Publications

This is an epidemiological study of carbapenem-resistant Enterobacteriaceae (CRE) in Veterans' Affairs medical centers (VAMCs). In 2017, almost 75% of VAMCs had at least 1 CRE case. We observed substantial geographic variability, with more cases in urban, complex facilities. This supports the benefit of tailoring infection control strategies to facility characteristics.

BACKGROUND: Infections caused by carbapenem-resistant Enterobacteriaceae (CRE) and carbapenemase-producing (CP) CRE are difficult to treat, resulting in high mortality in healthcare settings every year. The Veterans Health Administration (VHA) disseminated guidelines in 2015 and an updated directive in 2017 for control of CRE focused on laboratory testing, prevention, and management. The Consolidated Framework for Implementation Research (CFIR) framework was used to analyze qualitative interview data to identify contextual factors and best practices influencing implementation of the 2015 guidelines/2017 directive in VA Medical Centers (VAMCs). The overall goals were to determine CFIR constructs to target to improve CRE guideline/directive implementation and understand how CFIR, as a multi-level conceptual model, can be used to inform guideline implementation.

METHODS: Semi-structured interviews were conducted at 29 VAMCs with staff involved in implementing CRE guidelines at their facility. Survey and VHA administrative data were used to identify geographically representative large and small VAMCs with varying levels of CRE incidence. Interviews addressed perceptions of guideline dissemination, laboratory testing, staff attitudes and training, patient education, and technology support. Participant responses were coded using a consensus-based mixed deductive-inductive approach guided by CFIR. A quantitative analysis comparing qualitative CFIR constructs and emergent codes to sites actively screening for CRE (vs. non-screening) and any (vs. no) CRE-positive cultures was conducted using Fisher's exact test.

RESULTS: Forty-three semi-structured interviews were conducted between October 2017 and August 2018 with laboratory staff (47%), Multi-Drug-Resistant Organism Program Coordinators (MPCs, 35%), infection preventionists (12%), and physicians (6%). Participants requested more standardized tools to promote effective communication (e.g., electronic screening). Participants also indicated that CRE-specific educational materials were needed for staff, patient, and family members. Quantitative analysis identified CRE screening or presence of CRE as being significantly associated with the following qualitative CFIR constructs: leadership engagement, relative priority, available resources, team communication, and access to knowledge and information.

CONCLUSIONS: Effective CRE identification, prevention, and treatment require ongoing collaboration between clinical, microbiology, infection prevention, antimicrobial stewardship, and infectious diseases specialists. Our results emphasize the importance of leadership's role in promoting positive facility culture, including access to resources, improving communication, and facilitating successful implementation of the CRE guidelines.

BACKGROUND: Proton pump inhibitors (PPIs) are among the most prescribed medications and are often used unnecessarily. PPIs are used for the treatment of heartburn and acid-related disorders. Emerging evidence indicates that PPIs are associated with serious adverse events, such as increased risk of Clostridioides difficile infection. In this study, we designed and piloted a PPI de-implementation intervention among hospitalized non-intensive care unit patients.

METHODS: Using the Systems Engineering Initiative for Patient Safety (SEIPS) model as the framework, we developed an intervention with input from providers and patients. On a bi-weekly basis, a trainee pharmacist reviewed a random sample of eligible patients' charts to assess if PPI prescriptions were guideline-concordant; a recommendation to de-implement non-guideline-concordant PPI therapy was sent when applicable. We used convergent parallel mixed-methods design to evaluate the feasibility and outcomes of the intervention.

RESULTS: During the study period (September 2019 to August 2020), 2171 patients with an active PPI prescription were admitted. We randomly selected 155 patient charts for review. The mean age of patients was 70.9 ± 9 years, 97.4% were male, and 35% were on PPIs for ≥5 years. The average time (minutes) needed to complete the intervention was as follows: 5 to assess if the PPI was guideline-concordant, 5 to provide patient education, and 7 to follow-up with patients post-discharge. After intervention initiation, the week-to-week mean number of PPI prescriptions decreased by 0.5 (S<0.0001). Barriers and facilitators spanned the 5 elements of the SEIPS model and included factors such as providers' perception that PPIs are low priority medications and patients' willingness to make changes to their PPI therapy if needed, respectively. Ready access to pharmacists was another frequently reported facilitator to guideline-concordant PPI. Providers recommended a PPI de-implementation intervention that is specific and tells them exactly what they need to do with a PPI treatment.

CONCLUSION: In a busy inpatient setting, we developed a feasible way to assess PPI therapy, de-implement non-guideline-concordant PPI use, and provide follow-up to assess any unintended consequences. We documented barriers, facilitators, and provider recommendations that should be considered before implementing such an intervention on a large scale.

BACKGROUND: Advanced practice providers in the outpatient setting play a key role in antibiotic stewardship, yet little is known about how to engage these providers in stewardship activities and what factors influence their antibiotic prescribing practices.

METHODS: We used mixed methods to obtain data on practices and perceptions related to antibiotic prescribing by nurse practitioners (NP) and Veteran patients. We interviewed NPs working in the outpatient setting at one Veterans Affairs facility and conducted focus groups with Veterans. Emerging themes were mapped to the Systems Engineering Initiative for Patient Safety framework. We examined NP antibiotic prescribing data from 2017 to 2019.

RESULTS: We interviewed NPs and conducted Veteran focus groups. Nurse practitioners reported satisfaction with resources, including ready access to pharmacists and infectious disease specialists. Building patient trust was reported as essential to prescribing confidence level. Veterans indicated the need to better understand differences between viral and bacterial infections. NP prescribing patterns revealed a decline in antibiotics prescribed for upper respiratory illnesses over a 3-year period.

CONCLUSION: Outpatient NPs focus on educating the patient while balancing organizational access challenges. Further research is needed to determine how to include both NPs and patients when implementing outpatient antibiotic stewardship strategies. Further research is also needed to understand factors associated with the decline in nurse practitioner antibiotic prescribing observed in this study.

INTRODUCTION: The optimal method for implementing hospital-level restrictions for antibiotics that carry a high risk of Clostridioides difficile infection has not been identified. We aimed to explore barriers and facilitators to implementing restrictions for fluoroquinolones and third/fourth-generation cephalosporins.

METHODS: This mixed-methods study across a purposeful sample of 15 acute-care, geographically dispersed Veterans Health Administration hospitals included electronic surveys and semi-structured interviews (September 2018 to May 2019). Surveys on stewardship strategies were administered at each hospital and summarized with descriptive statistics. Interviews were performed with 30 antibiotic stewardship programme (ASP) champions across all 15 sites and 19 additional stakeholders at a subset of 5 sites; transcripts were analysed using thematic content analysis.

RESULTS: The most restricted agent was moxifloxacin, which was restricted at 12 (80%) sites. None of the 15 hospitals restricted ceftriaxone. Interviews identified differing opinions on the feasibility of restricting third/fourth-generation cephalosporins and fluoroquinolones. Some participants felt that restrictions could be implemented in a way that was not burdensome to clinicians and did not interfere with timely antibiotic administration. Others expressed concerns about restricting these agents, particularly through prior approval, given their frequent use, the difficulty of enforcing restrictions and potential unintended consequences of steering clinicians towards non-restricted antibiotics. A variety of stewardship strategies were perceived to be effective at reducing the use of these agents.

CONCLUSIONS: Across 15 hospitals, there were differing opinions on the feasibility of implementing antibiotic restrictions for third/fourth-generation cephalosporins and fluoroquinolones. While the perceived barrier to implementing restrictions was frequently high, many hospitals were effectively using restrictions and reported few barriers to their use.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors.

METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion.

RESULTS: In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic.

CONCLUSION: For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

The 2019 novel coronavirus (COVID-19) pandemic has placed a significant strain on hepatitis programs and interventions (screening, diagnosis, and treatment) at a critical moment in the context of hepatitis C virus (HCV) elimination. We sought to quantify changes in Direct Acting Antiviral (DAA) utilization among different countries during the pandemic. We conducted a cross-sectional time series analysis between 1 September 2018 and 31 August 2020, using the IQVIA MIDAS database, which contains DAA purchase data for 54 countries. We examined the percent change in DAA units dispensed (e.g., pills and capsules) from March to August 2019 to the same period of time in 2020 across the 54 countries. Interrupted time-series analysis was used to examine the impact of COVID-19 on monthly rates of DAA utilization across each of the major developed economies (G7 nations). Overall, 46 of 54 (85%) jurisdictions experienced a decline in DAA utilization during the pandemic, with an average of -43% (range: -1% in Finland to -93% in Brazil). All high HCV prevalence (HCV prevalence > 2%) countries in the database experienced a decline in utilization, average -49% (range: -17% in Kazakhstan to -90% in Egypt). Across the G7 nations, we also observed a decreased trend in DAA utilization during the early months of the pandemic, with significant declines (p < 0.01) for Canada, Germany, the United Kingdom, and the United States of America. The global response to COVID-19 led to a large decrease in DAA utilization globally. Deliberate efforts to counteract the impact of COVID-19 on treatment delivery are needed to support the goal of HCV elimination.

BACKGROUND: Outpatient antibiotic prescriptions drive antibiotic overuse in humans, and the Centers for Disease Control and Prevention has identified community pharmacies as potential partners in outpatient stewardship efforts. Clinical decision support (CDS) tools can potentially be used at community pharmacies to aid in outpatient stewardship efforts.

OBJECTIVES: We sought to determine community pharmacist attitudes toward using a computerized CDS tool to evaluate and manage common complaints and thus promote appropriate antibiotic prescribing.

METHODS: We conducted in-depth semistructured interviews of community pharmacists to determine attitudes toward using CDS tools in their practice and identify potential barriers in implementation. Thematic analysis was used to identify common themes and subthemes in the pharmacist responses.

RESULTS: We interviewed 21 pharmacists and identified 5 themes and 14 subthemes in our interviews. The pharmacists reported that patients frequently presented with complaints of acute infections and that they (the pharmacists) were universally supportive of a CDS intervention that would allow them to assess such patients and, in turn, guide appropriate antibiotic prescribing. They noted that communication difficulties with prescribing physicians and lack of information sharing currently made it difficult to implement stewardship interventions, and they stated that they were interested in any intervention that could help overcome these barriers.

CONCLUSION: Community pharmacies represent an important point of contact for patients and are a potentially valuable setting for outpatient stewardship interventions. Pharmacists were overwhelmingly supportive of using CDS tools to evaluate patients and promote antimicrobial stewardship. These results suggest that it would be feasible to pilot such an intervention in the community pharmacy setting.

INTRODUCTION: Gastrointestinal (GI) symptoms and disorders affect an increasingly large group of veterans. Opioid use may be rising in this population, but this is concerning from a patient safety perspective, given the risk of dependence and lack of evidence supporting opioid use to manage chronic pain. We examined the characteristics of opioid prescriptions and factors associated with chronic opioid use among chronic GI patients dually enrolled in the DVA and Medicare Part D.

MATERIALS AND METHODS: In this retrospective cohort study, we used linked, national patient-level data (from April 1, 2011, to December 31, 2014) from the VA and Centers for Medicare & Medicaid Services to identify chronic GI patients and observe opioid use. Veterans who had a chronic GI symptom or disorder were dually enrolled in VA and Part D and received ≥1 opioid prescription dispensed through the VA, Part D, or both. Chronic GI symptoms and disorders included chronic abdominal pain, chronic pancreatitis, inflammatory bowel diseases, and functional GI disorders. Key outcome measures were outpatient opioid prescription dispensing overall and chronic opioid use, defined as ≥90 consecutive days of opioid receipt over 12 months. We described patient characteristics and opioid use measures using descriptive statistics. Using multiple logistic regression modeling, we generated adjusted odds ratios and 95% CIs to determine variables independently associated with chronic opioid use. The final model included variables outlined in the literature and our conceptual framework.

RESULTS: We identified 141,805 veterans who had a chronic GI symptom or disorder, were dually enrolled in VA and Part D, and received ≥1 opioid prescription dispensed from the VA, Part D, or both. Twenty-six percent received opioids from the VA only, 69% received opioids from Medicare Part D only, and 5% were "dual users," receiving opioids through both VA and Part D. Compared to veterans who received opioids from the VA or Part D only, dual users had a greater likelihood of potentially unsafe opioid use outcomes, including greater number of days on opioids, higher daily doses, and higher odds of chronic use.

CONCLUSIONS: Chronic GI patients in the VA may be frequent users of opioids and may have a unique set of risk factors for unsafe opioid use. Careful monitoring of opioid use among chronic GI patients may help to begin risk stratifying this group. and develop tailored approaches to minimize chronic use. The findings underscore potential nuances within the opioid epidemic and suggest that components of the VA's Opioid Safety Initiative may need to be adapted around veterans at a higher risk of opioid-related adverse events.