Infectious complications of newer agents in the fight against diabetes.

Infectious complications have been reported with antidiabetic medications. Glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors have been associated with upper respiratory tract infections and urinary tract infections. Sodium-glucose cotransporter 2 inhibitors have been associated with lower limb amputations, urinary tract infections, genital mycotic infections, and Fournier gangrene.

Frontline perspective on credentialing and privileging of ambulatory care pharmacists.

OBJECTIVES: To present the current state of, and frontline advice on, the implementation of successful credentialing and privileging processes for practicing pharmacists in the United States. METHODS: The American Society of Health-System Pharmacists (ASHP) Section Advisory Group on Compensation and Practice Sustainability surveyed ambulatory care pharmacists via ASHP Connect about the status, structure and oversight of their ambulatory care clinical practice sites with credentialed and privileged (C&P) pharmacists. KEY FINDINGS: Over 80% of survey respondents identified themselves as a C&P pharmacist, and over 90% indicated it is 'Important' or 'Very Important' for pharmacists to be C&P. Qualitative survey responses indicated the most important considerations for establishing or expanding a credentialing and privileging process for ambulatory care pharmacists were 'don't re-create the wheel', 'establish a physician champion and/or obtain leadership buy-in', 'be persistent and patient', 'develop a guidance document' and 'work within existing processes'. CONCLUSIONS: Starting a credentialing and privileging process is critical in preparation for, or response to, provider status recognition of pharmacists in the United States. When used with existing guidance documents on credentialing and privileging, 'front line' advice from practicing pharmacists can help promote expanded roles for pharmacists within healthcare systems.

Admission type is a paradoxical predictor of performance in problem-based learning courses.

INTRODUCTION: To determine if a difference in problem-based learning (PBL) performance or student attrition exists based on admission type. METHODS: This retrospective review analyzed admission type and student academic performance in the PBL course series from 2002 to 2009. Student scores were compiled based on admission type: provisional (high school), traditional with degree (bachelor's or higher), and traditional without degree (some college). ANOVA was performed on overall scores amongst the three admission types. Continuous data were analyzed using two-sided unpaired t-tests, and dichotomous data were analyzed using chi-square test. RESULTS: 600 students received at least one score in the third-year (P3) PBL course series. 56% of students (n = 333) were admitted traditional without degree, while the remainder were split between provisional (n = 125) and traditional with degree (n = 142) admission. Provisionally admitted students had significantly higher scores than either of the other groups (p < 0.001 for both) and significantly fewer students failed a course versus either of the other groups (p < 0.001 for both). Additionally, traditional without degree students had significantly higher averages and fewer failing grades compared to traditional with degree students (p < 0.01 for both) over the eight years analyzed. CONCLUSIONS: This study's results suggest that degrees may not be predictive of success during PBL in the P3 year. Further work is needed in order to truly assess predictive nature of this and other factors among prospective pharmacy students.

Effect of fish oil supplement administration method on tolerability and adherence: a randomized pilot clinical trial.

OBJECTIVES: Anecdotally, several strategies have been suggested in order to improve tolerability of fish oil supplements, but there is little evidence supporting any of these strategies. The aim of this study was to determine if there is a difference among four methods of oral administration of fish oil supplementation in terms of tolerability and adherence. METHODS: A randomized, prospective, open-label, four-arm pilot study was conducted on 60 healthy adult subjects randomized to different fish oil supplement administration methods with (1) milk, (2) food, (3) an empty stomach, and (4) frozen capsules prior to ingestion. Each subject was instructed to take two capsules three times daily for 30 consecutive days. Adherence was assessed by pill counts. Adverse effects were assessed by survey and patient exit interview. RESULTS: No apparent differences were demonstrated among the four administration groups in terms of adherence, reasons for non-adherence, or self-reported adverse effects. CONCLUSIONS: Method of administration did not affect rates of adherence or incidence of adverse effects in a small cohort of healthy adults taking fish oil supplement capsules for 30 days. TRIAL REGISTRATION: ClinicalTrials.gov NCT01471366. Registered November 16, 2011.

Development of critical thinking in health professions education: A meta-analysis of longitudinal studies.

INTRODUCTION: While reports of critical thinking exist in the health professions literature, development of critical thinking across a broad range of health-professions students has not been systematically reviewed. METHODS: In this meta-analysis, multiple databases and journals were searched through February 2016 to identify longitudinal studies using standardized tests of critical thinking [California Critical Thinking Skills Test (CCTST), Health Science Reasoning Test (HSRT), and Defining Issues Test (DIT)] in any language. Two reviewers extracted information and collected information regarding primary author, publishing journal, health profession, critical thinking test, and time1/time2 means and standard deviations. Standardized mean differences (SMD) with 95% confidence intervals (CI) were reported using a random-effects model. RESULTS: Four hundred sixty-two studies were screened, and 79 studies (representing 6884 students) were included. Studies contained 37 CCTST, 22 DIT, and 20 HSRT. Health professions comprised nursing, pharmacy, physical therapy, occupational therapy, dentistry, medicine, veterinary medicine, dental hygiene, clinical laboratory sciences, and allied health. Cohen's kappa was strong (0.82) for inter-reviewer agreement. Both the CCTST (SMD = 0.37, 95% CI = 0.23-0.52) and DIT (SMD = 0.28, 95%CI = 0.18-0.39) demonstrated significant increases in total scores, but the HSRT (SMD = 0.03, 95%CI = -0.05-0.12) did not show improvement. DISCUSSION/CONCLUSIONS: In this meta-analysis, students from the majority of health professions consistently showed improvement in development of critical thinking. In this diverse population, only the CCTST and DIT appeared responsive to change.

Sodium Glucose Transporter 2 Inhibitors and Diabetic Ketoacidosis in Three Patients with Diabetes: Underlying Causation.

Sodium glucose transporter 2 inhibitors (SGLT2i) inhibit the reabsorption of glucose in the renal tubules reducing glycemia and increasing glucosuria. The increased glucosuria causes a shift in normal flora and colonization of pathogenic microorganisms leading to an increase in mycotic genital infections. Recent Food and Drug Administration reported cases of diabetic ketoacidosis (DKA) after initiation of SGLT2i probes the question of safety with such agents. The mechanisms of ketoacidosis and the breakdown of lipids are often misunderstood, and blame is placed on lack of insulin or on medications used to treat diabetes. However, many patients living with diabetes do not experience DKA if the proper treatment and management of concomitant comorbidities are addressed. After a retrospective chart review of 250 patients, three patients were identified with DKA while on SGLT2i, but for three distinct contrasting reasons. Assessment of the pharmacodynamics of SGLT2i and the pathophysiology of DKA infers that emphasis for prevention of SGLT2i-associated DKA should be placed on appropriate diagnosis, infection, and electrolyte abnormalities.

Evidence-based review of statin use in patients with HIV on antiretroviral therapy.

INTRODUCTION: As a result of improved safe and effective therapeutic options for human immunodeficiency virus (HIV), life expectancy of those living with HIV is increasing leading to new challenges (e.g., management of chronic diseases). Some chronic diseases (e.g., cardiovascular disease [CVD]), are up to two times more prevalent in patients with HIV. Statins are a mainstay of therapy for prevention of CVD; but, clinicians should be aware that not all statins are appropriate for use in the HIV population, especially those receiving antiretroviral therapy (ART). The purpose of this article is to review the pharmacokinetic and clinical data for statin therapy in HIV-infected patients receiving ART. METHODS: A systematic literature search using PubMed and MEDLINE databases was performed using each statin drug name combined with HIV, pharmacokinetics, AIDS, and/or human immunodeficiency virus. English language trials published from 1946 to November 2016 were considered, and results were limited to clinical efficacy trials. RESULTS: In general, atorvastatin and pravastatin are safe and effective for patients treated with protease-inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor-based ART. Rosuvastatin is generally considered safe if started at a low dose, but should be avoided if possible in patients receiving PI-based ART. Pitavastatin has limited supporting evidence, but appears safe for use based on its pharmacokinetic properties and low number of drug interactions. Fluvastatin, lovastatin, and simvastatin should be avoided in patients receiving ART due to drug interactions, adverse events, and/or limited clinical data. CONCLUSION: Clinicians need to be familiar with the intricacies of statin selection for the prevention of CVD in patients with HIV on ART.

Impact of mulberry leaf extract on type 2 diabetes (Mul-DM): A randomized, placebo-controlled pilot study.

AIMS: Mulberry leaves have been used anecdotally in Asia to treat many disease states, including glucose abnormalities. Animal and human studies illustrate potential benefit of mulberry leaf extract (MLE) in type 2 diabetes mellitus (DM2). The purpose of this study is to evaluate the glycemic and safety effects of MLE in patients with DM2. MATERIALS & METHODS: This randomized, double-blind, placebo-controlled pilot study evaluated MLE (1000mg standardized) versus matching placebo given three times daily with meals. Patients (n=24) were included if they had DM2 on single or combination oral therapy with a stable hemoglobin A1C (A1C). A 2-week placebo run-in (baseline) was followed by initiation of randomized medication for 3 months. Primary endpoints were change in A1C and self-monitoring blood glucoses (SMBG). Safety was also evaluated. RESULTS: Of 24 patients enrolled, 17 patients completed the study. Post-prandial SMBG was significantly decreased at 3 months in the MLE group versus baseline (16.1%; p<0.05). This improvement in post-prandial SMBG persisted when compared to placebo (18.2%; p<0.05). A1C decreased from 7.30% at baseline to 6.94% in the MLE group but did not reach statistical significance (p=0.079). There was no difference in A1C between MLE and placebo. A significant 15% increase occurred in serum creatinine when the MLE group was compared to baseline or placebo (p<0.05 for both). There was no significant effect on weight, fasting SMBG, blood pressure, hypoglycemia, or other safety evaluation markers. CONCLUSIONS: These results suggest that mulberry leaf extract may be a useful complementary mealtime glucose option for patients with DM2. ClinicalTrials.gov Identifier NCT00795704.

Comparison of Pharmacist and Physician Managed Annual Medicare Wellness Services.

BACKGROUND: Medicare Annual Wellness Visits (AWV) are a benefit provided for Medicare beneficiaries to increase focus on wellness and preventive measures. Pharmacists can conduct AWVs, which offers a potential avenue for outpatient revenue generation. PROGRAM DESCRIPTION: To compare a composite of interventions and screenings and revenue generated by a pharmacist with those made by a physician during a subsequent AWV. A report generated through the electronic health record was used to determine AWVs conducted by a pharmacist or 3 participating physicians from December 2013 to March 2016, including revenue generated. Through electronic chart review, documentation was accessed to quantify and categorize the number and types of referrals, health advice, laboratory tests, procedures, vaccinations, and screenings that were recommended during each patient's AWV. OBSERVATIONS: The pharmacist performed 19 subsequent visits, and the 3 physicians performed 89 subsequent visits. Overall, the composite of interventions and screenings was significantly higher in the pharmacist group than the physician group (P = 0.03). More interventions were made in the areas of health advice (P = 0.020), vaccine recommendations (P = 0.009), and screenings in the pharmacist group (P < 0.001). The physicians ordered significantly more laboratory tests per visit (P < 0.001). The pharmacist was reimbursed on average $105 per visit versus $99 per visit for the physicians. IMPLICATIONS: Pharmacist-provided AWVs are at least comparable to those provided by physicians and offer an additional access point for valuable services for Medicare beneficiaries. DISCLOSURES: There was no financial contribution to this study. Riche reports participation in the Speaker's Bureau for Merck and the Speaker's Bureau and Advisory Board for Novo Nordisk. The authors have no other conflicts of interest to report pertinent to this research. This data has not been previously published in any other location. Richie, Sewell, Malinowski, Jackson, and Fleming were involved in study design and manuscript preparation/approval. Jackson was involved in data collection, and Richie and Sewell were involved in data collection and data analysis. Sewell and Richie had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Risk Factors for Proliferative Diabetic Retinopathy in African Americans with Type 2 Diabetes.

PURPOSE: To assess personal and demographic risk factors for proliferative diabetic retinopathy in African Americans with type 2 diabetes. METHODS: In this prospective, non-interventional, cross-sectional case-control study, 380 African Americans with type 2 diabetes were enrolled. Participants were recruited prospectively and had to have either: (1) absence of diabetic retinopathy after ≥10 years of type 2 diabetes, or (2) presence of proliferative diabetic retinopathy when enrolled. Dilated, 7-field fundus photographs were graded using the Early Treatment Diabetic Retinopathy Study scale. Covariates including hemoglobin A1C (HbA1C), blood pressure, height, weight and waist circumference were collected prospectively. Multivariate regression models adjusted for age, sex and site were constructed to assess associations between risk factors and proliferative diabetic retinopathy. RESULTS: Proliferative diabetic retinopathy was associated with longer duration of diabetes (odds ratio, OR, 1.62, p < 0.001), higher systolic blood pressure (OR 1.65, p < 0.001) and insulin use (OR 6.65, p < 0.001) in the multivariate regression analysis. HbA1C was associated with proliferative diabetic retinopathy in the univariate analysis (OR 1.31, p = 0.002) but was no longer significant in the multivariate analysis. CONCLUSIONS: In this case-control study of African Americans with type 2 diabetes, duration of diabetes, systolic hypertension and insulin use were strong risk factors for the development of proliferative diabetic retinopathy. Interestingly, HbA1C did not confer additional risk in this cohort.

Impact of vitamin D status on statin-induced myopathy.

INTRODUCTION: There is a multitude of evidence supporting the benefit of statin use in cardiovascular disease; however, statin-induced myopathy is a major reason for statin discontinuation and non-adherence. Vitamin D deficiency has been independently associated with muscle weakness and severe myopathy, and may be a confounder for statin-induced myopathies. Since there is no consensus on a treatment course of action for statin-induced myopathy, investigation into potential confounders to elucidate the dynamics of statin-induced myopathy is warranted. METHODS: A retrospective chart review was conducted on 105 patients in a cardiometabolic clinic with a vitamin D drawn from December 2006 to April 2008. Patients exposed to statins were divided into two groups: (1) patients with low vitamin D (<32 ng/mL) [n = 52] and (2) patients with a sufficient vitamin D level (⩾32 ng/mL) [n = 32]. Data were compared via t-tests or Fisher's Exact, as appropriate. RESULTS: There were 41 statin-specific myopathies amongst the 24 statin-intolerant patients. Low vitamin D was significantly associated with statin-induced myopathy (p = 0.048). Following prescription vitamin D supplementation, statin tolerance rates were significantly higher in patients with a baseline vitamin D ⩽20 ng/mL than those with a baseline vitamin D >20 ng/mL (90% vs 33%; p = 0.036). CONCLUSION: Vitamin D status may be considered a modifiable risk factor for muscle-related adverse effects of statins, and supplementation of vitamin D (particularly when ⩽20 ng/mL) may improve statin tolerance.

Pathways to Improve Student Pharmacists' Experience in Research.

OBJECTIVE: To describe the implementation of a student research program and to provide outcomes from the initial 4 years' experience. DESIGN: Students conducted individual research projects in a 4-year longitudinal program (known as Pathway), with faculty member advising and peer mentoring. A prospective assessment compared perceptions of those who completed the Pathway program with those of students who did not. Descriptive statistics, t tests, and analysis of variance (ANOVA) were used. ASSESSMENT: The class of 2013 was the first to complete the Pathway program. In the Pathway assessment project, 59% (n=47) of students who responded reached self-set goals. Pathway students agreed that this research experience improved their ability to work/think independently, evaluate literature, and distinguish themselves from other students. CONCLUSION: The Pathway program helped students understand the research process and reach other self-set goals.

Impact of a residency interest group on students applying for residency.

OBJECTIVE: To determine the impact of a faculty-directed, residency interest group on the knowledge, confidence, and preparedness about residency-related topics of third-year (P3) and fourth-year (P4) pharmacy students. DESIGN: Faculty members implemented residency interest group sessions on residency and career preparation for P3 and P4 students. Group meetings consisted of four 2- to 3-hour sessions that covered topics such as residency timeline and resources, letter of intent and CV development, proper interview techniques, and navigating the midyear clinical meeting. Residency directors throughout Mississippi, current pharmacy residents, P3 and P4 students, and other faculty members were invited to attend these sessions. ASSESSMENT: Surveys were administered prior to and after completion of the interest group sessions. Students who attended the sessions demonstrated increased knowledge, confidence, and preparedness on residency-related topics. However, non-attendees also demonstrated increased knowledge, confidence, and preparedness from baseline. CONCLUSION: The majority of students who accepted a residency position had attended at least 1 residency interest group session, suggesting this program had a positive influence.

Pterostilbene on metabolic parameters: a randomized, double-blind, and placebo-controlled trial.

Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters. Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/or LDL ≥ 100 mg/dL. Subjects were divided into four groups: (1) pterostilbene 125 mg twice daily; (2) pterostilbene 50 mg twice daily; (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily; (4) matching placebo twice daily for 6-8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race. Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL; P = 0.001) which was not seen with GE combination (P = 0.47). Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (-7.8 mmHg; P < 0.01) and diastolic blood pressure (-7.3 mmHg; P < 0.001) were reduced with high dose pterostilbene. Patients not on cholesterol medication (n = 51) exhibited minor weight loss with pterostilbene (-0.62 kg/m(2); P = 0.012). Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.gov NCT01267227.

A multipreceptor approach to ambulatory care topic discussions.

OBJECTIVE: To assess the impact of a multipreceptor approach to facilitating topic discussions on students' knowledge and confidence in clinical decision-making during an ambulatory care advanced pharmacy practice experiences (APPEs). DESIGN: Faculty members with relevant expertise and experience facilitated discussions with fourth-year doctor of pharmacy (PharmD) students regarding 7 ambulatory care topics. A student self-assessment survey and knowledge-assessment instrument was administered before and after discussions. ASSESSMENT: Students' examination scores increased significantly from 59.1% ± 13.9% at baseline to 76.5% ± 12.6% at the end of the 5-week experience (p<0.001). The majority of participants were comfortable making therapeutic decisions regarding medication use as it related to all discussion topics except heart failure. CONCLUSIONS: Participation in topic discussions led by faculty members with expertise and experience for each ambulatory care topic was associated with a significant improvement in knowledge-assessment scores.

Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure: a systematic review and meta-analysis.

Sodium-glucose co-transporter 2 (SGLT2) inhibitors represent a new class of antihyperglycemic agents that block renal sodium and glucose reabsorption and may reduce blood pressure (BP). We assessed the BP lowering ability of these agents using meta-analytic techniques. PubMed, SCOPUS, and Cochrane Central were searched through October 2013. We included fully published randomized controlled trials (RCTs) that evaluated SGLT2 inhibitors in patients with type-2 diabetes mellitus and reported change in systolic and/or diastolic BP. Subgroup analyses were performed for placebo-controlled trials and those with active controls. We also conducted meta-regression to assess for a dose-response effect, and whether baseline BP, changes in body weight, heart rate, and hematocrit were associated with the BP effects. Twenty-seven RCTs (n = 12,960 participants) were included. SGLT2 inhibitors significantly reduced both systolic BP (weighted mean difference, -4.0 mm Hg; 95% confidence interval, -4.4 to -3.5) and diastolic BP (weighted mean difference, -1.6 mm Hg; 95% confidence interval, -1.9 to -1.3) from baseline. Only canagliflozin had a significant dose-response relationship with SBP (P = .008). Significant reductions in body weight and hematocrit were seen with the SGLTs. SGLTs had no significant effect on the incidence of orthostatic hypotension (P > .05). SGLT2 inhibitors significantly reduce BP in patients with type 2 diabetes.

Transdermal testosterone replacement therapy in men.

Androgen deficiency syndrome in men is a frequently diagnosed condition associated with clinical symptoms including fatigue, decreased libido, erectile dysfunction, and metabolic syndrome. Serum testosterone concentrations decline steadily with age. The prevalence of androgen deficiency syndrome in men varies depending on the age group, known and unknown comorbidities, and the respective study group. Reported prevalence rates may be underestimated, as not every man with symptoms of androgen deficiency seeks treatment. Additionally, men reporting symptoms of androgen deficiency may not be correctly diagnosed due to the vagueness of the symptom quality. The treatment of androgen deficiency syndrome or male hypogonadism may sometimes be difficult due to various reasons. There is no consensus as to when to start treating a respective man or with regards to the best treatment option for an individual patient. There is also lack of familiarity with treatment options among general practitioners. The formulations currently available on the market are generally expensive and dose adjustment protocols for each differ. All these factors add to the complexity of testosterone replacement therapy. In this article we will discuss the general indications of transdermal testosterone replacement therapy, available formulations, dosage, application sites, and recommended titration schedule.