Can the EU-ADR Database Network Detect Drug Safety Signals Faster than Spontaneous Reporting System?

Background: Several ongoing initiatives are exploring if mining electronic health records (EHRs) may fasten the process of drug safety signal detection. We investigated if the signal concerning rofecoxib and acute myocardial infarction could have been identified in EU-ADR database network faster than spontaneous reporting system (SRS), and earlier than rofecoxib withdrawal (30th September 2004). Methods: EU-ADR distributed network comprises of seven EHR databases covering approximately a population of almost 30 million persons from four European Countries during the years 1996–2010. Harmonized data extraction and analysis has been conducted in all databases through custom-built software Jerboa, which allows for data aggregation and elaboration while databases remained locally. A signal was defined as statistically significant (p-value