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

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  • 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
  • ,
  • EU-ADR consortium

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.

Original languageEnglish
JournalExpert Review of Clinical Pharmacology
Pages (from-to)95-102
Number of pages8
Publication statusPublished - Jan 2015

    Research areas

  • Adverse Drug Reaction Reporting Systems, Databases, Factual, Delivery of Health Care, Drug-Related Side Effects and Adverse Reactions, Humans, Pharmacovigilance, Prospective Studies

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