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Evaluation of the safety and tolerability of spironolactone in patients with heart failure and chronic kidney disease
No full textBackground: Spironolactone reduces morbidity and mortality in patients with heart failure (HF) with reduced ejection fraction (EF) and decreases hospitalizations in HF with preserved EF. To minimize the risk of hyperkalemia, patients must have an estimated glomerular filtration rate (eGFR) \u3e 30 mL/min/1.73 m2 and potassium \u3c 5.0 mEq/L prior to initiation; however, spironolactone is prescribed outside these parameters. The objective of this study was to evaluate the safety and tolerability of spironolactone in patients with HF and chronic kidney disease (CKD). Methods: This single-center, retrospective cohort study evaluated patients ≥ 18 years with HF and CKD stages 3–5 who received ≥ 48 h of spironolactone therapy and were hospitalized from February 2018 to August 2019. The primary outcome was incidence of hyperkalemia (potassium ≥ 5.5 mEq/L). Results: Overall, 121 patients were evaluated: 52.1% (n = 63) had an EF \u3e 40% and 47.9% (n = 58) had an EF ≤ 40% with 69.4% (n = 84) CKD stage 3, 24.8% (n = 30) stage 4, and 5.8% (n = 7) stage 5. Spironolactone was initiated prior to admission (PTA) for 54.5% (n = 66) of patients, while 45.5% (n = 55) of orders were initiated during hospitalization. Eight patients (6.6%) experienced inpatient hyperkalemia—all with PTA spironolactone. Patients who experienced inpatient hyperkalemia had a numerically lower eGFR that was not statistically significant (35.40 vs. 38.22 mL/min/1.73 m2; p = 0.730). Patients with CKD stage 3 (n = 4) had numerically higher rates of inpatient hyperkalemia than stages 4 (n = 1) or 5 (n = 3) (50%, 12.5%, and 37.5% respectively; p \u3c 0.05). Conclusion: Spironolactone may be safe to initiate in hospitalized patients with HF and CKD; however, appropriateness of therapy must be assessed upon admission to the hospital. Larger studies are needed for conclusive results
Efficacy of personal pharmacogenomic testing as an educational tool in the pharmacy curriculum: A nonblinded, randomized controlled trial
No full textPersonal genomic educational testing (PGET) has been suggested as a strategy to improve student learning for pharmacogenomics (PGx), but no randomized studies have evaluated PGET’s educational benefit. We investigated the effect of PGET on student knowledge, comfort, and attitudes related to PGx in a nonblinded, randomized controlled trial. Consenting participants were randomized to receive PGET or no PGET (NPGET) during 4 subsequent years of a PGx course. All participants completed a pre-survey and post-survey designed to assess (1) PGx knowledge, (2) comfort with PGx patient education and clinical skills, and (3) attitudes toward PGx. Instructors were blinded to PGET assignment. The Wilcoxon Rank Sum test was used to compare pre-survey and post-survey PGx knowledge, comfort, and attitudes. No differences in baseline characteristics were observed between PGET (n = 117) and NPGET (n = 116) participants. Among all participants, significant improvement was observed in PGx knowledge (mean 57% vs. 39% correct responses; p \u3c 0.001) with similar results for student comfort and attitudes. Change in pre/post-PGx knowledge, comfort, and attitudes were not significantly different between PGET and NPGET groups (mean 19.5% vs. 16.7% knowledge improvement, respectively; p = 0.41). Similar results were observed for PGET participants carrying a highly actionable PGx variant versus PGET participants without an actionable variant. Significant improvement in Likert scale responses were observed in PGET versus NPGET for questions that assessed student engagement (p = 0.020) and reinforcement of course concepts (p = 0.006). Although some evidence of improved engagement and participation was observed, the results of this study suggest that PGET does not directly improve student PGx knowledge, comfort, and attitudes
Victims Economic Safety and Security Act VESSA Policy - Interim
No full textThe University will provide up to two (2) weeks of unpaid leave and reasonable safety accommodations for employees who experience domestic or sexual violence as required under the Missouri Victims Economic Safety and Security Act (hereinafter referred to as “VESSA”)
Pharmacists views on participating in New Zealand’s community pharmacy anticoagulation management service: a mixed-methods study
No full textBackground Optimal anticoagulation management is key for improving outcomes. The Community Pharmacy Anticoagulation Management Service (CPAMS) has beneficial effects on anticoagulant management. However, limited research exists on pharmacists’ views of CPAMS provision, particularly the perspectives of pharmacists who do not provide CPAMS. Objectives To explore the experience and attitudes of pharmacists who do and do not provide CPAMS, and to identify factors that may influence further uptake of CPAMS. Setting CPAMS providing and non-providing pharmacies throughout New Zealand. Methods A mixed-methods study design was employed. Separate online surveys were conducted with CPAMS providers (N = 35) and non-providers (N = 73) to explore their views on the service. Twelve interviews were conducted with purposively selected participants, equally distributed between CPAMS providers and non-providers, to gain further insight into the issues surrounding CPAMS provision. Quantitative data were analysed using student’s t-test and Mann Whitney U-test, and thematic analysis was used for qualitative data. Main outcome measure Experiences of and attitudes towards CPAMS. Results Our survey findings demonstrated that community pharmacists have high self-efficacy and motivation to providing CPAMS, and CPAMS had increased job satisfaction amongst providers. The overwhelming majority of CPAMS providers’ survey participants believed that CPAMS improves the pharmacist–patient relationship, allowing them to assist patients with other aspects of their healthcare. Most non-provider survey participants also believed that their patients would benefit from CPAMS. The two most frequently reported barriers by non-providers survey participants were remuneration and staffing of pharmacists. The interview findings fell within five overarching themes: self-efficacy, CPAMS benefits to patients, barriers to providing CPAMS, the impact of CPAMS on pharmacist–patient and pharmacist–general practitioner relationships. Overall, the current funding model, the capping on the number of enrolled patients, and staffing were the main factors perceived by interview participants preventing the further uptake and implementation of CPAMS. CPAMS non-providers are willing to provide CPAMS; the main factor preventing this is availability of contracts. Conclusions Overall, pharmacists have favourable experiences of and attitudes towards CPAMS and strongly supported its wider implementation. Promoting the benefits and addressing the barriers highlighted in this study may lead to wider implementation of CPAMS
A conceptual framework for evaluation of community pharmacy pay-for-performance programs
No full textBackground: Recent interest in initiating pay-for-performance (P4P) programs indicates an underlying belief that economic incentives will have a direct impact on health care quality and efficiency. Evaluations of the impact of P4P programs on health care organizations and providers have been presented in the literature; however, none have focused on the impact of an incentive targeting community pharmacies. Objective: To propose a theory-derived conceptual framework of how a financial incentive might work in a community pharmacy. Methods: Studies from the fields of economics (agency theory), psychology (intrinsic and extrinsic motivators; expectancy theory), and organizational theory (ownership, institutional layers, organizational culture, and change management; quality improvement) were reviewed to inform the framework\u27s components. This proposed conceptual framework also integrated and expanded on previous health care–related P4P models. Results: P4P programs inherently use financial incentives to catalyze change; however, elements from psychology and organizational theories along with economic theory were identified as important considerations in how a financial incentive may operate when targeting a community pharmacy. Through the incorporation of these theories along with other P4P frameworks in health care, a conceptual framework was derived comprising 4 domains: incentive, pharmacy, other influencing factors, and P4P program measures. Hypothesized relationships among these domains were depicted. Conclusion: As focus on improving the quality of health care provision develops, opportunities for pharmacists to provide patient care services beyond dispensing will continue to advance, along with expanded reimbursement mechanisms extending beyond traditional product dispensing. The proposed theory-derived conceptual framework serves to depict how the integration of P4P and other factors may affect the pharmacy environment and subsequently affect a pharmacy\u27s capability to perform well on medication-related quality measures. This framework may be used as a foundation on which to design studies to investigate the association between community pharmacy factors and performance in a P4P program
Rimegepant: Acute treatment for migraine headaches
No full textMigraine headache treatment is quickly evolving. There have been three new acute migraine treatment options (i.e., lasmiditan, rimegepant, ubrogepant) and four new preventive migraine treatment options (i.e., erenumab, fremanezumab, galcanezumab, eptinezumab) released in the past 3 years. The new migraine treatments are focusing on pathways within the newly, better understood neurovascular hypothesis that further describes the pathophysiology of migraine headaches in more detail than before. The discovery of vasoactive peptides, such as calcitonin gene-related peptide, has led to the development of many of these migraine agents. Rimegepant is one of these newly approved agents for acute migraine treatment in adults with or without aura. Rimegepant has been found to decrease pain and symptoms associated with migraine attacks and is generally well-tolerated. Lay abstract Migraine headache treatment is quickly evolving. There have been three new fast-acting treatment options (i.e., lasmiditan, rimegepant, ubrogepant) and four new treatment options to preventive migraine headaches (i.e., erenumab, fremanezumab, galcanezumab, eptinezumab) approved for patient use in the past 3 years. The new migraine treatments are designed to target a new pathway to help treat patients suffering from migraine headaches. Researchers have discovered a new substance calcitonin gene-related peptide, within the body to specifically target to help treat or prevent a migraine headache. This article will focus on rimegepant, one of these newly approved agents for acute migraine treatment in adults. Clinical studies have found rimegepant decreases pain and symptoms related to migraine attacks and is generally well-tolerated
Short- Versus Standard-Course Nonmacrolide Antibiotic Treatment in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Retrospective, Observational Cohort Study
No full textPurpose: In critically ill patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and without positive microbiological data, the efficacy and tolerability of short-course nonmacrolide antibiotics are ill-described and have pertinent implications in antimicrobial stewardship. This study compared the efficacy and tolerability of nonmacrolide antibiotic strategies in critically ill patients with AECOPD and without pertinent positive microbiological testing. Methods: This single-center, retrospective cohort study was conducted in culture-negative critically ill adults admitted to an intensive care unit (ICU) between July 1, 2014, and July 1, 2019, for the treatment of AECOPD. Included patients received treatment with an empiric corticosteroid, azithromycin, and/or a nonmacrolide antibiotic. Patients treated with a nonmacrolide antibiotic for ≤3 and \u3e3 days made up the short- and standard-course groups, respectively. The prevalence of in-hospital mortality, progression to the need for ventilation, and/or readmission for AECOPD within 30 days (primary composite end point) was compared between the two groups. Additional end points included hospital and ICU lengths of stay (LOS), all-cause 30-day readmission, and prevalence of antibiotic-related adverse events. Findings: A total of 135 patients were included (short course, 66; standard course, 69). The differences in the primary composite end point (short vs standard, 24.2% vs 39.1%; P = 0.06) and its individual components were not significant. The median ICU LOS (2 vs 3 days) and hospital LOS (4 vs 6 days) were shorter in the short-course group (both, P \u3c 0.01). Multivariate logistic regression confirmed no association between group assignment and the primary end point. Implications: Short-course nonmacrolide therapy in patients with AECOPD and no positive microbiological testing was not associated with differences in mortality, progression to ventilation, readmission rate, or prevalence of adverse drug events. Larger-scale prospective studies are needed to validate these findings
Validation Assessment of a Pain Interference Questionnaire among Student Pharmacists
No full textValidation studies of pain interference instruments used among student pharmacists are rare yet essential for understanding their appropriate use and interpretation in pharmacy education and practice. This study conducted validation and reliability assessments of a five-item Pain Interference Scale previously administered to student pharmacists. Construct validity was assessed using Rasch analysis. Unidimensionality was measured using: point-biserial measure correlations; percent of raw variance explained by items; difference between expected; variance modeled by items; and Rasch model fit. To assess scale functioning, response frequency distribution, observed average and sample expected logit distribution, Andrich logit distribution, item separation, and item reliability were assessed. Visual examination of the Item-Person Map determined content validity. Items explained 64.2% of data raw variance. The difference between raw variance modeled and observed was 0.6. Point-biserial measure correlations were \u3e0.77. Item mean-square infits were 0.7-1.3 while outfit measures were 0.72-1.16. There were \u3e10 responses per response category, response frequency and Andrich thresholds progressively advanced, and observed average and sample expected logits advanced monotonically, Andrich logits = -2.33-1.69, item separation = 2.61, and item reliability = 0.87. Item probability curves indicated response categories were minimally yet adequately distinct. Cronbach\u27s alpha = 0.93. The Item-Person Map had a ceiling effect indicating content gaps. In conclusion, the pain interference instrument has acceptable construct validity yet contains content gaps. Additional difficult items should be added to the instrument to better capture pain interference among student pharmacists
Evaluating the relationship between quality measure adherence definitions and economic outcomes in commercial health plans: A retrospective diabetes cohort study
No full textBACKGROUND: Diabetes is a prevalent chronic condition in the United States that results in considerable morbidity and mortality, frequent use of the health care system, and high health care expenditures. Adherence to antidiabetic medications can help improve health outcomes and lower health care utilization and expenditures. The Pharmacy Quality Alliance (PQA) Proportion of Days Covered (PDC): Diabetes All Class medication adherence measure was developed and endorsed to improve adherence to noninsulin antidiabetic medications; however, it has not been assessed in a commercial population of diabetes patients over a 1-year time frame. OBJECTIVE: To determine the association between adherence, as defined in the PQA medication adherence measures, and health care utilization and expenditure among commercially insured individuals using antidiabetic medications. METHODS: This 1-year retrospective study evaluated a cohort of individuals from IBM MarketScan Research Databases (2009-2015) with noninsulin antidiabetic medications. Eligible study subjects included adults (aged ≥18 years at index date) with continuous enrollment in their health plans for 6 months before (i.e., baseline period) and 12 months after (i.e., study period) the index date and ≥2 prescriptions dispensed for any medication included in the PQA PDC Diabetes All Class medication adherence measure, with at least 150 days between the first and last fill during the study period. The index date was defined as the first fill for a medication included in the PQA PDC Diabetes All Class adherence measure after a 180-day baseline period. Generalized linear models with log link and gamma distribution (expenditure) or negative binomial distribution (utilization) assessed relationships between adherence (≥80% PDC) and health care utilization and expenditure while adjusting for potential confounders. Cost ratios (CR) and rate ratios (RR) were computed using beta coefficients. Cohort characteristics were compared using t-tests, Wilcoxon rank sum tests, or chi-square tests with an alpha level of 0.001 set a priori. RESULTS: A total of 1,576,112 individuals were eligible; of these, 1,028,176 (65.2%) were adherent. Significant differences in demographic characteristics were observed between adherent and nonadherent groups (P\u3c0.001). Multivariable analyses demonstrated that adherence was associated with the following: (a) 16.6% fewer inpatient (RR=0.834, 95% CI=0.819-0.850) and 3.6% more outpatient service visits (RR=1.036, 95% CI=1.032-1.039) and (b) 16.8% lower inpatient expenditures (CR=0.833, 95% CI=0.829-0.836); 2.6% lower outpatient expenditures (CR=0.974, 95% CI=0.970-0.978); 16.4% higher prescription drug expenditures (CR=1.164, 95% CI=1.159-1.169); and 4.2% lower total (CR=0.958, 95% CI=0.954-0.962) expenditures. Adherent subjects were associated with lower incremental per member per month expenditures for inpatient (−10.09), and total (−25.60) compared with nonadherent subjects. CONCLUSIONS: Adherence to noninsulin antidiabetic medications was associated with more outpatient and fewer inpatient visits, as well as lower total expenditures compared with nonadherence