I will follow these cases, and give updates to my readers.

 

 

Who Should NOT Be in Medication-Assisted Therapy with Methadone or Buprenorphine?

Liquid methadone

 

 

I spend much time and effort explaining how medication-assisted treatment for opioid use disorder works for many people. It occurred to me that I should explain who isn’t a good candidate for such treatment.

I enthusiastically support medication-assisted treatment (MAT) for opioid use disorder, but no treatment works for everyone. Some patients may be too ill for this form of treatment and some may not be ill enough, and find other treatments that work for them. Here are some reasons a patient may not be suitable for MAT:

The patient doesn’t have opioid use disorder. That seems obvious, but occasionally I encounter an addict who wants to be started on methadone even though he’s not using opioids. Rarely, people using cocaine, benzodiazepines or other drugs will come to the OTP after they have heard how well it worked for other people, who do have opioid use disorder. After I explain that buprenorphine (Suboxone) and methadone only work for opioids, some of these patients have become angry.

A few weeks ago, a woman came to our opioid treatment program who hadn’t used opioids for nine months, and – by her history – never had an obsession or compulsion to use them in destructive ways. When I explained to her why our treatment wasn’t appropriate for her, she became angry, and said it was her right to get treatment because of the CURES grant.

This made no sense to me, and I tried to explain myself several times, but she left, angry she was being denied a treatment that the government was paying for, because she felt that meant she was entitled to the medication if she wanted it.

The patient takes opioids for pain, but has never developed opioid use disorder.

Such a patient may be physically dependent, but lacks behaviors that indicate loss of control over opioids. The patient denies any misuse of medication, or obsession and compulsion to continue using opioids despite adverse consequences.

Opioid treatment programs (OTPs) have stringent regulations put on them by both federal and state governments. OTPs are designed to treat patients with opioid use disorder; these are patients who have lost the ability to control their intake of opioids, so the OTP regulates a maintenance dose of either methadone or buprenorphine to keep the patient out of withdrawal and able to function normally.

If a patient has only pain and no opioid use disorder, there’s no reason to enroll in an opioid treatment program, because patients without addiction are still able to take opioid medication as prescribed. Pain medication can be prescribed by any doctor with a DEA license.

While opioid treatment programs aren’t set up to treat chronic pain, many of our patients with both opioid use disorder and chronic pain find methadone and buprenorphine helps with pain. That’s a nice benefit. Many of these patients feel less pain once they’re out of the miserable cycle of intoxication and withdrawal. So less pain is a happy side effect of our treatment.

Having said this, there are those unfortunate patients who have been dismissed from pain clinics for reasons other than misuse of opioids. They don’t meet criteria for opioid use disorder, but they are clearly physically dependent on opioids and can’t find timely treatment. I have – at times – admitted these patients, under an exception filed with SAMHSA, with the understanding that they would be better served by eventually transferring to another pain management program.

The patient with opioid use disorder asking for maintenance treatment has been physically dependent for less than one year.

Methadone is difficult to taper off of, and federal and state regulations say it cannot be prescribed for people with opioid use disorder with less than one year of physical dependence. This is a somewhat arbitrary cut off, and the OTP physician can ask for an exception to this regulation if she feels it’s in the best interest of the patient.

Even if the OTP wants to treat the patient with maintenance buprenorphine (Suboxone), which is usually much easier to taper off of than methadone, permission must be sought from state and federal authorities before enrolling a patient who has used opioids less than one year.

This doesn’t apply to office-based buprenorphine practices, who don’t have to follow federal and state regulations for opioid treatment programs. If buprenorphine is prescribed in the office setting, the prescribing physician can use her best judgment about who is appropriate for treatment, without needing government approval.

To further confuse this issue, patients who have been on MAT in the past may be re-admitted onto MAT even without a year of physical dependence, if that patient thinks that relapse back into active opioid use disorder is imminent. Also, pregnant patients with opioid use disorder don’t have to meet the one-year requirement because of the benefits to both mom and baby with MAT.

The person with opioid use disorder can go to a prolonged inpatient residential treatment program.

This is controversial, because some doctors think medication-assisted treatment should be given to everyone because of its success rate compared to abstinence-only treatments.

But who gets the best of medical treatment in our country? Possibly it is medical professionals like doctors and dentists, airline pilots, politicians, and celebrities. They usually get the gold standard of treatment for whatever disease ails them.

If such people have opioid use disorder, they are often treated with inpatient medical detox, using buprenorphine to ease withdrawal, followed immediately with prolonged inpatient residential drug addiction treatment. I know doctors and dentists who spent six to nine months in treatment. After treatment, they must sign monitoring contracts with their licensing boards in able to go back to work. These contracts usually involve a mandated number of group sessions per week and random drug testing. With this kind of support and accountability, these medical professionals have excellent outcomes. Studies show that more than 80% are still off all drugs and alcohol at five years after entering treatment.

If only everyone could get that kind of treatment!

If this kind of treatment is available to the addict…take advantage of it. But most people with opioid use disorder can’t access this kind of treatment, with extensive post-treatment counseling, monitoring, and accountability.

A person with opioid use disorder is also physically addicted to alcohol, benzodiazepines or other sedatives.

These drugs can be deadly when mixed with methadone or buprenorphine. I prefer such patients enter a medical detox unit to get off these sedatives prior to entering treatment in an OTP. However, it’s a complicated problem, and the admitting physician needs to make a judgment about the risks of starting treatment while the patient is physically dependent on sedating medications, compared to the risks of delaying treatment for the opioid use disorder.

The FDA issued a statement in 2017 saying that “the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system…” They issued this statement after releasing the black box warning in 2016, saying opioids combined with benzodiazepines or other sedatives was dangerous and could result in death.

I believe this more recent statement was their way of indicating the risks may be outweighed by the benefits for patients contemplating admission to treatment for opioid use disorders with MAT. After all, patients with active opioid use disorder can die.

The person with opioid use disorder also has acute, severe mental illness. An actively suicidal patient is too sick for an outpatient opioid treatment program. So is an acutely psychotic patient who is having hallucinations and delusions. These patients often can’t to understand what is real and what isn’t. Ideally these patients need inpatient treatment at a facility that will treat both mental illness and opioid use disorder. Sadly, it’s getting ever harder to find such facilities for patients who need them.

Some patients may have neurologic dysfunctions that impair their ability to understand and consent to treatment. Such patients usually have people authorized to make decisions for them, and we must bring that person into the discussion and get consent to treat from them.

If a patient has some sort of temporary condition that impairs their ability to understand and consent to treatment, we may ask them to return on another day. For example, we sometimes have a new patient present for intake who is impaired to the point where consent is impossible. We make sure a responsible party can drive them home, and make plans for them to return the next day.

A patient has behavior that interferes with treatment.

OTPs have an obligation to all their patients to maintain a safe and orderly treatment environment. Patients who start physical fights, threaten staff or other patients, or sell drugs shouldn’t be kept in treatment. I know that sounds harsh, but OTPs have a hard enough time maintaining good standing in their communities without having to face accusations about illegal behavior on premises.

Patients need to be emotionally stable enough to conduct themselves in a non-threatening manner to be able to remain in treatment. Some patients, after being counseled about acceptable behavior, are able to comply with requests for behavioral changes. Some patients have erratic behavior due to mental illness, and shouldn’t be blamed, but their behavior still may be too disruptive for the OTP setting.

The patient has serious co-existing physical health problems.

Actually, I can’t think of any physical health problem that would make the treatment of opioid use disorder with methadone riskier to the patient than untreated opioid use disorder. We know for sure that untreated opioid use disorder produces high risks of death and disability.

Issues like severe lung disease and specific heart rhythm problems do increase the risk of medication-assisted treatment, especially with methadone. I try to contact the patient’s other doctors and consult with them before the patient goes above a low dose of methadone.

Ideally, I’d like to talk to the patient’s other doctors on the day of admission, before methadone is started, but that can’t always be done. With the time pressures doctors are under, it’s getting ever harder to claim some of their time for a patient consultation.

Some of these patients could be started on buprenorphine instead of methadone, which is safer with these health conditions, and has fewer medication interactions.

The patient has transportation difficulties.

Some patients can’t get a ride to their treatment program every day, which interferes with delivery of quality treatment. With buprenorphine, federal requirements for daily dosing were lifted, but states still have varying regulations. With methadone, the patient must come for treatment daily. During the first two weeks of stabilization, it’s important for medical personnel to be able to evaluate the patient every day, to assess the effects of dose increases. Most opioid treatment programs are open seven days a week for dosing.

A patient who enters treatment expecting to be completely drug free in the near future.

I try to make sure patients entering treatment with methadone or buprenorphine understand that I am not switching them from illicit opioids to these medications because tapering off of them is easier. Particularly with methadone, it is not. But both methadone and buprenorphine are so long-acting, they can be dosed once per day, giving the patient a steady level of opioids. This allows the addict to function normally, without withdrawal or impairment, once the dose has stabilized.

Both medications give the person with opioid use disorder time to regain physical and mental health. Once on a stable dose, the recovering person can make changes in his life, with the help of counselors and other OTP workers. He can get back to work, any criminal activity, form better relationships with his family and himself, and recover a better quality of life.

Will that person ever do well off methadone? There’s no way to know. Some patients can taper off methadone, if they bring the dose down slowly enough that they don’t feel intolerable withdrawal. Some, perhaps most, recovering people find they will do better if they stay on methadone.

All this is to say that the goal of entering an opioid treatment program isn’t necessarily to get off the treatment medication.

If a patient seeks to enter methadone treatment but also expresses a desire to be off buprenorphine or methadone within weeks to months, I tell them their expectations aren’t realistic. I try to explain these medications don’t work like that. If the patient wants to get off all medications quickly, I can give referrals to programs that can help them. This way, patients can’t later say they were misled, and feel like they have liquid handcuffs, chained forever to methadone, with its many regulations for treatment.

I hope this gives a little guidance as to which patients are most appropriate for medication-assisted treatment.

 

 

 

 

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

When the DEA Raids Buprenorphine Doctors

 

 

I had another blog post ready to go this week, but I’m postponing it to blog about another situation.

So far this year, two well-known and respected Addiction Medicine physicians have had their offices raided by the DEA.

The first one occurred in March of this year. Dr. Stuart Gitlow, the past president of ASAM (American Society of Addiction Medicine), who has a small buprenorphine (Suboxone and other name brands) practice in Woonsocket, Massachusetts, was raided by the DEA.

According to news reports, [1] the DEA raided his home and office, looking at patient records for evidence of wrongdoing. They wouldn’t tell him what they were looking for, and wouldn’t comment to reporters later because, they say, the raid was part of an ongoing investigation.

I searched the internet for some sort of follow up story, but found none.

Dr. Gitlow is an unlikely target for a DEA raid. He is so famous for his work in the field of Addiction Medicine that he has a Wikipedia page. According to that page, he is a psychiatrist specializing in the treatment of addiction. He earned an MBA from University of Rhode Island, and went to Mt. Sinai School of Medicine where he earned his M.D. degree. He did a psychiatry residency at University of Pittsburgh, along with a Master’s degree in Public Health. Then he went to Harvard University for a forensic fellowship.

I’ve heard him give lectures at ASAM meetings and he’s as good as lecturers get. He teaches at the University of Florida, and he’s on the editorial board of the Journal of Addictive Diseases.

Dr. Gitlow confirmed in an interview that the DEA looked at patient records, but he had no idea what they were looking for.

Then in early May of this year, the offices of Dr. Tom Reach were raided by the DEA. Dr. Reach, like Dr. Gitlow, is an outspoken advocate of medication-assisted treatment.

A news article [2] described how Dr. Reach’s nine treatment centers were closed for the DEA inspection, disrupting patient care. Dr. Reach’s home was also raided. In the interview, he said he heard the DEA thought he was doing something wrong, but he had no idea what it could be.

They also looked for controlled substances, but Dr. Reach, like most buprenorphine physicians, has never stored these drugs on-site. The record keeping that is necessary for storing controlled substances is considerable. He doesn’t contract with public insurance, so it couldn’t be problem with that.

Dr. Reach said the DEA took hard drives and cell phones, making it harder to continue with patient care.

Dr. Reach was the past president of the Tennessee chapter of ASAM. Dr. Reach was one of several physicians who were on the expert panel convened last year to draft Tennessee’s new guidelines around physician prescribing of buprenorphine. He’s spent his own time at the Tennessee statehouse, advocating for patients with opioid use disorder and their physicians.

Thus far, no charges have been filed against either physician.

Both physicians are politically active. Dr. Gitlow ran unsuccessfully, twice, for state representative in Massachusetts, as a Democrat. Dr. Reach contributes money – some would say a large amount of money – to political candidates he supports. [3]

These two leaders in addiction medicine are far from the only doctors being raided. Dr. Larry Ley, who had several treatment programs in Carmel, a suburb of Indianapolis, was ultimately acquitted of felony drug charges that he faced. Law enforcement personnel, posing as patients, lied about their need for opioid use disorder treatment. Dr. Ley was then charged when he issued prescriptions for Suboxone. [4]

I thought it was a felony to obtain a prescription for a controlled substance under false pretenses. How can a DEA agent pose as a patient and lie about their substance use history to obtain a prescription? Wouldn’t that be an illegal act? Maybe that’s why Dr. Ley was acquitted.

In this case, it seems the county’s head of drug task force didn’t agree with the idea of medication-assisted treatment, saying, ““This type of ruse of a clinic perpetuates the problem because people are still addicted to the drug, and this is what is happening,” said the head of the drug task force, in a press conference held after Ley’s arrest. “This is not fixing the problem.” [4]

Dr. Ley had to close his treatment centers, was left penniless due to legal fees, and is now suing both the city of Carmel and the DEA for conspiring to force him out of business.

Meanwhile, the opioid overdose death rate in Indiana has risen by double digits.

The DEA is authorized to inspect buprenorphine practices at any time. If you are a long-time reader of my blog, you’ll recall my office was inspected in late 2012. I wrote about the experience in a blog post on 12/16/12. The agents were pleasant and cordial. They were willing to meet with me when patients were not scheduled, so it didn’t interrupt my practice at all. They asked about how many patients I had, asked to see copies of patient prescriptions, and asked if I stored any controlled substances on site (of course not). The two agents were polite and cordial.

What happened to Drs. Reach and Gitlow was very different. They were both raided by the DEA, with a warrant that says material can be seized. In a raid, the DEA is so convinced that there’s criminal activity that they take computers, cell phone, and records. Inevitably this disrupts the medical treatment of patients. For both Dr. Reach and Dr. Gitlow, patients had to be turned away from scheduled appointments because of the raids. As Dr. Reach pointed out in a newspaper interview, this can have very real and possibly fatal outcomes for patients depending on buprenorphine to provide stability and keep them from using illicit opioids like heroin.

For a DEA raid to take place, investigators have expectations of finding criminal activities. They would not raid for issues like overprescribing, substandard care and the like. These types of problems would be handled by the state’s medical board.

Of course, I don’t know the circumstances that lead to these DEA raids. It’s remotely possible that a Harvard-educated physician leader of ASAM is slinging dope on some corner of Woonsocket, Massachusetts, in his free time…but I doubt it.

The trouble with these DEA raids is that while they make the papers when they happen, no news releases state what was found. If no wrongdoing was discovered in the masses of material seized by the DEA, the public won’t hear about this. All that remains is the taint of criminal investigation.

I’ve been working with some organizations to try to get more office-based physicians interested in treating patients with opioid use disorder with buprenorphine, a potentially life-saving medication. I’ve reassured worried doctors that they won’t become DEA targets just because they prescribe buprenorphine. I told them that unless they store medication on premises, the chances of getting raided are very small.

I hope I haven’t erred in telling new doctors this. I legitimately thought the nation’s leading health experts are pushing treatment for opioid use disorders, to stem the tide of opioid overdose deaths we’ve been having oer the past twenty years.

Now, with raids on well-respected practitioners, I don’t know what to think.

  1. http://www.woonsocketcall.com/news/city-doctor-s-home-office-raided-by-fbi/article_1e4270a0-2bb5-11e8-be84-b7f0c2501d63.html
  2. http://www.wjhl.com/local/dea-agents-raid-watauga-recovery-centers-in-tn-va-and-nc/1156361147
  3. http://doctorsofcourage.org/ralph-thomas-reach-md/
  4. https://www.thedailybeast.com/addiction-doctor-dea-shut-me-down-so-mayor-could-clean-up-town?ref=scroll

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.

Media Maintains Methadone is Menacing Mountains

 

NEWS CAT

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

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

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

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

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

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

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

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

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

All of that sounds very bad.

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

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

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

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

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

But not one such patient was interviewed for this report.

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

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

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

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

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

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

 

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

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

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

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

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

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

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

No controversy with that one.

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

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

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

In my opinion, WLOS bungled an opportunity.