Long-acting Injection Research Articles

Combination of Two Long-Acting Antipsychotics in Schizophrenia Spectrum Disorders: A Systematic Review.

Up to 34% of patients with schizophrenia are resistant to several treatment trials. Lack of continuous and adequate treatment is associated with relapse, rehospitalization, a lower effect of antipsychotic therapy, and higher risk of side effects. Long-acting injectables antipsychotics (LAI APs) enhance compliance and improve clinical outcomes and quality of life in patients with schizophrenia, and thus it may be advisable to administer two LAI APs at the same time in cases of treatment-resistant schizophrenia. The purpose of this review is to summarize the available literature regarding the combined use of two LAI APs in patients with schizophrenia or other psychotic spectrum disorders. An extensive literature search for relevant articles regarding any combination of two long-acting injectable antipsychotics has been performed from inception up to 9 February 2024, on PubMed, Scopus and APA PsycInfo, according to the PRISMA statement. Only studies reporting combination of two LAI APs and its clinical outcome in patients with schizophrenia and related disorders were selected. After the selection process, nine case reports, four case series and two observational retrospective studies were included in the final analysis. All patients treated with dual LAI APs reported a good response, and no new or unexpected adverse effects due to the combination of two LAIs were reported. Different drug combinations were used, and the most frequent association resulted in aripiprazole monohydrate + paliperidone palmitate once monthly (32 times). Our review highlights that the treatment regimen with two concurrent LAI APs is already widely used in clinical practice and is recognized as providing a promising, effective, and relatively safe therapeutic strategy for treating the schizophrenia spectrum disorders.

Long-Acting Injectable ART in Practice: A Mixed Methods Implementation Study Assessing the Feasibility of Using LAI ART in High Risk Populations and At Alternative Low Barrier Care Sites.

Long-acting injectable (LAI) antiretroviral therapy (ART) has the potential to change the lives of people living with HIV (PLWH). To ensure equitable access to new treatment modalities, we examined the feasibility and acceptability of administering Cabotegravir Rilpivirine Long Acting (CAB/RPV LA) to individuals who experience challenging social determinants of health (SDoH) and struggle with adherence to traditional oral ART. Quantitative and qualitative data were used to assess feasibility of utilizing ART at alternative clinic. Data were collected on individuals eligible to receive CAB/RPV LA at an alternative street-based clinic and on individuals receiving CAB/RPV LA at a traditional HIV clinic. After 6 months, participants were interviewed about their experience. Providers involved in the implementation were also interviewed about their experiences. Only one participant (out of 5) who received CAB/RPV LA at the alternative clinic received consistent treatment, whereas 17 out of 18 participants receiving CAB/RPV LA at the traditional clinic site were adherent. Participants and providers believed that LAI had potential for making treatment adherence easier, but identified several barriers, including discrepancies between patients' desires and their lifestyles, impact of LAI on interactions with the medical system, risk of resistance accompanying sub-optimal adherence, and need for a very high level of resources. While LAI has major potential benefits for high-risk patients, these benefits must be balanced with the complexities of implementation. Despite challenges that impacted study outcomes, improving treatment outcomes for PLWH requires addressing SDoH and substance use.

Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables.

Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance. Nevertheless, many challenges arise in the development and regulatory assessment of LAI drug products due to a limited understanding of the tissue response to injected particles (e.g., inflammation) impacting in vivo performance. Mechanism-based in silico methods may support the understanding of LAI-physiology interactions. The objectives of this study were as follows: (1) to use a mechanistic modeling approach to delineate the in vivo performance of DepoSubQ Provera® and formulation variants in preclinical species; (2) to predict human exposure based on the knowledge gained from the animal model. The PBPK model evaluated different elements involved in LAI administration and showed that (1) the effective in vivo particle size is potentially larger than the measured in vitro particle size, which could be due to particle aggregation at the injection site, and (2) local inflammation is a key process at the injection site that results in a transient increase in depot volume. This work highlights how a mechanistic modeling approach can identify critical physiological events and product attributes that may affect the in vivo performance of LAIs.

Outcomes of long-acting injectable antipsychotics use in pregnancy: A literature review.

Women with a history of serious psychotic disorders are at increased risk of disease relapse during pregnancy. Long-acting injectable (LAI) antipsychotics have been widely used to improve adherence and prevent relapse in patients with various severe psychotic disorders, but there is a lack of high-quality data from previous research on the safety of LAI antipsychotics during pregnancy. To summarize relevant data on maternal, pregnancy, neonatal, and developmental outcomes from published cases of LAI antipsychotic use in pregnancy. A literature search was performed through November 11, 2023, using three online databases: PubMed/MEDLINE, Scopus, and Web of Science. Case reports or case series that reported information about the outcomes of pregnancy in women who used LAI antipsychotics at any point in pregnancy, with available full texts, were included. Descriptive statistics, narrative summation, and tabulation of the extracted data were performed. A total of 19 publications satisfied the inclusion criteria: 3 case series, 15 case reports, and 1 conference abstract. They reported the outcomes of LAI antipsychotic use in 74 women and 77 pregnancies. The use of second-generation LAI antipsychotics was reported in the majority (n = 47; 61.0%) of pregnancies. First-generation LAI antipsychotics were administered during 30 pregnancies (39.0%). Most of the women (approximately 64%) had either satisfactory control of symptoms or no information about relapse, while approximately 12% of them had developed gestational diabetes mellitus. A minority of cases reported adverse outcomes such as stillbirth, spontaneous abortion, preterm birth, low birth weight, congenital anomalies, and neurological manifestations in newborns. However, there were no reports of negative long-term developmental outcomes. Currently available data seem reassuring, but further well-designed studies are required to properly evaluate the risks and benefits of LAI antipsychotic use during pregnancy.

Barriers to long-acting injectable atypical antipsychotic use in Japan: Insights from a comparative psychiatrist survey.

To investigate the negative attitudes of Japanese psychiatrists toward atypical long-acting injectable (LAI) antipsychotics, which are the current mainstream LAIs in Japan. We surveyed 69 Japanese psychiatrists using a 5-point Likert scale to assess their attitudes toward atypical LAI antipsychotics. Our assessment referenced concerns identified in a study conducted in Japan a decade ago, which found significant differences when compared with a survey of German psychiatrists. We also identified the factors influencing these negative attitudes. Additionally, the results were compared with those of previous Japanese and German studies. More than 50% of Japanese psychiatrists expressed negative attitudes toward atypical LAI antipsychotics in various areas. These concerns included apprehensions about cost, reluctance to recommend them initially, pain from injections, complexity of switching to LAI, usage in first-episode cases, and sufficient medication adherence with oral drugs. In all three studies, cost and adequate adherence to oral medication were concerns that exceeded the average of the three negative comments. Age and experience in psychiatry influenced the psychiatrists' attitudes toward using these drugs in first-episode cases. These findings shed light on the reasons for the underutilization of atypical LAI antipsychotics and suggest opportunities to enhance their appropriate use in clinical settings.

Assessing Preferences for Long-Acting Injectable Pre-Exposure Prophylaxis Among Young Adult Sexual Minority Men and Transgender Women

ObjectiveOral pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission. However, oral PrEP uptake is low, particularly among sexual and gender minority youth who are vulnerable to HIV infection. Alternative methods of PrEP delivery, such as long-acting injectable (LAI) PrEP may overcome barriers and be preferred. However, attitudes and preferences of younger sexual and gender minorities towards LAI PrEP have not been well studied. The purpose of this study is to describe preferences for initiating LAI PrEP among sexual and gender minority youth. MethodsWe analyzed data collected as part of an HIV prevention randomized trial from January 2022 to February 2023, using multiple regression to identify factors associated with a preference for LAI PrEP. ResultsThe study sample (N = 265) was 50% youth of color, mean age 25 years (SD=3.4, range=18–31), and primarily identified as gay (71%) and male (91%). Forty two percent had heard of LAI PrEP and 31% preferred LAI PrEP over other prevention methods. In multiple regression analysis, LAI PrEP preference was associated with identifying as White, previous PrEP experience, and perceived LAI PrEP efficacy. ConclusionsWe conclude that gaps in awareness exist for LAI PrEP, however it may be preferred over other prevention methods especially in White youth, those with PrEP experience and higher perceptions of its efficacy. More education and outreach are needed to prevent extension of existing race and ethnicity disparities in use of oral daily PrEP to LAI PrEP.

Population Pharmacokinetics and Dosing Simulations for Aripiprazole 2-Month Ready-to-Use Long-Acting Injectable in Adult Patients With Schizophrenia or Bipolar I Disorder.

A ready-to-use (RTU) long-acting injectable (LAI) formulation of aripiprazole monohydrate for administration once every 2 months, available in 960 mg (Ari 2MRTU 960) or 720 mg doses, has been developed for the treatment of schizophrenia or bipolar I disorder. A previously developed and validated population pharmacokinetic model for characterizing aripiprazole plasma concentrations following administration of oral aripiprazole or aripiprazole once-monthly (AOM) intramuscular injection was expanded to include the RTU LAI formulation of aripiprazole (Ari RTU LAI). Overall, 8899aripiprazole pharmacokinetic samples from 1191 adults from 10 clinical trials were included in the final combined analysis data set. Aripiprazole plasma concentration-time profiles were simulated for various Ari RTU LAI initiation and maintenance scenarios in 1000 virtual patients. Diagnostic plots demonstrated that the final population pharmacokinetic model, which incorporated data for oral aripiprazole, AOM, and Ari RTU LAI, adequately described aripiprazole concentrations following Ari RTU LAI administration. Absorption of Ari RTU LAI was modeled by a parallel zero-order and lagged first-order process. Simulations across multiple scenarios were performed to inform dosing recommendations, including various treatment initiation regimens for a 2-monthly formulation of Ari RTU LAI in patients with or without prior stabilization on oral aripiprazole, and for patients switching from AOM. Additional simulations accounted for missed/delayed doses, cytochrome (CYP) 2D6 metabolizer status, and concomitant use of CYP2D6 or CYP3A4 inhibitors. Overall, simulations across a variety of scenarios demonstrated an Ari RTU LAI pharmacokinetic exposure profile that was comparable to AOM, with a longer dosing interval.

GA Depot (Long-acting IM Injection of Glatiramer Acetate) Presents Improved Safety and Tolerability Features: Results from a Multinational, Double-blind, Placebo-controlled Phase III Study in Subjects with Relapsing Forms of Multiple Sclerosis (P8-6.018)

GA Depot (Long-acting IM Injection of Glatiramer Acetate) Presents Improved Safety and Tolerability Features: Results from a Multinational, Double-blind, Placebo-controlled Phase III Study in Subjects with Relapsing Forms of Multiple Sclerosis (P8-6.018)

Real-world effectiveness of long-acting injectable vs. oral antipsychotics in patients with bipolar I disorder: a 1-year retrospective observational study

Objective Long-acting injectable (LAI) antipsychotics are recommended in the treatment non-adherence. Despite the widespread use of LAI antipsychotics, there is limited data on clinical outcomes in bipolar I disorder (BD-I) patients with real-world data. We aimed to compare BD-I patients treated with LAI and oral antipsychotics (OAP) in terms of treatment effectiveness in a 1-year follow-up period. Methods The study was conducted retrospectively with electronic health records of 116 BDI patients. The primary outcomes were whether patients in the LAI group and the OAP group differed in relapse, rehospitalization, emergency room (ER) visits, and all-cause treatment discontinuation at 1-year follow-up after a mania episode. Cox regression modeling was used to predict the recurrence of any mood episode and all-cause treatment discontinuation during follow-up. The secondary outcomes evaluated were the effects of sociodemographic and clinical parameters and concomitant psychotropic medications on the course of the illness and treatment adherence. Results Of all 116 patients, 33 (28.4%) were under LAI, and 83 (71.6%) were under OAP treatment. LAI users had a history of more hospitalizations and total mood episodes. Patients in the LAI group had more treatment non-adherence before the index hospitalization. At 1-year follow-up, there was no difference between the groups in terms of any mood relapse, rehospitalization, ER visits, and all-cause treatment discontinuation. As a secondary outcome, lithium users were found to have fewer new episodes and discontinuations of treatments. Conclusions In real-world data, there is no evidence that LAI antipsychotics (compared to OAP) are superior in the maintenance treatment of BD. These results are important in terms of reflecting clinical practices for the treatment of BD-I. These results do not devalue the use of LAI therapy in BD; however, more studies are needed to identify positive predictors for LAI treatments in BD.

Abstract LB439: Intra-tumoral administration of releasable hydrogel microsphere drug conjugates for long acting therapeutics

Abstract Background. Intra-tumoral (IT) injections of therapeutics hold promise for the treatment of solid tumors. However, drugs administered directly in the tumor have short IT residence times potentially limiting their exposure and therefore efficacy. We are developing a platform of novel hydrogel microsphere (MS) conjugates that enables long-acting tumor residence after a single injection of the conjugate. We demonstrate this approach not only solves the problem of short acting intra-tumoral therapy, but also allows for the safe administration of two therapies with overlapping toxicities such as SN-38 and a PARP inhibitor (PARPi). Methods. Hydrogel microsphere (MS) conjugates were prepared and characterized. Using MS conjugates labeled with rhodamine and fluorescein, we established methods to directly measure the IT concentration and half-life of the released drug after IT administration into CT26 tumor bearing mice. We next measured the tissue pharmacokinetics and efficacy of MSs attached to SN-38, a potent topoisomerase 1 inhibitor and immunomodulator, using NSG mice bearing 22Rv1 ATM-/- xenografts. Finally, we measured the anti-tumor efficacy of MS~SN-38 in combination with an oral PARPi, talazoparib, in 22Rv1 ATM-/- xenografts. Results. We successfully established methods to quantify the concentration of released drug and MS bound drug from tumor biopsies using fluorescent surrogates. When applied to MS~SN-38 conjugates, locally injected tissues showed high levels of SN-38 with a long half-life of about one week. In contrast, the systemic half-life of free SN-38 is ~30 minutes. IT MS~SN-38 was ~10-fold more efficacious as an anti- tumor agent than systemic SN-38 from subcutaneous administration of MS~SN-38. Finally, we show high anti-tumor synergy from the SN-38 localized in a tumor by IT MS~SN-38 in combination with systemic administration of the PARPi talazoparib. Conclusions. This microsphere technology allows for sustained delivery of high local concentrations of drugs administered intratumorally. Here, IT MS~SN-38 resulted in an intra-tumoral half-life of ~1 week and marked anti-tumor efficacy in 22Rv1 ATM-/- xenografts. We also demonstrated that long-acting IT injections enables safe use of drug combinations with well-described overlapping toxicities such as SN-38 and PARPi. The microsphere technology may offer an alternative strategy for localizing and sustaining drugs in tumors and may mitigate toxicities from combination therapy where two agents have a similar toxicological profile. Other combinations, including small molecules and immuno-oncology agents, are being explored. Citation Format: John A. Hangasky, Jeff Henise, Deborah Charych, Christopher W. Carreras, Gary Ashley, Daniel V. Santi. Intra-tumoral administration of releasable hydrogel microsphere drug conjugates for long acting therapeutics [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr LB439.

The role of long-acting antipsychotics in illness relapse: an observational study

IntroductionIn patients affected by Schizophrenia and Bipolar Disorder disorders the use of antipsychotic drugs is essential in preventing the exacerbation of symptoms. The use of long-acting injectable (LAI) antipsychotics is considered an important treatment option. The aim of this study was to evaluate the incidence and predictors of relapse during antipsychotic treatment with LAIs in a sample of psychiatric outpatients up to a year after the start of long-acting therapy.ObjectivesThe study included 103 adult patients admitted to the psychiatric unit of Sant’Andrea University Hospital in Rome.MethodsWe evaluated duration of untreated illness, previous treatments, substance abuse, suicidal status, LAI dose, and use of other medicines for association with new episodes of illness or of symptomatic worsening as well as hospitalization, using bivariate and multivariate analyses.Results Seventy-three patients were diagnosed with schizophrenia spectrum and 30 with bipolar disorders. Age at study entry averaged 36.7 years (SD= 11.55). 40.8% of patients were women. The mean age at onset were 23.11 (SD= 7.0). All the other information were reported in Table 1. On 103 patients undergoing with LAI treatment for a year only 9 (8.7%) patients had a relapse during the study period. The two groups differed according to the presence of hospitalization during the 12 months before the LAI treatment (p = .022), in particular patients with relapse were more hospitalized than patients with no relapse (62.5% vs. 21.7%). Moreover, group with relapse were more at risk of suicide during the 12 months before the LAI treatment than the other group, for both suicidal ideation (11.1% vs. 4.3%; p= .015) and attempt (25.0% vs. 3.2%; p= .049). Finally, the two groups differed according to the side effects reported during the year of LAI treatment (χ² =38.48; p< .001). Specifically, patients’ group with relapse reported more side effects caused by parkinsonism (25.0% vs. 1.1%) and tremor (25.0% vs. 0%). No differences were found for the other variables (See table 1).Image:ConclusionsIn conclusion, our observations confirm the importance of LAI therapy in real word. However, our results indicate that these drugs might not prevent subsequent exacerbations for a proportion of individuals whose illness is stabilised on continuous antipsychotic treatment. Extra pyramidal symptoms in particular might have pathophysiological implications for relapse.Disclosure of InterestNone Declared

Paliperidone LAI-Induced Leukocytopenia: A Case Report

IntroductionAntipsychotics effectively manage psychotic symptoms but may have side effects. Patients with schizophrenia often lack insight into their condition, leading to nonadherence. Long-acting injectable (LAI) antipsychotics aim to overcome this, reducing relapse risks. Paliperidone LAI, a second-generation antipsychotic, has a lower side effect profile when compared to first-generation counterparts. Blood dyscrasias, like neutropenia and lymphopenia, increase infection susceptibility. This case report describes an instance of leukocytopenia arising during paliperidone LAI treatment, which quickly resolved after the discontinuation of the medication.ObjectivesThis case report describes an instance of leukocytopenia arising during paliperidone LAI treatment, which quickly resolved after the discontinuation of the medication.MethodsResultsCASEA 42-year-old female with schizophrenia, nonadherent to previously prescribed medication was admitted to our acute psychiatric department. She experienced positive symptoms (paranoid delusions), as well as disorganized thinking and behavior. Oral risperidone 4 mg two times a day was recommenced and titrated with mild improvement in her psychotic symptoms with the idea of switching to paliperidone LAI and eventually ceasing oral medication. Oral paliperidone was unavailable for prescription due to local restrictions. At admission her routine laboratory tests showed no abnormalities, but 5 days after receiving paliperidone LAI, routine laboratory tests showed a strong decrease in her WBC and absolute neutrophilic and lymphocytic count ( Lkc 2.89x109/L, Neut 1.57x 109/L, Lym 0.88x 109 /L ). Antipsychotic-induced blood dyscrasia was suspected and paliperidone depot was discontinued. The patient had rapid improvement in her WBC reaching the reference range in 10 days ( Lkc 4.23 x 109/L, Neut 2.51x10 9/L, Lym 0.98x 109/L). Sertindole was introduced consdering her history of a good therapeutic response to the drug, with improvement in psychotic symptoms. She is currently stable taking sertindole 16 mg/day, clonazepam 2 mg/day and alprazolam 0.5 mg/day.DISCUSSIONThe onset of neutropenia and lymphopenia post-paliperidone LAI initiation, resolving in 10 days,, indicate a direct association. Few cases report to date describe paliperidone-induced leukocytopenia, with rapid recovery post-discontinuation. Proposed mechanisms include bone marrow suppression and peripheral WBC destruction. It has been proposed that drug-induced neutropenia is often dose-dependent, which could explain why our patient exhibited tolerability to risperidone but developed cytopenia upon transitioning to depot paliperidone.ConclusionsWhile cases of agranulocytosis have been reported in association with the use of other antipsychotics these antipsychotics do not require the same monitoring as clozapine. Our case emphasizes the need for vigilant blood dyscrasia monitoring during antipsychotic therapy.Disclosure of InterestNone Declared

Initiation of Paliperidone palmitate 3-monthly injectable in an acute inpatient psychiatric unit

Introduction The treatment of patients with severe psychotic disorders presents significant clinical challenges, and the choice of appropriate therapy is essential to ensure long-term stability1. In this context, long-acting injectable antipsychotics (LAIs) have emerged as a promising therapeutic option. LAIs were developed to counteract poor treatment adherence in patients with psychotic disorders2.Paliperidone palmitate 3-monthly injectable (PP3M) is a novel formulation of intramuscular injectable paliperidone palmitate with a significantly longer half-life than the once-monthly formulation.PP3M has shown a longer time to relapse and good safety and tolerability in many studies3.ObjectivesThe aim of this work was to describe the profile of patients initiating PP3M in an acute inpatient psychiatric unit.Methods A descriptive study was conducted on patients admitted to the acute psychiatric unit from January 2021 to December 2022. The sample included 23 inpatients who initiated PP3M during the admission. Data were collected regarding age, gender, diagnosis, substance abuse, previous antipsychotic treatment, antipsychotic treatment adherence and adverse effects during the admission.Results23 patients sample, with an average age of 44.04 years-old, 16 male and 7 female, diagnosed with psychotic disorder (22) and schizoaffective disorder (1). Out of the 23 patients, 7 had active substance abuse upon admission. Out of the total simple, 9 of them were prescribed LAIs, with 6 on PP1M (Paliperidone palmitate 1-monthly injectable), 2 on PP3M, and 1 on aripiprazole long-acting injection. Twelve were prescribed oral antipsychotics, including 4 on paliperidone, 4 on risperidone, 1 on aripiprazole, 1 on olanzapine, and 2 on other oral antipsychotics. Two patients did not have a previous antipsychotic prescription.Among the 23 patients, 17 of them did not have previous antipsychotic treatment adherence.5 out of the 23 patients experienced adverse effects, with 3 of them having extrapyramidal symptoms and 2 hyperprolactinemia.Upon discharge, 11 out of the 23 patients were prescribed antipsychotic monotherapy with PP3M.ConclusionsIn this sample, we observed that inpatients who initiated PP3M in an acute psychiatric unit were males, with psychotic disorders, lacked adherence to previous antipsychotic treatment. Most of them did not experience adverse effects with PP3M during admission.More research should be done to assess the use of PP3M in an acute inpatient psychiatric unit.REFERENCES1. Morris MT, Tarpada SP. Psychopharmacol Bull. 2017 May 15;47(2):42-52.2. Brasso, C., Bellino, S., Bozzatello, P., Montemagni, C., & Rocca, P. (2017). Neuropsychiatric Disease and Treatment,3. Edinoff AN, Doppalapudi PK, Orellana C, Ochoa C, Patti S, Ghaffar Y, Cornett EM, Kaye AJ, Viswanath O, Urits I, Kaye AM, Kaye AD. Front Psychiatry. 2021.Disclosure of InterestNone Declared

Predictors of admission to an assertive outreach service for psychosis in Lebanon

IntroductionSchizophrenia is a chronic, debilitating mental illness that contributes significantly to the global burden of disease. Assertive outreach treatment for patients with schizophrenia and psychotic disorders has been implemented to improve treatment adherence and outcomes.The suitability of this model of care outside the western context has not been fully established. The Psychosis Recovery Outreach Program (PROP),staffed by a multidisciplinary team that applies principles of early intervention and assertive outreach, was initiated in February 2016 at a leading psychiatric facility in Lebanon.ObjectivesThe aim of this study is to identify and analyze clinical and demographic variables associated with patient enrollment in PROP, out of a typical clinical population attending a psychiatric outpatient department.MethodsThis retrospective study included patients above 18 y.o. at time of first point of care with a primary diagnosis of psychosis according to the International Classi-fication of Diseases 10 (ICD-10), and who presented to the outpatient psychiatry department at the American University of Beirut Medical Center (AUBMC) and were following up in PROP. We collected twelve-month data and used logistic regression models to identify predictor variables for enrollment in the service compared to those receiving standard treatment.ResultsIn total, 45 patients participated in the study. Patients were mostly males (77.8%), younger than 39 years (80%), of college or higher education (68.2%), and diagnosed with schizophrenia (46.7%) or schizoaffective disorder (48.9%). About one-quarter (22.7%) had a comorbid cannabis use disorder. A majority received more than one oral antipsychotic (75.6%) while half (51.1%) were maintained on a long-acting injectable (LAI) antipsychotic.The following variables were significant predictors of enrollment in PROP: having a comorbid cannabis use disorder (OR 2.83 [1.25 – 6.37]), being prescribed a LAI antipsychotic (OR 9.99 [4.93-20.24]) or more than one oral antipsychotic (OR 4.57 [2.22-9.39]), visiting the emergency department more than once (OR 8.7 [2.64-28.68]), and admission to the psychiatry unit (OR 13.91[3.17-60.94]). In addition, those following up in PROP were younger and less likely to be in the oldest age group (over 54 years) [OR 0.11 (0.01-0.93)], less likely to be females (OR0.39 [0.18-0.81]), and less likely to be diagnosed with “other psychotic disorder” as com-pared to schizophrenia (OR 0.14 [0.03 – 0.62]).ConclusionsPROP was the first community treatment program to use the principles of assertive outreachin Lebanon. Our findings highlight that the assertive out-reach model of care is applicable to its target population in the context of psychiatric care in Lebanon, namely young individuals with psychosis, higher comorbidities and a severe course of illness.Disclosure of InterestNone Declared

The relationship between homelessness and psychiatric disorders in an inpatient sample

IntroductionThere are more than ten thousand homeless people in Hungary. Earlier studies confirmed the connection between mental health issues and homelessness. Furthermore, homeless care places a significant burden on the healthcare system, with psychiatric departments being no exception.Objectivesto compare demographic and treatment characteristis of homeless and not homeless inpatients in the psychiatric department of Jahn Ferenc South Pest Hospital (JFSPH), and thus providing a different perspective compared to previous studies, shedding light on the relationships from a different angle.MethodsIn our retrospective study, we analyzed all inpatients’ data treated in the psychiatric department of JFSPH over a 4-month period (03/2023-07/2023). Patients were divided into two groups: those with housing and those who were homeless. We compared the two groups based on the following variables: gender, age, length of inpatient treatment, diagnosis, psychiatric history, employment status; smoking, alcohol and drug use; valid health insurance, invalidity pension and guardianship status; and long-acting injectable antipsychotic treatment.ResultsThe percentage of homeless individuals treated in the psychiatric department of JFSPH was 18%. There was a significant difference in the length of inpatient stay between the two groups, homeless patients spent more than 100% longer time under inpatient treatment. Regarding psychiatric history, there was no significant difference between the two patient groups. When examining the employment status of the sample, we found significantly more unemployed patients im the homeless group. Comparing to the control group, there were significantly more alcohol consumers, smokers, and substance users among the homeless. Long-acting antipsychotic injections were administered significantly more frequently to homeless patients. A significantly higher percentage of homeless individuals were declared invalidated, and a significantly higher proportion of them were placed under guardianship compared to the group with housing. Homeless individuals were significantly more likely to have no social insurance compared to the control group.ConclusionsIn summary, we can conclude that significant difference have been found between the homeless and not homeless groups in most of the examined variables. These results implicates that the inpatient care of homeless patients poses significant bourden on the inpatient system. Early prevention and effective rehabilitation of substance use disorders could decrease this burden. Establishing a proper social safety network and enhancing community psychiatric care could potentially also relieve the burden of inpatient care system.Disclosure of InterestNone Declared

Use of Long-Acting Injectables in Borderline Personality Disorder: What Do We Know?

IntroductionPsychotherapy serves as the foundation of care for individuals with borderline personality disorder (BPD), with pharmacotherapy being regarded as a supplementary measure to be considered when necessary. In clinical practice, however, most of BPD patients receive medication.A major problem in the treatment of BPD is the lack of compliance derived from the pathological impulsivity of BPD patients. The use of long-acting antipsychotics (LAI) may be an option.ObjectivesThis work aims to address the use of long-acting injectables in borderline personality disorder.MethodsNon-systematic review of literature using the PubMed ® database, based on terms “Borderline Personality Disorder” and “Long-acting antipsychotics”. Only six articles were found.ResultsSeveral studies have shown promising results in the treatment of Borderline Personality Disorder (BPD) with long-acting injectable (LAI) antipsychotics. A six-month study using IM risperidone demonstrated significant improvement, while LAI Aripiprazole also exhibited positive outcomes in individuals with BPD and Substance Abuse. Additionally, Palomares et al. (2015) found that palmitate paliperidone LAI reduced impulsive-disruptive behaviors and enhanced overall functioning in BPD patients. Carmona et al. (2021) compared oral and LAI antipsychotics and concluded that LAIs may have a role to play in the management of BPD.ConclusionsTreatment with LAIs may play an important role in clinical and functional improvement in BPD patients.Disclosure of InterestNone Declared

Training student pharmacists to administer long-acting injectable medications.

In June of 2022, the State of Maryland Board of Pharmacy issued regulations permitting pharmacist administration of maintenance injectable medications. Subsequently, the University of Maryland School of Pharmacy created a laboratory to train student pharmacists based on these regulations on administering long-acting maintenance injections. This training included a review of regulations, reconstitution and administration of medications, and education for patients and caregivers on long-acting injectable medications. This is the first training the authors are aware of incorporating both reconstitution and administration of these medications. The objective of this paper is to describe the laboratory details and future directions of the training course. The first training laboratory trained 94 student pharmacists in the administration technique of long-acting injectable medications. The program has been adapted for practicing pharmacists and other healthcare providers. Thus far, more than 300 practitioners have participated in the learning lab.

Improving the Sexual Wellbeing of Patients with Psychotic Illness

Introduction Sexual dysfunction (SD) is common in psychotic illness including schizophrenia, occurring in 30-82% of patients. It negatively impacts wellbeing and antipsychotic compliance, resulting in higher risk of relapse and hospitalisation. Due to over-reliance on spontaneous reports from patients, SD is typically under-identified which prevents investigation and treatment.ObjectivesTo establish whether SD is under-identified in patients with psychosis in a general adult community mental health team; to elicit whether the Arizona Sexual Experience Scale (ASEX) improves identification; to investigate and manage identified cases of SD; to make recommendations about identification and monitoring of SD in this patient population.MethodsA 12-month retrospective audit of patients with psychosis prescribed a long-acting injectable (LAI) antipsychotic (n=36) to identify sexual symptoms was completed. The ASEX was subsequently issued to screen for SD.ResultsAudit: 3/36 (8%) patients had documented sexual symptoms. Of the 18/36 patients that completed the ASEX: 10 (56%) exhibited SD. 4 consented to further investigation. 5 patients experienced significant difficulties with the language used in the ASEX. At the end of the project we revised the ASEX with simpler, colloquial language.ConclusionsImplementation of the ASEX results in clear improvements in identification and monitoring of SD. Maudsley Practice Guidelines can inform investigation and management of SD. We suggest a review of NICE guidance to incorporate the above into clinical practice. Further work is needed to establish whether the revised ASEX can be developed and validated.Disclosure of InterestNone Declared

A Quality By Design (QbD) Prospect in Fabrication of PLGA-based Antipsychotic Long-acting Microspheres: An Alternative to Combination Therapy

Background: Discontinuation and poor compliance with long-term oral medicine are major therapeutic issues in psychosis treatment. Poorer long-term outcomes may result from non-compliance as well as a higher chance of relapse. In order to sustain therapeutic drug plasma levels, co-administration of oral antipsychotics is necessary for commercially available longacting injections of second-generation antipsychotics, as they have a lag period of approximately three weeks during the drug release process. Methods: Poly(lactic-co-glycolic acid) (PLGA) encapsulated microspheres loaded with risperidone were fabricated in the current research for intramuscular administration. The single emulsion solvent evaporation technique was applied for the fabrication of microspheres. Risperidone microspheres were prepared using PLGA grade 75:25. Particle size, drug content and entrapment efficiency with a central composite design were the main optimization parameters for the formulation. The microspheres were characterized by different techniques, namely Fourier transform infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC), X-ray diffractometry (XRD), scanning electron microscopy (SEM), and transmission electron microscopy (TEM). The drug content, entrapment efficiency, morphology, particle size, and in vitro release profiles, along with release kinetics of the risperidone microspheres, were studied. Results and Discussion: The microspheres produced by the single emulsion solvent evaporation approach show smooth and spherical morphology, with particle size ranging from 3 μm to 6 μm, drug content of 99.7%, and entrapment efficiency of 98.2% with little burst release of 3% to 10%, providing drug release for 45 days and exhibiting zero order release kinetics and Korsmeyer- Peppas model for non-fickian drug release from the polymeric matrix. By applying the Quality by Design (QbD) approach and formulation parameters, microspheres with appropriate particle size, morphology, enhanced drug content, entrapment efficiency and desirable drug release profile for depot formulation can be obtained successfully. Conclusion: The optimized microspheres, in comparison to the marketed Risperdal Consta™, show enhanced potential for a better depot formulation, which can further improve patient compliance.

Med rec double check: Inpatient psychiatry medication errors identified on admission using Medicaid Web portals and electronic pharmaceutical claims data.

The role of pharmacists during medication reconciliation (MR) is well established, with a number of reports describing this in the context of psychiatric hospitalizations. However, medication errors (MEs) are common during transitions of care, with no exception during psychiatric hospitalizations. Our institution uses pharmacy-performed MR processes using patient interviews and reviewing objective sources, such as electronic pharmaceutical claims data (EPCD), which includes Medicaid Web portals. The inpatient psychiatric pharmacist reviews EPCD sources against previously pharmacy-completed MRs for new admissions, where if discrepancies are found, the patient is reinterviewed to identify and correct MEs. We performed a prospective quality improvement project during 28 days to evaluate the quantity and classification of MEs upon admission to a 22-bed inpatient psychiatry unit. Of 52 included patients, where a cumulative 426 medications were reviewed, a total of 29 MEs in 16 patients were identified. Eight patients had discrepancies on their home medication lists when compared to EPCD, where 7 of these had at least 1 ME due to inaccurate MR. Of all the MEs identified, the greatest quantity was found secondary to the EPCD "double-check" method. The most common MEs in all patients were the omission of home medications (34%), wrong frequency (28%), and ordering medication the patient is not taking (10%). All patients admitted on long-acting injection antipsychotics had errors in last dose received. No MEs resulted in patient harm, and they were identified and corrected by the psychiatric pharmacist 97% of the time.