Nilesh S. Bhutada

Efficacy and cost of single-dose rasburicase in prevention and treatment of adult tumour lysis syndrome: a meta-analysis

Single‐dose rasburicase for the treatment and prevention of hyperuricaemia in adult and paediatric patients with cancer at high risk of tumour lysis syndrome (TLS) has been widely adopted in pharmacy practice as unlabelled use with limited clinical evidence. This meta‐analysis study evaluated the efficacy and cost savings of a single‐dose rasburicase (SDR) regimen compared with the Food and Drug Administration‐approved daily dosing of rasburicase (DDR) for 5 days or the traditional treatment with allopurinol in adult cancer patients with hyperuricaemia or at high risk for TLS.

Patient Simulation to Demonstrate Students’ Competency in Core Domain Abilities Prior to Beginning Advanced Pharmacy Practice Experiences

Objective. To implement a simulation-based introductory pharmacy practice experience (IPPE) and determine its effectiveness in assessing pharmacy students’ core domain abilities prior to beginning advanced pharmacy practice experience (APPE). Design. A 60-hour IPPE that used simulation-based techniques to provide clinical experiences was implemented. Twenty-eight students were enrolled in this simulation IPPE, while 60 were enrolled in hospital and specialty IPPEs within the region. Assessment. The IPPE assessed 10 out of 11 of the pre-APPE core domain abilities, and on the practical examination, 67% of students passed compared to 52% of students in the control group. Students performed better on all 6 knowledge quizzes after completing the simulation IPPE. Based on scores on the Perception of Preparedness to Perform (PREP) survey, students felt more prepared regarding “technical” aspects after completing the simulation experience (p<0.001). Ninety-six percent of the respondents agreed with the statement “I am more aware of medication errors after this IPPE.” Conclusion. Simulation is an effective method for assessing the pre-APPE abilities of pharmacy students, preparing them for real clinical encounters, and for making them more aware of medication errors and other patient safety issues.

Assessing Pancreatic Cancer Risk Associated with Dipeptidyl Peptidase 4 Inhibitors: Data Mining of FDA Adverse Event Reporting System (FAERS)

Background: Identifying cancer risks associated with medicinal agents plays an important role in cancer control and prevention. Case reports of cancers associated with pharmacotherapy have been escalating in the Food and Drug Administration Adverse Event Reporting System (FAERS). The objective of this study is to assess the risk of pancreatic cancer associated with anti-diabetic drugs of dipeptidyl peptidase 4 (DPP 4) inhibitors with or without combination of metformin. Methods: Using the FAERS public database, the adverse event reports (ADRs) associated with widely used DPP 4 inhibitors with or without combination of metformin were generated and evaluated. Standardized pharmacovigilance tools were applied to detect the signal for cancer risks by calculating the proportional reporting ratio (PRR) and the reporting odds ratio (ROR). Results: Among 12618 ADRs associated with sitagliptin from 2007 to 2011, there were 223 cases of cancer. There was a significant correlation between the cancer reporting ratio and the time (R=0.796, P<0.001). Pancreatic cancers accounted for 22% of all combined cancer adverse events. Pharmacovigilance assessment from 2007 to 2012 indicated that there was a significant risk of pancreatic cancer associated with DPP 4 inhibitors treatment (ROR=5.922). Interestingly, minimal risk of pancreatic cancer risk was associated with metformin (ROR=1.214). Combination of DPP 4 inhibitor sitagliptin with metformin correlates with significantly lower risk of pancreatic cancer compared to sitagliptin treatment without metformin (OR=0.277, 95%CI: 0.210-0.365). Interpretation: There was a significant signal of pancreatic cancer risk associated with DPP 4 inhibitor treatment. For the first time we demonstrated that combination with metformin significantly reduced the risk signal of pancreatic cancer associated with DPP 4 inhibitors in FAERS. Considering the limitation of the FAERS, this study implied the potential strategy for cancer control and prevention in diabetic patients, and provided directions for future clinical studies.

Impact of celebrity endorsements in disease-specific direct-to-consumer (DTC) advertisements

Purpose – The purpose of this paper is to analyze the effects on consumer response between disease-specific advertising containing a celebrity compared to a non-celebrity endorser. Design/methodology/approach – A randomized, cross-sectional two (endorser type) by two (levels of disease state involvement) factorial design was used. Respondents (over the age of 18) were randomly shown one of the ad types and then responded to an online survey questionnaire containing questions and various scales measuring disease state involvement, endorser credibility, attitude toward the ad and company, attention to the ad, behavioral intentions and information search behavior. The disease-specific ad stimuli modeled the form of current print direct-to-consumer ads and were created following recent Food and Drug Administration guidelines, with the only difference being the specific pictorial used (celebrity versus non-celebrity). Findings – While endorser type did not significantly affect consumer attitudes, behavioral in...

Impact of Celebrity Pitch in Direct-to-Consumer Advertising of Prescription Drugs

Online surveys were conducted to determine the impact of endorser credibility, endorser effectiveness, and consumers’ involvement in direct-to-consumer advertising. In a randomized posttest only study, using the elaboration likelihood model, survey participants (U.S. adults) were either exposed to a fictitious prescription drug ad with a celebrity or a noncelebrity endorser. There was no significant difference in credibility and effectiveness between the celebrity and the noncelebrity endorser. High involvement consumers viewed the ad more favorably and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, consumers’ involvement did not moderate the effect of celebrity endorser.

Impact of Animated Spokes-Characters in Print Direct-to-Consumer Prescription Drug Advertising: An Elaboration Likelihood Model Approach

ABSTRACT A randomized, posttest-only online survey study of adult U.S. consumers determined the advertising effectiveness (attitude toward ad, brand, company, spokes-characters, attention paid to the ad, drug inquiry intention, and perceived product risk) of animated spokes-characters in print direct-to-consumer (DTC) advertising of prescription drugs and the moderating effects of consumers’ involvement. Consumers’ responses (n = 490) were recorded for animated versus nonanimated (human) spokes-characters in a fictitious DTC ad. Guided by the elaboration likelihood model, data were analyzed using a 2 (spokes-character type: animated/human) × 2 (involvement: high/low) factorial multivariate analysis of covariance (MANCOVA). The MANCOVA indicated significant main effects of spokes-character type and involvement on the dependent variables after controlling for covariate effects. Of the several ad effectiveness variables, consumers only differed on their attitude toward the spokes-characters between the two spokes-character types (specifically, more favorable attitudes toward the human spokes-character). Apart from perceived product risk, high-involvement consumers reacted more favorably to the remaining ad effectiveness variables compared to the low-involvement consumers, and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, the moderating effect of consumers’ involvement was not observed (nonsignificant interaction effect between spokes-character type and involvement).