Retrospective, multicenter analysis of the safety and effectiveness of direct oral anticoagulants for the treatment of venous thromboembolism in obesity.

BACKGROUND: Direct oral anticoagulants (DOACs) are the preferred treatment for venous thromboembolism (VTE). However, DOAC use in patients with a BMI greater than 40 kg/m2 has not been well studied despite the growing prevalence of obesity, and current literature is often underpowered. METHODS: This multicenter, retrospective, observational study evaluated patients 18 years and older who received DOACs for acute VTE treatment. Patients receiving DOACs for recurrent VTE or for failure of another agent were excluded. The primary efficacy outcome was recurrent VTE and the primary safety outcome was major bleeding within 12 months (or one month after stopping anticoagulation therapy). A propensity score analysis was performed to balance patient characteristics and evaluate the primary endpoints by BMI group. Time-to-event outcomes were analyzed using weighted Kaplan-Meier curves. RESULTS: There were 165 patients with a BMI of at least 40 kg/m2 and 320 patients with a BMI less than 40 kg/m2. The majority received apixaban (373, 77%). Recurrent VTE occurred in 5 (3.0%) and 13 (4.1%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 0.66; 95% CI: 0.16-2.69). Major bleeding occurred in 5 (3.0%) and 15 (4.7%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 1.19; 95% CI: 0.36-3.92). CONCLUSION: There was no significant difference in VTE recurrence or major bleeding related to BMI among patients treated with DOACs. This study showed that DOACs may be a safe and effective VTE treatment option in patients with obesity.

Implementation of Debriefing Services for Pharmacy Residents in a 24-Hour, In-House Clinical Pharmacy On-Call Program: A Pilot Study.

Background: This clinical pharmacy on-call program (CPOP) is a 24-hour, in-house service provided by pharmacy residents. During shifts, challenging situations may arise, which may correlate with depression, anxiety, and stress. Objective: This pilot study aims to describe the implementation of a debriefing program and characterize mental health patterns of residents in the CPOP. Methods: A structured debriefing process was developed to provide support to residents in the CPOP. Over a 1-year period, twelve outgoing pharmacy residents and ten incoming pharmacy residents completed a modified Depression Anxiety Stress Scale (mDASS-21) questionnaire and received a stress perception score (SPS) during debriefing. Data from first and final on-call shifts were compared via a paired Wilcoxon signed-rank test. Residents were referred to an Employee Assistance Program (EAP) based on mDASS-21 and SPS results. Scores from final on-call shifts were compared between residency classes via a Wilcoxon rank sum test. Results: Following successful implementation, 106 debriefing sessions were completed. Pharmacy residents responded to a median number of 38 events per shift. Significant reductions in anxiety and stress scores were observed from the first and final on-call shifts. Six residents were referred to EAP. A lower incidence of depression, anxiety, and stress was observed in pharmacy residents who received debriefing compared to previous residents. Conclusion: The debriefing program provided emotional support to pharmacy residents participating in the CPOP. Implementation of debriefing demonstrated a reduction of anxiety and stress from the beginning to the end of the academic year and in comparison to the previous year.

Impact of Inpatient Initiation of Sodium-Glucose Cotransporter-2 Inhibitors on Prescription Rates in Patients With Heart Failure With Reduced Ejection Fraction.

Despite large, randomized controlled trials and guideline recommendations, patients with heart failure with reduced ejection fraction (HFrEF) continue to receive suboptimal guideline-directed medical treatment (GDMT). This study aimed to evaluate the potential effect of inpatient initiation of sodium-glucose cotransport-2 (SGLT2) inhibitors on postdischarge prescribing rates and the downstream impact on clinical outcomes. The INitiation of SGlt2i in Hospital for HFrEF (INSIGHT-HF) study was a retrospective analysis of hospitalized patients older than 18 years with a left ventricular ejection fraction (LVEF) ≤40% conducted from July 2020 and July 2021. Our primary outcome was SGLT2i prescription rates at 30 days. Among 2,663 eligible patients with documented HFrEF, 177 (6.6%) had SGLT2i initiated during their index hospitalization. The rate of SGLT2i prescriptions at 30 days was significantly higher in those with inpatient initiation of SGLT2i compared with those who did not start while inpatient (96% vs 14.7%, p <0.0001). The heart failure readmission rate in the first 30 days was significantly lower in those with inpatient initiation of SGLT2i compared with those who did not start during hospitalization. (9.3% vs 22.7%, p = 0.04). Cardiovascular mortality was numerically, but not significantly, different between groups (4% vs 10.7%, p = 0.21). Inpatient initiation of an SGLT2i was associated with a significantly higher postdischarge rate of SGLT2i prescriptions and significantly lower heart failure readmission rates at 30 days. In conclusion, these findings highlight the importance of initiating SGLT2i during inpatient hospitalization to improve the quality of care in patients with HFrEF.

Opioid Use in Vaso-Occlusive Crisis During Intravenous Opioid Drug Shortage.

Introduction: In October 2017, the Food and Drug Administration announced a shortage of intravenous (IV) opioid medications. Patients with sickle cell disease (SCD) are particularly vulnerable, as high amounts of IV opioid medications are standard therapy during vaso-occlusive crises (VOC). Our institution responded to the crises by implementing IV to oral (PO) conversions of opioid therapies and encouraging multimodal pain management with non-opioid medications. Objectives: The primary objective was the assessment of IV opioid medication utilization before and during the shortage. Secondary objectives included total opioid consumption, length of stay, and prescribing of non-opioid analgesics. Methods: This single-institution retrospective study included patients >18 years of age admitted to adult medicine teams with VOC during February 2017 or February 2018. The amount of opioid medication administered to patients during both periods was assessed, and quantities were then converted to PO morphine milligram equivalents and compared between years. The number of patients receiving scheduled non-opioid medications were also compared. Length of stay and readmissions were compared between years. Results: Between 2017 and 2018, IV opioid use for VOC decreased by 52% on inpatient services, and there was a 34% reduction in overall opioid use. Oral opioid use more than doubled during the period (10.2% in 2017 vs 39.1% in 2018, P < .01). LOS between 2017 and 2018 (6 vs 6 days, P = .4774) and total number of ED visits (27 vs 8, P = .276) were similar. There were significantly fewer 30-day readmissions in 2018 versus 2017 (15 vs 28, P = .025). Conclusion: The implementation of IV opioid restrictions resulted in a decrease in IV opioid use in treatment of VOC in patients with SCD without causing increases in length of stay or readmissions. Oral opioids should be considered an option for VOC management in patients with SCD.

Reducing Inpatient Hypoglycemic Events: A Focus on Mealtime Insulin.

Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes an effort to reduce iatrogenic insulin-associated hypoglycemia at the University of Chicago Medical Center in Chicago, IL.

Impact of Ketamine in the Management of Painful Sickle Cell Disease Vaso-Occlusive Crisis.

The aim of the study is to determine if ketamine infusions in combination with opioid therapy for the management of sickle cell disease (SCD) presenting with vaso-occlusive crisis (VOC) resulted in a length-of-stay difference compared to when ketamine was not utilized. This single center, retrospective, observational study performed at an academic medical center evaluated 12 adult patients with SCD-VOC who received a ketamine infusion with standard opioid therapy between 2014 and 2017. Patients were excluded if the primary diagnosis was not VOC or they did not survive to discharge. Additionally, safety and oral morphine equivalents at various time points were compared. Patients were used as their own control using the previous SCD-VOC hospitalization to evaluate the relative impact of ketamine. Wilcoxon signed-rank and rank sum were used in statistical analysis. When comparing opioid doses during the ketamine infusion, a P-value <.005 was considered statistically significant to account for multiple comparisons. The median length-of stay when ketamine was employed was similar to the previous admission with only opioid therapy (12 vs 12 days, P = .317). The median opioid dose 24 hours prior to starting ketamine was greater than during the first 24 hours of ketamine use (1278 vs 1020 mg, P = .022) and 24 hours after stopping ketamine (1278 vs 1035 mg, P = .014); however, this was not statistically significant. During 5 ketamine infusions, patients experienced side effects; however, only 1 necessitated transfer to the intensive care unit. Compared to standard opioid therapy, ketamine infusions were generally well tolerated and may be effective at reducing opioid use during SCD-VOC but did not decrease hospital length-of-stay.

Rivaroxaban and apixaban for the treatment of suspected or confirmed heparin-induced thrombocytopenia.

WHAT IS KNOWN AND OBJECTIVE: Heparin-induced thrombocytopenia (HIT) is an adverse hematologic drug reaction that results in thrombocytopenia. This potentially life-threatening event is due to the administration of heparin products, such as unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). The incidence of HIT occurs in <0.1%-7% of hospitalized patients treated with heparin products, with a risk of thrombosis as high as 50%. In 2018, the American Society of Hematology (ASH) recommended the utilization of direct oral anticoagulants (DOACs) in clinically stable patients at average bleeding risk with HIT. The objective of this study was to evaluate the prescribing patterns of rivaroxaban and apixaban for the treatment of suspected or confirmed HIT. METHODS: This was a retrospective chart review from January 2013 through October 2019 at the University of Chicago Medicine. Twelve patients were identified to have received a DOAC for suspected or confirmed HIT. RESULTS: Rivaroxaban was utilized in seven (58%) patients, six of whom received argatroban prior to starting rivaroxaban. Five (71%) of these patients were started on the recommended dose of rivaroxaban for VTE. Apixaban was utilized in five (42%) patients; four patients were started on argatroban and transitioned to apixaban. One patient was started on the suggested dose of apixaban for VTE. WHAT IS NEW AND CONCLUSION: After starting DOACs for suspected HIT, no patients had new thrombosis during hospitalization. Eight patients (67%) followed up at our institution within 6 months of their discharge date. No subsequent thrombi formation were identified for any of these patients. The results of this study add to the expanding literature regarding the safety and efficacy of DOAC use in HIT, and indicate DOACs are being increasingly utilized for the treatment of confirmed or suspected HIT.

Residency Applicant Perceptions of Multiple Mini Interviews in Post-Graduate Year 1 Residency Interviews.

Introduction: Residency interviews offer an opportunity for both candidates and programs to evaluate whether the pairing is a good fit. Multiple mini interviews (MMIs) have been incorporated into interviews for medical training as a way to evaluate non-cognitive abilities. Objectives: To determine how candidates perceived the interview process at our institution, specifically related to the MMIs. Methods: This retrospective review evaluated candidates' perceptions of traditional interviews and MMIs through post-interview surveys over a 3-year period. Candidates evaluated the interview activities, time allowed for MMIs, and overall impression of the program during the 2-week period between submitting rank lists and the release of match results. Survey results are reported using descriptive statistics. Candidate perceptions on their ability to showcase skills in different types of interviews was evaluated with chi-square test. Results: The interview day increased the desire to pursue residency at our institution for 88% of candidates. Candidates reported similar ability to showcase skills developed during pharmacy school through the clinical and patient education MMIs compared to traditional interviews; however, they did not feel the collaboration MMI showcased their abilities as well as traditional MMIs. Conclusion: The introduction of MMIs to the residency interview day were perceived positively by most candidates and allowed candidates to showcase abilities in a different manner from traditional interviews.

Pharmacist intervention on prescribing errors: Use of a standardized approach in the inpatient setting.

PURPOSE: The objective of this study was to implement a standardized process across health systems to determine the prevalence and clinical relevance of prescribing errors intercepted by pharmacists. METHODS: This prospective, multicenter, observational study was conducted across 11 hospitals. Pharmacist-intercepted prescribing errors were collected during inpatient order verification over 6 consecutive weeks utilizing a standardized documentation process. The potential harm of each error was evaluated using a modified National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP) index with physician validation, and errors were stratified into those with potentially low, serious, or life-threatening harm. Endpoints included the median error rate per 1,000 patient days, error type, and potential harm with correlating cost avoidance. RESULTS: Pharmacists intervened on 7,187 errors, resulting in a mean error rate of 39 errors per 1,000 patient days. Among the errors, 46.6% (n = 3,349) were determined to have potentially serious consequences and 2.4% (n = 175) could have been life-threatening if not intercepted. This equates to $874,000 in avoided cost. The top 3 error types occurring with the highest frequency were "wrong dose/rate/frequency" (n = 2,298, 32.0%), "duplicate therapy" (n = 1,431, 19.9%), and "wrong timing" (n = 960, 13.4%). "Wrong dose/rate/frequency" (n = 49, 28%), "duplicate therapy" (n = 26, 14.9%), and "drug-disease interaction" (n = 24, 13.7%) errors occurred with the highest frequency among errors with potential for life-threatening harm. "Wrong dose/rate/frequency" (n = 1,028, 30.7%), "wrong timing" (n = 573, 17.1%), and "duplicate therapy" (n = 482, 14.4%) errors occurred with the highest frequency among errors with potentially serious harm. CONCLUSION: Documentation of pharmacist intervention on prescribing errors via a standardized process creates a platform for multicenter analysis of prescribing error trends and an opportunity for development of system-wide solutions to reduce potential harm from prescribing errors.

Point-of-care naloxone distribution in the emergency department: A pilot study.

PURPOSE: Opioid overdose education and naloxone distribution (OEND) for use by laypersons has been shown to be safe and effective, but implementation in the emergency department (ED) setting is challenging. Recent literature has shown a discouragingly low rate of obtainment of naloxone that is prescribed in the ED setting. We conducted a study to evaluate the feasibility of point-of-care (POC) distribution of naloxone in an ED, hypothesizing a rate of obtainment higher than prescription fill rates reported in previous studies. SUMMARY: A multidisciplinary team of experts, including pharmacists, physicians, nurses, and case management professionals used an iterative process to develop a protocol for POC OEND in the ED. The protocol includes 5 steps: (1) patient screening, (2) order placement in the electronic health record (EHR), (3) a patient training video, (4) dispensing of naloxone kit, and (5) written discharge instructions. The naloxone kits were assembled, labeled to meet requirements for a prescription, and stored in an automated dispensing cabinet. Two pharmacists, 30 attending physicians, 65 resident physicians, and 108 nurses were trained. In 8 months, 134 orders for take-home naloxone were entered and 117 naloxone kits were dispensed, resulting in an obtainment rate of 87.3%. The indication for take-home naloxone kit was heroin use for 61 patients (92.4%). CONCLUSION: POC naloxone distribution is feasible and yielded a rate of obtainment significantly higher than previous studies in which naloxone was prescribed. POC distribution can be replicated at other hospitals with low rates of obtainment.

Impact of a Nurse-Driven Diabetic Ketoacidosis Insulin Infusion Calculator on the Rate of Hypoglycemia.

OBJECTIVE: The aim of the study was to evaluate the impact of an insulin infusion calculator incorporated into electronic health record system in reducing the rate of hypoglycemia in diabetic ketoacidosis (DKA) management. METHODS: Retrospective chart review of patients with primary admission diagnosis of DKA was conducted in a university-affiliated academic medical center. End points including the rate of hypoglycemia, time to DKA resolution, rate of hypokalemia, time on insulin drip, and length of stay were measure before and after implementation of DKA calculator. RESULTS: Of 181 adult patients admitted for primary diagnosis of DKA, 103 were managed using the calculator. After implementation of the calculator, incidence of hypoglycemia and severe hypoglycemia were significantly reduced by 70% and 87%, respectively (P < 0.01). No difference was observed for time to DKA resolution, time on insulin drip, and length of stay. CONCLUSIONS: Implementation of DKA insulin infusion calculator significantly reduced the rate of hypoglycemia. Future improvements should focus on reducing time to DKA resolution and length of stay.

Characterization of clinical knowledge and problem-solving assessments employed in postgraduate year 1 pharmacy residency interviews.

PURPOSE: Attainment of postgraduate year 1 (PGY1) residency positions has become increasingly competitive. Inclusion of clinical knowledge and problem-solving assessments in onsite interviews has increased in recent years. Characterization of these assessments is necessary for applicants to best prepare for interviews and for mentors to provide guidance. METHODS: An online survey was emailed to program directors of PGY1 pharmacy residency programs accredited by the American Society of Health-System Pharmacists (ASHP). Data were analyzed using descriptive statistics. Chi-square and Fisher's exact tests were used to compare categorical data. The Mann-Whitney U test was used to analyze nonparametric continuous data. RESULTS: Of the 221 respondents, most identified their programs as based at community (48%) or academic (39%) medical centers. Ninety percent of programs reported inclusion of clinical knowledge and problem-solving assessments in the onsite interview process. The most common assessments included asking clinical questions (70%), development of a SOAP (subjective, objective, assessment, plan) note or care plan (42%), and formal presentations that applicants prepared prior to arrival (39%). Most programs (71%) reported incorporating multiple assessments, with 2 assessments included most commonly (43%). Clinical assessment performance accounted for 10% to 25% of the overall interview score in approximately half of programs. CONCLUSION: During onsite PGY1 residency interviews, applicants must be prepared to participate in at least 1 clinical knowledge and problem-solving assessment, including answering clinical questions, developing a SOAP note or care plan, and/or delivering a presentation. Applicants should expect that these assessments will account for a substantial portion of the interview evaluation.

Navigating the Institutional Review Board (IRB) Process for Pharmacy-Related Research.

Pharmacists' specialized training and knowledge qualify them to lead and engage in research pertaining to optimal medication use. Performing research promotes pharmacy professionalism and fosters interdisciplinary collaboration. To conduct research appropriately, one must have thorough knowledge of when institutional review board (IRB) approval is required and how to successfully navigate IRB processes. The overarching mission of the IRB overseeing research at an organization per federal guidelines is to protect the rights and welfare of human subjects participating in research. This article discusses the following general pharmacy practice-based considerations relating to IRB processes: strategies for developing research projects, key distinctions between quality improvement and research, practical considerations for submitting IRB applications and documentation, different categories of IRB submission, informed consent and conditions for waivers or alterations of consent, and principal investigator obligations for approved research. Pharmacists should also account for organization-specific IRB processes when designing, submitting, and implementing research projects.