Correcting Inappropriate Prescribing of Direct Oral Anticoagulants: A Population Health Approach

Direct oral anticoagulant (DOAC) use has expanded rapidly in the past decade for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. However, they are frequently prescribed off label with associated increased risk of hospitalization, bleeding, stroke, and death.1–3 Given the frequency of off-label use and overall growth in DOAC prescribing, methods to improve appropriateness of DOAC prescribing are needed. Patients newly starting DOAC medications at 1 of 3 academic health systems participating in the Blue Cross Blue Shield of Michigan-sponsored MAQI2 (Michigan Anticoagulation Quality Improvement Initiative) collaborative were randomly enrolled between November 1, 2017 and September 30, 2019. Off-label DOAC use was defined according to Food and Drug Administration prescribing information. Trained and audited data abstractors identified off-label DOAC prescribing using predefined data collection tools and a programmed alert. If these alerts occurred for actively prescribed medication-dose combinations, they were escalated to a MAQI2 site lead (physician or pharmacist) for review. The study site lead was not contacted if the off-label DOAC error was no longer an active issue at the time of chart abstraction. Following MAQI2 site lead verification, the DOAC prescribing clinician was contacted by the site lead. The result of prescribing clinician contact was obtained to determine any therapeutic change. A waiver of informed consent was approved by the institutional review board at each participating site. Statistical analysis was performed using SAS software (version 9.4, Cary, NC) using t tests and Pearson’s chisquare tests as appropriate. P<0.05 were considered significant. The data that support the findings of this study are available from the corresponding author on reasonable request. Of the 2947 patients enrolled, mean age was 67.3 years and 48.2% were male. Atrial fibrillation was the most common DOAC prescribing indication (1554, 52.7%). The majority of the study population was prescribed apixaban (1848, 62.8%) or rivaroxaban (1077, 36.6%) The majority of patients were prescribed a DOAC by primary care (927, 31.5%) or cardiology (855, 29.0%) and most frequently as an inpatient (1762, 59.8%). Off-label dosing occurred 308 times in 278/2947 (9.4%) patients (Table). Off-label DOAC dosing was more common among older patients, female patients, patients weighing less than 60 kg, and those with chronic kidney disease. Off-label prescribing was more common among patients using DOAC therapy for atrial fibrillation than venous thromboembolism. There was no significant difference in off-label DOAC prescribing by location (inpatient, outpatient, or emergency department). However, there was a difference in off-label usage among study sites.