Posts Tagged ‘NAS’

The “Protect Our Infants Act”

Rate of neonatal abstinence syndrome per 1,000 live births, by mother's county of residence

Rate of neonatal abstinence syndrome per 1,000 live births, by mother’s county of residence

(This map can be seen at:http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6405a4.htm )

I just read an interesting news piece about new legislature named “Protecting Our Infants Act.” This bill was sponsored last year by Rep. Katherine Clark of Massachusetts, but died during the session. Then she got support from other congressmen, including Rep. Steve Stivers from Ohio (who happens to represent the area of the country where I was raised, in Southeastern Ohio), and Sen. Bob Casey of Pennsylvania. When Majority leader Senator McConnell got onboard as a sponsor of the bill this year, it gained momentum, and is now in a congressional committee, waiting to be sent to the house or Senate.

When I first heard about this new bill, and that Senator McConnell was backing it, I worried it might be something weird and unscientific that would send us backward in time. But after reading the bill online for myself, I’m in favor of it: https://www.congress.gov/bill/113th-congress/senate-bill/2722/text

This bill asks the Secretary of Health and Human Services to collect and evaluate all of the best evidence-based information available about how to prevent and treat babies born dependent on opioids. The bill’s actual wording is that the secretary of HHS “shall conduct a study and develop recommendations for preventing and treating prenatal opioid abuse and neonatal abstinence syndrome, soliciting input from nongovernmental entities, including organizations representing patients, health care providers, hospitals, other treatment facilities and other entities, as appropriate.”

The bill asks for Health and Human Services to identify and also report on any gaps in our knowledge, where more research is needed. The bill also requests an evaluation of medical use of opioids during pregnancy, and an assessment regarding access to treatment for opioid-addicted pregnant women and post-partum women. The bill asks for an evaluation of the risk factors for opioid addiction, and the barriers to treatment.

According to the bill, the Secretary of Health and Human Services will collect all this information and post it on a website, available healthcare providers in the U.S., in no less than one year after the bill (hopefully) passes.

Our present Secretary of Health and Human services is Sylvia Mathews Burwell, who replaced Kathleen Sibelius last summer. I didn’t know much about her, so I went to the website for HHS, and found a blog post of hers, addressing our epidemic of opioid addiction: http://www.hhs.gov/blog/2015/03/26/its-time-act-reduce-opioid-related-injuries-deaths.html

I really like what I read. In her blog post, she emphasizes three areas which need attention: wider distribution of naloxone to prevent opioid overdose deaths, better prescribing practices by doctors, and…“using medication-assisted treatment to slowly move people out of opioid addiction.”

What a relief. She supports MAT. I mean, one would hope and expect such support for evidence-based treatments, but as my readers know, sometimes politicians take strong positions on matters about which they know little (oh yes I’m talking about Tennessee).

If the Secretary does a good job, this is a golden opportunity to promote evidence-based treatment of opioid addiction in pregnancy: MAT.

I also think some politicians could learn things they didn’t expect.

Is it possible that with such a prominent seal of approval, both methadone and buprenorphine treatment of opioid addiction will move out of the dark ages? Perhaps politicians will say, “Oh I now see I don’t know what I’m talking about when I limit access to treatment at methadone and buprenorphine programs! How foolish of me!”

Is it possible that someday in the future I’m going to call a certain obstetrician in my area about the methadone dose of a patient we both treat, and he will say, as he’s said before, “It’s wrong to treat pregnant patients with methadone. You need to get them off that stuff!”

And I will say…please go to the Health and Human Services website, to read what the experts say, since you won’t believe me. And he will read. And he will change his mind. He will begin to encourage all his opioid-addicted patients to seek effective, evidence-based treatment… And the health of the whole community will improve as we come to agree on evidence-based solutions to medical problems.

So my first train of thought was a happy engine, chugging along with optimism and relief. Then came the caboose of negativity.

Why do doctors need to have the Secretary of Health and Human Services research this issue for them? For prevention, yes, that’s a public health issue and more research would be valuable. But to find out how to treat a medical issue?? If doctors have a question about how to deal with a medical issue, we have sources that summarize and review best data to date. We go to a reliable source, to the experts in the field. For the topic of opioid addiction in pregnancy, one would ask obstetricians and addiction medicine doctors.

Oh wait. The American College of Obstetrics and Gynecology, along with the American Society of Addiction Medicine, already have published a position paper of best practices in this area. It is titled, “Opioid Abuse, Dependence, and Addiction in Pregnancy.” They didn’t hide their report in a dark cave. They published it. They posted it on the internet:

In fact, if you Google “pregnancy and opioid addiction,” one of the first options is ACOG’s paper: http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Health-Care-for-Underserved-Women/Opioid-Abuse-Dependence-and-Addiction-in-Pregnancy
And for those people who are deeply puzzled by how to treat opioid addiction in pregnancy, this is the summary sentence of the report, published in 2012: “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.”

That wasn’t so hard, was it?

Then I Googled “american academy of pediatrics and neonatal abstinence syndrome,” because I figure who knows kids better than pediatricians, and my first choice was a state of the art review article from 2014 describing NAS and its treatment in detail.

After considering the “Protecting our Infants Act,” I have several observations. First, it’s not terribly hard to find state of the art information about the treatment of opioid addiction in pregnancy, and the treatment of neonatal abstinence syndrome, if the healthcare worker really wants to find it. But if the healthcare worker can’t or won’t accept these answers due to ideology, a report from the Secretary of HHS may carry more weight than the science that’s already available.

I also believe we have a whole lot more to learn in this field. This new Act’s best feature is the mandate to assess areas where we need more research, and to investigate barriers to treatment, because there are many. For example, Eastern Tennessee has one of the highest rates of NAS in all the country, yet that state denied a certificate of need for a methadone clinic to be established to serve that area. I do believe that history will judge those politicians harshly.

I hope the bill passes. It would be interesting to see what the Act’s current sponsor, Senator Mitch McConnell, would think about the DHH report.

Opioid Addiction in Pregnancy: More Information about the Use of Methadone Versus Buprenorphine

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The MOTHER (Maternal Opioid Treatment: Human Experimental Research) trial of 2012 (Jones et al) gave us much-needed information about how buprenorphine compares to methadone when used to treat opioid-addicted pregnant women. This landmark study showed us buprenorphine can be just as effective as methadone. Babies born to moms on buprenorphine had the same incidence of opioid withdrawal (called neonatal abstinence syndrome, or NAS) at 50%, but the withdrawal was significantly less severe, the babies required about half the medication as the babies born to moms on methadone. Also, buprenorphine-exposed babies spent significantly less time in the hospital – about half as long as methadone-exposed infants.

Some doctors point out that more women on buprenorphine dropped out of that study than women on methadone, and say that proves buprenorphine is less effective. However, the majority of those women didn’t leave treatment; they just left the buprenorphine arm of the study.

This week I read another study, by Meyer et al, soon to be published in the Journal of Addiction Medicine. This study also looked at pregnant patients being treated for opioid addiction.

The authors of this new study pointed out that the MOTHER trial was a placebo- controlled, double- blind study comparing buprenorphine with methadone, but in real life, the decision to start an opioid-addicted pregnant woman on buprenorphine versus methadone is more complex, and determined by other factors. So the study by Meyer et al did a retrospective analysis. They looked at cases where the choice of buprenorphine versus methadone was made by the patient and physician, as happens in real life, then studied the outcomes. The authors of the new study believed findings will be more pertinent to what happens in everyday clinical practice.

In this retrospective cohort study, 609 pregnant patients were started on either buprenorphine (361) or methadone (248). This study took place over the years from 2000 to 2012 at a single site, University of Vermont.

The study collected various data about the newborns: their sex, estimate gestational age at delivery, birth weight, head circumference, length of stay in the hospital, whether the baby received breast milk, and if the child was sent home with the mother. The study also looked at if the newborn has NAS and if the baby needed medication, and length NAS treatment.

In the results, first-time mothers were significantly more likely to start buprenorphine than methadone. Mothers positive for Hepatitis C were more likely to be started on methadone. In both groups, more than 80% of the moms were smokers. About 30% of both groups had to have a C-section at delivery.

Both groups had similar prenatal care; more than 65% of the mother in both groups initiated care within the first trimester. However, women in the buprenorphine group were significantly more likely to get what the authors defined as “adequate” prenatal care. Women on buprenorphine were also more likely to already be in treatment when they became pregnant, compared to the women in the methadone group.

Nineteen women switched from buprenorphine to methadone, out of the three-hundred and sixty-one women who started on buprenorphine. Only five of those patients switched because buprenorphine was not strong enough for them, or other medication side effects. Most were switched to methadone because they needed more intensive monitoring at an opioid treatment program due to continued positive urine drug screens. Only three women out of the three-hundred and sixty-one started on buprenorphine dropped out and were lost from treatment.

No women were switched from methadone to buprenorphine, as one would expect. That’s because in order to switch from a full opioid, methadone, to a partial opioid, buprenorphine, the pregnant opioid addict would have to go into at least mild withdrawal, thus putting her at risk for adverse events. That’s not a risk most doctors are willing to consider.

Babies born to moms on buprenorphine, as compared to methadone, were significantly more likely to have longer gestational age. This is a good thing, because it means there were significantly fewer preterm deliveries on buprenorphine compared to methadone. The babies born to moms on buprenorphine were significantly more likely to have higher birth weights and bigger head circumference.

Just like what we saw in the MOTHER trial, this study also showed that the infants born to moms on buprenorphine required significantly less medication to treat neonatal abstinence syndrome. The buprenorphine-exposed babies required medication for a significantly shorter time than methadone-exposed newborns.

More than 95% of the infants were sent home in the care of the mother or family, which makes me think this study was done on women with fairly good stability at the time of delivery.

The authors of the study concluded that this evidence suggests that buprenorphine gives outcomes that are at least as good as with methadone.

I’d take that conclusion one step farther and say we now have several studies that show less neonatal withdrawal in babies exposed prenatally to buprenorphine compared to methadone. I have to ask myself: knowing what I do from these studies, which medication would I want to take during pregnancy? I’d prefer buprenorphine, and if it didn’t work for any reason, I’d switch to methadone.

I explain all of this to pregnant patients with opioid addiction upon admission, though I’m careful to also point out that methadone is still officially the gold standard in many places.

I think that will change soon. We are getting more information that shows outcomes equal to methadone with less severe neonatal withdrawal.