title: EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection.
abstract: The EU-ADR project aims to exploit different European electronic healthcare records (EHR) databases for drug safety signal detection. In this paper we report the preliminary results concerning the comparison of signal detection between EU-ADR network and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization databases. EU-ADR data sources consist of eight databases in four countries (Denmark, Italy, Netherlands, and United Kingdom) that are virtually linked through distributed data network. A custom-built software (Jerboa©) elaborates harmonized input data that are produced locally and generates aggregated data which are then stored in a central repository. Those data are subsequently analyzed through different statistics (i.e. Longitudinal Gamma Poisson Shrinker). As potential signals, all the drugs that are associated to six events of interest (bullous eruptions - BE, acute renal failure - ARF, acute myocardial infarction - AMI, anaphylactic shock - AS, rhabdomyolysis - RHABD, and upper gastrointestinal bleeding - UGIB) have been detected via different data mining techniques in the two systems. Subsequently a comparison concerning the number of drugs that could be investigated and the potential signals detected for each event in the spontaneous reporting systems (SRSs) and EU-ADR network was made. SRSs could explore, as potential signals, a larger number of drugs for the six events, in comparison to EU-ADR (range: 630-3,393 vs. 87-856), particularly for those events commonly thought to be potentially drug-induced (i.e. BE: 3,393 vs. 228). The highest proportion of signals detected in SRSs was found for BE, ARF and AS, while for ARF, and UGIB in EU-ADR. In conclusion, it seems that EU-ADR longitudinal database network may complement traditional spontaneous reporting system for signal detection, especially for those adverse events that are frequent in general population and are not commonly thought to be drug-induced. The methodology for signal detection in EU-ADR is still under development and testing phase.
authors.affiliation: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands. g.trifiro@erasmusmc.nl
authors.forename: Gianluca
authors.initials: G
authors.lastname: Trifirò
authors.forename: Vaishali
authors.initials: V
authors.lastname: Patadia
authors.forename: Martijn J
authors.initials: MJ
authors.lastname: Schuemie
authors.forename: Preciosa M
authors.initials: PM
authors.lastname: Coloma
authors.forename: Rosa
authors.initials: R
authors.lastname: Gini
authors.forename: Ron
authors.initials: R
authors.lastname: Herings
authors.forename: Julia
authors.initials: J
authors.lastname: Hippisley-Cox
authors.forename: Giampiero
authors.initials: G
authors.lastname: Mazzaglia
authors.forename: Carlo
authors.initials: C
authors.lastname: Giaquinto
authors.forename: Lorenza
authors.initials: L
authors.lastname: Scotti
authors.forename: Lars
authors.initials: L
authors.lastname: Pedersen
authors.forename: Paul
authors.initials: P
authors.lastname: Avillach
authors.forename: Miriam C J M
authors.initials: MC
authors.lastname: Sturkenboom
authors.forename: Johan
authors.initials: J
authors.lastname: van der Lei
authors.lastname: Eu-Adr Group
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D057225:Data Mining / Q000379:methods*; D016208:Databases, Factual / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005060:Europe; D006801:Humans; D016347:Medical Records Systems, Computerized / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization