Good afternoon, everyone. Thank you for coming to this late session in the day. I know that's hard, the early one, the first one, and the last one, right? I'm Jackie Hobbs, I'm chairing this session, and I have a wonderful team here of Dr. Richard Holbert, Dr. Lauren Schmidt, and Donna Vanderpool. And I'll let each one of them introduce themselves, tell you a little bit about themselves as they come forward to speak. We're going to be talking about women's mental health care in 2022, and we're going to provide you with some practice tips and resources for advancing the quality and reducing the risk of your care. We don't have any financial relationships to disclose. The objectives are here for you. We'll be reviewing foundational knowledge required for safe and quality care of women who are pregnant, postpartum, or lactating. We'll show you how to locate reliable and expert online resources and literature. And we will also demonstrate some sound risk management strategies. Also, we would love to hear about your cases. We have some, too, as time allows us to discuss those. But please, in the Q&A portion, please bring forth any questions or cases you may have. And just so you know before we start out that this is an ever-changing field, and sometimes there may be disagreements or controversies about certain treatments, whether to use or not use, and there's differing data. Even those of us on the panel, we've asked each other various questions about, what do you think about this? So feel free to do that. We would love this to be a discussion and that you would feel free to bring up anything that you don't agree with. All right. So I just want to give you a little background of who we are, what we do. We established a women's mental health clinic back in 2006. I'm a residency training director. Actually this was a little before I became training director. But I was working with the residents in the clinic, and a couple of them came forward and said, we really want to start a women's mental health clinic. Would you be willing to help us out, be our attending? And I was kind of like, sure. At the time, didn't really know a lot about this area of psychiatry, but learned very quickly. And I love imparting the things that I've learned over the years to anyone who wants to learn about this. So in general, we've focused a lot on pregnancy, peripartum, postpartum care. We love when it's preconception so that we can actually have the time to sort of figure out the best plan. And we see patients, we usually say, up to about a year, although we do have repeat patients who come back and have more children. And so it's always nice to get to work with them. This period of development for women and those going through pregnancy postpartum has its unique issues and concerns, and they're often looking for answers about the safety and efficacy of psychotropics during this time. And we really feel that all physicians need to understand this area and they're probably going to have to deal with it throughout their career. And these things show up on exams and MOC and things like that as well. So one of the things, again, as a training director, really try to teach residents about this stage of thinking about where, for any patient, doesn't matter pregnant or not, where are they in their life stage? And to be thinking about, for this in particular, the role of hormones and what might be going on and how that might affect their mental illness or the development of mental illness. We also want to be thinking about the various psychosocial stressors at these ages, lots of people dealing with career, school, and things like gender identity, racial bias, discrimination, relationship issues, and do they want to have children or not? And is there domestic violence or intimate partner violence, human trafficking, and cultural issues? So lots of things to sort of be aware of, keep track of. Some pearls I've sort of learned over the years, I remember one of the first lectures I went to on women's mental health, I think this was Zachary Stowe, many, many years ago, said that, you know, always ask women 9 to 49 about possible pregnancy as well as their form of birth control. It's just a quick way to sort of remember 9 to 49 because it rhymes. And I find that trainees don't always ask about this and they don't always document it. So very important to do that. You also want to document all possible exposures to medications or other drugs, especially during early pregnancy. And again, asking about domestic violence, intimate partner violence, and developing a mutually agreeable safety plan. And breastfeeding, always asking about that. I find that trainees forget to ask about that as well and you want to be asking about that early and not waiting until the end of pregnancy. And doing a lot of, I think, counseling about how this will affect them. I always say that breastfeeding is not always natural and it's something that sometimes takes a lot of work and a lot of coaching and different things. And sometimes it just doesn't work. So helping patients to feel comfortable and not have the societal pressures about that as well. And I'm happy to talk about that more later. So again, document, document, document all of the things that we've talked about. You know, this really is personalized medicine. Everybody has a different experience. You know, every pregnancy is different, every baby is different. And knowing the unique psychiatric and medical history, previous episodes of illness, the severity of it. And what's the patient's preference? You know, what do they want? You know, do they want to be on medicines or not? And then, you know, or some other treatments, you know, and helping to work through that with them. And again, documenting all of this. So, you know, you want to answer the patient's questions, also their partner's questions, if they are involved, and, you know, talk about risk factors, serious complications, prenatal care, you know, are they taking vitamins, drugs, alcohol, tobacco use, again those exposures, very important to document. Pregnancy health and complications. And also the permission to talk to their other providers, including their OB. You want to talk about their medications, get a good history of that. And also talk about the risks of untreated mental illness, very, very important because there are great risks with not treating as well. And then, again, risks of continuing or discontinuing treatments. Don't forget about psychotherapy, very important. Sometimes we're always just jumping immediately to medications. But sometimes, you know, it can be used as monotherapy for mild to moderate illness. And it can also help, you know, in combination with medications, can sometimes help to decrease the severity level. And I, with that, I will turn it over to Dr. Schmidt. I'm Lauren Schmidt. I'm an outpatient psychiatrist at the University of Florida. Thanks for coming to our talk. Feel free to ask questions. Again, you know, this stuff is always changing, so it'd be great to discuss some cases. So for my portion of this talk, I will jump around from using mother and parent. Not everyone that goes through pregnancy identifies as female, so we need to include our gender nonconforming and transgender population as well. So sometimes I will jump around. Okay. So let's focus on our medications now in pregnancy and breastfeeding. So about 50% of pregnancies in the United States are unplanned, and this is a good reminder for us as prescribers that we need to ask about contraceptive methods, birth control. Again, as a reminder, not everyone is on hormones or birth control for contraception purposes. And you know, nowadays we have different forms. People may also be on hormones for menopause or for gender-affirming hormone therapy. So here are a few medications that we prescribe quite often that interact with estrogen and progesterone. So these medications, and I know I prescribe a lot of them, will break down estrogen and progesterone faster, making the birth control less effective. So it's really important if I start, you know, a 25-year-old cis female on NuvaGel for ADHD that I am reminding her you may want to consider an IUD or additional barrier methods for practice. Lamotrigine, I think we prescribe a lot nowadays. Our neurology colleagues do as well. So this is just a reminder. So lamotrigine is metabolized by the UGT enzymes. Estrogen induces this, right? So if I have someone I'm seeing that's getting gender-affirming care with estradiol through their endocrinologist, I need to be mindful of this. The levels of the lamotrigine can drop by as much as 50% when you use estrogen with it. You can see here from Sidhu et al. this figure I pulled. We also see if a cis female takes birth control, as many women do, so three weeks with medication, one week placebo or sugar pill, that our lamotrigine levels are climbing again. So during that red interval or that pill-free week, we want to be assessing are they having any side effects from lamotrigine? So are they having diplopia, ataxia, dizziness? It's also really important because if I have a female who is on a lamotrigine dose of 200 at night and is still really unstable, if they are on an OCP, I may want to bump that dose up to 300 or 400. It's a reminder that lamotrigine will also lower progesterone. So in my practice, I let my patients know that it will lower progesterone about 20%. The research I've seen thus far says that it hasn't led to any unwanted pregnancies, but I usually let them know and I ask about breakthrough bleeding. So shifting gears now, antidepressants and anxiety medications. Biggest takeaway is pregnancy alone is not a protective factor. So I see a lot of times when we have our safety risk assessments, we'll put pregnancy as a protective factor. Not necessarily. So it's a reminder that stress, untreated depression, untreated anxiety leads to dysregulation of our hypothalamic pituitary axis. What happens is we get increased corticoreleasing hormone, which could lead to early labor and preterm delivery. We also see increased cortisol, which could lead to a decrease in placental blood flow in small gestational age. So I think a lot of our patients come in appropriately concerned about the effects the medications may have on their pregnancy, but we need to let them know, you know, untreated depression, untreated anxiety, there are also risks. Some of the newer research is looking into the neurodevelopment of the offspring as they grow. What we see is that a lot of offspring exposed to those who were untreated depressed or untreated anxiety actually have an increased vulnerability to mood and anxiety. There was this exciting paper that came out just last year that looked at MRI brains of offspring children three months to six months. They looked at it in children who were exposed to mothers, in this case, who had untreated depression. What they saw was that there were larger subcortical gray areas and smaller midbrain volumes on MRI compared to those whose, in this case, mothers were not diagnosed with clinical depression. What really was interesting was that they also looked at the kids who were exposed to SSRIs and didn't necessarily see this finding. There's thoughts that there are some connection differences between some of the prefrontal cortex and the amygdala in these individuals. SSRIs, so how many people feel comfortable using antidepressants, SSRIs, in pregnancy? Wonderful. You should, so that's great. We have lots of data on SSRIs and most of it is very good. It's a reminder that in the United States, the baseline risk of congenital malformations is about three to five percent. Overall, SSRIs do not increase this risk. I think a lot of our OB-GYN colleagues and family medicine colleagues tend to use Zoloft or Sertraline first. You guys see that? Yeah, because of a lot of the data earlier on. Zoloft's great. I love Zoloft. It has a very low amount gets into the breast milk, but don't switch someone to Zoloft just because of that. Basically whatever has worked to keep someone stable is probably what you should continue in pregnancy. Paxil or paroxetine has been more controversial and Dr. Hobbs can add to this as well. So in 2005, the FDA basically warned clinicians that paroxetine may be associated with increased cardiac defects through prenatal exposure, specifically septal defects and then right outflow defects. Then some studies went on and they kind of backtracked. I do think though that paroxetine still remains kind of controversial. This was done in 2014 looking at the risk of cardiac defects in different antidepressants. And so I know you can't read it, but the top A, so the top is unadjusted. So in the unadjusted analysis, yeah, things favored not using medications. In the middle there, we have adjusted for depression and then the bottom is adjusted for depression, but also co-founding variables. So stress, obesity, geographical location, socioeconomic status, race, et cetera. And actually in this, what they found was that there was no significant increase in the risk of cardiac defects with any of the medications. So this included the ones I have listed here. So what should we tell our patients who may want to continue an SSRI, SNRI, or start one in pregnancy? Well I think we need to let them know about the 25 to 35 percent risk of postnatal abstinence syndrome. So this is very common, babies born, and there may be some symptoms that are very transient, meaning may last a week or two weeks, usually do not require the baby to go to NICU, but possibly may for monitoring. Things like hypotonia, trouble maintaining their temperature, trouble maintaining blood glucose, very rare risk of seizures. And I get a lot of my information from MGH Women's Mental Health Center. So if anyone's out there, thanks for what you're doing for all of us, because you offer a lot of free resources. That's very helpful. But what those experts usually say is, this is not enough to recommend discontinuing the medication in the third trimester. If the mom's doing well, if the parent's doing well, continue it. But this is something we do want to let our patients know about. The second thing, so persistent pulmonary hypertension. So this is usually something seen in at-term babies developed within 12 hours of delivery, usually with dyspnea, trouble breathing. So there's increased resistance to the pulmonary arteries and leads to deoxygenation of a lot of the blood. And for a while, this is what we heard of. What we now know is that, yes, even though there is a significant risk with exposure to SSRIs and possibly SNRIs, it's a very small risk. So I usually tell my patients that there is an increased risk, but it's very, very small. And when they've looked at some research, here I pull Hubrex, if you're here and I mispronounced your name, I apologize, et al., and in theirs they found that actually black race, C-sections, in maternal diabetes were more associated with this than SSRI exposure during pregnancy. But these are the two things I like to make sure my patients know before making a decision. Just some takeaways on some of the others. So SNRIs overall has good data. I feel safe using it. There's some concern that maybe there may be some preterm births, bupropion, and this could be something that we may or may not agree on, I don't know. But early data showed that it may increase cardiac defects. We've had a lot more research, including the one I just showed you, that has not showed that. So I also feel comfortable using that. Mirtazapine. So mirtazapine, we just have less cases on it. So it may not be something you want to use first line if someone can be on a different SNRI or SSRI. But I would keep in mind special population, right? So remember, it's an antagonist of 5-HT3 receptors. And so, you know, our parents during pregnancy who are really nauseous, vomiting, upset, this may be an option for them. They may need something like this. Are we doing questions during the talk? Oh. Sorry. Yeah, let's wait. TCAs. So you can use them. We tend to use ones that are less anticholinergic, so you're not as worried about hypotension. And then MAOIs are a lot harder to use in pregnancy. Again, the risk of hypertensive crises. So I'm not going to repeat what Dr. Hobbs went over, but I would just be mindful of language. So feeding is really important. It's a personal decision. I think we now need to expand some of our language from just breastfeeding and formula feeding to chest feeding. We also have to be mindful of some of the patients and partners that they actually can do co-lactation. That's a thing. And then for people that cannot breast or chest feed, we do have a lot of human milk storage banks throughout the United States. So just things to keep in the back of your mind. Okay, moving on. So mood stabilizers, anticonvulsants, and antipsychotics. So here's a reminder of the medications we typically use in bipolar disorder for different episodes. And we'll start with lithium. So we know that lithium does have a significant increased risk of Epstein's anomaly. So even though it is true, the absolute risk is very low. So this would be early exposure, first trimester. So lithium exposure about 1 in 2 out of 1,000 versus at baseline 1 in 2 out of 20,000. Epstein anomaly is when the tricuspid valve is malfunctioned leading to an enlarged right ventricle. With lithium we also know that the risk is dose-dependent. This is really important because if we have made the decision with our patient that we need to use lithium in the first trimester, we really want to try and use the lowest dosage effective. So we see here the relative risk is above 3 once we get above a daily dose of 900 milligrams. So if we made the decision we're going to be using lithium throughout in an ideal world, this is what we would do. We would know where the patient is stable, what level before they enter pregnancy. Some people will say use BID dosing so that it's more stable throughout the 24-hour period. If you're in a larger academic or urban center where you can work with a high-risk OB-GYN, that would be great. So the first trimester, as a reminder, lithium level is going to start to decrease. So due to the changes in the clearance and the GFR, the level is going to start to go down. During this time we really want to be doing our regular lithium blood work every 3 weeks. As we enter the second trimester, the lithium level is going to hit the lowest. So clinically we may need to increase it. This is also a time where if you have OB-GYN involved that we want to be doing a fetal echo. So that's really important. And then as we enter the third trimester, changes are going to lead to the lithium level going up again. Past 34 weeks, the lab work really should go to weekly. So people have different opinions on this. I think in the past it's been mom, parent delivers, hold lithium, change the dosage right away. I think the newer trend has been monitor closely, don't freak out. Be of time to get the lithium back to the pre-pregnancy dosage. So monitoring is really important during this time. But I wouldn't panic. I wouldn't abruptly stop it. And this is really important, especially for CL colleagues. Isn't this baby cute? It's really cute. So lithium and breastfeeding, Dr. Hobbs and I were talking about this. She was saying in the past people have really said, don't breastfeed on lithium. It's changed some. I think the recommendation is still don't. However, if you have someone who really wants to and they have a pediatrician that can collaborate and work closely with you, it can be done. It just requires a lot of monitoring. So you see here some of the recommendations for what the monitoring would be and then how much lithium in the peak onset based on the formulation. So lamotrigine. Overall, lamotrigine looks very safe in pregnancies. I think the early studies showed facial cleft palate malformations. The more recent larger studies have not necessarily shown that. So what we can say is that oral cleft palate malformations are unlikely to be more than 1 in 550. I have tended to keep a lot of my patients on lamotrigine during pregnancy if they're doing well and have bipolar II, etc. And again, a lot of good data, IQ is expected, which is not true with every moot stabilizer. So as we spoke of earlier, there are interactions between estrogen and lamotrigine. So it's something to be mindful of during pregnancy. So the lamotrigine clearance is going to increase and thus the level is going to decrease. So unlike our neurology colleagues who really rely a lot of times on the lamotrigine level for anti-seizure stabilization of preventing seizures, I think as a psychiatrist we do it clinically. So I would not increase the lamotrigine in pregnancy just for the level, but you may need to increase it clinically if you see symptoms are worsening. And then again, about within a month after delivery, the lamotrigine level will tend to return to its pre-pregnancy baseline. So drugs to avoid. I think you have to have a really good reason to use Depakote in a reproductive cis female. And if you are going to use it, document really well. So Depakote, I mean, it's really scary to use in this population. So when we all know this, the neural tube risk is about 10%. The newer studies are showing that it affects IQ and neurodevelopmental disorders. So again, if you need to use it, really document carefully. Carbamazepine, oxycarbamazepine, arthcarbamazepine are similar, associated with about a 1% neural tube malformation risk. And then topiramate. So don't forget about topiramate. Again another med that a lot of our patients may be on through us or through neurology, but it does have an increased risk of facial cleft malformations. So if we need to use something and can't use Depakote or some other mood stabilizers, we may use an antipsychotic. So the typical antipsychotics have been around for a while. We have a lot of data on how dull in pregnancy, and overall it looks very good. There is an increased risk for these transient muscle-like movements in the baby, so something we can let the patient know. We're seeing a lot more second generation atypical antipsychotic use. So if you went downstairs to where all the vendors are, they have a lot of new fancy atypical antipsychotics. And we're seeing them at lower doses as well. So here's a summary of kind of what we know. So on the good side, no increased risk in miscarriage or stillbirth. Maybe early delivery. The babies could be different sizes. We don't always see small gestational age or large. Again the risk of some muscle movements. And then the bottom, so there are some studies that showed risks of cardiac and cleft palate defects with using risperidone or paliperidone. However those studies were also in the context of polypharmacy and substance use, so hard to untangle. So I do think, and we can talk about this later, a lot of providers are okay using risperidone during pregnancy. So risperidone, quetiapine, olanzapine, clozapine are associated with weight gain and gestational diabetes. And that's usually what I'm communicating to my patients, that this is a risk and they probably need to be monitored more closely. The OB-GYN or whoever is working with them should be doing glucose tolerance tests that are at a greater power than the ones they usually do. And then Seroquel is a nice med because it doesn't have a large placental passage rate, so it's something that a lot of people feel comfortable using. And then a lot of these are not contraindicated in breastfeeding. So what do you guys do with new or atypical antipsychotics? So the Latudas, the Vraylars, the Rixultis, and again we can talk about this after. I think it's hard. So we've definitely had a number of patients that have gone through pregnancy in our clinic. I know on Latuda. I think as providers we can let the patients know as a class the concerns. We may not have the data available for the individual medications. This is where there's no perfect answer. We can just provide the information we have. Clozapine. So I was talking to some of my OB-GYN friends, and they actually feel very comfortable using Clozapine throughout the pregnancy. They're just monitoring a lot more for diabetes and weight gain, and that's the risk. Prior to delivery, if you can, some suggest decreasing the dosage no more than 50%, but this could reduce hypotonia or floppy infant syndrome and seizures in the baby. And then breastfeeding is contraindicated because of neutropenia. Long-acting injectables. So research shows that prescribers tend to stop or not use long-acting injectables in pregnancy. Here you can see some patient criteria, reasons we may want to use an LAI in pregnancy. And I don't think this is surprising. Frequent hospitalizations, emergency medication use, really bad symptoms during postpartum or previous pregnancies. So here are a number of the LAIs we have available in the United States. A lot of people like using them during pregnancy, again, because of that constant level throughout the day. Certain medications we may pick that have a better metabolic profile than others. And then we just have to be mindful. So Abilify gets metabolized easier in pregnancy. We may need to increase the dosage. It's also a medication that often reduces prolactin levels. So it may interfere with breastfeeding versus other medications that are dopamine antagonists. They can lead to overproduction and the mother or the parent could be at risk for mastitis. So just things to monitor for. So this was really exciting. Antipsychotic medications and neurodevelopmental disorders. So it came out this year. And they looked at, it's exciting because they used Medicaid. So they used our public insurance and then they used the market scan research of our more private insurance patients. And we had a large sample size. And they followed the children that had exposure during second half of pregnancy to an antipsychotic. They used a number of atypicals. I believe they also used Haldol. And what they found is in the unadjusted that there was a big difference. There was an increased risk of neurodevelopmental disorders in those exposed versus those not. However, when they then controlled for, in this case, the maternal mental health morbidity, that difference overall went away except for Abilify. So with Abilify there was still a signal. The individuals that were in the study, they followed until age 14. They looked for things like ASD, ADHD, learning disabilities, behavioral disabilities, etc. And most of these are usually diagnosed by age 8, not always. So this is really exciting to be able to tell our patients that we have some research about neurodevelopmental disorders with exposure to antipsychotics. Again, it's really early, but something that I don't think we've been able to comment on for a long time. So ADHD in pregnancy. So Kolding et al. used this figure. From 2008 to 2013, they showed a five-fold increase in first trimester exposure to ADHD medication stimulants. This is something that we're seeing a lot in the clinic. In an ideal world, it would be great to have the discussion of whether your parent wants to stay on current dose, decrease dose, or stop stimulants prior to pregnancy. But again, we're not always able to do this with the number of unplanned pregnancies in the United States. We do know that for mothers who come off ADHD medications, they can have an increased risk of depression, and they can have worsening function at work and at home. So it's not an easy decision, especially for a lot of working parents. We're fortunate that we have at least two really large studies that looked at congenital malformations with stimulants. So the one I'm going to refer to here, 2017, they looked at, again, U.S. Medicaid and then the Nordic databases. What we see is after they adjust for the psychiatric comorbidity or morbidity, an overall congenital malformations, there was no difference. The big takeaway is that there is a small but significant increased risk in cardiac defects with exposure to methylphenidate, so something to discuss with your patients. If we stick with the same study, this one was just Medicaid. So this one here, we're pooling now Medicaid and the Nordic database, and they found pretty much the same thing. So you can see on the bottom, the axis favors the unexposed for cardiac malformations. So again, relative risk for any malformations, 1.07, but for cardiac is 1.28. Going on to a study from Colding et al. in 2021, they found similar things. So they found with methylphenidate, yes, there was concern with cardiac defects and the number needed to harm, they estimated, was 92. I'm seeing a lot more of nuvigil, provigil being used, especially in patients that struggle with chronic fatigue, ADHD, sleep concerns. I would say don't use this in pregnancy. As of now, we do know it's increased risk associated with a number of things. Stimulants and breastfeeding. So I think if you've made it through pregnancy, it becomes easier for us as the prescriber. So we may want to restart stimulants, especially if a parent has to return to work or to daily function, and we have a number of studies that looked at various doses in breastfeeding. I think the immediate release medications can be easier to dose with flexibility with sleep. So after mom or parent would take them, they would last about one to two hours, the peak in the breast milk, versus some of the sustained medications, which are going to remain elevated for some time. So it can be harder to dose. Postpartum. So I'm going to go through postpartum really quickly, just so I can make sure our co-presenters have time. But, oh, look what happened. So delivery and then the hormones plummet. I think in the past, there's been a critique that once baby is born, mom or parent is like the candy wrapper that gets thrown away. So postpartum period is really important. So that first year, 12 months after delivery. But it's also a reminder to us of all the hormone changes going on. So postpartum depression, different than postpartum blues. The blues we usually see within the first two weeks. Very sensitive to emotions, can cry over anything, a cartoon, versus postpartum depression where they're meeting criteria for depression. This can start two weeks, four weeks after delivery. It can also start three months after delivery. So it's really important that we're following this patient group throughout the year. So SSRIs are still the first-line treatment. Many of you have heard of the newer Zolresil or Brexan alone, which is a GABA receptor medication. And it's designed so that a patient would receive it. It takes effect pretty immediately. It will last for 30 days while the SSRI medication is kicking in. This form is IV. I believe they were coming out with maybe an oral medication. Relapse risk in bipolar disorder should scare people. It's very serious. And so we see that even our patients that stay on medications can have a high relapse rate during the postpartum period. Risk factors for bipolar relapse, so the severity of the illness. Have they had effective symptoms in a previous postpartum period? Is this the first pregnancy? Family history and then of course OB complications. Postpartum psychosis, you really want to think of it as a psychiatric emergency. So the first thing is evaluating for safety of the parent and of the baby and the family. This usually arises pretty quickly. So onset, I think I put here on average, is within the first two weeks. And new onset postpartum psychosis should be thought to be possible on new onset of bipolar disorder because that unfortunately often happens. Postpartum psychosis, so the risk factors I'll let you look at on the left. Treatment. So lithium actually has really good data, so this should be a medication we should consider. Also augmenting with an antipsychotic, ECT, which Dr. Holbert is going to talk about very soon. And then does this patient need to be in an inpatient facility? If this is the only psychotic episode, you know, after a period of 6 to 12 months, the patient may be able to come off the medication. I'm going to transition to Dr. Holbert. Thank you very much. I'm Rich Holbert from the University of Florida. I have a lot of titles. One of them has to do with neuromodulation. I'll end the introduction that way. So let's talk a little bit about neuromodulation in pregnancy. I won't talk about postpartum psychosis. I'm only going to talk about pregnancy. So hopefully by the end of this, you'll have some idea of the use of ECT in pregnancy and be able to describe the current use of TMS during pregnancy. So what are the indications for ECT in pregnancy? In reality, they're the same as the indication when someone's not pregnant. That's the bottom line. However, some would argue that the severity needs to be worse, such as someone who has such severe depression that they're not eating at all. They're not taking in fluids, just not able to care for themselves. Or patients who have severe mania where they're putting themselves at physical risk and also neuroleptic malignant syndrome. So what are the maternal risks of ECT in pregnancy? Pretty similar to the population who's not pregnant. So you have the cognitive side effects. You have the anesthetic side effects. You can have a risk of prolonged seizures. And this is extremely important in pregnancy. Because there's been a few documented deaths of fetuses receiving ECT in pregnancy. And one of the main reasons is due to status epilepticus. There is a risk of also vaginal bleeding, especially in the first trimester. But all of those documented cases, the bleeding has spontaneously resolved. And there's been no further adverse effects on mother or the fetus. And there's also a risk of premature labor. But let me add, there has not been shown to be premature birth. How about the fetal risks of ECT in pregnancy? Ectecharythmias, okay, not uncommon at all. Fetal bradycardia, and that occurs during the tonic phase of the seizure. And there's also the risk of death, as I had mentioned earlier. So we should remember that ECT can be used in all trimesters, first, second, and third. At the minimum, fetal heart rate monitoring should be done prior to the ECT and after each ECT session. And airway management is critical. So many, many recommend intubation after 14 weeks. Because those who are pregnant at 12 to 14 weeks are considered to have a full stomach. Some other things that I just want to mention in pregnancy. It's very, very important with the pregnancy to avoid aspiration pneumonia. And this can be done in a couple of ways. One is obviously by intubation. Another is by using sodium citrate to prevent gastric acidity contents from coming up. And as we always do with ECT, keep the patient NPO. Now the only problem keeping the patient NPO, which we have to, is that puts the person at risk for dehydration, which can increase the risk of preterm contractions. So if that occurs, you want to ensure that in subsequent treatments, you provide IV fluids. I'll just mention that hyperventilation in pregnant patients is debatable. Oftentimes we hyperventilate patients in ECT to supposedly lower the seizure threshold and provide so that we can utilize less charge to provide an adequate seizure. But what happens in pregnancy is pregnancy is a state in which there's chronic mild hyperventilation. So if you hyperventilate, that can cause respiratory alkalosis, which can lead, it doesn't always lead, but can lead to less passing of oxygen from mother to fetus. So to kind of close out ECT in pregnancy, the APA considers it safe and effective in pregnancy and so does the American College of Obstetricians and Gynecologists. But as I mentioned, not without risk. Now let's quickly talk about TMS in pregnancy because there's just not much data there. Through 2020, there's only 67 documented cases. That's it. So actually, I'm not going to go through the mechanism of transcranial magnetic stimulation. And I think you all know that. Fancy picture. Now, what are the side effects of TMS in patients who are not pregnant? Well, they include holocephalic headaches, okay? Almost always relatively mild, easily treatable with acetaminophen, ibuprofen. There's paresthesias at the coil site, right? I'm always interested and I'd love to get your feedback on those who do TMS. That's always considered not as frequent as headaches, but that happens in almost every patient at least the first couple of treatments. There's a theoretical risk of a seizure with TMS, but that risk seems to be less than with antidepressants. You can get lightheadedness, jaw pain, and there's no known cumulative toxicity with extended exposure. Now, what's ... And those risks are the same as in those who are pregnant, okay? So in summary, there's no definitive guidelines regarding TMS treatment in pregnant patients. There's none. As I mentioned, through 2020, 67 documented cases. Only one double-blind placebo-controlled trial by Kim et al. of 22 patients. Now in that study, the HAMDs statistically significantly decreased from sham treatment, but remission and response were not different. Now they also studied estradiol and progesterone pre-treatment and post-treatment, and there was no difference. So in summary, TMS may be effective. Seems to be safe because there's absolutely no documented obstetric complications or neurodevelopmental complications, but remember, 67. And the Pridmore review here is very nice and was the last nice review of TMS. So I highly recommend looking at that if you have not. Thank you so much. So I'm Donna Vanderpool, and I am the Director of Risk Management at Professional Risk Management Services. PRMS is a professional liability insurance company, and we sell to psychiatrists. So I wanted to thank you for letting this attorney chime in here with some risk management advice and thoughts from the legal perspective. We've heard a lot of clinical. Let's take a little bit of a sidetrack to get some legal perspective. So this slide just has a few reminders about your psychiatric malpractice risk in general. Psychiatry is the least often sued medical specialty. Your greatest exposure, not limited to reproductive psychiatry. In terms of frequency, it's going to be the psychopharmacology and suicides. Those are your greatest risks in terms of frequency. In terms of severity, it's actually not the death cases. It is the cases that have significant permanent physical or neurological injuries that require the need for lifelong care. So to prevail in a medical malpractice lawsuit, plaintiff, the one who is suing the physician, or the plaintiff's estate, has to prove all four of the elements listed on the slide. There's duty, duty to meet the standard of care, negligence. So negligence is not malpractice. It's one of four elements of a malpractice lawsuit. So negligence is the failure to meet the standard of care. So I keep saying the standard of care. I'll just throw out that there are specific factors that can evidence what the applicable standard of care is in any given clinical situation. And these would include laws, federal and state, regulatory guidance from your regulators, such as your licensing board or the DEA, authoritative clinical guidelines, such as those from the APA, ACOG, and then treatises, research journal articles, the FDA medication label, et cetera. And in litigation, it's going to be the expert witnesses, your colleagues in the role of expert witness who will testify as to what the exact standard of care is in any specific case. Another element the plaintiff has to prove is harm. This can be physical. It can be emotional. It can be financial. And then causation, that's the final element. And generally this is the most difficult element for a plaintiff to prove. Yes, there may have been patient harm. There may have been a suicide. And there may have even been negligence. The psychiatrist did not meet the standard of care. But negligence didn't actually cause the suicide. As psychiatrists, I will throw out that you are much more likely to get an administrative action filed against you, such as a licensing board complaint, than a claim, which is a demand for money outside of litigation, or a lawsuit. Okay? And this is unique to psychiatry, I believe. Not true with the other specialties, but our numbers, so we insure psychiatrists across the nation. Similar to 2020 and 2021, 72% of all the actions coming into our program were administrative actions. Only 28% were claims and lawsuits. Even pre-pandemic, oh, can we even remember pre-pandemic? 2019, 62% of all actions, again, coming into our office were administrative, 38% were claims and lawsuits. Why are licensing board actions so attractive to your patients? Because you don't have to prove, plaintiff doesn't have to prove, those four elements. There may be no harm, right, but the patient or the patient's family's mad. If they can't get you in court, they're going to want to go after your license. But as you've heard, you know, and I think a takeaway point, hopefully, from my section is, fear of liability should not prevent your appropriate treatment, okay? Now, let's move on to the reason that we're here, perinatal psychiatry. My advice comes from the legal actions that I see reported, I see brought against my insured psychiatrist. I'm old, I've been doing this for a long time, I've seen a lot have come through across my desk, but there is a dearth of reported cases on this topic. It does not mean that lawsuits don't exist. They do, they're just not reported. So in the vast majority of these cases, the psychiatrist may choose to settle to avoid a trial, settlements are not reported. And typically, only appellate decisions are reported. So I can't share the details of these cases, but I can share some common allegations. Harm from medications. Harm from failure to treat. Okay. This makes sense. Failure to treat can lead to bad outcomes, which can lead to malpractice actions. So a couple of variations on this failure to treat. It's treating but without medications, or not treating at all, terminating or as your patient will say, abandoning them. And then lack of informed consent, or often lack of adequate informed consent. I'm sure you've also heard about the class action suits against drug manufacturers, including those related to birth defects. Keep in mind that class action suits against pharma, they're very, very different from medical malpractice cases against the treating psychiatrist. These are going to be product liability cases against pharma, typically alleging lack of proper labeling. If the prescriber were to be named as a defendant, the drug manufacturer would get that prescriber dismissed almost instantly. Okay. They're not going to have any of their prescribers involved in that litigation. And then the good news, the best way to decrease your professional liability risk, as always, is to do what you already do, provide good clinical care. And the last point on the slide is a big one. You've already heard this from, I think, all the speakers. It's the risk-benefits of treating versus risk-benefits of not treating, and it's a balancing of risks. It has to be done for each and every perinatal patient. Harm to self or child is rare, but perinatal depression increases the risk of suicide, and mothers with depression report more thoughts of harming their infants than mothers without depression. So here is our framework for providing good clinical care. I'm not telling you how to practice psychiatry, rather I'm offering a framework to ensure nothing is forgotten. It's really just three strategies. It's the three C's. It's collecting information, communicating, and carefully documenting, and they apply in any clinical situation. We're going to go through some of these in the context of treating pregnant patients. So first C is collecting information and first about the patient, history. Has the patient had postpartum depression or psychosis? What's been the patient's response to medication? What's the current pregnancy status? If there are concerns about suicide or homicide, your colleagues who serve as expert witnesses will say under oath it is the standard of care to at least try to get past treatment records. Even if you're not successful, document your attempts. Now seeing prior treatment records may not change your course of treatment, but it could give you a more nuanced understanding of your patient. If you're treating inpatient, you've got to read as much of the record as you can. One case, the psychiatrist who was treating a pregnant inpatient was admitted after telling her OB of her wish to harm the fetus. The patient was discharged and the patient actually suicided the same day. The patient's estate argued that the discharge was negligent. And the psychiatrist had to admit that she hadn't seen a note in the hospital record about the patient continuing to have altered thoughts towards the baby. This makes it easier for plaintiff to say her discharge decision was negligent. I'm not saying if she had seen the note she should not have discharged the patient. It's always the psychiatrist's clinical decision. If she had seen it though, she could have addressed it in her note and explained why she still felt discharge was appropriate. And this is a true case prior to the actual trial starting, the psychiatrist moved for summary judgment, basically saying there's no negligence here, court, so there's no need for a trial. And the trial court disagreed and said, well, we understand that your expert says there was no negligence, but plaintiff's expert will testify to the opposite and say there is negligence. So the psychiatrist who lost the motion for summary judgment appealed that denial. And the appellate court confirmed the denial of summary judgment. The case was allowed to proceed. There is no reported outcome. So you want to systematically assess as needed for harm to self and or harm to the baby. History of violence including child abuse, history of psychosis. And as a risk manager, I can't help myself, please check your state's prescription monitoring program even if you're not technically required to. If you start practicing as this is a great way to get information you may have not otherwise obtained, I think you're going to be surprised occasionally at what you find in those PMPs. You also want to collect information about the treatment as you're doing right now attending this session. Other options, clinical textbook, the APA's textbook on reproductive mental health came out just this year, a little earlier. Treatment guidelines, APA and ACOG have a joint one, SAMHSA. Understand that plaintiff's attorneys, those wanting to sue you, they know all about these guidelines and will try to say they are the standard of care. They are not. They are just one factor that goes into determining the applicable standard of care. But if you deviate from an authoritative clinical guideline, document your reasoning. By doing so, plaintiff's attorney and plaintiff's experts don't get to make up their own story about what happened in your treatment and why. Also information on malpractice claims data may be useful. Our data, I want to share with you, shows it's not a surprise post-discharge, very, very high risk time for harm to self or infant. And sometimes it's literally on the way home from the hospital. You also need to be aware of what the FDA drug label says. If you are ever on the stand as a defendant in a medical malpractice case involving a medication, undoubtedly you will be asked whether you have read the label. You want to be able to say yes under oath. And remember the Learned Intermediary Doctrine, basically saying once a risk of a medication is known, it's the prescriber that's responsible for ensuring the medication is used appropriately. So you really need to be aware of what the FDA Medication Guides for Patients say. I'm just going to show you, I have three samples. This is the first one, fluoxetine, putting patients on notice of certain risks when used in pregnancy. You need to ensure this is covered in your informed consent discussions if you're choosing to use this medication. And a big part of what you may be discussing with the patient could be covered in these patient medication guides that the FDA puts out. Next one is on lithium, again from the patient guide. This is not to restrict your prescribing. It is still your clinical judgment based on an evaluation of the risks and benefits for your specific patient. And we've already heard, you know, it may not be the first choice, but there may be a very valid clinical reason why you want to keep your patient on lithium. Just understand, plaintiff's attorneys know about these medication guides. And you need to know what these guides say as well, and you want to document your clinical decision-making. Okay, last one is for lamotrigine, unknown risk to the baby, but it does pass into the breast milk and may cause problems. Second C is communicating, first with the patient, including your informed consent discussions. It's so important with this particular patient population. Risk benefits and alternatives including no treatment, pre-pregnancy including what to do upon learning of pregnancy. Maybe you want to tell them, don't stop medication without speaking to me. And we've heard, 50% of pregnancies are unplanned in the U.S. That means all psychiatrists with female patients could have patients who become pregnant unexpectedly while under their care and may be taking psych meds. You want to discuss pregnancy risks, again risk of medication versus risk of untreated illness. Medications can have breastfeeding risks. And the FDA patient medication guides again may be helpful. You give the patient a copy to take with them. You keep a copy in your chart so you know exactly which version was used because they are frequently updated. You also need that ongoing assessment of your patient. You're educating the patient, risks of meds, risks of untreated illness, and educating that going off a medication is not going to ensure a safe pregnancy. You've got to educate, manage their expectations. You may need to communicate with others such as the family or significant others, particularly if there are any safety concerns. You may need to communicate with the patient's health plan such as if you need the patient to stay inpatient a few days longer, communicate with the health plan. You'll be communicating with others involved in the patient's care, the treatment team, the OB, maybe a therapist. If the patient's hospitalized, you may be communicating with the discharge planning team, the outpatient psychiatrist. And consults, a favorite of risk managers. Get them. Never hesitate to get a consult even if it's to confirm how right you are, right. There are more and more reproductive psychiatry programs. Please give consults if you have expertise. Patient-to-physician consultation has almost no risk at all. Why? Because the physician asking for the consult is free to ignore what the consulting psychiatrist recommends. There may be times when an informal consult may not be appropriate and you need to refer the patient for a formal consultation. Our last C, careful documentation. Remember the primary purpose of documentation is continuity of care, enabling others to understand what happened in your treatment and why. So other speakers have brought up great points about what needs to be documented, document the consent, that shared communication process, document your assessments and monitoring, your decision-making process, what you did and why, and what you considered but rejected and why. Risk managers love the word because. It forces you to explain your thought process. Be sure to address in your documentation other information in the chart that seems to conflict with your actions. Plaintiffs' attorneys like this scenario. The psychiatrist okays the patient for discharge without addressing other information in the record indicating the patient's not ready for discharge, such as a therapist's note, a social worker's note. Another documentation point, it's a rule of evidence, the professional judgment rule, under which the treating physician is entitled to deference by the court as long as there's something to base that deference on. And that's the treating psychiatrist's contemporaneous documentation that allows the psychiatrist's treatment and decision-making to be understood. My last documentation point, documentation is a huge part of your defense. If your documentation shows identification of the issues, communication of the issues with the patient, again that allows your work to be understood, makes it much harder for the opposing side to make up their own version of what happened and why, and it's hard for them to criticize your professional judgment. And then I know you've had some resources all along. I'm going to add one risk manager's reading list. And thank you for the opportunity to share these thoughts. Thank you so much, Donna. So I'm just going to round things out very quickly with just some sort of risk management perspective from a physician's perspective. Just as Donna talked about the three C's, I kind of have the A, B, C, D, E's. Asking about the possibility of pregnancy, how many weeks, documenting all of that is very important. The breastfeeding, whether they plan to or not, contraception, as we've heard from our other speakers. I think instead of working, we use the term draw a crowd. I had a colleague who used to say that all the time. When in doubt, draw a crowd. And part of that can be working with consultants, working with OB, just working with your other colleagues around you if you have questions. And then exposures, documenting those, any prescribed, non-prescribed types of medications including over-the-counter type things. I want to draw your attention to some resources that are there for you. There was a focus that talked about risk management. There was clinician liability in prescribing antidepressants. That article had a section on pregnancy. And then also medicating during pregnancy was another article in that 2019 focus. And there's some great quotes out of these. And I think this is something that the APA is actually trying to address along with the CDC is to really help physicians, including psychiatrists, to understand don't just stop medications just because someone tells you they're pregnant or lactating. So it really has to be an informed consent and weighing of risk-benefit. And as we've seen, there are a lot of medications that are considered pretty safe to utilize and can help prevent things like suicide. And I always say, my Jackie Shakespeare, to medicate or not to medicate? That is the question. And really continuing the medication still seems in general to outweigh the risks, especially if someone has very severe illness. I think that things we have to keep in mind when we are looking at the literature, what kinds of studies are they? How extensive are they? Many of them have small ends. There are methodological issues, lack of controls and confounders. So really looking at those sorts of issues before you make decisions for your clinical care and remembering that case reports can be interesting and informative, but they're not always the best evidence. And a statistically significant association may not be clinically meaningful. We've all probably heard that in our training. And also a large change in relative risk of an adverse outcome may not be clinically meaningful. So we really have to look at that absolute risk. And I know that Dr. Schmidt talked a lot about some of the studies where the absolute risk was actually pretty low. And then some congenital malformations are very rare. So you would really need a large sample size sometimes. And so we don't always have that statistical power. There are rating scales that you can use. A big one in this field is the Edinburgh Postnatal Depression Scale. So I highly recommend that. It's in a lot of our electronic medical records. So if you have the ability to use that, definitely do it. Or just print it out and fill it out for your patient. Have them fill it out. And then, again, for safety's sake, always just looking for the potential for suicide, homicide, violence, and also psychosis. So using some sort of screen for that or clinically looking for these things. And really, you know, I think what Donna's case, really trying to understand if mom is having thoughts about harming the baby or herself. Get consultation whenever possible. Anyone who, you know, works in this area and has good information also using things like the Mass General Resource is very, very helpful and sort of have listed these for you as well for your use. But definitely just going to the womensmentalhealth.org can be very helpful. You can subscribe to an email, newsletter will come right to your inbox. And I think we'll, you know, COVID definitely has complicated things, led to increased stress, you know, depression and anxiety and suicide. So something we definitely want to keep in mind as we think about our patients. We're not going to cover the perimenopausal period, but it is important to remember, as I said in the very beginning, thinking about the life cycle for your patients. But we have some information there as well. And I think we will take questions. »» Thank you. »» Thank you. »» Thank you. And if you can come to a mic, if you have a question, we might need to put that one mic back. Because we are recording, so we do need to be able to hear those. »» I have two questions. One, I was curious about what are the administrative complaints that was coming up that you may have mentioned in like that 70%. And then also if you could talk more about the fetal related deaths in ECT. »» So I can start with the administrative actions. So remember to get into court you have to have damages. So a lot of the administrative actions, licensing board complaints being the bulk of it. Others could be like an OCR investigation for a HIPAA violation. You're talking the bulk of them, licensing board actions. It's a breach of confidentiality, right? You may be so mad that this happened but there's no real damages so it's not attractive to an attorney. Suicide cases where you've gone to, the plaintiff has gone to attorney after attorney after attorney and the attorney says, no, the care is well documented. I'm not going to risk my own money. I can't be sure I'm going to win this case because it's so documented what the doctor did. The doctor gets that deference. So it's not a case that these attorneys are going to take. And again, the unhappy family or the patient, you know, want some kind of something against you and you just pay somehow so they'll just go after your license. And realistically, they're very, very easy to file. And your state licensing boards have to investigate no matter how ridiculously meritless they are right in the complaint. The top, I won't take it very long, but the top one was, it was not an eating disorder session. The patient complained because the psychiatrist had a McDonald's bag in her trash can. And the board had to investigate. So that's why there's so many of them. It's just an easy outlet for an upset patient. And we know psych patients, you know, when they, you know, don't always agree with treatment, they can become easily upset. Okay, so ECT fetus deaths. So just some background. So the risk of death with ECT in the general population is 2.1 per 100,000 sessions. Pretty low. Now, in the literature, there's been a total, I believe, of 12 documented deaths, fetal deaths in a few hundred patients, a few hundred people treated during pregnancy. Now, why? I mean, why the deaths? Not usually described, not really described except for the couple cases of status epilepticus. It's a great question, and why? I mean, if you think about it theoretically, you would think it would be cardiac in nature, right? I mean, yeah, a lot of people shaking their head, absolutely. The data is not there for ECT or TMS, right? It's not there. There's just not a lot. Other questions? Yeah. I have a question. When you mentioned the medication label, do you mean that 10-page tiny print? So 10 pages, if you're lucky. I use Hippocrates, and that usually has enough information. So it's the exact FDA product label, that's what's been approved by the FDA, and that's what, if there's ever a question, the expectation is that, you know, you would have read this and be familiar. And then at the very bottom of the actual label is what I'm referring to as the patient medication guide. So it's at the end of the product label from the FDA are these patient medication guides. Super useful. They're written, I think, at eighth grade level. It's very easy to understand, and it really, in our opinion, facilitates communication for your informed consent discussions. Okay. Oh, so the patient isn't supposed to get that entire chart? No. The patient just gets the end. It's called the patient guide or patient medication guide. At the end of that? Mm-hmm. They're usually, sometimes they're one page, sometimes they're three, because the font's bigger, much bigger than the rest of the label. This is just a comment on the use of mood stabilizers and asking patients about birth control. Thank you about bringing that up. And thank you for this great lecture. Thank you. I usually end with my residents, it's like, you have to ask for it, you have to talk about it, you have to learn about them, because I think that we as physicians, we have the tool to do it, and sometimes we happen to be the only doctors that our patients are seeing. So, I had this patient, she was already about 10 months postpartum, she had broken up with her husband, and I kept on documenting in my notes about birth control after she stopped nursing. And she was like, no, I don't need that, I'm not having sex, no, I don't need that, I'm not having... And I kept on documenting. I was seeing her about every four to six weeks, she was bipolar on Depakote. And on one occasion, she calls me to tell me that she's already six and a half months pregnant. I almost wanted to die. Of course, I mean, I went back, I'm like, oh my God, did I talk about it? And thank God I had documented that supposedly she wasn't having sex, so the second coming up, the Virgin Mary ended up having, thank God, a healthy baby. But yes, thank you for the notation. Sure, sure. And I think that it's important to, I think a lot of you may be thinking about this in the outpatient realm, where you're seeing a patient sort of over and over again. Be very careful, too, in the inpatient setting, even on consults, I would say, that where you're maybe having a little more, like if you're having a very short acute stay in the hospital, and you're not really thinking about having that longer term relationship necessarily with a patient, that you need to know about, if it's someone who could potentially get pregnant, that you know, and you're going to put them on Depakote, right? We use a lot of Depakote, or valproic acid, so make sure that before you send them out, that you're talking to them about birth control. And I would say one other point that I thought about while Dr. Schmidt, I think, was talking is, you know, there's a lot of risk, again, like kind of in that, you know, first few weeks to months after delivery. Another thing that I have seen is that, you know, when women, sometimes when they stop breastfeeding, it's a hormonal change. It doesn't happen all the time, but I'm always just looking for those times when there's going to be some change. And some, I think some women are a lot more, you know, susceptible to those changes, very slight changes, even. And so they may be more prone to have symptoms of their illness. Any other points anyone wanted to bring up before we end? Thank you. Thank you. Thank you.

women's mental health care

2022

panel of experts

pregnancy

postpartum mental health

hormones

psychosocial stressors

medications

postpartum depression

personalized medicine

electroconvulsive therapy

risk management