BACKGROUND:Veterans enrolled in both Veterans Affairs (VA) health care and Medicare Part D can choose to obtain medications through the VA, Medicare Part D, or both, with each option differing in cost, coverage, and coordination of care. Poorly informed choices can lead to veteran frustration when their expectations are not met, delays in medication access, and increased risks. This study aimed to develop a decision aid (DA) to help veterans with diabetes make informed choices about medication sourcing (ie, whether to fill medications through VA health care only, Part D only, or both). METHODS:DA development was guided by the International Patient DA Standards and the Ottawa Decision Support Framework. Interviews with veterans and care partners informed the prototype design. Alpha testing with 18 end users (mostly veterans) and 12 stakeholders (pharmacists, doctors, payers, Medicare counselors, and others) assessed comprehensibility, usability, and acceptability. During beta testing, the feasibility of the revised DA was assessed during interviews with 20 end users and 8 stakeholders. For end-user interviews, a survey assessing decisional conflict, satisfaction, and knowledge was provided before and after respondents filled out the DA. RESULTS:Alpha testing feedback led to simplifying the cost and formulary comparison chart and expanding the medication list template to include more medications, fill location, and prescriber contact information. Based on beta testing responses (n = 16), the mean system usability scale score for the DA was 77.5 (SD = 14.4), suggesting usability. Beta testers also reported the DA to be acceptable in length (94%), balance (88%), and amount of information (81%). Based on pre- vs post-DA survey responses, decisional conflict was reduced, as indicated by an increase in the mean Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) score (pre-DA: 3.1, SD = 1.4 to all 16 respondents reporting a maximum SURE score of 4.0). Knowledge about VA and Medicare coverage of diabetes medications also improved: the proportion who answered all 5 comprehension questions correctly increased from 57% to 81%. Last, the proportion of respondents who reported being "very satisfied" with how they were currently filling their diabetes medicines (VA only, Part D only, or both) improved from 64% pre-DA to 81% post-DA. CONCLUSIONS:The DA developed iteratively was usable and acceptable and showed potential in reducing decisional conflict, increasing knowledge, and increasing satisfaction, so it may help Part D-enrolled veterans with decisions about medication sourcing.

OBJECTIVES:Early data suggested higher sedative requirements for ventilated COVID+ patients, deviating from established guidelines. We assessed the relationship between sedative use and outcomes in mechanically ventilated Veterans during the COVID-19 pandemic. DESIGN:Retrospective Medication Use Evaluation. SETTING:National Sample of 13 Distinct VA Medical Center Intensive Care Units. PATIENTS:Critically ill Veteran patients requiring mechanically ventilation for ≥2 days. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:The proportion of patients receiving fentanyl, midazolam and propofol was higher during COVID years. Compared with pre-COVID, median fentanyl dose was higher during Years 1 and 2 (1575mcg [(IQR) 1000-1650] vs. 1900 [1250-3000] vs. 1910 [1150-3500]). Adjuvant antipsychotics use was relatively low but tended to increase over time (pre = 10.5% vs. Year 1 = 12.3% vs. Year 2 = 14.1%). Most patients started on antipsychotics in the ICU were continued on the drug after extubation. Mortality was higher during COVID years (pre = 26.9% vs. 1 = 36.8% and 2 = 35.9%). In stratified analyses by COVID status years 1-2 (n = 79, 27%), a higher proportion of COVID+ patients received fentanyl (96% vs. 84%) and propofol (90% vs. 77%) and at higher doses (fentanyl = 1650mcg vs. 2688mcg median cumulative dose; propofol maximum infusion rate = 30 mc/kg/min (20-50) vs. 40 (25-50)). Sedative doses were similar to pre-COVID among non-COVID patients. Anti-psychotics were more frequently continued post extubation among COVID+ (34.6% vs. non-COVID+=14.9%). COVID+ patients were also less likely to have awakening and breathing trials at 48 hours after intubation (18% vs. 46%). CONCLUSIONS:Sedative use and dosing increased during the first two years of COVID compared to pre-COVID, especially for COVID+ patients. The sustained elevated levels of fentanyl use in Year 2 suggests possible 'therapeutic creep' away from guideline-concordant practices for COVID+ patients. Antipsychotic prescription during intubation and following extubation was also more common among COVID + . These findings could inform development and implementation of safer sedation practices across VA ICUs during respiratory pandemics.

Background New respiratory syncytial virus (RSV) vaccines have been approved in the USA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years and older. Information on the real-world effectiveness of these vaccines is needed. Methods We used electronic health records in the Veterans Health Administration to emulate a target trial comparing a single dose of a recombinant stabilised prefusion F protein RSV vaccine versus no vaccination among veterans aged 60 years and older. We matched eligible vaccine recipients with up to four unvaccinated individuals in four monthly nested sequential trials from Sept 1 to Dec 31, 2023. Outcomes were ascertained up to March 31, 2024. The primary outcome was any positive RSV test from day 14 following the matched index date. Secondary outcomes included hospitalisation and emergency department or urgent care encounter occurring within 1 day before or after a positive RSV test. We estimated vaccine effectiveness as 100 x (1-risk ratio). Findings We included 146 852 vaccinated individuals matched to 582 936 unique control individuals, weighted equally to represent 146 852 individuals. Across the two groups, 276 039 (940%) of 293 704 veterans were male, 17 665 (60%) were female, and median age was 759 years (IQR 717-797). Over a median follow-up of 124 days (IQR 102-150), the incidence rate of documented RSV infection was 17 (95% CI 14-21) events per 1000 person-years (88 total events) in the vaccinated group and 73 (66-81) per 1000 person-years in the unvaccinated group (372 total events), and vaccine effectiveness was estimated as 781% (726-835). Among the secondary outcomes, vaccine effectiveness was estimated at 787% (722-848) against RSV-associated emergency department or urgent care encounters, and 803% (658-901) against RSV-associated hospitalisation. Interpretation RSV vaccination was effective in preventing RSV-related illness, including associated health-care use, in adults aged 60 years and older during the 2023-24 respiratory illness season, supporting current recommendations for vaccination in this population.

In February 2017, the Department of Veterans Affairs (VA) restructured outpatient medication copayments, creating three medication tiers comparable with private-sector value-based insurance designs (with copayments: US$5, US$8, US$11 per 30-day supply for Tiers 1-3, respectively); however, Veteran medication management experiences have not been assessed following this change. We invited a random sample of Veterans with chronic conditions (e.g., diabetes, hypertension) who utilized VA services to complete a mailed survey about VA and non-VA pharmacy use and medication management experiences following this restructuring. There were 2,884 respondents (29% response rate). Veterans with the lowest proportion of medications from Tier 1 after the restructuring had the highest predicted probability of non-VA pharmacy use from regression analyses. Among respondents subject to VA copayments, 27% reported being better able to afford medications after the restructuring. However, 29% reported worrying about paying for medications, and 18% reported making tradeoffs (e.g., spending less on utilities, food) to pay for prescriptions.

BACKGROUND:The Department of Veterans Affairs (VA) now offers eligible Veterans an urgent care benefit covering visits and 14-day prescriptions outside of VA. Prescriptions written and dispensed outside VA lack the clinical decision support of VA-issued prescriptions, raising concerns about safety and polypharmacy. To date, there has been limited analyses of prescribing patterns through the urgent care benefit. METHODS:We used a repeated cross-sectional design to examine Veterans who filled non-VA urgent care prescriptions from 07/30/2019 to 03/20/2023. Data were sourced from the Community Care Reimbursement System (CCRS), which tracks all VA-paid medications dispensed by non-VA pharmacies. We identified potentially noncompliant prescriptions as those not meeting VA urgent care benefit restrictions. We also identified prescriptions continued in VA as a "new VA medication" after 30-days from the urgent care fill. RESULTS:Overall, 83,862 Veterans received 271,476 non-VA urgent care prescriptions. Veterans' average age was 55.9, with 79.3 % male, 73.0 % White, 86.7 % non-Hispanic, and 41.4 % rural dwelling. Urgent care use increased from 341 prescription fills in March 2020 to 9738 in January 2023. Frequently filled prescriptions included antimicrobials (n = 114,492, 42.2 %) and hormones/synthetics/modifiers, like steroids (n = 44,457, 16.4 %). Potentially noncompliant prescriptions accounted for 9.3 %, with 6.7 % not on the urgent/emergent formulary and 2.6 % supplied for over 14 days. Over 70,704 (26.0 %) prescriptions were continued in VA post-urgent care visit, of which 15 % had no prior VA fill (i.e., new VA medication). Veterans with new continued VA prescriptions were more likely to be male (79.4 % vs. 73.9 %) and from urban areas (59.3 % vs. 57.5 %) (All P < .001). CONCLUSIONS:Veterans increasingly received non-VA prescriptions through urgent care centers in the community from 2019 to 2023, including drug classes of interest to VA due to potential risks of inappropriate prescribing (e.g., steroids) or drug interactions (e.g., antibiotics). The CCRS database can be integrated with other VA databases as a quality improvement tool to improve care coordination and drug safety. IMPLICATIONS:This evaluation highlights the need for improved clinical decision support for non-VA prescriptions and demonstrates the potential of integrated data systems to monitor and enhance medication safety and coordination within VA. LEVEL OF EVIDENCE:Cross-sectional analysis of national VA data.

During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.

The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. This report describes the U.S. government’s COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program.

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.

Background Nirmatrelvir-ritonavir is recommended for persons at risk for severe coronavirus disease 2019 (COVID-19) but remains underutilized. Information on which eligible groups are likely to benefit from treatment is needed.Methods We conducted a target trial emulation study in the Veterans Health Administration comparing nirmatrelvir-ritonavir treated versus matched untreated veterans at risk for severe COVID-19 who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from April 2022 through March 2023. We measured incidence of any hospitalization or all-cause mortality at 30 days. Outcomes were measured for the entire cohort, as well as among subgroups defined by 30-day risk of death or hospitalization, estimated using an ensemble risk prediction model.Results Participants were 87% male with median age 66 years and 16% unvaccinated. Compared with matched untreated participants, those treated with nirmatrelvir-ritonavir (n = 24 205) had a lower 30-day risk for hospitalization (1.80% vs 2.30%; risk difference [RD], -0.50% points [95% confidence interval {CI}: -.69 to -.35]) and death (0.11% vs 0.30%; RD, -0.20 [95% CI: -.24 to -.13]). The greatest reductions in combined hospitalization or death were observed in the highest risk quartile (RD -2.85 [95% CI: -3.94 to -1.76]), immunocompromised persons (RD -1.91 [95% CI: -3.09 to -.74]), and persons aged >= 75 years (RD -1.16 [95% CI: -1.73 to -.59]). No reductions were observed in the 2 lowest risk quartiles or persons younger than 65 years.Conclusions Nirmatrelvir-ritonavir was effective in reducing 30-day hospitalization and death in older veterans, those at highest predicted risk for severe outcomes, and immunocompromised groups. Benefit was not observed in younger veterans or groups at lower predicted risk for hospitalization and death. Nirmatrelvir-ritonavir was associated with reductions in 30-day hospitalizations and deaths in older veterans, those at highest predicted risk for severe outcomes, and immunocompromised groups. Benefit was not observed in younger veterans or groups at lower predicted risk for hospitalization and death.

Background Vaccine hesitancy persists alongside concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines. We aimed to examine the effect of COVID-19 vaccination on risk of death among US veterans.Methods We conducted a target trial emulation to estimate and compare risk of death up to 60 days under two COVID-19 vaccination strategies: vaccination within 7 days of enrollment versus no vaccination through follow-up. The study cohort included individuals aged >= 18 years enrolled in the Veterans Health Administration system and eligible to receive a COVID-19 vaccination according to guideline recommendations from 1 March 2021 through 1 July 2021. The outcomes of interest included deaths from any cause and excluding a COVID-19 diagnosis. Observations were cloned to both treatment strategies, censored, and weighted to estimate per-protocol effects.Results We included 3 158 507 veterans. Under the vaccination strategy, 364 993 received vaccine within 7 days. At 60 days, there were 156 deaths per 100 000 veterans under the vaccination strategy versus 185 deaths under the no vaccination strategy, corresponding to an absolute risk difference of -25.9 (95% confidence limit [CL], -59.5 to 2.7) and relative risk of 0.86 (95% CL, .7 to 1.0). When those with a COVID-19 infection in the first 60 days were censored, the absolute risk difference was -20.6 (95% CL, -53.4 to 16.0) with a relative risk of 0.88 (95% CL, .7 to 1.1).Conclusions Vaccination against COVID-19 was associated with a lower but not statistically significantly different risk of death in the first 60 days. These results agree with prior scientific knowledge suggesting vaccination is safe with the potential for substantial health benefits. We conducted a target trial emulation to assess vaccine safety and risk of mortality in the 60 days after the first dose of coronavirus disease 2019 vaccination. All-cause risk of death in vaccinated versus no vaccination was similar up to day 60.

We described insulin glargine (originator) and insulin glargine-yfgn (biosimilar) treatment patterns, assessed effectiveness and safety outcomes, and identified reasons for switching back to the originator product from the biosimilar. This retrospective study included 328,463 Veterans 18 years of age and older who received one or more outpatient prescriptions for insulin glargine and/or insulin glargine-yfgn between 1 June 2021 and 31 December 2022. Patients were assigned to subgroups based on the initial prescription during the study period, prevalent versus incident use for originator insulin glargine, and prior versus no prior use of the originator before the biosimilar (i.e., prevalent originator non-switcher (n = 189,734), originator switch to biosimilar (n = 81,010), incident originator non-switcher (n = 49,401), and incident biosimilar (n = 8318)). There were no differences in the outcome of mean HbA1c (7.9% for all subgroups). There were also no differences in the unadjusted rates of hospitalization and/or emergency room visits for hyper- and hypoglycemia between the prevalent originator non-switcher and originator switched to biosimilar subgroups (p = 0.09 and 0.38, respectively) or the incident originator non-switcher and incident biosimilar subgroups (p = 0.054 and 0.61, respectively). Finally, none of the HbA1c or hyperglycemia outcomes adjusted for baseline characteristics were statistically different. Adjusted analyses for rates of hospitalization and/or emergency room visits for hypoglycemia could not be performed due to the low number of events. Overall, patients who received insulin glargine-yfgn had similar effectiveness and safety outcomes as patients who received the originator.

Purpose:The 2025 ASHP Pharmacy Forecast report is written to identify and contextualize emerging trends that will influence healthcare, health systems, and the pharmacy profession. It provides recommendations to inform strategic planning that should prompt action by pharmacists and health-system leaders. Methods:Drawing on the “wisdom of crowds” concept, a survey was constructed by an advisory committee with 6 themes, each with 7 focused statements and a seventh theme on preparedness (54 survey items in total). A survey panel of 321 pharmacy leaders was purposefully designed to capture opinions from a wide range of pharmacists across the United States. Panelists were asked to consider the likelihood of the statements occurring in the next 5 years as being likely, somewhat likely, somewhat unlikely, or very unlikely to occur. Forecast panelists also assessed health systems’ preparedness (from very unprepared to very prepared) for 12 of the statements. Results:The 6 survey themes identified were The Business of Healthcare: Challenges in Health-System Pharmacy, Managing Ultra-High-Cost Drugs, Addressing the Gap in Primary Care, Whole Person Health, Navigating Generative Artificial Intelligence: Opportunity and Risk, and Stabilizing the Pharmacy Workforce. The survey was completed by 269 respondents, yielding an 84% response rate. Descriptive statistics of the survey results were provided to chapter authors to inform commentary and strategic recommendations for each theme. Conclusion:The Pharmacy Forecast provides insights on large-scale, long-term trends that will influence healthcare and the pharmacy profession over the years ahead. Insight from the report can stimulate strategic thinking and provides a starting point to proactively position leaders, their teams, and departments for potential future trends.

Purpose:The 2024 ASHP Pharmacy Forecast identifies and contextualizes emerging issues and trends that will influence healthcare, health systems, and the pharmacy profession and provides recommendations to inform long-term strategic planning that should prompt action by pharmacists and health-system leaders.Methods:Drawing on the “wisdom of crowds” concept, a survey was constructed with 6 general themes, each with 6 to 9 focused statements and a seventh theme on preparedness (58 survey items in total). The size of and representation within the survey panel were intended to capture opinions from a wide range of pharmacy leaders. The survey instructed panelists to consider the likelihood of the events/scenarios described in the statements occurring in the next 5 years as being likely, somewhat likely, somewhat unlikely, or very unlikely. Then, survey panelists assessed the preparedness (from very unprepared to very prepared) for 12 of the statements.Results:The 6 survey themes identified were Urgent Public Health Priorities, Responding to the Mental Health Crisis, Achieving Care Equity, New Disease Paradigms and Treatment Innovations, Workforce: Focus on Culture for the Future, and Artificial Intelligence: Can Ethics and Regulators Catch Up? The survey was completed by 250 respondents, yielding an 88% response rate. Analysis of survey results was provided by chapter authors along with strategic recommendations to guide actions for each theme.Conclusion:The focus of the Pharmacy Forecast is on large-scale, long-term trends that will influence healthcare and the pharmacy profession over months and years and not on day-to-day situational dynamics. The report provides insight to stimulate thinking and discussion and provides a starting point to proactively position leaders, their teams, and departments for potential future events and trends.

BACKGROUND:Vaccine hesitancy persists alongside concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines. We aimed to examine the effect of COVID-19 vaccination on risk of death among US veterans.METHODS:We conducted a target trial emulation to estimate and compare risk of death up to 60 days under two COVID-19 vaccination strategies: vaccination within 7 days of enrollment versus no vaccination through follow-up. The study cohort included individuals aged ≥18 years enrolled in the Veterans Health Administration system and eligible to receive a COVID-19 vaccination according to guideline recommendations from 1 March 2021 through 1 July 2021. The outcomes of interest included deaths from any cause and excluding a COVID-19 diagnosis. Observations were cloned to both treatment strategies, censored, and weighted to estimate per-protocol effects.RESULTS:We included 3 158 507 veterans. Under the vaccination strategy, 364 993 received vaccine within 7 days. At 60 days, there were 156 deaths per 100 000 veterans under the vaccination strategy versus 185 deaths under the no vaccination strategy, corresponding to an absolute risk difference of -25.9 (95% confidence limit [CL], -59.5 to 2.7) and relative risk of 0.86 (95% CL, .7 to 1.0). When those with a COVID-19 infection in the first 60 days were censored, the absolute risk difference was -20.6 (95% CL, -53.4 to 16.0) with a relative risk of 0.88 (95% CL, .7 to 1.1).CONCLUSIONS:Vaccination against COVID-19 was associated with a lower but not statistically significantly different risk of death in the first 60 days. These results agree with prior scientific knowledge suggesting vaccination is safe with the potential for substantial health benefits.

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.

Pharmacogenetic (PGx) testing before initiation of thiopurine treatment and CBC monitoring post-initiation helps avoid adverse events and ensure patient safety. This study aims to evaluate trends in PGx testing and CBC monitoring among Veterans prescribed azathioprine, thioguanine, or mercaptopurine to demonstrate VA's efforts to improve medication safety after an adverse event. To assess testing patterns, we used VA electronic health report data to identify 20,524 Veterans who first began thiopurine treatment between January 1, 2010, to December 31, 2021. Aggregate monthly counts of thiopurine prescriptions and associated lab tests were tabulated, and the trend in the proportion of patients tested was analyzed using the Mann-Kendall test. The proportion of patients undergoing PGx testing rose from 30.0% in 2010 to 47.5% in late 2014 (July-December). However, PGx testing and overall testing only increased slightly after the sentinel event, and orders levelled off over time at slightly lower levels than before the sentinel event. Very little change was seen in the overall proportion of individuals receiving any testing across all patients with new prescriptions from the time of the sentinel event in 2014 to the end of 2021. A large portion of patients prescribed thiopurine drugs did not receive testing that could help prevent the development of potential adverse events, leading to a predominantly reactive approach. Increased PGx testing may result in a more proactive approach to the prevention of adverse events due to genetic interaction.

Background: COVID-19 has been linked to the development of many post-COVID-19 conditions (PCCs) after acute infection. Limited information is available on the effectiveness of oral antivirals used to treat acute COVID-19 in preventing the development of PCCs. Objective: To measure the effectiveness of outpatient treatment of COVID-19 with nirmatrelvir-ritonavir in preventing PCCs. Design: Retrospective target trial emulation study comparing matched cohorts receiving nirmatrelvir-ritonavir versus no treatment. Setting: Veterans Health Administration (VHA). Participants: Nonhospitalized veterans in VHA care who were at risk for severe COVID-19 and tested positive for SARS-CoV-2 during January through July 2022. Intervention: Nirmatrelvir-ritonavir treatment for acute COVID-19.Measurements: Cumulative incidence of 31 potential PCCs at 31 to 180 days after treatment or a matched index date, including cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, endocrine, and general conditions and symptoms. Results: Eighty-six percent of the participants were male, with a median age of 66 years, and 17.5% were unvaccinated. Baseline characteristics were well balanced between participants treated with nirmatrelvir-ritonavir and matched untreated comparators. No differences were observed between participants treated with nirmatrelvir-ritonavir (n = 9593) and their matched untreated comparators in the incidence of most PCCs examined individually or grouped by organ system, except for lower combined risk for venous thromboembolism and pulmonary embolism (subhazard ratio, 0.65 [95% CI, 0.44 to 0.97]; cumulative incidence difference, -0.29 percentage points [CI, -0.52 to -0.05 percentage points]). Limitations: Ascertainment of PCCs using International Classification of Diseases, 10th Revision codes may be inaccurate. Evaluation of many outcomes could have resulted in spurious associations with combined thromboembolic events by chance. Conclusion: Out of 31 potential PCCs, only combined thromboembolic events seemed to be reduced by nirmatrelvir-ritonavir. Primary Funding Source: U.S. Department of Veterans Affairs.

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.

Background: Retention of patients in buprenorphine medication treatment for opioid use disorder (B-MOUD) reduces harms associated with opioid use disorder (OUD). We sought to characterize the patients receiving BMOUD and courses of B-MOUD in a large healthcare system. Methods: We conducted a retrospective, open cohort study of patients with OUD who either did or did not receive B-MOUD courses within the Veterans Health Administration (VHA) from January 2006 through July 2019, using VHA clinical data. We compared patients receiving or not receiving B-MOUD, characterized B-MOUD courses (e. g., length and doses), and examined persistence, across patient characteristics, over time. We used analyses for normally or non-normally distributed continuous variables, categorical data, and persistence over time (KaplanResults: We identified 255,726 Veterans with OUD; 40,431 (15.8%) had received 63,929 B-MOUD courses. Compared to patients with OUD without B-MOUD, patients with B-MOUD were younger, more often of white race, and had more co-morbidities. The frequency of new B-MOUD starts and prevalent B-MOUD patients ranged half of patients experiencing multiple courses. Patient demographics seem to dictate the length of courses.