Hello and welcome. I'm Dr. Rob Cotez, Director of the Clinical and Research Program for Psychosis at Grady Health System and Associate Professor at Emory University School of Medicine. I'm so pleased that you're joining us for today's SMI Advisor webinar, Overcoming Barriers and Unlocking Clozapine, a panel shares clinic system and statewide strategies. Next slide, please. SMI Advisor, also known as the Clinical Support System for Serious Mental Illness, is an APA and SAMHSA initiative devoted to helping clinicians implement evidence-based care for those living with serious mental illness. Working with experts from across the SMI clinician community, our interdisciplinary effort has been designed to help you get the answers you need to care for your patients. Today's webinar has been designated for one AMA PRA category one credit for physicians. Credit for participating in today's webinar will be available until January 9, 2023. Next slide. Slides from the presentation today are available in the handouts area found in the lower portion of your control panel. Select the link to download the PDF. Please feel free to submit your questions throughout the presentation by typing them into the question area found in the lower portion of the control panel. We'll reserve 10 to 15 minutes at the end of the presentation for Q&A. Now I'd like to introduce you to the faculty for today's webinar, Dr. Mindy Asbury, Dr. Anna Kostakis, and Dr. Jessica Goren. Mindy Asbury, MD, PhD, is assistant professor at University of North Carolina School of Medicine at Chapel Hill. She also serves as medical director of UNC Wake ACT Team and UNC Encompass First Episode Psychosis Program, as well as director of North Carolina Clozapine Network, NCCN. She is the fellowship director of the UNC Faculty and Public Psychiatry Fellowship. Anna Kostakis, MD, MBA, is the adult ambulatory psychiatry director at the Northwell Zucker Hillside Hospital, where she also serves as faculty at the Hofstra Zucker School of Medicine. Jessica Goren, PharmD, BCPP, is a senior clinical pharmacist at Cambridge Health Alliance, and also instructor in psychiatry at Harvard Medical School. And again, I'm Rob Cotez. I direct the clinical research program for psychosis at Grady, and one of the components of that program is a large clozapine clinic called P-STAR. Okay, next slide. Here are our disclosures and our learning objectives. Upon the completion of this activity, you see the learning objectives there. So just to give everybody a quick run through of our plan today, I'm going to take about the first 15 minutes to summarize what we know about clozapine clinics, which unfortunately is not all that much. Then we're going to hear from each of our faculty members about clozapine use in their system. Then we'll have a panel discussion, and then we'll have time for Q&A. All right, next slide. So first of all, I'm going to talk a little bit about the underutilization of clozapine and what some of the barriers have been. Next slide. So I'm sure everybody is aware of this, but the APA Treatment of Patients with Schizophrenia Guideline was published in 2020, and there were basically three occurrences where clinicians should consider the use of clozapine, the first being clozapine after minimal or no response after two trials of antipsychotic medication. That's another term for treatment-resistant schizophrenia. And then the second recommendation is that patients with schizophrenia be treated with clozapine if the risk for suicide attempts or suicide remains substantial despite other treatments. Next slide. There's a lot of geographic variation in terms of clozapine use. And in this study by Mark Alston and colleagues in 2016, looking at a Medicaid data set, there was a significant degree of geographic variation with essentially less clozapine utilization in the Southeast. And where I am in Georgia, we're one of those states that is orange, and we need to increase, we need to do what we can to increase clozapine utilization. Next slide. We then did an analysis, members of the Clozapine Center of Excellence with McKinsey & Company, looking at a little bit more of an updated data set on the geographic variation and use of clozapine. So this is reporting patients with clozapine prescription per 10,000 population with a prescription. And this is different than in the previous slide where we were looking actually at percentage of people with schizophrenia who were prescribed clozapine. But really the similar trends remain. In a more updated data set from 2015 to 2020, you can see that, again, there was significant underutilization in the Southeast of the United States. There's pockets of greater clozapine utilization in some states than others. I want to give a quick shout out to Massachusetts, 17.4. I know there's been a lot of work there that's been done to also increase clozapine use, a number of statewide initiatives there. But you can see a lot of geographic variation. Next slide. This is another slide from the analysis that we did with McKinsey & Company and looked at the clozapine prescribing over time. And you can see that from 2015 to 2019, clozapine prescriptions were relatively static. But when you look at all antipsychotic medications, you can see that the use of antipsychotic medications really went way up without a really significant increase in clozapine prescription over that time. Next slide. In a recent meta-analysis that Dan Siskin conducted, looking prospectively at individuals with early psychosis or first episode psychosis, they found that about 23% of patients with schizophrenia ultimately developed treatment-resistant schizophrenia. And based on what we know from the Stroop and Olfson data, under 5% of individuals with schizophrenia are actually prescribed clozapine in the U.S. Then just click Next. So overall, I think what we're looking at is about an 18% gap of people with schizophrenia that could potentially be candidates for clozapine. And that doesn't include the suicidality indication, doesn't include the risk for violence, doesn't include other off-label indications. This is just for TRS. Next slide. There's a number of barriers that get in the way of using clozapine. And some people have divided those into client-related, prescriber-related, and then finally, administrative slash logistical barriers. There's a lot of different factors. A lot of what we've been doing at SMI Advisor has been focusing on the prescriber-related barriers, like developing webinars to help people feel more comfortable using clozapine, helping people to build a knowledge base, helping people to have conversations with clients that may be interested in a clozapine prescription. But there are a number of other barriers too, and some of those are administrative and logistical barriers. Just earlier in November, there's been some new guidance from the FDA about REMS, allowing inpatient pharmacies to dispense the amount of medicine that an individual has, like if they're on monthly monitoring, an inpatient pharmacy can now dispense 30 days. But there's a number of administrative and logistical barriers. And all of these things contribute to clozapine utilization. All right, next slide, please. Now, I think there's a lot of advantages to clozapine clinics. We're going to talk a little bit about clozapine clinics and what those are and how they're set up. They're set up in a lot of different ways. Next slide. But really, I think the key to clozapine clinics is being able to have the capacity to start new eligible patients on clozapine. And this is tricky because, especially for people who are on weekly monitoring, a clozapine clinic has to have the ability to see somebody relatively quickly and then have the ability to work with them on a weekly basis and ensure that their clozapine prescriptions are continued. So overall, an infrastructure, it often helps, must be in place to assume care quickly of clozapine patients discharged from inpatient settings. And I got a call just earlier this morning about a young man who is at a residential treatment facility. They're not sure when he's going to be discharged. He's on clozapine. After he leaves, he needs to be followed up and somebody has to be able to continue that clozapine. But there's uncertainty about when he's going to leave and our program basically has to be ready to work with that person. Okay, next slide. So this is an article that was published from Christophe Carell earlier in the year and colleagues, and they were looking at a guideline and checklist for initiating and managing clozapine treatment for individuals with treatment-resistant schizophrenia. And clozapine clinics can help basically to, can help to implement this type of monitoring. There are a number of ways that you can start people, a number of labs you can get prior to starting clozapine. But in this article, they recommended a myocarditis screening protocol using a troponin, CRP, creatinine kinase, and BNP as well, weekly for the first eight weeks. And then an EKG or an echo, if indicated. And sometimes in community mental health, it can be difficult to get those things, especially an electrocardiogram. So it's, it's sometimes can help to have an infrastructure built around. Also, very importantly in the early stages of one's clozapine initiation, being able to do daily vital signs is a real advantage. In our clinic, sometimes we get maybe vital signs three times a week for people who are starting clozapine, people who are just starting clozapine. Also, I thought that this was really good, but it didn't include therapeutic drug monitoring or obtaining clozapine levels. And typically we'll obtain a clozapine level after somebody is at, you know, week one or week two. All right, next slide. I think though there can be some additional benefits of clozapine clinics. So these are some findings from the literature. They've been associated with high client satisfaction scores. They can be a key place for trainees and include and sort of enhance clinician familiarity. Additionally, clozapine clinics can provide specialized and organized psychosocial interventions. Like in our clinic, we have some dedicated CBT for psychosis resources that are then integrated within our clozapine program. They've been a great source over the years for clozapine research, which more needs to be done and can help us to manage the complexities of clozapine REMS. Next slide. Also over the years, there's been a number of cases where systematic screening and treatment of various medical conditions have been done within the context of a clozapine clinic. And these are just a list of some of the things that have been looked at before. Hep C, metabolic syndrome, risk factors for CAD, food addiction, obstructive sleep apnea, and then the recent COVID-19 vaccination initiative. Next slide. So what are clozapine clinics anyway? Next slide. And there is no standard definition. There's no fidelity model. There's not a consensus definition. And importantly, they're not required in order to prescribe clozapine. So I think the point of this talk is to not steer people away from using clozapine because they don't have a clozapine clinic, but maybe to help encourage people to think about how to organize their services around a clozapine clinic. Next slide. Next slide. So the first mention in the literature of a clozapine clinic I could find came from an article in 1996, which I thought was quite prescient, and it's much what many clinics do today. So there are educational materials that are available for patients. The clinic also has group activities that encourage support from family and other relatives. Ideally, blood sampling and the dispensing of drugs would be done at the same time in the same location. So a one-stop shopping kind of setup. There would be staff allocated in the clozapine clinic to follow up on folks who maybe didn't attend the hematologic monitoring. There would be some sort of way to collect data, a registry of patients. And then also, you know, this need for continuous self-monitoring and improvement with the clinic having their ability to reassess needs and introduce individual psychosocial programs. Right. Next slide. Now, this is a study that one of our presenters, Dr. Goren, was a part of and was the lead author on. And if she talks about this later in the panel, I think that would be great. I don't want to speak for her on this research. But, you know, she was she looked at organizational criteria's characteristics in the VA setting of clinics with low and high clozapine utilization. But what I thought was interesting was in the high utilizing group, they used clozapine clinics. There was the integration of non-physician psychiatric providers. And it was also important that they created systems to avoid over-reliance on just a few individuals. Next slide. So, given the gaps in the literature of what we had seen in clozapine clinics, at SMI Advisor, we did a survey that was sent out to the SMI Advisor Clozapine Center of Excellence listserv in January 2020. And we were curious to know a little bit more about clozapine clinics and how they were structured. We had a pretty loose definition for clozapine clinics, and they just had to manage over one patient on clozapine, but there was a multiple-use definition for one patient on clozapine, but there was a multidisciplinary approach. Overall, we looked at 32 outpatient clozapine clinics in our survey. Next slide. So, in this study, there was a range of number of individuals that were followed in the clozapine clinics from three to 200 with a median of 45. There was a median interdisciplinary roles of the most common disciplines were psychiatrists, pharmacists, and nurses were the top three, but also psychiatric nurse practitioners were involved in over half, case managers and psychiatry residents in 44 percent. Next slide. A big question, I think, for us working in clozapine clinics is who actually enters the blood work into REMS and what kind of system is used about that, the feedback system, let's say, if somebody has neutropenia. And what we found was that 63 percent used a single discipline, some were pharmacists, some nurses, some psychiatrists, but also about a third used two or more disciplines and involved psychiatrists as part of that combination. And in our setting, for example, at Grady, psychiatrists enter the blood work into REMS. Next slide. We then created a Venn diagram to look at the five most common staffing disciplines. And this is here basically to show you that there were a lot of different types of configurations for the clozapine clinics and the additional types of interdisciplinary support. And in the middle, that number of two with the five most common disciplines, it was actually pretty uncommon. But you could see that there were different configurations and everyone used essentially what they had access to, what they had resources for. Next slide. We then took a look at the various services that were offered in the clozapine clinics. And there was a wide variation. The most common thing that occurred in the clozapine clinics, 78 percent, was an outreach to overdue patients. About two thirds had access to onsite phlebotomy. And I thought it was also interesting, about half had an onsite pharmacy. And then our sample, not a lot, used point-of-care testing. But we're going to get back to that in the panel discussion. Next slide. So our experience in sort of surveying clozapine clinics and thinking about our own clozapine clinics was to sort of consider a holistic model for people who take clozapine, in which sort of at the center was that individual. Around them was the prescriber, the pharmacist, and the hematologic monitoring. And then all of the other interventions that might help someone. Because I think, you know, if you're using clozapine, you quickly realize that people need a lot of other supports, a lot of other types of psychosocial interventions. And having those integrated can really be quite helpful. Okay, next slide. All right. And now I'd like to turn it over to Dr. Kostakis to talk a little bit about the experiences from Zucker Hillside. Thank you. All right, next slide, please. So just a historical framework, not to give you a history lesson, but the clozapine clinic at the clozapine clinic at Zucker Hillside Hospital, where I'm at. So this is the edge of Queens and Long Island in New York. It's the oldest clozapine clinic in the United States. So it opened in 1987. And it was the site of this foundational work done by John Kane and colleagues really establishing clozapine as a foundational treatment for treatment-resistant schizophrenia. Next slide, please. And I apologize. On the previous slide, just a quick note on that study. It was actually included 268 treatment refractory patients with schizophrenia who were randomized to clozapine versus chlorpromazine for six weeks. And it led this foundational study, which this was all a history lesson for me that I picked up along the way while working here for the last five years, clearly revealed superiority of clozapine. And this study then led to the approval of clozapine in 1989 for treatment-resistant schizophrenia coupled with weekly WBC monitoring. So there were all sorts of limitations placed on clozapine before the study came out, after this study went through the FDA then with the WBC monitoring. Next slide, please. So obviously, our clinic is very proud to serve still some of these patients from that foundational study, believe it or not. Thank God they have stuck around. But we continue to serve a large number of clozapine patients, 387 active patients. The clinic itself, the clozapine clinic is housed within our general outpatient clinic within Zucker Hillside. So to give you a bit of a frame because each setting is so very different. Our general outpatient clinic treats about 5,000 general patients, another 400 patients in there receiving long-acting injectables on the same campus with six subspecialty programs, including an on-track New York and first episode psychosis program, 10 inpatient psychiatric units, a partial hospitalization program, and an intensive outpatient program. So we are definitely, I'm biased in saying that we are surrounded by a paradise of psychiatry and being able to have so many resources around us. And so that allows us to provide really great wraparound care for these patients. But within the patients, the vast majority are in the maintenance mode. So they've been on Clozapine for longer than a year with monthly monitoring of the ANC. 4% of those patients have biweekly monitoring and 7% weekly. So they're just in the first six months of treatment. Next slide, please. So how do you organize this chaos, right? Almost 400 patients with varying frequencies of their ANCs within a very, very large clinic, right? I think some key points that I'd like to leave you with is that having one person to own this process and really be the central touch point for Clozapine within the clinic has been essential. Otherwise, if you have too many cooks in the kitchen, I think things get lost a bit. So we do and this person is right, you know, has a high school degree doesn't have to be tremendously educated. We but very skilled clerical person who has been with our clinic for 30 years, and is the the main person owning the REMS is we have backup for her, obviously, everything can't rest on her shoulders. But that backup and she are have full knowledge of the workflow and really own that process. The other piece of this that I think is tremendously important is a close relationship with both the pharmacy and the lab. So we have an onsite pharmacy through Northwell that's within our building. And they also do home delivery. This is huge, right? So when we start someone on Clozapine, we're able to get that information to the pharmacy, they're on board, they're keeping track, they're also checking REMS. So it's a collaborative work agreement, really to be able to get what the patient needs, or without all of the hassles. Um, the we also so one way that we found to be able to streamline the workflows is to create a separate registration area for all patients on Clozapine. So wherever someone on Clozapine goes within our ambulatory footprint, within Northwell, they have an episode that is open, that is CLOZ, close, and rather than separately enrolling in other sub clinics, they are always housed within that close episode. So that allows us to pull data on all of those patients to be able to track when they came in for blood work, when their last results were, making sure that everyone has entered into REMS, making sure that all the results are funneled into one place. We actually have a dedicated printer in our clerical area next to that clerical person who owns the process. And that printer, anytime any results for a Clozapine enrolled patient get processed, those results automatically print. And so in real time, as the result is processed, the point person for Clozapine is able to enter them into REMS. And it helps us to be able to streamline, making sure that patients don't fall through the cracks, flagging vitals, labs, anything that might have to be done. We do have an automated system that we've recently rolled out and starting patients on Clozapine. And as much as this helps us disseminate the information needed so that there's not 900 emails being sent all over the department, notifying anyone of a new Clozapine start, it also helps walk clinicians, trainees, anyone involved through the process and the workflow needed to be able to get someone started on Clozapine, just because there's so many pieces, which is oftentimes the part that scares someone away from starting Clozapine on their patient. Next slide, please. So this is just a quick screenshot of one part. So we use a REDCap database, but you could use, you could do the same thing within like an MS forms or something else where you have a form that then can populate to a dashboard or a database. The clinician just submits patient's last name, first name, date of birth, the clinician name. Next slide, please. Next slide, please. And then here's the list really, which, like I said, both for the use of the clinician to be able to help walk through the process, but also to notify everyone involved. So the date of the Clozapine initiation, which then helps us track how far out the patient is from initiation and the frequency of the blood work that's needed. We have, you know, we start, when starting someone on Clozapine, we immediately create that separate episode so that the registration area is separate. We also set up either that we enter orders for the labs within our system so that a patient comes onsite versus, and I think this is actually huge in allowing patients more access. We have a HomeDraw program that we've partnered with since the beginning of the pandemic that we fill out a form and that patient is set up with the program and the phlebotomist comes to the patient's home weekly at the same time or whatever arrangement is set up to be able to get that blood work done. So it really, it does not put out the patient in any way. I've even had the HomeDraw people come to someone's work environment where they're able to catch them at their lunch break once a week for that initial startup of the blood work since it's weekly and that can really be, take a big toll on the patient and their family trying to get them to a lab once a week. Pre-treatment physical, so we have an integrated medical clinic that we're able to get patients into with the primary care doc to be able to have a physical pre-starting and that includes the pre-treatment EKG. And then like I said, either HomeDraw or onsite labs reminding the clinician that it's the CBC with the CRP and troponin within our system that that's the standard that we're recommending for the beginning of treatment with clozapine. And just sort of tracking whether the patient is weekly, bi-weekly or monthly, if they're entering our system, not at the beginning of their clozapine titration. Next slide please. And then if someone comes off clozapine, tracking that as well, because the REM system really does make it very important for everyone to be aligned on any gaps in care and being able to enter that information. So our clerical point person is then equipped with all the information needed and a series of tasks to be able to discontinue that clozapine registration and REMS enrollment that we normally have. Next slide please. So this is a very dense slide and I apologize, but hopefully you will be able to zoom in on it. So the full workflow, and I wanted you to be able to see that it is not tremendously overwhelming. It's all in one place, right? So the MDRNP orders a CBC with DIF along with that CRP and troponin and possibly clozapine level in the beginning of treatment. The HomeDraw lab services are also an option. Then the MDRNP orders the clozapine from our pharmacy that manages the clozapine. The patient has the blood draw in our phlebotomy lab on site and while they're getting the blood draw, they get vital signs done each time and the clinician is flagged with those vital signs so that they can be monitored. And then all labs for those patients registered in the clozapine episode get printed as the results come into that set printer in our clerical area. As those results come in, that point person and clerical tracks them as being completed on time, ensures the results immediately into REMS and has all the lab results reviewed by the medical NP that we have on site before being placed in the MDRNP mailboxes to be reviewed before they're filed in the charts. So several eyes on these labs before they actually make it into the record. Any patient whose labs aren't getting done on time is contacted by the end of the week, letting them know that they need to get their CBC drawn and their clinician is notified. And then the patient fills their prescription at the pharmacy where REMS is verified as well. And any issues with obtaining the clozapine are routed only to that clerical point person that we have for clozapine. So once patients are usually seen monthly by the MDRNP, but if they're in that first year and they need to be seen weekly or biweekly with frequently changing doses and monitoring and lots of questions up front, when that's not possible, we also have that medical NP who double checks the labs, be able to meet with those patients. So sometimes we alternate actually. I'll meet with a patient one week, the medical NP the next week. Medical NP does not adjust the dosing, but helps to reinforce the titration schedule, check in on side effects, review vitals and labs. And as an additional support for the patient as they're starting on that process. And then if there are any issues in between, they're able to contact, the patient's able to contact that clerical point person, speak to the medical NP if there are other issues. And then if that's not able to take care of it, to be able to go to the MDRNP who's prescribing the medication. So all in all, it's a pretty airtight process. We also have, we have trainees, we have psychiatry residents, med students, social work interns and psychology trainees. So all of those are embedded within our treatment teams and the psychiatry residents provide after hours coverage. So when a patient calls our after hours hotline, they're able to speak to a psychiatry trainee who is already seeing patients themselves within the clinic and is very familiar with the workflow. So keeps things from people from falling through the cracks. Next slide please. That is it for me. I will pass the baton to Dr. Asbury. Thank you so much, Dr. Kostakis. Hi everybody. My name is Mindy Asbury and I have the pleasure of joining you today in representation of the University of North Carolina at Capitol Hill. As part of the North Carolina Clozapine Network. Next slide please. Great. The North Carolina Clozapine Network, which the acronym is NCCN, we are an expert service that offers technical support to providers and patients within North Carolina and also across the country. Globally, I'll provide a bird's eye overview as to how we have approached our mission of increasing Clozapine utilization. And perhaps by providing you the overview of how we have approached this, this may give you an idea of what could be successful in your local, regional, or statewide community. The most basic way to describe this is to say that we operate by first acknowledging and identifying the current provider, local, and regional barriers and challenges. We then create specific strategies to overcome each of those, or at least try to. As Dr. Kostakis pointed out, and as the data and literature demonstrate, there are many, many barriers to Clozapine utilization at each level, which is very unfortunate in and among itself. But at the same time, this fact also means that there are many places within the current system to which one can make improvements. And that's the way that we like to approach this. We've had success moving the needle inch by inch and sometimes only hair by hair. And we've done this by acknowledging that we're not going to solve the problem overnight. And local and small successes can turn into large ones. So let's look at the different levels of care that the NCCN is targeting. And most specifically, we are targeting the provider, and then local, and then regional slash state aims. At the provider level, we are aiming to increase provider comfort with and knowledge about prescribing Clozapine and also shaping provider attitudes. We try to do this in a few ways. One way that we do it is via the NCCN consultation service that offers Clozapine technical support. Most of our technical support inquiries are either clinical in nature or they're resource-related in nature. Our clinical questions get run through our expert panel that consists of four psychiatrists. We have a specialist cardiologist and hematologist who have particular interest in Clozapine. We have a nursing specialist and we have collaborating clinical pharmacists as well. But keep in mind that, again, a lot of our questions are geared towards resource questions. I've gotten questions from people from California, from New York, such as, hey, I'm moving to North Carolina and I cannot seem to find a prescriber for Clozapine. Hey, I can't find a pharmacy that carries Clozapine in my area. I think this is an under-recognized problem with increasing Clozapine utilization in general. It's a problem that lies at the pharmacy level. Having a resource as to what pharmacies have Clozapine in stock and what pharmacies carry multiple dosages of Clozapine is underappreciated. It's very hard to create a 25 milligram increment of Clozapine if that pharmacy only carries 100 milligram tablets. We also operate a expert website that's armed with a Clozapine toolkit that we also hope is useful in increasing provider comfort and knowledge that they can go to our website to provide tips as to how do I start someone on a outpatient Clozapine initiation? How do I do metabolic monitoring for Clozapine? How about weight loss with Metformin in the context of Clozapine use? The last way and the newest way that we have geared up to increase Clozapine utilization by changing the provider level of care, knowledge, comfort, and attitude is that the UNC Center for Excellence in Community Mental Health, which is directed by Dr. John Gilmore and is the parent organization of the North Carolina Clozapine Consultation Network, just finalized a partnership with Project ECHO. The first Project ECHO hub, excuse me, the first program of our Project ECHO hub will actually be launched and facilitated by the NCCN. We hope to increase awareness of Clozapine to provide case consultation and didactics to health systems, group practices, and community providers across the state. We already have 12 champions signed up that will host as liaisons between their group and the NCCN as we launch the Project ECHO. And maybe more importantly, we have most every North Carolina psychiatry residency signed up and slated to participate once the NCCN Project ECHO launches. We hope to also include a couple of primary care-based residencies to start to familiarize and train primary care providers to prescribe Clozapine because let's be realistic, that is the first point of contact most of the time that our patients have is with a primary care provider. Our hope is to have this Project ECHO be statewide for about nine months, and then we look to launch that nationally at that point in time. So that's provider level. At the local level, something that we have found success in is transitioning existing outpatient clinics to Clozapine-capable clinics. And we've done this in large part with comprehensive technical support with the NCCN. What we have found thus far in North Carolina, and I would imagine with states that have a similar payer setup to that of North Carolina, is that it is far easier, quicker, and higher likelihood of success to transition a current clinic using its infrastructure into a Clozapine-capable clinic than it is to de novo build a Clozapine clinic from ground up. The other thing that we have done with the NCCN and with the helps of Dr. Michael and Ted Zarzar is to create Clozapine Initiation Inpatient Program, where individuals can undergo inpatient hospitalization for the sole purpose of Clozapine initiation via referrals that have been facilitated by their community-based provider. So expanding on into regional-slash-state-level targets, this is where we are currently building out our most recent expansion into the western part of North Carolina. We have a Clozapine- capable clinic that was established here on July the 7th, and our blueprint here is to create a clinical hub and clinical-spoke model, wherein the NCCN supports this process. And the Clozapine- capable clinics to become the regional clinic hubs, to serve as Clozapine consultants for difficult cases of community or smaller group practices, which may look like a one-time visit for short-term management, or it may be a, you know, moderate-term management, but followed by a transfer back into the individual's community provider. And again, we want to create these hubs with support of NCCN as the central network to create a hub and spoke model across the state of North Carolina. The other thing that we're doing in finding success in regionally or statewide is building out additional inpatient Clozapine initiation units. Right now, we are in talks and action steps with one of our western partners in order to create another Clozapine initiation inpatient unit in the western part of the state. So, for states with similar funding structure as that of North Carolina, I would just leave with this. I think one of the most important things is to understand your funding structure and your funding flow, understand who your stakeholders are, and work to create relationships with those individuals. If those relationships aren't created yet, then work at creating them. And with that, I'll be mindful of everyone's time, and I will go ahead and pass it on to my next colleague. Thank you. Great. Thank you, Dr. Asbury. My name is Jessica Guerin, and I am a Clinical Pharmacist Specialist at Cambridge Health Alliance. We are a public safety net health system in the greater Boston area, and we created a Clozapine clinic to establish a way for providers to become more comfortable with Clozapine, as well as to increase our numbers of patients that are currently receiving Clozapine. Essentially, we are a support for clinicians to start new patients on Clozapine. And essentially, when people identify that they have a patient who might be appropriate for Clozapine, they refer the patients to our Clozapine clinic. That clinician still remains their primary psychiatric clinician who cares for all of their other medication needs, and we are in charge with starting, monitoring, and titrating their Clozapine. Through the course of that process, we also provide education, and we get patients enrolled in the REMS. We work up to having them at a stable clinical phase and work to having a good serum concentration of their medication. Once the patients are stable on their Clozapine, we actually hand them back to their primary clinicians, with the goal that they will now continue to monitor their Clozapine in an ongoing manner. We do offer a consult service beyond just starting patients with Clozapine, so anytime a clinician has any sort of issues associated with Clozapine or questions, they can refer their questions in a standard consult form to our clinic, and we will actually help them. As part of our goal with our clinic, we wanted to increase our Clozapine use, but also at the same time increase everybody's comfort with Clozapine so that patients wouldn't be reliant on coming only to our Clozapine clinic. There has been some improvement in terms of clinician acceptance of Clozapine. Once we started this and they get somebody back who's stable and they can continue the treatment, it's not quite as overwhelming of a process for them. Our numbers have increased substantially since we started this type of service. Some of the things we did to help support the clinicians are we did develop an intranet site within our own system that actually has a manual with every problem you can think of and how to handle it. It also includes information about our clinic. We do offer pre-COVID weekly group meetings for patients who are starting Clozapine with the goal of getting patients comfortable, as well as having them come in to get their blood work, to be assessed clinically, ideally to do other things like metabolic monitoring, and enable us to actually kind of get all of that in a one-stop shopping type environment. Behind the scenes, we have also done some significant outreach to increase clinician comfort with Clozapine. We do have our trainees rotate and our psychiatric trainees rotate through in their PGY three or four year, depending on their schedule. Most residents do a one-month rotation, but we have had some residents who have done longitudinal rotations of six months where they spend two days a month in our clinic and actually care for patients a little bit more longitudinally with their Clozapine. We provide regular seminars to all of our staff. We provide information for patients. One of our goals is actually to move forward to a point where we can have patient champions who can actually lead groups and explain to people who are considering Clozapine how Clozapine has been beneficial for them to other potential patients or their families. Our clinic is staffed with two psychiatrists and a clinical pharmacist right now. We did have a nurse practitioner, but unfortunately the nurse practitioner left and we have not had that full filled. We've also had a few struggles with COVID, which has required us to go to telehealth visits. Traditionally, we had conducted our visits and billed as a group visit, which happened once a week for our patients who are starting on Clozapine. Now we've moved to a telehealth model where patients still have to go out and get their labs. We're lucky in that we do have a large outpatient pharmacy that delivers across the entire state. And so patients can have their medications delivered from our pharmacy, or we do have some patients who prefer to use their local pharmacy. So any of that is possible. Some of the things we've done in terms of wraparound services are not housed necessarily within our Clozapine clinic. We do have case management. We take advantage of when insurance offers things such as intensive case management services to try and provide some wraparound services. To provide things, the VA study actually found that providing transportation was quite beneficial for patients being able to get to labs and appointments. So we do use the case management, intensive case managers to facilitate those types of services as well. We have created an electronic medical record linked database for our Clozapine registry patients, which does make it easier to follow our patients and make sure that everything is happening on time and that we have all of the information we need to continue. Some of the things that we're looking towards right now is trying to figure out how to go back to in-person meetings, in-person group meetings. We have identified that there are some patients who actually really prefer the telehealth model. So I think we will be going towards a hybrid model in order to ensure all patients can kind of meet us where they're at and whatever works for them is our preferred method. And then we also have been doing things like developing electronic medical record supported services. So we did develop a best practice alert, which actually mines the data in the background and lets clinicians know when they have a patient who has tried two different antipsychotics as standing medications in the past 10 years, who also have either had a hospitalization for psychiatric reasons or have a diagnosis of tardive dyskinesia and flagged them as a potential Clozapine patient. We've recently gotten the results of kind of the first round of who responds to those BPAs and what they do with them. And we're going to use that information to help us target some interventions that might make it easier for clinicians to refer patients into our services or to facilitate Clozapine use outside our services. We're happy wherever it is. And that's kind of just a quick thumbnail. I want to be cognizant of time and I'll hand it back to Dr. Kodes. Thank you so much. Wow. I mean, what a lot of great ideas, extremely innovative things from the programs that we've heard from. I just want to thank everybody again. And maybe what we could do is for time's sake, maybe we can go right into the Q and A and we can incorporate the panel discussion into the Q and A. All right. And before we do that, go into the Q and A, I just wanted to take a moment to let everybody know that SMI Advisor is available from your mobile device. Use the SMI Advisor app to access resources, education, and upcoming events, complete mental health rating scales, and even submit questions directly to our team of SMI experts. Okay. And now let's go into the Q and A. All right. Great. So with that, I just encourage the audience to put in questions into their panel. So why don't we go ahead and get started? First question is what tends to work well for your clozapine system? And we'll start off with Dr. Asbury on that one. Great. That's a good question, right? Because if we can emulate what works well, then there we go, all the problems are solved. I would say the most important thing that we've learned over time is that strong relationships work well. Again, having relationships with dependable pharmacies, pharmacies that you know will have clozapine in stock, be available, are clozapine ready pharmacists. Strong relationships with inpatient discharge coordinators, so you can make sure that you're the first point of contact for an individual being discharged on clozapine to go into your clinic. And strong relationships with stakeholders to make sure that, you know, we understand is this a fee-for-service or value-based care model that we're operating in? And if it's just fee-for-service, then how can you get additional stakeholder buy-in to help offset the cost that's associated with running a clozapine-capable clinic when fee-for-service receipts aren't enough? Transportation options for patients, having those available, I think is fundamental. Does it look like using a county-based service? Does the county operate a band that can pick patients up? What are the Medicaid transportation available options in your area? Are there access to peer support individuals within your clinic? And if so, you know, can those individuals go and help with transportation? And so having these things set up and ahead of time and with the clinic, I have found to be very helpful with, you know, making a successful operation in the clinic. And I think that one of the other most important things, and Dr. Kostakis alluded to this, is having a staff that understands clozapine. So having that RN or the CNA that is familiar with the RENTS process and familiar with navigating, right, the RENTS website, which we all need a gold star if we can successfully do, is enough to make or break a clozapine-capable clinic. Maybe we could go next to some of the challenges. I think maybe, Dr. Guerin, would you like to start with some of the challenges? Sure. I think some of the challenges are related to just the general clinician's reluctance. You know, research has clearly shown that clozapine is the second, should be the third line option for patients, and yet patients tend to get five to six antipsychotic trials earlier, before we move to clozapine, often including antipsychotic polypharmacy, which does not have the best database to support its use. I think interventions to increase clinicians, not just awareness that this is the third line medication, but also things to make them understand what that means in a patient's day-to-day life. I think peer support for patients can be helpful, but I also think there's some models where they've shown, where they've looked at having clozapine patients talk with clinicians and find that that can actually positively influence clinicians. Some of the other challenges we've had is we are a small group, and while over-reliance on a single person is difficult and can cause some problems, we still only have three people, and trying to make, again, a broader network of people comfortable with all of the processes associated with clozapine, hence why we like to help get patients started and then hand them back, so everything's kind of running smoothly with the goal that eventually clinicians will say, oh, well, I can do it when it's going smoothly. Let me figure out the REMS when there's this bump in the road and those types of issues as well. I'd like to give other people an opportunity, too, to kind of talk about their concerns. I mean, I think you referenced REMS as being a challenge. It's been, and I know that we've been speaking with the REMS folks, and I'm sure many can relate to that, in that it's been a bit of a moving target that even when you train someone on REMS, new rules come out, and each pharmacy seems to do something different, and not being able to ensure that someone is able to have their clozapine when they're discharged from the hospital is enough to add a lot of gray hair to my head, I'm sure everybody else's. So that definitely is a struggle. I think something that you said that made me think about the over-reliance on certain people and wanting to emphasize from my end that we found that incorporating trainees, although it adds stress to the process because you are reteaching the process of clozapine, and it almost seems like every July we're starting from scratch, but to send a new gaggle of 13 psychiatrists into the world who treat clozapine like it's their bread and butter to prescribe, I think we can do nothing better moving forward than to be able to equip them and continue to spread the love of clozapine wherever they go. I'm curious, are people finding that pharmacies are requiring prescribers to actually fax the labs to them in addition to using clozapine REMS? Not as much anymore, has been my experience. I think it's been a struggle with small mom and pop pharmacies. We have a lot of that in the boroughs of New York, so the larger pharmacies have streamlined workflows and they seem to have caught on to what needs to happen. We've stumbled across some small pharmacies that either require faxing or completely blow off REMS altogether. I'm not sure which is better. I think the problem is that it's so inconsistent across the board that if you're reinventing a workflow that needs to run smoothly for 400 patients to have each pharmacy have different rules attached, creates a significant challenge. Yeah, and I honestly think that the REMS needs to come up with a consistent message and there needs to be education because that inconsistency is absolutely unworkable in a lot of situations where had I or another clinical pharmacist not been involved in the case and gone to extreme lengths, something would have fallen for, you know, someone's meds would have fallen through the cracks. Yeah, and it's almost like what we find sometimes is that each individual client has their own workflow for how to navigate REMS and the phlebotomy and the picking up the medication. We have all that tracked, but it gets very complex very quickly with all the variation. You know, I think maybe one last question, clozapine-capable clinics fall in an interesting position I think in the system because, you know, a lot of what we do, it's not really ACT services, although I know Dr. Asbury works on an ACT team, but people who are on any sort of clozapine clinics often are sort of a step down beneath an ACT team, but often need a team-based approach with coordinated care. And I'm just sort of curious about how do you all sort of frame that coordination of care? Do you have treatment team meetings? Do you use services within your clinic or do you use services sort of outside of your clinic and try to coordinate that? Our setups are, we have services within the clinic. We're very fortunate that way to do that. And I think that's resource sharing. So that's another, you know, advantage I think of clozapine-capable clinic versus clozapine standalone clinic is that it does out, you know, a lot sometimes for resource sharing. But it is fundamental to have those additional supports, like you said, in particular, kind of a case management support. And we find a lot of times our individual therapists can fall into that role and it's a role that's necessary. And unfortunately, with just fee for service, it's not going to be paid for otherwise. I think that interdisciplinary team is really the key in being able to manage this complex population. And, you know, I speak of interdisciplinary team, including that pharmacy piece, the clerical piece, the phlebotomy lab, it's all part of it. They, everyone lays eyes on these patients at a different point and brings new information to the table to be able to gauge their progress. And maybe they answer everything with yes or no, when I ask them how they're doing. But really open up to the phlebotomist and they see a change in how they're presenting over time. And so we have weekly team meetings, then we run through the full list of those patients. And that is, I think, I don't think it's possible to treat this population without that cohesive care. Well, unfortunately, we're at the end of the webinar. This was so interesting, and I'm really inspired by the work that everybody's doing. Thank you so much. I think there's a lot of really innovative ideas here, and I'm really excited to take some of this back to Atlanta. All right. So with that, if there are any questions, I'm going to go ahead and ask them. If there are topics covered in this webinar that you'd like to discuss with colleagues in the mental health field, post a question or comment on SMI Advisors' webinar roundtable discussions. This is an easy way to network and share ideas with other clinicians, for people who participate in this webinar. If you have questions about this webinar or any other topic related to evidence-based care for SMI, you can get an answer within one business day from one of our staff. SMI Advisors are national experts on SMI. This service is available for all mental health clinicians, peer support specialists, administrators, and anyone else in the mental health field who works with individuals with SMI. It's totally free and confidential. Next slide. So SMI Advisors is just one of the many SAMHSA initiatives that are designed to help clinicians implement evidence-based care. We'd encourage you to explore the resources available on the Mental Health Addiction and Prevention TTCs, as well as the National Center of Excellence for Eating Disorders and the Suicide Prevention Resource Center. These initiatives cover a broad range of topics from school-based mental health to the opioid epidemic. Next slide. To claim credit for participating in today's webinar, you'll need to have met the requisite attendance threshold for your profession. Verification of attendance may take up to five minutes. You'll then be able to select next to advance and complete the program evaluation before claiming your credit. And finally, please join us next week on November 18th as Ashley Gonsler presents Improving Efficacy in Aftercare, Targeted Intervention for People Living with Serious Mental Illness. Again, this free webinar will be available November 18th from noon to 1 p.m. Friday. Thanks so much for joining us and take care. Until next time. you

clozapine utilization

serious mental illness treatment

Dr. Rob Cotez

Dr. Mindy Asbury

Dr. Anna Kostakis

Dr. Jessica Goren

clozapine clinics

pharmacy relationships

technology in mental health

interdisciplinary care