2024 Poster Session Abstracts

April 20, 2024

Efficacy and Safety of KarXT (xanomeline and trospium) in schizophrenia: Pooled results from the randomized, double-blind, placebo-controlled EMERGENT trials

Inder Kaul, Sharon Sawchak, RN, Stephen K. Brannan, MD
Karuna Therapeutics

  • INTRODUCTION: KarXT (xanomeline and trospium chloride) is a dual M1/M4 preferring muscarinic receptor agonist that lacks direct D2 dopamine receptor binding being developed for the treatment of schizophrenia. The efficacy and safety of KarXT in schizophrenia was demonstrated in the 5-week, randomized, double-blind, placebo-controlled EMERGENT-1 (NCT03697252), EMERGENT-2 (NCT04659161), and EMERGENT-3 (NCT04738123) trials.
  • METHODS: Data from the EMERGENT trials were pooled and efficacy and safety analyses were conducted in the modified intent-to-treat and safety populations. The primary efficacy endpoint was change from baseline to week 5 vs placebo in PANSS total score. Secondary endpoints were change from baseline to week 5 in PANSS positive and negative subscales, and CGI-S scores. Safety assessment included monitoring for spontaneous AEs after the first dose of trial drug until discharge.
  • RESULTS: Across trials, KarXT (n=314) was associated with a significantly greater reduction in PANSS total score at week 5 versus placebo (n=326), (KarXT, -19.4; placebo, -9.6; P<0.0001; Cohen’s d, 0.65) and a significantly greater reduction vs. placebo in PANSS positive and negative subscales and CGI-S scores. In the safety analyses, 51.8% on KarXT (n=340) reported ≥1 treatment-related AEs compared to 29.4% on placebo (n=343). Treatment-related AEs occurring in ≥5% of participants receiving KarXT and at least twice the placebo rate were nausea (17.1% vs 3.2%), constipation (15.0% vs 5.2%), dyspepsia (12.1% vs 2.3%), vomiting (10.9% vs 0.9%), and dry mouth (5.0% vs 1.5%). The most common treatment-related AEs in the KarXT group were mild or moderate in intensity.
  • CONCLUSIONS: In pooled analyses from the EMERGENT trials, KarXT demonstrated statistically significant improvements across efficacy measures with consistent and robust effect sizes and was generally well tolerated. These findings support the potential of KarXT to be first in a new class of medications to treat schizophrenia based on muscarinic receptor agonism and without any direct dopamine D2 receptor blocking activity.

Real-world study of adjuvanted influenza vaccine in preventing cardio-respiratory related hospitalizations in the elderly during the 2019-2020 U.S. influenza season

Andrew Rennekamp, Mahrukh Imran, Juan Puig-Barbera, Justin Ortiz, Lorena Lopez-Gonzalez, Alex Dean, Machaon Bonafede, Daniel Dudman, Mendel Haag
CSL Seqirus, FISABIO, University of Maryland School of Medicine, Veradigm

  • INTRODUCTION: Older adults’ immune systems generally respond less well to standard-dose egg-grown, influenza vaccines (QIVe) than young adults. Two contemporary vaccines were specifically developed to overcome this age-related immunosenescence: adjuvanted trivalent influenza vaccine (aTIV), which adds MF59 adjuvant to boost the recipient’s immune response, and high-dose trivalent influenza vaccine (HD-TIV), containing higher antigen dose. This study investigated the relative vaccine effectiveness (rVE) of aTIV vs. HD-TIV or QIVe in preventing cardio-respiratory related older adult hospitalizations.
  • METHODS: This retrospective observational cohort study was conducted from September 30, 2019 to March 7, 2020. The data comprised de-identified medical records of adults > 65 years of age who received aTIV, HD-TIV, or QIVe) during the 2019-2020 influenza season. Since influenza is associated with adverse cardio-respiratory events, the outcomes evaluated were cardio-respiratory-related hospitalizations and respiratory-related hospitalizations, and specifically influenza-related and pneumonia-related hospitalizations as well as hospitalizations related to myocardial infarction and ischemic stroke. Outcomes were defined as a diagnosis in any position of the claim and separately in the first position (regardless of the diagnoses in the subsequent positions). A doubly robust, inverse probability of treatment weighting methodology was used to obtain odds ratios (ORs) adjusted for possible confounds (e.g., age, sex, race, ethnicity, etc.). rVE was determined using the formula (1-ORadjusted)*10.
  • RESULTS: During the 2019-20 influenza season, 4,299,594 individuals met the study selection criteria. Of those, 1,083,466 (25.2%) received aTIV, 2,448,403 (56.9%) received HD-TIV, and 767,725 (17.9%) received QIVe. aTIV was more effective compared to QIVe and HD-TIV across all cardio-respiratory related hospitalization outcomes. Consistent trends were observed when limiting to the primary/admitting diagnosis, except for ischemic stroke related hospitalizations for which no difference was observed compared to HD-TIV.
  • CONCLUSIONS: This real-world study demonstrated the benefit of aTIV over QIVe and HD-TIV for the prevention of cardio-respiratory related hospitalization outcomes during the 2019-20 season, including influenza-related hospitalizations.

Pharmacy and nursing led quality improvement for oncology resources and workflows

Jamie Chin-Hon, Brooke Barrett, Jessica Kirk, Angelica Frisari, Hallie Horowitz, Megan Bulva, Jennifer Salazar, Jacqueline Migliardi, Stephanie Salazar, Elizabeth Mastropietro
NYU Langone Hospital - Long Island

  • INTRODUCTION: Caring for cancer patients is a unique and challenging responsibility clinically due to the complexity of the treatment regimens, supportive care, counseling and answering questions from the patient and family, and the coordination of care among the interprofessional medical team. Chemotherapy treatment regimens may include several medications and supportive medications as well as treatment arms for alternating cycles. Our nurses, pharmacists, and oncology fellows caring for patients may have varying level of comfort and experience.
  • OBJECTIVE: This quality improvement (QI) project aims to share our experiences with our oncology resources education, resources, and interprofessional collaboration. The primary outcome is to evaluate our nurses’ baseline knowledge. Secondary outcomes will be to evaluate selective complex chemotherapy regimens and the education and resources provided.
  • METHODS: This QI surveys our oncology nurses to assess baseline clinical knowledge, review of our policies, and asks for gaps in care to better support. Educational resources were developed and launched in phases. Nurses will be surveyed to assess the educational resources and obtain feedback to continue to develop and support our team.
  • RESULTS: A total of 24 nurses were surveyed at baseline. Our institution utilizes EPIC, which require nurse to review and release chemotherapy orders in which 54% of nurses responded they were somewhat comfortable. When asked if they know how to access and review treatment plan orders, 83% responded yes. When asked which labs are required to review prior to releasing treatment plan orders, 83% responded correctly. When asked about regimen deviations, 96% responded correctly about requiring documentation in treatment plan notes.
  • CONCLUSION: Our oncology nurses have a good baseline knowledge of the process of reviewing chemotherapy treatment plan orders since moving to EPIC. Tip sheets were developed to reinforce the correct process and explanation. The next phase are chemotherapy regimen specific surveys and resources.

Implementation of ambulatory clinical pharmacist type 2 diabetes care services within an integrated health-system specialty pharmacy

Rachel Quinn, Sharon Zhu, PharmD; Veronica Sozio, PharmD, BCPS; Kathleen Horan, PharmD; Kate Smullen, PharmD, CSP, MSCS, Martha Stutsky, PharmD, BCPS; Ameet Wattamwar, PharmD; Kenny Yu, PharmD, MBA, ACE
Shields Health Solutions

  • INTRODUCTION: Health-system specialty pharmacy (HSSP) models have shown benefits in specialty medication access, medication adherence, and clinical outcomes. As a result, an integrated HSSP clinical program provided Ambulatory Clinical Pharmacist (ACP) support to expand services in the type 2 diabetes mellitus (T2D) population.
  • OBJECTIVE: To describe the impact of implementation of ACP-led medication management services specializing in diabetes care within an integrated HSSP.
  • METHODS: Patients > 18 years who were filling prescriptions for GLP-1RA and SGLT-2i for the treatment of T2D between August 2022 and February 2023, had >2 clinical encounters with an ACP, a baseline A1C (collected< 3 months prior to enrollment), and >1 subsequent A1C collected since starting pharmacy services were included. The primary outcome was A1C changes after clinical encounters with an ACP. Secondary outcomes include weight reduction, percentage of patients achieving A1C<7%, and percentage of accepted interventions. Descriptive statistics were used to report outcomes.
  • RESULTS: Between August 2022 and February 2023, 367 patients were enrolled. 334 were on a GLP-1RA and/or an SGLT-2i for T2D. Of these 334 patients, 103 patients were included in the analysis. On average, patients reduced their A1C by 0.55% and achieved weight loss of –1.9kg. The percentage who achieved A1C< 7% was 53.4% vs. 38.8% at baseline. 63 (61.2%) patients were categorized as having uncontrolled diabetes with A1C ≥ 7%. They had an average baseline A1C of 8.4% and achieved an average A1C reduction of 0.85%. There were 83 clinical interventions recorded, of which 81 (97%) were accepted.
  • CONCLUSION: Data suggest the implementation of ACP-led medication management services specializing in diabetes care within an integrated HSSP has a positive impact improving outcomes for T2D population and its complications. These findings support the integrated ACP role in improving the management of T2D.

SURPASS(ING): An Era of Basal-Bolus Insulin Therapy: Tirzepatide Vs Insulin Lispro TID Added-On to Poorly Controlled Basal Insulin-Treated Type 2 Diabetes!

Hailey Lipinski, Julio Rosenstock1 Juan P. Frías2, Helena Rodbard3, Santiago TofÃ4 Emmalee Sears5, Ruth Huh5, Laura FernÃndez Landó , Hiren Patel5, Hailey Lipinski5
1Velocity Clinical Research at Medical City, Dallas, TX, USA; 2 Velocity Clinical Research, Los Angeles, CA, USA; 3Endocrine and Metabolic Consultants, Rockville, MD, USA; 4Department of Endocrinology and Nutrition, University Hospital Son Espases, Palma de Mallorca, Spain; 5Eli Lilly and Company, Indianapolis, IN, USA

  • INTRODUCTION: Tirzepatide (TZP) is a once weekly GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes (T2D).
  • OBJECTIVE: In this study we access the efficacy and safety of once weekly TZP vs insulin lispro (iLispro) was assessed in people with T2D with inadequately controlled glycemic control on insulin glargine (iGlar) with or without metformin.
  • METHODS: In this 52-wk open-label, multicenter, Phase 3b study, 1428 patients with T2D (mean baseline [BL] age 59 y; T2D duration 14 y; HbA1c 8.8%; BMI 33 kg/m^2; iGlar dose 46 IU/day) were randomized (1:1:1:3) to TZP (5, 10, 15 mg) or iLispro TID, as an add-on to iGlar ± metformin. Insulin doses were titrated to a target fasting and pre-prandial glucose of 100-125 mg/dL. Primary efficacy measure was change in HbA1c from BL for TZP (pooled) vs iLispro at 52 wk. Secondary measures were change from BL in fasting serum glucose and body weight (BW), and proportion of patients at HbA1c and BW loss goals (TZP pooled and each dose vs iLispro).
  • RESULTS: At 52 wk, TZP (pooled) was superior vs iLispro in change from BL in HbA1c, achieving a mean HbA1c of 6.5% vs 7.6%, with substantially less in insulin use (iGlar: 13 IU/day vs 42 IU/day [iLispro 62 IU/day]) and BW loss of 10 kg vs gain of 4 kg, respectively. Rate of Level 2 and 3 hypoglycemia was 10-fold higher with iLispro. The most common adverse events with TZP were nausea, diarrhea, and vomiting of mild to moderate severity.
  • CONCLUSIONS: In conclusion, TZP demonstrated clinically meaningful and superior glycemic and BW control vs iLispro associated with substantially less hypoglycemia and insulin use.^ denotes square root in this submission

Proteomic Methods to Screen Ixodes Scapularis in Broome County Parks for Potential Tick-Borne Pathogens

Paul Puccio Jr, Matthew Chin, Emma Draper, Matthew Nunez, Benjamin Policriti
Binghamton University School of Pharmacy and Pharmaceutical Sciences

  • INTRODUCTION: To identify potential infectious pathogens found in Ixodes scapularis found in parks across Broome County, NY, and the prevalence of these pathogens Comparison of shotgun proteomic methods to 1-D gel electrophoresis to see which method provided better efficacy for protein identification.
  • METHODS: Male and female Ixodes scapularis ticks were collected from 2 state parks within Broome County and separated by sex and park. Dissections occurred 5 ticks at a time, male or female, with the removal of legs, and cutting each tick in half. Tick proteins were separated from pathogen proteins utilizing RIPA buffer and trypsin within 2 methods, shotgun proteomics and 1-D gel electrophoresis. Study designs were created for each and analyzed which method amplified a larger amount of outer surface membrane proteins from pathogens. Pathogen outer membrane proteins were identified and confirmed with Uniprot, a protein database.
  • RESULTS: A batch of 5 ticks from 1-D gel electrophoresis had a yield of 387 microbial proteins compared to 4 microbial proteins being identified with shotgun proteomics for the same batch. With Uniprot, proteins were identified belonging to bacteria: Borrelia burgdorferi, Rickettsia rickettsii, Rickettsia buchneri, Rickettsia monocensis; and Babesia microti. Each tick sample had a different mix of proteins belonging to the microbes listed above. Outer surface protein identification was an important goal in this research because these proteins are part of the pathogenicity of the microbe.
  • CONCLUSION: Multiple pathogens were identified in male and female ticks. It is theoretically possible for female ticks to transmit multiple pathogens as outer surface proteins were found. It is unclear if R. buchneri transmits disease, as it predominates in ticks with fewer outer surface proteins for B. burgdorferi. The lesser-known parasite Babesia microti, which causes Babeosis, has increased in prevalence and was not affected by other pathogen presence.

Proactive Pharmacy-led Transition of Care Protocol to Increase Appropriate Oral Antibiotic Use for Patients with Uncomplicated Gram-Negative Bacteremia.

Cadhan McFadden, PharmD1, William DePasquale, PharmD1,2, Julia Kufel, PharmD1, BCIDP , Christine Rahme, PharmD BCPS1, Lisa Avery, PharmD BCPS BCIDP FCCP1,2.
1St. Joseph’s Hospital Health Center, 2Saint John Fisher University Wegmans School of Pharmacy

  • INTRODUCTION: Transition to an oral (PO) antibiotic regimen for uncomplicated gram-negative bacteremia (GNB) includes utilizing a highly bioavailable agent at optimal dosing for a total duration of therapy (DOT) of 7-14 days. Pharmacist involvement in the transitions of care phase has been successful in improving various patient outcomes. The purpose of this study is to assess the impact of implementing a pharmacist-led transition of care protocol for uncomplicated gram-negative bacteremia.
  • OBJECTIVES: The primary outcome of this study is a composite of the percentage of patients on protocol-compliant antibiotic therapy defined as appropriate drug, dosage regimen, and duration pre and post intervention. Secondary outcomes include each composite component and total length of stay, 30-day all-cause readmission due to infection or other causes, and antibiotic-associated adverse events.
  • METHODS: The institutional review board granted exempt status for this single-center, pre/post, observational study assessing patients admitted with a confirmed GNB through blood culture testing. The pre-intervention group includes patients from 8/1/22-9/30/23 and the post-intervention group 10/1/23-3/31/24. The intervention consists of creating an antimicrobial stewardship approved protocol outlining the definition of uncomplicated GNB, clinical improvement criteria, ranked order of preferred PO antibiotics with appropriate dosing based on patient demographics with duration of therapy. Protocol-based recommendations will be forwarded to provider by a pharmacist during the intervention period. Patients > 18 years old with confirmed uncomplicated GNB were included. Patients who are immunocompromised, have a non-functional gastrointestinal tract, were enrolled in hospice care, expired during hospitalization, pregnant, left against medical advice, have a polymicrobial infection, isolates resistant to all PO agents, inadequate source control, or those with infectious disease consultations were excluded.  Descriptive statistics will be used to summarize baseline characteristics, primary, and secondary outcomes. Comparative analyses included using Pearson’s x2 and Student’s t-Test where appropriate to compare baseline characteristics and outcomes.
  • RESULTS: Pending.
  • CONCLUSION: Pending.

Utilization of Lower Dose Cyclobenzaprine in the Older Inpatient and Impact on Outcomes

Katherine Coli, Jaylan Yuksel, Kenneth McCall, Jiajie Guan, Kelly Ulen, John Noviasky
St. Joseph's Hospital Health Center, Saint John Fisher University - Wegmans School of Pharmacy

  • INTRODUCTION: In older inpatients, anticholinergic medications can increase the risk of complications that may increase length of stay (LOS). Cyclobenzaprine is an anticholinergic medication associated with mental status changes, falls, and injuries in older patients. 
  • OBJECTIVE: The purpose of this study is to determine whether lower cyclobenzaprine dosing (5 mg) compared to higher dosing (10 mg) affects LOS, 30-day readmission rates, and need for injectable psychotropic agents in inpatients aged >  65 years.
  • METHODS: This was a retrospective cohort analysis comparing outcomes in patients aged > 65 years who received either a 5 mg or 10 mg cyclobenzaprine dose during their inpatient admission over a 2.5-year period. This research was granted IRB exemption status. The primary outcome was hospital LOS, adjusted using multivariate linear regression. Secondary outcomes included 30-day readmission rate, adjusted using logistic regression, and use of injectable antipsychotics or benzodiazepines. A sub-analysis evaluated the impact of the institution’s implementation of a geriatric prescribing context (GEM-CON) on cyclobenzaprine dose selection.
  • RESULTS: A total of 750 patients were included in the study, with 520 (69.3%) and 230 (30.7%) patients exposed to cyclobenzaprine 5 mg and 10 mg, respectively. LOS was significantly greater in patients who received higher dose cyclobenzaprine (P< 0.001). The adjusted LOS was 32.7% longer (95% CI: 25.9%, 39.9%) for patients exposed to the higher dose of cyclobenzaprine. Use of injectable antipsychotics or benzodiazepines was also significantly greater in the higher dose group (P< 0.001; P = 0.025, respectively). Cyclobenzaprine dose was not significantly associated with readmission on multivariate analysis (OR = 0.93, 95% CI [0.45, 1.93]). After GEM-CON implementation, there was a significant increase in use of the recommended lower cyclobenzaprine dose (P< 0.001).
  • CONCLUSIONS: Use of lower cyclobenzaprine dosing in older inpatients is associated with reduced hospital LOS and need for injectable antipsychotics and benzodiazepines.

Impact of Implementing a Pharmacy-Driven Intervention Bundle on Hospital Readmission Rates for Patients with Heart Failure

Lara Tran, PharmD1, Christine Rahme, PharmD, BCPS1, Sara Linnertz, PharmD, BCACP1, Greta Staubly, PharmD Candidate 20242, Kenneth McCall, PharmD, BCGP, FAPhA1,3.
1St. Joseph’s Hospital Health Center. 2University of Connecticut School of Pharmacy, 3Binghamton University School of Pharmacy and Pharmaceutical Sciences

  • INTRODUCTION: Evidence-based medicine for persons with heart failure (HF) has rapidly advanced and become increasingly complex. Despite progress in therapeutics, HF remains a leading cause of hospitalizations, readmissions, and death. An emerging body of literature has provided evidence that pharmacist care improves outcomes in patients with HF.
  • OBJECTIVES: The primary outcome of this study is to evaluate the impact of a pharmacy-driven intervention bundle compared to routine care on 30-day readmission rates for patients with HF. Secondary outcomes include the number and types of pharmacy interventions completed, the percentage of patients discharged on guideline-directed medical therapy (GDMT), evaluation of time to 30-day readmission, and the estimated cost avoidance.
  • METHODS: The institutional review board granted exempt status for this single center, pre/post intervention, observational study. A report generated from Epic identified eligible patients for the study from October 2022 to March 2024. Patients > 18 years old, with a primary or secondary diagnosis of HF, who were admitted, were included. Patients who were discharged on comfort/hospice care, who left against medical advice, expired during hospitalization, were pregnant, or who had advanced dementia without a caregiver were excluded.  The pharmacy-driven bundle included medication review at discharge to ensure GDMT, Meds2Beds services, discharge counseling and a post-discharge follow-up phone call. Using a baseline readmission rate for patients with HF at our institution of 22%, this study aimed to include 361 patients in each group to achieve 80% power to detect a difference of 8% in the primary outcome. A multivariable logistic regression model evaluated the outcome of 30-day readmission by including each component of the intervention bundle, age, sex, HF classification, and covariates that had univariate significance with the outcome (P< 0.1). Time to readmission was evaluated using the log-rank test. All tests were 2-sided, with P< 0.05 indicating statistical significance.
  • RESULTS: Pending.
  • CONCLUSION: Pending.

Impact of Geriatric Dosing for Psychotropic and Opioid-based Medication on Hospital Length of Stay

J Guan, J Brenner, J Noviasky
SUNY Upstate Community Hospital

  • INTRODUCTION: Older individuals may have increased drug exposure and are more susceptible to medication-related harms. Psychotropic and opioid-based medications are associated with various adverse drug events, including falls, delirium, and oversedation. As a result, drug dosing should be carefully selected to minimize the risk of harm. To ensure that medications are safely dosed, our institution implemented a geriatric maximum initial dose (GEM-X) procedure in 2020, suggesting the maximum initial dose of injectable antipsychotics (haloperidol, ziprasidone), injectable benzodiazepine (lorazepam), and opiates (fentanyl, morphine) for older patients in the emergency department (ED).
  • OBJECTIVE: Our study aims to determine the impact of lower initial doses versus higher initial doses of injectable antipsychotics, benzodiazepine, and opiates on hospital length of stay (LOS) in patients aged 65 and older. The secondary outcome of the study was to assess the impact on 30-day readmission rates.
  • METHODS: This retrospective, single-centered cohort study was conducted at a 735-bed, two-campus, academic medical center. An electronic medical record query was performed to identify patients aged 65 years and older from 7/1/2022 to 6/30/2023 who received either one of the GEM-X drugs while admitted. All data was collected using an electronic medical report. Descriptive and inferential statistics were conducted using SPSS. This project was given exemption by our Institutional Review Board.
  • RESULTS: Our result demonstrated that lower versus higher initial dose of lorazepam (8.9 vs. 11.2 days; P = 0.038), fentanyl (9.9 vs. 11.3 days; P = 0.023), and morphine (7.5 vs. 9.8 days; P = 0.025) were associated with a shorter hospital LOS. No significant difference was observed in ED LOS and 30-day readmission rates.
  • CONCLUSIONS: Use of GEM-X recommended dosing for lorazepam, fentanyl, and morphine was associated with a shorter hospital LOS among hospitalized older adults when compared with patients on higher dosages.

Evaluation of Time from Reconstitution-to-Administration for Intravenous Azacitidine

Gabriella Leto, PharmD, Christina Lombardi, PharmD, BCOP; Alice Thomasson, BS, PharmD, BCPS
St. Peter’s Hospital, Albany, NY

  • INTRODUCTION: Azacitidine is an antimetabolite chemotherapy agent used to treat chronic myelomonocytic leukemia (CMML), acute myeloid leukemia (AML), and myelodysplastic syndrome. Intravenous azacitidine must be infused over 10 to 40 minutes and the infusion must be completed within 1 hour of reconstitution. If the agent is not given according to this criteria, stability and efficacy become variable.
  • OBJECTIVE: The purpose of this evaluation was to determine the rate of proper reconstitution-to-administration instances for intravenous azacitidine regarding the 1-hour window. This review was conducted within St. Peter’s Health Partners and aimed to identify areas for quality improvement.
  • METHODS: This Institutional Review Board approved retrospective review included patients from 3 facilities under the St. Peter’s Health Partners System: St. Mary’s Cancer Treatment Center, St. Peter’s Hospital, and the St. Peter’s Cancer Care Center. This review used medical records to assess administration, preparation, and dispense times. Inclusion criteria consisted of patients 18 years or older who received azacitidine via intravenous piggy-back (IVPB) between April 2021 and November 2023. An analysis was performed to determine which administrations were given in contraindication to the package insert.
  • RESULTS: Of the 8 patients receiving azacitidine as an IVPB during the study period, there were a total of 436 administration instances. Of the 434 instances documented to completion, 8 instances appeared to be given past the 1-hour reconstitution-to-administration limit. The success rate of giving azacitidine in accordance with the package insert was 98.2%.
  • CONCLUSION: One common reason for late administration was a knowledge barrier. The proposed remediation tool is proper nursing and pharmacy education. Additionally, interdisciplinary communication must be strengthened to ensure that concomitant medications are given in order of acuity and align with provider preference. St. Peter’s Health Partners will continue to evaluate azacitidine administration compliance, as well as develop quality improvement measures within the health system.

Evaluating Pharmacist Collaborative Drug Therapy Management Practices in New York State

Kyle Eilert, Danielle Cabral, PharmD, BCACP, AAHIVP, Erin Pauling, PharmD, BCACP, Amanda Mogul, PharmD, BCACP, CDCES
Binghamton University School of Pharmacy and Pharmaceutical Sciences; United Health Services; Northwell Health Division of Allergy & Immunology

  • INTRODUCTION: Collaborative Drug Therapy Management (CDTM) is practiced by pharmacists widely across the country. However, legislation varies with regards to eligibility, location, and scope of practice. The objective of this study is to collect information regarding CDTM practices across New York State (NYS) by surveying practicing pharmacists. Increased knowledge on this subject could help to demonstrate pharmacists’ capabilities and highlight potential areas for improvement.
  • METHODS: An anonymous, IRB approved, survey collecting both qualitative and quantitative information was distributed via email to health system pharmacists across NYS. Pharmacists were eligible to participate in the survey if they are CDTM-certified in NYS and practicing under a CDTM agreement. Descriptive statistics were used to generate results from the study. Data collection and statistical analysis was generated using Google Forms. Information collected included practice site location, specialty area, billing practices, and privileges.
  • RESULTS: A total of 37 pharmacists completed the survey. Participants practice in specialty areas, including but not limited to, oncology, psychiatry, infectious disease, geriatrics, and cardiology. Regarding privileges under their CDTM agreement, 89.2% of pharmacists prescribe medications, 97.3% can stop or change medications, 91.9% order labs, and 48.6% order vaccines. Sixteen pharmacists (43.2%) participate in telehealth. When surveyed about billing practices, 54.1% bill using “incident-to” codes, 35.1% bill using other CPT codes, 5.4% bill for Medicare annual wellness visits, 43.2% do not bill for their services.
  • CONCLUSION: The ability to practice under a CDTM agreement has greatly expanded the scope of pharmacy practice. However, legislation and implementation continue to vary. This survey highlights areas for improvement, including the need to streamline and improve billing practices among practicing pharmacists. Improving billing practices can demonstrate pharmacist value to providers and healthcare systems. With continued advocacy and quality improvement, we can continue to advance the profession of pharmacy.

Risk Factors for Pseudomonas aeruginosa in Community-Acquired Pneumonia at an Academic Healthcare System

Mahvish Hoda, PharmD, Allison Stilwell, PharmD, BCIDP; Brian Nelson, PharmD, BCIDP
NewYork-Presbyterian Hospital

  • INTRODUCTION: Significantly increased use of antipseudomonal antibiotics for the treatment of community-acquired pneumonia (CAP) led to updated recommendations in the 2019 consensus guidelines for the management of CAP. The updated guidelines propose that clinicians should obtain local prevalence data on Pseudomonas aeruginosa (PA) in patients with CAP and determine locally-validated risk factors to guide empiric therapy selection. This recommendation is based on the absence of high-quality outcome studies and the assumption of very low prevalence of PA in most centers. Available studies regarding risk factors for PA CAP were mostly conducted outside of the United States, had many exclusion criteria, and were conducted prior to the publication of the updated recommendations.
  • OBJECTIVE: The objective of this study is to identify risk factors for Pseudomonas aeruginosa compared to typical CAP pathogens in patients with CAP presenting to NewYork-Presbyterian Hospital (NYPH).
  • METHODS: This is a retrospective, multi-site, case-control study of patients presenting to NYPH between January 2022 and June 2023 and diagnosed with CAP due to PA or a typical CAP pathogen(s), including Streptococcus pneumoniae, Haemophilus influenzae/parainfluenzae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis as isolated from a respiratory culture. The study was approved by the Institutional Review Board. Only the first positive CAP-related culture was included. A total of 362 patients with PA and 429 patients with a typical CAP pathogen were identified. A multivariable model will be constructed to identify independent risk factors for PA CAP. Subjects will be matched based on month, year, and hospital campus of index visit. Non-parametric analyses will be utilized to compare risk factors in each treatment arm. Categorical data will be compared using the chi squared test or Fisher’s exact test. Continuous data will be compared using the Mann-Whitney U test.
  • RESULTS: In progress
  • CONCLUSIONS: In progress

A Phase 2, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Omadacycline in Adult Subjects with Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc)

Maria Amodio-Groton, Julie V. Philley1, Daniel H. Deck2, Alissa Sirbu2, Amy Manley2, Anita F. Das2, Alisa W. Serio2, Randy Brenner2, Gail Berman2, Kevin Winthrop3
1University of Texas Health Science Center; 2Paratek Pharmaceuticals, Inc.; 3Division of Infectious Diseases, School of Medicine, Oregon Health & Science University

  • INTRODUCTION: Omadacycline has in vitro activity and in vivo efficacy in a mouse model against Mycobacterium abscessus complex (MABc). This Phase 2, double-blind, randomized, placebo-controlled, multicenter study evaluates the efficacy and safety of omadacycline in adults with MABc pulmonary disease (NCT04922554).
  • METHODS: Approximately 75 patients will be randomized 1.5:1 to 300 mg oral omadacycline (N=45) or placebo (N=30) daily for 84 days (D), stratified by prior use of antibiotics for MABc. Assessments occur at baseline, D14, D28, D56, D84 (end of treatment [EOT]), and D114 (safety follow-up). Inclusion criteria are age ≥ 18 years, diagnosis of MABc pulmonary disease per guideline criteria, ≥ 2 NTM symptoms at screening, ≥ 1 MABc-positive cultures within 6 months of screening and at screening, CT evidence of MABc within 3 months of screening, and guideline-directed antibiotic therapy not required within next 3 months.
  • RESULTS: Study objective is to explore the efficacy of omadacycline in patients with pulmonary MABc.  The primary efficacy endpoint is: clinical response at D84 defined as improvement in severity of at least 50% of the symptoms present at baseline and no deterioration in severity of symptoms present at baseline.  Secondary efficacy endpoints are: patient-reported outcomes, quality-of-life, and microbiological response from baseline to EOT.  Adverse events (AEs) and serious AEs, laboratory parameters, vital signs and electrocardiograms will be monitored for safety.  
  • CONCLUSION: The trial began in June 2021 and will provide data on the safety profile, clinical response, patient reported outcomes and quality of life for omadacycline in patients with MABc pulmonary disease.

Evaluation of Early versus Late Initiation of Corticosteroids in Adults with Septic Shock

Yakun Fu
Lenox Hill Hospital

  • INTRODUCTION: Current Surviving Sepsis Campaign guidelines suggest the use of intravenous hydrocortisone in patients with septic shock and ongoing requirement of vasopressors. However, the time of hydrocortisone initiation was not specified in the guideline and not consistent in major trials. A retrospective study found that the early initiation of hydrocortisone in septic shock was associated with better clinical outcomes.
  • OBJECTIVE: The purpose of this study is to assess if early initiation (within 24 hours) of hydrocortisone after septic shock onset results in better mortality or morbidity outcomes.
  • METHODS: This retrospective study will identify 100 patients aged 18 or older with septic shock and receipt of vasopressors (duration at least 4 hours) and hydrocortisone therapy in ICU setting. The following data will be collected: patient age, gender; blood pressure, heart rate, respiration rate, oxygen saturation, serum creatinine, temperature, white blood cell counts, lactate level at the time of septic shock onset (vasopressors initiation); SOFA and MEWS score; vasopressor dose at hydrocortisone initiation; vasopressor duration; time of steroid initiation after septic shock onset; duration of mechanical ventilation; duration of renal-replacement therapy; and length of stay in ICU and in hospital. Patient data will be excluded if patient received systemic corticosteroids for an indication other than septic shock, on systemic corticosteroid therapy before septic shock onset, or on dialysis therapy before admission. The primary outcome is 28-day mortality rate. The secondary outcomes are duration of vasopressor, mechanical ventilation, and renal replacement therapy; length of stay in ICU; and length of stay in hospital.
  • RESULT: In progress
  • CONCLUSION: In progress

Use of Glycerol Phenylbutyrate in Acute Liver Failure Patients for Refractory Hepatic Encephalopathy

Hui Lin, Kristen D Belfield, William S Asch, Kim Do, Ginger E Rouse
Touro College of Pharmacy, Yale New Haven Hospital, Yale School of Medicine

  • INTRODUCTION: Acute liver failure (ALF), although rare, is associated with high mortality secondary to cerebral herniation. Hyperammonemia is believed to play a large role in intracranial hypertension and hepatic encephalopathy leading to death. Currently, continuous renal replacement therapy remains the primary therapy to reduce hyperammonemia, but there is minimal data on use of supportive pharmacologic therapy. Glycerol phenylbutyrate, an ammonia scavenging agent, may help reduce ammonia levels for these patients.
  • CASE: We present a retrospective case series of four ALF patients receiving glycerol phenylbutyrate for hepatic encephalopathy at our institution. All patients presented with ammonia levels greater than 100 uM/L. Of the four patients observed, three saw additional reduction in ammonia levels either in conjunction or prior to use of renal replacement therapy. Two of the patients survived without need for transplant. No adverse effects were associated with glycerol phenylbutyrate use. This project has been reviewed by the Yale New Haven Hospital Institutional Review Board and determined not to be human subject research.
  • DISCUSSION: We report the first in use of glycerol phenylbutyrate in ALF with documented hepatic encephalopathy and hyperammonemia. Given the small sample of complex, heterogeneous patients, we cannot definitively conclude that the results observed are solely secondary to use of glycerol phenylbutyrate. However, this retrospective case series indicates that glycerol phenylbutyrate may potentially be used to reduce ammonia levels in ALF presenting with hyperammonemia and hepatic encephalopathy with inadequate response to or delayed renal replacement therapy.
  • CONCLUSIONS: Glycerol phenylbutyrate may be considered for additional ammonia lowering in hospitalized, ALF patients, but further randomized, controlled trials would be needed to define the optimal role of glycerol phenylbutyrate for hepatic encephalopathy in ALF.

Evaluating the Impact of Pharmacist-Delivered Educational Intervention on the Willingness to Receive HPV Vaccine in a Dental Clinic

Julian Azzouzi1, PharmD; Joanne Son1,2, PharmD, BCACP, AAHIVP; Katrin Tamari2, DDS; Eric Wachs2, DMD; Elizabeth Unni,1 PhD, MBA, BPharm.
1Touro College of Pharmacy, 2Touro College of Dental Medicine, Touro University, New York

  • INTRODUCTION: Human Papillomavirus (HPV) infections are the leading cause of oral and oropharyngeal cancers in the U.S., accounting for 70% of new diagnoses. The HPV vaccine remains 100% effective for at least 12 years, and vaccination prior to exposure could prevent 90% of HPV-related cancers. Collaboration between dentists and pharmacists to improve on patient-centered care and vaccine education holds significant potential to support national and state goals of increasing HPV vaccine rates among persons aged 9-26. Current literature exploring interprofessional collaboration between dentists and pharmacists suggests this partnership may address gaps in patient care, although examples of HPV vaccine initiatives are limited.
  • OBJECTIVE: To determine the impact of screening dental patients' HPV vaccine status paired with pharmacist-led HPV education on patients or guardians’ willingness to receive the HPV vaccine.
  • METHODS: Approved by the IRB, a cross-sectional prospective review of patients was conducted at a dental clinic. Patients aged 18-26 or guardians of those aged 9-17, who hadn't received the HPV vaccine, verified via the New York State Immunization Information System (NYSIIS), were included upon written consent. Participants received pharmacist-led education on HPV and the HPV vaccine, including an educational handout. Posit intervention, participants were surveyed to assess their intent to receive the vaccine. A one-sample proportion test comparing the proportion of participants willing to receive the vaccine intervention was utilized to analyze results.
  • RESULTS: Out of 67 approached patients/guardians, 32 agreed to participate, with 19 enrolled after exclusions. Based on our study, the proportion of participants willing to receive the HPV vaccine post pharmacist education and counseling was 89.5% (p<0.00001, CI: 0.83-0.97).
  • CONCLUSION: Screening dental patients’ HPV vaccine status paired with pharmacist-delivered HPV education and counseling has a positive impact on the willingness of unvaccinated patients or guardians to receive the HPV vaccine.

Clinical Practice Patterns, Rilonacept Appropriate Use for Recurrent Pericarditis

Shahad Almahmoud, PharmD, Getzabeth Bosques Gomez, PharmD, Gurminder Sanghera, PharmD, Victoria Michaels, MD, Khoa Ngo, MD, Michael Allen, MD, Jessica Farrell, PharmD
Albany Medical Center - Rheumatology Department

  • INTRODUCTION: Pericarditis is inflammation of the pericardial sac and is the most common pathologic process involving the pericardium. Pericarditis is defined as “recurrent” in case of relapse after a minimum symptom-free interval of 4–6 weeks. 1,2 Multiple case reports were published showing that the of pericarditis cases increased due to long-lasting COVID-19 symptoms and mRNA COVID vaccination. 3-5 First-line treatment include aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) with colchicine as an adjunct. Low-dose steroids should be considered for patients who have failed or have contraindication to aspirin/NSAIDs and colchicine. However, long-term use of steroids raises several concerns and should not be used. Antagonism of the IL-1 is highly effective to prevent recurrent pericarditis when proven autoinflammatory features. Rilonacept is an IL-1 inhibitor and is the first FDA-approved treatment for recurrent pericarditis, approved for this indication on March 18, 2021. To date, there is no published data that provides a standardized approach to utilize IL-1 agents, specifically rilonacept in recurrent pericarditis. More data is needed to evaluate the efficacy, safety, duration of use of rilonacept for recurrent pericarditis
  • OBJECTIVES: This study aims to evaluate the efficacy and safety of rilonacept for recurrent pericarditis. It will also provide a standardized approach to tapering NSAIDs, colchicine, and glucocorticoids and describe the transition of care process for patients hospitalized for recurrent, refractory pericarditis.
  • METHODS: The study is a retrospective observational study including patients followed by the rheumatology service and treated with rilonacept for recurrent pericarditis using the electronic health records of Albany Medical Center. We will investigate trends in patient characteristics, treatment patterns including initiation, corticosteroids use and transition process from anakinra, and clinical improvement. Statistical analysis will be mainly descriptive using means, percentages, and standard deviations. Regression will be measured to determine the relationship between treatment outcomes and different length of times needed to taper off other therapies.
  • RESULTS: In progress
  • CONCLUSION: In progress

Systematic review of estetrol for the management of menopausal symptoms

1Timothy C. Hutcherson, PharmD, 2Nicole E. Cieri-Hutcherson, PharmD, BCPS, MSCP; Rand Alishaqi, PharmD Candidate; Adrian G. Bess, PharmD Candidate
1D'Youville University; 2University at Buffalo School of Pharmacy and Pharmaceutical Sciences

  • INTRODUCTION: Menopause is the cessation of ovulatory function and often includes vasomotor symptoms (VMS). Hormone therapy with estrogen alone or in combination with a progestogen is indicated in persons with moderate to severe VMS. Estetrol (E4) is a novel estrogenic steroid with a potentially lower risk of venous thromboembolism than similar agents. This study aimed to characterize the literature pertaining to E4 treatment of VMS and related symptoms.
  • METHODS: A literature search was conducted through August 29, 2023, using Embase and MEDLINE ALL. Primary literature was eligible if it reported on the use of E4 in persons with menopausal VMS or related symptoms. Risk of bias was assessed using the Risk of Bias 2.0 and ROBINS-I tools. Certainty of evidence assessments were not performed due to heterogeneity in reported outcomes. This study was neither funded by nor registered with a third party, and authors report no conflicts of interest.
  • RESULTS: A total of five reports of three randomized controlled trials in 486 patients met eligibility criteria. All studies involved multiple doses of E4; one trial compared E4 to estradiol valerate and two trials used a placebo. Significant reductions in VMS frequency were seen at 4 and 12 weeks for persons receiving 15mg E4 compared to placebo (p = 0.049). Reduction in mean number of daily hot flashes at 8 weeks was similar in persons receiving E4 and estradiol valerate. Additional endocrine and thromboembolic surrogate markers are reported. Adverse events for E4 and comparators were similar by type, severity, and trial discontinuation rate. All trials demonstrated a low risk of bias.
  • DISCUSSION: The use E4 in the management of VMS is unclear. Although E4 appears safe, additional VMS and thromboembolic data are needed to confirm initial findings and risk of thromboembolism. Future studies should focus on clinical outcome measures over surrogate markers.

Clinical Interventions Made by Doctor of Pharmacy Candidates in a Geriatric-Focused Inpatient Care Advanced Pharmacy Practice Experience

Trisha Khong, Yamilex Tomala, Dr. Sum Lam
Albany Medical Center - Rheumatology Department

  • INTRODUCTION: The purposes of this descriptive study are to describe the workflow of medication reconciliation conducted by Pharm.D. candidates, document the number of patients who received medication reconciliations, and determine the percentage of prescriber-acceptance of clinical interventions during an APPE.
  • METHODS: Two Pharm.D. candidates conducted medication reconciliation from August 1 to September 11, 2023, in an Inpatient Geriatrics APPE at a 600-bed academic hospital. Candidates identified discrepancies, presented them to clinical faculty, and discussed them with the geriatric team. Candidates then documented the clinical interventions on a standardized data collection form, which included patient demographics, types of clinical interventions, pharmacologic category, and prescriber acceptance. Lastly, candidates analyzed data to determine the percentage of prescriber-accepted recommendations, further subdivided by intervention type and pharmacologic category. Institutional review board review is exempt.
  • RESULTS: Sixty-four patients (age range 60-101 yrs., average age 85 yrs., female 73%, male 27%) received medication reconciliation. A total of 53 clinical recommendations were made. The most common types of interventions were dose adjustments (n=15, 28%) and initiation of drug therapy (n=11, 21%). Majority of clinical recommendations pertained to anti-infectives (n=13, 25%), cardiovascular (n=12, 23%), and neuropsychiatric medications (n=7, 13%). Thirty-eight clinical recommendations (72%) were accepted by the prescribers. The most accepted types of interventions include dose adjustments (n=11, 29%) and initiation of therapy (n=8, 21%). Prescribers accepted the majority of clinical interventions pertaining to anti-infectives (n=11, 29%) and cardiovascular medications (n=10, 26%).
  • CONCLUSION: Candidates contributed to drug therapy optimization in older hospitalized patients by collaborating with an interprofessional geriatric care team. The most commonly accepted interventions were dose adjustments and initiation of drug therapy involving anti-infectives and cardiovascular medications. This APPE allowed candidates to apply pharmacy knowledge and skills to enhance drug therapy in the elderly.

Pharmacist Integration to Support Continuous Glucose Monitoring Initiation

James Thurston, Y Baratt, A Bradley, H Li
NewYork-Presbyterian Hospital

  • INTRODUCTION: The development of continuous glucose monitoring (CGM) modalities has expanded healthcare accessibility and improved glycemic control for patients with diabetes. Among healthcare professionals, clinical pharmacists are uniquely accessible and can provide support for increased CGM utilization through device education and affordability assistance. However, there is limited evidence specifically evaluating the effectiveness of clinical pharmacist-assisted CGM initiation.
  • OBJECTIVE: The objective of this study is to examine how clinical pharmacist-assisted CGM implementation can impact glycemic control among patients with diabetes.
  • METHODS: This is a single-center retrospective study that evaluated change in A1c among patients who were assisted with CGM device implementation in two outpatient clinics by a clinical pharmacist between January 1st, 2019, and December 31, 2023. The primary outcome was change in A1c from baseline (prior to CGM initiation) to the next subsequent A1c following CGM initiation. The study team also investigated change in A1c among a subgroup of patients followed independently by clinical pharmacists practicing under a collaborative drug therapy management (CDTM) agreement in addition to usual care. Other secondary outcomes included quantification of the types of clinical pharmacist interventions and assessment of patient adherence to CGM use.
  • RESULTS: Pharmacist-assisted CGM initiation led to statically significant decrease in mean A1c of -0.71 (CI 95% 0.41-1.00, p<0.001) across all patients. Following CGM initiation, patients who were referred to CDTM services for follow-up versus usual care alone had higher baseline A1c values (10.3 vs. 8.3). Within the CDTM subgroup, the mean A1c difference was -1.60 (CI 95% 0.64-2.55, p=0.002) while in the non-CDTM subgroup, the mean A1c difference was -0.50 (CI 95% 0.22-0.78, p<0.001).
  • CONCLUSIONS: Pharmacists are effective at helping patients reduce their A1c through assisting with CGM initiation, education, and follow-up. Larger prospective studies should compare the impact of CGM initiation among patients assisted by clinical pharmacists versus those who are not.