John P. Bentley

Do statins improve outcomes in patients with asthma on inhaled corticosteroid therapy? A retrospective cohort analysis

Objectives Animal studies and clinical trials have examined the potential benefits of statins in asthma management with contradictory results. The objective of this study was to determine if asthma patients on concurrent statins are less likely to have asthma-related hospitalisations. Design A retrospective cohort study using Mississippi Medicaid data for 2002–2004. Participants Asthma patients ≥18 years were identified using the ICD9 code 493.xx from 1 July 2002 through 31 December 2003. The index date for an exposed subject was any date within the identification period, 180 days prior to which the subject had at least one inhaled corticosteroid prescription and at least an 80% adherence rate to statins. Asthma patients on inhaled corticosteroids, but not on statins, were selected as the unexposed population. The two groups were matched and followed for 1 year beginning the index date. Main outcomes measures Patient outcomes in terms of hospitalisations and ER visits were compared using conditional logistic regression. Results After matching, there were 479 exposed subjects and 958 corresponding unexposed subjects. The odds of asthma-related hospitalisation and/or emergency room (ER) visits for asthma patients on concurrent statins were almost half the odds for patients not on statins (OR=0.55; 95% CI (0.37 to 0.84); p=0.0059). Similarly, the odds of asthma-related ER visits were significantly lower for patients on statins (OR=0.48; 95% CI (0.28 to 0.82); p=0.0069). Conclusion The findings suggest beneficial effects of statins in asthma management. Further prospective investigations are required to provide more conclusive evidence.

Quality of life assessment by community pharmacists: an exploratory study

Implicit in the evolving role of pharmacy is that its practitioners embrace the concept of quality of life (QoL). In recent years there has been an increased interest in incorporating health-related quality of life (HRQoL) measures into clinical practice, primarily focusing on the physician as the user of this information. Pharmacists may be able to use these instruments in their practices to provide better pharmaceutical care. To explore the feasibility of such an undertaking, questionnaires were mailed to a national sample of community pharmacies. In addition to the questionnaire, the respondents were provided with examples of two instruments: the Duke Health Profile and the QOLIE-10. A definition of HRQoL was provided to the respondents. After two mailings and a reminder postcard, a usable response rate of 27.2% was achieved. The results revealed that over 80% of the respondents currently discuss HRQoL issues with their patients. In addition, 66% reported that they attempt to assess the HRQoL of their patients, albeit usually on a subjective, informal basis. After viewing examples of HRQoL instruments, over three-quarters of the respondents reported a willingness to use HRQoL assessment tools in their practices. However, only 53.7% of the respondents were familiar with the concept of HRQoL. Less than 5% reported familiarity with formal instruments. The self-reported knowledge of pharmacists concerning HRQoL was low and the respondents recognized a significant gap between their current knowledge and the level of knowledge needed to assess the HRQoL of their patients formally. The results suggest a possible role for the pharmacist in HRQoL assessment. However, the use of HRQoL instruments in community pharmacies will require further training and education on the part of pharmacists concerning the concept of HRQoL, the issues involved in its measurement and how they can use HRQoL information in their practices. In addition, a number of unanswered questions must be addressed through the research process in order for HRQoL questionnaires to become clinical tools in the practice of pharmacy.

Teaching the science of safety in US colleges and schools of pharmacy.

This paper provides baseline information on integrating the science of safety into the professional degree curriculum at colleges and schools of pharmacy. A multi-method examination was conducted that included a literature review, key informant interviews of 30 individuals, and in-depth case studies of 5 colleges and schools of pharmacy. Educators believe that they are devoting adequate time to science of safety topics and doing a good job teaching students to identify, understand, report, manage, and communicate medication risk. Areas perceived to be in need of improvement include educating pharmacy students about the Food and Drug Administrations (FDAs) role in product safety, how to work with the FDA in post-marketing surveillance and other FDA safety initiatives, teaching students methods to improve safety, and educating students to practice in interprofessional teams. The report makes 10 recommendations to help pharmacy school graduates be more effective in protecting patients from preventable drug-related problems.

Perspectives on Educating Pharmacy Students About the Science of Safety

Objective. To identify opinions about pharmacy graduates’ science of safety (SoS) educational needs. Methods. Semi-structured interviews were performed with 25 educators and researchers at US pharmacy colleges and schools and 5 individuals from associations engaged in drug safety-related issues. Results. Themes that emerged from the 30 interviews with key informants included: pharmacists should meet minimum SoS requirements; medication safety education is inconsistent; and barriers exist to improving SoS curricula. Student deficiencies noted included the lack of: student acceptance of a “culture of safety”: ability to effectively communicate verbally about medication safety; knowledge of the drug development process; and quality improvement skills. Key informants did not agree on how to address these gaps. Conclusions. While educators, researchers, and other leaders in drug safety-related issues thought that US colleges and schools of pharmacy covered portions of SoS well, there were perceived deficiencies. Minimum standards should be set to assist with curricular adoption of SoS.

The science of safety curriculum in US colleges and schools of pharmacy.

Objective. To describe the integration of science of safety (SoS) topics in doctor of pharmacy (PharmD) curricula of US colleges and schools of pharmacy. Methods. A questionnaire that contained items pertaining to what and how SoS topics are taught in PharmD curricula was e-mailed to representatives at 107 US colleges and schools of pharmacy. Results. The majority of the colleges and schools responding indicated that they had integrated SoS topics into their curriculum, however, some gaps (eg, teaching students about communicating risk, Food and Drug Administration [FDA] Sentinel Initiative, utilizing patient databases) were identified that need to be addressed. Conclusions. The FDA and the American Association of Colleges of Pharmacy (AACP) should continue to collaborate to develop resources needed to ensure that topics proposed by the FDA in their SoS framework are taught at all colleges and schools of pharmacy.

Instrument to measure psychological contract violation in pharmacy students.

Objectives. To adapt and evaluate an instrument that measures perceived psychological contract violations in pharmacy students by schools and colleges of pharmacy. Design. A psychological contract violations measure was developed from existing literature and the 1997 ACPE Guidelines and pilot-tested with second-year pharmacy students at 2 schools of pharmacy. A revised measure then was administered to second-year pharmacy students at 6 schools of pharmacy. Using a 5-point Likert-type scale, participants were asked to indicate the level of obligations they received compared to what was promised by the school of pharmacy. Results. Exploratory factor analysis on the psychological contract violations measure was conducted using principal components analysis resulting in 7 factors, which led to a revised measure with 26 items. Using a sample of 339 students, the proposed 7-factor measurement model was tested using confirmatory factor analysis. In general, the results supported the hypothesized model. The final 23-item scale demonstrated both reliability and validity. Some students perceived certain aspects of the psychological contract that exists with their school of pharmacy were being violated. Conclusion. The psychological contract violations measure may serve as a valuable tool in helping to identify areas where their students believe that schools/colleges of pharmacy have not fulfilled promised obligations.

Cardiovascular risk associated with interactions among polymorphisms in genes from the renin-angiotensin, bradykinin, and fibrinolytic systems.

Background Vascular fibrinolytic balance is maintained primarily by interplay of tissue plasminogen activator (t-PA) and plasminogen activator inhibitor type 1 (PAI-1). Previous research has shown that polymorphisms in genes from the renin-angiotensin (RA), bradykinin, and fibrinolytic systems affect plasma concentrations of both t-PA and PAI-1 through a set of gene-gene interactions. In the present study, we extend this finding by exploring the effects of polymorphisms in genes from these systems on incident cardiovascular disease, explicitly examining two-way interactions in a large population-based study. Methodology/Principal Findings Data from the population-based PREVEND study in Groningen, The Netherlands (n = 8,138) were analyzed. The effects of the polymorphisms and their interactions on cardiovascular events were analyzed via Cox proportional hazards models. There was no association between five of the six polymorphisms singly and risk of cardiovascular disease. There was a significant main effect for the ACE I/D polymorphism for both dominant and additive coding schemes. There were significant interactions between the following polymorphism pairs even after adjustment for known risk factors: ACE I/D & PAI-1 4G/5G (p = 0.012), BDKRB2 C181T & ACE I/D (p = 0.016), BDKRB2 C58T & ACE I/D (p = 0.025), BDKRB2 exon 1 I/D & AT1R A1166C (p = 0.017), and BDKRB2 C58T & AT1R A1166C (p = 0.015). Conclusions/Significance This study suggests possible interactions between genes from the RA, bradykinin, and fibrinolytic systems on the risk of cardiovascular disease, extending previous research that has demonstrated that interactions among genes from these systems influence plasma concentrations of both t-PA and PAI-1. Further explorations of these interactions are needed.

Antecedents and consequences of pharmacy loyalty behavior

Purpose – This paper aims to identify antecedents and consequences of pharmacy loyalty behavior. Design/methodology/approach – A cross-sectional study was conducted. Constructs involved were measured using an online self-administered questionnaire. Data were analyzed using multivariate logistic and linear regression. Findings – In all, 400 usable responses were obtained. General satisfaction (odds ratio [OR] = 1.52; p < 0.01; 95 per cent confidence interval [CI] = 1.12 to 2.06) and trust (OR = 1.81; p < 0.01; 95 per cent CI = 1.32 to 2.50) were found to have statistically significant relationships with loyalty behavior. General satisfaction (regression coefficient = 0.20; p < 0.01; 95 per cent CI = 0.09 to 0.31), explanation component of satisfaction with service quality (regression coefficient = 0.13; p < 0.01; 95 per cent CI = 0.04 to 0.21), consideration and technical competence components of satisfaction with service quality (regression coefficient = 0.18; p = 0.02; 95 per cent CI = 0.03 to 0.33) and ...

Health Utility Assessment Using EQ-5D among Caregivers of Children with Autism

OBJECTIVES Health utility of caregivers of children with autism was assessed by using the EuroQol five-dimensional (EQ-5D) questionnaire. Utility scores of autism caregivers were compared with norms for the general adult US population. Predictors of health utility were identified. METHODS A cross-sectional online survey design was used. Caregivers registered with the Interactive Autism Network were approached for participation in the online survey. Three hundred and sixteen usable responses were received. Health utility among caregivers was calculated and compared with the US population norms by using Students t test. Problems in EQ-5D questionnaire domains and utility scores were analyzed by study characteristics by using Kruskal-Wallis analysis of variance. Factors predicting health utility were identified by using ordinary least square regression. RESULTS Roughly 94% of the caregivers who participated in the study were females. As compared to their counterparts in the general US population, caregivers who were aged 18 to 44 years and were females had lower utility scores (P < 0.001). Significant differences in utility scores were observed among caregivers. When compared to males, females had lower health utility. Caregivers of lower socioeconomic status had lower utility scores and reported more problems in EQ-5D questionnaire domains than did those from higher socioeconomic status. Caregiver burden was inversely correlated with health utility. Caregiver physical and mental health status, objective strain, education, and relationship with the care recipient were found to significantly predict health utility (adjusted R(2) ~57%). CONCLUSIONS Autism caregivers had lower health utility than did the general adult US population. There is an immediate need to address health concerns among this growing population.

Risk of adverse cardiovascular outcomes and all-cause mortality associated with concomitant use of clopidogrel and proton pump inhibitors in elderly patients

Abstract Objective: To examine the effect of concomitant use of clopidogrel and PPIs in a national sample of elderly Medicare beneficiaries (age ≥65 years). Methods: A nested case–control design was employed. A cohort of Medicare beneficiaries who initiated clopidogrel and did not have any gap of ≥30 days between clopidogrel fills between July 1, 2006 and December 31, 2008 was identified from a 5% national sample of Medicare claims data. Within this cohort, cases (beneficiaries who experienced any major cardiovascular event [MCE] [acute myocardial infarction, stroke, coronary artery bypass graft, or percutaneous coronary intervention] or all-cause mortality) and controls (beneficiaries who did not experience any MCE or all-cause mortality) were identified from inpatient and outpatient claims. Cases and controls were matched on age and the time to first clopidogrel fill. Conditional logistic regression was performed on the matched sample to evaluate the association between concomitant use of clopidogrel and PPIs and adverse health outcomes (MCEs and all-cause mortality). Results: A total of 43,159 clopidogrel users were identified. Among them, 15,415 (35.7%) received clopidogrel and a PPI concomitantly at any time during the study period, 3502 (8.1%) experienced a MCE, 7306 (17.1%) died, and a total of 9908 (22.8%) experienced the primary composite outcome (any MCE or all-cause mortality) during follow-up. The odds ratio (OR) for the primary composite outcome was 1.26 (95% confidence interval [CI]: 1.18–1.35). Secondary analyses indicated that elderly patients using clopidogrel and a PPI concomitantly were more likely to experience all-cause mortality (OR: 1.40; 95% CI: 1.29–1.53) as compared to those receiving clopidogrel only, but not MCEs (OR: 1.06; 95% CI: 0.95–1.18). Conclusions: Concomitant use of clopidogrel and PPIs was associated with a slightly increased risk of all-cause mortality but not MCEs.