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.

Patadia, V., Coloma, P., Schuemie, M., Herings, R., Gini, R., Mazzaglia, G., et al. (2014). Using real-world healthcare data for pharmacovigilance signal detection-the experience of the EU-ADR project. EXPERT REVIEW OF CLINICAL PHARMACOLOGY, 8(1), 95-102 [10.1586/17512433.2015.992878].

Using real-world healthcare data for pharmacovigilance signal detection-the experience of the EU-ADR project

Mazzaglia, G;FORNARI, CARLA;
2014

Abstract

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.
Articolo in rivista - Review Essay
adverse drug reactions; data mining; electronic health records; EU-ADR; FAERS; pharmacovigilance; real-world healthcare data; signal detection; spontaneous reporting systems; Adverse Drug Reaction Reporting Systems; Databases, Factual; Delivery of Health Care; Drug-Related Side Effects and Adverse Reactions; Humans; Prospective Studies; Pharmacovigilance; Pharmacology (medical); Pharmacology, Toxicology and Pharmaceutics (all); Medicine (all)
English
95
102
8
Patadia, V., Coloma, P., Schuemie, M., Herings, R., Gini, R., Mazzaglia, G., et al. (2014). Using real-world healthcare data for pharmacovigilance signal detection-the experience of the EU-ADR project. EXPERT REVIEW OF CLINICAL PHARMACOLOGY, 8(1), 95-102 [10.1586/17512433.2015.992878].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/89890
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