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

作者：Patadia Vaishali K^*; Coloma Preciosa; Schuemie Martijn J; Herings Ron; Gini Rosa; Mazzaglia Giampiero; Picelli Gino; Fornari Carla; Pedersen Lars; van der Lei Johan; Sturkenboom Miriam; Trifiro Gianluca

来源：Expert Review of Clinical Pharmacology, 2015, 8(1): 95-102.

DOI：10.1586/17512433.2015.992878

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

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.

• 出版日期2015-1