Considerations of management and marketing courses within pharmacy curricula in the United States.

INTRODUCTION: To assess the extent pharmacy programs are offering courses in management and marketing. METHODS: We sampled the extent of management and marketing coursework in the doctor of pharmacy (PharmD) curricula in the United States (US) by examining website descriptions of the best pharmacy schools in 2020 (N = 134) as ranked by the US News and World report. Links to curriculum descriptions and catalogs were reviewed for coursework having the words, marketing, management, entrepreneurship, or business plan in the title. RESULTS: Of the 134 PharmD curricula reviewed, 36 (27%) had no required or elective management courses, and 101 (75%) had no required or elective marketing courses in their curriculum. Most schools did offer a core (n = 89) or elective (n = 9) management course. However, of those, about half (n = 46) provided only a single management course over the entire curriculum. Only 33 (25%) schools offered a marketing course, of which most (n = 27) were elective. CONCLUSIONS: Many pharmacy schools in the US are not providing pharmacy graduates with the business management and marketing education required for the role of a pharmacist. Pharmacy education should consider curriculum changes that equip pharmacy students with sufficient business knowledge and skills to be innovative and entrepreneurial in all practice settings.

The association of vitamin D deficiency and glucose control among diabetic patients.

OBJECTIVE: To evaluate the association between the level of vitamin D and glycemic control among patients with diabetes. RESEARCH DESIGN AND METHOD: We analyzed data collected from NHANES 2003-2006. We included only non-pregnant adult diabetic persons 18 years or older. Participants who had vitamin D level less than 20 ng/ml were considered as having vitamin D deficiency. Participants were considered to have a glucose control if the HbA1c level was less than 7% [53 mmol/L]. We used student's t test to compare the difference in HbA1c means between people with Diabetes with and without a vitamin D deficiency. We used a multivariate logistic regression model to predict the relationship between glucose control and vitamin D deficiency. We used race/ethnicity, BMI, age, gender, type of diabetic medication used, having health insurance or not, and comorbid conditions (hypertension, anemia, cholesterol, liver disease, and kidney disease) as control variables. RESULTS: The study population included a total of 929 non-institutionalized, non-pregnant, diabetic adult persons. About 57% of patients with diabetes had a vitamin D deficiency. Blacks (non-Hispanic patients) with diabetes had the highest rate of vitamin D deficiency (79%). The unadjusted means of HbA1c were significantly different between diabetic patients with no vitamin D deficiency and those with a vitamin D deficiency (7.06% [54 mmol/L], 7.56 % [59 mmol/L], respectively, P < 0.0001). Multivariate adjustment showed a small but not significant, increase in odds (11%) of having uncontrolled diabetes in patients with a vitamin D deficiency after adjustment for other factors. CONCLUSION: Vitamin D deficiency is very common in patients with diabetes. We found no significant association between vitamin D level and glycemic control in patients with diabetes after adjustment for control variables.

The Incidence of Akathisia in the Treatment of Schizophrenia with Aripiprazole, Asenapine and Lurasidone: A Meta-Analysis.

Akathisia is a troubling side effect that leads to non-adherence with antipsychotic regimens. Second generation antipsychotics (SGAs) tend to cause less akathisia than older agents but the risk still exists and rates vary between agents. Little is known about the incidence of akathisia among the newer SGAs. The purpose of this study was to conduct a meta-analysis of akathisia incidence rates for three of the newer SGAs: aripiprazole, asenapine, and lurasidone. Data were drawn from published and unpublished clinical trials comparing the drug of interest to either placebo or another SGA in adults with schizophrenia. Twenty-four studies (11 aripiprazole, 5 asenapine, and 8 lurasidone) provided incidence rates for akathisia and related nervous system events. Data showed that the relative risk (RR) of akathisia was double that of controls, with lurasidone having the highest individual RR at 2.7 [CI: 2-3.6]. Sensitivity analysis changed the RR of akathisia to less than 10%. The RR of akathisia was still elevated (1.75 [1.4-2.1]) when these drugs were compared only to actives (older SGAs). Agitation and anxiety RRs were also higher with the newer SGAs as compared to the older SGAs. Previous theory suggests antagonism of serotonin (5-HT)2A receptors may decrease akathisia risk. Expectations were that aripiprazole, asenapine and lurasidone would have a low incidence of akathisia, as all display strong antagonism at 5-HT2A. However, in this study all three had a significantly higher risk of akathisia compared to placebo or other SGAs. This suggests the pathophysiology of akathisia involves other receptors and is multifactorial.

Adverse Drug Events Related to Ziprasidone: A Meta-analysis of Randomized, Placebo-Controlled Trials.

STUDY OBJECTIVE: To assess the drug-related risk of adverse events associated with ziprasidone. DESIGN: Meta-analysis of 19 randomized, placebo-controlled trials. PATIENTS: A total of 4132 adults taking oral ziprasidone who had adverse-event data reported in the studies identified. MEASUREMENTS AND MAIN RESULTS: A systematic review (January 1996-October 2010) was conducted by using the EMBASE and MEDLINE databases to identify Cochrane reviews, controlled clinical trials, meta-analyses, randomized controlled trials, and systematic reviews; studies were limited to those published in English and those conducted in humans. The www.ClinicalTrials.gov Web site was also searched for ziprasidone studies. A total of 887 citations were reviewed; 31 articles met the criteria for inclusion, of which 19 were included in the final analysis. Data were combined for the meta-analysis by using the Mantel-Haenszel method, random-effects model at 95% confidence. The overall rate of treatment-emergent adverse events for ziprasidone was 73% compared with 60% for patients receiving placebo (p<0.0001). Adverse events with the greatest frequency included somnolence (21%), extrapyramidal symptoms (13%), headache (13%), insomnia (11%) and respiratory disorders (10%). Adverse events with highest risk, evaluated by using the risk difference (RD) summary statistic (adverse events due to the drug itself and not the placebo effect), were somnolence (RD 14, 95% confidence interval [CI] 7-21), extrapyramidal symptoms (RD 6, 95% CI 1-10), asthenia (RD 5, 95% CI 1-8), weight gain (RD 4, 95% CI 2-7), dizziness (RD 4, 95% CI 2-6), and dyspepsia (RD 4, 95% CI 1-6). Adverse events reported but likely not caused by ziprasidone included headache (RD 0, 95% CI -2-3), QTc interval greater than 480 msec (RD 0, 95% CI -1-1), diarrhea (RD 0, 95% CI -2-2, and abdominal pain (RD 0, CI -2-2). CONCLUSION: Ziprasidone use increased the risk of 18 specific adverse events when compared with placebo. Small reductions in risk for insomnia, pain, and agitation are likely among patients with schizophrenia but not those with bipolar disorder. The results of the study are limited by the concomitant use of other drugs allowed during the trials, underreporting of adverse events in the clinical trials, and the short length of the trials (most 3-6 wks).

Evaluation of adverse drug event information in US manufacturer labels.

Pharmaceutical manufacturer labels are an important source of adverse drug event (ADE) information. The study objective was to determine the sufficiency of ADE reporting in US drug labels. A sample of 50 labels was evaluated from the top 200 drugs dispensed in the US. Electronic copies of labels were obtained and reviewed by 2 pharmacists for ADE incidence and discontinuation data. ADE incidence data were provided in 86% of labels. However, discontinuation rates due to ADEs and ADE incidence by dose were only reported in 60%. ADE incidence reporting by age (46%) or gender (18%) was also low. ADEs that occurred in less than 2% of the population were rarely reported. Incidence rates were based on small populations (median of 794) and short term studies (median of 84 days for chronic conditions). Labels for 19 drugs used chronically had no long term study data. Methods for collecting ADE data were stated in only 12% of labels. Adverse drug event and drug discontinuation data is under-reported in US labels. More information on adverse events causing discontinuation (especially serious events) and those related to dose, age, and gender is needed in labels to ensure safe prescribing and dispensing of drugs.

Tolerability of paliperidone: a meta-analysis of randomized, controlled trials.

Balancing tolerability and efficacy of medications can be problematic for clinicians when assessing appropriate therapy for patients. For antipsychotic therapy, this can be especially challenging because of the hazardous movement and metabolic effects associated with them. Paliperidone is an atypical antipsychotic used for the treatment of schizophrenia and schizoaffective disorder. A systematic review of the literature for the tolerability of the drug, paliperidone, was performed. A total of 15 articles met the criteria for inclusion representing a total of 3779 patients. Data combination was conducted using the Mantel-Haenszel method, random effects model at 95% confidence. Adverse events with the greatest incidence in the paliperidone population were any treatment emergent adverse event (68%), extra-pyramidal symptoms (23%), headache (14%), insomnia (11%), somnolence (9%), tachycardia (9%) and weight gain (8%). Reported events most likely related to paliperidone [largest attributable risks (AR)] were extra-pyramidal symptoms (AR=10), reduction in acute psychosis (AR=8), any treatment emergent adverse event (AR=6), tachycardia (AR=4), and weight gain (AR=4). Events where incidence was entirely because of paliperidone (incidence equals AR) were hypersalivation (3), dysarthria (2), and sexual dysfunction (1). Reported events totally unrelated to paliperidone (AR=0) included anxiety, asthenia, constipation, depression, dyspepsia, glucose related events, and vomiting. Overall, a 50% reduction in treatment emergent psychosis was seen in schizophrenic patients treated with paliperidone, however the reduction of a psychotic event is about equal to the occurrence of an adverse event with paliperidone.

Generic drug cost containment in Medicaid: lessons from five state MAC programs.

In Medicaid, generic drug cost containment revolves around two programs: the Federal upper limit (FUL) program and State maximum allowable cost (MAC) programs. This article analyzes MAC programs in five States and finds considerable variation between these programs and the FUL program in both size and pricing aggressiveness. We conclude that expansion of existing MAC programs and creation of new ones could contribute to cost containment efforts nationwide. Options for States seeking to optimize their efforts include focusing on pricing for drugs with high sales volumes, ensuring that MAC lists include prices for all forms and dosages of listed drug entities, and collaborating with other States or the Federal Government on MAC list operations.