2023 Poster Session Abstracts
April 22, 2023
- Authors: Emily Gibson, Lori Davidson, Elizabeth Laughlin, Janine Marie Garcia
- Title: Evaluating the Effects of a Pharmacist Led Transitions of Care Program on Patient Outcomes and Readmission Rates
- Abstract
- BACKGROUND: Medication errors are commonly made when patients transition through various phases of healthcare. The Pharmacist-led Transitions of Care program at United Health Services Hospitals (UHSH) was designed to reduce medication errors, improve patient outcomes, and reduce readmission rates.
- OBJECTIVE: The objective of this study is to assess the difference in outcomes between UHSH patients seen by a transitions of care pharmacist and a comparator group of patients that meet the criteria for a transitions of care pharmacy consult who were not seen by a transitions of care pharmacist.
- METHODS: A retrospective analysis will be conducted using encounter data from EPIC. Inclusion criteria will include UHSH patients over the age of 18 years old who meet the criteria for a transitions of care pharmacy consult. Participants will be included based on discharge from Wilson Hospital between August 1, 2021 and February 28, 2023. Eligible discharge criteria include routine discharge to home or discharge home with home health. The intervention group will be comprised of UHSH patients who were seen by a Transitions of Care Pharmacist and the comparator group will be those who were not seen by a Transitions of Care Pharmacist. Analysis will be conducted for overall cohorts and stratified based on the primary diagnosis. Key outcome metrics will include 30-day mortality, 30-day readmission, and subsequent 30-day hospital touchpoint.
- RESULTS: Research-In-Progress
- CONCLUSION: Research-In-Progress
- Author: James Felice
- Title: Difference in Mean Time to Administration of Alteplase vs. Tenecteplase in Ischemic Stroke: a Retrospective Chart Review
- Abstract
- BACKGROUND: Difference in mean time to administration of alteplase vs. tenecteplase in ischemic stroke: a retrospective chart review. Introduction: UHS has recently interchanged fibrinolytic agents within the stoke kits in its hospital's emergency departments. Alteplase was previously used for ischemic stroke patients but moving forward tenecteplase will be utilized in its place. Tenecteplase is nearly functionally identical to alteplase however it possesses increased specificity to the protein fibrin as well as increased resistance to plasminogen activator inhibitor-1 (PAI-1). These properties extend the half-life of tenecteplase (20-24 minutes) as compared to alteplase (5 minutes). The longer half-life of tenecteplase allows for a simpler dosing regimen.
- OBJECTIVES: The primary outcome of this study is to determine if the mean time to administration of tenecteplase is shorter than that of alteplase. UHS Wilson Medical Center is the largest hospital within the UHS organization and currently staffs a pharmacist in its emergency department for 8 hours per day on weekdays. A secondary outcome of this study is to determine if mean time to administration of fibrinolytic therapy is faster during pharmacist staffing hours.
- METHODS: Retrospective chart review will be used to analyze any patient who has received alteplase or tenecteplase in 2022 and 2023 for ischemic stroke. Exclusion criteria will be patients who received alteplase or tenecteplase for an indication other than ischemic stroke (i.e., MI, PE) as well as the inherent ineligibility criteria for receiving fibrinolytic therapy. These include current intracranial hemorrhage, subarachnoid hemorrhage, active internal bleeding, a trauma or intracranial/intraspinal surgery within the last 3 months, bleeding diathesis, current severe uncontrolled hypertension or presentation after 4.5 hours from symptom onset. Statistical analysis will be performed using an independent samples T-test to compare the mean times to administration of alteplase and tenecteplase.
- RESULTS: In progress.
- CONCLUSIONS: In progress.
- Authors: Jamie Chin-Hon, Erin Banta, MD, Elizabeth Stanley, RN, Mary Ryan, RN
- Title: Pharmacist Role in a Multidisciplinary Chemotherapy/Biotherapy Desensitization Process
- Abstract
- BACKGROUND: Patients treated with chemotherapy and or biologic therapy may develop hypersensitivity reactions, during or after parenteral administration, which may compromise the continuation of the standard of care treatment. When providers are notified about a hypersensitivity reaction, they may consult the allergy and immunology specialists to meet the patient and evaluate the hypersensitivity reaction onset, symptoms, responsiveness to hypersensitivity medications, how much of the medication was administered prior to the reaction, and if the patient was able to restart or tolerate more of the causative agent. Upon assessment to pursue a chemotherapy/biotherapy desensitization, a multidisciplinary team coordinates administration.
- OBJECTIVE: This project aims to share our experiences with our chemotherapy/biotherapy since transitioning to EPIC, since October 2019. The primary outcome is to evaluate the chemotherapy/biotherapy agents that patients have been desensitized to and to review the disease states and specialty services requiring desensitization to the chemotherapy/biotherapy agent. Secondary outcomes include analyzing how many patients successfully were transitioned to the outpatient setting and investigate how many patients successfully completed their planned course of therapy.
- METHODS: This is a retrospective, single institution, review of patients who have undergone chemotherapy/biotherapy desensitization since our EPIC transition.
- RESULTS: The most common agent requiring chemotherapy/biotherapy desensitization is rituximab followed by carboplatin, docetaxel, and paclitaxel. Other desensitized agents included oxaliplatin, cisplatin, ocrelizumab, brentuximab, filgrastim, and iron sucrose. Hematology-oncology is the most common service requiring chemotherapy desensitization with the next most common in gynecologic oncology.
- CONCLUSION: Coordination of care is crucial in facilitating chemotherapy/biotherapy desensitization at NYU Langone Hospital Long Island. The Long Island campus has the most active allergy and immunology service with the experience in chemotherapy/biotherapy desensitization leading to updating our health-system policy.
- Authors: Alice Voell-White, Nicole Albanese, PharmD, CDCES, BCACP
- Title: Impact of an Integrative Health in Pharmacy Elective in a Doctor of Pharmacy Program
- Abstract
- BACKGROUND: Integrative medicine is an approach to healthcare that identifies a patient's underlying problem and aims to treat the body as a whole. This approach has not been widely accepted by pharmacy programs across the country, although pharmacy involvement in chronic care has proven to significantly benefit clinical outcomes and decrease healthcare spending.
- OBJECTIVES: The objectives of this cross-sectional study were to determine the impact on academic performance and perceptions on integrative medicine among students before and after taking the course.
- METHODS: This was a cross-sectional study conducted at a single institution, the University at Buffalo School of Pharmacy and Pharmaceutical Sciences (UB SPPS), between January 2020 and May 2022. The pre and post-surveys included 10 questions focused on knowledge and 16 on perceptions on integrative medicine. The statistical analysis method used for the multiple-choice questions was two-sample T-test, and the ordinal data obtained from the Likert-type scale questions was analyzed using the Mann-Whitney U test.
- RESULTS: Pre and post survey data was collected from a total of 81 students enrolled in an Integrative Health in Pharmacy course. Differences in all but two knowledge questions were not statistically significant. These two questions were related to the collection of data in an Integrated Health workflow, and the basic definitions of Functional, Conventional, and Integrative medicine. Conversely, all but one perception focused question was statistically significant, which was related to confidence in knowledge of a vegetarian diet. The median increased for each Likert-type scale question, with more students answering agree or strongly agree in the post survey compared to the pre survey.
- CONCLUSION: This study suggests that the course Integrative Health in Pharmacy influenced perceptions of students, but knowledge of integrative medicine in this population remained unchanged.
- Authors: Alexandra Mirabile, Christopher Martens
- Title: Implementation of Pharmacy Interventions to Increase Methicillin-Resistant Staphylococcus Aureus Nasal Screening and Decrease Vancomycin Prescribing in Pneumonia Patients at an Acute Care Hospital
- Abstract
- BACKGROUND: Hospitalized patients with suspected pneumonia are often given broad-spectrum antibiotics, which may include vancomycin for Methicillin-Resistant Staphylococcus Aureus (MRSA) coverage. This MRSA coverage is usually unnecessary due to the low prevalence of MRSA pneumonias. To compound this overprescribing of vancomycin, sputum cultures are often unobtainable, making discontinuing vancomycin more difficult. With the use of a MRSA nares test, however, studies have shown a high negative predictive value, allowing providers to efficiently rule out MRSA pneumonia, and allow discontinuation of vancomycin. Allowing pharmacists to order MRSA nares, will enable more data to decide on antibiotic de-escalation.
- OBJECTIVES: The primary outcome of this study was an average reduced total number of vancomycin therapy days. The secondary outcomes of this study included discontinuation rate at 24 hours, discontinuation rate at 48 hours, and recorded acute kidney injuries (AKIs) in patients who stopped vancomycin within 48 hours vs patients who continued.
- METHODS: This was a prospective, single-center, cohort analysis to observe a new protocol. Patients prescribed vancomycin were identified using the kinetics navigator and cross-compared with Sentri7 between November 27th, 2022, and March 31st, 2023. Other antibiotic use was determined by the electronic medical record. Patients were included if they were 18 years or older, had a diagnosis or high suspicion of pneumonia, and were on antibiotics for less than 48 hours. Patients were excluded if they were deemed palliative care, received prophylactic vancomycin therapy for procedures, were diagnosed with other infections, had a vancomycin allergy, or had other MRSA coverage within 72 hours.
- RESULTS: In progress
- CONCLUSION: In progress
- Authors: Cameron Bogicevic, James Jester
- Title: Analysis of C. difficile Testing Interventions by Pharmacists
- Abstract
- BACKGROUND: Clostridioides difficile is a gram-positive, toxin-producing anaerobic bacterium. C. difficile infection (CDI) is a severe infectious colitis that leads to significant morbidity and mortality worldwide. Individuals may be colonized by C. difficile upon admission to the hospital without experiencing an active infection. There are several tests available for detecting the presence of C. difficile, though some do not distinguish between latent colonization and active infection. Inappropriate testing may result in false-positive CDI results and commonly occurs when medication side effects are mistaken for the symptoms of an active C. difficile infection. Pharmacists are qualified to identify adverse drug reactions (ADRs) and evaluate the appropriateness of ordered C. difficile tests. At United Health Services Hospitals (UHSH), a protocol was initiated whereby all new C. difficile stool test orders are reviewed by pharmacists. All interventions are documented and will be reviewed in this study. This study was approved by the institution's IRB.
- OBJECTIVES: The primary objective of this study is to measure the difference in health system C. difficile infection rates before and after the above protocol was initiated.Secondary objectives of this study will be to review the adherence rate to the above protocol and analyze barriers to pharmacist interventions.
- METHODS: All new C. difficile test orders populate in the notification inbox as a task within the hospitals electronic medical record (EMR) software. Each task has a section for written documentation to record interventions (or a lack thereof, in the event of an appropriate order). Responses are compiled and reviewed in an ongoing process. CDI rates are also documented in the EMR.
- RESULTS: In progress.
- CONCLUSION: In progress.
- Authors: Rebecca Khaimova, PharmD, BCACP, CDCES, Rachel Quinn, PharmD, BCACP, AE-C; Anthony Geber, PharmD, BCACP; Joanna DeAngelis, PharmD, BCIDP
- Title: Piloting a Virtual Regional Residency Workshop to Better Prepare Student-Pharmacists for Midyear and Residency Interviews
- Abstract
- BACKGROUND: This was the first year since the Coronavirus Disease 2019 (COVID-19) pandemic that students would attend the American Society of Health-System Pharmacists (ASHP) Midyear and residency showcase in-person. Based on feedback received from the Long Island University (LIU) New York Society of Health-System Pharmacists (NYSCHP) chapter, the Royal Counties Society of Health-System Pharmacists (RCSHP) created a regional residency workshop.
- OBJECTIVE: The objective was to evaluate if the Royals Regional Residency Conference better prepared students for midyear and residency interviews.
- METHODS: RCSHP started a subcommittee to develop and plan a virtual regional residency workshop in coordination with the LIU NYSCHP chapter. In September, a request for speakers and mock interviewers was sent out via email. In October, registration was disseminated through Constant ContactTM, an online marketing company. If students attended all required sessions denoted with an asterisk, they would receive a certificate of completion. An anonymous survey was sent via Google to participants in January 2023. The survey utilized a likert scale to see how students viewed the sessions and workshop and collect feedback to be utilized for future workshops. Descriptive statistics will be reported. The primary outcome was to evaluate if students felt these sessions were valuable. This will be evaluated based on the question I would recommend the Royals Regional Residency Workshop to other pharmacy students. Day 1: How to Write an Effective CV and Letter of Intent (1 hour)*LinkedIn Workshop (30 minutes)Day 2: Overview of Midyear (30 minutes)How to Prepare for an Interview (1 hour)*Day 3: Residency Program Director Panel Discussion* (1 hour)Day 4: Mock Interviews (1 hour)
- RESULTS: In progress
- CONCLUSION: In progress
- Authors: Anthony Gerber, Rachel Quinn
- Title: Establishing a Clinical Pearls Event for Student Pharmacists in the New York Metropolitan Area
- Abstract
- BACKGROUND: Due to the novel Coronavirus (2019) pandemic, pharmacy students had limited opportunities to present outside of the classroom setting. Based on feedback from students from Long Island University (LIU) New York Society of Health-System Pharmacists (NYSCHP) chapter, the Royal Counties Society of Health-System Pharmacists (RCSHP) created a two night continuing education event allowing students to present a 20 minute clinical pearl to pharmacists and technicians.
- OBJECTIVE: The objective was to assess student perception of the Royals Clinical Pearls of Wisdom event and assess their confidence with presentation skills.
- METHODS: In September 2022, RCSHP sent an email to faculty of LIU St John's University, and Touro College of Pharmacy to encourage students to submit topics for clinical pearl presentations. Students were required to provide a title for their presentation and identify a preceptor to review their presentations. Due to an overwhelming response rate RCSHP decided to split the event into two nights. One night would be in-person and one night would be virtual via Zoom. Overall seven students were selected to submit a 15 minute clinical pearl presentation. Four students were selected for the in-person event in November 2022 and three for the virtual event in December 2022. In January 2023, an anonymous survey was sent via Google Forms to assess the program. The survey utilized a likert scale to assess student perception of their preceptor, the event, their overall presentation confidence, and collect feedback to utilize for future workshops. Descriptive statistics will be used to report outcomes. The primary outcome is to evaluate if students felt this event was valuable. This will be evaluated based on the question I would recommend participation in this event to a friend or colleague.
- RESULTS: In progress
- CONCLUSION: In progress
- Authors: Carlton Menchaca, PharmD, Nicole Davis, PharmD, BCCCP; Manuela Haiduc, PharmD, BCCCP
- Title: Evaluation of Cangrelor Utilization at an Academic Medical Center
- Abstract
- BACKGROUND: Cangrelor is currently the only available intravenous P2Y12 receptor antagonist. Its onset and offset are rapid compared to other P2Y12 inhibitors, with platelet function recovery within 60 minutes after discontinuation of the infusion. Cangrelor is FDA approved as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis in patients who have not been treated with a P2Y12 inhibitor and who are not receiving a glycoprotein IIb/IIIa inhibitor. Additionally, it is used as a bridging agent in patients who require discontinuation of oral P2Y12 inhibitors prior to surgery based on the results of the BRIDGE trial. Utilizing pharmacodynamic evidence, the existing International Expert Consensus provides recommendations on the appropriate transition to oral P2Y12 inhibitors. As cangrelor is a high-cost and high-alert medication, its utilization should be evaluated for appropriateness.
- OBJECTIVE: The primary outcome is to evaluate the appropriate transition from intravenous cangrelor to oral therapy at Mount Sinai Hospital. Secondary outcomes include bleeding events, need for re-intervention within 7 days after discontinuation of cangrelor infusion, and mortality. A cost analysis will be performed on patients deemed on inappropriate transitions and inappropriate doses administered.
- METHODS: This was a retrospective, single-center, observational medication use evaluation of patients 18 years old who received IV cangrelor from August 1st 2020 - July 31st 2022. Patients that were pregnant or administered a glycoprotein IIb/IIIa antagonist 48 hours prior to start of cangrelor infusion were excluded from analysis.
- RESULTS: In progress
- CONCLUSION: In progress
- Authors: Karyssa Hurd, Emily Leppien, Bennett Doughty, Keira Strong, Brian Piper, Kenneth McCall
- Title: Newer Antiseizure Medications (ASMs) and Suicidality: Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) Database
- Abstract
- BACKGROUND: The aim of this study is to compare the safety profile of newer ASMs to older ASMs through an analysis of the United States FAERS database with a focus on suicidality.
- METHODS: We queried over 17 million reports in the FAERS database from 2012 to 2021 and identified cases involving ASMs. After removing incomplete and duplicate reports, the study cohort consisted of lacosamide (n=7593), perampanel (n=1813), clobazam (n=3827), brivaracetam (n=1166) and vigabatrin (n=5293) compared to a control group of older ASMs (topiramate, lamotrigine, valproic acid, carbamazepine, levetiracetam; n=71535). Cases of suicidality (completed suicide, suicidal ideation, attempted suicide, suicidal behavior, suicidal depression) were identified in each group. Adjusted (age and gender) odds ratios (aOR) and associated 95% confidence intervals (CI) were calculated using logistic regression analysis for each new drug when compared to the control group of older ASM drugs.
- RESULTS: A total of 6309 cases of suicidality were identified among reports with ASMs. Most reports were sourced from healthcare professionals (5516, 87.4%). The proportion of reports involving suicidality were 210/7593 (2.8%) for lacosamide, 185/1813 (10.2%) for perampanel, 108/3827 (2.8%) for clobazam, 57/1166 (4.9%) for brivaracetam, 14/5293 (0.3%) for vigabatrin, and 5735/71535 (8.0%) for older ASMs. The gender (% female) and age (mean) of cases involving suicidality were lacosamide (53.8%, 42.3 years), perampanel (48.6%, 37.9 years), clobazam (63.9%, 37.4 years), brivaracetam (61.4%, 37.7 years), vigabatrin (71.4%, 34.2 years) and older ASMs (64.2%, 42.2 years). Compared with older ASMs, the aOR for suicidality was 0.33 (95% CI, 0.28-0.38) for lacosamide, 1.34 (95% CI, 1.15-1.56) for perampanel, 0.35 (95% CI, 0.29-0.43) for clobazam, 0.60 (95% CI, 0.45-0.77) for brivaracetam, and 0.03 (95% CI, 0.02-0.05) for vigabatrin.
- CONCLUSION: When compared to older ASMs, four newer ASMs (lacosamide, clobazam, brivaracetam and vigabatrin) were found to have a significantly lower odds of suicidality while perampanel was found to have a significantly higher odds of suicidality. The results of this case control study of FDA adverse event reports spanning ten years and 6309 cases of suicidality, expand our understanding of the safety profile of newer ASMs.
- Authors: Lara Tran, PharmD Candidate 2023, Katherine Cabral, PharmD, BCPS, BCCP, AACC
- Title: Impact of a Pharmacist-Driven PCSK9-Inhibitor Consulting Service in Evaluating Efficacy and Tolerability with Inclisiran
- Abstract
- BACKGROUND: Dyslipidemia is a prevalent risk factor for atherosclerotic cardiovascular disease (ASCVD), and PCSK9-inhibitors have been shown to decrease this risk. Inclisiran, a novel small interfering RNA PCSK9-inhibitor, can help mitigate this risk by significantly reducing LDL. At Capital Cardiology Associates, a pharmacist-driven PCSK9-inhibitor consulting service was implemented to optimize patient care.
- OBJECTIVES: The primary objective is to determine patient tolerability to inclisiran and percent lipid reduction. The secondary objective is to describe the pharmacist's role in a PCSK9-inhibitor consulting service.
- METHODS: Capital Cardiology Associates, a large private ambulatory practice, expanded their PCSK9-inhibitor per pharmacy consult protocol to include inclisiran. A cardiologist refers a patient to the clinical pharmacy team for screening and evaluation of inclisiran use. The pharmacy team reviews past medical history, medication use, recent lipids, and insurance coverage. Once identified, the pharmacist discusses with the patient, either in person or via telehealth, about inclisiran's benefits, side effects, administration, and cost. If appropriate and patient is agreeable, their first injection is scheduled in office and their lipid panel is drawn three months later immediately prior to the second dose. Patients are followed closely, and labs and tolerability are reviewed.
- RESULTS: The study included 82 patients, who all received at least one inclisiran dose. Total cholesterol levels decreased by 32.2%, LDL levels decreased by 56.3%, HDL levels increased by 10.9%, and triglyceride levels decreased by 5.7%. Five patients (6.1%) reported side effects after the first injection, which included respiratory symptoms, abdominal pain, rash, and muscle aches. Of these 5 patients, one patient discontinued inclisiran treatment.
- CONCLUSIONS: Implementing a pharmacist-driven PCSK9-inhibitor consulting service can assist cardiologists in shared decision making, patient education, and monitoring effects to achieve and optimize significant LDL reduction. The improvements in lipid profiles and low discontinuation rates show patients are willing to be counseled and are appropriately tolerating inclisiran.
- Authors: Salma Hewady, Salma Hewady, PharmD; Kimberly Zammit, Pharm.D., MPH, BCPS, BCCCP, FASH; Steve Levy, PharmD, BCPS; Jerry Altshuler, PharmD, BCPS, BCCCP
- Title: Operationalization of Decentralized Pharmacy Services
- Abstract
- BACKGROUND: Decentralization of pharmacy services has been shown to enhance clinical, humanistic, and economic outcomes in inpatient settings. Activities conducted by decentralized pharmacists maximize their value by reducing their distributive responsibilities, allotting more time for clinical duties and direct patient care. The principal goal of the program will be to promote systemic uptake of evidence based practices into routine care, thereby improving the quality and effectiveness of health-services. Phase one of the project included a feasibility study to evaluate technical, financial, and operational viability of implementing decentralized pharmacy services. Based on current pharmacy operations, multiple models of implementation have been proposed, involving various levels of decentralization. It was determined that decentralized services can be provided to patients admitted to medicine floors being covered by decentralized personnel by using existing staff. Such services and their clinical objectives were determined in alignment with the health system's overarching goals. Areas of focus include intravenous to oral therapy conversions, vancomycin monitoring, anticoagulation stewardship, stress ulcer prophylaxis stewardship, code responses, and patient education. Policies/procedures surrounding these clinical enterprises were updated/established in preparation for decentralized services. Phase two included an assessment of the current state of pharmacist knowledge. The clinical acumen needed for successful decentralized practice extends beyond what is required for centralized practice, but varies based on the scope of services rendered. After evaluation of baseline knowledge, individualized learning plans were developed by the clinical pharmacy team to ensure adequate competency prior to assumption of additional clinical responsibilities. Following staff training, the final phase of the project will be a pilot with limited staff to test the service for any operational implications. Key performance indicators such as instances of suboptimal therapy/dosing identified and number of interventions surrounding focused clinical initiatives will be measured to ensure the program is providing the desired benefits and meeting patient needs.
- Authors: Madeline Ciccone, PharmD, BCPS, Frances Murray, PharmD
- Title: Evaluation of Traditional Vancomycin Dosing at a Medium-sized Academic Teaching Hospital
- Abstract
- BACKGROUND: Vancomycin must be dosed to ensure therapeutic serum concentrations are achieved to treat gram-positive infections. Serum trough concentrations have been used as the most practical method for monitoring safety and efficacy of vancomycin. Trough concentrations between 10 to 20 mcg/mL are indicated in most infections to achieve effective killing while minimizing toxicity.
- OBJECTIVE: The purpose of this study is to evaluate the effectiveness of the current vancomycin monitoring program at a medium-sized, community medical center.
- METHODS: A retrospective chart review will be conducted at a single-center hospital on all patients over the age of 18 admitted between April 2022 and June 2022. Patients will be included if they received at least two doses of vancomycin and had at least one vancomycin trough collected. Patients requiring renal replacement therapy and patients in acute kidney injury will be excluded. Baseline characteristics will include patient age, sex, weight, and serum creatinine. The primary outcome will be the number of patients that achieved an initial therapeutic concentration based on diagnosed infection. Secondary objectives will include the time to therapeutic concentration, the number of vancomycin dose adjustments, and the number of patients with an initial subtherapeutic or supratherapeutic trough concentration. Data will be collected through the electronic medical record. All data will be recorded without patient identifiers and confidentiality will be maintained.
- RESULTS: In progress.
- CONCLUSIONS: In progress.
- Authors: Ryan Kendra, Joanna E. Parkes, Jessica F. Boehler, Ning Li, Terrance P. O'Hanlon, Eric P. Hoffman, Jennifer M. Peterson, Frederick W. Miller, Lisa G. Rider, Kanneboyina Nagaraju
- Title: A Novel Rituximab Pathway to Mediate Myositis Response in Refractory Myositis
- Abstract
- BACKGROUND: Myositis is a group of autoimmune disorders associated with muscle inflammation and weakness. The Rituximab in Myositis (RIM) trial in dermatomyositis and polymyositis patients demonstrated that the majority of refractory myositis patients showed improvement with the use of the B-cell depleting biologic.. However, the role of B-cells in mediating myositis is not sufficient to explain the success of this therapeutic approach.
- OBJECTIVE: This study focused on identifying factors which explain the differential response of myositis patients to rituximab and identifying an alternative mechanism of action for this biologic.
- METHODS: Ten myositis patients from the RIM trial were characterized by those who had a clinical response to rituximab (n=5) and non-responders (n=5). Transcriptional patterns were measured in muscle biopsies at baseline and 16-weeks post-rituximab treatment via RNAseq and RT-qPCR. Immunofluorescence staining was performed to determine co-localization of sphingomyelinase-like phosphodiesterase 3 b (SMPDL3B) and rituximab in primary human myoblasts. This study was approved by an NIH IRB, and all patients provided informed consent.
- RESULTS: Analyses identified an increase in gene expression from biopsies of patients who previously had a clinical response to rituximab compared with non-responders. Differential profiles of microRNA and mRNA expressions were identified between the two groups following therapy, except for betaine--homocysteine S-methyltransferase 2 (BHMT2) mRNA (P<0.01). Immortalized myotubes and primary human dermatomyositis muscle cells were confirmed to have estrogen receptor 1 (ESR1) upregulation (P<0.05). Non-responders displayed a significant loss in SMPDL3B compared to responders following treatment (P<0.05).
- CONCLUSIONS: In addition to B-cell depletion, rituximab's clinical benefit in myositis may also be mediated by direct SMPDL3B binding on skeletal muscle cells. We suggest a model where the biologic binds and stabilizes SMPDL3B, increasing ESR1 signaling and decreasing inflammation and muscle damage. This mechanism opens SMPDL3B as a target in myositis treatments.
- Authors: Angelly Joy Miane, Jacqueline Savva, Dhara D. Shah, Ann Brownstein
- Title: Reducing the Delay in Initial Administrations of Tacrolimus Oral Suspensions in a Pediatric Population
- Abstract
- BACKGROUND: Tacrolimus is an immunosuppressive agent that has a narrow therapeutic index and requires routine therapeutic drug monitoring. To maintain a steady blood level, tacrolimus should be administered at the same time each day. When doses are adjusted based on levels, administration of the new orders are often late.
- OBJECTIVE: The objective of this study is to decrease the delay in initial administrations of tacrolimus oral suspensions by 30 minutes to ensure consistent administration of the hazardous drug.
- METHODS: The primary outcome is the difference between the time the dose was due and the actual time of administration of the dose of tacrolimus oral suspensions. We retrospectively reviewed tacrolimus oral suspension administration times from January 2022 - June 2022. Based on this data, we identified that 45 out of the total 400 administrations (11.25%) were late. For this project, we considered a medication administered an hour past its due time as late. Of these late orders, 84% were one-time orders or first doses in a series. The mean delay from the time the dose was due to the actual administration time was about 90 minutes. We plan to further investigate the cause of the delay in administration by evaluating our hazardous drug preparation process. This project will follow performance improvement methodology. Data will be obtained through Business Universe and DoseEdge and the following data will be collected: date and time the order was placed, the time the order was due and the time of the actual administration. This study has approval from the Institutional Review Board.
- RESULTS: In progress
- CONCLUSIONS: In progress
- Authors: Ariel Francis, PharmD, Susannah Franco, PharmD, BCPPS
- Title: Optimization of Furosemide Therapy for Respiratory Distress Syndrome (RDS) in a Level III Neonatal Intensive Care Unit (NICU)
- Abstract
- BACKGROUND: Premature neonates with respiratory distress syndrome are at risk of developing bronchopulmonary dysplasia (BPD). At our institution, furosemide is given once daily at 1 mg/kg intravenously or 2 mg/kg orally to manage RDS. Although the mechanisms behind furosemide therapy for the management of RDS are promising, its efficacy with regard to preventing BPD is unknown, and side effects may include electrolyte abnormalities, hyperglycemia, and excessive dehydration.
- OBJECTIVE(S):This study aims to examine the efficacy of furosemide for the prevention of BPD and provide guidance for its optimization.
- METHODS: This study includes premature infants admitted to the NICU at SUNY Downstate Health Sciences University between August 2020 and August 2022, less than 36 weeks postmenstrual age (PMA) with RDS, weighing less than 2.5 kg, on respiratory support, and treated with IV or PO furosemide for at least 48 hours. Patients who received courses of furosemide less than 48 hours in duration and patients with birth defects or Apgar score less than 3 were not included. The primary outcome is the development of BPD, defined as the use of supplemental oxygen or respiratory support at 36 weeks PMA. The secondary outcomes include change in level of respiratory support at 36 weeks PMA, use of supplemental drugs (e.g., inhaled bronchodilators, corticosteroids, caffeine, pulmonary surfactants, pulmonary vasodilators), and survival at 36 weeks PMA. Safety outcomes include assessment of serum electrolytes, serum glucose, and urine output. Outcomes will be analyzed utilizing descriptive statistics.
- RESULTS: In progress.
- CONCLUSIONS: In progress.
- Authors: Marina Juan, Mei Chang, Yi Guo, Terrence McSweeney, Hongkai Bao
- Title: Impact of Prospective Antiretroviral Therapy Reviews by Stewardship Pharmacists on Antiretroviral Therapy Medication Errors
- Abstract
- BACKGROUND: Patients living with human immunodeficiency virus (HIV) receiving antiretroviral therapy (ART) are at significantly greater risk for medication errors during hospitalization and at transitions of care than individuals without HIV. The frequency of inpatient ART errors has been reported to be as high as 86% in previous literature. Errors related to ART or other concomitant medications can lead to adverse effects, viral resistance, and treatment failure. At our institution, an antiretroviral stewardship program is not in place.
- OBJECTIVE: To increase the frequency of identified and corrected medication errors associated with ART orders in patients with HIV admitted to our institution by 40% by June 2023.
- METHODS: A performance improvement initiative will be conducted to increase rates of ART error correction. To establish a pre-intervention rate of error, a retrospective chart review of ART administrations will be conducted between January and February 2022 at three hospital sites within the institution. Patients less than 18 years of age and on ART for indications other than HIV treatment will be excluded. Using pre-intervention baseline data, key drivers that influence ART prescribing errors will be identified. We will assess associated prescriber types, hospital units, ART classes prescribed, infectious diseases involvement, and pharmacist interventions. The first PDSA (Plan-Do-Study-Act) cycle will involve implementation of a refreshable ART report in the electronic health record, reviewed by infectious diseases stewardship pharmacists weekly. Using this report, patients' ART regimens and associated medications will be assessed for appropriateness, and errors will be rectified in real time. Key performance indicators include frequency of ART errors and specific types of errors. Balancing measures include time spent by pharmacists on ART reviews. The primary endpoint is overall ART error correction rates pre- versus post-intervention. Secondary endpoints include type of error and rate of error by drug category. This study has received institutional review board approval.
- RESULTS: In progress
- CONCLUSION: In progress
- Authors: Leigh Briscoe-Dwyer, Jessica Mourani, Binoy Shah, Fredrick Campogni
- Title: Launch Embedded Health System Specialty Pharmacy Services
- Abstract
- BACKGROUND: Specialty medications are complex therapies with stringent requirements for access, on-treatment safety monitoring, and optimization to achieve therapeutic outcomes. The specialty medication market's rapid expansion outpaces medication access and care coordination, leading many health systems to establish specialty pharmacies to address this growing care gap. Insightful, real-world data is needed to understand best practices for an effective health system specialty pharmacy (HSSP) and its impact on patient engagement and outcomes. This study evaluates quantitative data to identify best practices and measure HSSP results.
- OBJECTIVE: The purpose of this study is to quantify an HSSP's impact on patient engagement and outcomes and best practices for designing an effective program.
- METHODS: This retrospective, descriptive analysis was conducted at United Health Services Hospital, Binghamton, NY. In 2022, the hospital transitioned management of its existing HSSP to Trellis Rx, a technology-enabled specialty pharmacy services provider. With Trellis Rx's support, UHS hired and embedded pharmacists into clinics and implemented an advanced EHR-integrated technology platform to support patient management and reporting. Continuous, parametric data was analyzed three months post-transition to evaluate impact on patient engagement, medication access, clinical outcomes, and program growth.
- RESULTS: Three months post-transition, the number of patients managed by the HSSP increased 81.5% from 845 to 1,534 patients. The HSSP also secured $6,180,476.50 in financial assistance for patients, and pharmacists collected RAPID3 scores for 100% of patients with rheumatoid arthritis to assess and monitor disease activity. Further, 3 patients graduated from the diabetes chronic diabetes management program after improved A1Cs and the number of specialty prescriptions managed by the HSSP also increased 52% post-transition.
- CONCLUSION: HSSP enhance the patient experience and improve medication access and clinical outcomes. Health systems can optimize HSSP growth and results with a care model that integrates pharmacists and leverages advanced, EHR-integrated technology to support patient management and reporting.
- Authors: Patrick Kohn, Katherine Dipalo, PharmD, MS, MBA; Toshiba Morgan-Joseph, BS, PharmD, BCPPS; Angela Cheng-Lai, PharmD, BCPS
- Title: Optimization of Maintenance Inhalation Therapy at Hospital Discharge in Patients with COPD
- Abstract
- BACKGROUND: Clinical inertia and under-prescribing of optimal therapy for COPD are problems at the national level and our own institution. A retrospective chart review was conducted in a sample of patients (n=60) discharged after a hospitalization for COPD between January and August 2022 at Montefiore Medical Center: Einstein Division. The baseline rate of optimal maintenance inhaler therapy prescribed at discharge was found to be 56.7%. This is a performance improvement initiative aiming to increase the rate of optimal maintenance inhaler therapy prescribed at discharge for patients hospitalized for an acute exacerbation of COPD (AECOPD).
- OBJECTIVE: The primary objective of this project is to increase the rate of optimal maintenance inhaler therapy prescribed at discharge for patients hospitalized for COPD from 56.7% to 90% by June 1, 2023. A secondary objective of the project will be to determine if an increase in the rate of optimal maintenance inhaler therapy prescribed at discharge at our institution is associated with a reduction in 30-day hospital readmissions for AECOPD.
- METHODS: The first Plan-Do-Study-Act (PDSA) cycle will involve implementation of a pharmacy resident- and student-driven e-consult note to identify patients currently admitted with AECOPD and opportunities for therapy escalation. Patients admitted for AECOPD will be identified using a census generated by the electronic health record.
- RESULTS: In progress
- CONCLUSIONS: In progress
- Author: Samantha Paone
- Title: Impact of a Collaborative Drug Therapy Management Clinical Pharmacist in an Outpatient Cancer Center
- Abstract
- BACKGROUND: Collaborative drug therapy management (CDTM) is a formal partnership between physicians and credentialed pharmacists allowing pharmacists to manage chronic disease states. Documentation of pharmacy interventions is an important component of CDTM. Currently there is limited data available documenting the clinical benefits of CDTM in the oncology setting. Therefore, routine recording of pharmacy activities can help demonstrate the clinical impact of CDTM pharmacists, help further the development of collaborative practice agreements, and potentially provide a foundation for reimbursement in the future.
- OBJECTIVE: The primary objective is to determine the quantity and types of interventions made by a CDTM clinical pharmacist in an outpatient cancer center.
- METHODS: This is a prospective, single center quality improvement project that will review documented interventions made by a clinical pharmacist from September 2021 through March 2022. Interventions made by the clinical pharmacist will be reviewed using descriptive statistics. The clinical pharmacist is involved in oncology medication education, medication acquisition, and with actions outlined in the practices CDTM agreement. There are currently six physicians entered into a CDTM agreement with a clinical pharmacist. The specific agreement authorizes the clinical pharmacist to manage cancer patients and co-morbid conditions, and other conditions referred to the pharmacist for management. Scope includes to initiate medications after consulting the physician, modify medications (strength, frequency, route of administration, brand/generic substitution), discontinue medications, refill medications, order and evaluate laboratory tests, and collect and review patient histories.
- RESULTS: In progress
- CONCLUSIONS: In progress
- Authors: Bibi Sulaiman, PharmD, MBA, Andrade J; Cerenzio J
- Title: Evaluate the Clinical Outcomes of Using BioFire 2.0 Paired with Pharmacist-Directed Antimicrobials Stewardship Program (ASP) Guidance to Achieve Targeted Treatment on Patients with Gram-Negative Bacteremia
- Abstract
- BACKGROUND: Rapid identification of microorganism and antimicrobial resistance is paramount for targeted treatment in serious bloodstream infections (BSI). In particular, Gram-negative (GN) bacteremia with inappropriate antibiotic therapy is associated with a high mortality rate. Implementation of antimicrobial stewardship programs (ASP) and rapid diagnostic tools such as BioFire Blood Culture Identification 2 Panel (BCID2) panel improve appropriate antibiotic prescribing. BCID2 is a system panel test used for highly specific identification of gram-positive and gram-negative bacteria, yeast, and 10 different antimicrobial resistance genes, making it a fast and effective tool for escalation and de-escalation of antimicrobial therapy.
- OBJECTIVE: To evaluate the incidence of 30-day infection-related mortality, and time to optimal therapy (TTOT) in the 96 hours after positive blood culture (PBC), and for our secondary outcomes, we will be evaluating incidence of 30-day infection reoccurrence of the same bloodstream infection, all-cause mortality, time to effective treatment (TOE), and the escalation and de-escalation of antimicrobial treatment based on phenotypic (i.e., minimum inhibitory concentration) and genotypic (i.e., Biofire resistance genes) results.
- METHODS: This study is a single-center, quasi-experimental, retrospective, observational study, evaluating patients treated for gram negative bacteremia (GNB) from May 2021 to April 2023. Patients were separated into two groups, pre-implementation and post-implementation. Pre-implementation is prior to BioFire, this data was collected from May 1st, 2021 to May 14th, 2022 and post-implementation, after BioFire was collected from May 15th, 2022 to April 30th, 2023. A report will be generated from the hospital's electronic medical record (EHR), Allscripts, and Medkeeper to identify patients for the study inclusion to evaluate the clinical outcomes in patients with gram-negative bacteremia. Anticipated number of patients included for data collection will be approximately 248 patients.
- RESULTS: In progress.
- CONCLUSION: In progress.
- Authors: Laraib Khan, Amanda Waldeck, PharmD, BCPS, BCPPS and Marie Varela, PharmD, BCPS
- Title: Evaluation of Argatroban Use at Stony Brook University Hospital
- Abstract:
- BACKGROUND Argatroban is a direct thrombin inhibitor indicated for heparin-induced thrombocytopenia and is monitored using activated partial thromboplastin clotting time (aPTT). At Stony Brook University Hospital (SBUH), patients with normal hepatic function receive an initial dose of 2 mcg/kg/min using a standardized argatroban protocol. The purpose of this medication use evaluation was to evaluate if 2 mcg/kg/min of argatroban is the ideal starting dose to attain adequate anticoagulation, as defined as having 2 consecutive therapeutic aPPT results.
- OBJECTIVE: The primary objective was to analyze what dose of argatroban results in therapeutic aPTT levels.
- METHODS: A retrospective chart review was conducted for 17 patients that were 18 years and received argatroban at SBUH from August 9th, 2022 to December 26th, 2022 who had 2 consecutive therapeutic aPPT results. The rate of the argatroban infusion when the patient had 2 consecutive therapeutic aPPT results was used to backwardly calculate this in mcg/kg/min based on documented body weight. Descriptive statistics were used to evaluate patient demographics and study results.
- RESULTS: There were 14/17 (82%) patients that received the standard argatroban protocol. In these 14 patients, the mode and the median therapeutic argatroban doses were both 2 mcg/kg/min and the mean was 1.89 mcg/kg/min using actual body weight. Of note, two of these patients weighed greater than 140 kg.
- CONCLUSIONS: Dosing argatroban based on actual body weight and using an initial dose of 2 mcg/kg/min in patients with normal hepatic function is most likely to result in therapeutic aPTT levels in the majority of patients. Additional evaluation of dosing patients weighing greater than 140 kg is needed.This project is under review as a quality improvement project through our institutional review board.
- Authors: Sum Lam, Beizer J, Conry J, See S.
- Title: Effectiveness of Using a Virtual Platform for Delivering a Continuing Education Program During the COVID-19 Pandemic
- Abstract:
- BACKGROUND: Due to the COVID-19 pandemic, educators pivoted from in-person to virtual teaching. This unprecedented change was necessary although the effectiveness of virtual teaching in achieving learning objectives was largely unknown. We delivered a four-hour educational program (called the Symposium) virtually via an online platform in April 2021. This study explored its effectiveness in achieving learning objectives.
- OBJECTIVE: To evaluate the effectiveness of a virtual educational program for pharmacists by comparing pre- and post-event survey results.
- METHODS: This was a survey study administered virtually via an online platform before and after the Symposium; no informed consent or institutional review board approval were required. Program attendees completed a pre-event survey with 15 items relating to learning objectives of the Symposium. After attending the Symposium, they also completed an identical post-event survey. The survey used a 5-level Likert scale in which responders specified their level of agreement to each learning objective: strongly disagree; disagree; neutral; agree or strongly agree. The pre-event and post-event surveys evaluated the attendee's knowledge prior to and after attending the Symposium. The primary outcome was the occurrence of the strongly agreed/agreed responses in both surveys; its increase in the post-event survey was considered knowledge gained from attending the Symposium. Chi-square test was utilized with a p-value; 0.05 indicating a statistically significant difference.
- RESULTS: Out of 72 program attendees, 69 (96%) completed the pre-event survey and 61 (85%) completed the post-event survey. The percentages of the strongly agreed/agreed responses ranged from 23% to 78% (pre-event) and 89% to 95% (post-event) to all questionnaire items (p; 0.05 for 14 items).
- CONCLUSIONS: There was a significant improvement in knowledge when comparing the pre-event with post-event responses related to learning objectives. This virtual educational program was effective in achieving learning objectives that may enhance clinical practice among pharmacists.Word count 298
- Authors: Pallak Sharma, Rachel Sussman
- Title: Transitions of Care Pharmacy Service Model for Heart Failure Patients at an Urban Teaching Hospital
- Abstract:
- BACKGROUND: From 2012 to 2014, heart failure (HF) related deaths per 100,000 people increased from 81.4 to 84.0. Through guideline-directed medical therapy (GDMT), morbidity and mortality of HF can be reduced. Pharmacy-led transitions of care (TOC) services for HF patients have been shown to promote medication adherence. In 2021, at Mount Sinai West, a pharmacy student-run TOC service was developed for patients with a new diagnosis or exacerbation of HF. Pharmacy services included medication reconciliation, counseling, and follow-up phone calls. This study aimed to determine the effects of pharmacy interventions on GDMT prescribed at discharge and 72-hour fill rates post-discharge.
- OBJECTIVE: The primary outcome is GDMT prescribed at discharge and medication fill-rates of the GDMT 72-hours post-discharge. The secondary outcome is medication discrepancies identified during the admission medication reconciliation process. Patients were excluded if they were<18 years of age, expired prior to discharge, discharged to hospice or post-acute care, or discharged against medical advice.
- METHODS: This study was a retrospective chart review at a single, urban teaching hospital and included patients admitted with a primary diagnosis of new onset or exacerbation of HF. The pharmacy TOC team identified patients using patient lists in the electronic medical record (EMR). Patients were screened for inclusion by the pharmacy team. For eligible patients, pharmacy TOC services were provided to address GDMT and barriers to medication access. Sixth-year pharmacy students served as pharmacy extenders under the supervision of clinical pharmacists and performed medication histories, counseled patients, and completed follow-up phone calls. The percentage of patients prescribed GDMT at discharge was evaluated by chart review and medication fill-rates 72 hours post-discharge were obtained through follow-up phone calls to outpatient pharmacies. The pharmacy also evaluated the number of discrepancies identified in the home medication list documented in the EMR.
- RESULTS: In progress
- CONCLUSIONS: In progress
- Authors: Britney Mbeng, Keely Barletta, Huwada Obaid, Paul Denvir
- Title: Empowerment and Partnership: Lessons Learned from a Student Pharmacist-led Asthma Clinic in an Underserved Community
- Abstract:
- BACKGROUND: Asthma is among the most common chronic illnesses in the US, affecting about 1 in 10 children under 18 and resulting in substantial racial/ethnic disparities. Effective asthma management requires attention to structural factors, such as air quality and matters of personal agency, including medication adherence.. In community clinics with limited resources, student pharmacists have an important role to play in meeting unmet needs around asthma, as well as other chronic conditions that require resources that are difficult to deliver consistently in primary care contexts. These models of patient care are situated at the disciplinary intersection of pharmacy and public health. Research is needed to identify the specific communication skills, cultural awareness and competency, and asthma management practices that maximize the contributions of both disciplines to improved and equitable asthma outcomes.
- Research Questions: What knowledge and skills are needed to empower student pharmacists to provide culturally competent asthma care in underserved populations?Data, Setting, and Participants: 10 in-depth interviews with clinical and administrative staff in a student pharmacist-led asthma clinic within a federally qualified health center in the Northeastern US. The clinic serves as a rotation site for student pharmacists completing APPE rotations in the final year of their training. Analytic method Atlas.ti-assisted inductive thematic analysis
- RESULTS: Findings: Themes are articulated as lessons learned from clinic personnel. Public health pharmacy should 1) embrace its role in health navigation to include community/social services that can reduce structural contributors to asthma and increase personal agency; (2) develop interdisciplinary and interprofessional skills to more effectively collaborate ; 3) expand beyond education about safe and effective medication use to include motivating health behavior change in culturally sensitive and non-judgmental ways.
- Author: Wynter Waite
- Title: Evaluating The Appropriateness Of Oral Antibiotic Prescriptions In Patients With Complicated Urinary Tract Infections Upon Hospital Discharge
- Abstract:
- BACKGROUND: In 2015 there were 62,700 urinary tract infections ( in acute care hospitals which accounted for more than 9.5% of infections. UTIs are classified as uncomplicated or complicated, including pyelonephritis Complicated UTIs involve structural and/or functional abnormalities urinary tract infections occurring in pregnant females, renal transplant patients and immunocompromised patients. Pyelonephritis occurs when a urinary tract infection spreads from the bladder to the kidneys. The treatment of complicated UTIs and pyelonephritis may require hospitalization and intravenous IV antibiotics. The treatment duration for complicated UTI is 7 10 days. The treatment duration for pyelonephritis is 14 days Overuse of antibiotics can increase the risk of antimicrobial resistance Clostridium difficile infection Many hospitals have implemented protocols to transition from IV to oral antibiotics and patients are usually discharged with an antibiotic prescription to complete their course of therapy
- OJBECTIVE: The purpose ofthis study is to evaluate the appropriateness of oral antibiotic prescriptions in patients with complicated UTI upon hospital discharge.
- METHODS: The study will include patients that were prescribed oral antibiotics after being diagnosed with complicated UTI before and after implementation of a duration of therapy guide and stewardship interventions The pre implementation group will consist of patients that were discharged from March 1, 2022, to August 31, 2022. In September 2022, our institution developed a Duration of Therapy guide which will serve as the basis for pharmacist led stewardship interventions. The post implementation group will prospectively evaluate patients that were prescribed oral antibiotics upon discharge The primary outcome will compare the median duration of antibiotics before and after the implementation of stewardship interventions. Secondary outcomes will include the incidence of patients that were readmitted within one month for any adverse events, the appropriateness of antibiotic dosage and frequency, and the appropriateness of antibiotic selection based on culture and sensitivity reports.
- RESULTS: In progress.
- CONCLUSIONS: In progress.
- Authors: Anthony Liang, Sara Salah, Kelsey Gregoire
- Title: Medication Use Evaluation: Albumin utilization across Catholic Health System Hospitals
- Abstract:
- BACKGROUND: Human albumin solution is currently FDA-approved for a wide variety of indications. The purpose of this medication use evaluation is to quantify and explain the pattern for the use of regimented albumin order sets based on indication across hospitals within a healthcare system.
- OBJECTIVES: The primary objective is to define the prescribing patterns and indications for use of albumin 5% and 25% solutions within the institutions. The secondary objective is to compare the indications and dosing regimens with those supported by primary literature and treatment guidelines.
- METHODS: This study is a retrospective, multi-center chart review over a 2-month period of 107 patients at least 18 years of age who were treated with IV human albumin 5% or 25% at multiple institutions within a healthcare system . A chart review was completed and the data collected included patient demographics (age, gender), albumin strength, dose, pre and post-albumin serum albumin and creatinine levels, cumulative duration of albumin treatment, concomitant and/or prior crystalloid therapy and concomitant vasopressor or loop diuretic use. Appropriate albumin use was determined utilizing criteria which included FDA labeled indications, Surviving Sepsis Campaign, and existing primary literature.
- RRESULTS / CONCLUSION: in progress will be accepted. If accepted, a finalized abstract must be submitted following the conference to be included in website publication.
- Authors: Andrew Rennekamp, C. Boikos, Ian McGovern, Deborah Molrine, Justin R. Ortiz, Joan Puig-Barbara, Mendel Haag
- Title: Real-World Effectiveness of Cell-Based Quadrivalent Influenza Vaccine in the 2017-2019 US Influenza Seasons
- Abstract:
- BACKGROUND: Adaptation of influenza seed viruses in egg culture can result in variable antigenic vaccine match each season. The cell-based quadrivalent inactivated influenza vaccine (IIV4c) contains viruses grown in mammalian cell lines rather than eggs. Because IIV4c is not subject to egg-adaptive changes it may offer improved protection relative to egg-based vaccines, depending on the degree of match to circulating influenza viruses. This study investigated the relative vaccine effectiveness (rVE) of IIV4c vs egg-based quadrivalent influenza vaccines (IIV4e) to prevent influenza-related medical encounters (IRMEs) from 3 consecutive US influenza seasons.
- METHODS: We reviewed three retrospective, observational cohort studies conducted using the same database during the 2017-2018, 2018-2019 and 2019-2020 U.S. influenza seasons. The studies included 18.4 million immunizations (IIV4c or IIV4e) in persons aged ≥4 years. The database used combined electronic medical records with pharmacy and medical claims data (claims used in 2017-2018 and 2019-2020 only). The outcome was influenza-related medical encounters (IRME) identified from patient records using codes specific to influenza disease diagnosis (ICD J09*-J11*). Vaccine effectiveness was estimated using propensity score methods adjusting for prespecified confounders (age, sex, race, ethnicity, geographic location, week of vaccination, health status). Subgroup analyses included specific age groups (pediatric 4-17, adult 18-64 and older adult 65 years) and those with high-risk medical conditions.
- RESULTS: IIV4c demonstrated a consistent benefit over IIV4e in the prevention of IRMEs in the overall population and in pediatric and adult subgroups over the three consecutive U.S. influenza seasons, except for the 4-17 year age group in 2017-2018 and adults 65 years in all seasons. The rVE for the overall population ranged from 7.6% for 2018-2019 season to 19.2% for 2017-2018 season.
- CONCLUSIONS: IIV4c consistently had higher relative effectiveness than IIV4e across all seasons assessed, which were characterized by different dominant circulating strains and variable antigenic drift or egg adaptation.
- Authors: Courtney Zeni, Seth C. Hopkins; Nina Dedic; Colleen Synan; Kenneth S. Koblan
- Title: Review of the TAAR1 Agonist Ulotaront: Part I - from Discovery to Clinic
- Abstract:
- BACKGROUND: Trace amine-associated receptors (TAARs) are a family of G-protein-coupled receptors (GPCRs). TAAR1 has emerged as a promising therapeutic target for several neuropsychiatric disorders due to its ability to modulate monoaminergic and glutamatergic neurotransmission. Ulotaront is the first therapeutic agent in this class to complete Phase 2 clinical trials. Here we provide a brief review of the discovery of ulotaront and the preclinical research suggesting its efficacy in schizophrenia, leading to the first clinical trial resulting in FDA designation of ulotaront as a Breakthrough Therapy.
- Methods: Candidate compounds were screened using a high-throughput, mouse-behavior phenotyping platform (SmartCube) in combination with in vitro anti-target screening designed to identify compounds exhibiting antipsychotic-like activity in the absence of dopamine (D2) and serotonin (5-HT2A) receptor activity. Ulotaront was identified and subsequently studied in established preclinical models of schizophrenia and tested against several panels of known molecular targets. Follow-up studies, including in vitro and in vivo electrophysiology recordings, as well as PET imaging, were conducted to elucidate the underlying mechanism of action.
- RESULTS: The high-throughput, mouse-behavior phenotyping methodology identified ulotaront as a promising drug candidate. In vivo, ulotaront demonstrated efficacy in preclinical models of schizophrenia, including phencyclidine (PCP)-induced hyperactivity, prepulse inhibition of the acoustic startle response, and subchronic PCP-induced deficits in social interaction. Although not fully elucidated, the mechanism is thought to be largely mediated by agonism at TAAR1 and 5-HT1A receptors. This was further corroborated with whole cell patch clamp recordings, demonstrating inhibition of dorsal raphe nucleus (DRN) and ventral tegmental area (VTA) neuronal firing via 5-HT1A and TAAR1 receptors. Furthermore, ulotaront attenuated the ketamine-induced increase in striatal dopamine synthesis capacity, suggesting that it may modulate presynaptic dopamine dysfunction, hypothesized to contribute to the pathophysiology of schizophrenia. The results of a standard preclinical abuse liability battery suggest that ulotaront is not likely to pose a risk for abuse in humans and may even have potential therapeutic utility as a treatment of substance use disorders.
- CONCLUSIONS: Findings from in vitro and in vivo studies have identified ulotaront as a TAAR1 agonist with robust antipsychotic-like activity in rodent models. Ulotaront's unique target profile led to its designation as a member of the new taront class of TAAR1 agonists, distinct from the approved D2/5-HT2A class of antipsychotics. A companion poster will summarize the broad-spectrum efficacy, tolerability, and safety features of ulotaront based on initial clinical trials in patients with schizophrenia.
- Authors: Courtney Zeni, Seth C. Hopkins; Heather Dworak; Kenneth S. Koblan
- Title: Review of the TAAR1 Agonist Ulotaront: Part II - Summary of Initial Clinical Efficacy/Safety Results
- Abstract:
- BACKGROUND: Ulotaront is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity whose efficacy in schizophrenia is distinguished from the antipsychotic class by its lack of D2 and 5-HT2A receptor blockade. Ulotaront has received FDA Breakthrough Therapy Designation for treatment of schizophrenia, and WHO, based on the INN naming convention, has specified taront as the stem for this new drug class. Here we summarize ongoing clinical research characterizing the efficacy and safety profile of ulotaront as a member of the novel TAAR1 agonist class.
- METHODS: Summarized are results from a double-blind, placebo-controlled study to evaluate the efficacy of ulotaront in an acute exacerbation of schizophrenia, and a 6-month, open-label follow-up study. Also summarized are post-hoc analyses comparing the effect of ulotaront vs. lurasidone on negative symptoms (based on a Marder PANSS negative symptom factor [MPNS] enrichment strategy); and analyses comparing key safety and adverse event (AE) domains for ulotaront vs. atypical antipsychotics (APs), including an Empirical Bayes Geometric Mean (EBGM) analysis of the FDA Adverse Event Reporting System (FAERS) database.
- RESULTS: In the double-blind study, ulotaront was associated with significant (p;0.001) endpoint improvement in the PANSS total score (effect size [ES]: 0.45), the CGI-Severity score (ES: 0.52) and the Brief Negative Symptom Scale total score (ES: 0.48). In a post-hoc enrichment analysis, ulotaront demonstrated moderate-to-large treatment effects on negative symptoms with an endpoint MPNS factor score effect size of 0.84 (vs. 0.33 on the atypical antipsychotic lurasidone). The incidence of any AE was lower on ulotaront vs. placebo (45.8% vs. 50.4%). Results of EBGM analyses of the FAERS database bh found treatment with ulotaront to be associated with markedly lower risk of both antipsychotic class-related AEs (EPS, akathisia, somnolence, nausea/vomiting), and adverse safety events frequently associated with APs (weight gain, increase in metabolic labs, prolactinemia). The follow-up study further confirmed the tolerability of ulotaront, with a 6-month completion rate of 67%, which compares favourably to benchmark 6-month completion rates in the CATIE study. Furthermore, 6 months of treatment was associated with a mean change from open-label baseline of -22.6 in PANSS total score and -1.0 in CGI-Severity score.
- DISCUSSION: The emerging profile of ulotaront, based on initial clinical trials, is characterized by statistically significant improvement in positive and negative symptoms of schizophrenia. The safety and tolerability profile of ulotaront is markedly different with respect to class-related AEs that are characteristic of both first- and second-generation antipsychotics. The benefit-risk profile of ulotaront, as a member of a novel TAAR1 agonist class, is distinguished from antipsychotics by lack of D2 and 5-HT2A receptor blockade.
- Authors: Maria Amodio-Groton, Holly Hoffman-Roberts, Thomas P. Lodise, Fan Mu, Emily Gao, Danni Yang, Erica Yim, Jingyi Chen, Gail Berman
- Title: Comparison of 30-Day Healthcare Resource Utilization (HRU) Among Adult Patients with Approved or Unapproved Omadacycline Prescriptions for Nontuberculous Mycobacterial Infections
- Abstract:
- BACKGROUND: Omadacycline is indicated for adults with ABSSSI and CABP. Preliminary clinical studies suggest omadacycline may be effective among patients with NTM. There is a need to understand the outcomes of patients with NTM who are treated with omadacycline. Consistent with other new agents, there is a high potential that an omadacycline prescription faces reimbursement challenges and it is not known if omadacycline prescription approval status impacts 30-day inpatient and ED visits.
- OBJECTIVE: To characterize the real-world outcomes of adults who were prescribed omadacycline for NTM, determine the incidence of unapproved omadacycline prescription and compare outcomes before and after patients index omadacycline claim among those who had an unapproved and those with an approved omadacycline claim.
- METHODS: The study population included patients who received omadacycline prescription from a large US claims database (10/2018-9/2020) and had an NTM diagnosis within -90 d to +30 d of omadacycline prescription. Patients were classified in the approved or unapproved cohorts based on the approval status of their index omadacycline prescription. Risks of 30-day inpatient and ED visits were compared.
- RESULTS: During study period, 172 NTM patients met the inclusion criteria: 117 (68%) approved and 55 (32%) unapproved omadacycline prescription. HRU significantly decreased after approved omadacycline prescription, driven by a reduction of inpatient visits. No significant reduction in HRU was seen for those with an unapproved omadacycline prescription. Thirty-day post-index inpatient visits for those with an approved vs unapproved claim was 8% vs 25%, respectively, corresponding to an unadjusted NNT of 6.
- CONCLUSIONS: This study provided the first real world characterization of NTM patients with omadacycline claims. A high incidence of unapproved claims was observed in this study. The findings suggested that 1 out of 6 patients with unapproved omadacycline claims had a 30-day inpatient visit that could have been potentially avoided if omadacycline was approved.Funding: Paratek Pharmaceuticals, Inc
- Authors: Joseph D'Antonio, Tony Davis, PhD, Eric Kelly, Juhi Gurtata, Mana Halaji Dezfuli
- Title: Development of a Differential Scanning Fluorimetry Assay to Screen for Modulators of the Mycobacterium tuberculosis Prokaryotic Proteasome System
- Abstract:
- BACKGROUND: Tuberculosis is a leading source of infectious disease fatalities globally and is caused by Mycobacterium tuberculosis (Mtb). Mtb is a member of a select few bacteria that utilize a proteasome system to regulate harmful substances and may be the reason it's effective at evading immune defenses. The pathway begins with our target deamidase protein, Dop. We hypothesize that inhibition may allow for harmful waste products to aggregate within the cell, and increase its susceptibility to immune defenses. Dop is a worthy target for therapeutics given its role in Mycobacterium's metabolic stability and pathogenicity, and absence of known similar targets in humans. Previous experimentation has shown favorable docking affinities for up to 32 small molecule drugs. We optimized a differential scanning fluorimetry (DSF) assay to verify the melting point of Dop, and then in the presence of the previously identified therapies. After expressing Dop and standardizing our assay, we examined the degradation point in the presence of 17 of the identified drug therapies. We were able to express and purify up to 4,000 µL of Dop enzyme at various concentrations between 44-108 µg/mL. We identified optimal conditions for our assay to be 0.48 micrograms of Dop in a final volume of 20 µL of total assay solution. Assay solution consists of 1.25x SYPRO dye and a maximum of 1% DMSO, in a remaining volume of buffered solution of 50 mmol HEPES and 200 mmol NaCl. The assay proved a consistent degradation curve in the 42-46 degrees celsius. In the presence of ATP the degradation point of Dop did not change. Of 17 therapies tested, 12 showed no changes in degradation, and 5 were unclear. While the 17 therapies experimented did not stabilize Dop, our study has verified a potentially valuable tool in the development of Dop-targeted therapeutics.
- Authors: Vera Bulakhova, Feng-Hua Loh
- Title: Results of Benralizumab in Asthma Treatment Compared to Omalizumab and Mepolizumab
- Abstract:
- OBJECTIVE: Systematic review of randomized, double-blind, and placebo-controlled studies of Fasenra medication for asthma treatment in adults older than 12 years old with severe asthma symptoms.
- METHODS: In our systematic review we used PRISMA guidelines. We made a systematic search in five health related journal databases between January 2017 and March 2021. Data extraction, quality assessment and study eligibility were completed independently. In this systematic review we compared the efficacy of Benralizumab with efficacy of Mepolizumab and Omalizumab. We included only randomized, double-blinded, placebo-controlled studies for listed medications. The primary outcome was lower blood eosinophils count.
- RESULTS: Our search identified 100 citations. 5 studies were included. All studies were randomized, double-blinded, and placebo-controlled. Study population included adults aged 18-75 years with uncontrolled eosinophilic asthma, who are using medium-dose or high-dose inhaled corticosteroids and LABA and with a postbronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of at least 12% at screening.
- CONCLUSION: The study results of Benralizumab show that the drug is useful for treating asthmatic patients on different levels. Using the analysis of different weeks and numerous participants, it is evident that the Benralizumab can be used for asthma of different levels. We identify that further research should be based on the side effects of Benralizumab and its effectiveness on different asthmatic levels.
- Authors: Rachel Quinn, Martha Stutsky, Carolkim Huynh, Christopher Barr, Shreevidya Periyasamy, Kate Smullen, Jennifer L. Donovan
- Title: Clinical Outcomes Evaluation and Reporting
- Abstract:
- BACKGROUND: Health system specialty pharmacies (HSSPs) deliver coordinated quality care for patients. Their integrated care model is uniquely positioned to improve patient outcomes for complex disease states. Currently, there is a lack of standardized clinical outcomes (CO) benchmarks within specialty pharmacy (SP), let alone HSSPs, to measure performance. To evaluate COs across multiple HSSPs, we established a systematic approach to defining and reporting COs for multiple disease states.
- OBJECTIVES: To describe the process of reporting COs across HSSPs with the goal of creating standard CO benchmarks to compare performance.
- METHODS: COs were identified through literature searches for hepatitis C virus (HCV), human immunodeficiency virus (HIV), rheumatoid arthritis (RA) and oncology (ONC), then deployed into the patient management platform (PMP) for multiple HSSPs using discrete data fields. Pharmacists completed a standardized clinical training program to ensure consistent documentation within the PMP. Patient time on service requirements and limits on historical data were established for each disease state. Patient inclusion and exclusion criteria were applied to each disease state to establish a reproducible framework for evaluating results across multiple HSSPs. De-identified data extractions for each disease state were validated prior to internal publication. Sustained virologic response, viral suppression, Routine Assessment of Patient Index Data 3, and hospitalization were selected for quarterly reporting for HCV, HIV, RA, and ONC respectively.
- RESULTS: From January to December 2022, COs were analyzed for patients enrolled in the integrated care model and followed by clinical pharmacists. The percentage (n/N) of patients that achieved SVR, viral suppression, RAPID3 improvement, and were hospitalized were as follows: 96% (3,454/3,595), 94% (33,419/35,722), 46% (2,085/4,496), 5.5% (6,247/113,479).
- CONCLUSIONS: A framework to develop and report COs was implemented for a network of HSSPs. Standardized criteria to uniformly evaluate COs allowed each HSSP to compare their performance and validate quality clinical care for patients.
- Authors: Daniel Levin, Alan Zhao, PharmD, BCPS, BCCCP; Bessma Hassani, PharmD, BCPS, BCIDP; Rachel Bain, PharmD, BCPS, BCGP
- Title: Risk of Oversedation and Respiratory Depression with Coadministration of Intramuscular Olanzapine and Parenteral Benzodiazepines in Patients with Acute Agitation
- Abstract:
- BACKGROUND: Intramuscular injections of olanzapine and parenteral injections of benzodiazepines are commonly used in combination to manage acute agitation. Both may cause cardiorespiratory depression and excessive sedation and there is concern of increased risk if given together, prompting an FDA warning.
- OBJECTIVE: The purpose of this study is to evaluate the risk of respiratory depression and excessive sedation when intramuscular olanzapine and parenteral benzodiazepines are given within an hour of each other.
- METHODS: This will be a retrospective chart review from January 1, 2019, to August 31, 2022 assessing adult patients who received intramuscular olanzapine and parenteral benzodiazepines within one hour of each other. Patients will be excluded if they are mechanically ventilated, have no vitals recorded three hours after administration of the second medication, or if they did not receive the study medications within one hour of each other. Pending institutional review board approval, the data collected from the electronic health record will include respiratory rate, oxygen saturation, Richmond Agitation-Sedation Scale or other alertness scales, and administration times of intramuscular olanzapine and parenteral benzodiazepines. The primary outcome will be the incidence of oversedation or respiratory depression within three hours of receiving both study medications.
- RESULTS: Pending.
- CONCLUSION: Pending results.
|