Archive for the ‘American Society of Addiction Medicine’ Category

Book Review: “Dopesick: Dealers, Doctors, and the Drug Company that Addicted America,” by Beth Macy

Dopesick, by Beth Macy

This well-written book has it all: compact information about how the opioid epidemic started, how our nation failed to act early to mitigate the damage of the epidemic, and how the epidemic shifted into our present predicament. The author did a great deal of research and talked to experts with vital information, but she humanized this data with personal stories about people affected by the opioid epidemic. She told this story not only from the view of the person with opioid use disorder, but also illustrated the grief of families who lost loved ones. The prolonged grief of families who have lost loved ones to opioid overdose deaths is rarely examined as well as it is in this book.

This is a book that will be staying on my shelf for a re-read.

The author is a journalist who works for the Roanoke Times newspaper, so this book focuses mostly on events in the western part of Virginia.

Avid readers on this topic will recall the book “Painkiller,” by Barry Meier, who also covered rural Western Virginia. Ms. Macy’s book picks up where Mr. Meier’s left off. They talk about many of the same communities and the same treatment providers, fifteen years later.

Mr. Meier’s book, published in 2003, could have been an early warning to the U.S. healthcare system. Unfortunately, the book wasn’t widely read, so few people took any note of what was going on, other than those of us already working in the field. I understand Mr. Meier wrote a second edition of “Painkiller” this year, and I plan to read and review it.

The most remarkable theme of Ms. Macy’s book is how the opioid use disorder epidemic grew worse over the past fifteen years. After physicians finally stopped prescribing so many opioid pain pills, these pills were less available on the black market. Many people with opioid use disorder switched to cheap and potent heroin.

In Ms. Macy’s book, she tells the experience of a rural physician, Dr. Art Van Zee, who was also interviewed for Barry Meier’s book. He was one of the brave people who stood up at conferences and raised the question about the ethics of Purdue Pharma, manufacturer of OxyContin, when it wasn’t easy to question anything about that drug company. He’s the first physician I can recall who actively sought answers about his perceived over-prescribing and mis-marketing of OxyContin.

This isn’t in the book: I remember Dr. Van Zee at an Addiction Medicine conference called “Pain and Addiction: Common Threads,” that I attended in 2003 o4 2004. I bought the recordings of the conference, because I was so excited to learn more about Addiction Medicine. I remember a recorded session where Dr. Van Zee asked a question after a lecture, asking – as I remember it many years later – why Purdue Pharma was still peddling their OxyContin as a relatively harmless opioid for chronic pain, while he was seeing patients with lives destroyed by this drug.

It was one of those moments where all you hear are crickets. His question wasn’t answered, but rather he was reprimanded by the speaker. He was cautioned to remember our conferences were sponsored in part by Purdue money, and that appropriate prescribing of OxyContin was a huge benefit to patients. He was told it wasn’t the drug, it was the prescribing that needed to be fixed.

Fast forward to 2007. As described in “Dopesick,” Purdue Pharma pled guilty to fraudulent marketing of OxyContin, which was a felony misbranding charge. Purdue paid $600 million in fines. Its top three executives pled guilty to misdemeanor versions of the same crime, and ordered to pay a total of $34.5 million.

So yes, inappropriate prescribing was a big part of the problem, but Purdue deliberately misinformed physicians about potential dangers of the drug, which contributed to inappropriate prescribing. From a 2018 perspective, that speaker’s answer to Dr. Van Zee seems disingenuous at best.

Dr. Van Zee’s perceptions, based on his clinical experiences, were correct. Around that same time, I was seeing the same thing in rural Western North Carolina. I remember having twenty to thirty new patients show up on admission day, all of them were using OxyContin, almost exclusively. This drug was easy to crush to snort and inject, and Purdue knew it.

Purdue Pharma testified before congress in 2003 that they were nearly ready to release a new formulation of their OxyContin pill that was more abuse resistant. As it turns out, that new formulation wasn’t released until 2010. With that change, people with opioid use disorder changed to other opioids, easier to misuse, such as Roxicodone and Opana. Eventually Opana underwent reformulation to a less abused form.

But I digress; back to the book. The author’s first few chapters summarize the history of opioid use disorder and the factors that lead up to the release and promotion of OxyContin. It related how this drug crept into the social fabric of Southwestern Virginia, and how early attempts to sound an alarm about its abuse were met with contempt from drug company representatives.

Chapter Three tells of the “unwinnable” case brought against Purdue Pharma by Virginia attorney general John Brownlee. He went up against the famous Rudy Giuliani, who was one of the lawyers who represented the drug company, and successfully negotiated the eleventh-largest fine against a pharmaceutical company. This chapter contrasts this legal victory with the devastating grief of parents who lost their children to overdose death with OxyContin. The book describes the creation of the “OxyKills.com” message board, which became a sort of a database for overdose deaths. The chapter after that contains depressing descriptions of how Purdue Pharma’s corporation executives and the owners, the Sackler family, distanced themselves from the profound harm caused by their medication and criminal mis- marketing.

The next several chapters contain the tragic stories of people who became addicted to opioids, and their journeys through the criminal justice system, the addiction treatment system, and the pain their families felt, every step of the way. The author illustrates the ridiculousness of our patchwork system of care for people with opioid use disorder, and how ineffective treatments are often pushed as first-line options.

Then the book details efforts to pursue the heroin ring that sprang up in Virginia, and how the ringleader, a man named Ronnie Jones, was eventually arrested, charged and convicted of trafficking heroin from Baltimore to the Roanoke suburbs. Many of Jones’ drug runners were addicted young adults, many female, from Roanoke’s suburbs. Families were shocked when they found out their children were involved with the drug trade. Heroin used to be an inner-city drug, but times have changed. Heroin is now plentiful in suburban and rural areas, as this book illustrates repeatedly.

I was most interested in the author’s description of available treatments. Usually I dread reading writers’ summaries of treatment for opioid use disorder. If they describe medication-assisted treatment at all, it’s often couched in negative terms. However, this author did her homework.

She describes the accurate reasons why medication-assisted treatment with buprenorphine and methadone is the gold standard of treatment, and even writes about some of the success stories. However, she also writes about the more common public perception of buprenorphine: “shoddy” prescribers located in strip malls who don’t mandate counseling or do drug testing patients. She writes about the poor opinion of Virginia law enforcement officials, who criticize doctors for not weaning people off the drug, and for allowing patients to inject the drug & sell it on the street.

However, it’s clear the author was able to grasp harm reduction principles, and latest research findings, since she said (on page 219) the unyielding opposition to MAT was the single biggest barrier to reducing overdose deaths.

I felt gratified to read this in print. I underlined it.

She also pointed out how some states’ refusal to expand Medicaid when given the opportunity kept many people with opioid use disorder from being able to access treatment. That’s more perceptive than I expect from a writer who isn’t trained in public health or substance use disorder treatment.

But my favorite part of the book was on page 221, where an addiction counselor named Anne Giles said of the opioid overdose death epidemic: “We should be sending helicopters!”

I underlined this too.

She pointed out that if the same number of people dying from opioid overdoses were dying of Ebola, the government would be sending helicopters of medical help to rescue people and contain the epidemic, and she’s right. We ought to be sending helicopters….helicopters loaded with emergency medical personnel and treatment medication. (By the way, per most recent data from NIDA, over 49,000 people in the U.S. died from opioid overdose in 2017. That’s one-hundred and thirty-four people per day. If they were dying from Ebola…helicopters for sure.)

So I heartily recommend this book to anyone interested in this topic. Even if you aren’t interested, it’s so well-written that it will entertain you. I particularly appreciate the author’s talent at describing so many facets of this opioid epidemic and the obvious scope of her research.

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What I Do With My Day

Dr. Cat

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Some of my friends and family still don’t understand what I do for a living. When I was working in primary care, they understood. Now that I work with patients with substance use disorders, they are unsure. I tell them I do the same thing I’ve always done: I take care of sick people.

“Yeah, but they’re not sick sick, right? Not like people who usually go to the doctor.”

“Um, sometimes they are.”

For them and anyone else who wonders what an addiction medicine doctor does all day, this blog entry is a summary of a recent workday at the opioid treatment program where I work.

This was a Wednesday, which I dedicate to established patients. On Wednesdays, I talk to patients who are established in treatment about numerous issues, including adequacy of their dose, other medical problems, new medications, and other things. I also do yearly history and physical exams on patients who have been with us for a while.

In the following, I have changed the patients’ characteristics to protect their identity, while still conveying the essence of our interaction.

My first patient has been with us for several years and has done very well. She was seeing me for her yearly exam. First, I asked about her if her dose was still working well for her, and she said yes. She has been on methadone 105mg for more than a year, and her drug screens have been positive only for only methadone and its metabolites, since shortly after her admission.

This is a nice quality of methadone. Most patients don’t develop a tolerance to the anti-withdrawal effects of their dose, allowing them to remain comfortable on the same dose for months or even years. Other patients have fluctuations in their dose requirements, for assorted reasons: changes in other medical problems, changes of other medications, or changes in activity level, to list a few.

My patient looked at her picture on our electronic record, taken at her intake nearly two years ago. “I hate that picture! It looks awful. Can I get a new picture?”

“Sure, just ask the receptionist or your counselor. You do look different now. You look like that person’s younger, happier sister. But maybe it’s good to keep that old picture, at least in your mind, to remind you what opioid use disorder took from you – your joy.”

We proceeded with her history and physical, and at the end, I told her I thought her biggest health issue was smoking cigarettes. She was now abstinent from illicit drugs for nearly two years, but was still smoking nearly a pack and a half per day. I asked her if she had considered trying to quit. She said she would like to quit but wasn’t yet ready to try. I told her I thought she could quit, because she was doing so well in her recovery already. I asked her if it would be OK for me to ask her about smoking cessation in the future, and she said yes.

It’s important to hit the right tone with patients on this issue. I don’t want to pressure her and demand she try to stop smoking right now, because – of course – that approach doesn’t usually lead to behavioral change. Instead, I wanted her to think about why quitting smoking would be best for her, and to support her efforts in any way I can.

I can’t ignore the smoking issue. Tobacco-related illnesses are one of the most frequent killers of people in recovery, and I would not be doing my job if I ignored such an essential health issue. I like my patients, and I don’t want them to suffer illness and disability from a preventable condition, especially since their lives have changed so dramatically already.

My next three patients all wanted dose increases. Two were on methadone, and both were on sub-therapeutic doses, as evidenced by late-day withdrawal symptoms. I examined both before they dosed, so I could see them when their symptoms were at their worst. Both had large pupils and sweaty hands, and I ordered dose increases for both.

The third patient was a little trickier. He was dosing on buprenorphine at 16mg, and said he felt withdrawal symptoms of sweating with muscle aches and runny nose, which started at around 1pm each day. Since he doses at around six-thirty in the morning, his withdrawal symptoms started around six hours after dosing.

I didn’t think increasing above 16mg would cover the patient for a full twenty-four hours. I talked to the patient about switching to methadone, since unlike buprenorphine, there’s no ceiling on its opioid effect. As a full opioid, the more you take, the more withdrawal blocking effect.

He was reluctant to switch. He said he heard bad things about methadone, about how it gets in your bones and rots your teeth, and he didn’t want that to happen.

Inwardly, I sighed. Such ideas are still all too common in this region of the country. There’s still more stigma against methadone than against buprenorphine. While I’d love it if all my patients felt normal while dosing with buprenorphine, that’s not the case. There will never be one medication that’s right for everyone, and methadone is a life-saving medication too.

I corrected his mistaken impressions about methadone, without downplaying the real risks of methadone. I told him it was easy to overdose on methadone if he used benzodiazepine or alcohol while on it. I acknowledged that methadone does appear to be more difficult for most people to taper off of, but since he was early in treatment, we weren’t anywhere near close to considering any kind of taper.

He agreed to the switch, and I wrote an order to stop buprenorphine and start methadone. When patients switch from buprenorphine to methadone, I usually start methadone at a lower dose, at around 20-25mg on the first day. If they are older, on many medications, or have serious medical conditions, I may need to start lower than 20mg on the first day. I planned to see him again in a few weeks to see how he was doing.

My next patient had been admitted to the hospital for exacerbation of COPD, and the day I saw her was her first day back at our OTP. She usually doses on methadone at 80mg per day. The hospital didn’t call to confirm her dose with us, so I was very worried that she had gone without methadone for the five days she was in the hospital, on top of the COPD exacerbation.

When I (finally) got her records, I saw she was dosed at 80mg per day, because that’s what she told them she was taking.

I’m glad they dosed her. But it seems to me they should confirm that with her treatment facility before dosing her at that amount. Nearly all our patients will tell their other physicians the truth, but what if the patient, in a misguided attempt to feel better, exaggerated her dose and said she was on 110mg per day?

What if this patient wasn’t even currently in our treatment program? Dosing a patient at 80mg per day who wasn’t already on methadone at that dose would be deadly. When the stakes are that high, why take that risk? I know our phone system has byzantine voicemail, but the 24-hour number is given at the beginning of the voicemail, so they should be able to reach an administrator at any time, who can get all needed information for them.

Anyway, my patient was feeling better, and had no gap in treatment since she’d been dosed while in the hospital. I made note of some new medications and applauded that she had five days without cigarettes and encouraged her to continue the nicotine patches she’d been started on.

I had asked to see my next patient for an odd reason: we got a call that this lady was injecting her methadone dose each day. The caller remained anonymous, which always makes me suspicious of the caller’s motives, but I felt I needed to check it out anyway.

It’s rare for anyone to inject methadone. For one thing, methadone has a high oral bioavailability, due to excellent oral absorption. With methadone, you can get around 90% of an intravenous dose just by swallowing that dose. But injection drug use is about more than just the physiology. Often there’s a psychological component. Patients accustomed to injecting drugs can get a rush of dopamine just with the ritual of injecting.

I didn’t think this patient I was seeing would be doing that, since she’d been in treatment for over a year. All of her urine drug screens were positive only for the expected methadone and its metabolites.

When I saw her, I told her we received reports that she was injecting her methadone, and that I was sorry to inconvenience her, but I needed to check for myself, for safety reasons. To my great surprise, I found track marks. I asked her about what caused the marks, and she denied any IV drug use of her methadone or anything else, but there was no mistaking what I was looking at.

I told her I was afraid to give her further take-home doses, and that she needed to dose with us on site from now on.

She was furious, and while I understood her anger, I was in a pickle. There was no way I was could give her take home doses, given what I saw. It wasn’t safe. Her explanations of how the tracks came to be there didn’t sound realistic at all (cat scratched her in the same place multiple times, repeated injury from a fishing hook in the same area multiple times). I tried to be frank with her, and told her I knew tracks when I saw them.

Some physicians might not be so confident. Early on in my career as a physician treating opioid use disorders, I might have been a little unsure. After seventeen years of doing this job, I know track marks when I see them.

She asked when she could get her take home levels back, and again I was stumped. How could I ever be confident this patient wouldn’t inject take home medication? I could keep a check on her arms, but of course she could use other sites, and do I really want to have to ask a patient to strip so I can be sure there’s no injection drug use? No, I’m not going to do that.

If I knew what happened, it would give us something to work with, but my patient was unwilling or unable to tell me, so she will have to dose with us daily.

The rest of the day continued like this, with patients asking for dose increases, some asking for recommendations about how to go about decreasing their dose, and others checking in because they were medically fragile. I like to see patients with significant medical issues every three to four months, so I can stay current about any new medications, and remain updated on the status of their other medical issues.

This is what I do during my work day. I love my job and feel like I can help people and make a difference in their lives. I’m better able to do that where I work now than I ever could during the years I worked in primary care.

I’ve got the best job in the world.

 

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.
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Buprenorphine Prescribed in Two Settings

 

It’s very confusing. Even medical professionals get confused, so imagine how it is for patients.

I’m referring to the different setting where buprenorphine can be prescribed for the treatment of opioid use disorder.

Opioid treatment programs deliver care for patients with opioid use disorder in a much more structured setting. OTPs are regulated by sets of federal, state, and sometimes even local agencies. This limits flexibility when responding to changing patient needs, but provides a much more structured – some would say rigid – treatment setting.

OTPs must do observed, on-site dosing, with established protocols. Take home doses can be given, but patients must first meet a set of eight criteria. Some states, along with the federal agency, dropped the time-in-treatment requirement for buprenorphine, since it’s a safer medication than methadone.

Substance use disorder counseling is built in this system with stricter monitoring. OTPs must do a minimum set number of observed drug screens on patients. Opioid treatment centers offer a more intense, controlled, and hopefully more supportive setting for patients new to buprenorphine treatment, or who are struggling in treatment.

Office-based settings for treatment with buprenorphine aren’t nearly as regulated. Providers in office-based settings have more freedom to customize the treatment to the needs of the patient. The prescriber can decide how often the patient needs to be seen for follow up appointments and for substance use disorder counseling. Drug screen frequency and counseling intensity are left up to the prescriber. Some practices do observed urine drug screening, and some practices do not.

Opioid treatment programs are inspected by a number of state and federal agencies. Office based practices are not inspected at all, in most states. Other states, like Tennessee and Virginia, have more regulation around office-based practices, but overall, office-based practices vary more widely in quality and intensity than opioid treatment programs do.

So which setting is best? It depends on the needs of the patient.

As I said above, opioid treatment programs may be best for new patients, or those patients who use other substances besides opioids. Office-based programs may be better for stable patients because their treatment can be customized, allowing more freedom.

Ideally, office-based programs and opioid treatment programs should work together, collaboratively, to provide the best care to meet the needs of the patients. This idea of continuity of care happens with other chronic illnesses; patients with asthma may see a pulmonologist during a bad flare of illness, then resume care with a primary care provider after the expert has done everything an expert can do.

But with opioid use disorder, we aren’t there yet. I still sense a spirit of competition rather than cooperation between OTPs and OBOTs (office-based opioid treatment). It’s as if providers think to themselves, “There are only so many patients to go around, and if my patient transfers to that other practice, I will lose money.”

Believe me…there are plenty of patients to go around, unfortunately.

Providers who work at OTPs sometimes make unkind statements, saying OBOT providers are careless, poorly educated about opioid use disorder, and make bad decisions that lead to diversion of buprenorphine products into the black market. Then OBOT providers talk badly about OTPs, saying they are nothing but for-profit juice bars.

I’m as guilty as any – in my blog from last December, I made fun of an OBOT provider who used the cut and paste option of producing notes for office visits, leading to a statement about the patient being 8 months pregnant at each monthly visit for more than a year. (but that was a funny example, no?)

Somehow, we’ve got to start cooperating.

In my next blog, I’ll describe a type of treatment program that was set up to be a bridge between acute care in the hospital or emergency department, and treatment at both settings, OBOT and OTP. It’s inspiring me to be more collaborative and cooperative.

 

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

North Carolina’s Addiction Medicine Conference

I had a great weekend.

I went to the annual NC Addiction Medicine Conference, held in April each year, in Asheville. This year, I took an extra day off work and went to the pre-conference workshops, which I haven’t done in the past, because of poor planning on my part.

I went to the workshop titled “Treating Women for Substance Use Disorder During the Perinatal Periods: Integrated Medical and Behavioral Health.” It was fantastic. Hendree Jones, PhD., lead author or the MOTHER study, was one of the main speakers. I’ve heard her talk before, and not only does she present information in a straightforward way, she epitomizes the empathy that providers should have towards their patients. Dr. Mishka Terplan, MD, was the other presenter, and was equally eloquent and gifted lecturer. During the workshop, we broke into small groups to interact with other participants about topics.

Here are the latest ideas I heard: it’s ok – really, it is ok – to treat pregnant women with buprenorphine/naloxone combination products. We don’t have to switch them to the monoproduct. I already knew a pregnant woman shouldn’t be switched from methadone to buprenorphine, but I learned a pregnant woman shouldn’t be switched from buprenorphine to methadone, either.

I learned the depressing news that screening and brief intervention for substance use disorders are less likely to be done in women than men, and when their screen is positive, women are less likely to receive any intervention. Also, physicians aren’t good at diagnosing substance use disorders in women who are on either end of the age spectrum.

I learned about the social determinants of health that influence the outcome of pregnancies and substance use disorders the same as they influence all of health.

I learned that split dosing in pregnancy can be helpful with buprenorphine, same as it is with methadone. I have been splitting the dose of pregnant patients on buprenorphine nearing the end of their pregnancies, but wasn’t sure there was data or expert opinion that supported doing this. There is.

These lecturers talked specifically about the Bell study – that pesky study out of Tennessee that concluded taper of medication-assisted treatment during pregnancy was a reasonable idea. Even Bell’s own data didn’t support that conclusion, since the incidence of neonatal abstinence wasn’t decreased with a taper (or cold turkey withdrawal in jail). Reduction of NAS is the main reason Tennessee physicians in TN and elsewhere taper the dose of buprenorphine/methadone during pregnancy.

I already knew these facts, but since I deal with some obstetricians who don’t approve of the use of buprenorphine/methadone for the treatment of pregnant women with opioid use disorder, it was nice to confirm my approach is based in facts and data. After so much resistance from local OBs, I start doubting myself, wondering if I’ve got it wrong because after all, I’m not an obstetrician. It’s a great feeling to have what I’ve been recommending confirmed by the experts.

The whole conference was great. On the day of the main conference, I gave a thirty-minute presentation about the state laws passed around opioid and buprenorphine prescribing. I think it went well. I was well-prepared, since I’d spent hours researching, then hours rehearsing my presentation. I hate speaking in public, and have jitters about it. The more I practice, the more confident I feel. I felt a flood of relief when it was over, and pleased I’d gathered the courage to do this.

Then I went to an outstanding presentation on LGBTQ patients. I learned a lot, and feel more confident that I can treat this population in a culturally competent way. That presentation was followed by one on peer support specialists. This is not necessarily a completely new idea, but now there’s funding available for such personnel. I know how valuable peer support specialists can be, since we have several who work with our patients. They can be a godsend.

It went on like this for the rest of the day and the next too. All the speakers I heard were outstanding.

At this (and similar) conferences, it’s not just the information I get, or the credit hours that I need to remain licensed. There’s also a delight in being around people with the same passion to help people with substance use disorders. Sometimes we argue. I don’t think a group of three hundred doctors will ever agree on everything. But we remember we have more in common than the few points about which we have disagreements.

It’s nice, being among providers who understand the joys and tribulations of caring for our patients.

Any provider interested in joining North Carolina’s Society of Addiction Medicine should go to these websites:

http://www.ncsam-asam.org/

https://governorsinstitute.org/

The advantages of joining the state chapter of Society of Addiction Medicine (and also the national organization, called American Society of Addiction Medicine, or ASAM) include reduced rates on conferences, access to other physicians interested in treating patients with substance use disorders, and access to online CME hours (ASAM).

And support. Lots and lots of support, because we have a job that can be challenging.

Additional resources for physicians include the Provider Clinical Support System (PCSS)

https://pcssnow.org/

Providers in North Carolina who want more data about providing office-based treatment of opioid use disorder using buprenorphine can join ECHO UNC, a program of weekly teleconferences that can be accessed by computer or by phone. This is free, and participants can get CME hours. The format is a case presentation, followed by questions and commentary about management options, then a short didactic session. Then the session wraps up with a second case presentation. It lasts 2 hours, and participants can join for all or part of the weekly conference. It’s held each Wednesday from 12:30-2:15 or so.

Interested providers can go to: https://echo.unc.edu/ to learn more and to sign up to participate.

Buprenorphine Regulations

Map is from vox.com

In response to the rise of opioid use disorders in this country, lawmakers in heavily affected states are passing laws they hope will help. But well-intentioned laws may have unintended consequences, requiring re-evaluation of those laws.

Nearly one year ago, The Virginia legislature asked the Virginia Board of Medicine to regulate prescribing of buprenorphine. Legislators were worried about the diversion of prescribed monoproduct buprenorphine to the streets. You can read about this in more detail in my blog entry dated February 24, 2017.

It’s been a year since that blog entry, and I have a little bit of data regarding some of the consequences of Virginia’s new rules.

Initially, the new Virginia Board of Medicine (VBOM) regulations said the buprenorphine monoproduct could only be prescribed for pregnant ladies and nursing mothers. They did this because the monoproduct, containing only buprenorphine and no naloxone, has a higher street value and is more likely to be injected and misused than the combination product.

The VBOM received so many complaint letters that they finally changed the regulations to say that each buprenorphine physician could prescribe buprenorphine monoproduct to up to three percent of their patients. Each of these patients must have documentation of their intolerance in their chart.

It was hoped that this compromise would limit the amount of buprenorphine monoproduct being prescribed, while still making allowances for some patents with intolerance to naloxone in the combination product.

The VBOM didn’t stop there. They passed regulations about care at opioid treatment programs (OTPs), which are already the most heavily regulated medical providers in the nation. The VBOM said if buprenorphine monoproduct was used, the patient had to consume it on site, with observed dosing, and that no take home doses could be allowed for the monoproduct.

To clarify, this meant that OTP patients dosing with buprenorphine monoproduct had to either switch to the combination product, buprenorphine/naloxone, to get their usual take homes, or dose daily at the OTP on the monoproduct and forfeit all the take homes they had earned.

Or they could switch to methadone, where take homes are still allowed, following standard guidelines.

This is the irony – methadone is a heavier and stronger opioid than buprenorphine, and more likely to cause overdose death if taken illicitly or diverted. Virginia patients can get methadone take home doses, after they have a period of stability and meet the guidelines which have been in place for decades.

OTPs must follow both state and federal guidelines, and must obey the stricter of the two. The federal guidelines dropped the time in treatment requirement for buprenorphine, meaning the federal agency decided to allow the admitting physician to decide how many take home doses were appropriate, from day one, for a buprenorphine patient.

Essentially, Virginia went the opposite direction, and eliminated take homes, at least for the monoproduct.

At the time the new regulations were implemented, there were 600 Virginia patients on buprenorphine at OTPs. Monoproduct was used because was about half the price of the combination product, and kept treatment more affordable for patients. Also, because OTPs already followed stricter regulations than office-based programs, the risk of diversion was felt to be lower than at office-based programs.

Of those 600 patients, 384 patients attended one of the four OTPs owned by Acadia Healthcare in Virginia. They collected data on what happened to their Virginia patients after these new regulations were implemented. Since I work for Acadia, that data was released to me for an upcoming presentation, but I’ll give my readers an early view.

Of those 384 patients, 260 made the switch to the combination product so that they could continue to get take home doses. In other words, two-thirds of the patients switched, and one-third did not.

The cost of medication doubled, but rather than pass this on to the patients, Acadia Healthcare absorbed all the extra cost. The patients paid the same as if they were getting the cheaper monoproduct. This was fortunate, since an overnight doubling of costs could have caused hundreds of patients to leave treatment.

To some lawmakers, an extra couple of hundred dollars per month might not seem like much. But to many patients, it’s the difference between being able to stay in treatment or having to leave and go back to illicit drug use.

So, what happened to the patients who didn’t make the switch?

  • 15 switched to methadone, and will be able to get take home doses once they meet criteria. It’s takes a while, but at least they can get take homes eventually.
  • 21 transferred to out-of-state opioid treatment programs because they had an intolerance to the combination product.
  • 24 (6%) patients dropped out of treatment.
  • 58 remained on the monoproduct and accepted that they will have to dose every single day that they are in treatment. Since all these clinics are in rural areas of Southwestern Virginia, I suspect some of these people are driving long distances daily, and incurring extra expenses for that travel.
  • 6 patients were lost to follow up, and couldn’t be contacted to see what happened.

Studies show the risk of death increases as much as eight-fold for patients who leave treatment, so those 24 people are at high risk. I suspect the 6 people who couldn’t be found are also in that risk group.

I have a little bit of data about what’s happened on the receiving end with patients on buprenorphine at Virginia OTPs. One OTP located in Boone, NC, received 12 patients in transfer from Virginia. Those patients could have been OTP patients or office-based patients; I don’t have that data.

I have my own office-based buprenorphine practice in the Lake Normal area of North Carolina, which is 73 miles from the North Carolina-Virginia border. My practice got around twenty phone calls last year, just after Virginia’s law changed. These patients were willing to drive from Virginia to my office if I would prescribe buprenorphine monoproduct. I declined to accept any of those patients, both because it is unworkable in the long run to come from such a distance, and because I was concerned about regulatory scrutiny in my own state.

You can draw your own conclusions based on this limited data. It appears that roughly two-thirds of patients, if forced to switch to the combination product, can do so and remain in treatment.

But remember, costs weren’t increased for those patients enrolled at Acadia OTPs.

That would not have been the case for office-based self-pay patients, who would have paid roughly double each month for their prescriptions for combo products at the pharmacy. Community pharmacies would not have absorbed the extra cost.

I combed the internet, trying to discover data on what happened to office-based patients in Virginia on the monoproduct. If data is out there, I haven’t found it. Or perhaps it’s still being collected and analyzed. I also looked to see if overdose death data changed much in 2017, but it’s likely too early for this.

The American Society of Addiction Medicine has written a public policy statement addressing regulations on office-based buprenorphine policy. This document outlines the most reasonable approach to assure appropriate care for patients while limiting onerous regulations for providers. State legislators would do well to read this policy and abide by its specific recommendations.

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

I’m tempted to give a summary of ASAM’s statement, but ASAM warns against this, at least without their permission. They don’t want people to use just a section of their policy to justify a position; they want their statement to be read in full.

I think that’s smart of ASAM. I encourage interested readers to check it out.