Preferences for pharmacogenomic testing in polypharmacy patients: a discrete choice experiment.

Aim: To elicit preferences for pharmacogenomic (PGx) testing in polypharmacy patients. Materials & methods: A face-to-face discrete choice experiment survey was designed and administered to adult polypharmacy patients recruited at a local retail pharmacy in Albuquerque (NM, USA). Results: A total of 128 eligible polypharmacy patients completed the discrete choice experiment survey and significantly preferred a PGx test with lower cost, better confidentiality and higher certainty of identifying best medication/dose and side effects and one that can be used to advocate for their treatment needs (all p < 0.01). Conclusion: This is the first study eliciting preferences for PGx testing among polypharmacy patients. The study found most polypharmacy patients were willing to take a PGx test and their preferences were mostly influenced by test cost.

Patients who concurrently take five or more medications are at a higher risk of experiencing side effects related to drug­drug/drug­gene interactions. 'One size doesn't fit all' ­ individuals may respond differently to the same dose of a medication. Pharmacogenomic (PGx) testing identifies individual genetic information that may help explain better or worse outcomes or potential problems with drug therapies and eventually may help optimize patient treatment. The authors conducted a face-to-face survey to assess preferences for PGx testing in polypharmacy patients and found that most polypharmacy patients were willing to take a PGx test and their preferences were mostly influenced by test cost and performance, as well as the confidentiality of test results.

Sodium-Glucose Cotransporter 2 Inhibitor Use Among Individuals Age <65 with Type 2 Diabetes and Heart Failure with Reduced Ejection Fraction: A Cost-Benefit Analysis.

Background: Type 2 diabetes (T2D) patients face increased risk of heart failure (HF) as they age. Sodium-glucose cotransporter 2 inhibitors (SGLT-2i) have demonstrated effectiveness in reducing HF hospitalizations in patients with T2D and HF with reduced ejection fraction (HFrEF). Diabetes guidelines recommend SGLT-2i therapy for patients with HFrEF; however, SGLT-2i cost is high. Objective: Study objectives were to assess SGLT-2i utilization and HF hospitalization rates in commercially insured adults (age <65) with T2D and heart failure with reduced ejection fraction (HFrEF) taking metformin with/without SGLT-2i use and conduct a cost-benefit analysis of SGLT-2i use from payer and societal perspectives. Methods: Economic models included HF hospitalization rates from real-world data (RWD) and hospitalization rate reductions from RWD and SGLT-2i clinical trials. Real-world HF hospitalization rates were obtained from claims data (MarketScan Commercial Database, years 2013-2018). Societal perspective analyses included indirect costs. Sensitivity analyses were conducted on key parameters. Results: Among adults with T2D and HFrEF age 30-64, SGLT-2i use increased (1.1% to 17.4%) between 2013 and 2018. The HF hospitalization rate without SGLT-2i use vs with was 15.5% vs 11.0% (absolute risk reduction of 4.5%). Base case scenario net-benefit was negative across all payer perspective models, while positive for societal-perspective. Payer perspective overall net-benefit in 30-64 population: -$1,725,758 (-$4106 per person). Societal perspective net-benefit in 30-64 population: $5,996,851 ($14,269 per person). In sensitivity analyses, estimated per person base case societal net-benefit of $14,269 was most sensitive to changes in baseline HF hospitalization rates, post-discharge mortality rates, and readmission rates. Lowering SGLT-2i prescription costs 50% and 80% resulted in per person net-benefit increases of $1737 and $4004, respectively. Conclusion: SGLT-2i utilization has steadily increased, with lower HF hospitalization rates observed among SGLT-2i users. Societal benefits of SGLT-2i use in this population are substantive; payer benefits are negative unless SGLT-2i cost is drastically reduced.

Increasing the Number of Underrepresented Minority Behavioral Health Researchers Partnering With Underresourced Communities: Lessons Learned From a Pilot Research Project Program.

To address critical health equity issues facing racially and ethnically diverse populations, it is essential to have researchers from similarly diverse backgrounds. Such researchers provide different perspectives that may lead to distinct research questions, novel interpretation of findings, and innovative recommendations for health promotion practice. There is a continuing need to increase the number of researchers leading health research studies who are from underrepresented minority populations (URMs). The literature demonstrates the effectiveness of mentoring for career development and the need to hone existing mentoring models. The TREE Center developed an innovative model for building capacity among early stage investigators, with a focus on URMs, to increase the inclusivity of the research pipeline. Our model involves community-engaged behavioral health research mentoring, career development, training for grantspersonship, and guidance for manuscript development and submission. A pilot project program provided opportunities for 10 early stage investigators to develop relationships with public health practitioners and other community partners, to obtain funding, to manage a complex pilot research project, and to generate preliminary data. Awardees worked with an academic mentor, a community mentor, and TREE Center faculty to conduct and disseminate their research. Lessons learned include the need to account for funding cycle timing, address challenges of recruiting URMs, consider overutilization of senior URM mentors, and overcome institutional bureaucracies that hinder transdisciplinary research across campuses. We discuss strategies for addressing these challenges. Our model is replicable and could be implemented, especially by academic programs interested in cultivating early stage URM investigators to conduct behavioral health research.

Addressing Latent Tuberculosis Infection Treatment Through a Collaborative Care Model With Community Pharmacies and a Health Department.

INTRODUCTION: The objective of this study was to evaluate a novel collaborative care model using community pharmacies as additional access points for latent tuberculosis infection (LTBI) treatment for patients using combination weekly therapy with isoniazid and rifapentine (3HP) plus directly observed therapy for 12 weeks. METHODS: This prospective pilot study included adult patients diagnosed with LTBI. Patients were eligible for study participation if they spoke English or Spanish and were followed by the New Mexico Department of Health (NM DOH). Patients were excluded if they were pregnant, receiving concomitant HIV antiretroviral therapy, or had contraindications to 3HP due to allergy or drug interactions. Community pharmacy sites included chain, independent, and hospital outpatient pharmacies in Albuquerque and Santa Fe, New Mexico. RESULTS: A total of 40 patients initiated treatment with 3HP and were included. Most were female (55%) and had a mean age of 46 years (standard deviation, 12.6 y). A total of 75.0% of patients completed LTBI treatment with 3HP in a community pharmacy site. Individuals of Hispanic ethnicity were more likely to complete treatment (76.7% vs 40.0%, P = .04). Most patients (60%; n = 24) reported experiencing an adverse drug event (ADE) with 3HP therapy. Patients who completed treatment were less likely to experience an ADE than patients who discontinued treatment (50.0% vs 90.0%, P = .03). Pharmacists performed 398 LTBI treatment visits (40 initial visits, 358 follow-up visits), saving the NM DOH approximately 143 hours in patient contact time. CONCLUSION: High completion rates and safe administration of LTBI treatment can be achieved in the community pharmacy setting.

Cost-effectiveness model of abiraterone plus prednisone, cabazitaxel plus prednisone and enzalutamide for visceral metastatic castration resistant prostate cancer therapy after docetaxel therapy resistance.

Aims: Among patients diagnosed with prostate cancer, 10-20% will develop castration-resistant prostate cancer (CRPC) within 5 years; for 70%, CRPC will metastasize, mostly to the lungs and/or liver. We performed a cost-effectiveness model comparing abiraterone plus prednisone (ABI + PRD), cabazitaxel plus prednisone (CAB + PRD) and enzalutamide (ENZ) for visceral metastatic CRPC post-docetaxel therapy resistance. Methods: A three-state (Progression-Free, Progression, Death) lifetime Markov model was constructed to compare ABI + PRD, CAB + PRD, and ENZ from a United States healthcare payer perspective (2019 US$; discount rate 3%/yr.). Effectiveness was measured in life-years (LYs) and quality-adjusted life years (QALYs). Inputs included treatment costs, grade III/IV adverse events with incidence ≥5%, physician follow-up, lab and imaging tests. Phase III trial Kaplan-Meier curves were extrapolated to estimate overall survival and Progression-Free transition probabilities. Incremental cost-effectiveness ratios (ICERs) and utility ratios (ICURs), probabilistic sensitivity analyses (PSAs) and cost-effectiveness acceptability curves at willingness-to-pay (WTP) thresholds were estimated. Results: Models estimated 3-year overall survival rates of 1.3% for patients treated with ABI + PRD, 16.2% for CAB + PRD, and 13.2% for ENZ. Estimated Progression-Free rates at 1.5 years were 0.51% for ABI + PRD, 0.27% for CAB + PRD, and 14.47% for ENZ. LYs and QALYs were 1.20 and 0.58 respectively for ABI + PRD, 1.48 and 0.56 for CAB + PRD, and 1.58 and 0.79 for ENZ. Total treatment costs were: $115,433 for ABI + PRD, $85,337 for CAB + PRD and $109,213 for ENZ. CAB + PRD and ENZ dominated ABI + PRD due to higher LYs gained. Incremental QALYs for ENZ vs. CAB + PRD were larger than incremental LYs. The ICUR for ENZ was $103,674/QALY compared to CAB + PRD. Conclusions: This analysis found ENZ provided greater LYs and QALYs than both ABI + PRD and CAB + PRD, at a lower cost than ABI + PRD, but at a higher cost compared to CAB + PRD. For patients with visceral mCRPC after docetaxel therapy resistance, ENZ was cost-effective 92% of the time with a WTP threshold of $100,000/QALY.

A cross-sectional survey evaluating transgender-related care education in United States pharmacy school curricula.

INTRODUCTION: The objectives of this study are to evaluate the extent of transgender-related care in current pharmacy school curricula, identify where transgender-related care is covered in the curriculum, describe how the content is delivered to pharmacy students, and review how student knowledge of transgender-related care is evaluated. METHODS: This cross-sectional study utilized an online survey of curricular contacts of 142 pharmacy schools in the United States. Survey questions regarding transgender-related care were presented as multiple choice, ranking, and free-response. The survey inquired about transgender-related care information taught, teaching methods, hours of education, and student assessment. RESULTS: Of the 66 schools that responded to the survey, 53% indicated that transgender-related education is a topic that is currently addressed somewhere within the curriculum. Twenty-two pharmacy schools incorporate this topic into the didactic curriculum, two into the experiential curriculum, and 10 into both didactic and experiential. Transgender-related care is only taught in the required curriculum of 41.2% of schools that responded to the survey. CONCLUSION: Transgender-related care education is taught to variable degrees throughout US doctor of pharmacy programs. This study should serve as a call to action to incorporate this necessary transgender-related care education and training into pharmacy curricula to effectively reduce health disparities among this population that is increasingly seeking care.

Pharmacist perceptions of the New Mexico pharmacist-performed tuberculosis testing program.

OBJECTIVE: This study evaluated pharmacists' perceptions of the New Mexico pharmacist-performed tuberculosis skin testing (PPTST) program. METHODS: This cross-sectional study was conducted using a telephone survey. New Mexico pharmacists who completed the tuberculin skin test (TST) training from March 2011 to June 2016 were eligible for inclusion. Data collected included demographics, years since licensure, pharmacy setting and location, reasons for obtaining certification, training time, training quality, self-perceived competency after training, whether the participant was performing TSTs, number of tests performed, time required to administer or interpret the test, and reasons for not testing. RESULTS: We attempted to contact all 209 pharmacists who completed the TST training during the evaluation period. Ninety-four of the 99 pharmacists contacted consented to participate (overall study response rate of 45%). The chain community pharmacy was the most common practice setting of respondents. After training completion, greater than 95% agreed or strongly agreed they felt confident in administering the TST. The percent of respondents working in New Mexico who were actively testing was 50.6%, with 42% of those pharmacists providing TSTs in small cities. Eleven pharmacists reported that they were performing TSTs in locations where testing would not otherwise have been available. An initial TST visit was approximately 6-15 minutes, and follow-up visits were typically 5 minutes or less. The most common reason reported for not testing was lack of employer support (61%). The strongest association with testing was training requirement by employer (odds ratio [OR], 20.4; 95% CI 4.2-99.2), followed by strong confidence in their ability to perform the TST (OR, 14.2; 95% CI 2.8-71.2). CONCLUSION: PPTST is positively perceived by New Mexico pharmacists and provides testing in non-urban areas where access may be low. Survey respondents were confident in their ability to perform the TST and report that testing typically takes less than 15 minutes. The main hindrance to implementing PPTST was lack of employer support.

Assessment of components included in published societal perspective or QALY outcome economic analyses for antiepileptic drug treatment in chronic epilepsy.

INTRODUCTION: Antiepileptic drug (AED) treatments seek to control seizures with minimal or no adverse effects, effects which can substantially impact costs and outcomes for patients, caregivers, and third party payers. The First and Second Panel on Cost-Effectiveness in Health and Medicine recommend inclusion of a societal reference case, even in studies conducted from a healthcare sector perspective, for comparability of findings across studies. Cost and outcome evaluation components include direct medical, non-direct medical-related (e.g. patient-time and transportation costs for treatment) and non-healthcare sectors (e.g. lost productivity). AREAS COVERED: Guided by Second Panel recommendations, this review developed an overall impact inventory and detailed adverse effect impact inventory to assess the scope and methods in published economic evaluations of AED treatments for adults with chronic epilepsy. Societal perspective evaluations or evaluations that utilized quality-adjusted life-years (QALYs) as an outcome were reviewed. The majority of reviewed articles were healthcare sector perspective studies, methods for estimating QALYs varied widely, and a minority considered specific AED treatment adverse effects. EXPERT COMMENTARY: Only considering a healthcare sector perspective fails to provide full information for patients on AED treatments. Using an impact inventory to guide study scope and design will facilitate full reporting of costs and benefits.

Clinical and Economic Effects of a Pharmacist-Administered Antiretroviral Therapy Adherence Clinic for Patients Living with HIV.

BACKGROUND: Pharmacists have demonstrated the ability to improve patient adherence to antiretroviral therapy (ART). OBJECTIVE: To determine the clinical and economic effects of a pharmacist-administered ART adherence clinic for patients living with human immunodeficiency virus (HIV). METHODS: This pilot study with a pretest-posttest design examined the effect of a pharmacy adherence clinic on patient HIV viral load and CD4 count over a 6-month period. Patients with documented adherence problems were referred to the clinic. The pharmacist counseled patients at baseline and met with patients 1-2 weeks, 6 weeks, 3 months, and 6 months after starting ART. A societal perspective net cost analysis of the pharmacy adherence clinic was conducted to assess the economic efficiency of the intervention. RESULTS: Twenty-eight patients were enrolled in the study, and 16 patients reached completion. Median HIV RNA significantly decreased from 48,000 copies/mL (interquartile range [IQR] = 16,750-139,000) to undetectable (< 20 copies/mL) at 6 months for all study participants who completed the full intervention (P = 0.001). In the 3 months following the intervention, we estimated that it prevented approximately 0.13 secondary HIV infections among the sexual partners of the 16 participants who completed the intervention. The total cost of the intervention was $16,811 ($1,051 per patient), which was less than the future savings in averted HIV-related medical care expenditures ($49,702). CONCLUSIONS: A pharmacy adherence clinic that focused on early and sustained ART adherence interventions helped patients with documented medication adherence problems achieve an undetectable HIV RNA. The intervention was highly cost saving, with a return of nearly $3 in future medical care savings per dollar spent on the intervention. DISCLOSURES: This work was supported in part by a research grant to Dilworth, Mercier, and Borrego from the American Society of Health-System Pharmacists Foundation. Klein and Pinkerton were supported in part by grants T32-MH19985 and P30-MH52776, respectively, from the National Institute of Mental Health. No funding bodies had any role in the study design, data collection, analysis, decision to publish, or preparation of the manuscript. The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Health Resources and Services Administration. The authors have no conflicts of interest to disclose. Study concept and design were contributed primarily by Dilworth, Mercier, and Borrego, along with the other authors. Dilworth took the lead in data collection, along with Pinkerton, Klein, Mercier, and Jakeman. Data interpretation was performed by Dilworth and Pinkerton, along with the other authors. The manuscript was written by Dilworth, Klein, and Jakeman, with assistance from the other authors, and revised by Dilworth, Jakeman, and Klein, with assistance from the other authors. The results from this study were presented in part at the 2015 United States Conference on AIDS in Washington, DC, on September 10-13, 2015.

Awareness, self-management behaviors, health literacy and kidney function relationships in specialty practice.

AIM: To determine the relationship between chronic kidney disease (CKD) awareness (CKD-A), self-management behaviors (CKD-SMB) knowledge, performance of CKD-SMBs, health literacy (HL) and kidney function. METHODS: Participants were eligible patients attending an outpatient nephrology clinic. Participants were administered: Newest Vital Sign to measure HL, CKD self-management knowledge tool (CKD-SMKT) to assess knowledge, past performance of CKD-SMB, CKD-A. Estimated GFR (eGFR) was determined using the MDRD-4 equation. Duration of clinic participation and CKD cause were extracted from medical charts. RESULTS: One-hundred-fifty patients participated in the study. eGFRs ranged from 17-152 mL/min per 1.73 m2. Majority (83%) of respondents had stage 3 or 4 CKD, low HL (63%), and were CKD aware (88%). Approximately 40% (10/25) of patients in stages 1 and 2 and 6.4% (8/125) in stages 3 and 4 were unaware of their CKD. CKD-A differed with stage (P < 0.001) but not by HL level, duration of clinic participation, or CKD cause. Majority of respondents (≥ 90%) correctly answered one or more CKD-SMKT items. Knowledge of one behavior, "controlling blood pressure" differed significantly by CKD-A. CKD-A was associated with past performance of two CKD-SMBs, "controlling blood pressure" (P = 0.02), and "keeping healthy body weight" (P = 0.01). Adjusted multivariate analyses between CKD-A and: (1) HL; and (2) CKD-SMB knowledge were non-significant. However, there was a significant relationship between CKD-A and kidney function after controlling for demographics, HL, and CKD-SMB (P < 0.05). CONCLUSION: CKD-A is not associated with HL, or better CKD-SMBs. CKD-A is significantly associated with kidney function and substantially lower eGFR, suggesting the need for focused patient education in CKD stages 1.

Once-Daily Versus Twice-Daily Enoxaparin for the Treatment of Acute Venous Thromboembolism in Cancer Patients.

BACKGROUND: No randomized controlled trials have investigated enoxaparin once versus twice daily for venous thromboembolism (VTE) treatment in cancer patients. OBJECTIVE: To compare the safety and efficacy of enoxaparin 1 mg/kg twice daily versus enoxaparin 1.5 mg/kg/day for the treatment of acute VTE in cancer patients. METHODS: This was a single-center, retrospective, observational cohort study. Adults with active cancer and an acute VTE were included. The primary outcome evaluated was the incidence of clinically relevant (major and nonmajor) bleeding (CRB) within 30 days of enoxaparin initiation. Secondary outcomes included the incidence of CRB, thrombosis, and death at 30, 90, and 180 days. The study protocol was approved by the institutional review board. RESULTS: A total of 123 patients met inclusion criteria; 85 patients (69%) were treated with once-daily and 38 patients (31%) with twice-daily enoxaparin. CRB was numerically higher at 30 days in the twice-daily enoxaparin group compared with the once-daily group (5.3% vs 2.4%, P = 0.587). There was a nonsignificant higher incidence of CRB in the once-daily enoxaparin group compared with the twice-daily group at 90 days (8.3% vs 8%, P = 1.0) and 180 days (12.5% vs 7.1%, P = 1.0). The composite outcome of CRB, thrombosis, and death was higher at all time points with enoxaparin once daily. CONCLUSIONS: Lack of statistical power in this study precludes definitive conclusions. Clinicians may consider twice-daily enoxaparin because of potentially fewer adverse events but may be limited by patient preference and/or financial constraints.

Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals: A Systematic Review.

OBJECTIVE: To systematically review and assess the quality of the novel drugs' economic evaluation literature in print during the drugs' early commercial availability following US regulatory approval. DATA SOURCES: MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009. STUDY SELECTION AND DATA EXTRACTION: The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses). We extracted and analyzed data from 36 articles considering 19 of the 50 drugs. Two reviewers assessed each publication's quality using the Quality of Health Economic Studies (QHES) instrument and summarized study quality on a 100-point scale. DATA SYNTHESIS: Study quality had a mean of 70.0 ± 16.2 QHES points. The only study characteristics associated with QHES score (with P < 0.05) were having used modeling or advanced statistics, 75.1 versus 61.9 without; using quality-adjusted life years as an outcome, 75.9 versus 64.7 without; and cost-utility versus cost-minimization analysis, 75.9 versus 58.7. Studies most often satisfied quality aspects about stating study design choices and least often satisfied aspects about justifying design choices. CONCLUSION: The reviewed literature considered a minority of the 2008-2009 novel drugs and had mixed study quality. Cost-effectiveness stakeholders might benefit from efforts to improve the quality and quantity of literature examining novel drugs. Editors and reviewers may support quality improvement by stringently imposing economic evaluation guidelines about justifying study design choices.

Heparin-induced thrombocytopenia: reducing misdiagnosis via collaboration between an inpatient anticoagulation pharmacy service and hospital reference laboratory.

Misdiagnosis of heparin-induced thrombocytopenia (HIT) is common and exposes patients to high-risk therapies and potentially serious adverse events. The primary objective of this study was to evaluate the impact of collaboration between an inpatient pharmacy-driven anticoagulation management service (AMS) and hospital reference laboratory to reduce inappropriate HIT antibody testing via pharmacist intervention and use of the 4T pre-test probability score. Secondary objectives included clinical outcomes and cost-savings realized through reduced laboratory testing and decreased unnecessary treatment of HIT. This was a single center, pre-post, observational study. The hospital reference laboratory contacted the AMS when they received a blood sample for an enzyme-linked immunosorbent HIT antibody (HIT Ab). Trained pharmacists prospectively scored each HIT Ab ordered by using the 4T score with subsequent communication to physicians recommending for or against processing and reporting of lab results. Utilizing retrospective chart review and a database for all patients with a HIT Ab ordered during the study period, we compared the incidence of HIT Ab testing before and after implementation of the pharmacy-driven 4T score intervention. Our intervention significantly reduced the number of inappropriate HIT Ab tests processed (176 vs. 63, p < 0.0001), with no increase in thrombotic or hemorrhagic events. Overall incidence of suspected and confirmed HIT was <3 and <0.005 %, respectively. Overall cost savings were $75,754 (US) or 62 % per patient exposed to heparin between the pre and post intervention groups. Collaboration between inpatient pharmacy AMS and hospital reference laboratories can result in reduction of misdiagnosis of HIT and significant cost savings with similar safety.

Complementary and Alternative Medicine and Therapy Use in a Diverse New Mexican Population.

OBJECTIVE: To describe differences, attitudes, and experiences in use of complementary and alternative medicines and therapy (CAMT) in people living in New Mexico (NM). DESIGN: Cross-sectional survey study. SETTING: Clinics staffed by the University of New Mexico College of Pharmacy faculty between September 2009 and August 2011 in Albuquerque, NM. PARTICIPANTS: Patients 18 years of age or older or parents of patients younger than age 18 years. OUTCOME MEASURES: Descriptive statistics for survey results and mean scores for attitudinal items. Chi-square, t-test, and analysis of variance were used to compare differences between groups across demographic variables. RESULTS: A convenience sample yielded 263 completed surveys. Of the respondents, 62% were male, 39% were single, and 50% were Hispanic. Nearly 56% of respondents used CAMT in the previous 6 months; 38% used CAMT in addition to and 11% used CAMT instead of prescription medications. Average number of CAMT used per respondent was 2.3 ± 1.6. A majority of respondents indicated that their CAMT use in the previous 6 months was useful, a good idea, easy to use, and likely to continue. CAMT use was significantly higher in female respondents (p = 0.03), those with a higher education level (p < 0.01), and those with a higher household income level (p = 0.03). CONCLUSION: Prevalence of CAMT is high in a diverse population of patients. Older respondents were more likely to use CAMT in addition to prescription medications, and younger respondents were more likely to use CAMT instead of prescription medications. Providers need to consider CAMT use when discussing treatment options with patients.

Severe COPD Exacerbation Risk and Long-Acting Bronchodilator Treatments: Comparison of Three Observational Data Analysis Methods.

OBJECTIVE: Results from three observational methods for assessing effectiveness of long-acting bronchodilator therapies for reducing severe exacerbations of chronic obstructive pulmonary disease (COPD) were compared: intent-to-treat (ITT), as protocol (AP), and an as-treated analysis that utilized a marginal structural model (MSM) incorporating time-varying covariates related to treatment adherence and moderate exacerbations. STUDY DESIGN AND SETTING: Severe exacerbation risk was assessed over a 2-year period using claims data for patients aged ≥40 years who initiated long-acting muscarinic antagonist (LAMA), inhaled corticosteroid/long-acting beta-agonist (ICS/LABA), or triple therapy (LAMA + ICS/LABA). RESULTS: A total of 5475 COPD patients met inclusion criteria. Six months post-initiation, 53.5 % of patients discontinued using any therapy. The ITT analysis found an increased severe exacerbation risk for triple therapy treatment (hazard ratio [HR] 1.24; 95 % confidence interval [CI] 1.00-1.53). No increased risk was found in the AP (HR 1.00; 95 % CI 0.73-1.36), or MSM analyses (HR 1.11; 95 % CI 0.68-1.81). The MSM highlighted important associations among post-index events. CONCLUSION: Neglecting to adjust for treatment discontinuation may produce biased risk estimates. The MSM approach is a promising tool to compare chronic disease management by illuminating relationships between treatment decisions, adherence, patient choices, and outcomes.

Assessing disparities in the receipt of inhaled corticosteroid prescriptions for asthma by Hispanic and non-Hispanic white patients.

RATIONALE: Inhaled corticosteroids (ICS) are widely used in the management of asthma. Prior research suggests that access to ICS among patients with asthma may vary by ethnicity. OBJECTIVES: Study objectives were to determine if there is a difference in the proportion of Hispanic and non-Hispanic white patients with asthma in the receipt of an ICS prescription and to determine independent predictors for the receipt of an ICS prescription for asthma. METHODS: The 2009 U.S. Medical Expenditure Panel Survey data were used to compare the receipt of ICS prescription among patients with asthma with the following inclusion criteria: Hispanic and non-Hispanic white ethnicity, age over 4 years, and diagnostic codes for asthma. Multiple logistic regression was used to determine the influence of race/ethnicity and other significant factors on the receipt of an ICS prescription. MEASUREMENTS AND MAIN RESULTS: There were 1,469 patients with asthma, corresponding to a weighted sample of 14,401,069 U.S. patients with asthma who met the inclusion criteria, represented by 16.1% Hispanic, 59.5% female, and mean age of 39.9 years. Among non-Hispanic white patients with asthma, 39.7% (35% children and 41% adults) had a receipt of an ICS prescription compared with 22.2% of Hispanic patients (23.9% children and 21.2% adults); P < 0.001. In the multiple regression model, Hispanic patients aged 18 years or older had 43% lower odds (odds ratio, 0.6; 95% confidence interval, 0.3-0.9) of having a receipt of an ICS prescription compared with non-Hispanic white patients, independent of other factors. There was no significant difference in receipt of an ICS prescription between Hispanic and non-Hispanic white children with asthma (aged 4-17 yr). CONCLUSIONS: The disparity in the receipt of ICS prescription between Hispanic and non-Hispanic white adult patients with asthma could result in suboptimal asthma management, a higher rate of exacerbations, and higher health care costs in this growing minority population. The differences and potential disparities in the receipt of an ICS prescription between Hispanic and non-Hispanic white patients with asthma warrant further investigation to better understand the reasons for such disparities, along with their impact on the U.S. health care burden and interventions that can be undertaken to reduce these disparities.

Predictors for mortality in hospitalized patients with chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) has been the only leading cause of death associated with a continuously increasing trend in the US over the past 30 years. OBJECTIVES: The aim of this research was to identify predictors for all-cause in-hospital mortality for COPD patients. METHODS: We conducted a cross-sectional study of patients with the discharge diagnosis of COPD, utilizing the 2007 Premier Perspective database. Inpatients aged 40 years and above were selected if they had a discharge with a primary diagnosis of COPD between January 1, 2007 and December 31, 2007. All data analyses were based on individual level. If a patient had multiple discharges, only the last discharge was included for mortality analysis. Predictors for mortality were identified by multiple logistic regressions. Bonferroni correction for multiple logistic regression models was adapted to control for family-wise errors. RESULTS: The total of 57,224 patients was selected for data analysis in the study. All-cause in-hospital mortality for patients with COPD was 2.4%. Older age, insurance coverage, elective admission, intensive care unit admission, prolonged length of stay, increased Deyo-adapted Charlson Index (DCI) score and Elixhauser comorbidities of renal failure, metastatic cancer, solid tumor without metastasis, and weight loss were identified as independent predictors for all-cause in-hospital mortality. Antibiotics and ß-blockers were predictors of lower all-cause in-hospital mortality risk after adjusting for other factors. CONCLUSIONS: The nationwide discharge database provides useful information to identify predictors for all-cause in-hospital mortality of patients with COPD.

Angiotensin-converting enzyme inhibitors versus angiotensin receptor blockers for end-stage renal disease/mortality in type 2 diabetes.

AIMS: To compare angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) for end-stage renal disease (ESRD) development and all-cause mortality in veterans with macroalbuminuria and with newly documented type 2 diabetes. METHODS: A retrospective cohort study utilizing data from the national Department of Veterans Affairs (VA) databases. The study followed 5166 subjects without a history of use of ACEIs or ARBs. To control for differences in baseline characteristics between groups, comparisons of subjects ACEIs and ARBs were made by incorporating propensity scores analysis into multivariate logistic regression. This resulted in adjusted odds ratios and 95% confidence intervals for ESRD development and all-cause mortality. RESULTS: The sample was followed up to five years with a mean follow-up of three years. Subjects taking ACEIs has lower odds of ESRD development (OR, 0.33 [95% CI, 0.13-0.82]) and all-cause mortality (OR, 0.10 [95% CI, 0.04-0.21]) than ARBs. CONCLUSIONS: This study shows that ACEIs are associated with lower ESRD development and all-cause mortality than ARBs. This may have implications for guidelines which currently suggest that these two therapeutic classes provide similar benefits in people with newly diagnosed type 2 diabetes and macroalbuminuria.

A literature review of cost-effectiveness analyses of prostate-specific antigen test in prostate cancer screening.

Prostate cancer is the most common non-skin cancer in American men, and prostate-specific antigen (PSA) testing is its common screening procedure. In May 2012, the US Preventive Services Task Force recommended against PSA-based screening. These recommendations contradict the current recommendations of other organizations such as the American Urological Association. The authors conducted a systematic review of PubMed, EMBASE and Cochrane to examine the published literature reporting the cost-effectiveness of PSA-based screening. The authors found ten studies each for US and non-US jurisdiction population. All reviewed studies concluded PSA-based screening to be cost effective in younger men (≤60 years of age) and at higher PSA levels (≥3 ng/ml). Further cost-effectiveness analyses reflecting latest clinical practice and current perspectives regarding adverse outcomes of potentially unnecessary treatment are required, especially from the US government perspective.

Economic, clinical, and humanistic outcomes (ECHOs) of pharmaceutical care services for minority patients: a literature review.

BACKGROUND: The U.S. population of racial/ethnic minorities continues to increase; however, health disparities and poor health outcomes among many of them continue to be a major public health problem confronting the U.S. health care system. OBJECTIVES: The objective of this review was to summarize published pharmaceutical care services literature reporting economic, clinical, and/or humanistic outcomes (ECHOs) among racial/ethnic minorities. Studies that reported differences by race/ethnicity and studies where most participants were from multiracial/ethnic minorities were included. METHODS: PubMed and International Pharmaceutical Abstracts databases were searched for articles that reported the effects of pharmaceutical care on ECHOs among racial/ethnic minorities published between January 1980 and November 2010. The literature review was focused on racial groups that included black/African-American, Native American, Indian American Asian, Alaska Native, Native Hawaiian, and Pacific Islander patients, and ethnic group that was non-white Hispanic/Latino patients. RESULTS: There were 24 articles that studied the impact of pharmaceutical care on ECHOs by race/ethnicity or where most participants were from multiracial/ethnic minorities. Twenty-three studies reported that pharmaceutical care has a positive impact on health outcomes of the studied populations. About half of the studies meeting inclusion criteria evaluated only 1 type of patient outcome, primarily clinical outcomes. Education/consultation and medication/therapy management were the most commonly evaluated types of pharmaceutical care services throughout the studied groups. Comprehensive disease management was evaluated mainly in multiracial/ethnic populations and blacks/African-Americans. Few studies adopted randomized controlled designs, which make it difficult to attribute changes in patient outcomes to the provision of pharmaceutical care. Nine studies that involved cooperation between pharmacists and other medical professionals reflect an increased tendency for interprofessional collaboration in the current health care system. CONCLUSION: This review shows that there is a positive relationship between pharmaceutical care and ECHOs in patients from racial/ethnic minority groups. However, more studies are needed to document the effects of pharmaceutical care on reducing racial/ethnic health disparities and to determine which interventions are most effective among certain groups with health disparities.