Use of Cumulative Assessments in U.S. Schools and Colleges of Pharmacy.

The Accreditation Council of Pharmacy Education (ACPE) has taken a strong stance on assessment in pharmacy education. One available assessment tool is cumulative assessments, which may be administered at various points in the curriculum. This article presents the results of a survey of U.S. schools of pharmacy regarding the use of cumulative assessments within their curriculum. A 20-question survey tool was emailed to 125 schools of pharmacy. A total of 105 out of 125 schools participated (response rate 84%). Of these, 52 schools currently have a cumulative assessment program; 18 have one cumulative exam prior to advanced pharmacy practice experiences (APPEs); 19 have a cumulative exam every didactic year; and seven have accumulative exams every semester, except during APPEs (n = 44). Increased faculty workload emerged as the top challenge faced by schools that have implemented a cumulative assessment program. Eighteen schools indicated that no outcomes are measured to determine the utility of the cumulative assessment. From these results, it appears that almost half of participating U.S. schools have implemented a cumulative assessment plan. However, it is apparent that more research needs to be done to determine which outcomes are expected to improve with the implementation of such an assessment plan.

Vemurafenib in patients with BRAF V600E mutation-positive advanced melanoma.

BACKGROUND: Vemurafenib is an oral, small-molecule kinase inhibitor that selectively targets activated BRAF V600E and has been approved for the treatment of advanced BRAF mutation-positive melanoma. OBJECTIVE: This article reviews the clinical pharmacology, efficacy, tolerability, and pharmacokinetics of vemurafenib and in addition outlines proposed mechanisms of vemurafenib resistance. METHODS: A literature search of MEDLINE and ScienceVerse Scopus was performed using the key words malignant melanoma, BRAF, vemurafenib, and PLX4032. Scientific abstracts, US Food and Drug Administration Web site data (www.accessdata.fda.gov), the manufacturer-submitted approval data from ClinicalTrials.gov (www.clinicaltrials.gov), and the references from applicable publications were also consulted. RESULTS: Clinical studies have reported that vemurafenib is efficacious and acceptably well-tolerated. In a Phase I study (BRIM-1), a 960-mg BID dose achieved an objective response rate of 81% among 32 patients with melanoma who carried a BRAF V600E mutation. Of the 26 responders, 2 achieved a complete response and 24 a partial response. In BRIM-2, 132 BRAF V600E-positive patients achieved an overall response rate of 53% (95% CI, 44%-62%); 6% achieved a complete response and 47%, a partial response. Response was noted at 6 weeks and lasted a median of 6.7 months (95% CI, 5.6-8.6). Median survival was 15.9 months (95% CI, 11.6-18.3); 77% of patients survived to 6 months (95% CI, 70-85) and 58% to 12 months (95% CI, 11.6-18.3), and an estimated 43% were expected to survive to 18 months (95% CI, 33-53). The Phase III study (BRIM-3) compared vemurafenib to dacarbazine. The hazard ratio (HR) for death with vemurafenib was 0.37 (95% CI, 0.26-0.55; P < 0.001). At 6 months, overall survival was 84% (95% CI, 78-89) versus 64% (95% CI, 56-73) in the vemurafenib and dacarbazine treatment arms, respectively. The HR for tumor progression in the vemurafenib cohort was 0.26 (95% CI, 0.20-0.33; P < 0.001), and the estimated median progression-free survival was 5.3 months with vemurafenib versus 1.6 months with dacarbazine. Finally, the difference in response rates was significant (48% vs 5%, respectively; P < 0.001). The most common adverse events reported have been arthralgia, rash, photosensitivity, fatigue, pruritus, alopecia, cutaneous squamous cell carcinoma, diarrhea, and mild to moderate nausea. CONCLUSIONS: Vemurafenib is effective for advanced melanomas expressing the BRAF V600E mutations. Resistance to BRAF inhibition can be problematic, but new evidence suggests that combination therapy may attenuate the issue. Targeting the cellular activity of melanoma cells is reported to be efficacious and is expected to delay progression and prolong survival.

Is alternate daily dose of atorvastatin effective in treating patients with hyperlipidemia? The Alternate Day Versus Daily Dosing of Atorvastatin Study (ADDAS).

BACKGROUND: The objective of this pilot study was to evaluate the comparative efficacy of alternate-day dosing of atorvastatin compared with the standard once-daily dose based on mean low-density lipoprotein (LDL) reduction from baseline at 6 and 12 weeks of treatment. METHODS: In a double-blind, placebo-controlled design, 35 eligible patients who met the National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II) guidelines for drug therapy, depending on their risk factors, were randomly assigned to receive 10 mg of atorvastatin as an initial dose every day or every other day. Patients were assessed at 6 and 12 weeks as to whether they met the LDL-C goal, and the dose was doubled if the goal was not reached. RESULTS: LDL-C decreased by 27% and 38%, in the every-other-day (n = 15) and every-day (n = 15) groups, respectively, at 6 weeks. At 12 weeks, the LDL-C was reduced by 35% and 38% in the every-other-day and every-day groups, respectively (P =.49). The mean dose was 18 mg (9 mg/d) in the alternate-day group (n = 14) and 12 mg/d in the every-day group (n = 12) at the end of the 12 weeks (P =.001). CONCLUSIONS: Although higher doses of atorvastatin were used on alternate days, these results suggest that the alternate-day administration of atorvastatin can produce a reduction in LDL-C comparable to that of daily administration in patients with hypercholesterolemia, and yet provide some cost savings.

Pharmacotherapy in congestive heart failure: diuretic resistance and strategies to overcome resistance in patients with congestive heart failure.

Congestive heart failure is a complex clinical hemodynamic disorder characterized by chronic and progressive pump failure and fluid accumulation. Although the overall impact of diuretic therapy on congestive heart failure mortality remains unknown, diuretics remain a vital component of symptomatic congestive heart failure management. Over time, sodium and water excretion are equalized before adequate fluid elimination occurs. This phenomenon is thought to occur in one out of three patients with congestive heart failure on diuretic therapy and is termed diuretic resistance. In congestive heart failure, both pharmacokinetic and pharmacodynamic alterations are thought to be responsible for diuretic resistance. Due to disease chronicity, symptomatic management is vital to improved quality of life and enhancing diuretic response is therefore pivotal.