Archive for the ‘methadone’ Category

Reproductive Health of Women in North Carolina’s Opioid Treatment Programs

 

 

 

 

 

The November/December issue of the Journal of Addiction Medicine, (Volume 13, Number 6), published a great article based on a 2017 survey of opioid treatment programs in North Carolina. This study was done by the University of Chapel Hill, and the article was titled, “Provision of and Barriers to Integrating Reproductive and Sexual Health Services for Reproductive-age Women in Opioid Treatment Programs.”

Of course, since this data is from my state of North Carolina, I read it with extra interest.

The article reminds us of what we know about women with opioid use disorders: they are more vulnerable to reproductive health issues. These women tend to have more pregnancies, with about 54% having four or more lifetime pregnancies, compared to 14% of women without opioid use disorder having four or more lifetime pregnancies. About 85% of the pregnancies of women with opioid use disorder are unintended, compared to around 45% for women without opioid use disorder. Women with opioid use disorders are less likely to use contraception and about five times more likely to have had an abortion.

Opioid use disorder increases the risk of gender-based violence and increases the risk of infections, for Hepatitis C and B, HIV, and sexually transmitted diseases. Adverse childhood events, termed ACEs, include stressful or traumatic life events, and are associated with reproductive health problems. Women with ACE history are much more likely to develop substance use disorders in general, including opioid use disorder, so a large portion of women enrolled in treatment at OTPs have this additional mental health burden affecting reproductive health.

Since medication is recommended for all patients with opioid use disorder, the authors of the article say pregnant and nonpregnant women with opioid use disorders could get care for reproductive health services within the opioid treatment program. They suggest this would be a way to reduce unwanted pregnancies, opioid-exposed pregnancies, sexually transmitted infections, and improve the overall health of women in these treatment programs.

The article described a survey sent to the medical directors and program directors of all forty-eight opioid treatment programs in the state, in order to assess the extent of reproductive health services offered to reproductive-age women enrolled in NC OTPs, as well as to explore perceived barriers to integrating such services into the care provided at OTPs.

Of the forty-eight OTPs surveyed, thirty-eight completed the survey. Of the programs that responded, 37% were private nonprofit organizations and 63% were private for-profit organizations. Thirty-four percent were in rural counties, 29% located in urban areas and 37% in suburban areas.

Only 21% of the responding OTPs offered female-specific programs.

Most OTPs accepted Medicaid, at 68%, and those programs served more women of reproductive age than did the non-Medicaid programs, which makes sense. The average length of treatment was longer for women in Medicaid program compared to non-Medicaid programs.

Twenty-one percent of OTPs offered non-prescription contraception, while only one program offered prescription contraception.

Only 89% of OTPs did on-site pregnancy tests, meaning 11% are not performing this simple and necessary test for patients.

To summarize this study, the OTPs of NC aren’t doing all they could to address female patient’s reproductive and sexual health issues.

I agree with this finding, and yet, I was a bit offended with the accompanying commentary in this issue of Journal of Addiction Medicine. Dr. Tricia Wright says that OTPs believe it’s outside the scope of their service to provide reproductive and sexual health services, and that this view is “dangerous and wrong.” She says such care is basic care and OTPs can and should do better for their female patients.

Now you’ve stepped on my toes and I’m going to have to step back.

I agree that more services should be provided, including female sexual and reproductive health. After all, as the article’s authors concluded, such efforts have the potential for great good. Increasing reproductive health of our female patients promotes health of children and families, and ultimately, society.

However, as this survey or providers discusses, there are obstacles to providing such services.

First, OTPs care for people with other equally important challenges. Our patients struggle with homelessness, lack of food, serious mental and physical health issues, all of which need addressed. Our resources are limited, both of time and money.

For example, a new patient injecting heroin might be homeless, with no way to afford food, and have serious mental health issues. Such a sick patient needs inpatient care which usually is not available. For example, our state-run program refused to admit a homeless diabetic because her blood sugars weren’t under control. They refused to admit an HIV positive patient because she wasn’t on proper medication for her HIV. Of course, with substance use disorders raging out of control, those goals weren’t realistic.

Our OTP takes care of many such challenging patients as best we can, because usually it’s their only option for care. Ultimately, we do hope to get them care for their other issues, in the form of referrals, because we don’t have the time or personnel to provide those services.

Second, OTPs may not have personnel with the expertise to manage reproductive health needs

I am trained in Internal Medicine. This means I could manage some simple primary care and even some uncomplicated gynecologic and mental health care for OTP patients. But my time is spent providing medication-assisted treatment to those patients. I would have to work additional hours if we provided primary care, probably at least double the hours that I now work. I would need a way to care for those patients for after-hours emergencies. I don’t work for free, and neither do the nurses. The company I work for would have to pay for this expense. They could bill Medicaid, but at least half our patients don’t have any insurance at all. Most uninsured patients get their OTP treatment paid for with grant money, but that doesn’t cover primary care services.

Many OTPs have a psychiatrist as a medical director. They could address mental health needs, but probably wouldn’t be comfortable doing and primary care, and certainly not reproductive health.

In order to meet even some of the reproductive and sexual health needs of just the female patients (ignoring male patients completely for some reason), additional providers would have to be hired. Who pays for that?

It makes more sense to me to have providers come to our OTP to provide essential services under one roof. One day could be for obstetric/gynecologic care. A local OB could come to our facility and see patients all day. Another day could be for a psychiatrist to come and treat patients, and maybe two days for primary care providers to see our OTP patients. It’s an ideal solution, except for finding willing providers, and a way to pay them.

Don’t even get me started on our patients’ dental care needs. We could hire a full-time dentist and keep her busy with only our opioid treatment program patients. But again, who would pay?

I get weary of unfunded mandates and recommendations for opioid treatment programs. I feel like much is expected of providers at opioid treatment programs, mainly because no other providers want to treat these patients.

Our patients often get superficial and substandard treatment from the local emergency department and local providers’ offices due to the stigma against people with substance use disorders in general. Part of this could be because some of our patients offend providers with their desperation and neediness. Patients enrolled at “that methadone clinic” face extra judgment from some providers, making it more difficult for our patients to access appropriate medical treatment.

It’s not feasible for OTPs to provide all the services that patients need, and certainly not fair to expect OTPs to provide this care for free because other providers don’t want to deal with our patients.

OTPs have and will pick up what pieces we can, but maybe it’s not fair to ask OTP providers to fix a broken healthcare system.

Opioid Use Disorder: Then and Now

 

 

 

 

I started working at an opioid treatment program in 2001, by accident. It’s a long story that I’ve told elsewhere, but once I saw data about the improvements for patients who start medications to treat opioid use disorder, I knew this was the field for me.

After a few weeks working in an opioid treatment program (OTP), I could help patients make huge and productive changes to their lives. Prescribing medications to treat opioid use disorder can have tremendous impact on the lives of people with this illness. Medications like methadone and buprenorphine reduce the risk of dying from an overdose at least three-fold, according to a recent study. [1] Methadone and buprenorphine used for opioid use disorders are also associated with improvements in physical and mental health, reduced risk of suicide, improvement in employment status, reduction in criminal activities, and increased life satisfaction for patients.

I started as a physician at a not-for-profit program in a southern city. I saw mostly patients using heroin, but also pain pills. We had patients drive from hours from more rural areas, and eventually this program expanded into seven additional programs, mostly located in the western part of the state.

By 2004, on Wednesdays I worked at a town of around 40,000 people. I saw patients who drove an hour or more for help. Some patients drove several hours from Tennessee. At this time, methadone was the only medication this OTP used. DATA 2000 had passed, and a few Suboxone providers prescribed in cities, but buprenorphine products weren’t widely available in smaller towns and rural areas.

Wednesdays were busy. We had dozens of people show up seeking admission, but because I was the only physician, I asked that we admit no more than 20 people per day. My requests were not honored, and I worked many long days, admitting up to 25 to 30 people on these days.

These were complicated patients, and it took time to unravel their medical, psychiatric, and drug use histories. We had limited staff, who already had more than fifty patients on their caseload. This exceeded state limits on the number of patients assigned per counselor and kept us under scrutiny by state authorities. It felt like the wild west.

I knew it wasn’t safe to admit so many people, but what was the alternative? There were no other opioid treatment programs around. That small city had one or two inpatient detoxification units, but as we know, the relapse rate is very high, as is the overdose death risk, for patients leaving these five -to -seven-day programs. Inpatient residential programs were difficult to access and weren’t acceptable to most patients anyway. If these patients didn’t get help with us, they probably couldn’t get any help. So, I worked long hours and did my best.

I felt a continued tension between trying to get people into treatment and taking good care of them once they were in treatment.

These people did not get the attention they deserved, but I’m comforted by data from “low threshold” methadone programs. These are programs that don’t require that patients participate in counseling services, and that don’t dismiss patients for positive drug screens. Data shows that patients entered in these programs do relatively well, despite receiving treatment that lacks the usual counseling requirements. [2]

That Wednesday waiting room was packed with urgency and misery. Imagine twenty or thirty people, in various stages of opioid withdrawal, impatient to see the doctor and get a dose of methadone that will help ease their suffering. I hated making people wait, but had to spend enough time with each of these complicated patients. Hiring additional physicians or physician extenders would have helped, but this program had a hard time keeping providers.

Almost all these patients were using OxyContin brand of pain pills. Patients described how easy it was to file off the time-release coating from “oxys,” as they were called, freeing the entire 20mg, 40mg, 80mg, (and for a time, 160mg) pill to be used at once. Most patients crushed the pill and either snorted it or injected it. Apparently, it easily dissolved in water, making it easy to shoot.

That’s a lot of opioid firepower to release all at once, and misused OxyContin killed many people. Sometimes people, not aware of how harmful this medication could be, thought that since it was prescription medication, it couldn’t hurt them.

Patients couldn’t be expected to know what their doctors didn’t even know. OxyContin was prescribed freely in most communities at this time. Some of it was prescribed by pain management physicians, but mostly it was prescribed by small-town physicians with little training in pain management. These physicians had been told by the so-called pain management experts that the risk of developing addiction was low, less than 1%. How wrong they were…

Our opioid treatment program never advertised services. We didn’t need to. Patients showed up because they were referred by friends or relatives. We had whole families in treatment. We might admit a husband and wife one week, only to admit their adult children the next week, plus cousins, an uncle, or a grandparent. Sometimes we would have three generations of a family in treatment.

Whole neighborhoods seemed to come for help. Addiction appeared to be part of the social fabric of the region, binding people together like a fondness for playing cards or baseball.

I remember in 2004, I admitted so many people from Gray, Tennessee, that I asked the rhetorical question, “What is going on in Gray, Tennessee? It looks like everyone in that town must have opioid use disorder.” As it turns out, the first opioid treatment program in Eastern Tennessee was opened in Gray, Tennessee…in 2017.

Benzodiazepines were freely prescribed back then, and we had patients overdose and die while on methadone. I struggled then, as now, trying to decide if a patient using benzodiazepines heavily can safely be admitted to treatmen. Current recommendations say we shouldn’t limit access to methadone and buprenorphine for patients with co-occurring benzodiazepine use disorder, but I’ve had such patients die, and remain wary. Each patient’s risk must be carefully assessed. If patients have taken benzodiazepines regularly for years, a taper could take weeks or months, and sometimes can be done in an outpatient setting, while the patient is getting treatment with medications for opioid use disorder. Other patients can’t control their use of benzodiazepines in an outpatient setting and must be admitted to an inpatient medical detox unit. They must be monitored carefully while reducing or stopping benzodiazepines. Patients can have seizures during withdrawal, just like patients withdrawing from alcohol

Back in 2004, we didn’t have a prescription monitoring program in North Carolina. Our program didn’t become functional until 2007. By then, I was medical director for this program that had around 3100 patients scattered over their eight opioid treatment programs. In December of 2007, when I got authorized to use our PMP, I spent most nights and weekends looking at patients on the system. In the end, around twenty-three percent of all our patients were filling another major controlled substance. Those medications varied from methadone, OxyContin, Xanax, and clonazepam.

I was asked to submit a narrative of my experience to Brandeis’ Center of Excellence. This narrative was later sent to OTP prescribers in a SAMHSA “Dear Colleague” letter and can be read here: https://www.pdmpassist.org/pdf/Resources/methadone_treatment_nff_%203_2_11.pdf

Once we could see what other medications patients were taking, our overdose death rates came down rapidly. I will always believe PMPs are life-saving.

Now I check all entering patients on our state’s prescription monitoring program and check all established patients once per quarter. I don’t get very many surprises these days on the PMP.

Compared to 2004, patients have more options for treatment for opioid use disorders. Still, financial barriers are considerable, especially in office-based setting prescribing buprenorphine products, and far too few people who need treatment can get it.

Many more OTPs in this state now take Medicaid, helping more patients get treatment. We also have grant programs for patients with no Medicaid or other insurance, funded through the CURES program in the past, and now by the state opioid response grants. Most new patients can get started in treatment even if they have no money, thanks to these grants.

Our OTP was lucky to be asked to participate in a MAT PDOA grant. I forget what the initials stands for, but this grant pays for treatment for patients on probation or parole who have opioid use disorder. This grant, which lasted three years, is ending soon, and we’ve treated hundreds of patients with it. For many, it was their first treatment experience. Some did very well, and some not so well, but the recovery seed has been planted. Some patients need a few tries at treatment before they get traction into recovery.

In the OTP where I work now, I have tons more contact with established patients and know them much better than I did at the OTP where I worked in 2004. There’s still much room for improvement, but today I do more than just admit patients. I also have time to talk with the staff, which I think helps all of us understand our patients better and provide better care.

Now, almost no patient mentions the brand name OxyContin. Some patients are using oxycodone, but not one brand. There’s still some Opana use, and certainly heroin is used by many entering patients. Some patients come for help because they prefer using illicit buprenorphine over heroin or other opioids, because buprenorphine can keep them out of withdrawal for a day or longer. Instead of paying $30 for one 8-milligram tablet on the street, they come to treatment programs to get cheaper, legal help. Most, though not all, patients are also happy they receive counseling.

I’ve change since 2004. I’m much more tolerant of continued drug use by patients. I cringe to remember that in the past, I tapered patients off medications to treat opioid use disorder because they wouldn’t stop using marijuana. I don’t do that now. I tell patients that though I’m not happy about their use of an illicit (in my state) drug, it’s not a deal-breaker for treatment. I still stress over patients’ use of benzodiazepines and alcohol, especially if they are on methadone.

Things change quickly in this field, and our OTP may look very different in the future than it does now. I pray that we continue to improve the quality of care for our patients and continue to reach ever more of the people who need help. I love my job, and after eighteen years, still believe I can do more to help people in one day at my OTP than I did in a week doing primary care.

  1. Sordo et al., “Mortality risk during and after opioid substitution treatment: systematic review and meta-analysis of cohort studies,” British Medical Journal, 2017.
  2. Christie et al., 2013

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.

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.

 

 

 

Methadone Overdose Deaths: First Two Weeks

Methadone

 

Methadone is a tricky drug to start, due to the narrow margin between therapeutic dose and fatal dose. Making it more difficult, people vary a great deal in the rate at which they metabolize methadone.  Some people have a methadone half -life as short as 15 hours, while others have half- lives as long as 60hours. The average is 22 hours. So even for people with a high tolerance to other opioids, increasing methadone too quickly can be deadly.

Methadone’s long half-life makes it good for a maintenance medication, since after stabilization, there’s not much fluctuation in the blood levels. However, the long half-life makes it more difficult to adjust the dose. The change I make in a patient’s dose today may not be fully experienced by the patient for five or more days.

The tolerance to the anti-pain effect of methadone builds faster than the tolerance to respiratory suppression, adding to the danger. When methadone is used inappropriately, patients may take more methadone to relieve pain, but by the time the pain is gone, they could easily have taken a methadone overdose.

All of this explains why the first two weeks of methadone maintenance treatment are the most dangerous. According to some studies, death rates for patients starting methadone at opioid treatment programs are actually higher during the first two weeks than when using illicit opioids. (1, 2)

Even so, it’s a risk worth taking, given the proven life-saving benefits of methadone (and buprenorphine) maintenance

Patient overdose during the first two weeks is a serious concern for doctors working at opioid treatment programs. We must do all we can to keep patients safe. It’s a fine line; if we start at too low of a dose or go up too slowly, we risk having our patients drop out of treatment. And if we increase the dose too quickly, it increases the risk of overdose…

The American Society of Addiction Medicine (ASAM) recently updated their methadone induction guidelines. In past years, doctors working at opioid treatment programs (OTPs) tended to start patients at 30-40mg and increase the dose rather quickly. Now, the expert ASAM panel recommends a starting dose of 10-30mg. If that dose isn’t sufficient to suppress withdrawal, a second dose can be given after three hours, so long as the total dose is not greater than 40mg. The expert panel recommends increasing the dose no more quickly than every five days, and no more than five milligrams at a time.

Some patients are more susceptible to overdose, and physicians should consider lower methadone starting doses for these people:

-Age over 60

-Using sedating drugs like benzodiazepines

-Regularly consume alcohol

-Are on prescription medications which can interact with methadone

-Medically fragile patients, for example patients with coronary artery disease, morbid obesity, -chronic obstructive pulmonary disease (COPD), or sleep apnea

-Have risk factors for prolonged QT interval, such as a recent heart attack, personal history of heart rhythm problems, or family history of heart disease

-Patients who have been abstinent from opioids for five or more days (e.g. recent incarceration, recent detoxification or hospitalization). These patients lose some of their tolerance and might be more prone to overdose with any opioid.

 

Interestingly, the degree of withdrawal that the patient has when entering treatment does not correlate with the dose of methadone they will need to get rid of withdrawal symptoms. In other words, one person in terrible withdrawal may need a smaller dose than another person with milder withdrawal. The degree of withdrawal that a patient feels is only partly due to opioid tolerance. Genetic makeup may be the reason why some people have more severe withdrawal than other people.

While I always ask my new patients how much opioid they have been using per day, that alone doesn’t determine methadone starting doses. There’s incomplete cross-tolerance between other opioids and methadone, meaning we can’t use the table of equianalgesic doses.

Last week I found an interesting article describing a large study of Canadian methadone patients, which will contribute even more to what we already know about risk during the first two weeks of methadone. This study showed which patient characteristics are associated with overdose death.

The study was done in Canada from 1994 until 2010, and covered over 43,000 patients enrolled in an opioid treatment program in those years. The study looked at all overdose deaths in this patient population and found 175 deaths deemed to be from opioids. These cases were matched with patients who entered treatment around the same time as the patient who died, creating a nested case-control study.

This study found, as expected, a higher degree of risk in the first few weeks on treatment. In this study, patients in the first two weeks of treatment were 16 times more likely to die in the first two weeks of treatment than any other time in treatment.

Psychotropic drugs were associated with a two-fold risk of overdose death overall, with antipsychotics associated with a 2.3-fold risk and benzodiazepines a 1.6-fold increased risk. Antidepressants were not associated with increased risk of overdose death. Alcohol use disorder diagnosis was also associated with a two-fold increase risk of overdose death.

Even more interesting, heart disease was associated with over five times increased risk of overdose death, and serious lung disorders (sleep apnea, COPD) were associated with a 1.7 times increase in overdose death.

This is a powerful study because it was so large.

This is information I can use. I’ve been stressing about patients whom I thought were at increased risk – those who use alcohol and benzodiazepines, and those with severe lung disease. While these patients are at higher risk, from this study it appears patients on anti-psychotics are at even higher risk. And I need to do a better job of getting patients to see primary care doctors, to screen for heart disease, which gave the highest risk of all.

As time goes on, I think we’ll get more information about which patients are at higher risk. Those patients need a higher degree of interaction with treatment center staff, and better coordination of care with mental health providers and primary care doctors. I know I plan to implement a system at the OTP where I work to make sure I see patients more often if they have the risk factors described.

Obviously any patient death is a terrible thing. Of course it’s worst for the family, but it also affects the treatment team. I feel badly for the families of those 175 patients in the Canadian study who died, but they gave us information that can hopefully help us provide better care for future patients.

 

  1. Caplehorn et al, “Mortality Associated with New South Wales Methadone Programs in 1994: Lives Lost and Saved,” Medical Journal of Australia, 1999 Feb 1;170(3):104-109
  2. Cousins et al, “Risks of drug-related mortality during periods of transition in methadone maintenance treatment: A cohort study,” Journal of Substance Abuse Treatment, October 2011, Vol 41(3); pp252-260.
  3. Leece et al, “Predictors of opioid-related death during methadone therapy,” Journal of Substance Abuse Treatment, Oct 2015,

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

addiction cartoon

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

I enthusiastically support medication-assisted treatment (MAT) of opioid addiction, but no treatment works for everyone. MAT doesn’t work for every opioid addict. Here are some reasons a patient may not be suitable for MAT:

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

One patient accused me of discriminating against her because of the type of drug she used. I said yes, but only because methadone doesn’t treat cocaine addiction. (I tried to refer her for more appropriate treatment.)

2. The patient takes opioids for pain, but has never developed the disease of addiction.
Such a patient may be physically dependent, but lacks the hallmark indicators of addiction, such as misuse of medication, obsession and compulsion regarding opioids.

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

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

Opioid treatment programs aren’t intended to treat chronic pain, but if a patient with both addiction and chronic pain finds methadone also helps with pain, it’s a nice benefit. Many of these patients do find they have less pain once they’re out of the miserable cycle of intoxication and withdrawal. So less pain is a happy side effect of addiction treatment.

3. The opioid addict presenting for treatment has been physically dependent for less than one year.
Methadone is difficult to get off of, and federal and state regulations say it cannot be prescribed for opioid addicts with less than one year of addiction (daily use or near daily use). This is a somewhat arbitrary cut off, and the OTP physician can ask for an exception to this regulation if needed. Even if the OTP wants to treat the patient with buprenorphine (Suboxone), which is usually much easier to taper off of than methadone, permission must be sought from state and federal authorities before enrolling a patient who has used opioids less than one year.

If buprenorphine is prescribed in the office setting, the prescribing physician can use her best judgment about who is appropriate for treatment, without needing government approval.

4. The opioid addict has the ability to go to a prolonged inpatient residential treatment program for his addiction.
This is controversial, because some doctors think medication-assisted treatment should be given to everyone because of its success rate compared to abstinence-only treatments.

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

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

If only everyone could get that kind of treatment!

If this kind of treatment is available to the addict…take advantage of it. But most opioid addicts can’t access this kind of treatment, with post-treatment accountability. Insurance companies might pay for a one-week stay in detox, which won’t help. Even if the addict gets a few weeks of inpatient treatment, it’s usually not enough. What I’m talking about is months of quality inpatient treatment.

5. An opioid addict who is also physically addicted to alcohol, benzodiazepines or other sedatives. These drugs can be deadly when mixed with methadone or buprenorphine. I prefer such patients enter a medical detox unit to get off these sedatives prior to entering treatment in an OTP.

Of course this is a complex issue, and there may be times when starting methadone or buprenorphine can be done, perhaps keeping the patient at a relatively low dose, while the patient undergoes a gradual taper from benzos. The OTP physician should be free to use her best judgment about how to treat these complex and high-risk patients.

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

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

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

8. The patient has serious co-existing physical health problems.
Actually, I can’t think of any physical health problem that would make the treatment of opioid addiction with methadone riskier to the patient than untreated opioid addiction. We know for sure that untreated opioid addiction produces high risk of death and disability.

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

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

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

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

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

Both medications give the opioid addict time to regain physical and mental health. Once on a stable dose, the recovering addict can make changes in his life, with the help of counselors and other OTP workers. The addict can get back to work, stop a life of crime, form better relationships with his family and himself, and recover a better quality of life.

Will that addict ever do well off methadone? There’s no way to be sure about this. Some patients can taper off methadone, as long as they address all of their issues prior to the taper, and if they bring the dose down slowly enough that they don’t feel intolerable withdrawal. Some, perhaps most, recovering addicts find they will do better if they stay on methadone.

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

So if a patient seeks to enter methadone treatment but also expresses a desire to be off buprenorphine or methadone within weeks to months, I tell them their expectations aren’t realistic. These medications don’t work like that. If the patient wants to get off all medications quickly, they need referral to an inpatient program. This way, patients can’t later say they were mislead, and they feel like they have liquid handcuffs, chained forever to methadone, with its many regulations for treatment.

News From the World of Addiction Medicine Research

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The latest issue of the Journal of Addiction Medicine, Vol. 7 (2) March/April 2013 had several interesting articles relating to opioid addiction and its treatment. Here’s my quick summary and thoughts on one of them, “Promethazine Misuse among Methadone Maintenance Patients and Community-Based Injection Drug Users,” by Brad Shapiro et al, pp. 96-1001.

This study attempted to get an idea of the prevalence of promethazine (better known under its brand name Phenergan) use in opioid addicts both in and out of treatment.

I was interested in this article because I’ve had methadone patients misuse promethazine. Most of these patients say that Phenergan gives them sedation with methadone, but most say it’s not a true euphoria, so I’m puzzled as to why they mix the two. Since promethazine can be sedating in many people, obviously I worry about overdose deaths when it’s mixed with methadone.

The authors of this study tested for promethazine in the patients enrolled in a county hospital methadone clinic in San Francisco. Twenty-six percent were positive for promethazine and only 15% had a prescription for this medication. Also, promethazine use was associated with benzodiazepine use.

The authors then recruited two hundred intravenous drug users, and discovered that only 139 were opioid addicts. Of those 139 addicts, seventeen percent reported promethazine use in the past month. However, of the addicts who had been on methadone in the past, twenty-four percent reported promethazine use in the past month.

What does this study tell us? The authors’ conclusion was that promethazine needs to be investigated further as a drug of abuse in opioid addicts.

Well, yeah.

My clinical experience gave me some thoughts about the study. For one thing, pregnant addicts were excluded. But in my experience, pregnant patients are the ones most likely to be prescribed Phenergan because of morning sickness during pregnancy. And this study doesn’t tell us much about the overdose risk when methadone and Phenergan are combined. Early in their article, they do provide some data: In Kentucky, over 14% of decedents from methadone toxicity overdose deaths also had promethazine present in their system. In Seattle, 2.5% of fatal overdoses had promethazine present.

Promethazine, along with many other medications, prolongs the QT interval just like methadone does. I haven’t seen any studies of methadone patients comparing QT intervals before and after promethazine, which may be helpful to further assess risk.