Inpatient Administration Research Articles

Outcomes of Outpatient Administration of Ciltacabtagene Autoleucel (Cilta-cel) in Relapsed Refractory Multiple Myeloma (RRMM)

Introduction Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR T-cell (CAR-T) therapy, is approved for treating relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy. As with other CAR-T treatments, it is typically administered in an inpatient setting, followed by close monitoring of patients at the treatment center for several weeks to manage serious adverse events (AEs) such as cytokine release syndrome (CRS) and neurotoxicity. There is however increasing interest in outpatient administration of cilta-cel with the aim to reduce healthcare costs and improve patient quality of life (QoL). This review aims to assess whether outpatient administration yields comparable outcomes to the traditional inpatient setting. Methods A systematic literature review was conducted, in accordance with PRISMA guidelines, in MEDLINE, Embase and Cochrane Library and conference proceedings through May 25, 2024 to identify literature on outpatient and inpatient use of cilta-cel in patients with multiple myeloma. Data related to efficacy outcomes (overall response rate [ORR], progression-free survival [PFS], overall survival [OS]), safety outcomes, healthcare resource use and related costs, and patient quality-of-life outcomes, were extracted from the shortlisted publications, collated and qualitatively synthesized. No restrictions were applied on study type or geography. Retrieved records were screened for eligibility by two reviewers independently against pre-defined PICOS criteria, and any disagreements were resolved by a third investigator. Results 40 unique publications, based on 5 clinical trials (9 sub-studies), 11 observational studies, 5 economic evaluations, and 1 physician survey, were included for data synthesis. Three studies, all real-world observational in nature, involved cilta-cel administration in the outpatient setting - Waqar et al. included both inpatient (N=6) and outpatient (N=27) settings and reported outcomes separately; Gregory et al. involved both settings (N=57; 37 outpatient, 20 inpatient) but reported only consolidated outcomes; Ly et al. involved only the outpatient setting (N=24). All other studies were based on cilta-cel administration in an inpatient setting, with the exception of 2 patients out of a total of 372 patients in CARTITUDE-1, CARTITUDE-2 and CARTITUDE-4 trials. ORR of cilta-cel was reported to be 95% in Ly et al. and 82% in Gregory et al., compared to 80-100% in studies based on administration in the inpatient setting. PFS at one year was 86% in Waqar et al. for outpatient administration, compared to 75-94% in the inpatient setting. OS rate at one year was 96% in Waqar et al. for outpatient administration, compared to 78-94% in the inpatient setting. Waqar et al. also reported that PFS and OS outcomes were similar across administration types. Any grade CRS was reported to be 79% in Ly et al. (median duration 2 days, median time to onset 6 days), compared to 60%-100% in inpatient administration (median duration 2.5-9 days, median time to onset 7-9 days). Immune effector cell-associated neurotoxicity syndrome was reported to be 17% in Ly et al., compared to 2-33% in the inpatient setting. Two studies evaluated the economic impact of cilta-cel administration in the outpatient setting. Jagannath et al. reported a cost savings of $18,922 per patient, while in the cost per responder analysis by Hansen et al., a scenario analysis with patients receiving outpatient infusion led to lower cost per complete responder and cost per month in PFS for cilta-cel (by $7,598 and $294, respectively) versus inpatient administration. In a mixed-methods qualitative study by Hansen et al., participants agreed that cilta-cel can be safely administered in an outpatient setting, with dedicated outpatient infrastructure and close outpatient monitoring for toxicity management, due to predictable, delayed onset of potential AEs offering financial sustainability, lower resource utilization, and greater patient autonomy. Conclusion Upon instituting recommended processes, outpatient administration and management of cilta-cel has been shown to produce clinical outcomes comparable to traditional inpatient administration, while resulting in cost savings and improved patient quality of life. No additional safety concerns were identified with outpatient administration.

Inpatient zoledronic acid in older hip fracture patients is well tolerated and safe.

According to the 2022 Dutch 'Osteoporosis and fracture prevention' guideline, zoledronic acid (ZA) is the preferred osteoporosis treatment for hip fracture patients. Less than 25% of hip fracture patients visit the outpatient fracture liaison service, therefore inpatient administration of ZA during the hip fracture hospitalization is now recommended in patients > 75years. In the OLVG Hospital, inpatient administration of ZA during hospitalization for hip fracture in older patients has been standard of care since 2020. This single center retrospective observational follow-up study included hip fracture patients > 75years admitted to the orthogeriatric ward of the OLVG Hospital, and treated with 5mg of ZA intravenously on the day of hospital discharge between June 2020 and December 2022. Life expectancy estimated < 12months, creatinine clearance < 35ml/min, hypocalcemia, and high risk of osteonecrosis of the jaw were contra-indications. During three months of follow-up (FU) adverse events, emergency room visits, hospital readmissions, and death were recorded. In 161 consecutive hospitalized hip fracture patients (mean age 86 ± 6years, 65% female, 18% nursing home) ZA was administered and no adverse events were recorded. During 3months of FU, 8 patients (5%) visited the emergency room, 19 patients (12%) were re-admitted to the hospital, 3 with a new fracture (2 contralateral hip, 1 radius), and 17 patients (11%) died of reasons unrelated to ZA. This study shows that inpatient administration of zoledronic acid during hip fracture hospitalization is safe and feasible to prevent future fragility fractures in older hip fracture patients.

6960 A Fracture Liaison Service To Address Vitamin D Deficiency For Patients Hospitalized For Osteoporotic Fracture

Abstract Disclosure: X. Sun: None. B. Leder: None. T.V. Ly: None. E. Franco-Garcia: None. M.B. Bolster: Grant Recipient; Self; Rheumatology Research Foundation Clinician Scholar Educator Award; Genentech, Cumberland, Inc, Corbus, Mitsubishi. Other; Self; Honoraria: The Merck Manual, American Board of Internal Medicine, Practice Update. W. Fan: None. Context: A Fracture Liaison Service (FLS) provides an important mechanism to address vitamin D deficiency (VDD) which is commonly found in patients hospitalized with a fragility fracture. Objectives: To study the prevalence of VDD and its associated clinical outcomes among patients hospitalized for osteoporotic fracture. To explore inpatient strategies of vitamin D repletion in the immediate post fracture setting. Design, Setting and Patients: An observational study of patients admitted to the Massachusetts General Hospital (MGH) with fractures between January 2016 to October 2023 who were cared by the FLS. Exposures and Intervention: A vitamin D repletion regimen consisting of ergocalciferol 50,000 international units (IU) oral daily for a number of days followed by maintenance cholecalciferol of 1000-1500 IU daily was studied in a subset of patients with VDD. Main Outcomes and Measures: Prevalence of VDD among MGH FLS patients. Efficacy of inpatient daily ergocalciferol administration to raise serum 25OHD. Results: Of the 2,951 consecutive patients, 724 (24.53%) were vitamin D deficient as defined by serum 25OHD level of ≤19ng/ml. Men (252 of 897, or 28.09%) were more likely than women (472 of 2,054, or 22.98%) to have VDD (p = 0.003). VDD was seen 41.79% (117 of 280), 24.41% (332 of 1,360) and 20.98% (275 out 1,311) of patients of ≤59, 60-79, and ≥80 years old, respectively (p &amp;lt; 0.00001).Of the 1,303 patients with hip fragility fractures, 327 (25.09%) had VDD. Patients with VDD, despite being younger (78.55±11.75 vs. 80.28±10.47, p=0.018), had longer average length-of-stay (aLOS) than those without VDD did (8.37±7.35 vs. 7.23±4.78 days, p=0.009). Re-admission and non-union rates up to two years following the index hip fracture were not different between the two groups.Among 32 patients, without known malabsorption or liver cirrhosis, who had 25OHD levels available before and after ergocalciferol treatment, each dose of ergocalciferol, on average, raised serum 25OHD by 3.62±2.35 (m±sd) ng/ml. Daily ergocalciferol administration did not change serum calcium and creatinine levels.Patients with chronic liver disease (CLD), who had higher prevalence of VDD (64 of 156 patients, or 41.04%), showed impaired per-dose-of-ergocalciferol 25OHD response (0.87±0.92. n=10) ng/ml. Conclusions and Relevance: Nearly 25% of patients hospitalized for osteoporotic fractures, cared for by MGH FLS, had VDD. Male sex, younger age, and CLD were associated with a higher prevalence of VDD. VDD was associated with, on average, one extra day of hospital stay among patients admitted for hip fracture. Daily ergocalciferol, with each dose of 50,000 IU raising serum 25OHD level by 3-4 ng/ml, followed by maintenance dose of cholecalciferol of 1000 to 1500 IU is potentially a practical way to quickly replete vitamin D among patients with VDD hospitalized for fracture. Presentation: 6/3/2024

S1361 Evening Timing of Inpatient Intravenous Infliximab Administration Is Associated With Worse Disease Outcomes

S1361 Evening Timing of Inpatient Intravenous Infliximab Administration Is Associated With Worse Disease Outcomes

Policy and perspective on outpatient programs for autologous hematopoietic cell transplantation and immune-effector cell therapy administration.

High-dose chemotherapy with autologous hematopoietic cell transplantation (AutoHCT) has long been an integral treatment modality for multiple myeloma and non-Hodgkin lymphoma. Over the past 25 years, numerous institutions have shifted this practice from requiring hospitalization to one that can be performed in an ambulatory setting, resulting in cost savings and improved quality of life for patients. The recent advent immune-effector cell (IEC) therapies and expansion of their indications is changing the treatment landscape for hematologic and non-hematologic malignancies. However, current financial models and reimbursement structures threaten the viability and sustainability of this treatment modality should it continue to require inpatient administration and management. This threat is leading institutions to develop outpatient IEC programs based off the outpatient AutoHCT templates. Integral to the success of both is a cohesive program with outpatient-specific standard operating protocols, highly-trained providers and staff with expertise specific in these treatment modalities, evidenced-based supportive care and prophylaxis plans, extensive caregiver vetting and education, and the infrastructure to support all individuals involved. In this policy and practice review we provide an overview of the guidelines and published academic experiences, give a perspective-based description of the roles and responsibilities of the individuals involved in this process at our institution, and highlight actionable recommendations that could allow for the dissemination and implementation of outpatient AutoHCT and IEC programs more broadly.

Overutilization of Proton Pump Inhibitors (PPIs) in a Community-Based Hospital: A QI Initiative

Introduction: Proton pump inhibitors (PPIs) are indicated for GERD, erosive esophagitis, and prophylactic use in patients at high risk for stress ulcerations. Long-term PPI therapy is associated with increased incidence of C. diff infections and community- and hospital-acquired pneumonia. Discontinuation of stress ulcer prophylaxis upon discharge and reevaluation of continued therapy will help reduce chronic, inappropriate treatment, which predisposes patients to adverse side effects. Aim: We sought to reform the process of inpatient PPI prescriptions based on clinical indications of therapy in order to reduce use and associated costs of PPIs by 30% over 6 months. Model for Improvement: We obtained an IRB exemption for a retrospective chart review study and collected pre-intervention data from 200 patients who had received PPI therapy between July-Aug 2022. Of these, 186 met inclusion criteria. We identified PPT overuse among all inpatient admissions, including those admitted under teaching services. Evaluating the timing of PPI initiation after admission, we found that a majority (83.8%) were started upon admission; 28.5% required PPIs throughout; and 25.2% of orders were placed within 1 day of discharge. The average duration of therapy was 3.9  2.59 days. On average, 50.5% of patients had a prior diagnosis of GERD, gastritis, or erosive esophagitis, justifying initiation of PPI therapy. However, almost a third (32.8%) met the criteria for stress ulcer prophylaxis. 17% of the cohort developed an adverse side effect, and almost 53% of patients were discharged with a new prescription for PPI. Measures: Root cause analysis revealed a lack of knowledge regarding adverse PPI effects leading to longer hospital stays. During the first PDSA, we conducted a session on “Use of PPI Inhibitors: Indications for Inpatient Prescriptions and Stress Ulcer Prophylaxis” in April 2023, educating Internal Medicine and Family Medicine resident teaching services about PPI therapy indications, contraindications, and adverse effects. Results: After our educational intervention, we collected and analyzed data from May 2023 to August 2023 and found 301 patients who met inclusion criteria. Their average age was 73.29 years. 169 patients (56%) had pre-existing diagnoses (GERD or erosive esophagitis), justifying initiation of Protonix. Of the remaining 132 without pre-existing conditions, 44 (35%) met criteria for starting stress ulcer prophylaxis. This was a 3% increase in appropriate utilization when compared to our pre-intervention data. 181 patients were discharged with a prescription for pantoprazole, of which 46 were PPI-naïve prior to admission. Conclusion: We found a decrease in inappropriate inpatient PPI administration by 3% after education. Although the post-intervention sample size was larger, the education resulted in a positive response in 1 month. The next PDSA cycle will alter the EMR order to provide only 3 orders for pantoprazole – one oral, one IV, and one for infusion, and orders will also require the selection of indication.

A retrospective analysis of perioperative medications for opioid-use disorder and tapering additional postsurgical opioids via a transitional pain service.

To investigate perioperative opioid requirements in patients on methadone or buprenorphine as medication for opioid-use disorder (MOUD) who attended a transitional pain clinic (Personalized Pain Program, PPP). This retrospective cohort study assessed adults on MOUD with surgery and attendance at the Johns Hopkins PPP between 2017 and 2022. Daily non-MOUD opioid use over 6 time-points was evaluated with regression models controlling for days since surgery. The time to complete non-MOUD opioid taper was analysed by accelerated failure time and Kaplan-Meier models. Fifty patients (28 on methadone, 22 on buprenorphine) were included with a median age of 44.3 years, 54% male, 62% Caucasian and 54% unemployed. MOUD inpatient administration occurred in 92.8% of patients on preoperative methadone but only in 36.3% of patients on preoperative buprenorphine. Non-MOUD opioid use decreased over time postoperatively (β = -0.54, P < .001) with a median decrease of 90 mg morphine equivalents (MME) between the first and last PPP visit, resulting in 46% tapered off by PPP completion. Older age and duration in PPP were associated with lower MME, while mental health conditions, longer hospital stays and higher discharge opioid prescriptions were associated with higher MME. The average time to non-MOUD opioid taper was 1.79× longer in patients on buprenorphine (P = .026), 2.75× in males (P = .023), 4.66× with mental health conditions (P < .001), 2.37× with chronic pain (P = .031) and 3.51× if on preoperative non-MOUD opioids; however, higher initial MOUD level decreased time to taper (P = .001). Postoperative opioid tapering utilizing a transitional pain service is possible in patients on MOUD.

Inpatient Infliximab Biosimilar Cost-Savings: Cost Analysis of Inpatient Treatment with Originator Infliximab (Remicade™) versus Biosimilar Infliximab (Renflexis™) for Acute Severe Ulcerative Colitis

Introduction: Infliximab (IFX) is a standard, inpatient salvage therapy for the treatment of refractory acute severe ulcerative colitis (ASUC). Remicade™ is the originator IFX. Its biosimilar Renflexis™ offers a reduced cost structure. We performed a cost-minimization analysis to compare costs with Remicade™ and Renflexis™ for the inpatient treatment of ASUC. Methods: Retrospective clinical and financial data were obtained from 34 inpatients with refractory ASUC who received Renflexis™ (n = 17) or Remicade™ (n = 17) between 2019 and 2021. Clinical data included admission and discharge laboratory values. Financial data included a decision support drug cost (DSDC), constituting the total cost associated with inpatient IFX administration, and total inpatient cost of care. The following equation generated a ratio (rDSDC) representing the percentage of drug cost (or DSDC) of the total inpatient cost of care, after controlling for IFX dose and length of stay: [DSDC of IFX/Number of Units of IFX] ÷ [Total Inpatient Cost of Care/Length of Stay in Days]. Median and non-parametric Wilcoxon ranked sum test were used for analyzing patient demographics, clinical, and financial data. Results: No differences were found in baseline or discharge clinical parameters. The median unadjusted ratio of DSDC to total inpatient cost of care was 0.387 versus 0.241 in the Remicade™ versus Renflexis™ groups (p = 0.0025), respectively, representing an absolute difference of ∼14%. Median adjusted rDSDC were 0.04 versus 0.024 in the Remicade™ versus Renflexis™ groups, respectively, representing a relative cost reduction of ∼40% (p = 0.0001). Discussion: The unadjusted absolute cost reduction and adjusted relative cost reduction were, respectively, 14% and 40% in the Renflexis™ group as compared to Remicade™, when treating inpatient ASUC. Our calculation included median DSDC as a percentage of the total inpatient cost of care, controlling for IFX dose and length of stay. This reduced cost structure promotes use of Renflexis™ for ASUC inpatients and may reduce costs systemically.

The Outcome of Outpatient Intermediate and High Dose Cytarabine Consolidation Chemotherapy in Patients with Acute Myeloid Leukemia. The Experience of King Fahad Specialist Hospital in Dammam, Saudi Arabia

Background: Adult patients with Acute Myeloid Leukemia (AML) have traditionally been hospitalized for the duration of intensive consolidation chemotherapy until blood count recovery to avoid complications. Recently, there has been a trend to shift the care of AML patients treated with intensive chemotherapy from inpatient to outpatient settings to reduce treatment costs and save beds. Methods and materials: A retrospective study of AML patients who received cytarabine consolidation chemotherapy between the 1st of August 2016 and the 31st of December 2023 at King Fahad Specialist Hospital in Dammam, Saudi Arabia was performed. Results: Over a period of 7 years and 4 months, 62 patients received a total of 127 cycles of intensive consolidation chemotherapy at outpatient setting. At diagnosis: 12 patients had extramedullary disease, and 17 patients had adverse cytogenetic abnormalities. Following the 127 cycles of chemotherapy, 38 episodes of febrile neutropenia were encountered, and 46 hospital admissions were required. No complications were encountered following 62.2% of the cycles of consolidation therapy and no early mortality due to intensive consolidation therapy was reported. Out of 62 patients studied, 36 patients underwent various forms of hematopoietic stem cell transplantation. Disease relapses were encountered in 24 patients and the 5-year incidence of relapse for the entire group of patients was 42%. The 5-year leukemia-free survival for the: entire study patients, transplanted patients, and non-transplanted patients were: 43%, 38%, and 50% respectively. The 5-year overall survival for the: entire study patients, transplanted patients, and non-transplanted patients were: 44%, 34%, and 65% respectively. At the end of follow-up: 37 patients (59.68%) were alive, 24 patients (38.71%) were dead, and the fate of 1 patient (1.61%) was unknown as the patient moved to another hospital. Conclusion: Administration of intensive consolidation chemotherapy for patients with AML at outpatient setting is safe, feasible, and cost-effective. The incidence of infectious complications was relatively low. No early treatment-related mortality due to intensive consolidation therapy was encountered. Outpatient administration of intensive consolidation therapy can save beds, reduce hospital costs, and is associated with short-term and long-term outcomes that are comparable to inpatient administration of consolidation therapy.

Outpatient CAR T-Cell Therapy as Standard of Care: Current Perspectives and Considerations.

Chimeric antigen receptor T-cell therapy (CAR-T) has altered the treatment landscape of several hematologic malignancies. Until recently, most CAR-T infusions have been administered in the inpatient setting, due to their toxicity profile. However, the advent of new product constructs, as well as improved detection and management of adverse effects, have greatly increased the safety in administering these therapies. CAR-T indications continue to expand, and inpatient administration is associated with increased healthcare resource utilization and overall cost. Therefore, transitioning CAR-T administration to the outpatient setting has been of great interest in an effort to improve access, reduce financial burden, and improve patient satisfaction. Establishment of a successful outpatient CAR-T requires several components, including a multidisciplinary cellular therapy team and an outpatient center with appropriate clinical space and personnel. Additionally, clear criteria for outpatient administration eligibility and for inpatient admission with pathways for prompt toxicity evaluation and admission, and toxicity management guidelines should be implemented. Education about CAR-T therapy and its associated toxicities is imperative for all clinical staff, as well as patients and their caregivers. Finally, rigorous financial planning and close collaboration with payers to ensure equitable access, while effectively managing cost, are essential to program success and sustainability. This review provides a summary of currently published experiences, as well as expert opinion regarding implementation of an outpatient CAR-T program.

Antimicrobial exposure during infancy in a longitudinal California cohort.

To describe temporal and sociodemographic patterns of antimicrobial exposure during the first year of life in a large US cohort. Singleton infants born 1998-2014 enrolled in Kaiser Permanente Northern California integrated health system (n = 345,550) were followed longitudinally via comprehensive electronic health records, capturing all systemic antimicrobial inpatient administrations and outpatient dispensings. Antimicrobial exposure was summarized by maternal and infant characteristics, birth year, inpatient/outpatient status, age in months, and drug class. Overall, 44% of infants in this cohort received at least one dose of antimicrobials during infancy. Decreases over time were driven by reduced outpatient dispensings specifically in later infancy, primarily for penicillins. Among infants receiving any antimicrobials the median number of exposure-days was 16. Inpatient dispensings peaked in the first 30 days of life and outpatient dispensings peaked at 10-11 months. Birth characteristics (i.e., NICU admission, gestational age) were strong independent predictors of antimicrobial exposure between 0- < 3 months; sociodemographic factors were modest predictors of exposure for3-12 months. Predictors of antimicrobial exposure in early and late infancy are distinct with early infancy exposures highly correlated to birth characteristics. The cumulative proportion of infants exposed has decreased due to fewer late infancy outpatient dispensings. Comprehensive antimicrobial exposure histories and the maternal and infant characteristics predicting exposure have not been well described in US populations. This analysis provides estimates of cumulative antimicrobial exposures by sociodemographic factors, delivery characteristics, month of life, inpatient/outpatient status, and antibiotic class among one of the largest US HMOs. Predictors of early infancy antimicrobial exposures differ from those in late infancy, with early exposures strongly correlated to birth characteristics and late infancy exposures modestly related to sociodemographic factors. Antimicrobial exposure among infants decreased over the time period primarily due to reduced outpatient dispensings in later infancy.

The Relationship Between The Implementation of Patient Safety and The Quality of Nursing Services at Purwokerto Islamic Hospital

Background : Patient safety in drug administration is still a top global health priority because patient safety has become the most important indicator in the health care system for good and bad patient health. The lower the implementation of patient safety in administering medication, the better the quality of nursing services will be. Research Objective: To determine the relationship between the implementation of patient safety in administering inpatient medication and the quality of nursing services at RSI Purwokerto. Method: Quantitative methods were used with a correlational descriptive design with a cross-sectional approach. The sampling technique was total sampling, totaling 90 respondents. Results: From this research, the results showed that there were 41 inpatient nurses (91.1%) who implemented patient safety in administering medication well, and 42 inpatient nurses (93.3%) who assessed the quality of nursing services at RSI Purwokerto as good . The results of the bivariate analysis showed that there was a significant relationship between the implementation of patient safety in administering medication and the quality of nursing services at RSI Purwokerto (p0.05). Conclusion: There is a relationship between the implementation of patient safety in inpatient medication administration and the quality of nursing services in hospitals.

Sistem Informasi Administrasi Pasien Rawat Jalan dan Rawat Inap Berbasis Web

Hospitals, as public service institutions, require an accurate, reliable, and adequate information system to enhance their services to patients and related environments. Given the extensive scope of services, many complex issues arise in the hospital's service processes. The numerous variables involved in hospital operations influence the speed of information flow required by both users and the hospital environment. Manual data management in hospitals presents significant drawbacks, including slow processing time and a high risk of errors. With the support of current information technology, manual data management can be replaced by a computerized information system. In addition to being faster and easier, data management becomes more accurate. Accurate data processing results in accurate information, which is crucial for decision-making, both for management and others. The purpose of this study is to facilitate patient registration for outpatient and inpatient visits, ease report generation, and assist the hospital management in improving service quality and decision-making processes. Based on the research conducted at Zainoel Abidin General Hospital in Aceh, the implementation of the outpatient and inpatient patient administration information system has proven to be precise and accurate, particularly in the pharmacy department. The system has also made it easier to obtain patient information and has addressed frequent issues such as challenges in monitoring and supervising patients and medical records. The system development lifecycle (SDLC) was utilized in designing this system.

Importance of Appropriate Medication Administration in Patients with Nasogastric Feeding Tube

Solid dosage forms like modified release and enteric coated formulations are considered inappropriate for nasogastric feeding tube (NGFT) administration due to varying pharmacokinetics which could lead to inadequate therapeutic responses or toxicity. An analysis was conducted to assess the appropriateness of prescribed medicines for NGFT administration in hospital inpatients so that physicians can be sensitized to the importance of this. In this cross-sectional study conducted in a large tertiary care centre, prescription data of in-patients with nasogastric feeding tube (NGFT) were retrieved through electronic pharmacy transactions. Adult patients who were admitted in the hospital for more than one day and were dispensed a NGFT were included. The appropriateness of medicines administered through NGFT was assessed using standard published literature. Details of medicines that were categorized as inappropriate were collated and analysed. In case of inappropriate prescribing, availability of appropriate dosage forms was also determined. A total of 510 patients were found eligible for analyses. Majority of the patients were dispensed at least one inappropriate dosage form. Among the dispensed oral solid dosage forms, 16.38% were found to be inappropriate for NGFT administration. Of these, 21.41% were dispensed on same day as the NGFT, 34.67% were dispensed before the NGFT and were continued throughout the hospital stay and 43.92% were dispensed within or after 24 hours of NGFT dispensation. These findings will improve awareness among healthcare professionals about the need for appropriate administration of oral formulations in patients intubated with NGFT. Keywords: Inappropriate Dosage Forms, Nasogastric Feeding Tube, Appropriate Dosage Forms, Modified Release Formulations

Exploring a Rarity: Incidence of and Therapeutic Approaches for Neurological Complications and Hypophysitis in Cancer Patients on Immune Checkpoint Inhibitors-A Single-Center Study.

Immune checkpoint inhibitors, such as anti-PD-1 and anti-CTLA-4 inhibitors, have become the standard of care for many cancer types. However, they induce immune-related adverse events (irAEs), including neurotoxicity and hypophysitis. The incidence and outcomes of neurotoxicity and hypophysitis in patients treated with immune checkpoint inhibitors are not well established. We conducted a retrospective study of 812 patients with solid cancers who received immune checkpoint inhibitors at the University General Hospital of Ioannina between January 2018 and January 2023. We assessed demographic and clinical data, including the severity of symptoms, treatment regimen, other irAEs, resolution type and time, and death. Two patients experienced neurotoxicity and two hypophysitis. All four patients required inpatient administration and received corticosteroids or/and hormone replacement. Three patients responded to the initial therapy, experiencing full recovery, while one patient was corticosteroid-resistant, and immunoglobin G was administered. Two patients never received immunotherapy after their toxicity due to the severity of symptoms; one patient continued monotherapy with nivolumab, changing from combination therapy with ipilimumab-nivolumab, while the fourth patient continued his initial treatment with nivolumab. Our study suggests that the incidence of neurotoxicity and hypophysitis in patients treated with immune checkpoint inhibitors is low, but careful monitoring and prompt treatment with corticosteroids are necessary for effective management.

The Impact of Outpatient versus Inpatient Administration of CAR-T Therapies on Clinical, Economic, and Humanistic Outcomes in Patients with Hematological Cancer: A Systematic Literature Review.

Although chimeric antigen receptor (CAR)-T cell therapies are typically administered in the inpatient setting, outpatient administration is rapidly expanding. However, there is limited summarized evidence comparing outcomes between outpatient and inpatient administration. This systematic literature review aims to compare the safety, efficacy, quality of life (QoL), costs, and healthcare resource utilization (HCRU) outcomes in patients with hematological cancer who are administered CAR-T therapy in an outpatient versus an inpatient setting. Publications (2016 or later) that reported the outcomes of interest in patients treated with a CAR-T therapy in both outpatient and inpatient settings, or only the outpatient setting, were reviewed. In total, 38 publications based on 21 studies were included. Safety findings suggested the comparable frequency of adverse events in the two settings. Eleven studies that reported data in both settings showed comparable response rates (80-82% in outpatient and 72-80% in inpatient). Improvements in the QoL were observed in both settings while costs associated with CAR-T therapy were lower in the outpatient setting. Although unplanned hospitalizations were higher in the outpatient cohort, overall HCRU was lower. Outpatient administration of CAR-T therapy appears to have comparable outcomes in safety, efficacy, and QoL to inpatient administration while reducing the economic burden.

Length of stay is related to inpatient antipsychotic use in Alzheimer type dementia at a large US based tertiary care hospital.

AbstractBackgroundAntipsychotic(AP) medications carry a black box warning for increased risk of death in the elderly and should be used judiciously in a dementia population. Studies have shown that encounters with healthcare facilities increase the risk of AP exposure1. We wanted to know how admissions at our institution impacted antipsychotic use in patients with Alzheimer’s disease. Here we describe the results of a retrospective analysis of inpatient antipsychotic use in patients with Alzheimer’s disease at Northwestern Memorial Hospital(NMH), Chicago IL.MethodOur cohort was generated using NMH’s Enterprise Data Warehouse, including patients over 65 with a chart diagnosis of AD admitted to the hospital for over 48hrs between May 2005 and March 2018. We excluded patients with schizophrenia, schizotypal disorder, bipolar disorder, or psychotic illness due to primary psychiatric disease, enrollment in hospice, presence of tracheostomy or PEG‐tube and pervasive developmental disorder.Result1712 patients were admitted for a total of 4603 admissions amounting to 25,721 hospital days during the period of analysis. Demographic information is provided in Table 1. A higher proportion of admissions were four days or longer in encounters with an antipsychotic(Figure 1). Though longer LOS becomes progressively less common, this trend continued through a LOS of 20 days. When comparing LOS for encounters with an AP in the home medication list to encounters without, there was no impact on LOS. However, when comparing encounters with an AP prescribed while inpatient to encounters without, inpatient AP administration was associated with a longer length of stay (Table 2).ConclusionThese findings indicate that a longer LOS is associated with antipsychotic use. Because a longer length of stay was associated with new antipsychotic use but not the continuation of a home antipsychotic, our findings suggest that length of stay may contribute to behavioral and psychological symptoms of dementia requiring pharmacological treatment.1. Koponen M, Lavikainen P, Taipale H, et al. Accumulation of Hospital Days Among Antipsychotic Initiators With Alzheimer’s Disease. J Am Med Dir Assoc. 2019;20(12):1488‐1494.e3. https://doi.org/10.1016/j.jamda.2019.07.009

Nonsteroidal anti-inflammatory drug “allergy” labeling is associated with increased postpartum opioid utilization

Current guidelines recommend a stepwise approach to postpartum pain management, beginning with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), with opioids added only if needed. Report of a prior NSAID-induced adverse drug reaction (ADR) may preclude use of first-line analgesics, despite evidence that many patients with this allergy label may safely tolerate NSAIDs. We assessed the association between reported NSAID ADRs and postpartum opioid utilization. We performed a retrospective cohort study of birthing people who delivered within an integrated health system (January 1, 2017, to December 31, 2020). Study outcomes were postpartum inpatient opioid administrations and opioid prescriptions at discharge. Statistical analysis was performed on a propensity score-matched sample, which was generated with the goal of matching to the covariate distributions from individuals with NSAID ADRs. Of 38,927 eligible participants, there were 883 (2.3%) with an NSAID ADR. Among individuals with reported NSAID ADRs, 49.5% received inpatient opioids in the postpartum period, compared to 34.5% of those with no NSAID ADRs (difference= 15.0%, 95% confidence interval 11.4-18.6%). For patients who received postpartum inpatient opioids, those with NSAID ADRs received a higher total cumulative dose between delivery and hospital discharge (median 30.0 vs 22.5 morphine milligram equivalents [MME] for vaginal deliveries; median 104.4 vs 75.0 MME for cesarean deliveries). The overall proportion of patients receiving an opioid prescription at the time of hospital discharge was higher for patients with NSAID ADRs compared to patients with no NSAID ADRs (39.3% vs 27.2%; difference= 12.1%, 95% confidence interval 8.6-15.6%). Patients with reported NSAID ADRs had higher postpartum inpatient opioid utilization and more frequently received opioid prescriptions at hospital discharge compared tothose without NSAID ADRs, regardless of mode of delivery.

Heterogeneity in Access and Toxicity Management of Commercially Available BCMA-Directed CAR-T and Bispecific T-Cell Engager Therapy Among the International Myeloma Community

Introduction: BCMA-directed CAR-T and Bispecific T-cell engager (BiTE) therapies have shown remarkable overall response rates in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). This has led to the approval of idecabtagene vicleucel, ciltacabtagene autoleucel and teclistamab by the FDA, EMA and other regulatory agencies. We performed a global survey on accessibility, practice patterns, and toxicity management of commercially available CAR-T and BiTE therapies. Methods: An online survey was completed by clinicians attending the International Myeloma Society's Immune Effector Cell Therapies in Multiple Myeloma Workshop, in-person or virtually, made available for 30 days after the meeting held in March 2023, Boston, MA. Results: 87 clinicians from 16 countries completed the survey, most practicing in an academic practice (86%) and in an urban environment (89%). Sixty-four percent of the respondents practice in North America followed by Europe (25.3%) including Germany, United Kingdom, Ireland, Italy, Netherlands, Spain, France, Greece, and Cyprus, and 6.9% from Asia and 3.4% from Australia. Seventy-seven percent reported CAR-T cell therapy was approved in their country with 44.8% treating 1-5 patients and 14.9% treating &amp;gt;5 patients per month; 67% reported BiTE therapy was approved in their country with 14.9% treating &amp;gt;5 patients per month. Of evaluable responses (n = 40), 62% administered CAR-T therapy inpatient and 15% administered CAR-T therapy outpatient ≥ 50% of the time. Length of time between decision to treat with CAR-T therapy to infusion was 6-12 weeks for 42% of responders and &amp;lt;6 weeks for only 20%. Most (75%) reported inpatient administration of BiTE therapy step-up dosing; 17.5% reported outpatient step-up dosing administered ≥ 50% of the time. Use of institutional or practice SOPs for CAR-T and BiTE therapy patient selection was reported by 85% and 58%, respectively, with the factors influencing SOP outlined in Table 1. Of available CAR-T therapies, 53% prefer cilta-cel and 23% reported CAR-T therapy preference depended most on patients' co-morbidities/frailty (89%), timing of next available apheresis (67%), age (56%), CNS disease (44%) and other factors. Maintenance therapy after CAR-T therapy was reportedly used by 25% and 5% of respondents in 1-10% and 11-50% of their patients, respectively, to “maintain level of response achieved” (50%) or “achieve a deeper level of response” (25%). About half (43%) of the respondents reported using an SOP or particular criteria for secondary Hemophagocytic Lympho-Histiocytosis/Macrophage Activation Syndrome/CAR-related-HLH (sHLH/MAS/CarHLH) management that varied between the use of ASTCT Working Group IEC associated HLH-like syndrome Criteria (47%) (Hines 2023), CARTOX HLH Criteria (24%) (Neelapu 2017) and HLH-2004 criteria (6%). Tocilizumab was used as cytokine release syndrome (CRS) prophylaxis only by one responder. Keppra neurologic prophylaxis was used by 47.5% and 15% of responders for CAR-T and BiTE therapy, respectively. Delayed neurotoxicity with CAR-T was reported in 1-5% of patients by 57.5% of responders and 6-10% of patients by 15% of responders; most common manifestations were other movement/neuromuscular disorder (62%), nerve palsy (55%), and Parkinsonism (45%). Infectious prophylaxis was used to protect against HSV (92.5%), PJP (90%), bacterial pathogens (55%), fungal pathogens (60%), and IVIG (77.5%). However, criteria for infectious prophylaxis use varies widely incorporating IgG levels, infectious history, CD4+ count, B-cell aplasia and cytopenias (48.1 - 88.9%). Most respondents (46.3 - 86.5%) reported completing an infectious work-up including CMV, EBV, Hep B/C, and HIV ( Table 2). Conclusions: Trends of CAR-T and BiTE therapy use and patterns of concurrent prophylactic and supportive care in MM vary widely among academic centers across the globe, demonstrating a need for further understanding of toxicity pathogenesis, toxicity management and consistent guidelines. This survey also demonstrates the great unmet need for access beyond urban centers among the international myeloma community. Prospective studies and claims data analysis should be utilized to evaluate the longitudinal cost of care, quality of life, duration of response and management of infectious disease, neurological or related complications of CAR-T and bispecific TCE therapies.

Outcomes of Lymphoma and Multiple Myeloma Patients Following Inpatient Antineoplastic Treatment

Introduction: Patients (pts) with hematologic malignancies receive more aggressive end-of-life care, including hospitalizations and antineoplastic therapy, compared to solid tumor. 1 In the modern era, treatment for lymphoma and multiple myeloma is mostly administered in the outpatient setting. Pts requiring inpatient treatment may have an aggressive disease course, decreased performance status, and comorbidities that impact clinical outcomes. Treatment decisions in the acute care setting are challenging due to the need to balance efficacy, toxicity, and cost. Given the paucity of data available to help guide decision-making, we sought to investigate the outcomes of inpatient administration of unplanned antineoplastic therapy. Methods: This retrospective cohort study included adults (≥18 years) with lymphoma and multiple myeloma who received unplanned inpatient antineoplastic therapy between June and October 2022. Pts who received planned chemotherapy or first cycle of treatment for newly diagnosed disease were excluded. Pts undergoing outpatient induction or salvage therapy admitted for complications who subsequently received their next cycle while admitted were included. Baseline characteristics, diagnosis, treatment, and clinical outcomes were abstracted from the electronic medical record. The primary endpoint was rate of treatment continuation or completion 60 days after first administration of inpatient therapy. Secondary endpoints included overall survival (OS); length of stay (LOS) following treatment; transfer to intensive care unit (ICU), emergency department (ED) visits, and readmissions within 30 days; and death within 30 and 60 days of inpatient treatment. Results: Of the 172 pts screened, 49 pts were included after excluding 122 pts (76 had planned chemo and 46 had newly diagnosed disease). Median age was 63 years (range, 34-88). Treatment was for a variety of diagnoses, including plasma cell neoplasm (53%), diffuse large B-cell lymphoma (18%), central nervous system lymphoma (14%), chronic lymphocytic leukemia (4%), as well as 1 pt each with T-cell prolymphocytic leukemia, follicular lymphoma, mantle cell lymphoma, NK/T-cell lymphoma, and T-cell lymphoma. Most had relapsed/refractory disease (90%). Thirteen (26%) pts received inpatient only regimens; however, these were not planned admissions. Fifteen (31%) pts received drugs traditionally restricted to outpatient use only (daratumumab (10), carfilzomib (3), obinutuzumab (1), loncastuximab tesirine (1), polatuzumab vedotin (1)). At 60 days after first inpatient treatment, 15 (31%) pts continued or completed treatment, while treatment was discontinued in 34 (69%) pts. Of the 15 pts who continued treatment, 53% (8/15) received ≤ 3 additional cycles after discharge. Median time to discharge following inpatient treatment initiation was 5 days (range, 0-38). Fourteen (29%) pts were transferred to the ICU, 16 (33%) pts presented to the ED after discharge, and 14 (29%) were readmitted within 30 days of inpatient treatment. Overall survival was 26.5% at a median follow up of 157 days. The 30- and 60-day mortality rates were 18% and 31% respectively. Univariate and multivariate analysis to identify prognostic factors for survival will be conducted. Conclusions: In this retrospective analysis, about a quarter of pts with lymphoid and plasma cell malignancies were alive at 5 months after receiving unplanned inpatient antineoplastic therapy. Better tools are needed to select pts who may benefit from urgent inpatient treatment, as a small subset of our cohort experienced continued clinical benefit. Combining such tools with multidisciplinary discussions may help to maximize favorable outcomes while minimizing use of aggressive end-of-life antineoplastic treatment. Ongoing analysis in our population will aim to identify patient-specific factors associated with positive outcomes.