Abstract

Background Direct oral anticoagulants (DOACs) have been developed to address some of the limitations of Vitamin-K antagonists. Deviations from the recommended use have been reported, sometimes leading to serious adverse events. Purpose Our objective was to evaluate the appropriateness of prescribing DOACs in real-life clinical practice. Material and methods We conducted a prospective study including patients admitted to a 450-bed teaching hospital from April to June 2013 and taking rivaroxaban or dabigatran in prevention of stroke or systemic embolism in non-valvular atrial fibrillation. A clinical pharmacist collected clinical and pharmaceutical data from the electronic medical record and patient interview. Appropriateness of prescribing was evaluated using 9 criteria of the Medication Appropriateness Index.2,3 Explicit instructions specific to the appropriate use of DOACs were added based on EU summary of the product characteristics and (inter)national guidelines. The primary outcome measure was the prevalence of patients with ≥1 inappropriate criterion. Results Fifty-two patients were evaluated (median age 74 years; 29 and 23 taking Xarelto® and Pradaxa®, respectively). Twenty-eight (53.8%) patients had at least one inappropriate rating: 1 inappropriate criterion in 26.9% and >1 in 26.9% of patients. The most frequent inappropriate criteria were: wrong dosage (32.7%, e.g. dose not adapted to renal function); inappropriate choice and modalities of administration (28.8%, e.g. prescription of a DOAC in a VKA-naive patient with extreme body weight, once daily administration of Pradaxa®); and unpractical modalities of administration (25.0%, e.g. Pradaxa® in non-adherent patients). Twenty-four patients (47.0%) had experienced one adverse event. The clinical pharmacist made 29 interventions during the study period; e.g. 11 request for specific coagulation assay, 8 switches to another oral anticoagulant. Conclusion The quality of prescribing DOACs was suboptimal. Off-label use was frequent and suggests that reinforcing education of patient and health care professionals is needed.

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