Publications

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.

BACKGROUND: The availability of Medicare Part D pharmacy coverage may increase veterans' options for obtaining medications outside of the Department of Veterans Affairs (VA) pharmacies. However, availability of Part D coverage raises the potential that veterans may be receiving similar medications from VA and non-VA pharmacies. The VA's personal health record portal, My HealtheVet, allows veterans to self-enter the non-VA medications that they obtained from community-based pharmacies, including those reimbursed by Medicare Part D. The Blue Button medication view feature of My HealtheVet allows veterans to view and download their VA and self-entered non-VA medication history. OBJECTIVE: To examine whether the use by veterans of the Blue Button feature of My HealtheVet was associated with less acquisition of similar medications from VA and community-based pharmacies reimbursed by Medicare Part D. METHODS: This study included a national sample of veterans who were new My HealtheVet users during fiscal year 2013 (October 1, 2012-September 30, 2013) and who used the Blue Button medication view feature of My HealtheVet at least once (users). We compared these veterans with a random sample of veterans who were not registered to use My HealtheVet (nonusers). From these groups, we identified veterans who were enrolled in Part D. We used multiple logistic regression analysis to assess the association of Blue Button medication view use with obtaining medications from the same drug classes (with overlap of 7 or more days) from VA and Part D-reimbursed pharmacies. RESULTS: There were 7,973 My HealtheVet medication view users and 65,985 nonusers. During a 12-month period, medication view users received more 30-day supplies of medications (one 90-day supply equals three 30-day supplies) than nonusers, on average (152.1 vs 71.3, P < 0.001). A larger percentage of users than nonusers obtained medications from VA and Part D-reimbursed pharmacies with overlapping days supply from the same drug classes (30% vs 23%, P < 0.001). However, for veterans who obtained greater numbers of 30-day supplies (82 or more), a significantly smaller percentage of users than nonusers obtained overlapping medications from VA and Part D-reimbursed pharmacies. Moreover, controlling for the total number of 30-day supplies that veterans received, the odds of obtaining medications from VA and Part D-reimbursed pharmacies with days supply that overlapped by at least 7 days for the same drug classes was 18% lower for users than nonusers (P=0.002). CONCLUSIONS: Veterans who used the Blue Button medication view feature of My HealtheVet obtained a larger number of 30-day supplies of medications from VA pharmacies than nonusers. For veterans who obtained a larger number of 30-day supplies of medications, use of the Blue Button medication view feature of My HealtheVet was associated with less overlap in days supply of medication from the same drug class from VA and Part D-reimbursed pharmacies. DISCLOSURES: This study was funded by the Department of Veterans Affairs, Office of Research and Development, Health Services Research and Development Service project IIR 14-041-2. The sponsor provided funding but was not involved in the development of the manuscript. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the Health Services Research and Development Service. All authors are employed in some capacity with the Department of Veterans Affairs and have no conflicts of interest to disclose.

BACKGROUND: Medicare Part B pharmaceutical spending has increased rapidly, more than doubling in 2006-2017. Yet, it is unclear whether this increase was driven by increased utilization or increased cost per claim. OBJECTIVE: To evaluate the relative impact of changes in drug utilization and cost per claim on changes in Medicare Part B pharmaceutical spending in 2008-2016 overall, by drug type (specialty and nonspecialty) and therapeutic category. METHODS: In this retrospective descriptive study, we extracted all claims in 2008-2016 for separately payable Part B drugs from a 5% random sample of Medicare beneficiaries. Our study included 3 outcomes calculated annually for all included drugs: (1) spending, defined as the sum of total payments; (2) utilization, defined as total number of claims; and (3) cost per claim, defined as spending divided by the number of claims. Estimates of spending and utilization were expressed per beneficiary-year. Spending and cost per claim were adjusted for inflation. For each outcome, we calculated relative changes in 2008-2016. We repeated analyses stratifying by drug type (specialty and nonspecialty) and therapeutic class. RESULTS: Pharmaceutical spending in Medicare Part B increased by 34% from 2008-2016, driven by a 53% increase in the cost per claim. Utilization decreased by 12%. Spending on specialty drugs increased by 56%, driven by a 48% increase in the cost per claim and a 6% utilization increase. Spending on nonspecialty drugs decreased by 32% driven by an 18% reduction in the cost per claim and a 17% reduction in utilization. Spending on ophthalmic preparations increased by 281%, driven by a 238% utilization increase and a 13% increase in the cost per claim. Spending on antiarthritic and immunologic agents increased by 159%, driven by a 117% increase in the cost per claim and a 19% utilization increase. CONCLUSIONS: Medicare Part B pharmaceutical spending grew in recent years, despite decreased utilization, driven by an overall increase in the cost per claim. This was a product of rising drug prices and increased utilization of more expensive specialty drugs. These findings support the development of policies that aim to spur competition and control price growth of provider-administered drugs. DISCLOSURES: The authors acknowledge funding from the Myers Family Foundation. Hernandez was funded by the National Heart, Lung and Blood Institute (grant number K01HL142847). Shrank is an employee of Humana. Good is an employee of the UPMC Health Plan Insurance Services Division. There are no other potential conflicts of interest to disclose.