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Purpose Costs of hospitalization due to severe adverse drug reactions (ADRs) were previously estimated within the Veterans Health Administration (VHA), but additional analyses are needed to infer potential interventions to mitigate these negative outcomes. The objective of this study was to compare specific adverse reaction–related hospitalization costs between medications with similar indications. Methods Mean hospitalization costs associated with the same ADR symptom were compared for different drugs with similar indications using adjusted generalized linear models with a Bonferroni correction for multiple comparisons as well as a gamma distribution. Results Overall, hospitalization costs between medications with similar indications were not significantly different for specific adverse reactions. However, gastrointestinal hemorrhage–associated costs were higher for warfarin versus nonsteroidal anti-inflammatory drugs (model estimate of mean cost, $18,114 [range of lower and upper model estimates, $12,522-$26,202] vs $14,255 [estimate range, $9,710-$20,929]). Similarly, the estimated mean hospitalization cost associated with angioedema was higher for losartan versus lisinopril or lisinopril/hydrochlorothiazide: $14,591 (range, $9467-$22,488) versus $8,935 (range, $6,301-$12,669) and $8,022 (range, $5,424-$11,865), respectively. Conclusion Although we found few differences in the cost of hospitalization when comparing drugs with similar indications and the same adverse reaction, there were specific drug-ADR pairs that merit attention and consideration of interventions to improve safe and appropriate medication use. Evaluation of the effect of those interventions on the incidence of ADRs is an area for future study.

Objective:As part of a project to implement antimicrobial dashboards at select facilities, we assessed physician attitudes and knowledge regarding antibiotic prescribing.Design:An online survey explored attitudes toward antimicrobial use and assessed respondents’ management of four clinical scenarios: cellulitis, community-acquired pneumonia, non–catheter-associated asymptomatic bacteriuria, and catheter-associated asymptomatic bacteriuria.Setting:This study was conducted across 16 Veterans’ Affairs (VA) medical centers in 2017.Participants:Physicians working in inpatient settings specializing in infectious diseases (ID), hospital medicine, and non-ID/hospitalist internal medicine.Methods:Scenario responses were scored by assigning +1 for answers most consistent with guidelines, 0 for less guideline-concordant but acceptable answers and −1 for guideline-discordant answers. Scores were normalized to 100% guideline concordant to 100% guideline discordant across all questions within a scenario, and mean scores were calculated across respondents by specialty. Differences in mean score per scenario were tested using analysis of variance (ANOVA).Results:Overall, 139 physicians completed the survey (19 ID physicians, 62 hospitalists, and 58 other internists). Attitudes were similar across the 3 groups. We detected a significant difference in cellulitis scenario scores (concordance: ID physicians, 76%; hospitalists, 58%; other internists, 52%; P = .0087). Scores were numerically but not significantly different across groups for community-acquired pneumonia (concordance: ID physicians, 75%; hospitalists, 60%; other internists, 56%; P = .0914), for non–catheter-associated asymptomatic bacteriuria (concordance: ID physicians, 65%; hospitalists, 55%; other internists, 40%; P = .322), and for catheter-associated asymptomatic bacteriuria (concordance: ID physicians, 27% concordant; hospitalists, 8% discordant; other internists 13% discordant; P = .12).Conclusions:Significant differences in performance regarding management of cellulitis and low overall performance regarding asymptomatic bacteriuria point to these conditions as being potentially high-yield targets for stewardship interventions.

Whether chlorthalidone is superior to hydrochlorothiazide for preventing major adverse cardiovascular events in patients with hypertension is unclear.In a pragmatic trial, we randomly assigned adults 65 years of age or older who were patients in the Department of Veterans Affairs health system and had been receiving hydrochlorothiazide at a daily dose of 25 or 50 mg to continue therapy with hydrochlorothiazide or to switch to chlorthalidone at a daily dose of 12.5 or 25 mg. The primary outcome was a composite of nonfatal myocardial infarction, stroke, heart failure resulting in hospitalization, urgent coronary revascularization for unstable angina, and non-cancer-related death. Safety was also assessed.A total of 13,523 patients underwent randomization. The mean age was 72 years. At baseline, hydrochlorothiazide at a dose of 25 mg per day had been prescribed in 12,781 patients (94.5%). The mean baseline systolic blood pressure in each group was 139 mm Hg. At a median follow-up of 2.4 years, there was little difference in the occurrence of primary-outcome events between the chlorthalidone group (702 patients [10.4%]) and the hydrochlorothiazide group (675 patients [10.0%]) (hazard ratio, 1.04; 95% confidence interval, 0.94 to 1.16; P = 0.45). There were no between-group differences in the occurrence of any of the components of the primary outcome. The incidence of hypokalemia was higher in the chlorthalidone group than in the hydrochlorothiazide group (6.0% vs. 4.4%, P0.001).In this large pragmatic trial of thiazide diuretics at doses commonly used in clinical practice, patients who received chlorthalidone did not have a lower occurrence of major cardiovascular outcome events or non-cancer-related deaths than patients who received hydrochlorothiazide. (Funded by the Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT02185417.).

Introduction The COVID-19 pandemic has had significant impact on clinical care and traditional clinical trial operations, but it is unclear whether these impacts persist in pragmatic trials with a centralized study design. The Diuretic Comparison Project (DCP) is a Point-of Care pragmatic trial testing the hypothesis that chlorthalidone is superior to hydrochlorothiazide at the prevention of major cardiovascular (CV) events and non-cancer death. DCP relies on telephone consent, data collection from the electronic health record and Medicare, forgoes study visits, and limits provider time beyond usual care. DCP paused recruitment on VA directive in response to COVID-19 from 3/17/2020 until 7/1/2020. We assessed the impact of the COVID-19 pandemic on the centralized recruitment, patient follow-up, data collection, and outcome ascertainment performed in the DCP. Methods To assess clinical activity level and trial metrics, we compared data from two 8-month time periods: Pre-Pandemic (July 2019 – February 2020) and Mid-Pandemic (July 2020 – February 2021). Consent and randomization rates, study medication adherence, blood pressure (BP) and electrolyte follow-up rates, VA records of CV events, all-cause hospitalization, and death rates were compared for these two periods. Results Providers agreed to participate at a lower rate mid-pandemic (71%) than pre-pandemic (65%), but more patients were contacted (5,363 vs. 7,622) and consented (3,048 vs. 3,718) mid-pandemic. Patients refilled medications and remained on their randomized diuretic at the same frequency (90%) in both periods. Overall, rates of BP, electrolyte measurements, and hospitalizations decreased mid-pandemic while deaths increased. Conclusions While recruitment, enrollment, and adherence did not suffer during the pandemic, documented blood pressure checks and laboratory evaluations decreased, likely due to fewer in-person visits during the pandemic. All-cause VA hospitalizations decreased, despite a considerable number of COVID-related hospitalizations. While this suggests some changes in clinical care during the pandemic, the overall impact on DCP’s ability to operate mostly unimpacted during a global pandemic is another important strength of Point of Care clinical trials. Clinical Trial Registration NCT02185417 Registered 9 July 9 2014 https://clinicaltrials.gov/ct2/show/NCT02185417

PURPOSE: To understand how patients and providers weigh the risks and benefits of long-term opioid therapy (LTOT) for cancer pain. METHODS: Researchers used VA approved audio-recording devices to record interviews. ATLAS t.i., a qualitative analysis software, was used for analysis of transcribed interview data. Participants included 20 Veteran patients and 20 interdisciplinary providers from primary care– and oncology-based practice settings. We conducted semistructured interviews and analyzed transcripts used thematic qualitative methods. Interviews explored factors that affect decision making about appropriateness of LTOT for cancer related pain. We saturated themes for providers and patients separately. RESULTS: Factors affecting patient decision-making included influence from various information sources, persuasion from trusted providers, and sometimes deferral of the decision to their provider. Relative prioritization of pain management as the focal patient concern varied with some patients describing comparatively more fear of chemotherapy than opioid analgesics, comparatively more knowledge of opioids in relation to other drugs;patients expressed a preference to spend the limited time they have with their oncologist discussing cancer treatment rather than opioid use. Factors affecting provider decision making included prognosis, patient goals, patient characteristics, and provider experience and biases. Providers differed in how they weigh the relative importance of alleviating pain or avoiding opioids in the face of treating patients with cancer and histories of substance abuse. CONCLUSION: Divergent perspectives on factors need to be considered when weighing risks and benefits. Policies and interventions should be designed to reduce variation in practice to promote equal access to adequate pain management. Improved shared decision-making initiatives will take advantage of patient decision-making factors and priorities.

BACKGROUND: Cancer pain is highly prevalent and often managed in primary care or by oncology providers in combination with primary care providers. OBJECTIVES: To understand interdisciplinary provider experiences coordinating opioid pain management for patients with chronic cancer–related pain in a large integrated healthcare system. DESIGN: Qualitative research. PARTICIPANTS: We conducted 20 semi-structured interviews with interdisciplinary providers in two large academically affiliated VA Medical Centers and their associated community-based outpatient clinics. Participants included primary care providers (PCPs) and oncology-based personnel (OBPs). APPROACH: We deductively identified 94 examples of care coordination for cancer pain in the 20 interviews. We secondarily used an inductive open coding approach and identified themes through constant comparison coming to research team consensus. RESULTS: Theme 1: PCPs and OBPs generally believed one provider should handle all opioid prescribing for a specific patient, but did not always agree on who that prescriber should be in the context of cancer pain. Theme 2: There are special circumstances where having multiple prescribers is appropriate (e.g., a pain crisis). Theme 3: A collaborative process to opioid cancer pain management would include real-time communication and negotiation between PCPs and oncology around who will handle opioid prescribing. Theme 4: Providers identified multiple barriers in coordinating cancer pain management across disciplines. CONCLUSIONS: Our findings highlight how real-time negotiation about roles in opioid pain management is needed between interdisciplinary clinicians. Lack of cross-disciplinary role agreement may result in delays in clinically appropriate cancer pain management. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-06747-z.

Context Signature informed consent (SIC) is a part of a Veterans Health Administration ethics initiative for patient education and shared decision making with long-term opioid therapy (LTOT). Historically, patients with cancer-related pain receiving LTOT are exempt from this process. Objectives Our objective is to understand patients' and providers' perspectives on using SIC for LTOT in patients with cancer-related pain. Methods Semistructured interviews with 20 opioid prescribers and 20 patients who were prescribed opioids at two large academically affiliated Veterans Health Administration Medical Centers. We used a combination of deductive and inductive approaches in content analysis to produce emergent themes. Results Potential advantages of SIC are that it can clarify and help patients comprehend LTOT risks and benefits, provide clear upfront boundaries and expectations, and involve the patient in shared decision making. Potential disadvantages of SIC include time delay to treatment, discouragement from recommended opioid use, and impaired trust in the patient-provider relationship. Providers and patients have misconceptions about the definition of SIC. Providers and patients question if SIC for LTOT is really informed consent. Providers and patients advocate for strategies to improve comprehension of SIC content. Providers had divergent perspectives on exemptions from SIC. Oncologists want SIC for LTOT to be tailored for patients with cancer. Conclusion Provider and patient interviews highlight various aspects about the advantages and disadvantages of requiring SIC for LTOT in cancer-related pain. Tailoring SIC for LTOT to be specific to cancer-related concerns and to have an appropriate literacy level are important considerations.

ObjectiveTo develop a descriptive model of the cognitive processes used to identify and resolve adverse drug reactions (ADRs) from the perspective of healthcare providers in order to inform future informatics effortsSettingInpatient and outpatient care at a tertiary care US Veterans Affairs Medical Center.ParticipantsPhysicians, nurse practitioners and pharmacists who report ADRs.OutcomesDescriptive model and emerging themes from interviews.ResultsWe conducted critical decision method interviews with 10 physicians and 10 pharmacists. No nurse practitioners submitted ADR incidents. We generated a descriptive model of an ADR decision-making process and analysed emerging themes, categorised into four stages: detection of potential ADR, investigation of the problem’s cause, risk/benefit consideration, and plan, action and follow-up. Healthcare professionals (HCPs) relied on several confirmatory or disconfirmatory cues to detect and investigate potential ADRs. Evaluating risks and benefits of related medications played an essential role in HCPs' pursuits of solutionsConclusionsThis study provides an illustrative model of how HCPs detect problems and make decisions regarding ADRs. The design of supporting technology for potential ADR problems should align with HCPs' real-world cognitive strategies, to assist fully in detecting and preventing ADRs for patients.

Introduction: The COVID-19 pandemic has had a significant impact on traditional clinical trial operations, but it is unclear whether the impact persists in pragmatic trials with a centralized study design. The Diuretic Comparison Project (DCP) is a Point-of Care pragmatic trial that operates through a usual care system to compare chlorthalidone and hydrochlorothiazide at preventing major cardiovascular (CV) events and non-cancer death. We assessed the impact of the COVID-19 pandemic on the centralized recruitment, patient follow-up, data collection, and outcome ascertainment performed in the DCP. Methods: We assessed operations in two 8-month periods: Pre-COVID-19 (Jul 2019 - Feb 2020) and Mid-COVID-19 (Jul 2020 - Feb 2021). Enrollment, study medication adherence, blood pressure (BP) and electrolyte follow-up rates, VA records of CV events, all-cause hospitalization, and death rates were compared. Results: Providers agreed to participate at a lower rate, but more patients were contacted and randomized during mid-COVID-19. While BP evaluations decreased, the rates of electrolyte, major CV, and medication prescription records were comparable to the pre-COVID-19 period ( Table 1 ). Conclusions: The DCP was able to recruit and maintain critical data collection at the pre-COVID-19 levels. There were some decreases in BP evaluations, likely due to fewer in-person visits. All-cause VA hospitalizations also decreased, despite rises in COVID-related hospitalizations and death. While the impact on outcome and safety rates awaits complete data from Medicare, the DCP has demonstrated a promising centralized design that can support pragmatic trial operations during a pandemic.

Dimethyl fumarate (DMF), a treatment for multiple sclerosis, may cause leukopenia and infection. Accordingly, periodic white blood cell (WBC) monitoring is recommended. We sought to evaluate the US Department of Veteran Affairs’ safety program which provides facilities with a list of patients prescribed DMF therapy without a documented white blood cell count (WBC). We identified 118 sites with patients treated with DMF from 1 January 2016 through 30 September 2016. Each site was asked if any of seven interventions were used to improve WBC monitoring (academic detailing, provider education without academic detailing, electronic clinical reminders, request for provider action plan, draft orders for WBC monitoring, patient mailings, and patient calls). The survey response rate was 78%. For the 92 responding sites (78%) included sites (1115 patients) the mean rate of WBC monitoring was 54%. In multivariate analysis, academic detailing increased the rate by 17% (95% CI 4 to 30%, p = 0.011) and provider education increased the rate by 9% (95% CI 0.6 to 18%, p = 0.037). The WBC monitoring rate increased by 3.8% for each additional intervention used (95% CI 1.2–6.4%, p = 0.005). Interventions focused on the physician, including academic detailing, were associated with improved WBC monitoring for patients at risk for leukopenia from DMF treatment.

PurposeTo examine the reporting rates of adverse drug events (ADEs) with apixaban and empagliflozin as reports move up to the next level of spontaneous reporting.MethodsThis was a retrospective cohort study of outpatients who discontinued apixaban or empagliflozin within 3 years of Food and Drug Administration (FDA) approval. We enriched the sample using an active surveillance strategy to identify subsets of patients with International Classification of Diseases (ICD) codes possibly associated with an ADE. Stratified random samples of charts were reviewed to determine if patients discontinued the medication due to an ADE. If so, we ascertained whether these were uploaded into the Veterans Administration (VA) electronic health record reporting system (Adverse Reaction Tracking System [ARTS]), VA national Web-based system (VA Adverse Drug Event Reporting System [VA ADERS]), and FDA MedWatch.ResultsFrom the cohort of 2,973 patients who discontinued apixaban, 321 patients (10.8%) were randomly sampled for chart review (including 61 patients with relevant ICD codes). During chart review, 88 ADEs were identified, with 40/61 (65.6%) from the subset with ICD codes. Of the total of 88 ADEs, 18.2%, 10.2%, and 6.8% were reported in ARTS, VA ADERS, and MedWatch, respectively. Of the 1,555 patients who discontinued empagliflozin, 179 patients (11.5%) were randomly sampled for chart review (40 patients with relevant ICD codes). During chart review, 78 ADEs were identified, with 19/40 (47.5%) from the subset with ICD codes. Of the 78 ADEs, 28.2%, 19.2%, and 7.7% were reported in ARTS, VA ADERS, and MedWatch, respectively.ConclusionWe found substantial underreporting of apixaban and empagliflozin ADEs that became worse at each higher level of spontaneous reporting.

Purpose The potentially vast supply of unused opioids in Americans’ homes has long been a public health concern. We conducted a needs assessment of how Veterans Affairs (VA) facilities address and manage disposal of unused opioid medications to identify opportunities for improvement. Methods We used rapid qualitative content analysis methods with team consensus to synthesize findings. Data were collected in 2 waves: (1) semistructured interviews with 19 providers in October 2019 and (2) structured questions to 21 providers in March to April of 2020 addressing how coronavirus disease 2019 (COVID-19) changed disposal priorities. Results While many diverse strategies have been tried in the VA, we found limited standardization of advice on opioid disposal and practices nationally. Providers offered the following recommendations: target specific patient scenarios for enhanced disposal efforts, emphasize mail-back envelopes, keep recommendations to providers and patients consistent and reinforce existing guidance, explore virtual modalities to monitor disposal activity, prioritize access to viable disposal strategies, and transition from pull to push communication. These themes were identified in the fall of 2019 and remained salient in the context of the COVID-19 pandemic. Conclusion A centralized VA national approach could include proactive communication with patients and providers, interventions tailored to specific settings and populations, and facilitated access to disposal options. All of the above strategies are feasible in the context of an extended period of social distancing.

Background: Dimethyl fumarate (DMF), a treatment for multiple sclerosis, may cause leukopenia and infection. Accordingly, periodic white blood cell (WBC) monitoring is recommended. We sought to evaluate the VA Medication Use Evaluation Tracker (MUET) initiative which provides VA facilities with a list of patients prescribed DMF therapy without a documented white blood cell count (WBC).Methods: We identified 118 VA facilities with patients treated with DMF from 1/1/2016 through 9/30/2016. We determined WBC measurements within three months of the first filled prescription. The lead pharmacist at each facility was surveyed asking if any of seven intervention types were used to improve WBC monitoring (academic detailing, provider education without academic detailing, electronic clinical reminders, request for provider action plan, draft orders for WBC monitoring, patient mailings, and patient calls).Results: The facility response rate for the survey was 78% (92 of 118 facilities). For the 92 included facilities (1,115 patients) the mean rate of WBC monitoring was 54%. Use of the at-risk patient lists was noted in 55% (51/92) of facilities. In multivariate analysis, only academic detailing and provider education remained significantly associated with higher WBC monitoring. From a base WBC monitoring rate of 46%, academic detailing increased the rate by 17% (95% CI 4 to 30%, p=0.011) and provider education increased the rate by 9% (95% CI 0.6 to 18%, p=0.037). The WBC monitoring rate increased by 3.8% for each additional intervention used (95% CI 1.2%-6.4%, p=0.005).Conclusions: Interventions focused on the physician, including academic detailing, were associated with improved WBC monitoring for patients at risk for leukopenia from dimethyl fumarate treatment.

Recent US guidelines recommend chlorthalidone over other thiazide-type diuretics for the treatment of hypertension based on its long half-life and proven ability to reduce CVD events. Despite recommendations most clinicians prescribe hydrochlorothiazide (HCTZ) over chlorthalidone (CTD). No randomized controlled data exist comparing these two diuretics on cardiovascular outcomes.The Diuretic Comparison Project (DCP) is a multicenter, two-arm, parallel, Prospective Randomized Open, Blinded End-point (PROBE) trial testing the primary hypothesis that CTD is superior to HCTZ in the prevention of non-fatal CVD events and non-cancer death. Patients with hypertension taking HCTZ 25 or 50 mg were randomly assigned to either continue their current HCTZ or switch to an equipotent dose of CTD. The primary outcome is time to the first occurrence of a composite outcome consisting of a non-fatal CVD event (stroke, myocardial infarction, urgent coronary revascularization because of unstable angina, or hospitalization for acute heart failure) or non-cancer death. The trial randomized 13,523 patients at 72 VA medical centers. The study is conducted by a centralized research team with site procedures embedded in the electronic health record and all data collected through administrative claims data, with no study related visits for participants. The trial will have 90% power to detect an absolute reduction in the composite event rate of 2.4%.Enrollment ended in November 2021. There are 4128 participting primary care providers and 16,595 patients individually consented to participate, 13,523 of whom were randomized.DCP should provide much needed evidence as to whether CTD is superior to HCTZ in preventing cardiovascular events in hypertensive patients.NCT02185417 [https://clinicaltrials.gov/ct2/show/NCT02185417].

The objective of this study was to evaluate the association between fluoroquinolone (FQ) use and the occurrence of aortic aneurysm/dissection (AA/AD), acute myocardial infarction (AMI), ventricular arrhythmias (VenA), and all‐cause mortality vs other commonly used antibiotics. We conducted a self‐controlled case series analysis of patients who experienced the outcomes of AA/AD, AMI, and VenA, based on diagnosis codes from emergency department visits and hospitalizations within Veterans Health Administration, and death in FY2014‐FY2018. These Veterans also received outpatient prescriptions for FQs. Conditional Poisson regression models were used to estimate the association between FQs and each of the outcomes vs antibiotics of interest (ie amoxicillin or amoxicillin/clavulanate, azithromycin, doxycycline, cefuroxime or cephalexin, or sulfamethoxazole‐trimethoprim), adjusted for time‐varying covariates. Using a 30‐day risk period after each antibiotic prescription, adjusted incidence rate ratios (aIRRs) for FQs vs each comparator antibiotic were not statistically different for outcomes of VenA or AMI. For AA/AD, incidence was higher during FQ risk periods vs amoxicillin [aIRR 1.50 (95% CI 1.01, 2.25)] and azithromycin [aIRR 2.15 (95% CI 1.27, 3.64)] risk periods. A significantly increased risk of mortality was observed with FQs vs each antibiotic of interest. FQs were associated with an increased risk of AA/AD vs amoxicillin and azithromycin and an increased risk of all‐cause mortality vs multiple antibiotics commonly used for outpatient infections. Although the differences in event rates are small, FQ use should be limited to serious infections without appropriate alternatives.

Key Points Question What is the real-world experience with edaravone in patients with amyotrophic lateral sclerosis (ALS) within a national integrated health care system? Findings In this cohort study of data from 369 US veterans with documented or probable ALS, a significantly greater proportion of acute all-cause hospitalizations was associated with edaravone treatment and, among users receiving at least 6 months of treatment, an increased likelihood of ALS-related hospitalization was associated with edaravone treatment compared with riluzole-only treatment. Meaning While these findings should be interpreted with caution, in this evaluation, edaravone (mostly used with riluzole) was associated with more hospitalizations compared with riluzole-only therapy; more evidence is needed to evaluate edaravone treatment outcomes in real-world settings., Importance Using real-world data, the US Department of Veterans Affairs (VA) initiated a surveillance evaluation of edaravone after its approval for amyotrophic lateral sclerosis (ALS) in 2017. The use and safety of edaravone for patients with ALS in the VA health care system remain to be assessed. Objective To describe a pharmacovigilance surveillance initiative with edaravone to monitor patient characteristics, utilization (edaravone cycles and riluzole use), and safety and to evaluate safety/effectiveness. Design, Setting, and Participants This propensity score–matched cohort study used data on 369 patients with documented definite or probable ALS in the Veterans Health Administration (VHA) with at least 1 prescription for edaravone between August 1, 2017, and September 30, 2019. The analysis compared edaravone (alone or with riluzole) with riluzole only. For chronic users (≥6 months of drug), a time-to-event model evaluated ALS-related outcomes, with censoring at outcome, death, or end of evaluation. Patients with Parkinson disease, dementia, schizophrenia, or significant respiratory insufficiency per diagnosis codes within 2 years before prescription initiation were excluded. In overall matched cohorts, 223 patients treated with edaravone were 1:3 propensity score matched based on predefined confounders. For the chronic user subgroup analysis, 96 patients receiving edaravone and 424 patients receiving riluzole only were included. Exposures Edaravone (alone or with riluzole) vs riluzole only. Main Outcomes and Measures Patient characteristics, ALS drug use, and mortality. Acute outcomes (within 6 months of index) included proportion and mean time to event for death, discontinuation, or all-cause hospitalization, and outcomes for chronic users (receiving >6 months of treatment) included hazard ratios of outcomes related to disease-state progression. Results Of 369 patients who received edaravone, most were older (mean [SD] age, 64.6 [11.3] years), male (346 [93.8%]), and White (261 [70.7%]). As of September 2019, 59.9% of edaravone patients had discontinued treatment; of those, 49.5% (108 of 218) received only 1 to 3 treatment cycles. Approximately 30% (110 patients) died. In a matched evaluation, significantly more acute all-cause hospitalization events occurred with edaravone (35.4% vs 22.0% for riluzole only); 72.6% of the edaravone cohort received edaravone with riluzole. Among chronic users, edaravone patients (70.8% edaravone with riluzole) had an increased hazard ratio of ALS-associated hospitalization (2.51; 95% CI, 1.18-8.16). The death rate was lower with edaravone but the difference was not statistically significant. Conclusions and Relevance Early edaravone discontinuation was common in the VA. Although outcomes favored use of riluzole only in the matched analysis, results should be interpreted with caution, as unmeasured bias in observational data is likely., This cohort study uses real-world data to assess patient characteristics and use as well as the safety and effectiveness of edaravone among patients with amyotrophic lateral sclerosis in the US Department of Veterans Affairs Health Care System.

Objective To evaluate antimicrobial stewards’ experiences of using a dashboard display integrating local and national antibiotic use data implemented in the U.S. Department of Veterans Affairs (VA). This paper reports early formative evaluation. Design Qualitative interviewing. Setting Eight VA hospitals participated with established antimicrobial stewardship (AS) programs participated in the pilot. Participants Six infectious disease physicians and eight clinical pharmacists agreed to be interviewed (n = 14). Methods A 3-part qualitative interview script was used involving a description of local stewardship activities, a Critical Incident description of dashboard use, and general questions regarding attitudes towards the tool. An inductive open coding approach was used for analysis. Results We found 4 themes showing the complexities of using stewardship tools: (1) Data validity is socially negotiated; (2) Performance feedback motivates and persuades social goals when situated in an empirical distribution; (3) Shared problem awareness is aided by authoritative data; and (4) The AS dashboard encourages connections with local quality improvement culture. Conclusions Social dimensions of AS tool use emerged as distinct from, and equally important as decision support provided by the dashboard. Successful stewardship tools should be designed to support both the social and cognitive needs of users.

BackgroundAntimicrobial stewards may benefit from comparative data to inform interventions that promote optimal inpatient antimicrobial use.MethodsAntimicrobial stewards from 8 geographically dispersed Veterans Affairs (VA) inpatient facilities participated in the development of antimicrobial use visualization tools that allowed for comparison to facilities of similar complexity. The visualization tools consisted of an interactive web-based antimicrobial dashboard and, later, a standardized antimicrobial usage report updated at user-selected intervals. Stewards participated in monthly learning collaboratives. The percent change in average monthly antimicrobial use (all antimicrobial agents, anti-methicillin-resistant Staphylococcus aureus [anti-MRSA] agents, and antipseudomonal agents) was analyzed using a pre–post (January 2014–January 2016 vs July 2016–January 2018) design with segmented regression and external comparison with uninvolved control facilities (n = 118).ResultsIntervention sites demonstrated a 2.1% decrease (95% confidence interval [CI], −5.7% to 1.6%) in total antimicrobial use pre–post intervention vs a 2.5% increase (95% CI, 0.8% to 4.1%) in nonintervention sites (absolute difference, 4.6%; P = .025). Anti-MRSA antimicrobial use decreased 11.3% (95% CI, −16.0% to −6.3%) at intervention sites vs a 6.6% decrease (95% CI, −9.1% to −3.9%) at nonintervention sites (absolute difference, 4.7%; P = .092). Antipseudomonal antimicrobial use decreased 3.4% (95% CI, −8.2% to 1.7%) at intervention sites vs a 3.6% increase (95% CI, 0.8% to 6.5%) at nonintervention sites (absolute difference, 7.0%; P = .018).ConclusionsComparative data visualization tool use by stewards at 8 VA facilities was associated with significant reductions in overall antimicrobial and antipseudomonal use relative to uninvolved facilities.

BACKGROUND: Medication errors are prevalent in healthcare institutions worldwide, often arising from difficulties in care coordination among primary care providers, specialists, and pharmacists. Greater knowledge about care coordination surrounding medication safety incidents can inform efforts to improve patient safety. OBJECTIVES: To identify strategies that hospital and outpatient healthcare professionals (HCPs) use, and barriers encountered, when they coordinate care during a medication safety incident involving an adverse drug reaction, drug-drug interaction, or drug-renal concern. DESIGN: We asked HCPs to complete a form whenever they encountered these incidents and intervened to prevent or mitigate patient harm. We stratified incidents across HCP roles and incident categories to conduct follow-up cognitive task analysis interviews with HCPs. PARTICIPANTS: We invited all physicians and pharmacists working in inpatient or outpatient care at a tertiary Veterans Affairs Medical Center. We examined 24 incidents: 12 from physicians and 12 from pharmacists, with a total of 8 incidents per category. APPROACH: Interviews were transcribed and analyzed via a two-stage inductive, qualitative analysis. In stage 1, we analyzed each incident to identify decision requirements. In stage 2, we analyzed results across incidents to identify emergent themes. KEY RESULTS: Most incidents (19, 79%) were from outpatient care. HCPs relied on four main strategies to coordinate care: cognitive decentering; collaborative decision-making; back-up behaviors; and contingency planning. HCPs encountered four main barriers: role ambiguity and constraints, breakdowns (e.g., delays) in care, challenges related to the electronic health record, and factors that increased coordination complexity. Each strategy and barrier occurred across all incident categories and HCP groups. Pharmacists went to extra effort to ensure safety plans were implemented. CONCLUSIONS: Similar strategies and barriers were evident across HCP groups and incident types. Strategies for enhancing patient safety may be strengthened by deliberate organizational support. Some barriers could be addressed by improving work systems. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-020-06386-w.

Author(s): Graber, Christopher J; Jones, Makoto M; Chou, Ann F; Zhang, Yue; Goetz, Matthew Bidwell; Madaras-Kelly, Karl; Samore, Matthew H; Glassman, Peter A | Abstract: BackgroundAntimicrobial stewardship programs (ASPs) have been advocated to improve antimicrobial utilization, but program implementation is variable. Antimicrobial stewardship programs (ASPs) have been advocated to improve antimicrobial utilization, but program implementation is variable.ObjectiveTo determine associations between ASPs and facility characteristics, and inpatient antimicrobial utilization measures in the Veterans Affairs (VA) system in 2012.DesignIn 2012, VA administered a survey on antimicrobial stewardship practices to designated ASP contacts at VA acute care hospitals. From the survey, we identified 34 variables across 3 domains (evidence, organizational context, and facilitation) that were assessed using multivariable least absolute shrinkage and selection operator regression against 4 antimicrobial utilization measures from 2012: aggregate acute care antimicrobial use, antimicrobial use in patients with non-infectious primary discharge diagnoses, missed opportunities to convert from parenteral to oral antimicrobial therapy, and double anaerobic coverage.SettingAll 130 VA facilities with acute care services.ResultsVariables associated with at least 3 favorable changes in antimicrobial utilization included presence of postgraduate physician/pharmacy training programs, number of antimicrobial-specific order sets, frequency of systematic de-escalation review, presence of pharmacists and/or infectious diseases (ID) attendings on acute care ward teams, and formal ID training of the lead ASP pharmacist. Variables associated with 2 unfavorable measures included bed size, the level of engagement with VA Antimicrobial Stewardship Task Force online resources, and utilization of antimicrobial stop orders.ConclusionsFormalization of ASP processes and presence of pharmacy and ID expertise are associated with favorable utilization. Systematic de-escalation review and order set establishment may be high-yield interventions. Journal of Hospital Medicine 2017;12:301-309.

BackgroundMany studies identify factors that contribute to renal prescribing errors, but few examine how healthcare professionals (HCPs) detect and recover from an error or potential patient safety concern. Knowledge of this information could inform advanced error detection systems and decision support tools that help prevent prescribing errors.ObjectiveTo examine the cognitive strategies that HCPs used to recognise and manage medication-related problems for patients with renal insufficiency.DesignHCPs submitted documentation about medication-related incidents. We then conducted cognitive task analysis interviews. Qualitative data were analysed inductively.SettingInpatient and outpatient facilities at a major US Veterans Affairs Medical Centre.ParticipantsPhysicians, nurses and pharmacists who took action to prevent or resolve a renal-drug problem in patients with renal insufficiency.OutcomesEmergent themes from interviews, as related to recognition of renal-drug problems and decision-making processes.ResultsWe interviewed 20 HCPs. Results yielded a descriptive model of the decision-making process, comprised of three main stages: detect, gather information and act. These stages often followed a cyclical path due largely to the gradual decline of patients’ renal function. Most HCPs relied on being vigilant to detect patients’ renal-drug problems rather than relying on systems to detect unanticipated cues. At each stage, HCPs relied on different cognitive cues depending on medication type: for renally eliminated medications, HCPs focused on gathering renal dosing guidelines, while for nephrotoxic medications, HCPs investigated the need for particular medication therapy, and if warranted, safer alternatives.ConclusionsOur model is useful for trainees so they can gain familiarity with managing renal-drug problems. Based on findings, improvements are warranted for three aspects of healthcare systems: (1) supporting the cyclical nature of renal-drug problem management via longitudinal tracking mechanisms, (2) providing tools to alleviate HCPs’ heavy reliance on vigilance and (3) supporting HCPs’ different decision-making needs for renally eliminated versus nephrotoxic medications.

Purpose Adverse drug events (ADEs) in the U.S. Department of Veterans Affairs (VA) were evaluated, and differences in age group report rates and reported medications in different age groups were assessed. Methods We utilized the VA Adverse Drug Event Reporting System (ADERS) to assess 10-year age groups regarding ADE reporting rates, event severity, and associated reported medications. Data were derived from 484,351 ADE reports from 395,703 patients included in VA ADERS from 2009 through 2016. Results Reported rates of ADEs per 10,000 unique users demonstrated a nonlinear relationship with age, peaking in the group aged 60-69 years (148.6 reports/10,000 unique users) and declining thereafter. However, the percentage of adverse events reported as severe consistently rose with age group (3% in patients age 20-29 years versus 6% in patients older than 90 years). The types of medications reported as causative agents shifted over time from predominantly mental health and pain medications in younger veterans (e.g., age 20-29 years) to medications for chronic diseases in older cohorts (e.g., age 60-69 years). Conclusion An analysis of VA ADE reports revealed a nonlinear relationship between age and events, with events peaking at age 60-69 years. Rates of severe ADEs increased in older age groups. Drugs commonly associated with ADEs tended to be those primarily used for mental health and pain treatment in younger patients and those used to address chronic disease states in older patients.

Background About 30–50% of inpatient antimicrobial therapy is sub-optimal. Health care facilities have utilized various antimicrobial stewardship (AS) strategies to optimize appropriate antimicrobial use, improve health outcomes, and promote patient safety. However, little evidence exists to assess relationships between AS strategies and antimicrobial use. This study examined the impact of changes in AS strategies on antimicrobial use over time. Methods This study used data from the Veterans Affairs (VA) Healthcare Analysis & Informatics Group (HAIG) AS survey, administered at 130 VA facilities in 2012 and 2015, and antimicrobial utilization from VA Corporate Data Warehouse. Four AS strategies were examined: having an AS team, feedback mechanism on antimicrobial use, infectious diseases (ID) attending physicians, and clinical pharmacist on wards. Change in AS strategies were computed by taking the difference in the presence of a given strategy in a facility between 2012–2015. The outcome was the difference between antimicrobial use per 1000 patient days in 2012–2013 and 2015–2016. Employing multiple regression analysis, changes in antimicrobial use was estimated as a function of changes in AS strategies, controlling for ID human resources in and organizational complexity. Results Of the 4 strategies, only change in availability of AS teams had an impact on antimicrobial use. Compared to facilities with no AS teams at both time points, antibiotic use decreased by 63.9 uses per 1000 patient days in facilities that did not have a AS team in 2012 but implemented one in 2015 (p=0.0183). Facilities that had an AS team at both time points decreased use by 62.2 per 1000 patient days (p=0.0324). Conclusion The findings showed that AS teams reduced inpatient antibiotic use over time. While changes in having feedback on antimicrobial use and clinical pharmacist on wards showed reduced antimicrobial use between 2012–2015, the differences were not statistically significant. These strategies may already be a part of a comprehensive AS program and employed by AS teams. In further development of stewardship programs within healthcare organizations, the association between AS teams and antibiotic use should inform program design and implementation. Disclosures All Authors: No reported disclosures

PurposeResults of a study to estimate the prevalence of look-alike/sound-alike (LASA) medication errors through analysis of Veterans Affairs (VA) administrative data are reported.MethodsVeterans with at least 2 filled prescriptions for 1 medication in 20 LASA drug pairs during the period April 2014–March 2015 and no history of use of both medications in the preceding 6 months were identified. First occurrences of potential LASA errors were identified by analyzing dispensing patterns and documented diagnoses. For 7 LASA drug pairs, potential errors were evaluated via chart review to determine if an actual error occurred.ResultsAmong LASA drug pairs with overlapping indications, the pairs associated with the highest potential-error rates, by percentage of treated patients, were tamsulosin and terazosin (3.05%), glipizide and glyburide (2.91%), extended- and sustained-release formulations of bupropion (1.53%), and metoprolol tartrate and metoprolol succinate (1.48%). Among pairs with distinct indications, the pairs associated with the highest potential-error rates were tramadol and trazodone (2.20%) and bupropion and buspirone (1.31%). For LASA drug pairs found to be associated with actual errors, the estimated error rates were as follows: lamivudine and lamotrigine, 0.003% (95% confidence interval [CI], 0–0.01%); carbamazepine and oxcarbazepine, 0.03% (95% CI, 0–0.09%); and morphine and hydromorphone, 0.02% (95% CI, 0–0.05%).ConclusionThrough the use of administrative databases, potential LASA errors that could be reviewed for an actual error via chart review were identified. While a high rate of potential LASA errors was detected, the number of actual errors identified was low.

Author(s): Chou, Ann F; Graber, Christopher J; Zhang, Yue; Jones, Makoto; Goetz, Matthew Bidwell; Madaras-Kelly, Karl; Samore, Matthew; Glassman, Peter A | Abstract: Objectives:Inappropriate antibiotic use poses a serious threat to patient safety. Antimicrobial stewardship programmes (ASPs) may optimize antimicrobial use and improve patient outcomes, but their implementation remains an organizational challenge. Using the Promoting Action on Research Implementation in Health Services (PARiHS) framework, this study aimed to identify organizational factors that may facilitate ASP design, development and implementation. Methods:Among 130 Veterans Affairs facilities that offered acute care, we classified organizational variables supporting antimicrobial stewardship activities into three PARiHS domains: evidence to encompass sources of knowledge; contexts to translate evidence into practice; and facilitation to enhance the implementation process. We conducted a series of exploratory factor analyses to identify conceptually linked factor scales. Cronbach's alphas were calculated. Variables with large uniqueness values were left as single factors. Results:We identified 32 factors, including six constructs derived from factor analyses under the three PARiHS domains. In the evidence domain, four factors described guidelines and clinical pathways. The context domain was broken into three main categories: (i) receptive context (15 factors describing resources, affiliations/networks, formalized policies/practices, decision-making, receptiveness to change); (ii) team functioning (1 factor); and (iii) evaluation/feedback (5 factors). Within facilitation, two factors described facilitator roles and tasks and five captured skills and training. Conclusions:We mapped survey data onto PARiHS domains to identify factors that may be adapted to facilitate ASP uptake. Our model encompasses mostly mutable factors whose relationships with performance outcomes may be explored to optimize antimicrobial use. Our framework also provides an analytical model for determining whether leveraging existing organizational processes can potentially optimize ASP performance.

Background Facilitating appropriate and safe prescribing of opioid medications for chronic pain management in primary care is a pressing public health concern. Interdisciplinary team-based models of primary care are exploring the expansion of clinical pharmacist roles to support disease management for chronic conditions, e.g. pain. Our study aims to 1) identify roles clinical pharmacists can assume in primary care team based chronic pain care processes and 2) understand the barriers to assuming these expanded roles. Methods Setting: Veterans Health Administration (VA) has implemented an interdisciplinary team-based model for primary care which includes clinical pharmacists. Design: We employed an inductive two part qualitative approach including focus groups and semi-structured interviews with key informants. Participants: 60 members of VA primary care teams in two states participated in nine preliminary interdisciplinary focus groups where a semi-structured interview guide elucidated provider experiences with screening for and managing chronic pain. To follow up on emergent themes relating to clinical pharmacist roles, an additional 14 primary care providers and clinical pharmacists were interviewed individually. We evaluated focus group and interview transcripts using the method of constant comparison and produced mutually agreed upon themes. Results Clinical pharmacists were identified by primary care providers as playing a central role with the ongoing management of opioid therapy including review of the state prescription drug monitoring program, managing laboratory screening, providing medication education, promoting naloxone use, and opioid tapering. Specific barriers to clinical pharmacists role expansion around pain care include: limitations of scopes of practice, insufficient institutional support (low staffing, dedicated time, insufficient training, lack of interdisciplinary leadership support), and challenges and opportunities for disseminating clinical pharmacists’ expanded roles. Conclusions Expanding the role of the clinical pharmacist to collaborate with providers around primary care based chronic pain management is a promising strategy for improving pain management on an interdisciplinary primary care team. However, expanded roles have to be balanced with competing responsibilities relating to other conditions. Interdisciplinary leadership is needed to facilitate training, resources, adequate staffing, as well as to prepare both clinical pharmacists and the providers they support, about expanded clinical pharmacists’ scopes of practice and capabilities.

Objectives To understand clinicians’ impressions of and decision-making processes regarding an informatics-supported antibiotic timeout program to re-evaluate the appropriateness of continuing vancomycin and piperacillin/tazobactam. Methods We implemented a multi-pronged informatics intervention, based on Dual Process Theory, to prompt discontinuation of unwarranted vancomycin and piperacillin/tazobactam on or after day three in a large Veterans Affairs Medical Center. Two workflow changes were introduced to facilitate cognitive deliberation about continuing antibiotics at day three: (1) teams completed an electronic template note, and (2) a paper summary of clinical and antibiotic-related information was provided to clinical teams. Shortly after starting the intervention, six focus groups were conducted with users or potential users. Interviews were recorded and transcribed. Iterative thematic analysis identified recurrent themes from feedback. Results Themes that emerged are represented by the following quotations: (1) captures and controls attention (“it reminds us to think about it”), (2) enhances informed and deliberative reasoning (“it makes you think twice”), (3) redirects decision direction (“…because [there was no indication] I just [discontinued] it without even trying”), (4) fosters autonomy and improves team empowerment (“the template… forces the team to really discuss it”), and (5) limits use of emotion-based heuristics (“my clinical concern is high enough I think they need more aggressive therapy…”). Conclusions Requiring template completion to continue antibiotics nudged clinicians to re-assess the appropriateness of specified antibiotics. Antibiotic timeouts can encourage deliberation on overprescribed antibiotics without substantially curtailing autonomy. An effective nudge should take into account clinician’s time, workflow, and thought processes.

Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare.We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews.We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection.The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

Importance Metronidazole hydrochloride has historically been considered first-line therapy for patients with mild to moderate Clostridium difficile infection (CDI) but is inferior to vancomycin hydrochloride for clinical cure. The choice of therapy may likewise have substantial consequences on other downstream outcomes, such as recurrence and mortality, although these secondary outcomes have been less studied. Objective To evaluate the risk of recurrence and all-cause 30-day mortality among patients receiving metronidazole or vancomycin for the treatment of mild to moderate and severe CDI. Design, Setting, and Participants This retrospective, propensity-matched cohort study evaluated patients treated for CDI, defined as a positive laboratory test result for the presence of C difficile toxins or toxin genes in a stool sample, in the US Department of Veterans Affairs health care system from January 1, 2005, through December 31, 2012. Data analysis was performed from February 7, 2015, through November 22, 2016. Exposures Treatment with vancomycin or metronidazole. Main Outcomes and Measures The outcomes of interest in this study were CDI recurrence and all-cause 30-day mortality. Recurrence was defined as a second positive laboratory test result within 8 weeks of the initial CDI diagnosis. All-cause 30-day mortality was defined as death from any cause within 30 days of the initial CDI diagnosis. Results A total of 47 471 patients (mean [SD] age, 68.8 [13.3] years; 1947 women [4.1%] and 45 524 men [95.9%]) developed CDI, were treated with vancomycin or metronidazole, and met criteria for entry into the study. Of 47 147 eligible first treatment episodes, 2068 (4.4%) were with vancomycin. Those 2068 patients were matched to 8069 patients in the metronidazole group for a total of 10 137 included patients. Subcohorts were constructed that comprised 5452 patients with mild to moderate disease and 3130 patients with severe disease. There were no differences in the risk of recurrence between patients treated with vancomycin vs those treated with metronidazole in any of the disease severity cohorts. Among patients in the any severity cohort, those who were treated with vancomycin were less likely to die (adjusted relative risk, 0.86; 95% CI, 0.74 to 0.98; adjusted risk difference, –0.02; 95% CI, –0.03 to –0.01). No significant difference was found in the risk of mortality between treatment groups among patients with mild to moderate CDI, but vancomycin significantly reduced the risk of all-cause 30-day mortality among patients with severe CDI (adjusted relative risk, 0.79; 95% CI, 0.65 to 0.97; adjusted risk difference, –0.04; 95% CI, –0.07 to –0.01). Conclusions and Relevance Recurrence rates were similar among patients treated with vancomycin and metronidazole. However, the risk of 30-day mortality was significantly reduced among patients who received vancomycin. Our findings may further justify the use of vancomycin as initial therapy for severe CDI.

Decisions to control pharmaceutical costs can cause conflicts as to what medications are covered. Such conflicts have ethical implications, however implicit, and given this fact, an ethical framework can help address them. In the following commentary, we discuss the more traditional, individual-level ethical considerations likely familiar to most clinicians. We, then, discuss population-level ethical constructs that clinicians may not as readily embrace. We also present a hypothetical cancer-care case to illustrate how imbalances in ethical foci between individual- and population-level constructs may lead to conflicts among health care actors and promote shifts in pharmaceutical decision making away from providers and toward payers, paradoxically reducing provider autonomy and hence patient autonomy. Finally, we propose a more comprehensive ethical framework to help converge individual, payer, and societal interests when making pharmaceutical use decisions. Pharmacists play a crucial role as pharmacy benefits managers and should be familiar with individual- and population-based ethical constructs.

Background Antimicrobial inappropriateness is highly contextual and dynamic, depending not only on the patient’s disease condition but also the information available at the time. To estimate the extent to which antimicrobials could theoretically be decreased with antimicrobial stewardship, we sought to capture unnecessary inpatient antimicrobial use in context over time as manifested in the electronic health record in Veterans Affairs (VA). Methods We extracted antimicrobial use, administrative, admission, and laboratory data from all acute care VA medical centers between 2010 and 2016. Information present during Choice (hospital day [HD] 1–3), Change (HD 4–5), Completion (HD 6–7), and Post-completion (thereafter) was used to determine context. All antimicrobial use without any documented infection was considered unnecessary (admission, discharge, or otherwise). Choice Anti-MRSA agents were considered unnecessary in cellulitis without history of or current positive culture for MRSA. Choice HOMDR agents were unnecessary in cellulitis without history of positive culture for ceftriaxone-resistant Gram-negative rods. Also unnecessary were broad-spectrum antimicrobials (anti-methicillin-resistant Staphylococcus aureus [MRSA] and hospital-onset multidrug-resistant [HOMDR] organisms antimicrobials as defined by the National Healthcare Safety Network) administered without evidence of multidrug-resistant organisms existed during Change and Completion time frames. Results Figure 1 demonstrates the distribution of facility proportions of unnecessary antimicrobials of different classes over time. Table 1 illustrates the percentage of unnecessary antimicrobials administered during choice, change, completion, and post-completion time-frames. Conclusion By this measure, unnecessary anti-MRSA and HOMDR use has been decreasing in VA over time. The bulk of unnecessary use is empiric but there is a substantial proportion that is used for longer stays, during which time more information was likely present. More research is necessary to determine how well these simple rules correlate with clinical determinations of appropriateness. Also ICD-10-CM was implemented in October 2015, which may have introduced an ascertainment bias. Disclosures V. Stevens, Pfizer, Inc.: Grant Investigator, Research grant.

32 Background: Many patients with cancerpain are appropriately managed on long-term opioid therapy (LTOT), but are at similar risk of overdose and addiction as are patients with non-cancer pain. Whether to commence opioids for cancer pain is often a shared decision between patient and provider. Little is known about this process. Methods: Semi-structured interviews with 20 cancer patients on LTOT and 20 interdisciplinary providers who prescribe LTOT from two VA medical centers. Transcripts were coded and analyzed using constant comparison to find common themes. Results: Providers and patients largely weighed the risks and benefits of LTOT similarly, except in the case of cancer patients with past/present substance use disorder (SUD). In those cases, providers felt the risks outweighed the benefits, while patients felt the benefits outweighed the risks. Generally, patients considered pain relief their overarching concern. Other factors that impacted their risk/benefit calculus included: personal/family experience with opioids and the opinions of trusted providers. Only rarely did patients defer decision making to providers. Factors that impacted the risk/benefit calculus of providers included: disease status, patient goals, patient characteristics, and providers' past experiences/biases. Of note, patients with past opioid exposure generally viewed their experience with opioids as positive, and usually anchored their risk assessment for opioids relative to those of chemotherapy. Patients also expressed that they would prefer to spend less physician time discussing LTOT and more time discussing cancer treatment instead. Conclusions: Patients and providers often agree on when it is appropriate to use LTOT for cancer pain. In cases where they disagree, providers are well advised to explore and address patients’ fears about the adequacy of pain management without opioids, as well as their lived experience with opioids. Patients are comfortable having such discussions with physician extenders in order to reserve face-to-face physician time to discuss cancer treatment instead.

Background Participation in the Antibiotic Use (AU) option of the National Health Safety Network (NHSN), provides medical facilities with the Standardized Antibiotic Administration Ratio (SAAR), a normalized ratio of facility antibiotic use. However, the range of antibiotic use by similar facilities is not provided and thus the opportunity to “nudge” behavior by comparing use with “best facilities” is lost. We developed reports of variations of antibiotic use that allow comparisons of local antibiotic use with that of 107 other VA facilities. Methods Data for 2018 were extracted from the VA Corporate Data Warehouse. Antibiotic use in CY2018 on acute inpatient care units was assessed as days of therapy (using CDC-defined drug classes) per 1000 days-present. In addition, we assessed the proportion of patients with pneumonia, urinary tract infections or skin-soft-tissue infections (collectively, PUS) who received anti-MRSA therapy or ß-lactam therapy directed against multi-drug-resistant and hospital GNR (anti-MDRGNR) during hospital days 0–2 (CHOICE, a timeframe representing empiric therapy). Results Rates of total antibiotic use by VA facility varied over two-fold from 460 to 965 days of therapy (DOT)/1000 days-present (DP); anti-MRSA and anti-MDRGNR varied over four-fold, from 44 to 184 and, 55 to 262, respectively. Fluoroquinolone variation was even higher, ranging over 8-fold, from 17 to 145 DOT/1000 DP (Figure 1). Substantial variations were also observed in the frequency of administration of anti-MRSA and anti-MDRGNR therapy for PUS during CHOICE (14 to 49% and 15 to 65%, respectively; Figure 2). Conclusion The large variations in the use of total antibiotic therapy, anti-MRSA, anti-MDRGNR and fluoroquinolone therapies are greater than can be readily explained by known variations in antibiotic resistance or differences in case-mix within the VA. Efforts are underway in the VA to strengthen antimicrobial stewardship programs. In other work, we have shown improvements in antimicrobial use among sites that have access to reports that provide the data described herein and that participate in group collaboratives. Our group is now making these data available to all VA facilities. Disclosures All authors: No reported disclosures.

Background To identify areas for improved antibiotic use, we developed and pilot-tested visualization tools to quantify antibiotic use at 8 VA facilities. These tools allow a facility to review its patterns of total use, and use by antibiotic class, compared with patterns of use at VA facilities with similar (or user-selected) complexity levels. Methods Antibiotic stewards from 8 VA facilities participated in iterative report development and implementation, with the final product consisting of two components: an interactive web-based antibiotic dashboard and a standardized antibiotic usage report updated at user-selected intervals. Stewards also participated in monthly learning collaboratives. The percent change in average monthly antimicrobial use (all antibiotics; anti-methicillin-resistant S. aureus agents (anti-MRSA); and broad-spectrum agents predominantly used for hospital-onset/multi-drug-resistant organisms (anti-MDRO)) was analyzed using a pre-post (January 2014–January 2016 vs. July 2016–January 2018) with un-involved controls (all other inpatient VA facilities, n = 132) design modeled using Generalized Estimation Equations segmented regression. Results Intervention sites had a 2.1% decrease (95% CI = [−5.7%,1.6%]) in all antibiotic use pre-post-intervention, vs. a 2.5% increase (95% CI = [0.8%, 4.1%]) in nonintervention sites (P = 0.025 for difference). Anti-MRSA antibiotic use decreased 11.3% (95% CI = [−16.0%,−6.3%]) at intervention sites vs. a 6.6% decrease (95% CI=[−9.1%, −3.9%]) at nonintervention sites (P = 0.092 for difference). Anti-MDRO antibiotic use decreased 3.4% (95% CI = [−8.2%,1.7%]) at intervention sites vs. a 3.6% increase (95% CI = [0.8%,6.5%]) at nonintervention sites (P = 0.018 for difference) (Figure 1). Examples of graphs include overall antibacterial use (Figure 2), and usage of broad-spectrum Gram-negative therapy (Figure 3) in intensive care units. Conclusion The use of data visualization tools use and participation in monthly learning collaboratives by antimicrobial stewards in a pilot implementation project at eight VA facilities was associated with decreases in antimicrobial use relative to uninvolved sites. Disclosures All authors: No reported disclosures.

Purpose A Web-based application for coordinating medication-use evaluation (MUE) initiatives within the Veterans Affairs (VA) health care system is described. Summary The MUE Tracker (MUET) software program was created to improve VA’s ability to conduct national medication-related interventions throughout its network of 147 medical centers. MUET initiatives are centrally coordinated by the VA Center for Medication Safety (VAMedSAFE), which monitors the agency’s integrated databases for indications of suboptimal prescribing or drug therapy monitoring and adverse treatment outcomes. When a pharmacovigilance signal is detected, VAMedSAFE identifies “trigger groups” of at-risk veterans and uploads patient lists to the secure MUET application, where locally designated personnel (typically pharmacists) can access and use the data to target risk-reduction efforts. Local data on patient-specific interventions are stored in a centralized database and regularly updated to enable tracking and reporting for surveillance and quality-improvement purposes; aggregated data can be further analyzed for provider education and benchmarking. In a three-year pilot project, the MUET program was found effective in promoting improved prescribing of erythropoiesis-stimulating agents (ESAs) and enhanced laboratory monitoring of ESA-treated patients in all specified trigger groups. The MUET initiative has since been expanded to target other high-risk drugs, and efforts are underway to refine the tool for broader utility. Conclusion The MUET application has enabled the increased standardization of medication safety initiatives across the VA system and may serve as a useful model for the development of pharmacovigilance tools by other large integrated health care systems.

UnlabelledOver the past decade, the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services (PBM) has enhanced its formulary management activities and added programs to ensure that the national drug plan continues to meet the pharmacy needs of veterans and to promote safe and appropriate drug therapy in the face of rising medication expenditures. This article describes the broad range of services provided by the VA PBM that work in partnership to deliver a high-quality and sustainable pharmacy benefit for veterans. In support of formulary management, VA PBM pharmacists prepare extensive clinical guidance documents (e.g., drug monographs and criteria for use) that are used by physicians and pharmacists with operational and clinical oversight of the VA national formulary. The VA PBM has utilized various contracting techniques and continually evaluates drug utilization data to identify opportunities for potential savings. Remarkably, since before 2004, the average acquisition cost for a 1-month supply of medication has remained fairly stable at approximately $13-$15. Two new VA PBM programs are the VA Center for Medication Safety (VA MedSAFE) and the Clinical Pharmacy Practice Office (CPPO). VA MedSAFE is a comprehensive pharmacovigilance program focused on the detection, assessment, and prevention of adverse drug events, and CPPO is dedicated to improving safe and appropriate medication use by supporting and expanding clinical pharmacy practice. Moving forward, the VA PBM will consider new initiatives to stay at the forefront of providing quality care while maintaining economic viability.DisclosuresNo outside funding supported this research. This work was supported by VA Pharmacy Benefits Management Services (VA PBM), Hines, Illinois, and VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania. Glassman is co-director of the VA Center for Medication Safety, which is part of the VA PBM. He is also part of the Medical Advisory Panel for the VA PMB. All other authors are employed by the VA PBM. The views expressed in this article are those of the authors, and no official endorsement by the U.S. Department of Veteran Affairs or the U.S. government is intended or should be inferred. Study concept and design were contributed by Valentino, Cunningham, Good, Aspinall, and Sales. Calabrese and Ourth took the lead in data collection, along with Good, Cunningham, Aspinall, Sales, Burk, Moore, Neuhauser, and Golterman. Data interpretation was performed by Burk, Newhauser, and Golterman, along with Glassman, Calabrese, Moore, and Ourth. The manuscript was written by Aspinall and Sales, along with Burk, Newhauser, Golterman, Ourth, and Cunningham. Good, Glassman, and Moore revised the manuscript, along with Calabrese, Valentino, and Aspinall.

BACKGROUNDAntimicrobial stewardship programs (ASPs) are variably implemented.OBJECTIVETo characterize variations of antimicrobial stewardship structure and practices across all inpatient Veterans Affairs facilities in 2012 and correlate key characteristics with antimicrobial usage.DESIGNA web-based survey regarding stewardship activities was administered to each facility’s designated contact. Bivariate associations between facility characteristics and inpatient antimicrobial use during 2012 were determined.SETTINGTotal of 130 Veterans Affairs facilities with inpatient services.RESULTSOf 130 responding facilities, 29 (22%) had a formal policy establishing an ASP, and 12 (9%) had an approved ASP business plan. Antimicrobial stewardship teams were present in 49 facilities (38%); 34 teams included a clinical pharmacist with formal infectious diseases (ID) training. Stewardship activities varied across facilities, including development of yearly antibiograms (122 [94%]), formulary restrictions (120 [92%]), stop orders for antimicrobial duration (98 [75%]), and written clinical pathways for specific conditions (96 [74%]). Decreased antimicrobial usage was associated with having at least 1 full-time ID physician (P=.03), an ID fellowship program (P=.003), and a clinical pharmacist with formal ID training (P=.006) as well as frequency of systematic patient-level reviews of antimicrobial use (P=.01) and having a policy to address antimicrobial use in the context of Clostridium difficile infection (P=.01). Stop orders for antimicrobial duration were associated with increased use (P=.03).CONCLUSIONSASP-related activities varied considerably. Decreased antibiotic use appeared related to ID presence and certain select practices. Further statistical assessments may help optimize antimicrobial practices.Infect Control Hosp Epidemiol 2016;37:647–654

BackgroundAll Department of Veterans Affairs Medical Centers (VAMCs) operate under a single national drug formulary, yet substantial variation in prescribing and spending exists across facilities. Local management of the national formulary may differ across VAMCs and may be one cause of this variation.ObjectiveTo characterize variation in the management of nonformulary medication requests and pharmacy and therapeutics (P&T) committee member perceptions of the formulary environment at VAMCs nationwide.MethodsWe performed an online survey of the chief of pharmacy and an additional staff pharmacist and physician on the P&T committee at all VAMCs. Respondents were asked questions regarding criteria for use for nonformulary medications, specific procedures for ordering nonformulary medications in general and specific lipid-lowering and diabetes agents, the appeals process, and the formulary environment at their VAMCs. We compared responses across facilities and between chiefs of pharmacy, pharmacists, and physicians.ResultsA total of 212 chief pharmacists (n = 80), staff pharmacists (n = 78), and physicians (n = 54) responded, for an overall response rate of 49%. In total, 107/143 (75%) different VAMCs were represented. The majority of VAMCs reported adhering to national criteria for use, with 38 (36%) being very adherent and 69 (65%) being mostly adherent. There was substantial variation between VAMCs regarding how nonformulary drugs were ordered, evaluated, and appealed. The nonformulary lipid-lowering drugs ezetimibe, rosuvastatin, and atorvastatin were viewable to providers in the order entry screen at 67 (63%), 67 (63%), and 64 (60%) VAMCs, respectively. The nonformulary diabetes medication pioglitazone was only viewable at 58 (55%) VAMCs. In the remaining VAMCs, providers could not order these nonformulary drugs through the normal order-entry process. For questions about the formulary environment, physician respondent perceptions differed from those of staff pharmacists and chief pharmacists. Compared with pharmacy chiefs and staff pharmacists, physicians were less likely to agree that providers at their VAMC prescribed too many nonformulary medications (47% and 44% vs. 12%, P < 0.001), more likely to agree that providers must jump through too many hoops to prescribe nonformulary medication (5% and 3% vs. 25%, P < 0.001), and more likely to agree that providers make an effort to convert new patients from nonformulary to formulary lipid-lowering (65% and 73% vs. 94%, P