Retrospective analysis and patient satisfaction assessment of insulin pump therapy in patients with type 2 diabetes.

OBJECTIVES: To evaluate and assess glycemic control, total daily insulin requirements, weight, and patient satisfaction after changing from multiple daily injections (MDI) to continuous subcutaneous insulin infusion (CSII) therapy in patients with type 2 diabetes. METHODS: This was a retrospective cross-sectional cohort analysis of an electronic medical records database from a private physician's clinic. Patients over 18 years of age who had type 2 diabetes and who utilized CSII for at least six months were analyzed. Variables of interest included glycosylated hemoglobin, total daily insulin requirements, and weight at the time of conversion from MDI to CSII. Patients were also asked to complete a satisfaction survey comparing MDI to CSII. RESULTS: Thirty patients who met the inclusion criteria were identified. Hemoglobin A1c (HbA1c) decreased from 9.25% ± 2.20 to 7.94% ± 1.65 (P < 0.001) at six months, total daily insulin dose decreased from 1.33 ± 0.66 u/kg/day to 1.08 ± 0.70 u/kg/day (P < 0.001) at six months, and weight increased from 106.66 ± 19.17 kg to 109.75 ± 18.01 kg (P < 0.001). After twelve months, HbA1c did not significantly change and weight returned to baseline; however, total daily insulin dose significantly decreased. 95% of patients preferred CSII therapy to previous injection regimen for various reasons. CONCLUSION: Insulin pump therapy provided better glycemic control and reduced the total amount of insulin utilized. Patients who utilized CSII thought that the treatment was more convenient, less burdensome, and provided better control of fluctuations in blood glucose. CSII was preferred by patients over multiple daily injections.

Drug use evaluation of sitagliptin dosing by pharmacist versus nonpharmacist clinicians in an internal medicine department of a private physician-owned multispecialty clinic.

BACKGROUND: Sitagliptin is recommended for initial and maintenance dosing at 100 mg daily. Downward dose adjustment is recommended in patients with moderate or severe renal insufficiency. OBJECTIVE: To determine the prevalence of the potentially inappropriate initial dosing of sitagliptin based on estimated glomerular filtration rate (GFR) at baseline for pharmacist versus nonpharmacist prescribers in an internal medicine department of a private physician-owned multispecialty clinic that included a pharmacist-managed diabetes program. METHODS: This was a retrospective cross-sectional cohort analysis using data from an electronic medical record database of a private physicianowned multispecialty clinic that included a pharmacist-managed diabetes program. For patients prescribed sitagliptin between October 17, 2006, and June 5, 2008, the variables of interest were (a) the initial sitagliptin dose; (b) the GFR, calculated for each patient using the 4-point Modification of Dosing in Renal Disease (MDRD) formula at the time of initiation of sitagliptin; and (c) whether the clinician initiating the dose was a pharmacist or nonpharmacist (i.e., internal medicine physician, nurse practitioner, or physician assistant). RESULTS: Of the 290 patients prescribed sitagliptin for the first time between October 17, 2006, and June 5, 2008, 35 (12.1%) received a potentially inappropriate initial dose according to product labeling regarding renal function; 21 were over-dosed and 14 were under-dosed. Potentially inappropriate dosing occurred in 1 of 158 patients (0.6%) who had initial dosing prescribed by a pharmacist compared with 34 of 132 patients (25.8%) for nonpharmacists (P < 0.001, Fisher's exact test). CONCLUSION: Potentially inappropriate initial dosing of sitagliptin based on assessment of renal function was more likely to occur with nonpharmacist prescribers than with a pharmacist prescriber.

Student Pharmacists' Personal Finance Perceptions, Projected Indebtedness Upon Graduation, and Career Decision-making.

Objective. To evaluate the extent to which Doctor of Pharmacy students' personal finance perceptions, projected student loan indebtedness, and demographic characteristics predict postgraduation career intentions. Methods. Students at three pharmacy colleges completed a 31-item survey instrument that assessed personal finance perceptions, self-efficacy beliefs, anticipated student loan debt upon graduation, postgraduate intentions, anticipated practice setting upon graduation, and demographic characteristics. Logistic regression models were used to examine the extent to which personal finance perceptions, student loan indebtedness, and demographic characteristics predicted postgraduate intentions and anticipated practice setting. Results. There were 763 usable responses obtained (response rate=90.3%). Students reported an anticipated personal student loan debt at graduation of $162,747 (SD=$87,093) and an estimated 7.4 (SD=5.8) years to pay off non-mortgage debt postgraduation. Fifty-three percent of students reported planning to practice in a community pharmacy setting postgraduation, and 54% indicated they intended to enter practice directly. Student loan indebtedness was not a significant predictor of whether students planned to pursue postgraduate training. There was a significant association between debt influence and pressure perceptions and students' plans to pursue postgraduate training (aOR=0.78; 95% CI=0.65-0.94). The odds of indicating hospital (vs chain community) pharmacy as the anticipated setting decreased 36% with every one point increase in debt influence and pressure perceptions (aOR=0.64; 95% CI=0.50-0.81). Conclusion. Pharmacy students' perceived debt pressure and influence predicted their intention to enter practice directly (vs pursuing postgraduate training) and to select a career in chain community pharmacy (vs hospital pharmacy). Student loan indebtedness was not a significant predictor of postgraduate training intentions. These findings suggest that interventions that equip students to manage the pressure associated with large student loan debts should be explored.

Academic Pharmacy: Where is Our Influence?

Objective. To evaluate the talents of fellows from cohorts 1-10 of the Academic Leadership Fellows Program (ALFP). Methods. This was a descriptive analysis of previously collected ALFP cohort data reflecting the talents using the Clifton StrengthsFinder assessment tool. Data consisted of 295 fellows from the first 10 years of the ALFP program. The Clifton StrengthsFinder talents were aggregated and analyzed to determine talents (strengths) distribution and domain. The aggregate of the four domains were compared among ALFP fellows using a chi-square analysis with an a priori alpha of .05. Results. Lowest frequency of talents was found in the influencing domain (11.2%), while the domains with the largest frequency of talents were strategic thinking (34.4%) and executing (31.1%). When looking at the specific talents within the domains among the ALFP fellows, achiever (in the executing domain) and learner (in the strategic thinking domain) were the most frequent talents, while command (in the influencing domain) and adaptability (in the relationship building domain) were the least frequent talents. Conclusions. Since the profession is deficient in the influencing and relationship building domains (command and adaptability talents, respectively), this could help explain our slow progress in moving the profession from a product-focused role to a provider-based role. Perhaps the profession should be using a strategy better aligned with our signature leadership domains of executing and strategic thinking and focus on being a member of the health care team by aligning with team-based care rather than obtaining provider status.

The Report of the 2016-2017 Advocacy Standing Committee.

Based on the growing importance of community engagement and the recognition of its importance by the American Association of Colleges of Pharmacy (AACP), the committee offers several examples of community engagement activities for consideration and replication by our academy and beyond. These activities, including those of winning institutions of the Lawrence J. Weaver Transformational Community Engagement Award, can be mapped to the core components of community engagement presented in Table 1. The committee, using an implementation readiness framework, provides the reader with insight into the challenges that may impact successful community engagement and encourages our academy to continue its work to support faculty capacity in this area. Toward that end, the committee offers a policy statement that encourages schools and colleges of pharmacy to have an office or designate a faculty member whose focus is specifically on community engagement. The committee also offers a recommendation that the core components be included in the criteria for the Weaver Award.

Oral combination therapy with thiazolidinediones in type 2 diabetes.

Insulin resistance occurs early in the type 2 diabetes disease process, leading to progressive beta cell failure and overt diabetes. By the time the diagnosis of diabetes is made, advanced macrovascular disease may already be present. Monotherapy with a sulfonylurea or metformin can slow, but does not prevent, the progression of disease. Successful management requires combination therapy that addresses both insulin resistance and beta cell dysfunction. Clinical trials support the use of combinations of agents with complementary mechanisms of action, such as a sulfonylurea or metformin plus a thiazolidinedione. Early aggressive treatment can improve patient outcomes while reducing overall healthcare costs.

Gender differences in the use of peak flow meters and their effect on peak expiratory flow.

STUDY OBJECTIVE: To determine if gender differences in the skill of using peak flow meters affect peak expiratory flow (PEF). DESIGN: Prospective observational study. SETTING: University classroom. SUBJECTS: One hundred sixteen first-year pharmacy students (76 women, 40 men). INTERVENTION: Students were taught correct use of a peak flow meter by means of classroom discussion and demonstrations. MEASUREMENTS AND MAIN RESULTS: The students' technique in use of the peak flow meter was scored 3 times, and their PEF was recorded. Men scored higher than women (p=0.03) for the steps of "inhale fully" and "exhale as hard and as fast as you can" in the first attempt. Percentage increases in PEF did not significantly differ between the groups. Percentage change in PEF improved from the second attempt to the third attempt in women (p=0.036) but not men. On the third attempt, 13.2% of women versus 2.6% of men had an increase in PEF of more than 50% (p=0.1). CONCLUSION: This study found that men learned the correct technique for using a peak flow meter and attained their best PEF more quickly than women.

The safety and efficacy of lorcaserin in the management of obesity.

Lorcaserin represents a new serotonergic medication used as an adjunct to a reduced-calorie diet and increased physical activity treatment plan for chronic weight management in adult patients with an initial body mass index ≥ 30 kg/m 2 or in adult patients with an initial body mass index ≥ 27 kg/m 2 who have ≥ 1 comorbid condition associated with weight (eg, hypertension, dyslipidemia, or type 2 diabetes mellitus). In 2012, lorcaserin became the first obesity treatment medication to gain US Food and Drug Administration (FDA) approval since 1999. Lorcaserin is a centrally acting, selective serotonin C (5-HT2C) receptor full agonist that is associated with increased satiety and decreased food consumption in patients. The selectivity of lorcaserin for 5-HT2C receptors should reduce patient risk for the serious adverse complications that are associated with nonselective 5-HT agonist therapies, such as cardiac valvulopathy and pulmonary hypertension. The safety and efficacy of lorcaserin (10 mg twice daily) for ≥ 52 weeks has been evaluated in 3 separate Phase 3 trials. The primary outcome of patient weight loss in the 3 trials satisfied the FDA categorical benchmark but patient outcomes in the trials failed to achieve the FDA mean benchmark of patient weight loss. Secondary patient outcomes after lorcaserin therapy were favorable. Lorcaserin appears to be well tolerated in patients and the most common adverse events reported did not include serious complications. The incidence of FDA-defined valvulopathy in patients after 1 year of treatment was low and nonsignificant, but the statistical analysis of this safety endpoint was limited due to the small size of the study populations and high patient dropout rates. Continued post-marketing surveillance of patients taking lorcaserin is warranted.

Clinical utility of ß-blockers for primary and secondary prevention of coronary artery disease.

The number of myocardial infarctions (MIs) in population remains high and this event is a significant predictor of mortality. Information in the literature points to a reduction in mortality, reinfarction and sudden death in first year, especially in patients with high risk, if ß-blockers (BBs) are used after MI. In a perspective study, Zuckerman et al. have determined outcome following pharmacotherapy after acute MI in older adults. It is apparent that a number of matters require consideration in evaluation of the effectiveness of BBs. It seems that not all patients benefit equally from treatment with BBs but such an intervention reduces mortality. It is also important to recognize that the beneficial effects of BBs should not be considered in isolation since the biological system is too complex to manipulate with the use of a single class of drugs.

Insulin glargine and cancer risk: an opinion statement of the Endocrine and Metabolism Practice and Research Network of the American College of Clinical Pharmacy.

Diabetes mellitus has reached epidemic proportions worldwide, eliciting extensive research on both the disease process and its treatment. Regardless of diabetes type, the progressive nature of the disease makes insulin the long-term mainstay of diabetes management. Recently, the insulin analog glargine was reported in several epidemiologic studies to be associated with an increased risk of cancer. Inconsistent study results and media attention have caused much angst and concern to health care professionals and the general population. A clear understanding of the current evidence is needed to adequately develop a patient-oriented risk:benefit assessment. Members of the Endocrine and Metabolism Practice and Research Network of the American College of Clinical Pharmacy evaluated available evidence to provide guidance and discussion on the risk of cancer with insulin glargine use. We believe the current link between insulin glargine and cancer is tenuous but merits further evaluation. An independent analysis of all available glargine clinical trial data should be performed, and a vigorous postmarketing safety study of glargine should be conducted. Until more substantial data are available, however, neither the choice of initial insulin therapy nor insulin maintenance regimens should be influenced by the current information linking insulin glargine to cancer.

Falsely low hemoglobin A1c levels in a patient receiving ribavirin and peginterferon alfa-2b for hepatitis C.

The effect of treatment for hepatitis C viral infection on hemoglobin A(1c) (A1C) levels is not well described in the literature. We describe a 59-year-old man with type 2 diabetes mellitus whose A1C level became falsely low when ribavirin and peginterferon alfa-2b therapy were started for treatment of hepatitis C. After treatment was discontinued, the patient's A1C returned to its previous baseline value. Use of the Naranjo adverse drug reaction probability scale indicated a probable relationship (score of 7) between the patient's low AIC level and his ribavirin-peginterferon alfa-2b therapy. Clinicians should be aware that combination therapy for hepatitis C may affect A1C values. To maintain accurate glucose control in patients with diabetes who are receiving treatment for hepatitis C, it is important that they self-monitor their blood glucose levels in conjunction with A1C data, especially when A1C values become falsely low.

Spironolactone for hirsutism in polycystic ovary syndrome.

OBJECTIVE: To evaluate the level of evidence for treatment of hirsutism associated with polycystic ovary syndrome (PCOS) with spironolactone. DATA SOURCES: Studies and reports were located in MEDLINE (1966-January 2005), EMBASE, and International Pharmaceutical Abstracts through the second week of January 2005. DATA SYNTHESIS: Hirsutism is a common clinical problem and is often associated with PCOS. Research has been performed to assess the efficacy of spironolactone therapy in patients with hirsute characteristics. Five studies that evaluated the effectiveness of spironolactone for hirsutism in PCOS were identified and reviewed. CONCLUSIONS: The effects of multiple treatment options on the subjective and objective measures of hirsutism have displayed varying results. The outcomes reported to date have shown a positive trend toward using spironolactone in women with PCOS and hirsutism.

Combination drug therapy for gastroesophageal reflux disease.

OBJECTIVE: To evaluate the role of combination therapy with proton-pump inhibitors (PPIs) and histamine(2) receptor antagonists in gastroesophageal reflux disease (GERD). DATA SOURCES: Clinical literature identified through MEDLINE (January 1966-August 2001). Key search terms included gastroesophageal reflux, benzimidazoles; omeprazole; lansoprazole; pantoprazole; rabeprazole; receptor antagonists, histamine(2); therapy, combination drug; therapy, combined modality; and combinations, drug. DATA SYNTHESIS: Approximately 80-90% of patients show healing of reflux esophagitis after 8 weeks of once-daily PPI therapy. Patients taking PPI therapy twice daily still have nocturnal acid breakthrough (periods of gastric pH <4 lasting for > or =60 min during the night) as much as 70% of the time. The clinical application of this finding has not been shown. One trial has shown that omeprazole in the morning plus ranitidine at bedtime is not as effective as omeprazole twice daily given before the morning and evening meals at controlling nocturnal acid breakthrough. Further, 1 small trial in healthy subjects without GERD showed that the addition of a 1-time dose of ranitidine at bedtime to a twice-daily regimen of omeprazole may decrease the occurrence of nocturnal acid breakthrough. However, the clinical significance of this finding is not clear. CONCLUSIONS: No studies in patients with GERD demonstrate that the addition of histamine(2) receptor antagonists to twice-daily PPI therapy provides any further benefit above that derived from PPIs alone. The parameter used to measure the efficacy of combination regimens for GERD thus far--nocturnal acid breakthrough--has not been proven to correlate with improvement of GERD symptoms in any controlled or prospective clinical trials. Further investigation is needed to determine optimal therapy in patients refractory to standard doses of PPIs.

Treatment of migraine headaches with sumatriptan in pregnancy.

OBJECTIVE: To review the literature for treatment of migraine headaches with sumatriptan during pregnancy. DATA SOURCES: Studies and reports were located in International Pharmaceutical Abstracts (1970-September 2003) and MEDLINE (1966-week 3 September 2003). DATA SYNTHESIS: Research has been performed to evaluate the risk of teratogenesis after sumatriptan exposure in pregnant patients. Data have been collected in areas including placental transmission of sumatriptan, prospective pregnancy registries, open-labeled and controlled prospective studies, and a retrospective prescription-linked study. As of August 6, 2004, no randomized controlled trials have been conducted with exposure to sumatriptan during pregnancy. CONCLUSIONS: Teratogenesis occurs in approximately 150 000 births per year which represents an incidence of 3-5%. Available literature to date indicates that exposure to sumatriptan during pregnancy has no additional risk of birth defects compared with the incidence in the general population.