Publications

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.

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.

BACKGROUND: Chronic liver disease (CLD) is among the strongest risk factors for adverse prescription opioid-related events. Yet, the current prevalence and factors associated with high-risk opioid prescribing in patients with chronic liver disease (CLD) remain unclear, making it challenging to address opioid safety in this population. Therefore, we aimed to characterize opioid prescribing patterns among patients with CLD.

METHODS: This retrospective cohort study included patients with CLD identified at a single medical center and followed for one year from 10/1/2015-9/30/2016. Multivariable, multinomial regression was used identify the patient characteristics, including demographics, medical conditions, and liver-related factors, that were associated with opioid prescriptions and high-risk prescriptions (≥90mg morphine equivalents per day [MME/day] or co-prescribed with benzodiazepines).

RESULTS: Nearly half (47%) of 12,425 patients with CLD were prescribed opioids over a one-year period, with 17% of these receiving high-risk prescriptions. The baseline factors significantly associated with high-risk opioid prescriptions included female gender (adjusted incident rate ratio, AIRR = 1.32, 95% CI = 1.14-1.53), Medicaid insurance (AIRR = 1.68, 95% CI = 1.36-2.06), cirrhosis (AIRR = 1.22, 95% CI = 1.04-1.43) and baseline chronic pain (AIRR = 3.40, 95% CI = 2.94-4.01), depression (AIRR = 1.93, 95% CI = 1.60-2.32), anxiety (AIRR = 1.84, 95% CI = 1.53-2.22), substance use disorder (AIRR = 2.16, 95% CI = 1.67-2.79), and Charlson comorbidity score (AIRR = 1.27, 95% CI = 1.22-1.32). Non-alcoholic fatty liver disease was associated with decreased high-risk opioid prescriptions (AIRR = 0.56, 95% CI = 0.47-0.66).

CONCLUSION: Opioid medications continue to be prescribed to nearly half of patients with CLD, despite efforts to curtail opioid prescribing due to known adverse events in this population.

BACKGROUND: Survivors of opioid overdose have substantially increased mortality risk, although this risk is not evenly distributed across individuals. No study has focused on predicting an individual's risk of death after a nonfatal opioid overdose.

OBJECTIVE: To predict risk of death after a nonfatal opioid overdose.

DESIGN AND PARTICIPANTS: This retrospective cohort study included 9686 Pennsylvania Medicaid beneficiaries with an emergency department or inpatient claim for nonfatal opioid overdose in 2014-2016. The index date was the first overdose claim during this period.

EXPOSURES, MAIN OUTCOME, AND MEASURES: Predictor candidates were measured in the 180 days before the index overdose. Primary outcome was 180-day all-cause mortality. Using a gradient boosting machine model, we classified beneficiaries into six subgroups according to their risk of mortality (< 25th percentile of the risk score, 25th to < 50th, 50th to < 75th, 75th to < 90th, 90th to < 98th, ≥ 98th). We then measured receipt of medication for opioid use disorder (OUD), risk mitigation interventions (e.g., prescriptions for naloxone), and prescription opioids filled in the 180 days after the index overdose, by risk subgroup.

KEY RESULTS: Of eligible beneficiaries, 347 (3.6%) died within 180 days after the index overdose. The C-statistic of the mortality prediction model was 0.71. In the highest risk subgroup, the observed 180-day mortality rate was 20.3%, while in the lowest risk subgroup, it was 1.5%. Medication for OUD and risk mitigation interventions after overdose were more commonly seen in lower risk groups, while opioid prescriptions were more likely to be used in higher risk groups (both p trends < .001).

CONCLUSIONS: A risk prediction model performed well for classifying mortality risk after a nonfatal opioid overdose. This prediction score can identify high-risk subgroups to target interventions to improve outcomes among overdose survivors.