<v ->Hello, welcome to the Provider's Clinical Support System.</v> And this topic is treating pregnant people for opioid use disorder, and we're going to be talking about some of the clinical challenges and opportunities. My name is Dr. Hendrée Jones, I'm a professor at UNC Chapel Hill in the Department of Obstetrics and Gynecology, and I also oversee the UNC Horizons program, which is a clinical care program that provides comprehensive care for pregnant and parenting individuals and their children, who have substance use disorders or are substance exposed. Disclosures, I do not have any for this educational activity that would compete with what I'm going to say today. And our target audience is really, the intent is to train healthcare professionals on the best evidence-based practices for the prevention and treatment of opioid use disorders. And today we're going to be focusing on prescribing medications during pregnancy and the postpartum period, as well as preventing and treatment of substance use disorders themselves. Our educational objectives, so hopefully by the time that you have completed this webinar, you'll be able to name at least two, if not more, current and historical influences that the opioid crisis has had on pregnant individuals. We're going to be comparing and contrasting both the risks as well as the benefits of medication to treat opioid use disorders, and comparing that to a medication assisted withdrawal, commonly known as detoxification, to effectively treat patients that have opioid use disorders, both during the pregnancy and the postpartum period. We're going to be looking at risks and benefits of methadone and buprenorphine for treatment during pregnancy, for the birthing person, the fetus and the child, and then, finally, being able to identify factors, at least three, that are related to reducing neonatal abstinence syndrome, that withdrawal that babies can have having been prenatally exposed to opiates and other drugs, or what is also known as neonatal opioid withdrawal syndrome among those children that have been prenatally exposed to opiates, as well as methadone or buprenorphine. Here's the outline that we're going to be walking through today to meet our objectives. So, you can see if we're going to start with some context, historical, look at this current scope of the problem, we're going to be defining neonatal abstinence syndrome and neonatal opioid withdrawal. We're going to be looking at those different treatment options, the methadone, buprenorphine, and talking about the promising approach of naltrexone to treat opioid use disorder during pregnancy. We're going to be looking at the differences between medication to treat opioid use disorder and medication assisted withdrawal. And then, finally, we're going to be summarizing. Just an informational note, that we are using information from the World Health Organization, from SAMHSA, from ACOG, ASAM, and there's some links there. And then to also remember that when we're talking about medications to treat opioid use disorder during pregnancy, these can be prescribed within label, so we will never have a specific indication for these medications during pregnancy because they are not treating specific pregnancy conditions, they treat opioid use disorders which pregnant and postpartum people have. Another note, as we begin, is around language. I'm going to be doing the best that I can do to talk in person first and recovery language, and we're also using gender inclusive language, so I'm going to be talking about pregnant people as well as women or woman, in some cases, I'll switch back and forth. And the idea is not to exclude anyone but to actually be inclusive, and to remember that we want to be as inclusive and reduce bias and discrimination with our language. So, let's start with a case study. Think into your practice and if you suddenly had a person who was 24 years old, 15 weeks pregnant, and they're coming to you looking for opioid use disorder treatment, this pregnant person has been using opiates for seven years and just recently started injecting fentanyl. This pregnant person is reporting tobacco use and having had a three year old child in the home, and with a partner who is in recovery for three years. So, what would you do? Take a moment to write down some of the thoughts that you might have about this person. Some of the things that I think about is, first and foremost, what can we do to immediately establish trust? What are the concerns that bring that patient in today, and asking that pregnant patient that. Thinking about the physical health issues, of course, with injection as well as other substance use, thinking about what the past experiences have been with opioid use disorder treatment, detoxification, in-patient, out-patient, medication like methadone or buprenorphine. What is that person's preferences? What are the person's values? What are their mental health issues? What else is going on at home? So, really getting that life story and understanding the role that substances have been playing in this person's life, and what the goals are for a healthy pregnancy outcome. And, finally, to also think about you don't have to do this alone, who are the people in your care network or team that you can reach out to for help and support to help this patient and the fetus, and the family have the best outcomes? As we go through this, we're going to be talking about this clinical guidance that was published in 2018, it is currently in the process of being updated. And then five main recommendations coming out of this guidance document is that medication assisted withdrawal, that detoxification, is not recommended during pregnancy. Methadone and buprenorphine are recommended during pregnancy, they're the safest medications that we have to treat opioid use disorder. Transitioning from a methadone to buprenorphine, or the reverse, is not recommended if patients are having a good clinical response to the medication that they've been taking, breastfeeding is compatible with methadone and buprenorphine for patients who are treated with these medications. And, finally, neonatal abstinence syndrome or neonatal opioid withdrawal should not be treated with dilute tincture of opium, given the amount of alcohol that's in it. So, let's take a little look at our history. We know that this is not the first opioid crisis that we've had in the United States, in the 1800s was our first wave, and the vast majority of individuals that were identified as using opiates were white women who were receiving medication opiates from their physicians. We know that as laws changed, policies changed, there was an intersection of sex and drugs and public policy and policy makers, and media really turned people against those individuals that were using substances and started to criminalize it. And this had negative effects for the patients treating the women, as well as the women themselves. In the 1940s and 50s we saw increases in reports of teenage substance use, particularly opioid use disorders, and there was a book called "The Road to H" where women were portrayed as unloving, as selfish, as hard to treat, as bad mothers. And unfortunately, those negative stereotypes have continued until today. In the 60s through the 70s, we have important focus on prenatal opioid exposure, NIDA has funded some of the very first studies, longitudinal studies looking at prenatal exposure, and we had scoring systems to determine the extent and characterize withdrawal that babies experience after they had been prenatally exposed to opiates. And then more recently, of course, we've had the most recent opioid crisis starting with prescription pain medications, pain is the fifth vital sign, of course, was a one of the many drivers in the increase of prescribing of pain medications. And then, of course, most recently a change to synthetic illicit opiates like fentanyl. And so as we talk about pregnancy and opioids we can't talk about that without defining neonatal abstinence syndrome, so this is the traditional definition that we've had since the 70s, it includes prenatal exposure to both opiates and often other substances, polysubstance use, alcohol, tobacco, cannabis, and we know that there are alterations that we can observe in the neonate. So, cut across central nervous system dysfunction like high pitch crying, irritability that sort of recoiling when being touched, exaggerated reflexes, tight muscles, tremors, autonomic system, that sweating, that fever, the yawning, the sneezing that you might see in babies, and then the gastrointestinal distress that suck, swallow, that is discoordinated, having difficulty feeding, having difficulty keeping food down, and then in some cases signs of respiratory distress. What we know is that neonatal abstinence syndrome is not the same thing as fetal alcohol syndrome. We do not have conclusive data to suggest that having a neonatal abstinence syndrome or being treated for one results in long term deleterious consequences for the children, because of the neonatal abstinence syndrome. We know that it is a treatable condition and we also know that when we can get the caregiver or the birthing parent and child off on the right foot with a healthy attachment, with being able to be attuned to cues to being able to understand the neonatal abstinence syndrome, and being able to respond in a supportive approach, that this can really reduce chances of risk and improve resiliency. Just a little more history about methadone and pregnancy. Methadone, since the 60s, was really the only medication that we had to treat opioid use disorder in a managed chronic long-term way. In 1973, the FDA actually forbid pregnant patients from being treated with methadone, demanded that they all be detoxed. There were a number of physicians that wrote out of concern with the things that they were seeing with pregnant individuals and the fetuses, and quickly the FDA reversed course. Now we have decades, five decades, worth of research that shows that when we provide methadone we can prevent opioid overdose, we can reduce maternal craving, we can reduce that high and low, that repeated cycle of high and withdrawal that the birthing person feels as well as the fetus, and then when we can provide methadone in a maternal context of a comprehensive program, we can improve birth outcomes in terms of babies being born on time and of healthy birth weight. In the early 2000s and late 1990s, there were a series of studies that were done to look at buprenorphine, buprenorphine was the newest medication that was being studied for non-pregnant individuals and we knew that when patients were abruptly discontinued from their buprenorphine, that they showed milder withdrawal effects than they did from being abruptly discontinued from methadone. And so our thinking was that if this is true for non-pregnant individuals perhaps this would be true for pregnant individuals, so that when the baby was born, the cord was cut, the drug supply of methadone or buprenorphine was abruptly discontinued, perhaps we would have a milder neonatal abstinence syndrome or baby withdrawal from prenatal exposure to buprenorphine than methadone. And so we had a series of studies that did this early proof of concept, we were able to then quickly do larger studies which I'm going to share with you in just a minute. But as we think about substance use disorders and the pregnant patient that you are caring for, I want to just reground us in what is a substance use disorder, because so often pregnant and postpartum individuals experience incredible stigma and discrimination. And so as we look at this DSM-5 criteria that I know you're very familiar with, I want to just remind us that there are only two signs that tolerance and withdrawal that are truly pharmacological. All the other ones, those that you see in purple that represent our social impairment, the blue that represents impaired control, and the red that represents that risky use, those are all behaviors. And so when we see patients that are exhibiting these behaviors, rather than shunning them we want to virtually or really wrap our arms around them with comprehensive care so that we can best support them to reduce the signs of their illness. We also know, as a society we haven't been doing a great job of doing that, of wrapping our arms around people virtually and with services, and as you can see in this slide we've had more overdose deaths than ever have been recorded. I can say I've been in this field since 1994 and I've never seen a chart looking at the blue, the synthetic opioids, that literally almost goes straight up. So, as a call to action, we need to do some different things in this country in order to reverse and prevent those overdose deaths that are happening, not only with fentanyl but also with stimulants. We can also see that we have to have a conversation about structural discrimination in this country against people of color. We can see from this slide, from the Kaiser Family Foundation, that overdose deaths are going up in our individuals that are black and Hispanic, and Alaskan Native and American Indian. And so, again, this provides an important foundation to continue to have conversations about what we can do in our own practices to improve equity and reduce discrimination. Unfortunately, it is not that easy to access drug treatment and we know that while sort of the rates of those using substances have been relatively stable, those people that are dying from substance use are going up because the drugs that they are using are more deadly. And we know that when people that are socio economically disadvantaged, that they face even greater risks from their drug use disorders. And so when we talk about pregnant individuals, we want to make sure that we're looking at the whole picture in terms of who is using what types of substances, and so you can see these are national data from SAMSA, and 2016 in light blue, 2017 in the green, 2018 in gray, and 2019 in the dark blue, shows that the most common substances that pregnant individuals report using are tobacco and alcohol. Within illicit substances the most common substance used is marijuana or cannabis, and while fewer people are reporting opioids and cocaine use, we know that those tend to get the most attention during pregnancy. And we also know that alcohol and tobacco we have the most data on in terms of the relationship between prenatal exposure and long term risks for children. And so when we look at opioid use disorder and why would we want this special focus, we know that neonatal abstinence syndrome, that baby withdrawal is going up. So you can see in 2004, 1.5 per every thousand deliveries had neonatal abstinence syndrome, and then when we look in 2017 it goes up to 7.3. And we know when we have babies that are recognized as having a neonatal abstinence syndrome, we're going to have maternal opioid related diagnoses, and those two have risen in prevalence. And so, of great note, we know during the COVID pandemic that fewer people are coming to hospitals to have their babies, and if we have untreated opioid use disorder we have very good data to show that, that is related with very adverse health consequences, premature delivery and low birth weight; and so we need medical approaches to be able to help support healthy birth outcomes. So what happens when people who use drugs become pregnant? As you can see here, looking at across the trimesters many individuals who are pregnant spontaneously stop using their substances, however, not everybody does that, and for those individuals who continue to use substances during pregnancy, there is an opportunity for help for them. And so when we think about who might need help, basically if you remember the DSM-5 criteria that I had just put up on the slide a few minutes ago, one of those risky use features is important for pregnancy. So, if people are continuing to use their substances in spite of their health consequences during pregnancy, then we know that there is an opportunity for change. We also know that pregnant people really fear healthcare, I can't tell you how many patients have come into UNC Horizons or that I've talked to you through the years that are very scared that if they disclose to their provider that they are using substances during pregnancy, that they're going to be incarcerated or that their children are going to be taken at birth. And oftentimes those fears are very valid, and so we have to have honest conversations about what it's like in our community and what the response is from child perspective services and other places in the community towards pregnant individuals. We also know that keeping patients in prenatal care is vital even if patients don't stop using, if they can continue to come to prenatal care, that will be a resilience factor for having healthy birth outcomes. We also know that when we can engage the pregnant person and help them have healthier outcomes, that we also know that having healthy parents leads to having healthy children, and so that is a key determinant for the next generation. When we think about birthing people and substance use, we cannot have a conversation without talking about drug policies. We know that in many places pregnancy is uniquely criminalized, those who are pregnant using substances are uniquely criminalized, there are many people in the criminal legal system now; and we also know that this is not an effective approach for being able to promote healthy birth outcomes or to being able to reduce the numbers of individuals who are using substances during pregnancy. We know that prisons and jails might require restraints during labor and delivery, and they might deny breastfeeding. So this is your opportunity, if you work in those types of settings or work in hospital settings, to ask questions and to do what you can do within your sphere of control to help promote safety, equity, and dignity during the birthing process and postpartum. We also need to talk about urine drug testing. So often there is an over-reliance in urine drug testing to determine if child protective services needs to be called, and if a child needs to be removed from their birthing parent. I want to remind us that a urine drug test is only a snapshot, it is not a diagnosis for a substance use disorder, all it tells you is with the limits of the test that there has potentially been substance use recently. It is also not a parenting test, so we cannot use urine drug testing to rely on, to determine parental safety for the health of a baby going home. So, we need to be talking to our parents and we need to be providing other resources and supports to our team to help them make the best decisions for the health and safety of the baby, as well as the parent. There's been some wonderful publications that have come out, and so I would like to refer you to this document that reminds birthing people of their rights, and so they have rights to receive medication, they have rights to receive pain relief during labor, they have rights to prevent law enforcement from accessing their medical records. And so those are just a few of the things, I would also like to suggest that you look at the latest ASAM statement around birthing people and pregnancy, and substance use, that has just recently been published. And when you have that pregnant patient or postpartum patient that's in your practice, please remember that there is a whole response, there's levels of continuum of care, everything from early intervention and outpatient treatment all the way through that intensive hospital patient services, and so we know that not all pregnant patients or remediate postpartum patients need residential care, that it really depends on the severity of their use and other needs, as to what type of treatment they need. One of the really exciting things that has happened during the COVID-19 pandemic, and I always try and look for silver linings, is that there has been an increase in flexibility in how we are responding with prenatal care and with substance use disorder treatment, and these are just some data to show that when Patton et al. compared a hybrid model to a face-to-face model, she found that the hybrid model really improved no-show rates. There's so many wonderful opportunities in terms of not having to have transportation or childcare for those virtual appointments, and then maybe not having to be in a clinical setting where you might feel a little stigmatized or ostracized in the waiting room. So, really, this is an opportunity to consider how you can use telehealth and the virtual environment to supplement the care that you provide. There's also been some studies that have looked at the downside of telemedicine and, certainly, there is less structure and less accountability. There might be less information to really inform that clinical decision-making, the challenges, too, is that people in rural areas or in greatly under resourced areas might not have the capability of having a phone or the band access to be able to attend and be a part of those virtual sessions. One on the plus side, though, being able to see our patients in their homes and actually ask them, "Hey, let's look in your refrigerator, let's see what's going on." What are the challenges that you're having can be a really increased window into ways to be able to have conversations and to help them, that we wouldn't have in a face-to-face visit. So, now let's talk a little bit about medication and medication assisted withdrawal. And so this is a clinical question, again, for you to think about what are some of those things that might be important for us. This case we have a 23 year old person who is five months pregnant. This person has endocarditis, a sexually transmitted infection, reports smoking cannabis regularly and also reports using fentanyl by injection, as well as methamphetamine. And so what are some of the things that you would want to think about with this person? One of the things that I think about is that change happens at this speed of trust, so what is it that I need to do to get this person to trust me? How do I earn this person's trust, and asking, "What's bothering you the most today? What are the things that most concern you?" Is a great way to start to have a conversation. Obviously we need to be attending to the endocarditis and the other physical health issues, and is hospitalization needed to get a workup and determine a course of medication that that person can complete, but making sure, too, that we are working from a shared decision framework, and those three essential elements of that shared decision framework is first recognizing and acknowledging we have decisions that need to be made, knowing and understanding the best available evidence and, hopefully, from this talk you'll get a little bit more of that. And then, finally, making sure that we're asking the patient about values and preferences, and incorporating them into that shared decision-making. And so as we go through, we are going to take a look at the different medications and medically assisted withdrawal. We know that medically assisted withdrawal is not supported by the evidence, while it is the most common approach to treating opioid use disorders still in this country, we know that it is an acute care approach to a long-term chronic medical condition, and we see a great return to use having completed that detoxification, and we also see that particularly with pregnancy, that that can create continued risk factors for poor birth outcomes. So, really, our evidence just doesn't support medication assisted withdrawal as a recommended treatment. What is recommended is medication to treat opioid use disorder, we know that it can help patients avoid return to substance use, it can also prevent overdose and death. We know that we also need to take a case by case approach, so just because medication works for the vast majority of people doesn't mean that we should completely avoid medication assisted withdrawal. So, again, that shared decision-making approach needs to be a part, maybe there aren't resources for the person to have a medication in their community. And then thinking, too, if you're going to use a medication assisted withdrawal approach, making sure that you have a safety plan, that you're intentionally talking through what it will look like if there is a return to use, what is that safety plan for that individual, Do they have naloxone available and can they reach out to you if they make a change or want to make a change in their plans? And so what supports the idea behind medication to treat opioid use disorders during pregnancy? This is a graphic of our mother study, which was a blind double dummy comparison of methadone and buprenorphine to treat opioid use disorder during pregnancy, we had eight sites and we had flexible dosing. So, we looked at anything from 20 to 140 milligrams of methadone to two to 32 milligrams of buprenorphine. And what we were able to find in this multi-site study that was blinded, so neither the patients nor the providers knew what medication was being received by the patient, is that we had very similar maternal outcomes and, in fact, we had similar proportions of babies that were treated for neonatal abstinence syndrome, as you can see in that far left graph. But what was different is when we had babies that were prenatal exposed to buprenorphine, we had significantly less morphine that was required for treatment, if they needed treatment compared to their methadone counterparts, and we had buprenorphine exposed baby stays a significantly shorter period of time in the hospital. So, what this study really told us was, one, that we have clinical evidence, randomized clinical trial support for methadone and its relative safety and efficacy as well as buprenorphine. These are some of the secondary outcomes that we had and, again, you can see, we did not have statistically significant differences here, And so what this allowed was evidence to support both medications to treat, it gave patients choice of methadone or buprenorphine for the treatment of opioid use disorders. We followed a number of the children up to 36 months, and as we looked at them we compared methadone to buprenorphine prenatal exposure and did not see differences in physical or behavioral or cognitive outcomes. When we compared children to the cognitive norm test or the developmental tests, we also didn't see differences. Children were on the lower end of normal in terms of the norms for tests, but they were still within those normal limits. And so, this should be reassuring data that providing prenatal exposure to methadone and buprenorphine during pregnancy did not appear to create an adverse pattern of growth or cognitive, or psychological development in the children up to 36 months. And so when we look at this table of methadone and buprenorphine, we know that they have very similar advantages. So they block the effects of other opioids, they last for often or can prevent withdrawal for more than 24 hours. Methadone has the traditional advantage of having higher treatment retention than buprenorphine. We also know that buprenorphine is related with sort of less interactions with other medications. Methadone in terms of its disadvantages, it takes a little bit to achieve a stable dose. There's obviously a risk of overdose compared to no treatment at all. And we know that there is a longer neonatal abstinence syndrome duration and it often requires more medication to treat in the context of a scored standardized Finnegan measurement of neonatal abstinence syndrome. We have new data looking at the eat, sleep and console that seems to be showing similar advantages for methadone and for buprenorphine. In terms of buprenorphine disadvantages, we know that you need to be in mild to moderate withdrawal to be successfully inducted onto buprenorphine, although we are learning more about induction strategies, and so that disadvantage might be going away in the literature. And then certainly because buprenorphine is less regulated than methadone, you have to go to a clinic, an OTP, for your methadone, whereas you don't for your buprenorphine, it can be prescribed by physicians in their offices or other designated care providers out of their offices, that there is increased risk of diversion. And oftentimes that comes when there's just not enough access to treatment and medication in communities. There was a meta-analysis that was done comparing methadone and buprenorphine for prenatal exposure, and as you can see there were 515 neonates born to mothers receiving methadone and 855 neonates born to mothers who were receiving buprenorphine across 12 studies, and the kind of summary of this meta-analysis was that there were advantages with buprenorphine compared to methadone from those 12 studies. So, you can see what those are on the slide in terms of buprenorphine exposed neonates had a higher gestational age, greater birth weight, they were longer and their head circumference was larger overall, and fewer women treated with buprenorphine tended to use illicit opioids near delivery. So, again, these are meta-analysis data and it always comes down to individual shared decision-making with the patient in your office. And so as you're thinking about this study, I invite you to think about a person who has severe opioid use disorder, who is well maintained with methadone, finds out they're pregnant, how would you respond? So, certainly, we have these data to suggest that buprenorphine might be better for the baby, but we also know that switching medications can create a period of vulnerability. So, if you have a patient that is well maintained with their methadone, they're used to it, they're having a good clinical response, there is no reason to switch it. These are data, too, so when we looked at the mother study data that I shared with you just a moment ago, that was that study and pretty much majority of the randomized, all the randomized controlled studies that we have, we're looking at the buprenorphine alone product. What is most commonly prescribed now is the combination product of buprenorphine plus naloxone. And so Link and colleagues have completed the systematic review and a meta-analysis, and didn't find that outcomes were worse or in any real way different for the combination product compared to the buprenorphine alone. And so, again, this should be reassuring data that we are able to use buprenorphine/naloxone combination products to effectively treat pregnant patients that have opioid use disorder. Let's talk for a moment about dosing. So, in the traditional way that probably many of us were trained, we were trained to provide what a single dose day of either methadone or buprenorphine, now we are learning so much more about split dosing, Jack McCarthy has done a terrific job really sharing evidence with us and generating evidence around split dosing or multiple daily dosing for methadone during pregnancy. And so you can see the benefits on the left-hand of the slide and the risks on the right-hand. And so, the benefits I think far outweigh the risks for most individuals, again, we can prevent that over sedation, we can be able to prevent withdrawal, we can be able to have more effective dosing so that patients aren't going through feeling over sedated and then under sedated, and it reduces that giving patients their medication to take home prevents that fear that they're going to wake up in withdrawal. In terms of the risks, obviously there could be diversion, and then potentially less structure that patients may benefit from; but we are getting more data every month about this to really continue to support the evidence around multiple daily dosing. And the same is true for buprenorphine, we're seeing more and more data suggesting that splitting the dose or giving it three times a day is also a patient-centered, effective way of being able to manage opioid use disorder during pregnancy. And so regardless of what medication you're using or how you are dosing, we need to really, again, be looking at what tools we can use to help join with our patients to make shared decision-making in the treatment that patients are receiving. And so Connie Gail and her colleagues have created a shared decision-making tool, and then this tool was really looking at helping patients decide if they want to continue or discontinue their medication. And so there's some items here that you can look at, the risk of return to use, patient preference recommendations, and we're making sure that we're reviewing their values and preferences and desires, as well as the evidence together at each visit and then planning for delivery, for breastfeeding and for pain management. Let's talk briefly about naltrexone during pregnancy. There is an ongoing trial that Elisha Wachman and colleagues are in the process of hopefully concluding in the next couple of years, to give us relative safety and efficacy data for naltrexone during pregnancy and the postpartum period, we know we have a number of a studies from Australia looking at an implant for naltrexone, and at the present moment we have some very preliminary strong outcomes that don't look like we have deleterious consequences for the children or immediate birth outcomes to be concerned about. And so these are just some data to kind of support that from Elisha and her colleagues in terms of less neonatal abstinence syndrome compared to buprenorphine, and of course a shorter length of hospital stay. However, the jury is still out, we're still waiting for that study and waiting for the larger study, and also waiting for more information and data to come out about the relative safety and efficacy of naltrexone. So, if you have patients that are receiving naltrexone and become pregnant, I invite you to think about is changing their medication, given the data that we have, really in their best interest? And so having that shared decision-making and documenting that discussion, perhaps they might be invited to stay on the naltrexone if the benefits of staying on that medication outweighs the risks. There are things to think about, if they do stay on, in terms of any kind of pain relief and how you're going to manage pain during labor and delivery, and the postpartum period, and then also breastfeeding perhaps due to reduced milk production, that we know. And so having those conversations ahead of time and figuring out intentional plans can be really helpful for those patients. I also wanted to mention that this field right now is incredibly dynamic and we have a changing definition of neonatal abstinence syndrome, neonatal opiod withdrawal, and this neonatal withdrawal, a definition has just recently been published by Dr. Jilani and her colleagues, and so what this expert group panel concluded is that a diagnosis of opioid withdrawal in the neonate can be determined by a history of opioid exposure, which means that you don't necessarily have to use toxicology to determine opioid exposure, and that there needs to be a presence of at least two common clinical signs that excessive crying, fragmented sleep, the tremors that babies might have that increase muscle tone or gastrointestinal dysfunction, and so it kind of revolutionizes the way that we've been thinking about neonatal withdrawal. And so, again, stay tuned, there'll be more data coming out about that. And then when we think about our traditional definition of neonatal abstinence syndrome, that larger prenatal exposure with polysubstance or neonatal opioid withdrawal, the more narrow definition of just prenatal exposure to opiates, we know that when we have babies that need to be managed there are so many factors that go into if a baby's going to be treated, what they're going to be treated with, how long they're going to be treated, how long they're going to stay in the hospital. And so we know that having a protocol that everyone is using can reduce the length of stay, for example, that babies are in the hospital. We know that if we can keep babies out of the neonatal intensive care unit, that as long as they don't have other issues that would put them in there, that that can also shorten the course of medication and shorten the length of stay. We know that the type of medication can determine how much medication, how long they get it, as can the initiation and weaning protocols. And then certainly breastfeeding has been related to a less severe neonatal abstinence syndrome, and when we can keep mothers and babies together they often require we can drop the rate of babies that require treatment in half. So thinking, again, in that clinical question, if you have a pregnant person in your office with an opioid use disorder and they want to know what they can do to help their baby avoid withdrawal, one of the things to do is to ask about the hospital policies, where are they going to deliver, let's find out about the hospital policies and let's see if we can create a plan and have conversations in advance about rooming in, about breastfeeding, about being a part of that care plan to help empower patients to care for their children and to have better outcomes. There are also a couple of things that can't be controlled, and that's genetics. We know that there are genetic data that show that babies might be predisposed to have a more severe neonatal abstinence syndrome, we know that smoking tobacco, the more cigarettes you smoke the greater chances are that the baby's going to have a more severe neonatal abstinence syndrome, which means they need more medication to treat it and they stay in the hospital for a longer period of time. And then birth weight, it kind of goes back and forth, we can see heavier birth weight babies often have more severe neonatal abstinence syndrome. I'll tell you the one thing that's super important to remember is that the dose of medication, either methadone or buprenorphine, does not consistently relate to the severity of the neonatal abstinence syndrome. So, you need to make sure that you are giving the dose of medication that adequately treats that pregnant person's opioid use disorder, because when you treat the patient to their best it gives you the opportunity to have a healthier fetus and healthier child. And so I'd mentioned that there are new paradigms to treat neonatal abstinence syndrome, to assess it, and eat, sleep and console developed by Matt Grossman at Yale has kind of revolutionized our field and the way we think about it, and there are many different studies that are ongoing now comparing it to the traditional scoring Finnegan approach, but at least from the initial data that we have from eat, sleep and console, it seems to dramatically reduce the numbers of babies that require medication and gets them out of the hospital in a shorter period of time, without seeing, at least presently, greater readmissions or adverse events. And this is just an example of how eat, sleep, and console changed our hospital and our outcomes at the University of North Carolina, and so you can see our sort of length of stay there bouncing around in the black boxes was about 10.3, and when we adopted eat, sleep, and console, it dropped it to 4.9 days. And one of the big changes around eat, sleep, and console is that the parents are part of helping to monitor or assess the baby, and we also use medication in a PRN. So we give fewer doses of medication, and if we do give medication we don't create an initiation, monitoring and weaning period, we're just giving it as needed. Let's talk to now about the fourth trimester or that incredibly important postpartum period. So often pregnant individuals get a lot of attention from prenatal care providers, or from other sort of caring systems, but then once they deliver their baby all of that care and concern turns to the baby, and we know that there's an emphasis on newborn care and on breastfeeding, mood changes happen with our birthing parent's sleeping, it gets completely disrupted and anybody that thinks that they're the ideal birthing person or ideal mother, that kind of idea goes out the window because we are sleep deprived and we are stressed, even in the best of circumstances. And so making sure that when you do have that postpartum person you are asking about depression, you are asking about how things are going, they are providing supports where possible in terms of social supports, and with breastfeeding or even looking at housing, looking at transportation, looking at all of those other things that go into being a successful, nurturing parent. We also need to talk about a birthing people in that fourth trimester and how we know that there is structural racism in our country, And you can see this play out with deaths in the postpartum period And we have non-Hispanic black individuals, in particular here you can see have much greater rates of deaths during that postpartum period. So we have an opportunity to make important changes And, again, I invite you to look at your own data in your own community to see if there are disparities, and then have conversations about what can structurally be done to change that, to help keep our mothers alive. We also know that as the opioid crisis in this country has continued that we have more children being removed from their parents, as you can see here the national average is 37.7% with children out of home care at some point. And so looking at what is going on with our Child Protective Services, we know that removing children doesn't necessarily lead to reductions in use during pregnancy of substances, or nor does it lead to improved birth outcomes. So what can we do to help provide support to pregnant and parenting individuals rather than removing children from their care? We also know that children are more likely, or black newborns are more likely to be reported to Child Protective Services than their white counterparts. So, again, this is an invitation to look at what's happening in your community. When we talk about labor and delivery, it's really important that we do not disrupt the schedule of medication receipt by our patients, our methadone or our buprenorphine, we want to continue them on their medication uninterrupted during labor and delivery, and the postpartum period. And there have been a number of papers that have been published looking at pain relief. So, we can provide opioid agonist for pain relief and we can also have many other types of epidural or other types of pain procedures that can help make patients more comfortable, most importantly, we need to be asking our patients about pain and taking them seriously, because we know that untreated pain can set up a return to use, it can set up a whole spiral of adverse consequences and risks that can happen for the postpartum patient, and then potentially the child too if we don't have a well supported patient. One thing is that we want to avoid partial opioid agonists and antagonists because we will precipitate a withdrawal, so please, please, please never give butorphanol, nalbuphine or pentazocine to you patients that are receiving methadone or buprenorphine because you will create a withdrawal, and that is really horrific to see for them and difficult to manage for you. In terms of breastfeeding, we know that this is compatible with those individuals who are receiving methadone or buprenorphine in the postpartum period, we know that the amount of medication getting into the breast milk is incredibly low and particularly for buprenorphine, remember it has very low oral bioavailability so even the tiny amount of buprenorphine isn't going to be able to be utilized by the baby or you're not going to have effects on the baby because of that. We know that the act of breastfeeding can be very helpful with reducing the signs and symptoms of neonatal opioid withdrawal or neonatal abstinence syndrome. In terms of documentation, please make sure that you are having good documentation about the risks and benefits of if you're talking about detoxification, if you're talking about medications, making sure that you're documenting in the records so that other care providers know that patients are receiving their medications, and so that can guide pain management during labor and delivery, and postpartum, making sure that you are using person-first positive language, recovery language, in your documentation. I can't tell you how many charts I've seen that use words like addict, non-compliant, left AMA, is recalcitrant, all sorts of shaming and blaming words and not understanding the whole context of the individual. And so making sure that we have also co-prescribing naloxone, and making sure that we are having good communication across the team to best support the whole entire birthing experience and postpartum in neonatal stay for the birthing person, as well as for the baby. There's always a question of how long should somebody stay on their medication to treat opioid use disorder, and that is absolutely an individualized conversation using shared decision-making. One of the things that we know is that the longer a patient continues on their medication, the lower there is a risk for return to substance use. So, again, if a patient is insistent, understanding what's driving that, oftentimes there's external pressures, pressures from the legal system, pressures from family, pressures from a job, and so making a plan with the patient about if they're going to do this, how are they going to know it's working for them? And then how to have a return to do something different, if needed. So, again, really that medication only needs to be discontinued when it's in that best interest of the person and the diad, making sure we have that safety plan in in place, making sure that we're going to do the discontinuation of medication gradually, and so that the patient can get used to it and know when to stop or when to hold for a moment. Some of the sort of rules that we use is that we like to at least delay the discontinuation of medication until the baby is consistently sleeping through the night and has completed that breastfeeding, again, a more stable birthing parent is going to be a more stable baby, and the reverse, more stable babies lead to more stable parents. Other ways that we can support postpartum people include every time, every interaction that you have with that diad you have a chance to either build them up or tear them down, so make sure that you acknowledge the strengths that you see in that birthing person and how they are relating to their child model, so if you see maybe the birthing person not responding to a cry you don't say, "Oh," you respond to that cry and then engage the parent in also responding to the baby's cry. Support their recovery efforts, help the birthing parent be able to better read their infants cues, differentiating a hunger cry from a fussy cry, from a diaper change cry. And being able to provide that empathy, that compassionate care, and successfully help the parent care for the infant, show them how to do things don't just tell them what to do. I could spend a whole talk on recovery oriented systems of care. And, again, we all work in our own silo, but making sure that we're taking the time whenever we have a patient experience that maybe isn't going the way we want, maybe a patient isn't doing what we want, I invite you to stop, I invite you to pause and I invite you to think about the larger web, what's going on in that patient's life? How did that patient get to you? What transportation did they take? What kind of employment or lack of employment do they have? How are they getting money to survive? Where is their food coming from? What's going on in their home? How safe do they feel in their home? Those are all things, do they even have a home, that can help create a context for a more healthy environment or an environment that creates incredible challenges just to get to you to receive their treatment for substance use disorders and/or prenatal postpartum care. And so I invite you to look at this and really think about, in your own community, where are these services available for pregnant and postpartum family? And so just to end here, I want you to think about our case study and think about that person who has come into your office 15 weeks pregnant, who is seeking treatment for opioid use disorder, who's been using opiates for for seven years and just started injecting fentanyl because that's the only thing that's available in that person's community. The person is reporting tobacco use and having a three year old child at home with a partner who has also in recovery, so how would you approach care to this person? What are you going to ask them? How have your answers that you wrote down at the start of the presentation maybe changed now that you have completed the presentation? And so, again, I invite you to think about what are the physical health issues, but, most importantly, what can you do to establish and maintain that person's trust so they will come back to see you again, making sure that you are asking what they want, what their needs are, what their goals are, and addressing their goals first, and then addressing your goals. And making sure that you're using that shared decision-making approach where you're giving evidence but also responding, you're recognizing that there's a decision to be made about the treatment, that there's a crossroads, that you're giving the evidence that you know of, and then also seeking input and a shared approach in terms of the person's values and needs, and preferences. So just to summarize the talk that I've given, we certainly know that fatal overdose continues to be a growing concern and a crisis in the United States, and we know that pregnancy is not a protective factor against it. We know that untreated opioid use disorders creates a whole host of risks for pregnant and postpartum individuals, we also know that the vast, vast majority of individuals are using substances and become pregnant, it's not that they start using substances after they're pregnant. We know that neonatal abstinence syndrome and neonatal opioid withdrawal are serious conditions and their treatable conditions, and the sooner and the more supportive approaches that we have to support the birthing parent and the child and that diad together, the greater the resilience opportunities we have to improve outcomes. We certainly know that there are a lot of factors in our own control to help reduce the severity of neonatal abstinence syndrome or neonatal opioid withdrawal. So look at your protocols, what are you doing? What is your hospital doing? What can you do to be a change agent to improve dyadic care? Remember that medication assisted withdrawal is not recommended during pregnancy, so if you're going to do that have an individual shared decision-making approach. Remember that both methadone and buprenorphine are approved and product inserts talk about pregnancy and lactation, and other related issues. And we know that those are the most proven treatments to treat opioid use disorder both during pregnancy and in the non-pregnancy period. Remember that we don't have to have more complicated induction procedures with methadone or buprenorphine, we certainly know that the advent of fentanyl has changed the way that we are doing our inductions, and that is a very dynamic field right now with more data to come soon. And we know that when we increase doses or divide the total daily dose and give those smaller doses more frequently, that this can help stabilize our pregnant and postpartum patients, and that breastfeeding is certainly recommended. No medication is perfect, there are advantages and disadvantages. And so, again, taking that tailored approach for what's going to work best for the patient in your office and what they want are good keys to remember. Hopefully we will get more information about naltrexone during pregnancy soon, and that we also know that while all of these medications are found in breast milk, oftentimes the relative benefits outweigh the risks for helping pregnant patients support the best nutrition for their babies. These are a whole bunch of references that we have to support Everything that I said today. I want to make sure that you're aware of the mentoring program, this is a wonderful opportunity for people to have mentor and mentee relationships so that we don't have to do this in isolation. There's also a clinical discussion forum so if you have a clinical question, you can phone a friend, you can ask a colleague so that, again, it takes an entire village to be able to provide the best and highest quality care for our patients. And, finally, this is a collaborative effort, the PCSS, that is led by the American Academy of Addiction Psychiatry but you can see all of the wonderful partners here. And thank you so much for your time and attention.

Dr. Hendrée Jones

pregnant individuals

opioid use disorder

medication-assisted treatment

neonatal abstinence syndrome

methadone

buprenorphine

naltrexone

individualized treatment plans