Archive for the ‘Evidence-based Treatments’ Category

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
Advertisements

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.

News You Can Use

 

 

 

 

 

 

 

 

New ACOG Recommendations:

The American College of Obstetrics and Gynecology (ACOG) just released an updated recommendation about the treatment of opioid use disorder in pregnant women: https://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Opioid-Use-and-Opioid-Use-Disorder-in-Pregnancy

Their last statement was issued in 2012, in cooperation with the American Society of Addiction Medicine (ASAM). This newer statement was released earlier this month, also in cooperation with ASAM.

By my reading, this update is more direct about recommending medication-assisted treatment for pregnant women with opioid use disorder, and specifically discouraged medically supervised withdrawal from opioids during pregnancy.

This statement was in the update’s conclusions: “For pregnant women with an opioid use disorder, opioid agonist pharmacotherapy is the recommended therapy and is preferable to medically supervised withdrawal because withdrawal is associated with high relapse rates, which lead to worse outcomes. More research is needed to assess the safety (particularly regarding maternal relapse), efficacy, and long-term outcomes of medically supervised withdrawal.”

I suspect this released update may have been prompted by the actions of obstetricians in certain locations (Tennessee, for example), where medically supervised withdrawal is routinely recommended by obstetricians. As you recall in a blog earlier this summer, I showed you a letter written by OBs from TN, recommending “medically supervised withdrawal” for patients on medication-assisted treatment of opioid use disorders.

As the ACOG update emphasizes, there’s scant evidence to show medically supervised withdrawal provides any better outcomes for the baby, but certainly places the mother at risk for relapse.

I am pleased to see this update, and plan to mail it to a few obstetrics practices in my own area. Some OBs may be giving patients recommendations not supported by their own professional organization out of ignorance, in which case more information can help. Other OBs do it for ideological reasons, in which case I doubt any amount of information can help, but at least I’ll know I’ve tried to do something.

Screening for substance use disorders was also strongly emphasized in the new document, with specific recommendations about how this should be done. In other words, asking a pregnant patient, “You don’t take any drugs, do you?” is not considered to be adequate or recommended screening.

Increased Risk for Death in Patients with Opioid Use Disorder who Leave Buprenorphine Treatment

We have multiple studies, dating back decades, showing patients with opioid use disorder who leave treatment with methadone have higher risks of overdose deaths. We believe the same thing is true with buprenorphine treatment, but now we have more data to support that assumption.

A French study of 713 buprenorphine patients showed that being out of buprenorphine treatment was associated with a 30-fold increase in death, compared with patients who stay on buprenorphine treatment.

Now that’s impressive.

This was a study done in France, where most patients with opioid use disorder are treated by general practitioners in private practice. This would be roughly equivalent to what physicians do now in the U.S. in their office-based buprenorphine practices, often called OBOT treatment.

The study was published in the July/August 2017 issue of the Annals of Family Medicine, by Dupouy et al. It looked at new patients admitted onto buprenorphine treatment from early 2007 until the end of 2011, and covered over 3,000 person -years of treatment.

The authors say that the data showed, “…being out of treatment was associated with sharply elevated mortality risk.”

We already knew that people with opioid use disorder have an increased risk of death. Early in this article, the authors state that the accepted mortality rate of untreated heroin use disorder is around 2 people per 100 patient years. This means that if you follow 100 heroin users for a year, it is likely that 2 will be dead at the end of the year. An older study, by Hser et al., followed people with opioid use disorder over time, and found that around 50% were dead at 30 years.

We’ve had other studies that show being in treatment with buprenorphine or methadone decreases risk of death, but this may be the first study showing that getting help in a primary care setting reduces the risk of death so remarkably.

This was a very large study, so the data is more impressive to me All this data supports the conclusion that opioid use disorder is a serious and potentially fatal disease, and that being in medication-assisted treatment markedly reduces the risk of death.

 

What’s a Doctor To Do?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

 

New Treatment for Neonatal Abstinence Syndrome

 

 

 

 

 

 

 

 

 

 

The June 15, 2017 issue of the New England Journal of Medicine contained an article of great interest. Written by Kraft et al., this article titled, “Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome,” described a study comparing buprenorphine with morphine solution to treat opioid withdrawal in the newborn. This study showed significantly shorter duration of treatment and shorter median length of hospitalization for babies with neonatal abstinence syndrome when treated with sublingual buprenorphine compared to traditional treatment with morphine oral solution.

This study covers a hot topic. Many people are alarmed at the rising rate of NAS in our nation’s hospitals. The incidence of NAS has risen four-fold from 2003 to 2012, and cost $316 million in care for those babies just in 2012. [1] Any new treatment that can reduce the duration of withdrawal in newborns, and thus reduce treatment costs and parental anxiety, is an exciting new development.

The NEJM study described was done at Thomas Jefferson University in Philadelphia, Pennsylvania, with subjects enrolled from late 2011 until mid-2016. To qualify for the study, the babies had to be born full-term, defined as more than 37 weeks of gestation, and had to have been exposed to opioids during the pregnancy. The infants had to have signs and symptoms of neonatal abstinence syndrome (NAS), and parental consent to participate in the study.

The study, abbreviated BBORN, for “blinded buprenorphine or neonatal morphine solution,” excluded babies with low birth weight, exposure to benzodiazepines within 30 days of delivery, or serious other medical conditions. For the first part of patient enrollment, breast fed babies were excluded, but this restriction was lifted by 2013, with the national trend of that encouraged these mothers to breast feed. Nearly all of the mothers were on methadone maintenance, with doses ranging from 25 to 265 in the group assigned to buprenorphine treatment, and 30-260 in the group assigned to morphine oral solution, regarded as treatment as usual.

The design of this study was very strong, since it was doubly blinded, which means the providers caring for these infants didn’t know which were randomized to buprenorphine and which were randomized to morphine.

This double-blind approach is important in general, but especially important when dealing with the evaluation of babies in withdrawal. Sometimes nurses and other medical professionals who are evaluating withdrawal in babies have an emotional reactions. Some of these people can overestimate the degree of withdrawal, leading to longer hospitalization and over-medication.

If you are wondering “How do they get the babies to keep the medication under their tongue?” I wondered the same thing. The study explained that after getting a buprenorphine dose (or placebo, if their active drug was morphine solution), the babies were given a pacifier to extend the time the medication is in contact with the sublingual mucosa.

How clever. When my cat Yoshi was prescribed buprenorphine for urethritis, I had to dose him with buprenorphine, but there’s no way he kept it under his tongue. I thought some had to have gotten absorbed just from the oral mucosa. He definitely had a response to the medication, being opioid-naïve…he fell asleep, which gave him respite from frantic over-grooming of his urethra…

But I digress.

Anyway, this study showed buprenorphine significant decreased the duration of treatment for NAS, by an average of thirteen days, with no increase in adverse events, as compared to treatment as usual with morphine oral solution. The study authors postulate that the long half-life of buprenorphine levels the peaks and troughs seen with the shorter-acting morphine solution.

The study was limited by its small sample size. The authors wanted to get at least 40 subjects in each treatment arm, but had a hard time recruiting parents willing to enter their newborn into a treatment trial. They ended up with 30 patients in the buprenorphine treatment arm, and 28 in the morphine treatment as usual arm.

I can only imagine how hard it was to convince nervous mothers-to-be to enter their babies in this study. They were likely already worried about NAS in their infants, and perhaps feeling guilty about being pregnant while having the disease of opioid use disorder. Asking a mom – or dad – to then enroll in a study using a new medication (new for this use, at least) would be a hard sell.

Thankfully even with fewer test subjects than desired, the data still reached statistical significance. If future studies can replicate these outcomes, we will have a new medication with which to treat NAS, which will reduce the length of stay in the hospital for babies, reduce medical costs, and get these babies home sooner.

  1. Corr et al., “The Economic Burden of Neonatal Abstinence Syndrome in the United States,” Addiction, 6/13/17 http://onlinelibrary.wiley.com/doi/10.1111/add.13842/abstract