A Retrospective Observational Descriptive Study on the Effectiveness and Usage of Emicizumab and Antihemophilic Factor (recombinant), Fc Fusion Protein in Patients with Hemophilia A in the US

Introduction Hemophilia A is a rare bleeding disorder characterized by coagulation Factor VIII (FVIII) deficiency. Symptoms are primarily bleeding episodes that occur spontaneously or following injury, trauma, or surgical procedure. The treatment for hemophilia A involves replacement of FVIII for on-demand or prophylactic care. The aim of this analysis was to describe treatment outcomes and patterns between patients with hemophilia A who switch to emicizumab (Hemlibra®), Fc fusion protein (rFVIIIFc; Eloctate®), or other factor therapy using specialty pharmacy data from the US. Methods This was a retrospective observational descriptive study conducted between November 2014 and January 2021 using specialty pharmacy data including over 5,000 total patients with hemophilia A in the US. Patients included in the analysis were male, had a diagnosis of hemophilia A without a history of inhibitors, and had a minimum of 6 months baseline pre-index data and 6 months follow-up data post-index. Index date was defined as the first dispense of emicizumab after October 2018 or rFVIIIFc after May 2015. Patient reported and claims-based treatment outcomes assessed pre- and post-treatment included: annualized bleeding rate (ABR, calculated from patient bleed logs), any factor usage including on-demand FVIII use, prescribed and dispensed dosage of treatment, and frequency. Wastage as a percentage was a calculated as: (prophylaxis logged - prophylaxis prescribed)/prophylaxis dispensed. Results 118 patients treated with emicizumab and 55 patients treated with rFVIIIFc were included in the analysis. Additionally, 26 patients switched from rFVIIIFc to emicizumab, and therefore met inclusion criteria for both treatment groups (these patients are described separately). Baseline characteristics are reported in Table 1; the majority of patients in all cohorts had severe hemophilia and prior prophylaxis therapy. The most frequently prescribed dosing patterns for patients in the emicizumab cohort was once every 2 weeks (Q2W) for 56 patients (47.5%) and once weekly (Q1W) for 51 patients (43.2%). Whereas the most frequently prescribed dosing patterns for the rFVIIIFc only cohort was twice per week (BIW) in 27 patients (49.1%), every 4 days (Q4D) in 15 patients (27.3%), and Q1W in 2 patients (3.6%). Total mean (95% confidence intervals [CI]) weekly prophylaxis consumption was 1.68 (1.65; 1.72) mg/kg in the emicizumab cohort and 83.17 (72.06; 94.29) IU/kg in the rFVIIIFc cohort post index. Mean (95% CI) weekly dispensed dosage for prophylaxis was 1.81 (1.76; 1.86) mg/kg emicizumab and 83.83 (72.55; 95.11) IU/kg rFVIIIFc post index. Mean (95% CI) total supplied FVIII for on-demand factor on hand was 5.14 (2.92; 7.35) IU/kg in the emicizumab cohort and 11.76 (9.06; 14.46) IU/kg in the rFVIIIFc cohort post index. Weekly percentage of supplied dosage wasted was 6.03% (4.50; 7.57; p<0.01) emicizumab for the overall cohort, with a mean (standard deviation [SD]) of 10.46% (12.21) wasted per patient within the emicizumab age <12 years cohort. Weekly percentage of supplied dosage wasted was 0.70 (-0.10; 1.50; p=0.09) rFVIIIFc for the overall cohort, with a mean (SD) of 2.63% (3.53) wasted per patient within the rFVIIIFc age <12 years cohort. Mean (95% CI) change in overall ABR pre- and post-treatment was -1.14 (-2.16; -0.18) in the rFVIIIFc cohort and -0.91 (-1.36; -0.50) in the emicizumab cohort (Table 2). Mean (95% CI) changes in spontaneous ABR and spontaneous joint ABR pre- and post-treatment were -0.36 (-1.12; 0.27) and -0.16 (-0.70; 0.31), respectively, in patients treated with rFVIIIFc, whereas within the emicizumab group they were -0.40 (-0.71; -0.13) and -0.37 (-0.66; -0.12). Conclusion Patients were prescribed emicizumab labeled dosing primarily on a Q1W or Q2W pattern, whereas patients prescribed rFVIIIFc had more individualized dosing primarily being prescribed Q4D or BIW. FVIII for on-demand treatment use was found post index in both the factor and non-factor treated cohorts. Overall product wastage with emicizumab is higher than previously reported. Product wastage was highest among emicizumab patients under 12 years, but wastage was still considerable in patients 12 or older. This descriptive analysis indicated that both treatments remained effective with lower bleed rates than prior FVIII therapies. Figure 1 Figure 1. Disclosures Cockerham: Sanofi: Current Employment, Current equity holder in publicly-traded company. Wilson: Sanofi: Current Employment, Current equity holder in publicly-traded company; Alexion: Current equity holder in publicly-traded company. Frick: Trio Health, Inc.: Current Employment; Sanofi S.A.: Research Funding. Dasmahapatra: Sanofi: Current Employment, Current equity holder in publicly-traded company.

Evaluation of Electronic Health Record and Long-Term Care Pharmacy Data for Tracking and Reporting Antibiotic Use in the United States

Background: Antibiotics are frequently prescribed in nursing homes, often inappropriately. Data sources are needed to facilitate measurement and reporting of antibiotic use to inform antibiotic stewardship efforts. Previous analyses have shown that the type of nursing-home stay, that is, short stay (<100 days), is a strong predictor of high antibiotic use compared to longer nursing-home stays. The study objective was to compare 2 different data sources, electronic health record (EHR) and long-term care (LTC) pharmacy data, for surveillance of antibiotic use and type of nursing-home stay. Methods: EHR and pharmacy data during 2017 were included from 1,933 and 1,348 US-based nursing homes, respectively. We compared data elements available in each data source for antibiotic use reporting. In each data set, we attempted to describe antibiotic use as the proportion of residents on an antibiotic, days-of-therapy (DOT) per 1,000 resident days (RD), and distribution of antibiotic course duration, overall and at the facility level. Facility proportion of short-stay and long-stay (>100 days) nursing-home residents were calculated using admission dates and census data in the EHR data set and a payor variable in the pharmacy data set (Figure 1). The 2 data sources also provided antibiotic characteristics, including antibiotic class, agent, and route of administration. The deidentified nature of facility data prevented direct comparison of antibiotic use measures between facilities. Results: The EHR and pharmacy data sets contained 381,382 and 326,713 residents, respectively (Table 1). Within the EHR, 51% of residents were prescribed an antibiotic in 2017, at a median rate of 77 DOT per 1,000 RD. In the LTC pharmacy, 46% of residents were prescribed an antibiotic at a median rate of 79 DOT per 1,000 RD (Table 1). Short-stay residents contributed a smaller proportion of total RDs in the EHR relative to the pharmacy cohort (21% vs 50%, respectively). Conclusions: Nursing-home antibiotic use data obtained from EHR and pharmacy vendors can be used for calculating antibiotic use measures, which is important for antibiotic use reporting and facility-level tracking to identify opportunities for improving prescribing practices and provide facility-level benchmarks. Further validation of both data sources in the same facilities is needed to compare antibiotic use rates and to determine the most appropriate proxy for type of nursing-home stay for facility-level risk adjustment of antibiotic use rates.Funding: NoDisclosures: None

PHARMACEUTICAL CARE PRACTICE IN THE COMMUNITY PHARMACY BY UTILIZING PROBLEM-BASED LEARNING IN REFLECTIVE PEDAGOGY PARADIGM METHOD

This study follows the previous study entitle Problem-based Learning (PBL) in reflective pedagogy paradigm (RPP): Innovative learning in pharmaceutical care, which identified the learning material as complicated. This study aimed to provide an appropriate method for performing pharmacy management and pharmaceutical care in Community Pharmacy. Data collection was done using an assessment instrument to identify student’s achievement. The previous study encompasses preceptors and students in developing learning material, which cause it more valid and reliable to be implemented. The study was conducted in Yogyakarta, Surakarta, and Semarang city. The effectiveness of the learning material was shown by the grade of student’s achievement in learning outcome and the clear state with confidence in the expression of reflection and action-plan. Most of the students in the 3 cities achieved an excellent grade both in the problem-solving field, and presentation of the assignment. The students reflected that the learning material is simple and suitable in practicing pharmaceutical care and pharmacy management, moreover, they can state their plan to work as a Community Pharmacist with confidence. Therefore, PBL in the RPP method is ready to be used in practicing pharmaceutical care in the Community Pharmacy.

Trends in Prescribing of Antibiotics and Drugs Investigated for Coronavirus Disease 2019 (COVID-19) Treatment in US Nursing Home Residents During the COVID-19 Pandemic

Background Trends in prescribing for nursing home (NH) residents, which may have been influenced by the coronavirus disease 2019 (COVID-19) pandemic, have not been characterized. Methods Long-term care pharmacy data from 1944 US NHs were used to evaluate trends in prescribing of antibiotics and drugs that were investigated for COVID-19 treatment, including hydroxychloroquine, famotidine, and dexamethasone. To account for seasonal variability in antibiotic prescribing and decreased NH occupancy during the pandemic, monthly prevalence of residents with a prescription dispensed per 1000 residents serviced was calculated from January to October and compared as relative percent change from 2019 to 2020. Results In April 2020, prescribing was significantly higher in NHs for drugs investigated for COVID-19 treatment than 2019; including hydroxychloroquine (+563%, 95% confidence interval [CI]: 5.87, 7.48) and azithromycin (+150%, 95% CI: 2.37, 2.63). Ceftriaxone prescribing also increased (+43%, 95% CI: 1.34, 1.54). Prescribing of dexamethasone was 36% lower in April (95% CI: .55, .73) and 303% higher in July (95% CI: 3.66, 4.45). Although azithromycin and ceftriaxone prescribing increased, total antibiotic prescribing among residents was lower from May (−5%, 95% CI: .94, .97) through October (−4%, 95% CI: .94, .97) in 2020 compared to 2019. Conclusions During the pandemic, large numbers of residents were prescribed drugs investigated for COVID-19 treatment, and an increase in prescribing of antibiotics commonly used for respiratory infections was observed. Prescribing of these drugs may increase the risk of adverse events, without providing clear benefits. Surveillance of NH prescribing practices is critical to evaluate concordance with guideline-recommended therapy and improve resident safety.

Gerofit Decreases Medication Use Among Older Veterans

We examined whether Veterans enrolled in Gerofit for at least 12 months between 10/2012-3/2017 saw reductions in their medication utilization (5 sites, 226 Veterans). VA outpatient pharmacy data was used to identify medications used 12-months prior, and 12-months following Gerofit enrollment. Seven drug classes were identified (cardiovascular, diabetic, lipid, mental health, opioids, vitamins, other medications). Nearest-neighbor propensity-matched analyses was conducted with exact match on number of baseline medications and site. At baseline, Gerofit participants were taking, on average, 11.6 medications (1.7 cardiovascular, 0.6 diabetes, 0.7 lipid lowering, 0.7 mental health, 0.5 opioids, 0.6 vitamins, 7.0 other). At 12-month follow-up, Gerofit patients were taking fewer medications: any (-2.7 [-4.4, -1.0]); cardiovascular (-0.5 [-0.7, -0.3]); diabetes (-0.7 [-1.2, -0.2]); mental health (-0.9 [-1.5, -0.2]); and other (-2.4 [-3.5, -1.4]) compared to matched comparisons. No significant differences at 12-months were found for lipid lowering, opioids, or vitamins. Conclusion: Gerofit participation reduced medication use.

Application of Artificial Intelligence Methods to Pharmacy Data for Cancer Surveillance and Epidemiology Research: A Systematic Review

PURPOSE The implementation and utilization of electronic health records is generating a large volume and variety of data, which are difficult to process using traditional techniques. However, these data could help answer important questions in cancer surveillance and epidemiology research. Artificial intelligence (AI) data processing methods are capable of evaluating large volumes of data, yet current literature on their use in this context of pharmacy informatics is not well characterized. METHODS A systematic literature review was conducted to evaluate relevant publications within four domains (cancer, pharmacy, AI methods, population science) across PubMed, EMBASE, Scopus, and the Cochrane Library and included all publications indexed between July 17, 2008, and December 31, 2018. The search returned 3,271 publications, which were evaluated for inclusion. RESULTS There were 36 studies that met criteria for full-text abstraction. Of those, only 45% specifically identified the pharmacy data source, and 55% specified drug agents or drug classes. Multiple AI methods were used; 25% used machine learning (ML), 67% used natural language processing (NLP), and 8% combined ML and NLP. CONCLUSION This review demonstrates that the application of AI data methods for pharmacy informatics and cancer epidemiology research is expanding. However, the data sources and representations are often missing, challenging study replicability. In addition, there is no consistent format for reporting results, and one of the preferred metrics, F-score, is often missing. There is a resultant need for greater transparency of original data sources and performance of AI methods with pharmacy data to improve the translation of these results into meaningful outcomes.

232. Impact of Weekend Initiation of Vancomycin or Piperacillin/Tazobactam on Days of Therapy Received upon Hospital Admission

Background Antibiotic therapy for inpatients with suspected infections is typically empirically initiated and therapy narrowed or altered when additional diagnostic evidence becomes available. For patients whose therapy is initiated on a weekend, differences in hospital staffing may impact the timing of therapy changes. We aimed to compare the duration of therapy of vancomycin and piperacillin-tazobactam between those who had therapy initiated on a weekday versus a weekend day. Methods We performed a cross-sectional study among U.S. hospitals that contributed pharmacy data for inpatients to the Vizient clinical database in 2016. We identified vancomycin and piperacillin-tazobactam courses initiated within the first 48 hours of admission; courses were categorized as weekend initiation (Friday, Saturday, Sunday) versus weekday initiation. The median days of therapy were compared between weekend and weekday initiation using the Wilcoxon rank-sum test. Results Among the 145 hospitals representing approximately 3.7 million patient encounters there were 401,101 encounters with vancomycin and 221,751 with piperacillin/tazobactam initiated within the first 48 hours of admission. Of these courses, 33% of vancomycin and 40% of piperacillin/tazobactam were initiated on a weekend day. The median (IQR) days of therapy for vancomycin initiated on a weekend was 2 days (1–4 days) compared to 2 days (1–3 days) when initiated on a weekday (p&lt; .01). The median (IQR) days of therapy for piperacillin/tazobactam was 3 days (2–5 days) for courses initiated on either a weekend or weekday (p&lt; .01). Conclusion We observed a statistically significant difference in the days of therapy received by patient encounters with vancomycin or piperacillin/tazobactam initiated on weekdays versus weekends. However, because of the large sample size in this study, we had power to identify small differences as statistically significant. Still, for vancomycin the 75th percentile received at least one additional day of therapy when initiated on a weekend versus a weekday. Further exploration is needed to identify if weekend initiation is associated with extended durations of therapy in specific sub-populations of patients. Disclosures All Authors: No reported disclosures