Catherine Cone

Hepatotoxicity Associated with Metformin Therapy in Treatment of Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease

Objective: To report a case of idiosyncratic hepatotoxicity associated with metformin in the treatment of type 2 diabetes with nonalcoholic fatty liver disease (NAFLD). Case Summary: A 61-year-old obese man presented with jaundice, nausea, fatigue, and an unintentional weight loss 2 weeks following initiation of metformin. Laboratory findings revealed aminotransferase values 10–15 times the upper limit of normal. Potential causative agents, including metformin, simvastatin, and Niaspan (extended-release niacin), were discontinued. Two months later, the patients signs and symptoms had resolved and aminotransferase values returned to normal. An objective causality assessment revealed that the adverse reaction was probably associated with metformin. Discussion: Since numerous medications and disease states can cause abnormalities in liver enzymes, it is important for providers to be able to distinguish the cause(s) and take appropriate actions. This can take a great deal of time and effort in patients with multiple medications and comorbidities. In this patients case, viral hepatitis, worsening NAFLD, and the concomitant drugs were highly suspected. As hydroxymethylglutaryl coenzyme A reductase inhibitors offer substantial cardiovascular benefits and as metformin is a first-line agent in helping to lower blood glucose concentrations and to normalize the metabolic profile in type 2 diabetes, reintroduction of metformin and simvastatin would likely be beneficial. Conclusions: This is a case report of metformin-induced hepatotoxicity. As the prevalence of type 2 diabetes and subsequent metabolic effects increases in the US, metformin use will likewise increase. As potential for increased idiosyncratic hepatotoxicity associated with metformin use is likely to occur, clinicians should be vigilant.

Instructional Scaffolding to Improve Students’ Skills in Evaluating Clinical Literature

Objective. To implement and assess the effectiveness of an activity to teach pharmacy students to critically evaluate clinical literature using instructional scaffolding and a Clinical Trial Evaluation Rubric. Design. The literature evaluation activity centered on a single clinical research article and involved individual, small group, and large group instruction, with carefully structured, evidence-based scaffolds and support materials centered around 3 educational themes: (1) the readers awareness of text organization, (2) contextual/background information and vocabulary, and (3) questioning, prompting, and self-monitoring (metacognition). Assessment. Students initially read the article, scored it using the rubric, and wrote an evaluation. Students then worked individually using a worksheet to identify and define 4 to 5 vocabulary/concept knowledge gaps. They then worked in small groups and as a class to further improve their skills. Finally, they assessed the same article using the rubric and writing a second evaluation. Students’ rubric scores for the article decreased significantly from a mean pre-activity score of 76.7% to a post-activity score of 61.7%, indicating that their skills in identifying weaknesses in the articles study design had improved. Conclusion. Use of instructional scaffolding in the form of vocabulary supports and the Clinical Trial Evaluation Rubric improved students’ ability to critically evaluate a clinical study compared to lecture-based coursework alone.

Relationship between diet, exercise habits, and health status among patients with diabetes.

BACKGROUND The American Diabetes Association recommends that people with diabetes should engage in physical activity and healthy eating. Similarly, diets rich in fruits or vegetables (5-13 servings) have been found to lower the risk of stroke, cardiovascular conditions, cancer, and diabetes. OBJECTIVES To examine the associations between eating fruits and vegetables and exercising on physical/mental health among diabetes patients. A secondary objective was to describe the relationship between socioeconomic status and physical/mental health. Finally, we used the Health Belief Model (HBM) to help providers understand how they can work best with their patients to implement healthy lifestyle. METHODS The 2005 Centers for Disease Controls Behavioral Risk Factor Surveillance System was used to determine the relationship between eating fruits/vegetables and exercise on physical and mental health. The sample was restricted to individuals who self-reported being diagnosed with diabetes (N=33,320) in 2005. Eating fruits and vegetables was categorized by the number of fruit and vegetable servings consumed daily (0, 1-2, 3-4, and ≥5). Poisson regression was used to assess these associations. RESULTS Only 26% of individuals ate 5 or more servings of fruits and vegetables, whereas only 33% met exercise recommendations. Individuals who ate 5 or more servings of fruits and vegetables reported better mental health but poor physical health. Compared with meeting exercise recommendations, no exercise was associated with more days of poor physical/mental health. CONCLUSIONS Reinforcement of daily exercise is helpful to patients with diabetes (PWDS); meeting exercise recommendations was associated with better outcomes of physical and mental health. Pharmacists and other public health providers should focus on interventions that incorporate the promotion of healthy lifestyles. The HBM can be used to improve health behavior among PWDS. Pharmacists are in a unique position to advocate change with consistent access to care.

Incorporation of an Explicit Critical-Thinking Curriculum to Improve Pharmacy Students’ Critical-Thinking Skills

Objective. The Health Sciences Reasoning Test (HSRT) is a validated instrument to assess critical-thinking skills. The objective of this study was to determine if HSRT results improved in second-year student pharmacists after exposure to an explicit curriculum designed to develop critical-thinking skills. Methods. In December 2012, the HSRT was administered to students who were in their first year of pharmacy school. Starting in August 2013, students attended a 16-week laboratory curriculum using simulation, formative feedback, and clinical reasoning to teach critical-thinking skills. Following completion of this course, the HSRT was readministered to the same cohort of students. Results. All students enrolled in the course (83) took the HSRT, and following exclusion criteria, 90% of the scores were included in the statistical analysis. Exclusion criteria included students who did not finish more than 60% of the questions or who took less than 15 minutes to complete the test. Significant changes in the HSRT occurred in overall scores and in the subdomains of deduction, evaluation, and inference after students completed the critical-thinking curriculum. Conclusions. Significant improvement in HSRT scores occurred following student immersion in an explicit critical-thinking curriculum. The HSRT was useful in detecting these changes, showing that critical-thinking skills can be learned and then assessed over a relatively short period using a standardized, validated assessment tool like the HSRT.

Alignment of Pharmacotherapy Course Assessments With Course Objectives

Objective. To determine whether instructor-prepared classroom examinations for pharmacotherapy courses were aligned with course goals and objectives. Design. Assessment items from examinations in 2 pharmacotherapy courses were evaluated. Four categories of alignment (depth of knowledge, categorical concurrence, range of knowledge, and balance of representation) were used to match course assessments with objectives. Assessment. While assessments met the criteria for acceptable alignment, there were areas for improvement. Goals and objectives were unevenly assessed, with 1 goal aligning with 45% of all assessment items. The assessments covered all content categories and the range of knowledge established by the objectives, but objectives under specific goals were not evenly assessed. Conclusion. This alignment study provided quantitative data useful for review and revision of pharmacotherapy course objectives and assessments and demonstrated the usefulness of alignment assessment as a tool for continuous quality improvement.

Convulsions associated with moxifloxacin

Fluoroquinolones are generally well tolerated but can cause central nervous system (CNS) toxicities.[1][1] We are unaware of published case reports of moxifloxacin causing new-onset convulsions, though one case associating the drug with seizures in a patient with a history of epilepsy has been