Karen R. Sando

Nonstatin Therapies for Management of Dyslipidemia: A Review

PURPOSE Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Recently published cholesterol treatment guidelines emphasize the use of statins as the preferred treatment strategy for both primary and secondary prevention of CVD. However, the optimal treatment strategy for patients who cannot tolerate statin therapy or those who need additional lipid-lowering therapy is unclear in light of recent evidence that demonstrates a lack of improved cardiovascular outcomes with combination therapy. The purpose of this review is to summarize and interpret evidence that evaluates nonstatin drug classes in reducing cardiovascular outcomes, to provide recommendations for use of nonstatin therapies in clinical practice, and to review emerging nonstatin therapies for management of dyslipidemia. METHODS Relevant articles were identified through searches of PubMed, International Pharmaceutical Abstracts, and the Cochrane Database of Systematic Reviews by using the terms niacin, omega-3 fatty acids (FAs), clofibrate, fibrate, fenofibrate, fenofibric acid, gemfibrozil, cholestyramine, colestipol, colesevelam, ezetimibe, proprotein convertase subtilisin/kexin 9 (PCSK9), cholesteryl ester transfer protein (CETP), and cardiovascular outcomes. Only English language, human clinical trials, meta-analyses, and systematic reviews were included. Additional references were identified from citations of published articles. FINDINGS Niacin may reduce cardiovascular events as monotherapy; however, recent trials in combination with statins have failed to show a benefit. Trials with omega-3 FAs have failed to demonstrate significant reductions in cardiovascular outcomes. Fibrates may improve cardiovascular outcomes as monotherapy; however, trials in combination with statins have failed to show a benefit, except in those with elevated triglycerides (>200 mg/dL) or low HDL-C (<40 mg/dL). There is a lack of data that evaluates bile acid sequestrant in combination with statin therapy on reducing cardiovascular events. Ezetimibe-statin combination therapy can reduce cardiovascular outcomes in those with chronic kidney disease and following vascular surgery or acute coronary syndrome. Long-term effects of emerging nonstatin therapies (CETP and PCSK9 inhibitors) are currently being evaluated in ongoing Phase III trials. IMPLICATIONS Nonstatin therapies have a limited role in reducing cardiovascular events in those maintained on guideline-directed statin therapy. In certain clinical situations, such as patients who are unable to tolerate statin therapy or recommended intensities of statin therapy, those with persistent severe elevations in triglycerides, or patients with high cardiovascular risk, some nonstatin therapies may be useful in reducing cardiovascular events. Future research is needed to evaluate the role of nonstatin therapies in those who are unable to tolerate guideline-directed statin doses.

Pharmacists’ Impact on Improving Outcomes in Patients With Type 2 Diabetes Mellitus:

Purpose The purpose of this study was to evaluate a diabetes education program that includes a pharmacist as a member of the diabetes management team by assessing the change in hemoglobin A1c (A1C), cholesterol, and blood pressure for patients with type 2 diabetes in outpatient clinics. Methods This was a retrospective study in outpatient clinics at Shands Jacksonville Medical Center. The patients were assigned into either the pharmacist group or the nonpharmacist group, according to the presence or the absence of a pharmacist in the clinic. The primary end point was the absolute change in A1C versus baseline. Secondary end points included change in cholesterol and blood pressure and the number of patients to attain American Diabetes Association goals. End points were recorded to correlate within 3 months of the initial visit and final visit with a provider. Results Compared to the nonpharmacist group, patients in the pharmacist group had more advanced and uncontrolled diabetes at baseline. The pharmacist group showed a greater percent change in A1C and improvement between the initial and final clinic visits, after adjusting for baseline confounders. Despite the statistically significant improvement in A1C in the pharmacist group, there was no difference found between the 2 groups for the end points of cholesterol and blood pressure. Conclusion Including a pharmacist as a part of the diabetes management team may result in lower A1C in patients with more advanced and uncontrolled type 2 diabetes mellitus versus a health care team without a pharmacist.

An educational tool for teaching medication history taking to pharmacy students.

Objective. To implement and evaluate the use of a situated-learning experience to prepare second-year pharmacy students to conduct medication history interviews in preparation for introductory pharmacy practice experiences (IPPE) at ambulatory clinic sites. Design. Second-year doctor of pharmacy (PharmD) students (n=200) used the Medication Mysteries Infinite Case Tool, a game-like educational tool in which groups of 3 students assumed the roles of pharmacist, patient, and observer and rolled a die and drew cards to determine the drugs, patient personality, medication problems, and other variables that guided a medication history taking session. Assessment. After the laboratory session, faculty members assessed students’ medication history-taking skills. One hundred sixteen (58%) and 78 (39%) of 200 students achieved excellence or competence, respectively, on the final assessment. Two weeks after the assessment, 53 of 200 (26.5%) students completed a survey instrument. The respondents indicated that their self-confidence in conducting medical history taking significantly improved following completion of the learning experience. Conclusion. Using the Medication Mysteries Infinite Case Tool increased students’ confidence and skills in conducting medication history taking prior to their clinical IPPE experience.

Feasibility of Extended-interval Follow-up for Patients Receiving Warfarin.

AIMS The 2012 American College of Chest Physician Evidence-Based Management of Anticoagulant Therapy guidelines suggest an international normalized ratio (INR) testing interval of up to 12 weeks, rather than every 4 weeks, for patients with consistently stable INRs while taking vitamin K antagonists. We aimed to examine the feasibility of extended-interval follow-up in a real-world setting. METHODS Patients receiving stable warfarin therapy for ≥ 12 weeks at baseline began extended-interval follow-up with visits occurring at 6 weeks, 14 weeks, and every 12 weeks thereafter to a maximum of 68 weeks or until they were no longer suitable for extended-interval follow-up. A single INR excursion >0.3 from goal was permitted if a reversible precipitating factor was identified and the INR was expected to return to goal without dose adjustment. The primary outcome was the proportion of patients completing all study follow-up visits. RESULTS Of 48 patients enrolled, 47 had evaluable data. The most common indication for anticoagulation was atrial fibrillation/flutter (53.2%). At baseline, mean prior warfarin treatment duration was 6.7 ± 6 years and median number of weeks on a stable regimen was 24 weeks (IQR, 19-37.5). Eleven patients (23%) completed all study follow-up visits, whereas 17 (36%) did not maintain a stable INR past the 14-week follow-up. CONCLUSION A large proportion of patients with previously stable (≥ 3 months) INRs were not able to maintain stable INRs during extended-interval follow-up. More research is needed to identify patient characteristics predictive of success with extended-interval follow-up prior to broad implementation.

Recent diabetes issues affecting the primary care clinician.

Diabetes accounts for millions of office visits each year to primary care offices in the United States. Successful care of the patient with type 2 diabetes requires not only focus on glucose management but also on comorbidities such as hypertension, dyslipidemia and obesity which are closely linked to microvascular and macrovascular complications. Primary care clinicians must stay abreast of frequently published diabetes literature and new treatments to care for these increasingly complex patients. Metformin and its effect on B12 absorption continues to be an issue encountered by clinicians in daily clinical practice. There has also been recent discussion regarding the increased risk of diabetes with statins; data to date on this issue have been conflicting. Rosiglitazone continues to face public scrutiny and there are now Food and Drug Administration regulations regarding its increased risk of cardiovascular disease. Liraglutide and saxagliptin represent new treatment options for type 2 diabetes, increasing the available options for treating this complex disease. A review of the primary literature involving these topics is provided.

Do Electronic Cigarettes Have a Role in Tobacco Cessation

Tobacco use continues to be a major cause of morbidity and mortality. Even with behavioral and pharmacologic treatment, long‐term tobacco cessation rates are low. Electronic nicotine delivery systems, commonly referred to as electronic cigarettes or e‐cigarettes, are increasingly used for tobacco cessation. Because e‐cigarettes are widely used in this setting, health care professionals need to know if they are safe and effective. The purpose of this article is to review literature regarding use of e‐cigarettes as a tool for tobacco cessation in patients who are ready to quit, as well as those who are not ready to quit, along with some selected patient populations. The safety and clinical implications of e‐cigarette use are also reviewed. Small, short‐term studies assessing smokers’ use of e‐cigarettes suggest that e‐cigarettes may be well tolerated and modestly effective in achieving abstinence. High‐quality studies are lacking to support e‐cigarettes use for cessation in patients with mental health issues. One small prospective cohort study concluded that patients with mental health issues reduced cigarette use with e‐cigarette use. Although one study found that patients with cancer reported using e‐cigarettes as a tobacco‐cessation strategy, e‐cigarettes were not effective in supporting abstinence 6 and 12 months later. Additional research is needed to evaluate the use of e‐cigarettes for smoking cessation in patients with pulmonary diseases. No data exist to describe the efficacy of e‐cigarettes for smoking cessation in pregnant women. Although study subjects report minimal adverse effects with e‐cigarettes and the incidence of adverse effects decreases over time, long‐term safety data are lacking. Health care providers should assess e‐cigarette use in their patients as part of the tobacco cessation process.

Pharmacist Impact on Treatment Intensification and Hemoglobin A1C in Patients With Type 2 Diabetes Mellitus at an Academic Health Center

Background: Achievement of treatment goals for patients with type 2 diabetes mellitus (T2DM) is suboptimal. This is in part driven by a lack of treatment intensification when warranted, termed “clinical inertia.” Objectives: To investigate time to treatment intensification and changes in A1C among pharmacist–physician managed (PPM) patients compared to usual medical care (UMC) in patients with T2DM. Methods: Retrospective matched cohort study at 2 academic family medicine clinics. Patients in each cohort were matched 1:1 based on age (±5 years), primary care provider, gender, and race. Results: A total of 50 patients met inclusion criteria. Mean time to treatment intensification was longer in the UMC cohort as compared with the PPM cohort (325 (66) days vs 200 (62) days [P = .50]). A higher percentage of patients in the PPM cohort achieved ≥0.5% reduction in A1C in comparison to the UMC cohort (60% vs 44%, respectively [P = .41]). Patients in the PPM cohort experienced a greater mean decrease in A1C from baseline when compared to patients in the UMC cohort (−1% (1.8%) vs −0.4% (2.2%) [P = .24]). Conclusion: Patients exposed to a pharmacist in this retrospective matched cohort study experienced shorter time to treatment intensification and a greater reduction in A1C than those managed solely by a medical provider, although results were not statistically significant. Additional research is needed to evaluate the role of the pharmacist in improving clinical inertia in the management of T2DM.

Pharmacy resident teaching and learning curriculum program outcomes: Student performance and quality assessment

INTRODUCTION The purpose of this study was to assess: (1) student performance on topics taught by first and second year postgraduate pharmacy residents and (2) the quality of learning objectives and multiple choice questions prepared by pharmacy residents. METHODS Using a retrospective cohort design, residents and students who taught or were enrolled, respectively, in the Medication Therapy Management course in years 2010 to 2012 were participants in this study. Student performance was assessed using scores earned on the individual readiness assurance tests (iRATs), team readiness assurance tests (tRATs), and course examinations. To assess the quality of the learning objectives and multiple choice questions written by pharmacy residents, criteria were established by the authors. Each learning objective and multiple choice question was then evaluated independently by two authors to determine if these criteria were met. RESULTS Statistical differences were observed in student performance across all content areas among the three years for iRAT, tRAT, and course examination scores, with the exception of the heart failure course examination (p = 0.05; all other p-values < 0.05). A total of 20 (42%) learning objectives met all quality review criteria, while 73 (79%) of the multiple-choice questions met all quality review criteria. DISCUSSION AND CONCLUSIONS Student performance varied significantly depending on the content, but the overall impact of resident instructors on student course performance was not educationally significant. Teaching and learning curriculum programs should focus on teaching residents to create quality learning objectives that help students focus on learning the most important course content.

Assessment of SOAP note evaluation tools in colleges and schools of pharmacy

INTRODUCTION To describe current methods used to assess SOAP notes in colleges and schools of pharmacy. METHODS Members of the American Association of Colleges of Pharmacy Laboratory Instructors Special Interest Group were invited to share assessment tools for SOAP notes. Content of submissions was evaluated to characterize overall qualities and how the tools assessed subjective, objective, assessment, and plan information. RESULTS Thirty-nine assessment tools from 25 schools were evaluated. Twenty-nine (74%) of the tools were rubrics and ten (26%) were checklists. All rubrics included analytic scoring elements, while two (7%) were mixed with holistic and analytic scoring elements. A majority of the rubrics (35%) used a four-item rating scale. Substantial variability existed in how tools evaluated subjective and objective sections. All tools included problem identification in the assessment section. Other assessment items included goals (82%) and rationale (69%). Seventy-seven percent assessed drug therapy; however, only 33% assessed non-drug therapy. Other plan items included education (59%) and follow-up (90%). DISCUSSION AND CONCLUSIONS There is a great deal of variation in the specific elements used to evaluate SOAP notes in colleges and schools of pharmacy. Improved consistency in assessment methods to evaluate SOAP notes may better prepare students to produce standardized documentation when entering practice.