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Expert Rev Clin Pharmacol. 2015 Jan;8(1):95-102. doi: 10.1586/17512433.2015.992878.

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

Author information

1
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.

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.

KEYWORDS:

EU-ADR; FAERS; adverse drug reactions; data mining; electronic health records; pharmacovigilance; real-world healthcare data; signal detection; spontaneous reporting systems

PMID:
25487079
DOI:
10.1586/17512433.2015.992878
[Indexed for MEDLINE]

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