Purpose An advisory panel of experts was convened by the ASHP Foundation as a part of its Medication-Use Evaluation Resources initiative to provide commentary on an approach to antibiotic stewardship in the treatment of skin and soft tissue infections (SSTIs), with a focus on oral antibiotics in the emergency department (ED) setting for patients who will be treated as outpatients. Considerations include a need to update existing guidelines to reflect new antibiotics and susceptibility patterns, patient-specific criteria impacting antibiotic selection, and logistics unique to the ED setting.Summary While national guidelines serve as the gold standard on which to base SSTI treatment decisions, our advisory panel stressed that institutional guidelines must be regularly updated and grounded in local antimicrobial resistance patterns, patient-specific factors, and logistical considerations. Convening a team of experts locally to establish institution-specific guidelines as part of a comprehensive antibiotic stewardship program can ensure patients receive the most appropriate oral therapy for the outpatient treatment of SSTIs in patients visiting the ED.Conclusion SSTI treatment considerations for antibiotic selection in the ED supported by current, evidence-based guidelines, including guidance on optimal oral antibiotic selection for patients discharged for outpatient treatment, are a useful tool to improve the quality and efficiency of care, enhance patient-centric outcomes and satisfaction, decrease healthcare costs, and reduce overuse of antibiotics.

Rationale:Controlled trials have demonstrated successful weight loss associated with certain weight management medications (WMMs). However, there are limited real-world data on prescribing patterns and efficacy and safety profiles of WMMs in Veterans Affairs (VA) patients. Objective:To evaluate: utilization patterns of WMMs liraglutide, naltrexone/bupropion, orlistat, phentermine, phentermine/topiramate, and semaglutide; weight loss at three, six, twelve, and more than 12 months; safety; and treatment barriers. Methods:A retrospective, cross-sectional medication use evaluation (MUE) was conducted using electronic health records of outpatient Veterans newly initiated on WMMs at 37 VA Medical Centers between 1 March 2020 and 31 March 2022. Chart review was used to identify WMM utilization and capture rates of clinical response, defined as 5% and 10% or greater weight loss at the final weight, adverse drug events (ADEs), non-adherence, and discontinuations. Site-specific surveys evaluated local practices and barriers. Results:Among 1959 eligible Veterans, semaglutide, phentermine/topiramate, and orlistat were most frequently prescribed. The clinical response was highest among phentermine/topiramate, liraglutide, and semaglutide. Naltrexone/bupropion and phentermine demonstrated the highest and lowest ADE rates, respectively. Potential barriers to WMM utilization and successful treatment by site reports were drug shortages, patient perceptions of therapeutic course, personal preferences, and VA WMM use criteria. Conclusions:Smaller weight loss and higher discontinuation rates were observed relative to clinical trials. The MUE data allow for better assessment of benefits and risks for Veterans prescribed WMMs.

Background:Although the benefits outweigh the risks, COVID-19 vaccines have been associated with an increased risk of myocarditis and pericarditis. This report is based on a national US veteran population with confirmed myocarditis/pericarditis following mRNA COVID-19 vaccines according to the near real-time active surveillance program of Veterans Affairs.Methods:This study is based on a cohort evaluation of all adults administered ≥1 mRNA COVID-19 vaccine, including boosters, in the Veterans Health Administration between 14 December 2020 and 9 October 2022. ICD-10-CM diagnosis codes were used to identify potential safety signals in near real time through a database analysis. All potential cases of myocarditis/pericarditis identified in the database analysis underwent in-depth chart review and case validation by a team of pharmacists and expert clinicians. Our main outcome was the incidence rate of confirmed myocarditis/pericarditis among vaccine recipients (overall and those aged 18-39 years) within 21 days of a first, second, or booster dose of a mRNA COVID-19 vaccine. We calculated the ratio of observed events among COVID-19 vaccine recipients over expected events from historical vaccine recipient controls (2015-2020) in the Veterans Health Administration. We used confirmed cases to calculate incidence rates and 95% CIs.Results:Through 9 October 2022, 3 877 453 doses of BNT162b2 (Pfizer-BioNTech) and 4 221 397 doses of mRNA-1273 (Moderna) were administered as first or second dose across Veterans Affairs, and 1 012 561 BNT162b2 and 1 156 160 mRNA-1273 booster doses were administered. Among all doses, the rapid cycle analysis identified 178 potential cases of myocarditis/pericarditis among vaccinees of any age and 22 potential cases among those aged 18-39 years. Of these, 33 cases, including 6 among those 18-39 years old, were confirmed after in-depth chart review and validation, corresponding with an overall incidence rate per million ranging from 0.46 (95% CI, .01-2.55) for Moderna dose 1 to 6.91 (95% CI, 2.78-14.24) for Pfizer booster. Among those aged 18-39, incidence rates ranged from 7.1 (95% CI, .18-39.56) for Moderna dose 2 to 19.76 (95% CI, 5.38-50.58) for Pfizer dose 2. Patients with confirmed cases were hospitalized for a mean 4.1 days (range, 1-15). The final disposition for 32 (97%) of 33 cases was discharge to home.Conclusions:This report is a real-world demonstration of the Veterans Affairs' active surveillance system for vaccines. Although the rapid cycle analysis initially identified 178 potential cases of myocarditis/pericarditis, only 1 of 5 cases was confirmed to be related to a COVID-19 vaccine after chart review. These findings highlight the paramount importance of active surveillance and chart validation for rare but serious adverse events related to COVID-19 vaccines.

PURPOSE:Early data suggest that mechanically ventilated COVID-infected (COVID+) patients had increased sedation requirements compared with historical controls.The impact of these sedation practices on patient-relevant clinical outcomes remains unknown.To evaluate this concern for increased sedative use, we conducted a quality improvement medication use evaluation (MUE) project to assess sedation practice patterns and observed outcomes for mechanically ventilated COVID+ Veterans in intensive care units (ICUs).Our results are from pilot chart review. METHODS:A multidisciplinary team comprised of senior VA Center for Medication Safety (VAMedSAFE) staff, critical care providers, clinical pharmacists, and statisticians collaborated on the design of this MUE to measure sedation practices and clinical outcomes during the COVID pandemic across the Veterans Health Administration.A total of 13 VA medical centers (VAMCs) completed data use agreements to conduct local chart reviews.Given potential practice variations over the course of the pandemic, three time periods were selected for review: pre-(3/2019-2/2020), COVID Year 1 (3/2020-2/2021), and COVID Year 2 (3/2021-3/ 2022).Each participating VAMC will screen at least 75 patients from each of the 3 time periods from their site (anticipated total patient charts screened n¼2925).Any ICU patient intubated for $2 calendar days will be eligible for analysis.Patients transferred from a non-VA facility, transferred out of the ICU within 48 hours of admission, or those intubated for >14 days will be excluded.Our primary outcomes include dose and duration of sedative exposure, hospital length of stay (LOS), new antipsychotic prescription, ileus, delirium, and overall mortality.Outcomes and covariates will be ascertained by structured data, when available, and validated by chart review.The MUE pilot was conducted from 1/2023-3/2023. RESULTS:The pilot identified challenges in operationalizing definitions for chart review.Among 83 patients from 11 participating sites, 49% met inclusion criteria.Most exclusions were due to ICU LOS restrictions in the initial MUE chart abstraction tool.As a result, we adapted the existing tool to restrict by intubation days >14 (vs.total ICU LOS).Our pilot also revealed wide variation in clinical pain assessment and spontaneous awakening trials.To maximize fidelity of these domains, we adapted the MUE to allow for open-ended and semi-structured responses. CONCLUSIONS:The MUE may inform opportunities to develop system-level medication use improvements at VAMCs.Understanding sedation use during high volume pandemic periods may also mitigate the strain from drug shortages in future respiratory pandemics.CLINICAL IMPLICATIONS: Formal assessment of prescribing practices and patient-relevant clinical outcomes via this MUE will help to guide creation and implementation of safer sedation guidelines within the VA healthcare system.

Background The Opioid Safety Initiative (OSI) was implemented in 2013 to enhance the safe and appropriate use of opioids in the Veterans Health Administration (VA). Opioid use decreased nationally in subsequent years, but characterization of opioid de-prescribing practices has not been well established. Objectives To describe changes in patient characteristics and patterns of de-prescribing since OSI implementation for opioid users at > 90 morphine equivalent daily dose for at least 90 days for those that discontinued opioids within the VA. Design Retrospective observational pre-post intervention medication use evaluation using VA data and electronic health records to identify differences in opioid de-prescribing between fiscal year 2013 (FY13; early OSI) and FY17 (late OSI). Reviewers' insights for local opioid management and de-prescribing practices collected through web-based post-data collection survey. Participants Veterans prescribed high-dose long-term opioid therapy in FY13 and FY17 who subsequently discontinued opioids at 27 VA medical centers. Main measures Chart review data from local facility reviewers identified socioeconomic characteristics, opioid de-prescribing rationale (e.g., risk-benefit, diversion) and practices (e.g., rate of opioid discontinuation, taper monitoring activities, withdrawal monitoring), and outcomes following discontinuation. Key Results Among 315 patients in FY13 and 322 patients in FY17 with opioid discontinuation, discontinuation rationale focused on diversion in FY13 and risk-benefit in FY17. Clinical pharmacists and pain management specialists had increased involvement in FY17 opioid discontinuations (36% versus 16%). Of all discontinuations, 56% of patients were tapered in FY13 versus 70% of patients in FY17. Tapering plans were longer in FY17 than in FY13 (163 days versus 65 days). Transitions to non-opioid pain therapy following opioid discontinuation were higher in FY17 compared to FY13 (70% versus 60%). Conclusions Veterans discontinued from high-dose long-term opioids in FY17 were more optimally managed compared to those in FY13. Findings suggest improvements in opioid de-prescribing following OSI implementation, but interpretation is limited by study design.

Abstract Objective: To conduct a contemporary detailed assessment of outpatient antibiotic prescribing and outcomes for positive urine cultures in a mixed-sex cohort. Design: Multicenter retrospective cohort review. Setting: The study was conducted using data from 31 Veterans’ Affairs medical centers. Patients: Outpatient adults with positive urine cultures. Methods: From 2016 to 2019, data were extracted through a nationwide database and manual chart review. Positive urine cultures were reviewed at the chart, clinician, and aggregate levels. Cases were classified as cystitis, pyelonephritis, or asymptomatic bacteriuria (ASB) based upon documented signs and symptoms. Preferred therapy definitions were applied for subdiagnoses: ASB (no antibiotics), cystitis (trimethoprim-sulfamethoxazole, nitrofurantoin, β-lactams), and pyelonephritis (trimethoprim-sulfamethoxazole, fluoroquinolone). Outcomes included 30-day clinical failure or hospitalization. Odds ratios for outcomes between treatments were estimated using logistic regression. Results: Of 3,255 cases reviewed, ASB was identified in 1,628 cases (50%), cystitis was identified in 1,156 cases (36%), and pyelonephritis was identified in 471 cases (15%). Of all 2,831 cases, 1,298 (46%) received preferred therapy selection and duration for cases where it could be defined. The most common antibiotic class prescribed was a fluoroquinolone (34%). Patients prescribed preferred therapy had lower odds of clinical failure: preferred (8%) versus nonpreferred (10%) (unadjusted OR, 0.74; 95% confidence interval [CI], 0.58–0.95; P = .018). They also had lower odds of 30-day hospitalization: preferred therapy (3%) versus nonpreferred therapy (5%) (unadjusted OR, 0.55; 95% CI, 0.37–0.81; P = .002). Odds of clinical treatment failure or hospitalization was higher for β-lactams relative to ciprofloxacin (unadjusted OR, 1.89; 95% CI, 1.23–2.90; P = .002). Conclusions: Clinicians prescribed preferred therapy 46% of the time. Those prescribed preferred therapy had lower odds of clinical failure and of being hospitalized.

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.

We evaluated adverse drug events (ADEs) by chart review in a random national sample of 428 veterans with coronavirus disease 2019 (COVID-19) who received tocilizumab (n = 173 of 428). ADEs (median time, 5 days) occurred in 51 of 173 (29%) and included hepatoxicity (n = 29) and infection (n = 13). Concomitant medication discontinuation occurred in 22% of ADE patients; mortality was 39%.

These guidelines describe essential elements of the medication-use evaluation (MUE) process for healthcare organizations. These elements include the goals and objectives of a MUE, performance improvement methods, a description of indicators suggesting the need for an MUE, how to prioritize and select medications and processes for evaluation, typical steps in the process, the roles and responsibilities of the interdisciplinary team, common problems and pitfalls, and useful resources. MUE is a systematic and interdisciplinary performance improvement method with an overarching goal of optimizing patient outcomes via ongoing evaluation and improvement of medication utilization.1 Various terms have been employed to describe programs intended to achieve this goal; in addition to MUE, drug use evaluation (DUE) and drug utilization review (DUR) have also been used.1-3 Although these terms are sometimes used interchangeably, MUE may be differentiated in that it emphasizes improving patient outcomes and quality of...

Background. Skin and soft tissue infections (SSTIs) are a key antimicrobial stewardship target because they are a common infection in hospitalized patients, and non-guideline-concordant antibiotic use is frequent. To inform antimicrobial stewardship interventions, we evaluated the proportion of veterans hospitalized with SSTIs who received guideline-concordant empiric antibiotics or an appropriate total duration of antibiotics. Methods. A retrospective medication use evaluation was performed in 34 Veterans Affairs Medical Centers between 2016 and 2017. Hospitalized patients who received antibiotics for uncomplicated SSTI were included. Exclusion criteria were complicated SSTI, severe immunosuppression, and antibiotics for any non-SSTI indication. Data were collected by manual chart review. The primary outcome was the proportion of patients receiving both guideline-concordant empiric antibiotics and appropriate treatment duration, defined as 5-10 days of antibiotics. Data were analyzed and reported using descriptive statistics. Results. Of the 3890 patients manually evaluated for inclusion, 1828 patients met inclusion criteria. There were 1299 nonpurulent (71%) and 529 purulent SSTIs (29%). Overall, 250 patients (14%) received guideline-concordant empiric therapy and an appropriate duration. The most common reason for non-guideline-concordance was receipt of antibiotics targeting methicillin-resistant Staphylococcus aureus (MRSA) in 906 patients (70%) with a nonpurulent SSTI. Additionally, 819 patients (45%) received broad-spectrum Gram-negative coverage, and 860 patients (48%) received an antibiotic duration >10 days. Conclusions. We identified 3 common opportunities to improve antibiotic use for patients hospitalized with uncomplicated SSTIs: use of anti-MRSA antibiotics in patients with nonpurulent SSTIs, use of broad-spectrum Gram-negative antibiotics, and prolonged durations of therapy.

Background: Inappropriate use of MRSA-spectrum antibiotics is an important antimicrobial stewardship target. Contributors to inappropriate use include empiric treatment of patients who are determined to not be infected or who are infected but lack MRSA risk factors, and by excessive treatment duration when suspected MRSA infection is disproven. To characterize opportunities for improvement, we conducted a medical use evaluation (MUE) in 27 VA medical centers. The primary objectives were to assess the following proportions: (1) courses of unjustified empiric vancomycin therapy (patients in whom all antibacterials were halted within 2 days or without a principal or secondary discharge infection diagnosis); (2) courses of unjustified continuation of anti-MRSA therapy beyond day 4 (no MRSA risk factors or proven MRSA infection); and (3) excess anti-MRSA days of therapy (DOT), that is, DOT in unjustified empiric courses plus DOT after day 4 in unjustified continued courses. Methods: Clinical pharmacists performed retrospective, structured, manual record reviews of patients started on intravenous vancomycin on day 1 or 2 of hospitalization from June 2017 to May 2018. Exclusion criteria included surgical prophylaxis, recent MRSA infection, β-lactam allergy, renal insufficiency, severe immunosuppression, or infection that warranted anti-MRSA therapy other than vancomycin. Results: Of 2,493 evaluated patients, 1,320 met the inclusion criteria. Among them, 44% of courses were initiated in the emergency department, 37% of patients had ≥1 risk factor for healthcare-associated infections, and 50% of patients had ≥2 SIRS criteria or required vasopressor support. The most common admission diagnoses were skin and soft-tissue infection (SSTI, 40%; 68% nonpurulent) and pneumonia (27%; 46% without healthcare risk factors). Clinical cultures recovered MRSA from 8% of patients. Empiric therapy was not justified in 342 patients (26%; 57% were clinically stable). Continued therapy was unjustified in 46% of the 320 patients who received >4 days of anti-MRSA therapy. Of all days of anti-MRSA therapy, 23% were unjustified; 65% of these were due to unjustified empiric therapy. Site-specific variations in unjustified empiric therapy better correlated with the proportion of unjustified DOT than did unjustified continuation of therapy (Pearson correlation coefficients [PCC], 0.75 and 0.54, respectively) (Fig. 1). Facility-specific proportions of unjustified DOT modestly correlated with anti-MRSA DOT (PCC, 0.45; n = 27) (Fig. 2) but not the anti-MRSA standardized antimicrobial administration ratio (PCC, 0.15; n = 21). Conclusions: In this multicenter MUE, 26% of all days of anti-MRSA therapy lacked justification; this rate correlated with total facility-specific anti-MRSA DOT. Unnecessary empiric therapy, largely in the ED and for nonpurulent SSTIs and pneumonia without risk factors, was the principal contributor to unjustified DOT.Funding: NoneDisclosures: None

BACKGROUND Antibiotics are overprescribed for acute respiratory tract infections (ARIs). Guidelines provide criteria to determine which patients should receive antibiotics. We assessed congruence between documentation of ARI diagnostic and treatment practices with guideline recommendations, treatment appropriateness, and outcomes. METHODS A multicenter quality improvement evaluation was conducted in 28 Veterans Affairs facilities. We included visits for pharyngitis, rhinosinusitis, bronchitis, and upper respiratory tract infections (URI-NOS) that occurred during the 2015-2016 winter season. A manual record review identified complicated cases, which were excluded. Data were extracted for visits meeting criteria, followed by analysis of practice patterns, guideline congruence, and outcomes. RESULTS Of 5,740 visits, 4,305 met our inclusion criteria: pharyngitis (n = 558), rhinosinusitis (n = 715), bronchitis (n = 1,155), URI-NOS (n = 1,475), or mixed diagnoses (>1 ARI diagnosis) (n = 402). Antibiotics were prescribed in 68% of visits: pharyngitis (69%), rhinosinusitis (89%), bronchitis (86%), URI-NOS (37%), and mixed diagnosis (86%). Streptococcal diagnostic testing was performed in 33% of pharyngitis visits; group A Streptococcus was identified in 3% of visits. Streptococcal tests were ordered less frequently for patients who received antibiotics (28%) than those who did not receive antibiotics 44%; P < .01). Although 68% of visits for rhinosinusitis had documentation of symptoms, only 32% met diagnostic criteria for antibiotics. Overall, 39% of patients with uncomplicated ARIs received appropriate antibiotic management. The proportion of 30-day return visits for ARI care was similar for appropriate (11%) or inappropriate (10%) antibiotic management (P = .22). CONCLUSIONS Antibiotics were prescribed in most uncomplicated ARI visits, indicating substantial overuse. Practice was frequently discordant with guideline diagnostic and treatment recommendations.

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Purpose. Results 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. Methods. Veterans 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. Results. Among 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%). Conclusion. Through 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.

Objectives: Pain is the most prevalent problem among veterans, who receive pain diagnoses 5 times more frequently than the general population. Opioids are commonly prescribed for pain, but they have potential for misuse and serious adverse events. The study objective was to evaluate opioid dispensing patterns and predictors for overlap in veterans who are eligible for Medicare Part D benefits.Methods: A sample of male and all female veterans aged 66 years and older without cancer in 2005-2009 was included. Overlapping days' supply of opioids were evaluated within the U.S. Department of Veterans Affairs (VA), within Part D, and in cross-system users of VA and Part D reimbursed pharmacies during 2007-2009. Dispensing patterns were analyzed with t tests and chi-square tests. Predictors of overlap were identified with general estimating equations.Results: At least 1 opioid was dispensed to 88.5% of the sample. In 2006 after Part D implementation, 55.2% of opioids were dispensed by VA, decreasing to 44.3% in 2009 (P <0.0001). Opioids dispensed from Part D reimbursed pharmacies had a higher frequency of overlap compared to those filled at a VA facility (P <0.0001). While overlapping days' supply for opioids filled at VA decreased, overlap increased for prescriptions filled at Part D reimbursed pharmacies (P <0.0001). There was minimal overlap in opioids between systems, but cross system use increased over the study period. Predictors for overlap include females, Part D enrollment, no VA medication copay, sleep disorders, psychiatric diagnoses, and substance or alcohol abuse (all P <0.01). Veterans who were Hispanic, older, and had higher incomes had lower overlap odds (all P <0.0001).Conclusions: Opioids dispensed from Part D reimbursed pharmacies had a higher frequency of overlapping days' supply as compared to those filled by the VA, but there was minimal overlap between systems. While overlapping opioid prescriptions filled by the VA decreased from 2007 to 2009, overlap increased for prescriptions filled at Part D reimbursed pharmacies. Tools, such as drug monitoring programs, should be used by VA and non-VA providers to decrease opioid-related harms and misuse. Published by Elsevier Inc. on behalf of the American Pharmacists Association.