Retrospective assessment of chemotherapy/biotherapy toxicity in a Hispanic/Latinx population versus published study population.

INTRODUCTION: Eskenazi Health in Indianapolis, Indiana, USA. services diverse communities in Central Indiana, including the Hispanic/Latinx community. It has been postulated that this population experiences toxicities at a higher rate and with a faster onset than the general population when treated with chemotherapy or biotherapy. The published clinical trials that have evaluated chemotherapy/biotherapy efficacy and toxicity have not adequately represented the Hispanic/Latinx population. This retrospective analysis aims to analyze the incidence and severity of adverse drug events in the Hispanic/Latinx population compared to the general study population. METHODS: A retrospective chart review included patients reported as Hispanic/Latinx in the electronic medical record who had breast cancer, colon cancer, acute myeloid leukemia, or multiple myeloma currently receiving chemotherapy/biotherapy and/or received chemotherapy/biotherapy during the study period. Seventy-three instances of patients receiving chemotherapy/biotherapy and 46 unique patients were included in the final analysis. RESULTS: Of the 73 instances, 29 (40%) had toxicity at baseline prior to chemotherapy/biotherapy received during the study period. Of those 29 baseline toxicities, 26 (90%) of them had new toxicity during the study period. Of the 73 instances, 62 (85%) experienced toxicities during the study period. CONCLUSION: Ethnicity has a proven effect on medication efficacy and safety, but the specific impact of ethnicity on chemotherapy/biotherapy toxicity risk has not been well elucidated. This study found that a majority (85%) of Hispanic/Latinx patients treated with chemotherapy/biotherapy experienced toxicity of any grade, and the majority (90%) patients who had prior toxicity experienced another toxicity.

Examining adherence to oral anticancer medications through a human factors engineering framework: Protocol for a scoping review.

BACKGROUND: The number of oral anticancer medications has increased over the past few decades, opening new possibilities in cancer care and improving convenience for patients and caregivers. However, adherence levels continue to be suboptimal, potentially jeopardizing therapeutic benefits. Poor adherence levels may indicate gaps in current strategies and interventions aimed at enhancing medication adherence and the extent to which they address the complex and multi-faceted medication management needs of patients and their caregivers. Beyond commonly understood barriers (e.g., forgetting to take medications), adherence interventions must address systemic barriers that may not be fully appreciated by members of the healthcare system. This scoping review aims to apply a systems framework (human factors engineering framework) to examine system elements targeted by adherence enhancing interventions. METHODS: Studies published in English, reporting adherence interventions for oral anticancer medications with adherence and/or persistence as primary outcome measures will be included in this review. We will search the following electronic databases with no limits on dates: Ovid MEDLINE, Cochrane Library, Web of Science Core Collection, Embase, CINAHL Complete, PsycInfo, and Scopus. Two reviewers will independently screen study titles and abstracts for inclusion with a third reviewer adjudicating conflicts. Full text of included articles will be used to extract information on systemic barriers targeted by adherence interventions as well as information about intervention type, outcomes, and study characteristics. Extracted information will be synthesized to generate a summary of work system factors targeted by adherence interventions. DISCUSSION: Through application of a systems-based approach, this scoping review is expected to shed light on the complex and multifaceted nature of factors influencing adherence to oral anticancer agents. The review may also identify areas that are ripe for further research.

Pharmacoeconomic, Medication Access, and Patient-Satisfaction Analysis of a Pharmacist-Managed VTE Clinic Compared to Primary Care Physician Outpatient Therapy.

Venous thromboembolism (VTE) is a common medical condition often treated with direct oral anticoagulants (DOACs). Current literature supports outpatient treatment of select, low-risk VTE patients by a pharmacist with DOACs; however, no studies exist to demonstrate if a pharmacist-managed VTE clinic provides financial benefit compared to physician-managed outpatient care. To compare the financial implications and patient satisfaction of pharmacist-managed VTE care versus outpatient VTE care by a primary care physician. A single-center retrospective chart review was conducted on all patients seen at a pharmacist-managed VTE clinic for safety and reimbursement outcomes between August 1, 2018 and July 31, 2019. These data points were used to assess the primary endpoint of net gain per patient visit and secondary outcomes, including patient satisfaction score. The primary outcome median (IQR) for net gain per visit was $16.57 (16.57, 16.57) for the pharmacist-managed group and $64.37 (47.04, 64.37) in the physician-managed group with a 95% CI of 39.13-47.80. The median cost to the organization per visit was $4.96 (4.96, 4.96) for the pharmacist-managed group and $39.41 (23.65, 39.41) for the physician managed group with a 95% CI of 26.57-34.45. Statistical difference was also found for a secondary outcome of percentage of days covered for the pharmacist-managed group compared to the physician managed group, median (IQR) 100% (76,100) vs 92.2% (67.2, 98.9) respectfully, with a p-value of 0.043. The pharmacist-managed VTE clinic, although financially sustainable, provides significantly less net revenue per patient than physician managed clinics, demonstrating the need for increased payer recognition for pharmacists.

High-Alert Medication Stratification Tool-Revised Phase II: A Multisite Study Examining the Validity, Interrater Reliability, and Ease of Use of the High-Alert Medication Stratification Tool-Revised.

OBJECTIVES: The primary objective of this multisite study, High-Alert Medication Stratification Tool-Revised (HAMST-R) phase II, was to assess the content validity of HAMST-R. Secondary outcomes included interrater reliability and ease of use. METHODS: HAMST-R was designed as an objective tool to evaluate high-alert medications (HAMs) at a single site during HAMST-R Phase I. Medication safety experts from 7 health systems across the United States volunteered to participate in this phase II study. Participants completed a demographic survey, oversaw evaluation of 47 HAMs and 35 non-HAMs using HAMST-R, and submitted scores for each medication evaluated. In addition, participants rated each question of HAMST-R on its relevance to assess a medication's safety risk, measured as scale-content validity index. Positive and negative predictive values were evaluated in a post hoc analysis. Interrater reliability was evaluated using the Kendall coefficient of concordance (K), and ease of use was assessed using a mixed-methods approach. RESULTS: Scale-content validity index was 0.80, indicating that the tool was valid. Positive predictive value was 90.5% (95% confidence interval, 87.2%-93.0%), and negative predictive value was 98.2% (95% confidence interval, 95.4%-99.3%). A score of 4 or more differentiated between HAMs and non-HAMs, confirming phase I findings. K was 0.56, indicating moderate agreement. Participants confirmed that the tool was easy to use and plan to incorporate the tool into HAM policies and procedures, formulary review, and safety strategy implementation. CONCLUSIONS: HAMST-R is a valid, objective, and easy to use method that institutions may implement to evaluate a medication's potential safety risk.

High-Alert Medication Stratification Tool-Revised: An Exploratory Study of an Objective, Standardized Medication Safety Tool.

OBJECTIVE: To develop an objective tool designed to standardize the identification of high-alert medications (HAMs) according to patient safety risk. METHODS: Medications were evaluated using the High-Alert Medication Stratification Tool (HAMST). Tool revision occurred through assessing medications on an organization-approved HAM list and comparing scores with control medications not included on the list. Because of variations in HAMST interpretation by end users in interdisciplinary committees, a revision of the scoring tool was completed to create the High-Alert Medication Stratification Tool-Revised (HAMST-R), and the assessment was repeated. Both tools range from 0 to 10, with 10 describing agents with highest risk. RESULTS: The median (interquartile range [IQR]) initial HAM (n = 44) score using HAMST was 6 (5-7). The median (IQR) control (n = 45) score was 1 (0-2). Using the modified tool, HAMST-R, the median (IQR) HAM score was 4 (4-6) versus 1 (0-1) for controls. Scores for HAMs were significantly higher than controls using both tools (P < 0.001). A HAMST-R score of 4 or higher defines medications as high alert, as this score includes 75% of HAMs and no controls. CONCLUSIONS: Through this exploratory study, clarification of the tool was required to increase its concurrent validity, interrater reliability, and implementation among other health systems. The revised tool, HAMST-R, is a newly developed, objective tool for standardized identification of HAMs. The tool may also be used for prospective identification of medications as high risk to patient safety during formulary review.

Retrospective analysis of the incidence and severity of acute kidney injury (AKI) in patients with head and neck cancer receiving weekly cisplatin with radiotherapy (RAISe-AKI).

INTRODUCTION: Low-dose, weekly cisplatin (40 mg/m2) regimens are currently utilized at Eskenazi Health in Indianapolis, Indiana for the treatment of head and neck cancer due to enhanced tolerability. This retrospective analysis analyzes the incidence, severity, and risk factors for AKI in patients who received this regimen. METHODS: A retrospective chart review was conducted including patients with head and neck cancer treated with weekly, low dose cisplatin (40 mg/m2) with concurrent radiotherapy (RT). From this criteria, 22 patients were identified and included in the final analysis. AKI was defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. RESULTS: Of the 22 patients included, 12 (54.5%) experienced AKI, with 10 patients (45.5%) experiencing grade 1 AKI and 2 patients (9.1%) experiencing grade 2 AKI. Six patients (27.3%) required dose adjustments or delays due to renal adverse events, all of which had initial cisplatin total weekly doses of >70 mg. Those receiving a total weekly cisplatin dose of >70 mg were found to have a higher risk of developing an episode of AKI compared to the group receiving <70 mg (p = 0.029). CONCLUSION: This analysis showed patients receiving weekly doses >70 mg of cisplatin as their initial treatment dose for head and neck cancer were more likely to experience AKI. There are inconsistencies in the frequency of AKI in our study compared to published literature; however, this comparison is difficult due to the small sample size of our trial. This demonstrates the need for further investigation into the issue.

Metabolic monitoring of second-generation antipsychotics: Evaluation of a pharmacist- and nurse-driven protocol.

OBJECTIVE: Second-generation antipsychotic therapy can lead to metabolic abnormalities, increasing the risk of cardiovascular disease and death in patients with serious mental illness. However, the literature suggests there is a lack of appropriate monitoring in individuals receiving these therapies. This study aims to evaluate whether the implementation of a pharmacist- and nurse-driven metabolic monitoring protocol will increase monitoring in patients prescribed second-generation antipsychotic therapy in an outpatient community mental health clinic. METHODS: A retrospective review of adult outpatients in a community mental health clinic who were prescribed second-generation antipsychotics was conducted from October 1, 2017, to March 31, 2019. Pre- and postprotocol implementation groups were compared to assess the impact of the protocol on the primary outcome of appropriateness in monitoring for metabolic parameters. RESULTS: A total of 160 patients who met the inclusion criteria were randomly selected and reviewed, allowing for 80 individuals in each group. Improvement in the appropriateness of monitoring was found for 4 of 5 metabolic parameters after protocol implementation, including blood pressure (17.5% to 43.8%, P < 0.001), weight (17.5% to 43.8%, P < 0.001), hemoglobin A1C (27.5% to 42.5%, P = 0.044), and lipid levels (17.5% to 31.3%, P = 0.04). Primary care physicians ordered most of the laboratory values (44.5% to 46.2%); however, pharmacists and nurses ordered 7% of laboratory tests after the protocol implementation. CONCLUSION: Despite the knowledge that second-generation antipsychotic therapies commonly lead to metabolic syndrome and therefore increased cardiovascular disease risk, monitoring for metabolic effects remains poor, and there is a lack in diversity of strategies to improve this monitoring. Although further research on the effectiveness of a pharmacist- and nurse-driven metabolic monitoring protocol in this setting is warranted, this protocol serves as an example of a novel strategy with the potential to improve metabolic monitoring of second-generation antipsychotic therapy.