Posts Tagged ‘SAMHSA’

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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National Prescription Drug Action Plan

Yesterday, government officials proclaimed the formation of collaborative plan to address this nation’s problem with prescription opioid abuse and addiction. Speakers included Mr. Gil Kerlikowske, the director of the ONDCP (Office of National Drug Control Policy), Dr. Howard Koh, from the department of Health and Human Services (DHHS), Dr. Margaret Hamburg from the Food and Drug Administration ( FDA), and Ms. Michele Leonhart, administrator of the Drug Enforcement Administration (DEA).

 Speakers recited pertinent statistics regarding the state of opioid addiction and abuse in the U.S.  It’s now the faster growing public health problem in our country. Around 28,000 citizens died from unintentional drug overdose in 2007, the latest year for which data is available.  More people in the U.S. now die of unintentional drug overdose than gunshot wounds. In seventeen states and Washington D.C., unintentional overdose deaths outnumber deaths from motor vehicle accidents.

 The plan has four main points. First, both patients and prescribers of controlled substances will be provided with better education about these potentially dangerous medications. The drug manufacturers will be asked to develop educational products for both patients and providers for education, which will be reviewed by the FDA before approved for release. The medications included will likely include sustained-release oxycodone, oxymorphone, hydromorphone, and methadone. Fentanyl patches will also be included. The ONDCP is seeking to introduce legislation that will change the Controlled Substances Act in order to make training mandatory for doctors who prescribe long-acting opioids.

 Second, the national government will push the few remaining states that don’t have function prescription monitoring programs to put them in place, and to be able to share data with adjacent states.

 Third, the government will support more medication “take back” days in communities across the U.S. Citizens will be encouraged to bring old medication to community sites in order for proper disposal. Previous take back days have been very successful, with tons of pills collected and disposed. This will reduce the number of prescription opioid pills available for diversion. Surveys reveal that round 70% of the pills obtained by people misusing prescription medication for the first time are obtained from friends and family members, often without permission, from old prescription bottles.

 Fourth, state and federal agencies plan to crack down further on rogue doctors and clinics that are “pill mills.” This will require participation from state medical boards, law enforcement, and the DEA.

 At the end of this presentation, Karen Perry, founder of NOPE, told the story of her son, a bright young college student who died of an unintentional drug overdose. She described how his death affected her and his siblings. Her face was etched with the grief that can only come from such a profound loss

 The goal of this plan is to achieve a 15% reduction in prescription opioid misuse in this country by at within the next five years.

 I’m so pleased to see this announcement. Back in 2001, when I first started treating prescription opioid addiction, I was amazed at the numbers of people seeking treatment for this disorder. Studies since then have shown the situation has gotten much worse.

 There will be problems with this plan. Many doctors will not be happy they must have mandatory training in order to be able to prescribe some controlled substances (probably schedule II). Some will stand up on their hind legs and protest this new regulation, if it is passed by congress. But after seeing the prescribing habits of some of my brethren and sistren, it’s obvious we need this. We don’t get much education about appropriate prescribing of opioids, recognizing addiction, and referral for treatment. I’ve blogged before about this (see February 10th’s entry)

 I’ve been blathering on to anyone who will listen about the need for prescription monitoring plans (see prior blog entries for March 6, 8, and 31), so I’m delighted more attention is being paid to this. But I still worry about how states will communicate with each other. For example, my practice is close to South Carolina, yet that state has denied me access to their database. The only allow access to doctors licensed in South Carolina. I use the prescription monitoring program in my state both at the two Opioid Treatment Programs where I work and in my own office, where I see Suboxone patients. I’ve been using it since 2007.

I support the pill “take back” programs. While such events probably won’t do much for those with established addiction, they can help reduce the number of new users and experimental users. Remember, opioid overdose deaths don’t just happen to addicts. Youngsters experimenting with opioids can die from overdoses. In fact, new users dabbling with these pills, because they think they’re safer than “street” drugs, may be more likely to die because they don’t have any tolerance to opioids.

 We need good judgment and balance when shutting down pill mills. How can the DEA tell a pill mill from a legitimate pain treatment practice? I believe this is best done by other doctors. In this state, the medical board does investigations, which I feel is more appropriate than having investigations done by law enforcement. Law enforcement personnel just don’t have the training to tell the difference between appropriate care and careless prescribing with disregard for patients. Let other doctors do that. Granted, a few places will be so obvious that little investigation is needed.

 We don’t want the opioid pendulum to swing to the opposite side again, and become completely opioiphobic. These pain medications are addictive, but are also godsends in the right setting and used in the right way. Let’s take care not to throw out the good with the bad. The best people to set policy in this area are well-trained doctors who approach this issue with common sense and balance.

 Coming as late as it does in this epidemic, I could be negative and say the government has had an epiphany of the obvious. But I do know it takes time for all of these agencies to come together in a cooperative manner and form a plan of action. I’m just thankful that action is finally being taken.