Key result
Among DOAC dosage error reports in the EudraVigilance database, underdosing (51.56%) was more frequently reported than overdosing (18.54%), with rivaroxaban accounting for 54.02% of reports.
Why the study?
What are the patterns of dosage errors and associated adverse reactions reported for DOACs in the EudraVigilance database?
Observational
What are the patterns of dosage errors and associated adverse reactions reported for DOACs in the EudraVigilance database?
Analysis of the EudraVigilance database reveals that DOAC dosage errors are predominantly due to underdosing rather than overdosing, highlighting the need for careful dose management.
May flag ADRs from DOAC dosing errors in practice; leaves open incidence, causality, and prevention needs.
Direct oral anticoagulant drugs (DOACs) interfere with the coagulation process, thus improving patient care for those who require anticoagulant treatment. This study presents a descriptive analysis of adverse reactions (ADRs) attributed to DOAC dosage errors (overdose, underdose, and improper dose). The analysis was performed based on the Individual Case Safety Reports from the EudraVigilance (EV) database. Results show that data reported for rivaroxaban, apixaban, edoxaban, and dabigatran are mostly regarding underdosing (51.56%) compared to overdosing (18.54%). The most dosage error reports were identified for rivaroxaban (54.02%), followed by apixaban (33.61%). Dabigatran and edoxaban had similar percentages (6.26% and 6.11%, respectively) regarding dosage error reports. Since coagulation issues can become life-threatening events, and factors such as advanced age and renal failure can influence the pharmacokinetics of drugs, the correct usage of DOACs is of utmost importance for the management and prevention of venous thromboembolism. Thus, the collaboration and the complementarity of knowledge of physicians and pharmacists may offer a reliable solution for DOAC dose management and improve patient care.
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Morgovan et al. (2023) conducted an observational in DOAC dosage errors. Direct oral anticoagulant drugs (DOACs) was evaluated on Proportion of dosage error types and drug involvement. Among DOAC dosage error reports in the EudraVigilance database, underdosing (51.56%) was more frequently reported than overdosing (18.54%), with rivaroxaban accounting for 54.02% of reports.
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