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Burnout is defined as high emotional exhaustion and depersonalization, and low personal accomplishment from work. Prevalence of burnout among health-system and ambulatory care pharmacists is unknown during the COVID-19 pandemic.The purpose of this research is to analyze burnout prevalence among health-system pharmacists (HSPs) and ambulatory care pharmacists (ACPs) using the Oldenburg Burnout Inventory and Maslach Burnout Inventory.An electronic survey was sent to HSPs at two academic health systems in Chicago, IL. Demographics, risk of burnout based on two validated assessments (the Oldenburg Burnout Inventory [OLBI] and the Maslach Burnout Inventory [MBI]), burnout contributors, burnout mitigation strategies, and change in burnout due to COVID-19 were collected. Burnout was defined as meeting any one criterion for high burnout on the following dimensions: exhaustion score and disengagement on the OLBI, and emotional exhaustion and depersonalization on the MBI. The co-primary outcomes were the prevalence of burnout among HSPs, and the comparison of ACP burnout to that of non-ambulatory HSPs. Secondary outcomes were comparison of burnout between the OLBI and MBI assessments, conceptualization of the causes and contributors of burnout and mitigation strategies among HSPs, and the self-perceived effect of COVID-19 on burnout severity.Of the 113 pharmacists included in the study, HSP burnout prevalence as defined above was 87.6%, ACP burnout was 88.4%, and non-ambulatory HSP burnout was 87.1%. There was no statistical difference between ACP and non-ambulatory HSP burnout prevalence, either overall or in any specific burnout dimension. The OLBI and MBI captured similar rates of burnout. The commonly reported burnout causes were staffing and scheduling issues, precepting requirements, and patient needs. Participants' most reported coping strategies were spending time with family/friends, sleep, exercise, and recreational/relaxation activities. A majority of HSPs (78.2%) reported higher levels of burnout due to COVID-19.HSP burnout during COVID-19 pandemic is higher than cited in the pre-COVID literature. Individual coping strategies are poor buffers for work-related burnout.

Anticoagulation of patients treated with the Impella percutaneous mechanical circulatory support (MCS) devices is complex and lacks consistency across centers, potentially increasing the risk of complications. In order to optimize safety and efficacy, an expert committee synthesized all available evidence evaluating anticoagulation for patients receiving Impella support in order to provide consensus recommendations for the management of anticoagulation with these devices. The evidence synthesis led to the creation of 42 recommendations to improve anticoagulation management related to the use of the Impella devices. Recommendations address purge solution management, intravenous anticoagulation, monitoring, evaluation and management of heparin-induced thrombocytopenia (HIT), and management during combination MCS support. The use of a heparinized, dextrose-containing purge solution is critical for optimal device function, and a bicarbonate-based purge solution may be an alternative in certain situations. Likewise, intravenous (ie, systemic) anticoagulation with heparin is often necessary, although evidence supporting the optimal assay and target range for monitoring the level of anticoagulation is generally lacking. Patients treated with an Impella MCS device may develop HIT, which is more difficult to evaluate and treat in this setting. Lastly, the use of Impella with extracorporeal membrane oxygenation or for biventricular support creates additional anticoagulation challenges.

Perform a cost-effectiveness analysis comparing strategies for selecting P2Y12 inhibitors in acute coronary syndrome (ACS). Six strategies for selection of P2Y12 inhibitors in ACS were compared from the US healthcare system perspective: (1) clopidogrel for all (universal clopidogrel); (2) ticagrelor guided by platelet reactivity assay (PRA; clopidogrel + phenotype); (3) ticagrelor use only in CYP2C19 poor metabolizers (genotype + conservative ticagrelor); (4) ticagrelor use in both CYP2C19 intermediate and poor metabolizers (genotype + liberal ticagrelor); (5) ticagrelor use only in patients with CYP2C19 polymorphisms and clopidogrel nonresponse by PRA (genotype + phenotype); and (6) ticagrelor for all (universal ticagrelor). A decision model was developed to model major adverse cardiovascular events and bleeding during 1 year of treatment with a P2Y12 inhibitor. Model inputs were identified from the literature. Lifetime costs were adjusted to 2017 US dollars; quality-adjusted life-years (QALYs) were projected using a Markov model. The primary endpoint was the incremental cost-effectiveness compared to the next best option along the cost-effectiveness continuum. Sensitivity analyses were performed on all model inputs to assess their influence on the incremental cost-effectiveness. In the base case analysis, incremental cost-effectiveness ratios (ICER) for the clopidogrel + phenotype, genotype + liberal ticagrelor, and universal ticagrelor strategies were $12,119/QALY, $29,412/QALY, and $142,456/QALY, respectively. Genotype + conservative ticagrelor and genotype + phenotype were not cost-effective due to second-order dominance. Genotype + liberal ticagrelor compared to clopidogrel + phenotype demonstrated the highest acceptance (97%) at a willingness to pay (WTP) threshold of $100,000/QALY. Cost-effective strategies to personalize P2Y12 inhibition in ACS include clopidogrel +phenotype and genotype + liberal ticagrelor. Universal ticagrelor may be considered cost-effective at a higher WTP threshold ($150,000/QALY). Genotype + liberal ticagrelor exhibited the highest acceptability compared to clopidogrel + phenotype over the widest range of WTP thresholds and may be preferred.

Purpose The study was designed to characterize "on-label" use of i.v. diltiazem in patients with acute atrial fibrillation or flutter (AFF). Methods An IRB-approved, single-center, retrospective, observational design was used. Eligible patients had acute AFF with heart rate >120 bpm and received i.v. diltiazem from June 1, 2012, to June 30, 2014. The primary outcome was frequency of on-label use of i.v. diltiazem, defined as use of at least one FDA-approved weight-based bolus dose followed by an infusion, if appropriate, in the absence of contraindications. Results A total of 300 patients were screened; 97 patients were included for analysis. I.V. diltiazem was used on-label in only 14 patients (14%). Of the 96 patients who received an initial diltiazem bolus injection, the median dose was significantly higher in patients for whom the diltiazem dose was on-label, as follows: 17.5 mg (interquartile range [IQR]), 10-20 mg vs. 10.0 mg (IQR, 10-20 mg), p < 0.02). Twenty-nine patients (35%) in the off-label group had a therapeutic response to diltiazem alone compared with 8 patients (57%) in the on-label group (p = 0.11). More patients treated with off-label diltiazem bolus injection required additional rate control medications (41% vs. 7%, p < 0.04). Conclusion In most patients, i.v. diltiazem was not used in accordance with FDA labeling. For most, i.v. diltiazem doses were lower than recommended and many of these patients required additional rate control medications to achieve a therapeutic response.

Once a routine part of atrial fibrillation (AF) management, digoxin use has declined. Likely hastening this decline are findings from several studies and systematic reviews identifying a potential association between digoxin use and all-cause mortality in AF populations. However, inconsistency exists within some of these studies potentially leading to confusion among clinicians. To critically evaluate the current literature to contextualize the associations between digoxin and mortality risk in patients with AF by performing an overview of systematic reviews. We searched MEDLINE, Cochrane Central Database of Systematic Reviews, and SCOPUS from their earliest date through October 12, 2020, to identify systematic reviews (SRs) that included studies enrolling patients with AF or atrial flutter and evaluated the association between digoxin use and all-cause mortality. We used the AMSTAR 2 tool to assess the risk of bias for each included SR. Results from reviews are qualitatively synthesized. Our search identified 10 SRs that met our inclusion criteria. Of the 41 unique AF studies included in these SRs, 41% were cohort studies, 29% were post hoc analyses of randomized controlled trials (RCTs), 15% were RCTs, and 15% were registry studies. Based on our AMSTAR 2 assessment, the overall confidence in the results of the 10 reviews was rated as "moderate" in three SRs, "low" in three SRs, and "critically low" in the rest. Except for one review, each included SR shows that digoxin use in AF is associated with a 15 to 38% higher risk of all-cause mortality. This association may be greater when AF-only populations are considered compared with a mix of AF and heart failure populations. Serum digoxin concentration (SDC) data were infrequently considered, but available data suggested a greater association between increasing SDC and all-cause mortality. This overview of reviews found general consistency regarding the association between digoxin use and higher all-cause mortality in AF populations. However, heterogeneity exists among and between SRs and an unmet need exists for additional study in a RCT setting with close monitoring and reporting of SDC to better inform clinical practice.

This observational cohort study compares the odds of cardiac events among new users of azithromycin relative to new users of amoxicillin using real-world data., Key Points Question Using a large health care database, what is the risk of cardiac events in azithromycin users compared with amoxicillin users? Findings In a cohort study of 2 141 285 episodes of azithromycin use that were matched to episodes of amoxicillin use with high-dimensional propensity scores, no difference in the rate of cardiac events occurred at 5, 10, and 30 days after therapy initiation. However, concurrent use of QT-prolonging drugs with azithromycin was associated with 40% greater odds of cardiac events compared with amoxicillin. Meaning Azithromycin and amoxicillin appear to pose similar odds of cardiac events except for concurrent use of QT-prolonging drugs with azithromycin; therefore, clinicians should use amoxicillin or another antibiotic among such patients., Importance Conflicting evidence exists on the association between azithromycin use and cardiac events. Objective To compare the odds of cardiac events among new users of azithromycin relative to new users of amoxicillin using real-world data. Design, Setting, and Participants This retrospective cohort study used data from Truven Health Analytics MarketScan database from January 1, 2009, to June 30, 2015. Patients receiving either amoxicillin or azithromycin and enrolled in a health care plan 365 days before (baseline period) the dispensing date (index date) were included in the study. Patients were matched 1:1 on high-dimensional propensity scores. Data were analyzed from October 1, 2018, to December 31, 2019. Exposures New use of azithromycin compared with new use of amoxicillin. Main Outcomes and Measures The primary outcome consisted of cardiac events, including syncope, palpitations, ventricular arrhythmias, cardiac arrest, or death as a primary diagnosis for hospitalization at 5, 10, and 30 days from the index date. Logistic regression models were used to estimate odds ratios (ORs) with 95% CIs. Results After matching, the final cohort included 2 141 285 episodes of each index therapy (N = 4 282 570) (mean [SD] age of patients, 35.7 [22.3] years; 52.6% female). Within 5 days after therapy initiation, 1474 cardiac events (0.03%) occurred (708 in the amoxicillin cohort and 766 in the azithromycin cohort). The 2 most frequent events were syncope (1032 [70.0%]) and palpitations (331 [22.5%]). The odds of cardiac events with azithromycin compared with amoxicillin were not significantly higher at 5 days (OR, 1.08; 95% CI, 0.98-1.20), 10 days (OR, 1.05; 95% CI, 0.97-1.15), and 30 days (OR, 0.98; 95% CI, 0.92-1.04). Among patients receiving any concurrent QT-prolonging drug, the odds of cardiac events with azithromycin were 1.40 (95% CI, 1.04-1.87) greater compared with amoxicillin. Among patients 65 years or older and those with a history of cardiovascular disease and other risk factors, no increased risk of cardiac events with azithromycin was noted. Conclusions and Relevance This study found no association of cardiac events with azithromycin compared with amoxicillin except among patients using other QT-prolonging drugs concurrently. Although azithromycin is a safe therapy, clinicians should carefully consider its use among patients concurrently using other QT-prolonging drugs.

In patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI), newer antiplatelet agents prasugrel and ticagrelor have lower rates of cardiovascular events when compared with clopidogrel. However, it is unclear whether there are differences in economic outcomes when comparing these agents in ACS-PCI patients.To assess aggregated costs and medical resource utilization among ACS-PCI patients prescribed prasugrel, ticagrelor, or generic clopidogrel, using a large commercial insurance claims database.Costs attributable to any medical and pharmacy service and resource utilization including number of admissions, length of hospital stay, emergency room visits, and office visits over the 180-day postdischarge period were compared. All-cause and cardiovascular health care costs and resource utilization were separately analyzed for patients enrolled in the data over the continuous follow-up (CFU) period, and for patients continuously taking their initial treatment for 6 months (CTX). Potential confounders collected over a 6-month baseline assessment period were controlled for, using a generalized linear model.Over the 180-day follow-up, prasugrel and ticagrelor patients underwent fewer admissions (rate ratio [RR] = 0.87, 95% CI = 0.80-0.95) from CFU and RR = 0.81, 95% CI = 0.71-0.89 from CTX) compared with clopidogrel patients. The newer agent cohort incurred more overall health care costs than the generic clopidogrel group, with added costs of $957 (95% CI = $236-$1,725) in the CFU group and $1,122 (95% CI = $455-$1,865) in the CTX group, which were smaller than the increase in all-cause outpatient pharmacy costs associated with the newer agents versus clopidogrel (CFU: $1,175, 95% CI = $1,079-$1,278 and CTX: $1,360, 95% CI = $1,256-$1,487). Overall, there was no statistically significant difference in the economic outcomes associated with prasugrel and ticagrelor. There were, however, significant correlations between all-cause and cardiovascular-related outcomes.The higher price of prasugrel and ticagrelor was partially offset by a decrease in hospital admission compared with generic clopidogrel over a 6-month postdischarge period. Aggregated medical costs and resource utilization were not significantly different between prasugrel and ticagrelor patients.No funding was received for this study. DiDomenico has received an honorarium from Amgen for preparation of a heart failure drug monograph for Pharmacy Practice News and serves as an advisory board member for a heart failure program at Otsuka America Pharmaceuticals and for Novartis Pharmaceuticals. Touchette has received unrestricted grant funding from Cardinal Health, Sunovion Pharmaceuticals, and Takeda and has served as a consultant to and director of the American College of Clinical Pharmacy Practice-Based Research Network on a study funded by Pfizer. Walton has served as a paid consultant for Bristol-Myers Squibb, Baxter, Merck, Genentech, Primus, Takeda, and Abbott. The other authors have nothing to disclose.

Objective Sacubitril/valsartan (SAC/VAL) has been shown to reduce mortality and hospitalization in patients with heart failure with reduced ejection fraction (HFrEF) compared with enalapril but at a substantially higher cost. This study evaluates the cost-effectiveness of SAC/VAL versus enalapril in patients with HFrEF over a 5-year time horizon from the U.S. payer perspective. Methods A cohort-based Markov model was developed to compare costs and quality-adjusted life years (QALYs) between SAC/VAL and enalapril in patients with HFrEF over a 5-year time horizon. Markov states included New York Heart Association (NYHA) class (II-IV) and death. Treatment discontinuation, HF-related hospitalizations, and NYHA class progression were modeled as transition states based on data from the PARADIGM trial. Other probabilities, costs, and utilities were obtained from published literature and public databases. Results In the base case analysis, SAC/VAL cost more than enalapril ($81,943 vs $67,287) and was more effective (2.647 QALYs vs 2.546 QALYs), resulting in an incremental cost-effectiveness ratio of $143,891/QALY gained. At a willingness to pay (WTP) of $100,000/QALY, SAC/VAL was cost-effective up to a cost of $298/month. Results were most sensitive to SAC/VAL cost, SAC/VAL mortality benefit, and NYHA progression probability. SAC/VAL had a 10% and 52% probability of being cost-effective at WTP thresholds of $100,000/QALY and $150,000/QALY, respectively. Conclusions SAC/VAL is associated with clinical benefit and may be cost-effective compared with the current standard of care over realistic treatment durations from the payer perspective. Results of this analysis can inform discussions on the value and position of SAC/VAL in the current market.

As an author, there is no better feeling than to receive correspondence from a journal editor that your paper has been accepted for publication. However, that sense of elation can quickly turn to dread if the author has to respond to dozens, even hundreds, of comments from peer reviewers. We have

Peer review is a shared responsibility intended to enhance the quality of manuscripts published in biomedical journals. Under ideal circumstances, everyone—authors, reviewers, and editors—understands their role and responsibilities, approaching the process with deliberate thoughtfulness. In our

Publishing manuscripts in the peer-reviewed literature is essential for the advancement of both science and healthcare.[1][1] For those who work in academic environments, including residency or fellowship training programs, disseminating one’s work in peer-reviewed journals and other forums is

STUDY OBJECTIVE To measure the prevalence of cardiac risk factors among patients prescribed azithromycin before and after the United States Food and Drug Administration (FDA) issued a warning on May 17, 2012, on the risk of potentially fatal heart rhythms associated with the drug. DESIGN Retrospective cohort study using administrative claims data. DATA SOURCE Truven Health Analytics MarketScan database. PATIENTS A total of 12,971,078 unique patients with 23,749,652 azithromycin prescriptions dispensed between January 2009 and June 2015 were included. Patients had to be continuously enrolled in a health plan for at least 365 days (baseline) before the date of azithromycin dispensing (index date). Cohorts were assigned based on the index dates of the azithromycin prescriptions, either before (January 1, 2009-May 1, 2012) or after (June 1, 2012-June 30, 2015) the FDA warning was issued. MEASUREMENTS AND MAIN RESULTS A cardiac risk factor included either a cardiac condition (heart failure or dysrhythmias) or concurrent use of drugs that prolong the QT interval. The unit of analysis was each prescription of azithromycin. Multivariable logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the prevalence of cardiac risk factors. Mean age of the patients was 40.1 ± 21.3 years old, with 60.8% females. Prior to the FDA warning, 11,596,022 (48.8%) azithromycin prescriptions were identified, and 12,153,630 (51.2%) were identified after the warning. The prevalence of a preexisting cardiac condition was 7.3% versus 7.9% (p

Perform a cost-effectiveness analysis comparing strategies for selecting P2YSix strategies for selection of P2YIn the base case analysis, incremental cost-effectiveness ratios (ICER) for the clopidogrel + phenotype, genotype + liberal ticagrelor, and universal ticagrelor strategies were $12,119/QALY, $29,412/QALY, and $142,456/QALY, respectively. Genotype + conservative ticagrelor and genotype + phenotype were not cost-effective due to second-order dominance. Genotype + liberal ticagrelor compared to clopidogrel + phenotype demonstrated the highest acceptance (97%) at a willingness to pay (WTP) threshold of $100,000/QALY.Cost-effective strategies to personalize P2Y

Previous work indicates the potential for community health workers and peer coaches serving as patient navigators to improve processes of care and health outcomes during care transitions, but have not been sufficiently tested to determine if such programs improve measures of patient experience in minority serving institutions. The objectives of the Patient Navigator to Reduce Readmissions (PArTNER) study was to: 1) conduct a pragmatic clinical effectiveness trial comparing a multi-faceted, stakeholder-supported Navigator intervention (in-person CHW visits in the hospital and after hospital discharge, plus telephone-based peer coaching) versus usual care on the experience of hospital-to-home care transitions in patients hospitalized with heart failure, pneumonia, chronic obstructive pulmonary disease, myocardial infarction, or sickle cell disease; 2) examine the effectiveness of the Navigator intervention in patient subgroups; and 3) understand the barriers and facilitators of successfully implementing the Navigator intervention across patient populations. The co-primary outcomes are the 30-day changes in: 1) Patient Reported Outcomes Measurement Information System (PROMIS) emotional distress-anxiety, and 2) PROMIS informational support. Secondary outcomes at 30 and 60 days include other PROMIS health measures and hospital readmissions. Innovative features of the PArTNER study include early and continuous engagement of patients, their caregivers, clinicians, health system administrators, and other stakeholders to inform the design and implementation of the Navigator intervention. In this report, we describe the design of the PArTNER study. Keywords: Pragmatic clinical trial, Hospital-to-home transition, Hospital readmissions, Community health worker, Peer coaching

Limited socioeconomic resources contribute to high readmission rates at minority serving institutions (MSIs). A better understanding of patient-level factors and need for patient navigators could inform approaches to enhance care transitions tailored to these vulnerable patient populations. We sought to understand the perspectives of patients and their caregivers about hospital to home transitions from an MSI, as well as their attitudes about patient navigators to facilitate care transitions. We conducted qualitative research using focus groups (FGs)-five disease-specific patient FGs and two caregiver FGs, including 23 patients and 10 caregivers. Findings support the need for additional services to address: (1) gaps in the hospital discharge; (2) socioeconomic resources; (3) access to post-discharge care; (4) patient's health care seeking behaviors; (5) patient anxiety; (6) self-management education; and (7) social supports for patients and caregivers. While caregivers uniformly expressed interest in patient navigators, support for navigators among patients was more variable.

Introduction Heart failure guidelines recommend that patients with acute decompensated heart failure (ADHF) be transitioned to oral (PO) loop diuretics prior to discharge but little evidence supports this recommendation. Objectives We sought to identify the frequency that patients admitted for ADHF are transitioned to PO loop diuretics prior to discharge, identify predictors for transitioning to PO loop diuretics, and compare outcomes between patients converted to PO loop diuretics (PO group) to those who were not (IV group). Methods We conducted a retrospective chart review of unique adult patients hospitalized for ADHF at our facility between 9/1/2017 and 8/31/2019. Patients hospitalized for ADHF (ICD-10 I50.xx) with evidence of fluid overload, treated with IV loop diuretics during the first 24 hours of admission, and discharged home with a prescription for PO loop diuretic were included. Patients were excluded if they were on dialysis, left against medical advice, received palliative care referral while inpatient, or had a history of cirrhosis or received > 50mg of aldosterone antagonist a day. Patient demographics, clinical features, and practice patterns were characterized to identify predictors of PO transition. Thirty-day readmission rates were compared between the PO and IV groups. Results Among 240 patients included, 155 (65%) patients were transitioned to PO loop diuretics prior to discharge (PO group). Mean age was 63 years, most were men (55%) of African American (66%) descent. Compared to the IV group, the PO group had higher baseline potassium (4.3 vs 4.1 mEq/L, p=0.010), lower eGFR (52 vs 60 mL/min/1.73m2, p=0.016), were less likely to be on hydralazine (12.9% vs 24.7%, p=0.020), and more likely to be on a thiazide-type diuretic (9.7% vs 2.4%, p=0.034) on admission. Neither age, gender, blood pressure, renal function, nor electrolytes were significant predictors of transitioning to PO loop diuretics prior to hospital discharge. Within 30 days, 36 (23.2%) patients in the PO group were rehospitalized compared to 19 (22.4%) patients in the IV group (p=0.88). Conclusions Most patients admitted for ADHF were transitioned to PO loop diuretics prior to discharge. Although differences were noted in baseline characteristics, we did not identify any significant predictors for patients transitioned to PO diuretics. Thirty-day readmission rates were similar between patients who were and were not transitioned. Further study is warranted to identify the best approach for transitioning ADHF patients to PO diuretics prior to discharge.

Objectives. To characterize anticoagulation practices with the Impella percutaneous ventricular assist device (pVAD). Background. Managing anticoagulation in patients being supported by the Impella pVAD is made challenging by several unique features of the device. These include the release of a dextrose-based purge solution containing unfractionated heparin (UFH), the need to concurrently administer systemic anticoagulation with intravenous UFH, and the lack of an alternative strategy in patients with contraindications to UFH. Methods. To characterize anticoagulation practices with the Impella pVAD, we conducted a survey of centers in the United States performing a high volume of Impella cases, which we defined as > 1 per month. Centers were contacted via email or phone and individuals who agreed to participate were provided with a link to complete the survey online. The primary measures of interest were variations in practice across centers and variations from the manufacturer’s recommendations. Results. Practices varied considerably among respondents (65 of 182 centers, or 35.7%) and often diverged from manufacturer recommendations. Approximately half of centers (52.4%) reported using a UFH concentration of 50 units/mL in the purge solution, whereas most of the remaining centers (41.3%) reported using lower concentrations. Strategies for the initiation and adjustment of systemic therapy also varied, as did practices for routinely monitoring for hemolysis. Nearly one-fifth of centers (16.7%) had not developed an alternative strategy for the purge solution in patients with contraindications to UFH. Most centers (58.4%) reported using argatroban or bivalirudin in this scenario, a strategy that diverges from the manufacturer’s recommendations. Conclusions. Given these findings, studies to determine a systematic approach to anticoagulation with the Impella device are warranted.

For pharmacy residency candidates, their preceptors, and residency program directors, the time between the ASHP Midyear Clinical Meeting (MCM), in early December, and mid-January is typically very chaotic. During this interval, candidates complete residency applications and secure letters of

Percutaneous mechanical circulatory support (MCS) devices, including the intraaortic balloon pump, Impella, and TandemHeart, are often used for hemodynamic support in the setting of refractory cardiogenic shock. The thrombotic and bleeding complications associated with these devices is well recognized, and the Impella and TandemHeart devices have unique anticoagulation considerations that may influence patient outcomes. Both devices typically require use of a heparinized purge solution in combination with intravenous unfractionated heparin, thereby providing multiple sources of heparin exposure. Each device also has specific monitoring requirements and goal ranges. This review provides an overview of percutaneous MCS devices commonly used in the acute management of left ventricular failure, with an emphasis on pharmacologic considerations. We review recent evidence and guidelines and provide recommendations for appropriate use of anticoagulation during device support. Approaches to managing heparinized purge solutions, monitoring, and the utility of nonheparin anticoagulants are also provided because high-quality evidence in the literature is limited.

Objective In randomized controlled trials, prasugrel and ticagrelor reduced cardiovascular complications in patients with acute coronary syndrome (ACS) compared to clopidogrel. However, there have been limited head-to-head comparisons across the three anti-platelet agents using real-world data. The aim of this study was to compare clinical outcomes of three strategies during a 1-year post percutaneous coronary intervention (PCI) period. Methods Rates of all-cause and acute myocardial infarction (AMI) related hospitalizations were retrospectively compared using an insurance claims database. Patients who filled a prescription for an oral antiplatelet agent between September 2011 and December 2013 for post ACS-PCI care were identified. Time to all-cause and AMI hospitalization for a 365-day post-discharge period was compared using Cox-proportional hazard models controlling for potential confounders within a propensity score matched cohort. Results A matched cohort of 9,504 clopidogrel, 7,128 prasugrel and 2,376 ticagrelor patients was analyzed. The 1-year hazard ratio (HR) for the two newer agents vs. clopidogrel was 0.84 [0.78; 0.91]. The HR for the newer agents vs. clopidogrel of admission with AMI as the primary diagnosis was 0.78 [0.61; 1.03], and for AMI as any diagnosis during a hospitalization was 0.88 [0.77; 1.00]. The HR of all-cause admission for ticagrelor vs. prasugrel was 0.97 [0.84; 1.13], and the HRs of AMI related admission were not statistically significant between the two agents. Robustness checks across statistical methods to control for potential confounders did not influence the conclusion. Conclusion This real-world study demonstrated that use of the newer agents following PCI was associated with a decrease in all-cause and AMI related hospitalizations. However, there was no significant difference in the rate of admission between ticagrelor vs. prasugrel. Due to concerns regarding statistical power future studies should examine larger cohorts to obtain more precise estimates for AMI hospitalization for ticagrelor and prasugrel. This article is protected by copyright. All rights reserved.

Study Objectives To characterize the balance of clinical and academic responsibilities of clinical track pharmacy faculty in the United States and evaluate organizational structures that promote satisfactory balance between these responsibilities. Design Prospective cross-sectional survey. Setting A 22-item online survey was developed and distributed via Qualtrics software. Participants Clinical faculty members of the American College of Clinical Pharmacy Adult Medicine, Ambulatory Care, Cardiology, Critical Care, Gastrointestinal/Liver/Nutrition, Immunology/Transplantation, Infectious Disease, and Pediatrics Practice and Research Networks (PRNs) were invited to participate via the PRN electronic mailing list. Measurements and Main Results The survey comprised questions related to demographics, organizational structure, and balance of clinical and academic responsibilities. A total of 344 participants responded to some or all of the survey questions. The demographics were relatively equally balanced between faculty at state and private academic institutions, academic rank, and practice setting. Expected and actual effort allocations were similar for each of the clinical and academic responsibilities, with direct patient care and clinical teaching representing more than 50% effort allocation cumulatively. Clinical faculty at state institutions devoted a larger proportion of time to clinical service, whereas clinical faculty at private institutions devoted a greater proportion of time to didactic teaching. When asked about time constraints, 157 (69.8%) of the 225 survey participants responding to this question did not believe they had sufficient time to fulfill their nonclinical academic needs. Clinical faculty who were provided “protected time” away from clinical service had a significantly more favorable opinion of this question. Conclusion Most of the clinical track pharmacy faculty indicated that they have insufficient time to fulfill their nonclinical academic responsibilities. Provision of protected time may alleviate some of these time constraints.

OBJECTIVE The purpose of this study was to determine if institutions with inpatient cardiovascular credentialed pharmacists exhibit improved quality measures for acute myocardial infarction (AMI) and heart failure (HF) care compared with institutions without inpatient cardiovascular credentialed pharmacists. METHODS We conducted a multicenter, retrospective, cross-sectional, matched case-control study. Hospitals with at least one Added Qualification in Cardiology (AQCV) inpatient pharmacist were included in the case group. Each case group hospital was matched to hospitals without an AQCV pharmacist by region, number of cardiovascular discharges, and teaching hospital designation in a 1:3 ratio (case:control). The 34 AQCV hospitals were matched to 102 non-AQCV hospitals. The proportions of discharges meeting HF and AMI process of care measures and 30-day outcomes (readmission and mortality) for each hospital were determined from public data and compared between the case and control groups. RESULTS Hospitals with AQCV pharmacists performed better on process of care measures than hospitals without AQCV pharmacists (odds ratio 1.41, 95% confidence interval 1.25–1.58, p

Background Heart failure (HF) care takes place in multiple settings, with a variety of providers, and generally involves patients who have multiple comorbidities. This situation is a “perfect storm” of factors that predispose patients to medication errors. Methods and Results The goals of this paper are to outline potential roles for clinical pharmacists in a multidisciplinary HF team, to document outcomes associated with interventions by clinical pharmacists, to recommend minimum training for clinical pharmacists engaged in HF care, and to suggest financial strategies to support clinical pharmacy services within a multidisciplinary team. As patients transition from inpatient to outpatient settings and between multiple caregivers, pharmacists can positively affect medication reconciliation and education, assure consistency in management that results in improvements in patient satisfaction and medication adherence, and reduce medication errors. For mechanical circulatory support and heart transplant teams, the Centers for Medicare and Medicaid Services considers the participation of a transplant pharmacology expert (e.g., clinical pharmacist) to be a requirement for accreditation, given the highly specialized and complex drug regimens used. Although reports of outcomes from pharmacist interventions have been mixed owing to differences in study design, benefits such as increased use of evidence-based therapies, decreases in HF hospitalizations and emergency department visits, and decreases in all-cause readmissions have been demonstrated. Clinical pharmacists participating in HF or heart transplant teams should have completed specialized postdoctoral training in the form of residencies and/or fellowships in cardiovascular and/or transplant pharmacotherapy, and board certification is recommended. Financial mechanisms to support pharmacist participation in the HF teams are variable. Conclusions Positive outcomes associated with clinical pharmacist activities support the value of making this resource available to HF teams.

Recent trials demonstrated the efficacy of prasugrel and ticagrelor compared with clopidogrel in the reduction of cardiovascular complications in patients with acute coronary syndrome (ACS). However, it is unclear how use of the 3 antiplatelet medications has changed in commercially insured patients since the advent of the new agents.To (a) describe the adoption of prasugrel and ticagrelor in patients who received percutaneous coronary intervention (PCI) for the onset of ACS and (b) explore patient factors associated with the selection of the drug to provide insight into utilization patterns of these antiplatelet agents.Patients who received a new dispensing of an antiplatelet agent following a hospitalization for a PCI administered for ACS were identified from insurance claims between 2009 and 2013. Demographics and comorbid conditions were determined based on a 6-month period before the ACS event. Longitudinal trends in antiplatelet agent selection were illustrated using descriptive statistics segmented by month and quarter. Using logistic regressions with stepwise model selection, factors associated with use of the newer medications, as well as with the selection between ticagrelor and prasugrel, were identified.The analysis included 66,335 subjects. The use of clopidogrel decreased from 100% to roughly 65% of total antiplatelet agent use by the end of 2011 and leveled off thereafter. The introduction of ticagrelor in 2011 coincided with a drop in prasugrel initiation from 35%-18% by December 2013. The use of new agents as opposed to use of clopidogrel was associated with younger age (65 years), male gender, and a diagnosis of ST-elevation myocardial infarction. In addition, conditions increasing mortality and risk of cardiovascular complication were associated with higher odds of using clopidogrel. The odds of using ticagrelor over prasugrel increased with older age and history of a cerebrovascular event.In 2013, clopidogrel remained the most prescribed agent. Meanwhile, ticagrelor had gradually replaced a substantial portion of prasugrel initiation. Further investigation into outcomes associated with the newer agents, as well as reasons behind the conservative use of the antiplatelet agents, is warranted.No funding was received for the conduct of this study. DiDomenico received an honorarium from Amgen for the preparation of a heart failure drug monograph for Pharmacy Practice News and was a co-investigator on funded research for the Patient-Centered Outcomes Research Institute. DiDomenico also serves as an advisory board member for a heart failure program at Otsuka America Pharmaceuticals and as an advisory board member at Novartis Pharmaceuticals. Touchette has received unrestricted grant funding from Cardinal Health and Sunovion Pharmaceuticals and has also served as a consultant to and director of the American College of Clinical Pharmacy Practice-Based Research Network on a study funded by Pfizer. None of the authors of this study are involved in financial or personal relationships with agencies, institutions, or organizations that inappropriately influenced the statistical analysis plan or interpretation of the results. Study concept and design were contributed by Kim, Lee, Touchette, and Walton, with assistance from DiDomenico and Ardati. Kim and Lee collected the data, and data interpretation was performed by Lee, DiDomenico, and Ardati, along with Kim and Walton and assisted by Touchette. The manuscript was written by Kim and Walton, with assistance from the other authors, and revised by Kim, Walton, and Lee, with assistance from the other authors.

Although the period from 1953 to 2001 resulted in the approval of more than 30 medications currently used to treat heart failure (HF), few novel drugs have been approved in the last decade. However, the investigational pipeline for HF medications once again appears promising. In patients with chronic heart failure with reduced ejection fraction (HFrEF), ivabradine and valsartan/sucubitril (LCZ696) were recently approved by the US Food and Drug Administration. Both agents have been shown to reduce the risk of cardiovascular death and HF hospitalization. In the treatment of acute HF, serelaxin and ularitide are the farthest along in development. Both agents have demonstrated favorable effects on surrogate end points and preliminary data suggest a possible mortality benefit with serelaxin. Consequently, phase 3 trials are ongoing to evaluate the effect of serelaxin and ularitide on clinical outcomes. Given the poor history of recent investigational acute HF drugs that have advanced to phase 3/4 studies, enthusiasm for both serelaxin and ularitide must be tempered until these trials are completed.

DISCLOSURES: None of the authors of this study are involved in financial or personal relationships with agencies, institutions, or organizations that inappropriately influenced the statistical analysis plan or interpretation of the study results. DiDomenico received an honorarium from Amgen for the preparation of a heart failure drug monograph for Pharmacy Practice News and was a coinvestigator on funded research for the Patient-Centered Outcomes Research Institute. DiDomenico also serves as an advisory board member for a heart failure program at Otsuka America Pharmaceuticals and as an advisory board member at Novartis Pharmaceuticals. Touchette has received unrestricted grant funding from Cardinal Health and Sunovion Pharmaceuticals and has also served as a consultant to, and director of, the American College of Clinical Pharmacy Practice-Based Research Network on a study funded by Pfizer.

Study Objective. To compare lifetime costs and health outcomes of rate control versus rhythm control for management of atrial fibrillation in patients with coexisting heart failure from the third-party payer perspective. Design. A Markov decision analysis model constructed from costs, utility, and transition probability inputs obtained from randomized clinical trials and publically available databases. Patients. A simulated cohort aged 65 years or older with persistent or paroxysmal atrial fibrillation and heart failure. Measurements and Main Results. Markov states for rhythm control were cardioversion plus amiodarone and maintenance amiodarone, and those for rate control were β-blocker, digoxin, and calcium channel blocker. Transition states included treatment success, hospitalizations for atrial fibrillation and/or heart failure, and severe adverse effects. Economic inputs included cost for drugs, cost of hospitalizations for atrial fibrillation and/or heart failure, and cost of management of severe adverse effects. Costs were measured in 2009 U.S. dollars, and clinical outcomes in quality-adjusted life-years (QALYs). One-way and multivariable sensitivity analyses were conducted. Uncertainty intervals (UIs) were obtained from probabilistic sensitivity analyses. Rate control was found to be less costly and more effective than rhythm control. Base case and probabilistic sensitivity analyses cost and effectiveness values for rate control were $7231 (95% UI $5517–9016) and 2.395 QALYs (95% UI 2.366–2.424 QALYs); whereas those for rhythm control were $16,291 (95% UI $11,033–21,434) and 2.197 QALYs (95% UI 2.155–2.237 QALYs). No critical values were found for any model parameters in the one-way sensitivity analyses. The cost-effectiveness acceptability curves showed that rate control was considered cost-effective in 100% of cases at willingness-to-pay ratios between $0 and $200,000/QALY. Conclusion. Rate control is less costly and more effective than rhythm control and should be the initial treatment for atrial fibrillation among patients with coexisting heart failure.

Background: It is unclear to what extent hospitals use guidelines or protocols in treating acute decompensated heart failure (ADHF) and whether nesiritide is included in these guidelines or protocols. Objective: To assess the formulary status of currently used drugs, therapeutic guidelines, and perceptions about the appropriateness of treatment of ADHF in community hospitals. Methods: A Web-based survey of pharmacy directors at community hospitals that were part of a national group purchasing organization was conducted. Results: One hundred seven hospitals participated in the survey (response rate 47.1%). Diuretics such as furosemide and bumetanide were more commonly included (100% and 94.4%, respectively) on hospital formularies than was torsemide (69.2%). Dopamine and dobutamine were more common (94.4% each) on the formulary than was milrinone (68.2%), Nitroprusside and nitroglycerin were listed on the formularies of more than 90% of participating institutions, while nesiritide was listed on the formularies in only 48.6% of hospitals and was placed on restricted status in 36.4% of hospitals. Guidelines for care of patients with ADHF were used in the emergency department (ED), inpatient care units, and outpatient clinics in 18.6%, 43.0%, and 8.5% of hospitals, respectively. Overall, ADHF care, including general treatment as well as specific use of nesiritide, was deemed appropriate in the majority of patients, but nearly twice as many respondents perceived the management of ADHF and specific use of nesiritide as inappropriate in the ED compared with inpatient treatment. Only 41.1% of the respondents reported following Braunwald recommendations for the use of nesiritide. Conclusions: A sizable percentage of responding community hospitals do not have guidelines for treatment of ADHF despite the existence of such guidelines in the literature. There are opportunities for improvement in the general treatment of ADHF as well as for the use of nesiritide in ADHF, especially in the ED or observation unit versus inpatient units.

Background There is a paucity of data comparing practice patterns between board-certified specialists with added qualifications in cardiology (AQCV) and cardiovascular pharmacists without these credentials. Purpose The purpose is to characterize differences in practice between inpatient pharmacists with and without AQCV. Methods We conducted a multicenter, retrospective, cross-sectional, case-controlled survey. An AQCV pharmacist list was extracted from the Board of Pharmacy Specialties Web site. Hospitals with AQCV pharmacists comprised the case group. Hospitals were excluded if the AQCV pharmacists did not provide direct patient care, practiced in the outpatient setting, or were in a Veterans Affairs hospital. Each case hospital was matched to hospitals without an AQCV pharmacist in a 1:3 ratio (case:control) by region, cardiovascular discharges, and teaching hospital status. Institutions completed a survey characterizing their pharmacy services. Results Fifty-six hospitals completed the survey (21 AQCV, 35 non-AQCV). More AQCV pharmacists participated on rounds (100% vs 82.9%, P = .04) and devoted more time performing administrative tasks (20.5% ± 15.3% vs 11.1% ± 8.1%, P = .001) than non-AQCV pharmacists. Conversely, AQCV pharmacists spent less time providing clinical care (52.4% ± 14.5% vs 66.2% ± 19.8%, P = .007), were less involved with drug protocol management (71.4% vs 91.4%, P = .05), and performed less order verification than non-AQCV pharmacists. Conclusions Practice patterns differ between inpatient pharmacists with and without AQCV. Further research is needed to determine whether AQCV credentialing improves patient outcomes and to delineate what specific tasks performed by inpatient cardiology pharmacists may improve patient outcomes.

Warfarin and heparin have formed the mainstay in the prophylaxis of deep vein thrombosis (DVT), stroke prevention in atrial fibrillation, and treatment of thromboembolic disease (TED). However, these choices are hampered by difficult administration, interactions with other medications, side effect profile, and limited indications for treatment. Anti-factor Xa (anti-Xa) inhibitors have already entered the drug market with the drug Fondaparinux being the first anti- Xa inhibitor to be approved for use in the U.S. by the Food and Drug Administration (FDA), and other drugs such as idraparinux being currently in development. A new class of medications, known as direct thrombin inhibitors (DTI), includes the parental agents lepirudin, argatroban and bivalirudin which have been approved by the FDA and the oral agents ximelagatran, melagatran and dabigatran. The latter three drugs which are oral DTIs may soon replace warfarin and heparin as the preferred medications for DVT prophylaxis and for reducing the relative risk of stroke. These drugs do not rely on blocking serine proteases nor do they require a co-factor (antithrombin III) like unfractionated heparin (UFH) or low molecular weight heparin (LMWH). DTIs are rapid in onset, easy to administer, do not interact with other medications or foods, have limited side effects, and can be administered in a fixed dose. The DTI ximelagatran has already been approved in several European and Asian countries, and over a dozen randomized clinical trials have been conducted demonstrating its performance to be on par with warfarin. However, approval by the FDA in the U.S. remains pending in view of reported incidences of elevations in hepatic enzymes that are currently under evaluation. This review examines the role of DTIs in the prevention and treatment of TED and the recent patents reported in the literature.

Because of the common use of digoxin and because of its narrow therapeutic index, digoxin toxicity has been prevalent historically and, therefore, most clinicians are well aware of the classical dose/concentration-related signs and symptoms of toxicity. Yet, in the modern era the incidence of digoxin toxicity has been declining for a variety of reasons, including a new (lower) therapeutic range, the development of more effective drug therapies for heart failure, and more accurate dosing methods. In addition, digoxin toxicity, once commonly fatal, can now be quickly and effectively treated by the emergency administration of antidigoxin Fab fragments. Indeed, it may be possible to expand the use of Fab fragments to select patients with non-life-threatening digoxin toxicity, in order to save costs and improve patient comfort. Most cases of digoxin toxicity are caused by inappropriately high dosages, which are usually prescribed in the setting of renal dysfunction, while other cases can be attributed to system errors such as multiple prescriptions, poor patient counseling, or errors in transcribing. With modern computerized prescribing systems, such as direct physician order entry and prompts that alert the clinician to the potential for error, it is possible to decrease the incidence of digoxin toxicity even further. A realistic goal is to nearly eradicate once commonplace digoxin toxicity or at least make its occurrence a rare event.