Lessons learned from a formative study evaluating student pharmacists' experience with a case-based learning "choose your own adventure" activity.

BACKGROUND: A case-based learning "Choose Your Own Adventure" (CBL-CYOA) activity was designed to support students in learning to identify drug-related problems and make clinical decisions related to drug therapy management. The purpose of this study was to describe student pharmacists' experiences in order to understand, from their perspective, which design features of the CBL-CYOA activity were valued as useful for developing clinical decision-making skills in an Applied Pharmacy Practice I course. However, several limitations with various features of study design minimized the usefulness of results. IMPACT: In retrospect, methodological limitations with both the survey and focus group designs negatively impacted the interpretation of results in this study. RECOMMENDATIONS: Attention to thoughtful survey development with better alignment to the purpose of the study and neutral questions may produce more useful results. Further, additional focus groups and a purposeful sampling strategy may add to increasing the credibility of the findings in this study. DISCUSSION: Overall, formative studies like this one have the potential to produce insights into how innovative instructional designs operate in real-world contexts. They also have the capacity to output results that provide an evidence base for refining and improving those designs. We hope that our reflections in this paper may be useful to other educators and researchers working to plan similar projects in the future.

Team feedback: A missing piece of the interprofessional education puzzle.

INTRODUCTION: The ambulatory care practice model has long embraced interprofessional collaboration, well before it was formalized by the Interprofessional Education Collaborative. Establishing a mechanism to gather insight from other members of the interprofessional team may facilitate further development of interprofessional education (IPE). COMMENTARY: There is limited evidence investigating non-pharmacy trainees and medical provider perceptions of advanced pharmacy practice experience (APPE) student involvement in IPE. Most available evidence evaluates the satisfaction of non-pharmacy trainees and other health care professionals with APPE student recommendations. IMPLICATIONS: Emphasis on IPE, such as formalizing feedback from other health care professionals during experiential rotations, may assist preceptors in adapting interactions, strengthening interprofessional collaborations, and ensuring that students are valued team members who contribute to providing quality patient care.

Sodium-Glucose Cotransporter-2 Inhibitors and the Risk of Amputation: What Is Currently Known?

BACKGROUND: Diabetes mellitus is a major cause of morbidity and mortality in the United States. Twelve medication classes on the market reduce serum glucose including sodium-glucose cotransporter-2 (SGLT2) inhibitors. Potential benefits of these agents include improved glycemic control, weight loss, reduction in blood pressure, and possible reduction in cardiovascular events in patients with elevated cardiovascular risk. AREAS OF UNCERTAINTY: Recently, several adverse events have been identified including increased possible risk of amputation associated with SGLT2 inhibitor therapy. DATA SOURCE: We conducted a review of published literature and identified 32 trials reviewing incidence of SGLT2 inhibitor-related amputation. RESULTS: The potential increased risk for amputation is mostly of the lower extremities. Of the SGLT2 inhibitors currently available, canagliflozin has the highest association with an increased risk of lower extremity amputation and is the only agent with a Food and drug Administration Black Box Warning. Most canagliflozin amputation occurred in a single study. Risk factors for amputation with SGLT2 inhibitors may include those who have a history of amputations, susceptible to foot ulcers and those with baseline cardiovascular disease. CONCLUSIONS: For at-risk patients who desire an agent from this drug class, empagliflozin or dapagliflozin should be considered, as studies have not found a significant increase in amputations when compared with placebo or in retrospective reviews. Despite the increased risk of amputation found with canagliflozin, providers can use SGLT2 inhibitors with frequent monitoring to safely manage diabetes in low-risk patients. Patient education on associated risks is warranted. Diabetes educators can inform patients of risk factors to assist with monitoring.

Civilian pharmacy involvement in Department of Defense Innovative Readiness Training.

OBJECTIVES: Innovative Readiness Training (IRT) is a United States military exercise that provides training for military personnel while providing services for communities. The objective of this paper was to describe civilian pharmacy services provided during an IRT, Operation Empower Health. SETTING: Operation Empower Health took place on May 10 to 18, 2018, in Savannah and Garden City, Georgia. Pharmacy operations included a limited formulary of medications. Civilian pharmacy volunteers were paired with military persons at 2 of 4 locations. PRACTICE DESCRIPTION: Student pharmacists, residents, preceptors, and faculty provided disease state education to patients during triage. After receiving medical or dental services, patients were provided prescription and over-the-counter medications at the dispensing and counseling station. Civilian pharmacy personnel worked with military personnel to dispense and counsel on medications. Many patients required additional health services or postclinic care. University of Georgia College of Pharmacy faculty members were able to meet with patients for follow-up. An in-service to military personnel was provided by the pharmacists regarding common medication errors. EVALUATION: Within Operation Empower Health, 7942 patients were provided health care services at no cost. A total of 11 students, 5 residents, 2 University of Georgia College of Pharmacy faculty, and 1 preceptor provided pharmacy services during the event. Civilian pharmacy personnel were able to educate 566 patients for a total of 2700 minutes. In addition to medications, patients were counseled on lifestyle interventions. CONCLUSION: Overall, IRT builds mutually beneficial civilian-military partnerships between communities and the Department of Defense. Civilian pharmacy personnel were able to offer medication and lifestyle counseling in addition to managing medication dispensing. Student pharmacists, in particular, were given a unique interprofessional learning opportunity in addition to having a culturally competent experience.

Employer-Sponsored Wellness Programs for Hypertension and Dyslipidemia in a 2-Hospital Health System.

BACKGROUND: The increasing prevalence of chronic disease states, such as hypertension and dyslipidemia, in the United States has placed a growing economic burden on the nation's healthcare system, and incentives for cost reductions have been used by various private health insurers. OBJECTIVE: To analyze the clinical outcomes of pharmacy department-managed, employer-sponsored wellness programs for dyslipidemia and hypertension in a 2-hospital health system. METHODS: Using a retrospective chart review, we evaluated outcomes of employees and their spouses who were enrolled in our dyslipidemia and hypertension Wellpath programs between November 2015 and April 2017. Employees or their spouses were referred to these programs, which were coordinated by the pharmacy department. Enrollees completed in-person appointments and telephone interviews with a pharmacist or an advanced practice nurse, who provided evidence-based lifestyle and pharmacologic recommendations. The primary outcomes were lipid changes in the dyslipidemia program, and changes in systolic or diastolic blood pressure in the hypertension program. The secondary outcome was the total number of pharmacologic interventions. Paired sample t-tests were used to assess the results. RESULTS: A total of 138 enrollees met the study inclusion criteria. The mean difference in systolic and diastolic blood pressure between baseline and completion of the program was -8.33 mm Hg (P = .001; 95% confidence interval [CI], 3.58-13.09) and -3.67 mm Hg (P = .015; 95% CI, 0.75-6.58), respectively. The mean differences in total cholesterol, low-density lipoprotein, and triglycerides from baseline were -27.67 mg/dL (P <.001; 95% CI, 19.36-35.99), -23.16 mg/dL (P <.001; 95% CI, 15.41-30.92), and -67.62 mg/dL (P <.001; 95% CI, 30.73-104.52), respectively. In all, 46 (46.9%) of the 98 enrollees in the dyslipidemia program required a pharmacologic intervention. In the hypertension program, 18 (31.6%) of 57 enrollees required a pharmacologic intervention. CONCLUSION: Our findings demonstrate that the use of a pharmacy department-managed, employer-sponsored wellness program that is managed by pharmacists and an advanced practice nurse could lead to significant reductions in blood pressure and lipid levels for employees and for their spouses who are enrolled in the program.

Past and present of antiobesity agents: focus on monoamine modulators.

PURPOSE: A review of recently approved antiobesity medications, including their neuropharmacology, efficacy data from clinical trials, and important patient safety considerations, is presented. SUMMARY: Obesity affects roughly 34% of Americans and is associated with increased risks of type 2 diabetes, hypertension, and coronary artery disease, as well as increased mortality and healthcare costs. Most pharmacologic agents used to treat obesity work by modulating monoamine neurotransmitters such as serotonin, norepinephrine, and dopamine. Since the U.S. market withdrawal of agents such as fenfluramine, dexfenfluramine, and sibutramine due to safety concerns, the Food and Drug Administration (FDA) has approved three monoamine modulators for long-term obesity management: the serotonergic agent lorcaserin (approved by FDA in 2012), a combination product containing phentermine and extended-release (ER) topiramate (also approved in 2012), and another combination product consisting of ER naltrexone and ER bupropion (approved in late 2014). In Phase III trials of the three products, mean weight reductions ranging from 4.7 to 10.2 kg over periods of one and two years were reported, with substantial percentages of patients achieving weight loss of ≥5%. Adverse effects reported among clinical trial participants were generally mild; however, as the trials excluded patients with significant cardiovascular risks (e.g., uncontrolled hypertension, valvular heart disease), cautious patient selection and monitoring are advised. CONCLUSION: Recently approved medications for long-term management of obesity include lorcaserin, phentermine-topiramate, and naltrexone-bupropion. When these drugs are used to facilitate weight loss, pharmacists can play an important role in helping to ensure appropriate patient selection and monitoring.

VKORC1 Asp36Tyr geographic distribution and its impact on warfarin dose requirements in Egyptians.

The VKORC1 Asp36Tyr single nucleotide polymorphism (SNP) is one of the most promising predictors of high warfarin dose, but data on its population prevalence is incomplete. We determined the frequency of this SNP in participants from seven countries on four continents and investigated its effect on warfarin dose requirement. One thousand samples were analysed to define the population prevalence of this SNP. Those samples included individuals from Egypt, Ghana, Sudan, Kenya, Saudi Arabia, Peru and African Americans from the United States. A total of 206 Egyptian samples were then used to investigate the effect of this SNP on warfarin dose requirements. This SNP was most frequent among Kenyans and Sudanese, with a minor allele frequency (MAF) of 6% followed by Saudi Arabians and Egyptians with a MAF of 3% and 2.5%, respectively. It was not detected in West Africans, based on our data from Ghana, and a large cohort of African Americans. Egyptian carriers of the VKORC1 Tyr36 showed higher warfarin dose requirement (57.1 ± 29.4 mg/week) than those with the Asp36Asp genotype (35.8 ± 16.6 mg/week; p=0.03). In linear regression analysis, this SNP had the greatest effect size among the genetic factors (16.6 mg/week increase in dose per allele), and improved the warfarin dose variability explained in Egyptians (model R2 from 31% to 36.5%). The warfarin resistant VKORC1 Asp36Tyr appears to be confined to north-eastern Africa and nearby Middle-Eastern populations, but in those populations where it is present, it has a significant influence on warfarin dose requirement and the percent of warfarin dose variability that can be explained.

Assessing the utility of whole genome amplified DNA as a template for DMET Plus array.

BACKGROUND: Large amounts of high quality DNA are typically required for high-throughput genotyping arrays but sometimes study participant DNA is in limited supply. Multiple displacement amplification (MDA)-based whole genome amplification is an in vitro technique that permits the genetic analysis of limited amounts of high molecular weight genomic DNA (gDNA). METHODS: The performance of MDA-whole genome amplified DNA (wgaDNA) as a template for DMET Plus (Affymetrix) was assessed. wgaDNA was generated from gDNA from three HapMap CEU cell lines and 11 breast cancer patients. One HapMap sample and three patient samples were randomly selected for replication to assess reproducibility. Accuracy was assessed by comparing the wgaDNA genotypes with gDNA genotypes. The kappa (κ) statistic was used to measure genotype concordance between paired gDNA-wgaDNA and wgaDNA-wgaDNA samples. Copy number variants (CNV) were not included in concordance analysis in this study. RESULTS: A good genotype call rate of 98.8%±1.06% (mean±standard deviation, 1931 markers) was observed for all 18 wgaDNA samples with three samples having call rates lower than 98%. High genotype concordance rates were observed between four HapMap wgaDNA-gDNA pairs (98.5%, κ=0.9817, p<0.0001, 1931 markers) and 14 patient wgaDNA-gDNA pairs (100%, κ=1.00, p<0.0001, 19 markers among CYP2D6 and CYP2C19). Excellent genotype concordance was also observed between four independently amplified duplicate samples (98.0%, κ=0.9745; p<0.0001, 1931 markers). CONCLUSIONS: MDA-produced wgaDNA provides accurate and reproducible genotypes with the DMET Plus array and is therefore a suitable template for this targeted pharmacogenetic genotyping array.

A capillary electrophoresis method for genotyping the 9-bp exon 1 insertion/deletion in BDKRB2.

AIM: To develop and apply a novel genotyping method for the 9-bp exon 1 insertion/deletion polymorphism in BDKRB2. MATERIALS & METHODS: DNA from 718 patients with heart failure was extracted using standard methods and a region containing exon 1 of BDKRB2 was amplified with PCR. The PCR product was separated using the Qiagen QIAxcel® capillary electrophoresis system. The bp size of the PCR product was calculated and the genotypes determined using Qiagen BioCalculator® software. RESULTS: Capillary electrophoresis accurately genotyped samples with >99% call rate and 700 s run time per row of a 96-well plate (i.e., less than 1 min per sample). The frequency of the deletion was 49% in the Caucasian patients (n = 441) and 45% in the African-American (n = 277). CONCLUSION: Capillary electrophoresis is a rapid, accurate and sensitive method for genotyping the 9-bp exon 1 insertion/deletion polymorphism in BDKRB2.