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Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease that affects approximately 1.5 million people in the US. Tumour necrosis factor (TNF)-α inhibitors have been shown to effectively treat and maintain remission in patients with moderately to severely active RA compared with conventional agents. The high acquisition cost of TNF-α inhibitors prohibits access, which mandates economic investigations into their affordability. The lack of head-to-head comparisons between these agents makes it difficult to determine which agent is the most cost effective.Objective: This study aimed to determine which TNF-α inhibitor was the most cost-effective agent for the treatment of moderately to severely active RA from the US healthcare payer's perspective.Methods: A Markov model was constructed to analyse the cost utility of five TNF-α inhibitors (in combination with methotrexate [+MTX]) versus MTX monotherapy using Bayesian methods for evidence synthesis. The model had a cycle length of 3 months and an overall time horizon of 5 years. Transition probabilities and utility scores were based on published studies. Total direct costs were adjusted to year 2009 $US using the medical component of the Consumer Price Index. All costs and QALYs were discounted at a rate of 3% per year. Patient response to the different strategies was determined by the American College of Rheumatology (ACR)50 criteria. One-way and probabilistic sensitivity analyses (PSAs) were performed to test the robustness of the base-case scenario. The base-case scenario was changed to ACR20 criteria (scenario 1) and ACR70 criteria (scenario 2) to determine the model's robustness. Cost-effectiveness acceptability curves and cost-effectiveness frontiers were used to estimate the cost-effectiveness probability of each treatment strategy. A willingness-to-pay (WTP) threshold was defined as three times the US GDP per capita ($US139,143 per additional QALY gained). Primary results were presented as incremental cost-effective ratios (ICERs).Results: Etanercept+MTX was the most cost-effective treatment strategy in the base-case scenario up to a WTP threshold of $US2 185,497 per QALY gained. At a WTP threshold of greater than $US2 185,497 per QALY gained, certolizumab+MTX was the most cost-effective treatment strategy. One-way analyses showed that the base-case scenario was sensitive to the probability of achieving ACR50 criteria for MTX and each TNF-α inhibitor, and changes in the utility score for patients who achieved the ACR50 criteria. With the exception of infliximab, all of the TNF-α inhibitors were sensitive to drug cost per cycle. In the scenario analyses, certolizumab+MTX was a dominant treatment strategy using ACR20 criteria, but etanercept+MTX was a dominant treatment strategy using ACR70 criteria.Conclusions: Etanercept+MTX was a cost-effective treatment strategy in the base-case scenario; however, the model was sensitive to parameter uncertainties and ACR response criteria. Although Bayesian methods were used to determine transition probabilities, future studies will need to focus on head-to-head comparisons of multiple TNF-α inhibitors to provide valid comparisons. [ABSTRACT FROM AUTHOR]

PURPOSE: To analyze patient satisfaction with care provided at two retail clinics by family nurse practitioners (FNPs) and physician assistants (PAs). To analyze patient characteristics and preferences of those patients seeking care at two retail clinics. DATA SOURCES: Anonymous, voluntary, self-report surveys completed by patient, or parents of minor patients, in one of two medical retail clinics located in grocery stores in Arizona between May 2006 and July 2007. CONCLUSIONS: We found that clients with varied incomes and different ethnicities valued the same attributes of retail health clinic care as those found in initial studies: convenient location, no appointment necessary, short wait time, and low cost. IMPLICATIONS FOR PRACTICE: The high degree of patient satisfaction found for retail health clinic care indicates that this type of entrepreneurial primary health care will continue to increase in numbers. Retail health clinics are a viable source of employment for FNPs. [ABSTRACT FROM AUTHOR]

The market withdrawal of troglitazone forced the Department of Veterans Affairs (VA) to perform a systemwide switch from troglitazone to rosiglitazone or pioglitazone. The potency, dosing equivalents, and safety of these agents had not been specifically assessed in the complex VA patient base, which includes elderly patients. The VA Pharmacy Benefits Management Strategic Healthcare Group (VA PBM) performed a national drug utilization evaluation (DUE) of the conversion from troglitazone to rosiglitazone or pioglitazone. The objectives were to: 1) assess dosing potency and equivalence of con-version doses; 2) evaluate the effects of rosiglitazone and pioglitazone on HgbA1C, lipid panel, LFTs, and Hgb/Hct; and 3) monitor adverse drug events. Nine VA facilities participated in collecting a minimum of 4 months' data for analysis by the VA PBM. A standard dose conversion table was provided. The dosing equivalent appeared less potent for pioglitazone compared to rosiglitazone as demonstrated by more frequent dosage increases (28% vs 16%). The most common ADEs detected were weight gain (27%), mild LFT elevation (23%), and CHF symptoms (9.4%). The findings of this DUE warrant close monitoring of patients placed on thiazolidinedione therapy, particularly with regards to CHF exacerbation and potential hepatotoxicity, which prompted the initiation of a VA National Thiazolidinedione Registry. [ABSTRACT FROM AUTHOR]

Focuses on the assessment of potential digoxin-rabeprazole interaction after formulary conversion of proton-pump inhibitors (PPI). Types of proton-pump inhibitors marketed in the U.S.; Role of PPI in hte treatment of gastric acid-related injury; Digoxin concentrations before and after the conversion. [ABSTRACT FROM AUTHOR]

Purpose: The complexity of patients with mental healthcare needs cared for by clinical pharmacists is not well delineated. We evaluated the complexity of patients with schizophrenia, bipolar disorder, and major depressive disorder (MDD) in Veterans Affairs (VA) cared for by mental health clinical pharmacist practitioners (MH CPPs)., Methods: Patients at 42 VA sites with schizophrenia, bipolar disorder, or MDD in 2016 through 2019 were classified by MH CPP visits into those with 2 or more visits ("ongoing MH CPP care"), those with 1 visit ("consultative MH CPP care"), and those with no visits ("no MH CPP care"). Patient complexity for each condition was defined by medication regimen and service utilization., Results: For schizophrenia, more patients in ongoing MH CPP care were complex than those with no MH CPP care, based on all measures examined: the number of primary medications (15.3% vs 8.1%), inpatient (13.7% vs 9.1%) and outpatient (42.6% vs 29.7%) utilization, and receipt of long-acting injectable antipsychotics (36.7% vs 25.8%) and clozapine (20.5% vs 9.5%). For bipolar disorder, more patients receiving ongoing or consultative MH CPP care were complex than those with no MH CPP care based on the number of primary medications (27.9% vs 30.5% vs 17.7%) and overlapping mood stabilizers (10.1% vs 11.6% vs 6.2%). For MDD, more patients receiving ongoing or consultative MH CPP care were complex based on the number of primary medications (36.8% vs 35.5% vs 29.2%) and augmentation of antidepressants (56.1% vs 54.4% vs 47.0%) than patients without MH CPP care. All comparisons were significant (P < 0.01)., Conclusion: MH CPPs provide care for complex patients with schizophrenia, bipolar disorder, and MDD in VA., (Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2024.)

Patient experience is considered an important dimension of health care quality and thus is included as part of the quadruple aim of health care. The VHA Clinical Pharmacist Practitioner (CPP) operates as an advanced practice provider (APP) providing comprehensive medication management (CMM) with authority to initiate, discontinue or modify medication under a scope of practice (SOP). The VHA CPP practices in many different outpatient clinical areas to include but not limited to primary care, mental health, pain management, cardiology, substance use disorder and anticoagulation. While literature regarding the ability of the VHA CPP to increase access and quality of care is well published, very little information exist regarding patient experience with the VHA CPP. We sought to report the patient experience with VHA CPP as measured electronically over 1 year by Veterans. Patient experience surveys were electronically sent to randomly selected Veterans via email to evaluate a recent outpatient healthcare encounter at a VA medical center or outpatient clinic with a CPP with scoring on a Likert scale of 1-5 with 5 being optimal. A total of 743 Veteran surveys were completed for a response rate of 20%. For individual domains of patient experience based on respondent scores of 4 or 5, ease and simplicity were rated at 94.4%, quality 91.9%, employee helpfulness 94.9%, satisfaction 95.0% and confidence/trust 91.9%. Results demonstrate that Veterans' experience with the CPP in every patient care experience domain was positive with scores ranging from the low to high 90th percentile., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: To evaluate whether clinical pharmacist practitioners (CPPs) are being utilized to care for patients with complex medication regimens and multiple chronic illnesses, we compared the clinical complexity of diabetes patients referred to CPPs in team primary care and those in care by other team providers (OTPs)., Methods: In this cross-sectional comparison of patients with diabetes in the US Department of Veterans Affairs (VA) healthcare system in the 2017-2019 period, patient complexity was based on clinical factors likely to indicate need for more time and resources in medication and disease state management. These factors include insulin prescriptions; use of 3 or more other diabetes medication classes; use of 6 or more other medication classes; 5 or more vascular complications; metabolic complications; 8 or more other complex chronic conditions; chronic kidney disease stage 3b or higher; glycated hemoglobin level of ≥10%; and medication regime nonadherence., Results: Patients with diabetes referred to one of 110 CPPs for care (n = 12,728) scored substantially higher (P < 0.001) than patients with diabetes in care with one of 544 OTPs (n = 81,183) on every complexity measure, even after adjustment for age, sex, race, and marital status. Based on composite summary scores, the likelihood of complexity was 3.42 (interquartile range, 3.25-3.60) times higher for those in ongoing CPP care (ie, those with 2 or more visits) versus OTP care. Patients in CPP care also were, on average, younger, more obese, and had more prior outpatient visits and hospital stays., Conclusion: The greater complexity of patients with diabetes seen by CPPs in primary care suggests that CPPs are providing valuable services in comprehensive medication and disease management of complex patients., (Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2023.)

Abstract: Clinical pharmacy specialists (CPS) were deployed nationally to improve care access and relieve provider burden in primary care.The aim of this study was to assess CPS integration in primary care and the Clinical Pharmacy Specialist Rural Veteran Access (CRVA) initiative's effectiveness in improving access.Concurrent embedded mixed-methods evaluation of participating CRVA CPS and their clinical team members (primary care providers, others).Health care providers on primary care teams in Veterans Health Administration (VHA).Perceived CPS integration in comprehensive medication management assessed using the MUPM and semi-structured interviews, and access measured with patient encounter data.There were 496,323 medical encounters with CPS in primary care over a 3-year period. One hundred twenty-four CPS and 1177 other clinical team members responded to a self-administered web-based questionnaire, with semi-structured interviews completed by 22 CPS and clinicians. Survey results indicated that all clinical provider groups rank CPS as making major contributions to CMM. CPS ranked themselves as contributing more to CMM than did their physician team members. CPS reported higher job satisfaction, less burn out, and better role fit; but CPS gave lower scores for communication and decision making as clinic organizational attributes. Themes in provider interviews focused on value of CPS in teams, relieving provider burden, facilitators to integration, and team communication issues.This evaluation indicates good integration of CPS on primary care teams as perceived by other team members despite some communication and role clarification challenges. CPS may play an important role in improving access to primary care., Competing Interests: The authors have no conflicts of interest to report., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Purpose: Access to care is a critical issue facing healthcare and affects patients living in rural and underserved areas more significantly. This led the Department of Veterans Affairs (VA) to launch a project that leveraged the expertise of the clinical pharmacy specialist (CPS) provider, embedding 180 CPS providers into primary care, mental health, and pain management across the nation., Methods: This multidimensional project resulted in hiring 111 CPS providers in primary care, 40 CPS providers in mental health, and 35 CPS providers in pain management to serve rural veterans' needs. From October 2017 to March 2020, CPS providers provided direct patient care to 213,477 veterans within 606,987 visits. This was an average of 43,000 additional visits each quarter to support comprehensive medication management services, demonstrating an additional 219,823 visits in fiscal year 2018 and 232,030 visits in fiscal year 2019. Over the course of the project, the team provided mentorship to 164 CPS providers, performed consultative visits at 27 VA facilities, and trained 180 CPS providers in educational boot camps., Conclusion: VA funding of rural health initiatives adding CPS providers to primary care, mental health, and pain teams has resulted in positive measures of comprehensive medication management, interdisciplinary team satisfaction, facility leadership acceptance, and multiple positive outcomes., (Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2021.)

Background: With the restructuring of primary care into patient-centered medical homes (PCMH), researchers have described role transformations that accompany the formation of core primary care teamlets (eg, primary care provider, registered nurse care manager, licensed practical nurse, medical support assistant). However, few studies offer insight into how primary care teamlets, once established, integrate additional extended team members, and the factors that influence the quality of their integration., Methods: We examine the process of integrating Clinical Pharmacy Specialists (CPS) into primary care teams in the Veterans Health Administration (VHA). We conducted semi-structured interviews with CPS (n = 6) and clinical team members (n = 16) and performed a thematic analysis of interview transcripts., Results: We characterize 2 ways CPS are integrated into primary care teamlets: in consultative roles and collaborative roles. CPS may be limited to consultative roles by team members' misconceptions about their competencies (ie, if CPS are perceived to handle only medication-related issues like refills) and by primary care providers' opinions about distributing responsibilities for patient care. Over time, teams may correct misconceptions and integrate the CPS in a more collaborative role (ie, CPS helps manage disease states with comprehensive medication management)., Conclusions: CPS integrated into collaborative roles may have more opportunities to optimize their contributions to primary care, underscoring the importance of clarifying roles as part of adequately integrating advanced practitioners in interprofessional teams., Competing Interests: Conflict of interest: None., (© Copyright 2021 by the American Board of Family Medicine.)

For the past 2 decades, the earnings gap between genders has narrowed for pharmacists, making it 1 of the smallest for a high-wage profession. Gender bias is reflected in 2 main areas, pay and opportunity. The Department of Veterans Affairs (VA) is the largest integrated health care system in the country, and the authors performed an analysis to see if there was any evidence of gender bias within its pharmacist workforce. The distribution of pharmacists by gender, age, and years of service was examined and whether part-time employment had any impact was also studied. Overall, there is a high degree of gender egalitarianism in terms of pay and opportunity for pharmacists at the VA. The level of step achievement, and thus, pay for men and women, was not associated with gender but rather years of service., (Published by Elsevier Inc.)

In a recent IJHPR article, Schwartzberg and colleagues report on clinical and other specialty services offered by pharmacists in the community in Israel and in the international arena. The article covers examples of activities recently introduced due to legislative changes which expanded the pharmacist's scope of practice, along with obstacles that are serving to slow broader expansion and availability of these services. This commentary details the success of clinical pharmacy services being provided by the United States Veterans Health Administration, and offers a framework of elements that support clinical pharmacy practice expansion.

Objectives: To increase access to hepatitis C virus (HCV) care and cure by deploying clinical pharmacy specialist (CPS) providers across the largest integrated health care system in the United States., Setting: National integrated health care system., Practice Description: In late 2016, the Department of Veterans Affairs (VA) Pharmacy Benefits Management Clinical Pharmacy Practice Office (CPPO) partnered with the VA HIV, Hepatitis, and Related Conditions Program with the central priority of expanding veteran access to novel HCV treatments and timely cure to ultimately prevent morbidity and mortality associated with HCV disease progression. This successful collaboration resulted in clinical resource funding to bolster access to HCV treatment through the deployment of CPS providers. This enterprise-wide initiative to expand clinical pharmacy services for unmet health care needs in HCV treatment resulted in 52 VA facilities submitting full-time employment equivalent (FTEE) funding requests totaling more than $10 million dollars. Facilities may have requested funding for 1 or more FTEEs., Results: Facilities hired 47 CPS providers and 5 clinical pharmacy technicians. CPS providers in this project recorded 24,888 patient care encounters providing care for 9593 unique patients and initiated new HCV treatment for 1191 treatment-naïve patients. For an additional 8402 patients, the CPS provided HCV care activities such as evaluation and monitoring before, during, and after treatment. CPPO estimates that the same care delivered by nonpharmacist provider specialists (e.g., specialty physicians) cost an additional $936,535, or 48% more., Conclusion: The deployment of HCV CPS resulted in a significant number of new HCV patients being screened and treated within the VA system., (Published by Elsevier Inc.)

Purpose: The results of a study to assess the effectiveness and safety of hyperglycemia management provided by clinical pharmacy specialists (CPSs) versus usual care in outpatients with diabetes from 53 Veterans Affairs (VA) medical centers are reported., Methods: An historical cohort study of outpatients with baseline glycosylated hemoglobin (HbA1c) values of >9% who were referred to a CPS for management of hyperglycemia and primary care patients who were not referred to a CPS was conducted. The primary outcomes were change in HbA1c over time and time to reach an HbA1c value of <8%. Secondary outcomes included the number of visits to achieve an HbA1c value of <8%, proportion of patients with an HbA1c value of <6% who were receiving secretagogues, and proportion of patients with serious hypoglycemia., Results: After propensity score matching by baseline characteristics, there were 12,327 patients in each group. The mean ± S.D. number of visits to reach an HbA1c value of <8% was 2.46 ± 1.58 in the pharmacist-managed group and 1.82 ± 1.27 with usual care (p < 0.001). The proportion of patients with an HbA1c value of <6% who were receiving secretagogues was 39.9% with pharmacist-managed care and 38.6% with usual care (p = 0.73). Serious hypoglycemia was noted in 4.3% of pharmacist-managed patients and 3.1% of usual care patients (p < 0.001)., Conclusion: Data from 53 VA medical centers revealed that CPSs managed the care of ambulatory care patients with hyperglycemia as well as primary care providers., (Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2018.)

Purpose: The methods and processes utilized to deploy the Pharmacists Achieve Results with Medications Documentation (PhARMD) Project intervention template across the largest integrated healthcare system in the United States are described., Summary: The PhARMD Project team at the Department of Veterans Affairs (VA) designed, developed, and deployed a standardized template within VA's electronic health record (EHR) that allows the clinical pharmacy specialist (CPS) to efficiently document select interventions made during patient care encounters that specifically contribute to the overall care provided and patient outcomes. The template is completed by the CPSs as part of progress note documentation within the EHR. Using point-and-click functionality, a CPS selects the check boxes corresponding to specific interventions made during that patient care encounter. This improves workflow and negates the need to document interventions in a separate software system, streamlining documentation. The implementation and use of the PhARMD template at each VA facility are voluntary. From October 1, 2016, to September 30, 2017, 4,728 CPSs documented 3,805,323 interventions during 2,384,771 patient care encounters. These interventions were documented across 592,126 unique patients, with a mean of 6.4 interventions per patient during this period. Most interventions (95%) were performed by CPSs functioning as advanced practice providers and with autonomous prescriptive authority authorized under their scope of practice., Conclusion: The PhARMD template demonstrated that the capture of clinical pharmacy interventions and outcomes can be achieved across a large integrated healthcare system by thousands of CPSs in numerous practice settings., (Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

The majority of clinical pharmacy specialists are using global scopes of practice, which allow more autonomy to provide direct patient care and comprehensive medication management services to home-based primary care veterans., Competing Interests: Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.

Background: A data collection tool was developed and nationally deployed to clinical pharmacists (CPs) working in advanced practice provider roles within the Department of Veterans Affairs to document interventions and associated clinical outcomes. Intervention and short-term clinical outcome data derived from the tool were used to populate a validated clinical outcomes modeling program to predict long-term clinical and economic effects., Objective: To predict the long-term effect of CP-provided pharmacotherapy management on outcomes and costs for patients with type 2 diabetes., Methods: Baseline patient demographics and biomarkers were extracted for type 2 diabetic patients having > 1 encounter with a CP using the tool between January 5, 2013, and November 20, 2014. Treatment biomarker values were extracted 12 months after the patient's initial visit with the CP. The number of visits with the CP was extracted from the electronic medical record, and duration of visit time was quantified by Current Procedural Terminology codes. Simulation modeling was performed on 3 patient cohorts-those with a baseline hemoglobin A1c of 8% to < 9%, 9% to < 10%, and ≥ 10%-to estimate long-term cost and clinical outcomes using modeling based on pivotal trial data (the Archimedes Model). A sensitivity analysis was conducted to assess the extent to which our results were dependent on assumptions related to program effectiveness and costs., Results: A total of 7,310 patients were included in the analysis. Analysis of costs and events on 2-, 3-, 5-, and 10-year time horizons demonstrated significant reductions in major adverse cardiovascular events (MACEs), myocardial infarctions (MIs), episodes of acute heart failure, foot ulcers, and foot amputations in comparison with a control group receiving usual guideline-directed medical care. In the cohort with a baseline A1c of ≥ 10%, the absolute risk reduction was 1.82% for MACE, 1.73% for MI, 2.43% for acute heart failure, 5.38% for foot ulcers, and 2.03% for foot amputations. The incremental cost-effectiveness ratios for cost per quality-adjusted life-year during the 2-, 3-, 5-, and 10-year time horizons were cost-effective for the cohorts of patients with a baseline A1c of 9% to < 10% and ≥ 10%., Conclusions: CPs acting as advanced practice providers reduced A1c from baseline for veterans with type 2 diabetes compared with modeled usual care. Archimedes modeling of the A1c reductions projects a decreased incidence of diabetes complications and overall health care spending when compared with modeled usual care., Disclosures: There was no outside funding source or sponsor for this project. None of the authors report any conflicts of interest. The views expressed in this article are those of the authors and do not necessarily reflect the views or policies of the U.S. Department of Veterans Affairs. Preliminary data from this project were previously presented in abstract form at the Academy of Managed Care Pharmacy 27th Annual Meeting and Expo; April 8-10, 2015; in San Diego, California.

Purpose: The development and validation of a staffing calculator and its use in creating staffing guidance for antimicrobial stewardship programs (ASPs) in Veterans Health Administration (VHA) facilities are described., Methods: The Tools and Resources Work Group of the Antimicrobial Stewardship Task Force and PBM Clinical Pharmacy Practice Office of the Department of Veterans Affairs developed, tested, and validated a staffing calculator to track patient care and ASP management activities needed to maintain a comprehensive ASP. Time spent on activities was based on time-in-motion tracking studies and input from experienced antimicrobial stewards. The staffing calculator was validated across VHA facilities of varying sizes and complexities to determine the number of needed clinical pharmacist full-time equivalents (FTEs) to implement and maintain ASPs per 100 occupied beds., Results: A total of 12 facilities completed the staffing calculator for 1 calendar week. The median number of occupied beds was 226. Most facilities had at least 100 occupied beds, and 6 of the 12 were considered high complexity facilities. The median calculated FTE personnel requirement was 2.62, or 1.01 per 100 occupied beds. The majority of FTE time (70%) was spent on patient care activities and 30% on program management activities, including infectious diseases or ASP rounds. The final recommendations indicated that in order to implement and manage a robust ASP, a pharmacist FTE investment of 1.0 per 100 occupied beds would be needed., Conclusion: A staffing calculator to account for the time needed to implement ASP activities and provide staffing guidance across a large health-care system was validated., (Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Context: Testosterone prescribing rates have increased substantially in the past decade. However, little is known about the context within which such prescriptions occur., Objective: We evaluated provider- and site-level determinants of receipt of testosterone and of guideline-concordant testosterone prescribing., Design: This study was cross-sectional in design., Setting: This study was conducted at the Veterans Health Administration (VA)., Participants: Study participants were a national cohort of male patients who had received at least one outpatient prescription within the VA during fiscal year (FY) 2008 to FY 2012. A total of 38,648 providers and 130 stations were associated with these patients., Main Outcome Measure: This study measured receipt of testosterone and guideline-concordant testosterone prescribing., Results: Providers ranging in age from 31 to 60 years, with less experience in the VA [all adjusted odds ratio (AOR), <2; P < 0.01] and credentialed as medical doctors in endocrinology (AOR, 3.88; P < 0.01) and urology (AOR, 1.48; P < 0.01) were more likely to prescribe testosterone compared with older providers, providers of longer VA tenure, and primary care providers, respectively. Sites located in the West compared with the Northeast [AOR, 1.75; 95% confidence interval (CI), 1.45-2.11] and care received at a community-based outpatient clinic compared with a medical center (AOR, 1.22; 95% CI, 1.20-1.24) also predicted testosterone use. Although they were more likely to prescribe testosterone, endocrinologists were also more likely to obtain an appropriate workup before prescribing compared with primary care providers (AOR, 2.14; 95% CI, 1.54-2.97)., Conclusions: Our results highlight the opportunity to intervene at both the provider and the site levels to improve testosterone prescribing. This study also provides a useful example of how to examine contributions to prescribing variation at different levels of the health care system., (Copyright © 2017 Endocrine Society)

Background: Improved anticoagulation control with warfarin reduces adverse events and represents a target for quality improvement. No previous study has described an effort to improve anticoagulation control across a health system., Objective: To describe the results of an effort to improve anticoagulation control in the New England region of the Veterans Health Administration (VA)., Methods: Our intervention encompassed 8 VA sites managing warfarin for more than 5000 patients in New England (Veterans Integrated Service Network 1 [VISN 1]). We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site-level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges. We used a difference-in-differences (DID) model to examine changes in anticoagulation control, measured as percentage time in therapeutic range (TTR), as well as process measures and compared VISN 1 sites with 116 VA sites located outside VISN 1., Results: VISN 1 sites improved on TTR, our main indicator of quality, from 66.4% to 69.2%, whereas sites outside VISN 1 improved from 65.9% to 66.4% (DID 2.3%, P < 0.001). Improvement in TTR correlated strongly with the extent of improvement on process-of-care measures, which varied widely across VISN 1 sites., Conclusions: A regional quality improvement initiative, using performance measurement with audit and feedback, improved TTR by 2.3% more than control sites, which is a clinically important difference. Improving relevant processes of care can improve outcomes for patients receiving warfarin.

OBJECTIVE To detail the activities of the Veterans Health Administration (VHA) Antimicrobial Stewardship Initiative and evaluate outcomes of the program. DESIGN Observational analysis. SETTING The VHA is a large integrated healthcare system serving approximately 6 million individuals annually at more than 140 medical facilities. METHODS Utilization of nationally developed resources, proportional distribution of antibiotics, changes in stewardship practices and patient safety measures were reported. In addition, inpatient antimicrobial use was evaluated before and after implementation of national stewardship activities. RESULTS Nationally developed stewardship resources were well utilized, and many stewardship practices significantly increased, including development of written stewardship policies at 92% of facilities by 2015 (P<.05). While the proportional distribution of antibiotics did not change, inpatient antibiotic use significantly decreased after VHA Antimicrobial Stewardship Initiative activities began (P<.0001). A 12% decrease in antibiotic use was noted overall. The VHA has also noted significantly declining use of antimicrobials prescribed for resistant Gram-negative organisms, including carbapenems, as well as declining hospital readmission and mortality rates. Concurrently, the VHA reported decreasing rates of Clostridium difficile infection. CONCLUSIONS The VHA National Antimicrobial Stewardship Initiative includes continuing education, disease-specific guidelines, and development of example policies in addition to other highly utilized resources. While no specific ideal level of antimicrobial utilization has been established, the VHA has shown that improving antimicrobial usage in a large healthcare system may be achieved through national guidance and resources with local implementation of antimicrobial stewardship programs. Infect Control Hosp Epidemiol 2017;38:513-520.

Background: In 2012 U.S. diabetes costs were estimated to be $245 billion, with $176 billion related to direct diabetes treatment and associated complications. Although a few studies have reported positive glycemic and economic benefits for diabetes patients treated under primary care physician (PCP)-pharmacist collaborative practice models, no studies have evaluated the cost-effectiveness of an endocrinologist-pharmacist collaborative practice model treating complex diabetes patients versus usual PCP care for similar patients., Objective: To estimate the cost-effectiveness and cost benefit of a collaborative endocrinologist-pharmacist Diabetes Intense Medical Management (DIMM) "Tune-Up" clinic for complex diabetes patients versus usual PCP care from 3 perspectives (clinic, health system, payer) and time frames., Methods: Data from a retrospective cohort study of adult patients with type 2 diabetes mellitus (T2DM) and glycosylated hemoglobin A1c (A1c) ≥ 8% who were referred to the DIMM clinic at the Veterans Affairs San Diego Health System were used for cost analyses against a comparator group of PCP patients meeting the same criteria. The DIMM clinic took more time with patients, compared with usual PCP visits. It provided personalized care in three 60-minute visits over 6 months, combining medication therapy management with patient-specific diabetes education, to achieve A1c treatment goals before discharge back to the PCP. Data for DIMM versus PCP patients were used to evaluate cost-effectiveness and cost benefit. Analyses included incremental cost-effectiveness ratios (ICERs) at 6 months, 3-year estimated total medical costs avoided and return on investment (ROI), absolute risk reduction of complications, resultant medical costs, and quality-adjusted life-years (QALYs) over 10 years., Results: Base case ICER results indicated that from the clinic perspective, the DIMM clinic costs $21 per additional percentage point of A1c improvement and $115-$164 per additional patient at target A1c goal level compared with the PCP group. From the health system perspective, medical cost avoidance due to improved A1c was $8,793 per DIMM patient versus $3,506 per PCP patient (P = 0.009), resulting in an ROI of $9.01 per dollar spent. From the payer perspective, DIMM patients had estimated lower total medical costs, a greater number of QALYs gained, and appreciable risk reductions for diabetes-related complications over 2-, 5- and 10-year time frames, indicating that the DIMM clinic was dominant. Sensitivity analyses indicated results were robust, and overall conclusions did not change appreciably when key parameters (including DIMM clinic effectiveness and cost) were varied within plausible ranges., Conclusions: The DIMM clinic endocrinologist-pharmacist collaborative practice model, in which the pharmacist spent more time providing personalized care, improved glycemic control at a minimal cost per additional A1c benefit gained and produced greater cost avoidance, appreciable ROI, reduction in long-term complication risk, and lower cost for a greater gain in QALYs. Overall, the DIMM clinic represents an advanced pharmacy practice model with proven clinical and economic benefits from multiple perspectives for patients with T2DM and high medication and comorbidity complexity., Disclosures: No outside funding supported this study. The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Preliminary versions of the study data were presented in abstract form at the American Pharmacists Association Annual Meeting & Exposition; March 27, 2015; San Diego, California, and the Academy of Managed Care Pharmacy Annual Meeting; April 21, 2016; San Francisco, California. Study concept and design were contributed by Hirsch, Bounthavong, and Edelman, along with Morello and Morreale. Arjmand, Ourth, Ha, Cadiz, and Zimmerman collected the data. Data interpretation was performed by Ha, Morreale, and Morello, along with Cadiz, Ourth, and Hirsch. The manuscript was written primarily by Hirsch and Zimmerman, along with Arjamand, Ourth, and Morello, and was revised by Hirsch and Cadiz, along with Bounthavong, Ha, Morreale, and Morello.

Background: There has been concern about the growing off-label use of testosterone. Understanding the context within which testosterone is prescribed may contribute to interventions to improve prescribing., Objective: To evaluate patient characteristics associated with receipt of testosterone., Design: Cross-sectional., Setting: A national cohort of male patients, who had received at least one outpatient prescription within the Veterans Affairs (VA) system during Fiscal Year 2008- Fiscal Year 2012., Participants: The study sample consisted of 682,915 non-HIV male patients, of whom 132,764 had received testosterone and a random 10% sample, 550,151, had not., Main Measures: Conditions and medications associated with testosterone prescription., Key Results: Only 6.3% of men who received testosterone from the VA during the study period had a disorder of the testis, pituitary or hypothalamus associated with male hypogonadism. Among patients without a diagnosed disorder of hypogonadism, the use of opioids and obesity were the strongest predictors of testosterone prescription. Patients receiving >100 mg/equivalents of oral morphine daily (adjusted odds ratio = 5.75, p < 0.001) and those with body mass index (BMI) >40 kg/m 2 (adjusted odds ratio = 3.01, p < 0.001) were more likely to receive testosterone than non-opioid users and men with BMI <25 kg/m 2 . Certain demographics (age 40-54, White race), comorbid conditions (sleep apnea, depression, and diabetes), and medications (antidepressants, systemic corticosteroids) also predicted a higher likelihood of testosterone receipt, all with an adjusted odds ratio less than 2 (p < 0.001)., Conclusions: In the VA, 93.7% of men receiving testosterone did not have a diagnosed condition of the testes, pituitary, or hypothalamus. The strongest predictors of testosterone receipt (e.g., obesity, receipt of opioids), which though are associated with unapproved, off-label use, may be valid reasons for therapy. Interventions should aim to increase the proportion of testosterone recipients who have a valid indication.

Purpose: A comprehensive overview of clinical pharmacist prescribing authority and collaborative drug therapy management activities within the Veterans Health Administration (VHA) is presented., Summary: In VHA terminology, "scope of practice" (SOP) denotes authorization to perform as an advanced practice provider, autonomously or collaboratively managing all facets of a patient's disease or condition; VHA clinical pharmacists with an SOP have prescribing authority. National policies outline the broad requirements for conferral of an SOP to VHA clinical pharmacists and processes for SOP development and oversight, as well as the responsibilities of facility and clinical pharmacy leaders to support the role of the clinical pharmacist within the VHA healthcare system. The limits of each pharmacist's SOP are determined at the facility level, with prescribing and other patient care authorities granted according to demonstrated competence. There are approximately 7700 VHA clinical pharmacists, of whom about 3200 (41%) have an active SOP. During fiscal year 2015, VHA clinical pharmacists accounted for more than 5 million patient encounters and 1.9 million prescriptions for chronic disease-targeted medications, generating at least 20% of prescriptions for hepatitis C therapies, hypoglycemic agents, and erythropoiesis-stimulating agents and 69% of prescriptions for anticoagulants systemwide., Conclusion: Clinical pharmacists with an SOP constitute a rapidly expanding workforce within the VHA system, as illustrated by tremendous growth in their numbers since 2010. These individuals play a key role as advanced practice providers, helping to improve access to high-quality chronic disease and medication management for the nation's veterans., (Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Background: Clinical pharmacists (CPs) with a scope of practice operate as direct care providers and health care team members. Research often focuses on one role or the other; little is understood about the dynamic relationship between roles in practice settings., Objective: To identify the challenges CPs face in balancing dual roles as direct care providers and health care team members and the implications for CP effectiveness and quality of care., Methods: Pharmacists were interviewed with a primary purpose of informing an implementation effort. Besides the implementation, there were emergent themes regarding the challenges posed for CPs in negotiating dual roles. This study is, therefore, a secondary analysis of semistructured interviews and direct observation of 48 CPs, addressing this phenomenon. Interview data were entered into NVivo 10 and systematically analyzed using an emergent thematic coding strategy., Results: Pharmacists describe role ambiguity, where they perform as direct providers or team members simultaneously or in quick succession. They note the existence of a "transaction cost," where switching causes loss of momentum or disruption of work flow. Additionally, pharmacists feel that fellow providers lack an understanding of what they do and that CP contributions are not evaluated accurately by other health professionals., Conclusion: It is a challenge for CPs to balance the distinct roles of serving as collaborators and primary providers. Frequent role switching is not conducive to optimal work efficiency or patient care. Our findings suggest concrete steps that medical centers can take to improve both CP worklife and quality of patient care., (© The Author(s) 2014.)

Background: There are limited studies available analyzing association between copayment and hormonal contraception adherence. The study was conducted to investigate the association between copayment status and hormonal contraceptive adherence in a female veteran population when stratified by socioeconomic status., Methods: This 4-year, retrospective, cohort study of women Veterans from the Veterans Integrated Service Network 22, a network of Veterans Affairs facilities that includes Southern California and Nevada, included patients who received a new hormonal contraceptive prescription between October 1, 2008, and September 30, 2012. Patients were split into five quintiles (one having the lowest income and five the highest) dependent on zip code-based median annual household income from the 2007-2011 American Community Survey data. Medication possession ratio difference of copayment versus no copayment group for each respective quintile was the primary outcome. Analysis was done using multiple linear regression models., Results: A total of 3,622 patients met the inclusion criteria and were included in the analysis. Over the entire population, copayment was significantly associated with reduced adherence (-0.034; 95% confidence interval [CI], -0.06 to -0.008). Patients in the highest socioeconomic group, quintile five, had the largest reduction in adherence associated with having a copayment (-0.073; 95% CI, -0.129 to -0.017). Patients in the other four quintiles saw varying levels of decreased adherence respectively, although the differences did not achieve statistical significance., Conclusion: The association between adherence and copayment status varied by socioeconomic status. Our findings suggest that even affluent patients may be discouraged from adherence when subject to a copayment. If larger studies substantiate these findings, consideration should be given to a policy that exempts women veterans from copayments for hormonal contraceptives., (Published by Elsevier Inc.)

Objective: To evaluate the cost-effectiveness of intravitreal bevacizumab to ranibizumab in patients with neovascular age-related macular degeneration (AMD)., Methods: A cost-utility analysis using a Markov model was performed to evaluate incremental cost-effectiveness ratio [ICER, $US per quality-adjusted life year (QALY) gained] between bevacizumab and ranibizumab from a US payer perspective. Transition probabilities for ranibizumab and bevacizumab were extrapolated from published studies and local institutional data. Utility values, likewise, were obtained from another published study. Mortality rates were determined from the Centers for Disease Control 2003 Life Tables. Resource utilization and total direct costs were estimated using the Centers for Medicare and Medicaid Services and the Veterans Affairs Decision Support System. A hypothetical cohort of 1000 patients was simulated through the model for 20 years. Sensitivity analyses were performed using univariate and probabilistic sensitivity analysis (PSA) on all costs, transition probabilities and utility values. An acceptability curve was generated to illustrate the cost-effectiveness probability of bevacizumab to ranibizumab with increasing willingness-to-pay (WTP)., Results: The cost-effectiveness ratios (CER) for bevacizumab and ranibizumab were $1405 per QALY and $12,177 per QALY, respectively. The ICER for bevacizumab was dominant compared to ranibizumab. The base-case CER was sensitive to drug costs of the study medications with a breakeven point of $44 for ranibizumab and $2666 for bevacizumab. PSA revealed a 95% probability of bevacizumab being more cost-effective than ranibizumab at a WTP of $50,000 per QALY gained., Conclusion: Based on a WTP defined at $50,000 per QALY gained, bevacizumab was cost-effective versus ranibizumab 95% of the time because of lower acquisition costs and increased efficacy., (© 2010 Blackwell Publishing Ltd.)

Purpose: The implementation of a comprehensive, 24-hour emergency department pharmacy program (EDPP) is described., Summary: An EDPP was created at the Veterans Affairs San Diego Healthcare System to address deficiencies identified by the pharmacy service within the ED, including medication tracking, documentation of doses administered, and formulary management. The documentation system used in the EDPP, including a computerized spreadsheet and documentation cards, allowed the activities of the ED pharmacists to be tracked on a 24-hour basis. This type of data collection allowed us to evaluate the impact of the program based on the quality of patient care delivered as well as cost. During the initial six-month implementation period, the ED pharmacists recorded 9,568 interventions. The information from these interventions was used to assess the safety components and to estimate the cost avoidance of their activities. A staff satisfaction survey was also created to assess the pharmacist's impact on providers and nurses, as well as its effect on workflow within the ED. Among the many benefits realized, the EDPP improved the quality of patient care, decreased medication errors and patient wait times, improved the medication reconciliation process, enhanced formulary management, ensured prospective medication order review, and increased overall patient safety, as evidenced by the documented interventions and staff satisfaction survey. The projected cost savings for the medical center during the first year of EDPP implementation was calculated as $1,691,185., Conclusion: A tertiary care teaching hospital successfully implemented a 24-hour, comprehensive ED pharmacy service that enhanced the efficiency and delivery of patient care and resulted in significant cost savings.

PTX3 is an acute phase glycoprotein that plays key roles in resistance to certain pathogens and in female fertility. PTX3 exerts its functions by interacting with a number of structurally unrelated molecules, a capacity that is likely to rely on its complex multimeric structure stabilized by interchain disulfide bonds. In this study, PAGE analyses performed under both native and denaturing conditions indicated that human recombinant PTX3 is mainly composed of covalently linked octamers. The network of disulfide bonds supporting this octameric assembly was resolved by mass spectrometry and Cys to Ser site-directed mutagenesis. Here we report that cysteine residues at positions 47, 49, and 103 in the N-terminal domain form three symmetric interchain disulfide bonds stabilizing four protein subunits in a tetrameric arrangement. Additional interchain disulfide bonds formed by the C-terminal domain cysteines Cys(317) and Cys(318) are responsible for linking the PTX3 tetramers into octamers. We also identified three intrachain disulfide bonds within the C-terminal domain that we used as structural constraints to build a new three-dimensional model for this domain. Previously it has been shown that PTX3 is a key component of the cumulus oophorus extracellular matrix, which forms around the oocyte prior to ovulation, because cumuli from PTX3(-/-) mice show defective matrix organization. Recombinant PTX3 is able to restore the normal phenotype ex vivo in cumuli from PTX3(-/-) mice. Here we demonstrate that PTX3 Cys to Ser mutants, mainly assembled into tetramers, exhibited wild type rescue activity, whereas a mutant, predominantly composed of dimers, had impaired functionality. These findings indicate that protein oligomerization is essential for PTX3 activity within the cumulus matrix and implicate PTX3 tetramers as the functional molecular units required for cumulus matrix organization and stabilization.

The interaction of celecoxib and rofecoxib with warfarin was studied. Patients stable on warfarin therapy and concurrently taking a cyclooxygenase-2 (COX-2) inhibitor comparator (traditional nonsteroidal antiinflammatory medications, salsalate, or acetaminophen) randomly received celecoxib 200 mg/day or rofecoxib 25 mg/day for three weeks. After a one-week washout period, the patients were crossed over to treatment with the opposite COX-2 inhibitor for three more weeks. The International Normalized Ratio (INR) was measured at baseline and at weeks 1, 2, and 3 of therapy with each COX-2 inhibitor by testing blood samples obtained by finger stick. Data for 16 patients were analyzed. The INR increased by 13%, 6%, and 5% on average in patients taking celecoxib at weeks 1, 2, and 3, respectively, and by 5%, 9%, and 5% in patients taking rofecoxib. Changes in the INR were statistically significant at week 1 for celecoxib and at week 2 for rofecoxib. Of the 12 subjects who had a clinically significant > or = 15% change in the INR while receiving either COX-2 inhibitor, 4 showed this change for both agents. Adverse drug reactions were similar for each COX-2 inhibitor, but the rate of edema requiring medical intervention was higher in the rofecoxib group. Significant increases in the INR were observed in patients who were stable on warfarin therapy after the addition of therapy with rofecoxib or celecoxib.