Original Research ARTICLE
Preventable cases of oral anticoagulant-induced bleeding: data from the spontaneous reporting system
- 1Second University of Naples, Italy
Background: Despite the risk of bleeding is a well-known adverse effect of oral anticoagulants, there is scarce evidence on the preventability of oral anticoagulant-induced bleedings. Therefore, we investigated the potential risk factors related to preventable cases of oral anticoagulant-induced bleedings.
Methods: We performed a study using Individual Case Safety Reports (ICSRs) with an oral anticoagulant as suspected drug among those reported through the spontaneous reporting system of Campania Region from 1 July 2012 to 31 December 2017. The P-method was used for the preventability assessment of all cases of bleeding.
Results: In total, 58 cases out of 253 (22.9%) were preventable, and the most reported suspected drug was an indirect oral anticoagulant (warfarin). Sixty-seven critical criteria for preventability were identified, all related to healthcare professionals’ practices. The most detected risk factor related to healthcare professionals’ practices was the labelled drug–drug interaction for both direct and indirect oral anticoagulants.
Conclusions: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory, and to reduce the burden of medication errors and inappropriate prescription.
Keywords: oral anticoagulant, bleeding, preventability assessment, Spontaneous reporting system, adverse effect
Received: 09 Jan 2019;
Accepted: 03 Apr 2019.
Edited by:Ali H. Eid, American University of Beirut, Lebanon
Reviewed by:Leonardo A. Moraes, National University of Singapore, Singapore
Jun X. Feng, The First Affiliated Hospital, University of Science and Technology of China, China
Alessandro Di Minno, Department of Pharmacy, University of Naples Federico II, Italy
Copyright: © 2019 Mascolo. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: PhD. Annamaria Mascolo, Second University of Naples, Naples, Italy, firstname.lastname@example.org