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Direct oral anticoagulants (DOACs) are considered high risk medicines and are frequently associated with medication errors. The nature of incidents and associated outcomes of such incidents are poorly understood. Using a national patient safety reporting database, the National Reporting and Learning System (NRLS), this study aimed to report the contributory factors and outcomes including severe harm and deaths related to all safety incidents involving DOACs reported in England and Wales between 2017–2019. Reason’s accident causation model was used to classify the incidents. A total of 15,730 incident reports were analyzed. A total of 25 deaths were reported with a further 270 and 55 incidents leading to moderate and severe harm, respectively. A further 8.8% ( n  = 1381) of incidents were associated with low degree of harm. The majority of the incidents involved active failures ( n  = 13776; 87.58) including duplication of anticoagulant therapies, patients being discharged without DOACs, non-consideration of renal function, and lack of commencement of DOACs post-surgery suggesting preventability of such reported incidents. This study shows that medication incidents involving DOACs have the potential to cause severe harm and deaths, and there is a need to promote guideline adherence through education, training, and decision support technologies.

expert opinion on drug safety

Contributory factors and patient harm including deaths associated direct acting oral anticoagulants (DOACs) medication incidents: evaluation of real world data reported to the National Reporting and Learning System