Archive for the ‘Should I taper?’ Category

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.

 

 

 

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Barring Healthcare Professionals from Working while on Buprenorphine

While buprenorphine has been prescribed for many patients over the last 10 years, there’s still controversy about whether healthcare professionals should be allowed to work while on buprenorphine.

In an article in March 2012 Mayo Clinic Proceedings, Hamza and Bryson  cite studies that support their conclusion that medical professionals should not be allowed to work while taking buprenorphine as maintenance for opioid addiction. The authors say studies show that people taking buprenorphine have some impairment when performing safety-sensitive tasks that are required in practice as a physician. (1)

I read this article with great interest, since I have been prescribing buprenorphine and telling my patients they won’t be impaired while taking a maintenance dose. Wanting to know if I am misleading patients, I scrutinized the studies cited in this paper.

I’m not sure the authors’ conclusions are backed up by the studies they cite.

The most worrisome misinterpretation was the Schindler et al study. The Mayo study by Hamza and Bryson interpreted the Schindler study thusly: “significant differences were found between them [methadone and buprenorphine groups] and the controls.” But when I read the original study, the authors’ conclusion was really the opposite: “The synthetic opioid-maintained subjects investigated in the current study did not differ significantly in comparison to healthy controls…” (2)

Hmmm…I’m confused.

When I looked at other articles cited by Hamza and Bryson, I discovered that what I read didn’t match Hamza and Bryson’s conclusions of what I read.

Three of the studies cited in the Mayo article (Pickworth et.al., Jensen et. al., and Zacny et.al.) all looked at healthy volunteers who were given buprenorphine, then tested to see if they were impaired. In other words, these test subjects weren’t opioid dependent. All three studies showed impairment, and I don’t doubt it, because opioid-naïve subjects would be expected to feel a great deal of opioid effect with their first dose of buprenorphine. But studies of opioids-naïve subjects given buprenorphine don’t seem applicable to opioid-addicted patients on buprenorphine for maintenance.

The Rapeli et al study looked at methadone and buprenorphine patients in early recovery, so these groups would be expected to be different than those on established maintenance therapy.

Soyka et al compared opioid addicts on buprenorphine and methadone at 2 weeks, then at 8-10 weeks. This study also had a control group. The patients on methadone and buprenorphine had impaired cognition on testing compared to the controls, but they improved with length in treatment. This study was randomized but not blinded. This means patients and researchers knew who was on methadone, buprenorphine, and who was a control subject. Interestingly, in a later letter to the editor defending their conclusions, Hamza and Bryson mistakenly claimed the study was double-blinded, but clearly it was not.  Also the study was relatively small, since only 46 patients completed the study. The purpose of the study was to see if methadone was more impairing than buprenorphine. The authors of the Soyka study didn’t conclude the buprenorphine group was impaired to the point they were unable to work, only that they performed better than methadone patients.

One study, by Messinis et al, did compare abstinent heroin addicts on naltrexone with opioid addicts on maintenance buprenorphine, and showed the buprenorphine group had more cognitive impairment than the naltrexone group in cognitive functions. To me, this is the main study that speaks to the actual issue of impairment. It gives a basis to require more studies be done. However, the small size of the study, 18 patients, limits the impact of this study. (3)

The ideal study to resolve this issue would be a double blinded prospective study of opioid-addicted healthcare professionals who are randomized either to abstinence-base treatment or buprenorphine maintenance treatment. Then cognitive abilities can be compared at various times during recovery, like 3 months, 6 months, 1 years, and 2 years. Such a test is unlikely to be done, since most addicted professionals enter abstinence-based recovery, and have a high rate of success.

I do think medication-free recovery is the ideal. I acknowledge that’s my bias, even though I strongly believe medication-assisted treatment is a life-saving option. But then, medication-free treatment is the ideal for all diseases. If a patient can achieve good blood pressure control by changing her diet and exercise, I think most of us would agree that’s a superior outcome to taking blood pressure medication to achieve the same result.

Most doctors and dentists have the resources to afford the prolonged inpatient treatment needed for medication-free recovery. The monitoring required for continued licensure is additional leverage and accountability that most opioid addicts don’t have after leaving inpatient treatment. These factors produce excellent recovery rates in these healthcare professionals, much better than that achieved by the average opioid addict.

But no recovery works for everyone. If a healthcare professional has failed traditional abstinence-based recovery, but is able to do well on medication-assisted recovery with buprenorphine, is the data strong enough to say such a recovering person on a stable dose of buprenorphine can’t work in healthcare?

We must be careful about this decision. If the decision is going to be based solely on patient safety, and not on a bias against medication-assisted recovery, then healthcare professionals on opioids for acute or chronic pain must also logically be removed from the workforce, unless we can prove they don’t have cognitive deficits from prescribed opioids. And what of other medications, like benzodiazepines, which are more likely than opioids to cause impairment?

If professional monitoring boards rely on the evidence cited by this study to refuse to allow healthcare professionals on buprenorphine to return to work, they leave themselves open to accusations inconsistent safety standards if they allow other healthcare professionals to work while being prescribed opioids or benzodiazepines.

It would be a mammoth task to monitor every healthcare professional who is prescribed a controlled substance. But if a professional on stable a dose of buprenorphine can’t work safely, how can we assume a surgeon who takes legitimately prescribed opioids for back pain is safe to work?

Frankly I suspect most of the posturing about the dangers of healthcare workers on buprenorphine is really an attempt to remove medication-assisted recovery as a treatment option for healthcare professionals. I don’t know if the mayo article authors, Hamza and Bryson, have any underlying bias against medication-assisted treatments, or perhaps biases favoring abstinence as the only worthy treatment goal. I don’t know these two people at all. But my impression is that they have taken a sweeping position supported by shaky evidence. The studies they cite are evidence enough to call for larger studies, but don’t seem adequate in themselves to deny a potentially life-saving treatment to a healthcare professional.

  1. Hamza H, and Bryson E, “Buprenorphine Maintenance Therapy in Opioid-Addicted Health Care Professionals Returning to Clinical Practice: A Hidden Controversy, Mayo Clinic Proceedings., 2012, 87(3);260-267
  2. Schindler SD, et al, “Maintenance therapy with synthetic opioids and driving aptitude, European Addiction Research, 2004; 10(2):80-87acol.
  3. Messinis et al, “Neuropsychological functioning in buprenorphine maintained patients versus abstinent heroin abusers on naltrexone hydrochloride therapy”. Hum. Psycholpharm. 2009;24(7):524-531

To Taper Methadone or Not To Taper? That Is the Question

Most of the patients I see who are doing well on methadone want to taper off of it at some point. Should these patients come off of methadone?

The studies show that relapse rates – and death rates – for patients who taper off methadone (and buprenorphine) are higher than for those who stay on methadone. We must remember that this is a potentially fatal illness, and the reasons for wanting to taper need to be compelling before tapering a successful patient off maintenance medication. (1, 2, 3, 4, 5, 6)

However, if you read these studies, they were done with heroin addicts, not pain pill addicts. Even though the opioid effect on the human body is the same, there may be differences between pill users and heroin users. It’s possible pain pill addicts have better rates of relapse-free recovery after tapering off methadone (or buprenorphine). We’re waiting for more information from studies with pain pill addicts that are underway.

Also, the referenced studies weren’t done with patients who were necessarily doing great in treatment. They compared patients who left treatment with those retained in treatment. There are many reasons to leave treatment, and a desire to taper and be drug-free is only one reason. Patients with strong desires to be completely clean may have different outcomes than patient who left treatment because they wanted to get high, or because they were discharged from treatment for violent behavior.

The desires of the patient are paramount. Methadone treatment can be expense and inconvenient, and unfortunately there’s still a stigma attached to it, even after four decades of proven benefit to patients.  Plus, for any chronic medical condition (diabetes, hypertension) most of us prefer treatment without medications, if possible. If a patient says they want to taper, we must respect patient autonomy and begin a taper. Treatment centers can’t refuse a patient’s request to taper their dose. As the prescribing doctor to patients on methadone, I can give them my opinion of their readiness to taper, based on my knowledge and experience, but the patient makes the final decision.

I’ve seen many patients taper off methadone and Suboxone successfully. As far as I know they are still doing well. A few patients call periodically to let me know they are doing well, but for the most part, I haven’t heard from them.

 I do often see patients who have relapses after tapering, because fortunately they return to treatment, rather than remain in active addiction. Then we can look at what went wrong, and learn from the experience, since they were lucky they didn’t die in the relapse.

 I see differences between the patients who are successful and the ones who relapse. Overall, successful patients have done the work of recovery before they taper. In my next set of blog entries, I’ll elaborate on what I think must be done by the patient prior to considering tapering off maintenance medication. These include:

  • No longer using any illicit drugs, and no misuse of prescription drugs
  • Patients has acquired skills to manage negative emotions without the use of drugs (I’m not counting anti-depressants and non-addicting anti-anxiety medications)
  • Patient has had extensive counseling around all issues that could ambush the patient in recovery.
  • No ongoing physical health issues that cause pain or can be relapse triggers.
  • No untreated mental health illness.
  • No ongoing ties with drug -using buddies (or family members).
  • Stable home and work environments, free from drug use.
  • Have a plan of how to handle an acute painful medical situation so that relapse risk is minimized.
  • Taper during a time that’s relatively free from emotional turmoil.
  • Don’t rush the taper.
  • Rehearse medication refusal for when the patient encounters a prior drug connection (it will happen, usually at the gas station, for some reason).
  • I really encourage patients to be established in some sort of 12-step support group.

I know that last one is unpopular, and we’ll get to that in a future blog.

For the rest of this blog, let’s talk about why it’s so important for the patient to have stopped the use of all addicting drugs. The bottom line is that it increases the use of relapse back to opioid use, probably for several reasons.

First of all, there’s a kindling effect in the pleasure centers of the brain. When one pleasure-producing chemical or activity is undertaken, the desire for other pleasure-producing drugs or activities increases. For example, some people smoke more when they drink alcohol, because the two seem to go together. Another example is that of smoking after sex, or smoking after a pleasurable meal. While these examples include pleasures other than drugs, it illustrates what I’m trying to say.

Second of all, use of an addicting chemical often impairs our judgment. If a recovering opioid addict drinks alcohol, he’s likely to make poor decisions about other drug use. We don’t do our best thinking under the influence of alcohol, even a small amount. Alcohol can make nonsense seem reasonable (“I can take just one pill. I’ve been clean for so long, it won’t bother me”). Plus, an opioid addict is at very high risk to drink alcohol in an addictive and harmful way. Sadly I’ve seen too many people in recovery from opioid addiction end up dying from alcoholic liver cirrhosis.

Thirdly, for illegal drugs like marijuana, if you have to buy it from someone, that person is likely to have other drugs available for your use, like opioids. Apparently, many drug dealers have diversified their product lines.

Patients often try to argue with me, saying marijuana should be an exception. They claim they should be able to keep using it, because it doesn’t cause harm to the body, it’s natural, and therefore OK to keep using once off methadone. They’re missing the point. There’s no way I would argue the physical harm of marijuana, because I’d lose credibility. It’s much less toxic to the body than alcohol, which is legal. And yes, it is natural… but so are opium, cocaine, non-distilled alcohol, and hemlock. Natural doesn’t mean harmless.

Many people can use marijuana and not be addicted to it, but after a person develops addiction, it changes everything. It doesn’t matter if it’s legal/illegal, natural/man- made, harmful/harmless. It only matters if it stimulates the pleasure center of the brain, and marijuana does do that.

In my next blog entry, I’ll talk about the importance of having coping skills to deal with life’s ups and downs before tapering off maintenance medications.

  1. Caplehorn JR, Dalton MS, et. al., Methadone maintenance and addicts’ risk of fatal heroin overdose. Substance Use and Misuse, 1996 Jan, 31(2):177-196. In this study of heroin addicts, the addicts in methadone treatment were one-quarter as likely to die by heroin overdose or suicide. This study followed two hundred and ninety-six methadone heroin addicts for more than fifteen years.
  2. Clausen T, Waal H, Thoresen M, Gossop M; Mortality among opiate users: opioid maintenance therapy, age and causes of death. Addiction 2009; 104(8) 1356-62. This study looked at the causes of death for opioid addicts admitted to opioid maintenance therapy in Norway from 1997-2003. The authors found high rates of overdose deaths both prior to admission and after leaving treatment. Older patients retained in treatment died from medical reasons, other than overdose.
  3.  Goldstein A, Herrera J, Heroin addicts and methadone treatment in Albuquerque: a year follow-up. Drug and Alcohol Dependence 1995 Dec; 40 (2): p. 139-150. A group of heroin addicts were followed over twenty years. One-third died within that time, and of the survivors, 48% were on a methadone maintenance program. The author concluded that heroin addiction is a chronic disease with a high fatality rate, and methadone maintenance offered a significant benefit.
  4. Gronbladh L, Ohlund LS, Gunne LM, Mortality in heroin addiction: Impact of methadone treatment, Acta Psychiatrica Scandinavica Volume 82 (3) p. 223-227. Treatment of heroin addicts with methadone maintenance resulted in a significant drop in mortality, compared to untreated heroin addicts. Untreated addicts had a death rate 63 times expected for their age and gender; heroin addicts maintained on methadone had a death rate of 8 times expected, and most of that mortality was from diseases acquired prior to treatment with methadone.
  5. Scherbaum N, Specka M, et.al., Does maintenance treatment reduce the mortality rate of opioid addicts? Fortschr Neurol Psychiatr, 2002, 70(9):455-461. Opioid addicts in continuous treatment with methadone had a much lower mortality rate (1.6% per year) than opioid addicts who left treatment (8.1% per year).
  6. Zanis D, Woody G; One-year mortality rates following methadone treatment discharge. Drug and Alcohol Dependence, 1998: vol.52 (3) 257-260. Five hundred and seven patients in a methadone maintenance program were followed for one year. In that time, 110 patients were discharged and were not in treatment anywhere. Of these patients, 8.2% were dead, mostly from heroin overdose. Of the patients retained in treatment, only 1% died. The authors conclude that even if patients enrolled in methadone maintenance treatment have a less-than-desired response to treatment, given the high death rate for heroin addicts not in treatment, these addicts should not be kicked out of the methadone clinic.