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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
Volume8
Issue1
Pages (from-to)95-102
Number of pages8
ISSN1751-2433
DOIs
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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