Timing of Off-Label Dosing of Direct Oral Anticoagulants in Three Large Health Systems

Author:

Herron Grace C.1,DeCamillo Deborah1,Kong Xiaowen1,Haymart Brian1,Kaatz Scott2,Ellsworth Stacy3,Ali Mona A.4,Giuliano Christopher,Froehlich James B.1,Barnes Geoffrey D.1ORCID

Affiliation:

1. Division of Cardiovascular Medicine, Department of Internal Medicine, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, Michigan, United States

2. Division of Hospital Medicine, Department of Medicine, Henry Ford Health, Detroit, Michigan, United States

3. Department of Internal Medicine, Henry Ford Health, Detroit, Michigan, United States

4. Department of Heart and Vascular Services, Corewell Health William Beaumont University Hospital, Royal Oak, Michigan, United States

Abstract

Background While direct oral anticoagulants (DOACs) may be viewed as simpler to manage then warfarin, they present their own unique management challenges resulting in frequent off-label dosing. It is unknown to what extent off-label dosing occurs when a patient is started on a DOAC versus later in their treatment. Objectives We aimed to better characterize when off-label DOAC dosing is occurring and to evaluate the effectiveness of prescribing oversight using a registry-based intervention. Methods We evaluated data from the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry, a retrospective quality-improvement process using data abstractors, from 2018 to 2022 on the number of “alerts” that are generated in response to dosing deviating from the U.S. Food and Drug Administration instructions for atrial fibrillation (AF) and venous thromboembolism (VTE). Results Among a sample of 789 to 1,022 annual AF patients and 381 to 484 annual VTE patients prescribed a DOAC in the MAQI2 registry, off-label dosing was relatively common. Over the 5-year period (2018–2022), there were 569 alerts for AF patients and 162 alerts for VTE patients. Alerts occurred more frequently during follow-up than at the time of initial prescribing in AF patients (78.2 vs. 21.8%), but more commonly at initial prescribing in VTE patients (59.9 vs. 40.1%). After initial review by quality-improvement abstractors, 19.3% of AF alerts and 14.8% of VTE alerts resulted in contact to the prescriber. When the prescriber was contacted, it led to an intervention about 75% of the time for both populations. The most common intervention was a change in DOAC dosing. Conclusion This study demonstrates the benefit of DOAC prescribing oversight using a registry-based intervention to monitor for off-label dosing for the entirety of the time period a patient is prescribed DOAC, particularly for patients with AF, as off-label prescribing occurs frequently during the follow-up period.

Funder

U.S. Department of Health and Human Services

U.S. Public Health Service

Agency for Healthcare Research and Quality

Blue Cross Blue Shield of Michigan Foundation

Publisher

Georg Thieme Verlag KG

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