Medication errors associated with direct-acting oral anticoagulants: analysis of data from national pharmacovigilance and local incidents reporting databases.

BACKGROUND: For more than a decade, direct oral anticoagulants (DOACs) have been approved in clinical practice for multiple indications such as stroke prevention in non-valvular atrial fibrillation treatment of deep vein thrombosis and pulmonary embolism. This study aimed to explore the nature and contributory factors related to medication errors associated with DOACs in hospital settings. METHODS: Analysis of error reports using data from (a) Saudi Food and Drug Authority pharmacovigilance database and (b) local incidents reporting system from two tertiary care hospitals were included. Errors reported between January 2010 to December 2020 were also included. Statistical analyses were performed using IBM (SPSS) Statistics Version 24.0 software. RESULTS: A total of 199 medication error incidents were included. The mean (range) age of affected patients was 63.5 (19-96) years. The mean reported duration of treatment when incidents happened was 90 days, with a very wide range from one day to 12 months. Prescribing error was the most common error type representing 81.4% of all errors. Apixaban was the most frequent drug associated with error reporting with 134 (67.3%) incidents, followed by rivaroxaban (18.6%) and dabigatran (14.1%). The majority of the patients (n = 188, 94.5%) showed comorbidities in addition to the conditions related to DOACs. Polypharmacy, an indication of treatment and duration of therapy were amongst the important contributory factors associated with errors. CONCLUSIONS: This observational study demonstrates the nature of DOAC related medication errors in clinical practice. Developing risk prevention and reduction strategies using the expertise of clinical pharmacists are imperative in promoting patient safety associated with DOAC use.