• Vaishali K Patadia, Preciosa Coloma, Martijn J Schuemie, Ron Herings, Rosa Gini, Giampiero Mazzaglia, Gino Picelli, Carla Fornari, Lars Pedersen, Johan van der Lei, Miriam Sturkenboom, Gianluca Trifirò, and EU-ADR consortium.
• Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
• Expert Rev Clin Pharmacol. 2015 Jan 1; 8 (1): 95-102.

AbstractA 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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