Resumen de Detection of serious suspected adverse reactions associated with direct oral anticoagulants through two proactive pharmacovigilance systems
J.L. Marco Garbayo, Manuel Koninckx Cañada, Mª Teresa Faus Soler, Isabel Pérez Castelló, Lucrecia Bourgon Baquedano
Objective: To develop and to analyze a proactive search system of suspected adverse drug reactions (sADR) due to direct oral anticoagulants (DOAC) by sequencing of primary data searching and their subsequent crossing.
Method: A retrospective, descriptive, observational study of hospital admissions for bleeding associated with DOAC, during 2016. The warning cases were detected through hospital discharge reports revision by using the information management tool of Orion Clinic (the hospital electronic medical history); and by the sequencing of primary data searching using Alumbra (business intelligence that works on the corporate data warehouse) and IRIS (Hospital Information System where hospital admissions are recorded and coded) and their subsequent crossing. The active ingredients (apixaban, dabigatran, edoxaban, rivaroxaban) and the range of dates (01/01/2016-12/31/2016) were selected as localizers; the SIP (Population Information System) numbers as identifiers of each person under Valencian Health System coverage; and the International Classification of Diseases, 9th revision, clinical modification to identify the sADR. Alerting cases with a score ≥5 of the Naranjo algorithm were included.
Results: Among the 356 hospital admissions analyzed by hospital discharge reports revision, 22 (6.2%; 95% CI: 3.5-8.8) were due to bleeding events associated with DOAC. 17 of these 22 cases were also detected by the crossing method, with a sensitivity of 77.3% (95% CI: 54.6-92.2) and a specificity of 94.1% (95% CI: 91.4-96.8).
Conclusion: The proactive search of sADR through data crossing from electronic information systems allows generating useful knowledge in the field ofpharmacovigilance
