ABSTRACT
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.
ABSTRACT
Background Direct oral anticoagulants (DOACs) have revolutionised anticoagulant pharmacotherapy. However, DOAC-related medication incidents are known to be common. Objective To assess medication incidents associated with DOACs using an error theory and to analyse pharmacists' contributions in minimising medication incidents in hospital in-patients. Setting A large University academic hospital in the West Midlands of England. Methods Medication incident data from the incident reporting system (48-months period) and pharmacists' interventions data from the prescribing system (26-month period) relating to hospital in-patients were extracted. Reason's Accident Causation Model was used to identify potential causality of the incidents. Pharmacists' intervention data were thematically analysed. Main outcome measure (a) Frequency, type and potential causality of DOAC-related incidents; (b) nature of pharmacists' interventions. Results A total of 812 reports were included in the study (124 medication incidents and 688 intervention reports). Missing drug/omission was the most common incident type (26.6%, n = 33) followed by wrong drug (16.1%, n = 20) and wrong dose/strength (11.3%, n = 14). A high majority (89.5%, n = 111) of medication incidents were caused by active failures. Patient discharge without anticoagulation supply and failure to restart DOACs post procedure/scan were commonly recurring themes. Pharmacists' interventions most frequently related to changes in pharmacological strategy, including drug or dose changes (38.1%, n = 262). Impaired renal function was the most common reason for dose adjustments. Conclusion Prescribers' active failure rather than system errors (i.e. latent failures) contributed to the majority of DOAC-related incidents. Reinforcement of guideline adherence, prescriber education, harnessing pharmacists' roles and mandating renal function information in prescriptions are likely to improve patient safety.
