title: Using real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project.
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.
authors.affiliation: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Vaishali K
authors.initials: VK
authors.lastname: Patadia
authors.forename: Preciosa
authors.initials: P
authors.lastname: Coloma
authors.forename: Martijn J
authors.initials: MJ
authors.lastname: Schuemie
authors.forename: Ron
authors.initials: R
authors.lastname: Herings
authors.forename: Rosa
authors.initials: R
authors.lastname: Gini
authors.forename: Giampiero
authors.initials: G
authors.lastname: Mazzaglia
authors.forename: Gino
authors.initials: G
authors.lastname: Picelli
authors.forename: Carla
authors.initials: C
authors.lastname: Fornari
authors.forename: Lars
authors.initials: L
authors.lastname: Pedersen
authors.forename: Johan
authors.initials: J
authors.lastname: van der Lei
authors.forename: Miriam
authors.initials: M
authors.lastname: Sturkenboom
authors.forename: Gianluca
authors.initials: G
authors.lastname: Trifirò
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D016208:Databases, Factual; D003695:Delivery of Health Care / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D006801:Humans; D060735:Pharmacovigilance; D011446:Prospective Studies
keywords: EU-ADR; FAERS; adverse drug reactions; data mining; electronic health records; pharmacovigilance; real-world healthcare data; signal detection; spontaneous reporting systems