Okay, good afternoon. Hello and welcome. I'm Dr. Donna Rowland, Psychiatric Mental Health Nurse Practitioner Program Director at UT Austin School of Nursing and the clinical nursing expert for SMI Advisor. I am pleased that you're joining us today for our SMI Advisor webinar, Long-Acting Injectable Antipsychotic Medications in an Aging Population. 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 1 Credit for Physicians and one Nursing Continuing Professional Development Contact Out. Credit for participating in today's webinar will be available until August 7th. Slides from the presentation today are available to download in the webinar chat. Select the link to view. Along the way, please feel free to submit your questions throughout this presentation by typing them into the question area found in the lower portion of your 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. Megan Aratt. Dr. Megan Aratt is a professor at University of Maryland School of Pharmacy in the Department of Practice, Sciences, and Health Outcomes Research and is a co-director of the Mental Health Program. She is a past president of the American Association of Psychiatric Pharmacists. Her current interests include psychotropic medication adherence and the incorporation of the psychiatric pharmacist in practice. Thank you, Dr. Aratt, for leading today's webinar. Thank you, Donna. I'm very glad to be with everyone today to be presenting this amazing topic at looking at the LAIs in an aging population. There are no disclosures related to the subject matter of this presentation today. The learning objectives. I'd like to focus our education today on evaluating the utilization of long-acting injectable antipsychotic medications in the elderly population. So looking at this aging population and determining what is currently being done and what we might think about for the future. We'll consider the management of adverse effects of long-acting injectable antipsychotic medications in this population. And then at the end, we'll develop an administration and treatment plan for the use of these medications in the aging population. So I'd like to start with a little bit of background information and think about psychosis and the elderly. Many of us know and understand that most of the illnesses that we treat with SMI tend to typically occur earlier in life. We might see them starting in the teens, maybe 20s, 30s, and then less likely as patients age. But improvements in medicine and technology have been occurring over the course of time and we've seen increased life expectancies. So we now have populations of individuals greater than 65, larger than we may have seen in the past. And with this, there are a twofold sort of occurrence here. One, increase in life expectancy means that patients that do have severe mental illness may survive longer and later into life. And so we need to think about the differences in treatment for those who have had serious mental illness throughout their lifetime. But also, we can see an increase in the incidence of late-onset mental illnesses. And in the elderly, there can be an increased risk of psychosis. And there are several reasons listed here on the slide that you can see. We can see age-related deterioration of the cortical areas of the brain. We're going to talk about some of the neurochemical changes that can occur in the elderly that may put them at increased risk. Comorbid physical illnesses may lead to psychosis. Additionally, there's evidence to suggest that social isolation may increase the risk of psychosis as people age. Sensory deficits and polypharmacy. And we have a wide variety of diagnoses. Delirium, schizophrenia, delusional disorder, mood disorder, dementia, substance abuse, metabolic disturbances, neurologic conditions, and drug-induced psychosis, all of which can continue to occur as people age. And we'll sort of gather some of this information and think about how we might utilize the long-acting injectables for their treatment. It is important to think about primary and secondary disorders. Primary disorders are conditions in which the psychotic symptoms are the main clinical presentation of the illness. And many of us treat these. Schizophrenia spectrum, major depressive disorder with psychotic features, bipolar disorder with psychotic features. And again, we know that the majority of patients who develop schizophrenia have an onset earlier in life, but 15% of patients have an onset of symptoms after the age of 40, 7% after the age of 50, and there can be 3% thereafter. And so we will see new patients who may present later in life. With that late onset, there can be more of a chronic course, and symptoms such as hallucinations and persecutory delusions are especially common. This may be rationale for continuing antipsychotics longer than maybe in a patient who may have had an earlier onset. Available evidence also suggests that among older adults, approximately 60% of the cases of psychosis that we'll see are secondary disorders. And secondary disorders are illnesses in which psychosis is the secondary or associated symptom, and not the core clinical features. So these would be delirium, neurocognitive disorders, psychosis due to drugs or drugs of abuse or prescribed medications, psychosis due to medical or neurologic disorders. Most recently with dementia, we've seen symptoms of psychosis, agitation, and this may present as delusions and hallucinations, aggression, disinhibition, and these are common and often challenging to caregivers. And we know that there are black box warnings about using antipsychotics in the treatment of dementia. And so we're really going to try to focus really on the primary conditions today, but to keep in mind that there may be secondary illnesses which are presenting as well, and the need to make sure that you're considering diagnoses for patients. We'll explore some of the treatment strategies. Again, for secondary illness, we really want to address possible causes of the psychosis that is occurring. And this will be important when we think about treatment. For pharmacologic treatment, when we are using this, we want to use it cautiously in our elderly population, and we'll present some of the evidence for this today. Think about the risk-benefit analysis, physical condition of the patient, comorbid medical disorders that are occurring, and recommendations would be to start at a quarter to half the starting dose for adults. We know that many of our patients may need less medication, and we'll go through some of the evidence for that today and some of the pharmacokinetic and dynamic changes that we're going to see in this particular population. And then gradual titrations to the optimal dose. What we have seen in literature and what has been gathered is that the total daily maintenance dose ranges about 25 to 50 percent of the usual adult dose, and that's typically what might be needed for an aging population. So, it is a bit different than what we might see for our younger patients. So, we do need to keep in mind that over time, we may need to consider dose reductions for our patients as they begin to age. Other recommendations for the use of antipsychotic medications in that aging population, we want to consider short-term use of antipsychotics to treat psychotic symptoms, and this can be due to the risk of adverse effects. So, there is rationale for making sure that we're using the lowest effective dose of the medication to avoid adverse effects, which are what our population is more at risk for. There is very limited data regarding discontinuation of antipsychotic medications. We do know that patients that have an earlier onset of illness, over time and as the patient ages, the positive symptoms of hallucinations and delusions do tend to decrease, and those that have a later onset, those hallucinations and delusions will not. And so, depending on when your patient is diagnosed, you may consider decreasing the dose as they age and maybe consideration for discontinuation. Reasons to consider this, maybe the patient hasn't adequately responded to the medications if they have resulted in intolerable adverse effects, and if the individual has demonstrated long-standing clinical remission, this might be something that you would consider later as the patient ages. But all of this would be on a very case-by-case and patient-specific information. And again, decreasing the dose to the lowest effective dose is recommended. Medication non-adherence is not limited to the younger population. And as people age, there is potential for increase in medication non-adherence. We do know that 10% of hospitalizations are due to medication non-adherence, and it's probably increasing as time goes on. Patients greater than 60 years of age consume 50% of the dispensed prescription medications. And with this consumption of prescription medications, we do see increase in volume and complexity of medication regimens. As many of us look at different medication regimens, you might see medications that are once a day, some that are twice, some are three times a day. And then when we add in long-acting injectables and think about, now this one's once a month, and you're still taking orals, there is increased complexity within these regimens that I even think of myself as a pharmacist can struggle with when thinking about needing to follow all of these regimens. There is adverse medication reactions, and these do increase in the elderly. Polypharmacy, many older adults take anywhere from six to eight medications a day. So not only are we using various antipsychotics or psychotropic medications, we do need to consider the entire medication profile that patients are taking. There is potential for decreased visibility and motor dexterity. Labels can contain a lot of information. Typically, they're very small in font and difficult to read for elderly patients with visual impairment. And so it's important that we make sure that we are adequately describing to the caretaker or the patient how to take these medications. And difficulty opening pill bottles, even non-childproof ones can lead to medication non-adherence. The decreased autonomy, limited ability to move, drive, maybe get to the pharmacy to pick up their refills, can lead to delayed refills, delayed consumption of medication. And so all of these things can lead to non-adherence, which may lead us to think that perhaps a long-acting injectable medication might be of greater value for our particular patient. It's important to understand the age-related differences in response to medication, as this is important to think about the dosing that we might consider for our particular patient. As patients age, there can be delayed gastric emptying, reduced levels of plasma proteins, particularly albumin, maybe particular for the antipsychotics, but for medications such as Divalpro-X, which is highly protein-bound, you might see some differences in those medication levels and making sure we're monitoring those appropriately. Reduced circulatory volume, decreased cerebrovascular perfusion, decreased synthesis and activity of the hepatitis, and so there is less metabolism of medications occurring, which can lead to additional medication lingering longer than we may have had it before. Increased relative and absolute amount of adipose tissue, and this will become a large consideration for our LAIs in particular, especially those which are given in a muscular. Decreased body water, with the decreases in the total body water and the lean body mass, with this increase in adipose tissue, lipid-soluble medications, such as the antipsychotics, have an increased volume of distribution and subsequently a prolonged time of activity. So, these medications can be of great benefit to our patients, but they may not be so. These medications may need a decrease in dose just because of the differences that are occurring. There can be decreased renal blood flow, impaired glomerular filtration, reduced renal drug clearance. So, understanding which of the antipsychotics may be eliminated renally is also going to be important. These are all pharmacokinetic changes. There's also important consideration for pharmacodynamic changes. We see a decrease in density of neurotransmitter receptors, including serotonin and dopamine, as the patient population ages. So, we could see some changes in efficacy as well for the particular medications because of the density of the neurotransmitter system changing. So, this particular table sort of breaks down the various pharmacokinetic changes that we see and possible associated adverse effects with this. So, with the decreased hydrochloric acid secretion, increased gastric pH, we did see that slowing of the gastric motility and emptying. Medications can linger around longer. There could be drug interactions that also may further slow gastric motility, and we may see an increase in drug levels as medications are around longer. Again, the decrease in lean muscle mass and total body water, increased fat content, volume of distributions, prolonged elimination can occur from the lipophilic medications. We can see accumulation of medication, particularly the psychotropics will accumulate in the body over time. Renal function, again, the changes in the renal function can lead to a decrease in clearance of medications, in particular lithium. We may see accumulation of metabolites of the antidepressants with hepatic function decreasing as well. We can see increased concentrations of unmetabolized medications and decreased clearance of most of the psychotropics that we utilize do get cleared through the liver. So, there are a lot of changes that are going on pharmacokinetically that are important for us to consider over time with our patients. Other pharmacodynamic changes to consider, again, the decreased dopamine neurons, decreased dopamine receptors. We can see decreased alpha and beta adrenergic receptor quantities and receptor responsiveness. There can be a loss in cholinergic neurons, a decreased function of choline acetyltransferase, an increased permeability of the blood-brain barrier. This can lead to increased concentrations of medications in the central nervous system, potential for increased adverse effects, including development of delirium or tardive dyskinesias. So, with all of that wonderful news about all of the things we must keep track of, I thought it was important for us to review the Beers criteria. For those of you that may not be aware, the Beers criteria were developed by the late Mark Beers, who's a physician, and he and his colleagues at the University of California, Los Angeles, developed these criteria in 1991. The American Geriatric Society continues to update these particular criteria, and these are applied to adults 65 years of age and older in an ambulatory, acute, or institutionalized setting of care. And they're relevant, except for hospice and end-of-life care settings, where we may be utilizing all of these medications. And they should be thoughtfully used and in a manner that supports rather than replaces shared decision-making with our patients. But I thought it important to review the criteria and think about their review of the antipsychotics first and second generation. As we are aware, there is an increased risk of stroke and greater rate of cognitive decline and mortality in persons with dementia. Additional evidence suggests an association of increased risk between antipsychotic medication and mortality independent of dementia. But the recommendation from the criteria is to avoid antipsychotics, except in FDA-approved indications, such as schizophrenia, bipolar, Parkinson disease psychosis, adjunctive treatment of major depressive disorder, or short-term use as an anti-emetic, which you may see. So really being thoughtful about making sure that we are considering diagnoses over time for the use of these particular medications. When we consider the long-acting injectable medications, there really is a very small amount of literature regarding the use of these types of medications in the aging population. When the discussion of this particular webinar and the topic was presented, I was very excited thinking like, this will be an opportunity to make sure that we review all of the relevant literature and came to find out that the relevant literature is very tiny. So today we won't be going through tons of randomized controlled trials, looking at all of these different medications. We're really gonna look at what is available in the literature regarding the use of these particular medications and think about what we need for the future and also about some of the important aspects of providing these medications to the patients and making sure that we understand injection techniques a little bit with the elderly population. So we think about long-acting injectable medications. They are a very great option. They provide predictable and stable plasma concentrations of an active medication. We have a pattern of regular contact with the healthcare provider when we utilize these particular medications. And we do know that they can decrease relapse and hospitalization rates. So all a lot of positive benefits, even in an aging population. We do know there is reluctance to accept injections. Some patients may see a perceived loss of control or pain or discomfort on an injection site. And that is no different in an aging population as well, that these are all barriers that we may encounter when considering these types of medications. So what I'd like to do is transition a bit into what's available in the literature, what is out there and what can we garner from this. The majority of work probably has been done with the traditional antipsychotics. There were three studies, and you can see that these are much older studies. We tend to like to have literature that is within the last five years. And there is not a ton of evidence here in the last five years on this particular population. So we went back a little bit and found three studies, and you can see here, there is a small study of 20 patients that looked at flufenazine 12 and a half milligrams every 21 days for six months. This was significantly effective in treating symptoms of psychosis, emotional withdrawal, blunted affect, suspiciousness, and thought disturbances. Another 10 patients were published in 1990, looking at low dose flufenazine. After 16 weeks, there was improvements noted. And then another 13 patients who either had haloperidol or flufenazine, and they did note improvement more so with flufenazine when haloperidol. Low doses of haloperidol and flufenazine appear to be equally effective here. These tend to be the preferred traditional antipsychotics for elderly patients. Here in the US, these are the only two available. There may be less tendency to cause sedation, postural hypotension, and anticholinergic effects seen in these particular studies. But again, keep in mind, these are very small numbers of patients who are treated in these studies. We do know that there are many adverse effects from the traditional antipsychotics. The postural hypotension, sedation, anticholinergics can still occur. Motor effects, the EPS, chart of dyskinesias can occur. We do know EPS and hyperprolactinemia likely remain dose-dependent side effects, whether they're oral or LAI, but those are definite things that we do need to monitor for. And older adults should be monitored particularly closely for the development of chart of dyskinesia if considering the utilization of this. When we get a little bit further in the presentation, I'm going to present on some descriptive data that was collected that looked over a four-year period at antipsychotic use, and in particular with the traditional antipsychotics. This work demonstrated that when switches did occur from traditional to an atypical or second-generation antipsychotic LAI, it was typically due to the movement disorders. And so the literature would suggest that it's very important that we are monitoring for any sort of movement disorders in this population. We'll move along to the second-generation antipsychotics. There were two particular studies that were done. The first one was done with risperidone microspheres. This study looked at the various doses. We do know that the risperidone 75 milligrams is not an FDA-approved dose of this particular medication, but they had patients anywhere from 25 to 75 milligrams every two weeks. These patients were clinically stable at study entry. 49% saw improvement in PANS. The mean PANS improved significantly throughout the study and at end point. Another particular study looked at various antipsychotic long-acting injectable regimens. This had a much larger number of patients. This particular study, the LAI group had significantly lower rehospitalization rates. The number needed to treat within this particular study was eight and had significantly longer time to rehospitalization within one year of discharge compared to the oral meds. So 257 days for LAIs. So both of these, again, show improvement with the LAIs, which I don't think that any of us would not anticipate with these particular regimens. But I think it's important as we continue to move through our discussion to think about adverse effects and administration. There is one case report of paliperidone palmitate once monthly. This particular case report had the patient receiving 150 and 100 milligram treatments on day one and eight as the loading doses and then subsequent 100 milligram doses monthly. They saw a reduction of PANS total score that was noted over 28 weeks of the case report. They did see blood glucose levels, prolactin levels, QTC intervals, and weight as important areas to monitor when considering this in an older population. We do know with second-generation antipsychotics that there is the potential for lower risk of EPS and tardive dyskinesia versus traditional agents, although it's important to note that it can still occur. And we do need to continue to monitor that, in particular, given all of the pharmacokinetic changes that we see in the population. The medical comorbidity of metabolic syndrome as patients age, they may already have or have developed hypertension, dyslipidemia, diabetes. And so we may be adding to those additional medical comorbidity with use of second generations. In the particular risperidone study, they saw insomnia, constipation, bronchitis, psychosis, and rhinitis also within their particular study as adverse effects to consider with the patient. I found this particular report, and this is a report that looked at a study period between 2014 and 2018 to describe a community psychogeriatric service. Within this service, they described the selection of patients that were receiving long-acting injectable antipsychotics. They also outlined how many were receiving each particular agent, how many of them had maybe had switches or decompensated on these particular medications. And I think this was a very important piece of information to pull just to get an understanding because of the very limited literature that's available on these medications, maybe to understand what's happening in clinical practice. So again, from 2014 to 2018, this was a community psychogeriatric service. Over this course of time, they had 142 patients who received a long-acting injectable medication, and this was about 16% of this particular clinic. The majority of their patients were 70 to 79 years of age, and they had more females on the long-acting injectables compared to male patients. The majority of the patients were living at home with 76% versus about 24% in the nursing home, and all patients had a diagnosis of a psychotic disorder. It's important to note that 37 had an additional diagnosis of dementia as well. So here is a breakdown of the types of medications and then the year across the top with the total and then the percentage of patients. And I was interested in this just to see what other clinics are using and doing with this particular population. So the most popular medication at this particular clinic was the paliperidone once monthly. So over the course of time, they had 72 patients who had received this. In comparison to the paliperidone every three months, do keep in mind that this wasn't readily available until later in the study, but they did have two patients who did receive that. The aripiprazole, it wasn't listed here, but perhaps the assumption could be made that this was the aripiprazole monohydrate given the time of the study and had some patients about 11 on this. And then risperidone, and then our first generations here as well. So it's a very, just a nice pictorial to sort of see what sort of antipsychotics are being used. When they looked at the relapse data in this particular service across the top is the number of patients on LAI and the percentage of those that relapsed. And so total, they had about 13.4% of patients who relapsed over the course of the four year on those LAIs. The number of patients who had their LAI switched over the course of time, and so you do see some variation across the years, but it looks at about 37.5% had them switched over the course of time. And recall from earlier that if they were switching from a first gen to second gen, most of that switching that occurred occurred because of movement disorders that were noticed. And then patients who had their LAI ceased or discontinued, you can see here was probably about 44% so who had their LAI discontinued. I think it's a very intriguing numbers to think about. Although there isn't a lot of great information on what people were switched to or how all of this occurred, but just to provide some initial data on thinking about what happens over the course of time with patients. Adverse effect considerations, anticholinergic, adrenergic, thinking about constipation, urinary retention, delirium, orthostatic hypotension is very important with these patients. The medical comorbidities of dyslipidemia, hyperglycemia, increased risk of EPS and tardive dyskinesia are all items that need to be considered regardless if it's oral or an LAI, but definitely if this patient population continues to increase and polypharmacy increases, all of these need to be taken into account. So now that we've considered a lot of the changes that happen pharmacokinetically, pharmacodynamically, considered what's currently being used, looking at some of the resources for literature, I thought important to spend a little bit of time today thinking about injection administration. Many of us may or may not be the ones that are doing the research or may or may not be the ones that are doing the administration of these particular medications, but I think it's very relevant as providers to consider all of these different information that I'm about to present when you're making a selection of medications. Very early on when LAIs were there, we might've had two or three. We had our first gens and then we had Risperdal or Risperidone microspheres that was available, but now we have a plethora of medications to select from and there is a lot of information that we can use in our aging population to think about what might be the correct medication to select for. So one of the first things for consideration would be injection volume. As patients age, they may have less muscle mass and so they have more adipose tissue. So it might be important to think about injection site and then injection volume. Some of the literature that I'll show in a bit suggest that the aging population can really tolerate about a two milliliter IM injection. So that may preclude some medications which have a much larger injection volume if your patient doesn't have the muscle mass to be able to sustain such a large injection volume. And there's not a ton of data looking at the tolerability of some of these injection volumes in various populations, but I'm gonna show you a little bit of what's available. But here for the aripiprazole products, you'll see the various products available here, the various strengths that are available in the injection site. So all of our aripiprazole products are intermuscular and there are varying volumes of injection. So you may select which aripiprazole product, potentially one of the considerations might be the injection volume. There is a particular dose that you're using, the ability to convert between these various products based on what oral dose that the patient might be receiving is going to be important. Currently for elanzapine, there's only one product available. Again, this particular product is intermuscular only and does have some varying injection volumes depending on the strength that the patient requires. For paliperidone, we have three paliperidone products. Please keep in mind that these particular products usually are done in a stepwise approach. The patient gets started on the once monthly, may move to the every three months and then move to the every six, or they could go from the every one month to the every six month site as well. But these again are all intermuscular injections and have various volumes all the way up to five milliliters. And so we would really need to consider if our patient could tolerate such a high volume of injection if we needed to consider that product. Our risperidone products, this is probably the one with the most selection here. And we have some different selections that can be made for this particular product. So you can have different injection sites. These are available as sub-Q and there's also intermuscular. So it does allow a different injection site for patients who may be struggling with intermuscular injections. It does allow for a much smaller volume of injection in that population as well. And there's a lot to unpack here based on what oral dose your patient is on. And so if you do have questions on these particular products, there is a lot of tips within the SMI Advisor Clinical Center of Excellence for LAIs on all of the oral conversions here. But considering these volumes of injection size for our population is gonna be very important and their ability to tolerate that particular injection. So best practice for administration in the elderly. I went on a search and was really hopeful to find trials or information on best practices for administration in the elderly. There's probably a great deal of information about vaccines and different things that we could extrapolate to this. But I thought it was important to pull this one particular study that really looked at the aging population and how to give injections. Recommendations out of this particular study really focused on four major points. Looking at the determination of body type. What does this person's body mass look like? And that's not probably any different than what we might do for a younger patient as well. Thinking about different needle sizes that come with all of these various kits. So all of the second generation medications all come with standard kits. And so you only have your choice of the needles that are provided within that kit. But first generation, you do need to provide your own needles. So it's important to assess the person's body mass. Is there more adipose versus muscle mass? And thinking about the ability to provide an intermuscular injection. And so important when selecting the right needle size for the patient. What is the volume of injection? Again, older adults and thin patients may only tolerate up to two milliliters in a single injection. So it might be important to re-review which medication you're selecting. And then making sure that the angle of the injection, subcutaneous going in at a 45 versus your IM that's going in at a 90 degree angle to make sure that the patient can tolerate those. When we think about landmarking the injection site, it's also important that we look at our own fingers. Sometimes we use fingers and we say, oh, put three fingers here or two fingers here, making sure that we actually make sure that our fingers span that five centimeter rule so that we're making sure we're really hitting the muscle and not hitting any sort of bone or adipose tissue if we're using those intermuscular injections. Accurate location of any bony structures. So when thinking about gluteal injections, making sure that you could accurately identify all of the bony structures and so that we're not hitting the bones in any of our injection techniques. When we think about subcutaneous injections, it's important for consideration of bunching and flattening the type of skin that the patient has and important that we're monitoring that. Some of these injections require you to pinch two inches of skin and making sure that the patient you're able to do that before providing some of those subcutaneous injections. So there's a lot that needs to be considered, especially if we're not doing this on a routine basis. We only have a handful of patients that might have some of these changes. It's important for us to routinely consider them in this population. In summary, for the consideration of long-acting injectables in the aging population, definitely a consideration for non-adherence. And again, remember there are lots of reasons beyond adverse effects that people may not be taking their medications. It could be an inability to open the pill bottles, an inability to go to the pharmacy to receive them, an inability to read the label or reading the label incorrectly. This can all lead to irregularity in taking particular medications, which can lead to relapses in symptoms. If they are taking more than prescribed, it can lead to an increase in adverse effects. Other characteristics, memory, vision, audio, or auditory impairment are all important considerations as well. Does the patient know how to take the medication? Are they able to read the vials? Do they understand maybe what the pharmacist or the provider, the instructions that are being provided? All of the MA psychotics we know are equivalent in terms of efficacy. If we look at any of our guidelines, there isn't one that's pointed out as first, except for clozapine, obviously for treatment-resistant schizophrenia. So consideration for which particular medications you're using could vary amongst a variety of reasons. An important consideration, therapeutic drug monitoring. As patients age and over the course of time, if we had baseline therapeutic drug monitoring and knew a level that the patient responded to, over the course of time, if we stay on that dose and they develop various pharmacokinetic changes, maybe we can decrease the dose and figure out how to keep that patient at that particular level with a decrease in dose based on some of the changes that are occurring. So recommending therapeutic drug monitoring over the course of time can be very helpful as we try to maintain a particular steady state concentration. Important to consider adverse effect monitoring, in particular the movement disorders are really important to be monitoring as a drug accumulation occurs. Think about dose adjustments as people age, and this is where therapeutic drug monitoring is very important. The ability to decrease doses for those that need it, and definitely thinking about our injection technique and the importance of thinking about, can the patient tolerate this? Are we doing it right? Are we hitting the muscle versus any of the adipose tissue that the patient might have instead? So lots of considerations for treatment in the elderly, and so I want to thank everyone for attending today, and hopefully we can have some good discussion here as we sort of wrap out the end. So I'm going to, there are references here in this slide deck for you for all of the literature that was provided today, including the studies, and I want to thank you for your time, and I'm going to turn it back over to Donna. Thank you so much for an interesting presentation, Dr. Arad. Before we shift into Q&A, I'd like to take a moment and let everyone know that SMI Advisor is accessible from your mobile device. Use the SMI Advisor app to access resources, education, and upcoming events, complete mental health reading skills, and even submit questions directly to our team of SMI experts. Download the app now at smiadvisor.org app, and now we'll turn into Q&A for a bit. We've got some questions that have come in. Let's see, the first one asked just about the role of DSM-5TR. Do you have any comments on that, Megan? This is a, it's a little bit challenging without a context. I think it's important. I think the next question, too, helps a bit thinking about diagnosis, because I think it's important as regulations increase regarding use of the antipsychotics, and there are various there are various rules and regulations about making sure that we're always doing gradual dose reductions for the antipsychotics over the course of time, and I think it's important that we make sure that we are utilizing appropriate diagnoses so that one, that they will be paid for, as well as making sure that we're not doing things off label without consent of patients. So, I think there is a role in making sure that we're adequately diagnosing patients, but I hate to speak more on diagnoses because I really feel it's outside of the role of a pharmacist. I don't know, Donna, if you have any other thoughts. Yeah, why don't I read that next question? Yeah. I have access to it, and we can talk a bit about it. So, the next person said, CMS does not allow us to prescribe antipsychotics except for three diagnoses, schizophrenia, Huntington's, and Tourette's. CMS contraindicated injectables for elderly patients in nursing facilities, and even if we prescribe the above for the above diagnosis, CMS has pharmacists hound us for gradual dose reduction on antipsychotics. Now, President Biden wants pharmacists and state inspectors to make a list of nursing facilities with antipsychotics and find them or bring their stars down and cut funds, and then next, second, CMS manual has a statement for the PharmDs that do nursing home reviews that schizophrenia is rare before age 10, never after 40 years, and pharmacists keep following this manual, which is wrong. Currently, 25% of schizophrenia in elderly being diagnosed above age 40, and I guess I probably have a few comments on this since I did do some prescribing in long-term care facilities for many years, and this is true with the exception of that we can't, whereas the statement that we're contraindicated and LAIs are contraindicated for elderly. So, even though we are getting those notices to attempt a gradual dose reduction every two to three months on any patient that just gets audited and is on an antipsychotic in a long-term care facility, there is still always an option to say this person has had a lifelong serious mental illness and requires this medication. So, we can do that, and that doesn't go against the ratings, but there are public ratings. That is true. Those star ratings are public. So, it's really, it puts facilities and clinicians in a tough spot, but if you're diligent in following those notices and documenting why patients need to be on these medications, we are absolutely able to continue them on the medications. I agree, Donna. I know the pharmacists are, in those particular facilities, are bound by the rules of all of these gradual dose reductions and recommending those gradual dose reductions. Again, I agree that the challenge is that there is late onset of schizophrenia, and it's not zero. So, there probably is that internal struggle of being able to say this person has this chronic long-term illness, when potentially it could have been something that might have been diagnosed later in life, and that there is that challenge. I understand on both sides it can be very aggravating with trying to keep up with all of the documentation on the gradual dose reductions as well, especially if you've attempted those in the past and they haven't gone successfully. Right, right. Okay, so there's another question. Could you share more about how to proceed with treatment when elderly individuals have both a behavioral health diagnosis, including symptoms of psychosis, as well as dementia? And then there's a related question I might as well read now. Yeah. We're going to see this problem with CMS now with Rexalti, and as well, since it is an antipsychotic and is approved for FDA for dementia, if Alzheimer's type with agitation. Of course, we know that that's a brand new indication, but we haven't talked with ASGP to pursue this with CMS, so the pharmacists don't hound us for a gradual dose reduction on Rexalti. This is a definite interesting scenario we're about to engage in. When we think about behavioral health diagnosis with symptoms of psychosis, as well as dementia, using the lowest effective doses are always the most rational ways, and I think this helps too with the gradual dose reduction and making sure that you're using that lowest effective dose, because patients with behavioral health diagnoses, if they have schizophrenia as well as dementia, you can't potentially just continue their antipsychotic because there's this black box warning with dementia. These might be medications that patients need to continue on, and it'll be interesting, I think, to sort of see how this Rexalti indication changes the playing field or the landscape of practice for agitation in dementia. It will be a very interesting, it'll be interesting to sort of see how it starts getting used clinically. We haven't done it yet, but I'm very interested to see sort of how it all sort of rolls out, but I definitely think using lowest effective doses, if they do have that dual diagnosis, which I think we're going to see more as people continue to live longer, before where patients with mental illness might have had a shorter life expectancy given changes in medicine and things like that, we may see patients living longer. Great. It's going to be very interesting. I'm watching for it. Yeah, I am very intrigued and have inquired and need to thoroughly review that literature to sort of understand the outcomes that were reviewed to provide Rexalti with this particular indication, because I think that will be important as we pursue CMS so that we don't continually need to go with gradual dose reductions if that's the indication we're using it for. All right, I think we've got time for one more quick question. You mentioned earlier pharmacokinetic changes. Can you talk specifically about the renally excreted antipsychotics to consider? The major renally excreted antipsychotic to consider definitely is paliperidone. This particular medication, in particular, when you think about the long-acting injectables for this particular medication, if there is mild renal impairment, there is a decrease in the loading dose and maintenance dose. The loading dose changes, but your max dose for maintenance is less as well. It's not recommended in moderate or severe renal impairment, but this would be the large antipsychotic which would be considered for dose reductions in those with renal impairment or changes in renal function. Over the course of time, this might be one that you'd have to consider dose reductions in patients whose renal function changes. It's important to be proactively monitoring that over the course of time for a potential decrease in dose. Got it. Thank you so much. Okay, so we will start to wind down. Next slide. 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long-acting injectable antipsychotic medications

aging population

evidence-based care

serious mental illness

plasma concentrations

pharmacokinetic changes

pharmacodynamic changes

medication adherence

injection administration

challenges