A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. The potential for signal detection in the EU-ADR system was found to be dependent on frequency of the event and utilization of drugs in the general population. The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice.

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doi.org/10.1586/17512433.2015.992878, hdl.handle.net/1765/88634
Expert Review of Clinical Pharmacology
Department of Medical Informatics

Patadia, V.K, Coloma, P.M, Schuemie, M.J, Herings, R.M.C, Gini, R, Mazzaglia, G, … Trifirò, G. (2014). Using real-world healthcare data for pharmacovigilance signal detection-the experience of the EU-ADR project. Expert Review of Clinical Pharmacology (Vol. 8, pp. 95–102). doi:10.1586/17512433.2015.992878