Implementation of self-care scenario simulations in a skills-based first year doctor of pharmacy course for student application of the Pharmacists' Patient Care Process.

BACKGROUND AND PURPOSE: The objective of this project was to assess the impact of self-care scenario simulations on first year doctor of pharmacy student performance and self-perceived confidence in applying the Pharmacists' Patient Care Process (PPCP) during self-care encounters. EDUCATIONAL ACTIVITY AND SETTINGS: Self-care scenarios were developed and used during low fidelity simulations in laboratory sessions in a skills-based course. Students met individually with faculty facilitators role-playing patients to apply the PPCP in four simulations. Facilitators graded student performance; a comparison was made between performance on the first and fourth simulation. Students completed a pre- and post-course survey regarding their self-perceived confidence in performance and knowledge in applying the PPCP in self-care encounters. FINDINGS: One hundred and eight (100%) of enrolled students voluntarily agreed to participate in this IRB-approved study. The median percentage of student scores on the fourth simulation, 90.7%, was higher compared to the median percentage of student scores on the first simulation, 82.4%, P < 0.001 with a raw difference of 8.3 percentage points, for participants with scores for both simulations, 106 (98%). For the self-perceived PPCP confidence survey, 100 (92.5%) participants completed both pre- and post-course surveys. Self-perceived confidence on 12 of the 15 survey items where students ranked their confidence in performance and knowledge in self-care encounters increased post- versus pre-course. SUMMARY: Simulations served as a useful tool in improving student performance in applying the PPCP in self-care encounters in a first year doctor of pharmacy course. Student self-perceived confidence in performance and knowledge in self-care encounters also increased.

Development of a script concordance test to assess clinical reasoning in a pharmacy curriculum.

INTRODUCTION: Clinical reasoning is a vital skill for student pharmacists in the provision of patient-centered care, but these skills are often difficult to assess in the didactic curriculum. A script concordance test (SCT) is an innovative assessment method that can be used to assess clinical reasoning skills. The objective of this study was to develop and refine an SCT to assess clinical reasoning skills of third year student pharmacists (P3s). METHODS: An SCT was written and administered to P3s. Pharmacy practice faculty members served as the expert group. The SCT was scored and Rasch analysis was performed. RESULTS: The SCT included 20 case vignettes and 60 questions. Test reliability was 0.34 with mean square values for all items between 0.7 and 1.3. Forty-two questions had a difficulty score between 0 and - 1 logits, indicating there were multiple questions with similar difficulty levels. Two case vignettes and 43.3% of questions (n = 26) were revised to enhance clarity and decrease ambiguity. CONCLUSIONS: The SCT is a tool to assess clinical reasoning in the didactic curriculum. Faculty can create the SCT and use statistical methods such as Rasch analysis to assess validity and reliability of the SCT.

A Safety Analysis of Programmed Death 1 Pathway Inhibitors in Patients With Solid Tumor Malignancies and Preexisting Autoimmune Disease.

OBJECTIVE: The aim of this study was to characterize the safety of programmed death 1 inhibitors in patients with preexisting autoimmune disease. METHODS: A medical records review study was conducted on adults with solid tumor malignancies who received ≥1 dose of pembrolizumab or nivolumab at Emory Healthcare from September 4, 2014 until December 31, 2019. All autoimmune patients were included (n = 77), whereas the nonautoimmune patients were randomized and the first 156 patients were included in a 2:1 ratio to autoimmune patients. The primary objective was the comparison of incidence of immune-related adverse events (irAEs) between patients with preexisting autoimmune disease and those without. Secondary objectives included irAE characterization, irAE treatment, and survival analyses. RESULTS: Preexisting autoimmune disease was controlled in all of the autoimmune patients before immunotherapy initiation. The rate of irAE was 32.7% in the nonautoimmune group and 42.9% in the autoimmune group (odds ratio, 0.65; 95% confidence interval, 0.37-1.14; p = 0.130). In the patient population diagnosed with a rheumatologic autoimmune disease, 23.81% of irAEs were considered to be a flare of their preexisting autoimmune disease. Less patients in the autoimmune group experienced a grade ≥3 irAE (21.21% vs 37.25%, p = 0.379) and received systemic corticosteroids (54.55% vs 67.35%, p = 0.241) for the treatment of the irAE. CONCLUSIONS: These results suggest that pembrolizumab and nivolumab can be safely administered in patients with controlled preexisting autoimmune diseases without a significant increase in irAE compared with patients without autoimmune diseases. Inclusion of patients with preexisting autoimmune diseases in prospective clinical trials is warranted.

Evaluating Practice Readiness of Advanced Pharmacy Practice Experience Students Using the Core Entrustable Professional Activities.

Objective. To evaluate levels of entrustability and practice readiness in advanced pharmacy practice experience (APPE) students using a pilot instrument designed to assess their competency in performing the entrustable professional activities (EPAs) expected of new pharmacy graduates. Methods. A pilot instrument was developed directly from EPAs to measure entrustability levels on a scale of one to five. Five APPE preceptors from several different practice areas participated. Fourth-year students used the instrument to self-evaluate their knowledge and skills at the beginning, midpoint, and end of the APPE. The preceptors evaluated students using the same instrument at APPE midpoint and end. The instrument had assigned weights for each EPA and entrustability level for a score of 100 if all items were marked five. If a rating of non-applicable was chosen, score adjustments were made. All students in the graduating class of 2018 were invited to perform a self-evaluation at the end of the fourth (APPE) year using the same instrument that study participants used. Results. Twenty-eight students and five preceptors completed evaluations during the APPE year. Overall scores from both preceptor evaluations of students and student self-evaluations increased significantly from pre-APPE to midpoint to final. Student self-evaluations were only slightly higher than preceptor evaluations. The mean (SD) preceptor scores for students and student self-assessment scores at the end of each APPE were 85.4% (7.1) and 87.2% (10.3), respectfully. One practice manager EPA and three population health EPAs were considered to not be applicable by preceptors on ≥50% of evaluations. Approximately 94% of all graduating students completed the year-end self-evaluations, with a mean (SD) score of 89% (8.6) and no EPAs marked as not applicable. Conclusion. Pharmacy students' proficiency in EPA improved during individual APPEs. According to preceptors, students' greatest improvement in entrustability was in educating patients and colleagues regarding appropriate use of medications and collecting information to identify medication-related problems.

CETP genotype and concentrations of HDL and lipoprotein subclasses in African-American men.

Aim: To assess the association between the CETP Taq1B and I405V polymorphisms with levels of lipoprotein subclasses in African-American (AA) men with and without Type 2 diabetes (T2DM). Patients & methods: AA men, over 30 years of age, with (n = 54) or without T2DM (n = 50), and not receiving lipid-lowering agents, underwent advanced lipid analysis and genotyping. Results & conclusion: In the total patient population Taq1B B2-allele carriers had significantly higher levels of large HDL subclasses (HDL-2b [p = 0.017] and HDL-L [p = 0.019]), lower levels of small-HDL subclasses (HDL-3a [p = 0.004] and HDL-3b [p = 0.031]), and lower levels of LDL subclasses (LDL-IVa [p = 0.012] and LDL-IIIb [p = 0.009]). The only significant genotype-diabetes interaction occurred with the HDL-2a subclass (p = 0.015). No statistically significant associations were seen with I405V genotype. Our observations of lower levels of small-HDL and higher levels of large-HDL suggest that a potentially important HDL subclass-CETP relationship exists.

A qualitative study of nuisance bleeding and medication-related beliefs with dual antiplatelet drug therapy.

OBJECTIVES: The purpose of this qualitative study was to explore perceptions of nuisance bleeding and medication-related beliefs among adults taking dual antiplatelet drug therapy. METHODS: We conducted qualitative telephone interviews with 34 community-dwelling adults with cardiovascular disease. RESULTS: Using qualitative content analysis, we identified 4 dominant themes: nuisance bruising, nuisance bleeding, importance of medication adherence, and duration of therapy. Participants' bruising was frequently more severe than expected given the force of the bump that caused it. Concerns focused on whether increased bleeding tendencies would lead to hemorrhage in the event of a major traumatic injury, confusion about the duration of therapy, and the rationale for when and why therapy should be discontinued. CONCLUSION: Excessive bruising and medication-related concerns about hemorrhage and duration of treatment were salient issues for participants. Effective clinician-patient communication should be used to assist individuals in managing concerns to help assure positive health outcomes with antiplatelet drugs.

A compliance assessment of midpoint formative assessments completed by APPE preceptors.

INTRODUCTION: Experiential pharmacy preceptors should provide formative and summative feedback during a learning experience. Preceptors are required to provide colleges and schools of pharmacy with assessments or evaluations of students' performance. Students and experiential programs value on-time completion of midpoint evaluations by preceptors. The objective of this study was to determine the number of on-time electronically documented formative midpoint evaluations completed by preceptors during advanced pharmacy practice experiences (APPEs). METHODS: Compliance rates of on-time electronically documented formative midpoint evaluations were reviewed by the Office of Experiential Education of a five-member consortium during the two-year study period prior to the adoption of Standards 2016. Pearson chi-square test and generalized linear models were used to determine if statistically significant differences were present. RESULTS: Average midpoint compliance rates for the two-year research period were 40.7% and 41% respectively. No statistical significance was noted comparing compliance rates for year one versus year two. However, statistical significance was present when comparing compliance rates between schools during year two. Feedback from students and preceptors pointed to the need for brief formal midpoint evaluations that require minimal time to complete, user friendly experiential management software, and methods for documenting verbal feedback through student self-reflection. CONCLUSIONS: Additional education and training to both affiliate and faculty preceptors on the importance of written formative feedback at midpoint is critical to remaining in compliance with Standards 2016.

Student pharmacists' preparedness to evaluate primary literature pre- and post-Advanced Pharmacy Practice Experiences.

BACKGROUND AND PURPOSE: The primary objective of this study was to assess the effect of formal primary literature evaluation (PLE) during advanced pharmacy practice experiences (APPEs) on student pharmacists' preparedness and knowledge related to literature evaluation. EDUCATIONAL ACTIVITY AND SETTING: A perception of preparedness survey and knowledge assessment was given to student pharmacists pre- and post-APPEs. Student pharmacists were also asked to characterize their opportunities for formal PLE during APPEs. Literature evaluation experiences, knowledge base and preparedness data were compared between student pharmacists who completed two or more PLE on APPE and those who did not. FINDINGS: A total of 211 student pharmacists completed 529 formal PLE during their APPE experiences. Quiz grades and average perception of preparedness increased significantly from pre- to post-APPE regardless of whether student pharmacists had the opportunity for formal PLE on APPE. Student pharmacists who completed two or more PLE on APPE stated they felt more confident in evaluating primary literature after APPE, had greater post-APPE preparedness scores and a trend towards higher post-APPE quiz scores. DISCUSSION AND CONCLUSION: APPEs provide an important opportunity for student pharmacists to improve their PLE knowledge.

Factors Associated With Clopidogrel Adherence in Community-Dwelling Patients.

OBJECTIVE: The purpose of this study was to characterize predictors of adherence to clopidogrel therapy focusing on patients' perceptions of clopidogrel and nuisance bleeding. METHODS: This was a cross-sectional study of community-dwelling cardiovascular patients with a self-reported prescription for clopidogrel. Self-report questionnaires assessed depressive symptoms, social support, nuisance bleeding, perceptions of clopidogrel, and adherence to therapy. Low, moderate, and high adherence groups based on the Morisky Medication Adherence Scale were compared and hierarchical multiple linear regression analysis was used to predict adherence. RESULTS: A total of 102 subjects were enrolled, and 55%, 28%, and 16% were classified as having low, moderate, and high adherence, respectively. Greater perceptions of clopidogrel necessity, lower perception of clopidogrel concern, and increased severity of nuisance bleeding were predictors of better adherence. CONCLUSIONS: Data from this cross-sectional study suggest that concerns about clopidogrel and feelings about its necessity play an important role in clopidogrel adherence.

Simulated Order Verification and Medication Reconciliation during an Introductory Pharmacy Practice Experience.

Objective. To create, implement, and assess a simulated medication reconciliation and an order verification activity using hospital training software. Design. A simulated patient with medication orders and home medications was built into existing hospital training software. Students in an institutional introductory pharmacy practice experience (IPPE) reconciled the patient's medications and determined whether or not to verify the inpatient orders based on his medical history and laboratory data. After reconciliation, students identified medication discrepancies and documented their rationale for rejecting inpatient orders. Assessment. For a 3-year period, the majority of students agreed the simulation enhanced their learning, taught valuable clinical decision-making skills, integrated material from previous courses, and stimulated their interest in institutional pharmacy. Overall feedback from student evaluations about the IPPE also was favorable. Conclusion. Use of existing hospital training software can affordably simulate the pharmacist's role in order verification and medication reconciliation, as well as improve clinical decision-making.

A patient with HIV and tuberculosis with diminished clopidogrel response.

Patients with HIV are at an increased risk for cardiovascular disease, both as a result of treatment with protease inhibitors and from the disease itself. The medication regimens of patients with HIV and cardiovascular comorbidities are complex and require careful assessment for potentially serious drug-drug interactions. We report a case of clopidogrel non-responsiveness in a patient with HIV, latent tuberculosis and cardiovascular disease with a history of myocardial infarction. To our knowledge, this is the first report of significant drug interactions between clopidogrel, isoniazid and ritonavir. This case underscores the importance of a detailed drug interaction screening in infectious disease patients taking complex medication regimens, including clopidogrel.

Impact of abbreviated lecture with interactive mini-cases vs traditional lecture on student performance in the large classroom.

OBJECTIVE: To compare the impact of 2 different teaching and learning methods on student mastery of learning objectives in a pharmacotherapy module in the large classroom setting. DESIGN: Two teaching and learning methods were implemented and compared in a required pharmacotherapy module for 2 years. The first year, multiple interactive mini-cases with inclass individual assessment and an abbreviated lecture were used to teach osteoarthritis; a traditional lecture with 1 inclass case discussion was used to teach gout. In the second year, the same topics were used but the methods were flipped. Student performance on pre/post individual readiness assessment tests (iRATs), case questions, and subsequent examinations were compared each year by the teaching and learning method and then between years by topic for each method. Students also voluntarily completed a 20-item evaluation of the teaching and learning methods. ASSESSMENT: Postpresentation iRATs were significantly higher than prepresentation iRATs for each topic each year with the interactive mini-cases; there was no significant difference in iRATs before and after traditional lecture. For osteoarthritis, postpresentation iRATs after interactive mini-cases in year 1 were significantly higher than postpresentation iRATs after traditional lecture in year 2; the difference in iRATs for gout per learning method was not significant. The difference between examination performance for osteoarthritis and gout was not significant when the teaching and learning methods were compared. On the student evaluations, 2 items were significant both years when answers were compared by teaching and learning method. Each year, students ranked their class participation higher with interactive cases than with traditional lecture, but both years they reported enjoying the traditional lecture format more. CONCLUSION: Multiple interactive mini-cases with an abbreviated lecture improved immediate mastery of learning objectives compared to a traditional lecture format, regardless of therapeutic topic, but did not improve student performance on subsequent examinations.

A comparison of students' self-assessments with faculty evaluations of their communication skills.

OBJECTIVE: To compare students' self-assessment of their communication skills with faculty members' formal evaluation of their skills in a therapeutics course. METHODS: Over a 3-year period, faculty members evaluated second-year pharmacy students' communication skills as part of a requirement in a therapeutics course. Immediately following an individual oral assessment and again following a group oral assessment, students self-assessed their communication skills using the same rubric the faculty members had used. Students' self-assessments were then compared with faculty members' evaluation of students' communication skills. RESULTS: Four hundred one (97.3%) students consented to participate in this study. Faculty evaluation scores of students for both the individual and group oral assessments were significantly higher than students' self-assessment scores. Students' self-assessment scores of their communication skills increased from the individual to the group oral assessment. CONCLUSION: Students' self-assessments of communication skills were consistently lower than faculty members' evaluations. Greater use of oral assessments throughout the pharmacy curriculum may help to improve students' confidence in and self-assessment of their communication skills.

Statins personalized.

3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitor medications, commonly referred to as statins, are among the most widely prescribed medications. Variation in individual response to statins concerning low-density lipoprotein cholesterol reduction, clinical event benefit, and side effects has been observed. Some of this variability is attributed to demographic and environmental issues, chief of which is compliance. A large portion of the individual response to statin therapy is attributed to single nucleotide polymorphisms that have recently been elucidated, several of which seem to have clinical utility.

Lack of a pharmacokinetic drug-drug interaction with venlafaxine extended-release/indinavir and desvenlafaxine extended-release/indinavir.

PURPOSE: To assess the effects of venlafaxine extended-release (XR) capsules and desvenlafaxine extended-release (XR) tablets upon indinavir pharmacokinetic properties when co-administrated to healthy volunteers. METHODS: This was an open-label, two-period, fixed-dose study conducted at the clinical research unit located on a university campus. Twenty-four healthy volunteers enrolled in the study (mean age 28.3 ± 8.0 years). Each subject received a single dose of indinavir 800 mg on day 1. Subsequently, subjects were then randomly assigned to either the venlafaxine XR group (N = 12) or the desvenlafaxine XR group (N = 12). Starting on day 2, venlafaxine XR was dosed at 37.5 mg/day for 4 days and increased to 75 mg/day for 6 days. Desvenlafaxine XR was dosed at 50 mg/day for 10 days. On day 12, indivanvir 800 mg was co-administered to both the venlafaxine XR and the desvenlafaxine XR groups. The pharmacokinetics of indinavir were determined both before and at the end of antidepressant dosing. Plasma indinavir, venlafaxine, and desvenlafaxine concentrations were assayed by high-performance liquid chromatography with ultra-violet (UV) detection. Indinavir pharmacokinetic parameters were calculated by noncompartmental analysis using validated computer software. RESULTS: Venlafaxine XR and desvenlafaxine XR did not produce any significant changes in indinavir disposition. Both antidepressants were well tolerated by the subjects with only minor adverse side effects. CONCLUSIONS: No pharmacokinetic drug-drug interaction was demonstrated between venlafaxine XR and indinavir or between desvenlafaxine XR and indinvair. The lack of interaction could be due to the venlafaxine and desvenlafaxine extended-release formulation.

Genetic testing for early detection of individuals at risk of coronary heart disease and monitoring response to therapy: challenges and promises.

Coronary heart disease (CHD) often presents suddenly with little warning. Traditional risk factors are inadequate to identify the asymptomatic high-risk individuals. Early identification of patients with subclinical coronary artery disease using noninvasive imaging modalities would allow the early adoption of aggressive preventative interventions. Currently, it is impractical to screen the entire population with noninvasive coronary imaging tools. The use of relatively simple and inexpensive genetic markers of increased CHD risk can identify a population subgroup in which benefit of atherosclerotic imaging modalities would be increased despite nominal cost and radiation exposure. Additionally, genetic markers are fixed and need only be measured once in a patient's lifetime, can help guide therapy selection, and may be of utility in family counseling.

Firefighters, heart disease, and aspects of insulin resistance: the FEMA Firefighter Heart Disease Prevention study.

OBJECTIVE: To determine the association of cardiovascular risk markers with noninvasive imaging of atherosclerosis in firefighters. METHODS: Cross-sectional investigation of subclinical atherosclerosis with metabolic, work related, and life-style variables in 296 professional firefighters. RESULTS: Calcified coronary atherosclerosis (CAC), carotid arterial intimal thickness (CIMT), and electrocardiogram provided independent CVD assessments. Homeostatic Model Assessment (HOMA) concentrations were related to heart-rate-corrected QT (QTc) (slope ± SE: 2.16 ± 65, P = 0.001), average common CIMT (0.019 ± 0.005 mm, P = 0.0005), and total CAC lesions (0.269 ± 0.116, P = 0.02). Stepwise linear regression selected fasting insulin as the strongest predictor for QTc, HOMA as the strongest predictor of average CIMT, and fasting glucose as the strongest predictor of total coronary lesion number and score. CONCLUSION: Firemen's HOMA and fasting insulin and glucose concentrations were significantly associated with three measures of CVD. Aspects of insulin resistance are related to CVD risk among firefighters.

Pharmacogenomics of warfarin dose requirements in Hispanics.

While Hispanics are the largest and most rapidly growing minority population in the United States, they are underrepresented in pharmacogenomic studies with warfarin. We sought to determine the combination of clinical and genetic influences of warfarin dose requirements in Hispanics. In addition, we tested the performance of published warfarin dosing algorithms derived from largely non-Hispanic cohorts in an inner-city U.S. Hispanic population. Genetic samples and clinical data were obtained from 50 Hispanics on a stable dose of warfarin. The contribution of cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex-1 (VKORC1) genotypes and clinical factors to warfarin dose requirements was determined. The correlation between the predicted dose using published algorithms and therapeutic dose was also assessed. Compared to the VKORC1-1639 GG genotype, warfarin dose requirements were 30% and 62% lower with the GA and AA genotypes, respectively (p=0.001). The combination of the VKORC1-1639G>A and CYP2C9 genotypes and clinical factors explained 56% of the inter-patient variability in warfarin dose. Warfarin dose predicted using algorithms derived from mostly non-Hispanic cohorts was significantly correlated with the therapeutic dose in our Hispanic cohort (r(2)=0.43 to 0.49; p<0.001); the predicted dose was within 1.0 mg/day of the therapeutic dose for 40% to 50% of patients. Our data suggest that factors influencing warfarin dose requirements in Hispanic Caucasians are similar to those previously described in European Caucasians and that dosing algorithms derived from non-Hispanic Caucasian cohorts are applicable to Hispanics living in the U.S.