Content, delivery, and curricular integration: Bridging the gap between foundational sciences and pharmacy communications.

BACKGROUND AND PURPOSE: The purpose of this study was to assess impact on knowledge, communication skills, and self-confidence of an oral presentation through integrated learning within a pharmaceutical sciences course and a pharmacy practice course within the first year of a three-year, accelerated pharmacy curriculum. EDUCATIONAL ACTIVITY AND SETTING: First-year, first-quarter students were assigned to research, prepare, and give an oral presentation of an immunology topic pertaining to an autoimmune disease or an immune deficiency. In addition to assessments of content (immunology) and delivery (communications), students completed a 15-item, four-point Likert scale anonymous post-presentation survey, which provided an opportunity for the students to provide feedback about the assignments. Students were also encouraged to provide subjective feedback. FINDINGS: A total of 140 students (88%) completed the survey. Results indicated favorable student response to the assignments. On average, students viewed this activity as a positive experience (total mean = 1.44 (95.71%)). Furthermore, students strongly agreed that the activity helped with public speaking and reinforced basic immune system concepts. Analysis of student responses and comments indicated positive reaction to active learning and self-directed learning. SUMMARY: Overall results indicated an improvement in student confidence in ability to communicate specific material learned in a pharmaceutical sciences course. Curricular integration through oral presentations is one approach to increase student knowledge of pharmaceutical sciences and improve confidence and student self-awareness of personal communication skills.

Assessment of the effect of communication skills training on communication apprehension in first year pharmacy students - A two-year study.

INTRODUCTION: The purpose of the study is to assess the impact of a communication skills course on communication apprehension (CA) in two cohorts of first-year (P1), first quarter pharmacy students over a consecutive two-year span. METHODS: The personal report of CA (PCRA-24) was administered at the beginning and completion (pre-post) of a skills-centered communication course to two cohorts of P1, first quarter pharmacy students over a consecutive two-year period. The delivery of the communications course was redesigned during this timeframe based on post-course analysis data and student feedback to incorporate opportunities for students to engage in active learning activities throughout the course. RESULTS: Results of the study revealed a statistically significant reduction of total CA in both cohorts. Cohort 1 had significant reduction of CA in all four measured domains: group discussion meetings, interpersonal communication, and public speaking. Cohort 2 had significant reduction in two of the domains (group and meeting). CONCLUSIONS: Overall, this study indicated that the format of this P1, first quarter communications course had a positive effect on student CA. In addition to the data collected for this research project, post-course evaluations and student comments indicated an overall positive reaction to the design and delivery of the course material, active learning assignments, and assessments.

The relationship between four health-related quality-of-life indicators and use of mammography and Pap test screening in US women.

PURPOSE: Limited evidence is available to explain the role of four components of health-related quality of life (HRQoL) on breast and cervical cancer screening. The objective of this study was to determine the relationship between four HRQoL aspects and use of mammography and Pap test screening in US women. METHODS: Data were obtained from the 2012 Behavioral Risk Factor Surveillance System (BRFSS). The outcome variables were receiving mammogram <2 versus ≥2 years in women aged 50-74 years, and receiving Pap test <3 versus ≥3 years in women aged 18-64 years. Eight logistic regression models were conducted to test the role of four HRQoL aspects (general health status, physical HRQoL, mental HRQoL, and activity limitation) on the two screening variables, after adjusting for covariates. Statistical analysis accounted for the complex sampling design of the BRFSS, and the a priori alpha error was set at p ≤ 0.05. RESULTS: Among respondents, approximately 74 and 78 % of the women received mammography and Pap test, respectively. Three HRQoL aspects (general health status, physical HRQoL, and activity limitation) were significantly associated with mammography use (all p values < 0.05), whereas two HRQoL aspects (general health status and physical HRQoL) were significantly associated with Pap test (p values ≤ 0.05). All significant relationships demonstrated higher cancer screening rates among individuals with better HRQoL. CONCLUSIONS: HRQoL is an important factor associated with use of mammography and Pap test. Future studies should explore the mechanisms associated with an individual's HRQoL and use HRQoL assessment as an avenue to influence adherence to use of mammography and Pap tests.

Cost-effectiveness analysis of allopurinol versus febuxostat in chronic gout patients: a U.S. payer perspective.

BACKGROUND: Gout is a chronic inflammatory condition associated with poor urate metabolism. Xanthine oxidase inhibitors such as allopurinol and febuxostat are recommended to reduce uric acid levels and to prevent gout attacks in adult patients. Under budget-driven constraints, health care payers are faced with the broader challenge of assessing the economic value of these agents for formulary placement. However, the economic value of allopurinol versus febuxostat has not be assessed in patients with gout over a 5-year time period in the United States. OBJECTIVE: To evaluate the cost-effectiveness of allopurinol versus febuxostat in adult patients with gout over a 5-year time period from a U.S. health care payer's perspective. METHODS: A Markov model was developed to compare the total direct costs and success of serum uric acid (sUA) level reduction associated with allopurinol and febuxostat. Treatment success was defined as patient achievement of a sUA level less than 6 mg/dL (0.36 mmol/L) at 6 months. Event probabilities were based on published phase III randomized clinical trials and included long-term sequelae from open-label extension studies. A hypothetical cohort of 1,000 adult gout patients with sUA levels of ≥ 8 mg/dL (0.48 mmol/L) who had received either allopurinol 300 mg or febuxostat 80 mg at model entry transitioned among the 4 health states defined by treatment success, treatment failure and switch, treatment dropout, and death. The length of each Markov cycle was 6 months. Costs were gathered from the RED BOOK, Medicare fee schedules, Healthcare Cost and Utilization Project's Nationwide Inpatient Sample, and for a limited number of inputs, expert consultation. Direct costs included treatment drug costs, costs for prophylaxis drugs, diagnostic laboratory tests, and the treatment and management of acute gout flare. Resource utilization was based on clinical evidence and expert consultation. All costs were inflated to 2014 U.S. dollars and were discounted at 3% in the base case. One-way sensitivity analysis and probabilistic sensitivity analyses (PSAs) were performed to assess the robustness of the results. RESULTS: The total per patient cost incurred over 5 years was $50,295 for febuxostat and $48,413 for allopurinol, with an incremental total cost of $1,882. The expected percentage of treatment success during the 5-year period was 72 for febuxostat and 42 for allopurinol, resulting in an incremental percentage of treatment success of 30. The estimated incremental cost-effectiveness ratio for febuxostat compared with allopurinol was $6,322 per treatment success over a 5-year time period. The one-way sensitivity analysis indicated that the results were sensitive to probability of treatment success for allopurinol, probability of treatment dropouts for both allopurinol and febuxostat, and the probability of failure and switch to allopurinol. PSAs demonstrated that at a willingness-to-pay threshold of $50,000 per treatment success, febuxostat was cost-effective compared with allopurinol. CONCLUSIONS: Febuxostat was found to be a cost-effective option compared with allopurinol based on a U.S. payer perspective.

Investigation of pegloticase-associated adverse events from a nationwide reporting system database.

PURPOSE: Pegloticase-associated adverse events reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) database in the United States were evaluated. METHODS: Retrospective data-mining analysis of FAERS case reports listing Krystexxa or pegloticase as the suspect drug and specific adverse events (cardiovascular events, infusion-related reactions, gout flares, and anaphylaxis) was conducted from the drug's approval date (September 14, 2010) through August 27, 2012. Initial and follow-up reports with the same primary linked identification number were identified as unique to each patient case. When multiple reports for the same patient were identified with a common case number, the report with the most recent date was used to eliminate duplicate reports. Bayesian confidence propagation neural network methodology was used to identify signals of drug-associated adverse events. A potential signal for drug-adverse event reports is generated when the lower limit of the 95% two-sided confidence interval of the information component is greater than 0. RESULTS: A total of 118 unique cases of adverse events involving pegloticase in the United States were identified during the study period. Fourteen reports were related to pegloticase-associated cardiovascular events, and 35 were related to pegloticase-associated infusion-related reactions. Twenty-six reports were related to pegloticase-associated gout, and 11 were reports of pegloticase-associated anaphylaxis. Bayesian statistics identified potential signals for all pegloticase-associated adverse events (cardiovascular events, infusion reactions, gout flares, and anaphylaxis). CONCLUSION: Analysis of pegloticase-associated adverse events submitted to the FAERS database found that cardiovascular events, infusion-related reactions, gout flares, and anaphylaxis occurred more frequently than was statistically expected.

Dabigatran-dronedarone interaction in a spontaneous reporting system.

OBJECTIVES: To investigate the risk of bleeding events associated with concurrent administration of dabigatran-dronedarone compared with dabigatran standalone therapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and to identify the characteristics of patients with bleeding events associated with concurrent use of dabigatran and dronedarone. DESIGN: Retrospective data mining analysis. SETTING: United States, from the dabigatran approval date (October 19, 2010) through the fourth quarter of 2011. PATIENTS: Cases from FAERS with bleeding events (combined in a single term based on adverse event reports such as hemorrhage and rectal hemorrhage) as the adverse event. INTERVENTION: Cases listing concomitant use of the terms Pradaxa, dabigatran, or dabigatran etexilate with Multaq or dronedarone as the suspect drug from FAERS and cases listing dabigatran and dronedarone as standalone therapies were extracted for analysis. MAIN OUTCOME MEASURE: Risk of bleeding among those using dabigatran-dronedarone concomitantly compared with those using dabigatran standalone therapy. RESULTS: 108 dabigatran-dronedarone interaction reports and 14,913 reports concerning bleeding events were extracted from FAERS. Of 108 dabigatran-dronedarone interaction cases, 51 were associated with bleeding events. The odds ratio (OR) for risk of bleeding in patients using dabigatran and dronedarone concomitantly compared with those using neither of the suspect drugs was 13.80 (95% CI 9.45-20.14). The OR for risk of bleeding in patients using only dabigatran compared with those using neither of the suspect drugs was 16.06 (15.00-17.19). CONCLUSION: The likelihood of reporting bleeding events to FAERS among patients using dabigatran only was similar to that among patients using dabigatran and dronedarone concomitantly.

Cardiovascular thromboembolic events associated with febuxostat: investigation of cases from the FDA adverse event reporting system database.

OBJECTIVE: Uloric (Febuxostat) has been linked with cardiovascular thromboembolic events in gout patients. However, no post-marketing data analysis has investigated these drug-associated adverse event reports. The study objective was to identify febuxostat-associated cardiovascular thromboembolic event reports in the US using the Food and Drug Administration adverse event reporting system (AERS) database. METHODS: Reports listing uloric and febuxostat as the suspect drug and cardiovascular thromboembolic events (combined in a single term based on adverse event reports of myocardial infarction, stroke, among others) as the adverse event were extracted from the drug's approval date through the fourth quarter of 2011. Bayesian statistics within the neural network architecture was implemented to identify potential signals of febuxostat-associated cardiovascular thromboembolic events. A potential signal for the drug-adverse event combination reports is generated when the lower limit of the 95% two-sided confidence interval of the information component (IC), denoted by IC025 is greater than zero. RESULTS: Twenty-one combination reports of febuxostat-associated cardiovascular thromboembolic events were identified in gout patients in the US. The mean age of combination cases was 64 years. Potential signals (IC025 = 4.09) was generated for combination reports of febuxostat-associated cardiovascular thromboembolic events. CONCLUSION: AERS indicated potential signals of febuxostat-associated cardiovascular thromboembolic events. AERS is not capable of establishing the causal link and detecting the true frequency of an adverse event associated with a drug. The positive IC value found in this study merits continued surveillance and assessment of cardiovascular thromboembolic events associated with Febuxostat.

Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: investigation from the United States Food and Drug Administration adverse event reporting system database.

STUDY OBJECTIVE: To investigate reports of thrombotic events associated with the use of C1 esterase inhibitor products in patients with hereditary angioedema in the United States. DESIGN: Retrospective data mining analysis. SOURCE: The United States Food and Drug Administration (FDA) adverse event reporting system (AERS) database. MEASUREMENTS AND MAIN RESULTS: Case reports of C1 esterase inhibitor products, thrombotic events, and C1 esterase inhibitor product-associated thrombotic events (i.e., combination cases) were extracted from the AERS database, using the time frames of each respective product's FDA approval date through the second quarter of 2011. Bayesian statistical methodology within the neural network architecture was implemented to identify potential signals of a drug-associated adverse event. A potential signal is generated when the lower limit of the 95% 2-sided confidence interval of the information component, denoted by IC025 , is greater than zero. This suggests that the particular drug-associated adverse event was reported to the database more often than statistically expected from reports available in the database. Ten combination cases of thrombotic events associated with the use of one C1 esterase inhibitor product (Cinryze) were identified in patients with hereditary angioedema. A potential signal demonstrated by an IC025 value greater than zero (IC025 = 2.91) was generated for these combination cases. CONCLUSION: The extracted cases from the AERS indicate continuing reports of thrombotic events associated with the use of one C1 esterase inhibitor product among patients with hereditary angioedema. The AERS is incapable of establishing a causal link and detecting the true frequency of an adverse event associated with a drug; however, potential signals of C1 esterase inhibitor product-associated thrombotic events among patients with hereditary angioedema were identified in the extracted combination cases.

Debt, investment and endowment accumulation: the case of not-for-profit hospitals.

Not-for-profit hospitals benefit from special tax rules that allow state authorities to issue tax-exempt bonds on their behalf, which may affect their investment and financing choices. Hospitals may respond by increasing their investment in physical assets; however, they may also engage in tax arbitrage by using the tax-exempt debt while maintaining endowment assets. The paper combines data from tax (information) returns and the annual survey of hospitals by the American Hospital Association for 1993-1996. Overall, the results are consistent with substantial tax planning by not-for-profit hospitals. Of the US$ 55.9 billion in tax-exempt liabilities of hospitals in 1996, as much as US$ 32.6 billion could have been eliminated if hospitals spent their endowments instead of borrowing. Furthermore, controlling for hospital size (in terms of revenues and operating assets), endowment assets are associated with a higher ratio of tax-exempt (or total) debt to operating assets. In contrast, endowment assets are not related to taxable debt suggesting that the effects of the endowment on borrowing are motivated by tax incentives. Investment and endowment accumulation regressions suggest that increases in debt increase both physical investment and endowment accumulation but these effects are concentrated among cash-rich hospitals for which the effects on endowment accumulation effects are larger than the effects on physical investment.