Abstract

New oral anticoagulant agents continue to emerge on the market and their safety requires assessment to provide evidence of their suitability for clinical use. There-fore, we searched standard databases to summarize the English language literature on medicine-related problems (MRPs) of direct oral anticoagulants DOACs (dabigtran, rivaroxban, apixban, and edoxban) in the treatment of adults with atri-al fibrillation. Electronic databases including Medline, Embase, International Pharmaceutical Abstract (IPA), Scopus, CINAHL, the Web of Science and Cochrane were searched from 2008 through 2016 for original articles. Studies pub-lished in English reporting MRPs of DOACs in adult patients with AF were in-cluded. Seventeen studies were identified using standardized protocols, and two reviewers serially abstracted data from each article. Most articles were inconclusive on major safety end points including major bleeding. Data on major safety end points were combined with efficacy. Most studies inconsistently reported adverse drug reactions and not adverse events or medication error, and no definitions were consistent across studies. Some harmful drug effects were not assessed in studies and may have been overlooked. Little evidence is provided on MRPs of DOACs in patients with AF and, therefore, further studies are needed to establish the safety of DOACs in real-life clinical practice.

Highlights

  • The identification, resolution, and prevention of medicine-related problems (MRPs) has been described as an essential process of pharmaceutical care, where pharmacists and other health care professionals as well as patients work together to achieve improved therapeutic outcomes and quality of life (Basger et al, 2015)

  • There have been no systematic investigations of MRPs in adult patients with atrial fibrillation (AF) using direct oral anticoagulants (DOACs) in clinical practice

  • This review indicates that DOACs have a favourable risk/safety profile for treatment of patients with AF, given the reduced risk of ADRrelated major and minor bleeding events; there was a variation in the measured risk among the studies

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Summary

Introduction

The identification, resolution, and prevention of medicine-related problems (MRPs) has been described as an essential process of pharmaceutical care, where pharmacists and other health care professionals as well as patients work together to achieve improved therapeutic outcomes and quality of life (Basger et al, 2015). According to the Pharmaceutical Care Network Europe, an MRP can be defined as “an event or circumstance involving drug therapy that or potentially interferes with desired health outcomes”. This includes therapeutic failure, patient behaviour, adherence to the medication, and inappropriate drug use. These may set off or comprise risk factors leading to medication errors (MEs) and adverse drug reactions/events (ADRs/ADEs), which could affect patient health outcome. ADEs are injuries resulting from the use of a medicinal product, the causality of the relationship has not been determined (Strand et al, 1990)

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