Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: The EU-ADR Experience

Safety-related warnings and market withdrawal of prominent drugs in recent years have fueled efforts to consider other data sources for surveillance and to develop new methodologies in order to supplement existing pharmacovigilance systems. One of the important resources posited to have enormous potential for proactive safety surveillance are electronic healthcare records (EHRs). Linking of healthcare databases for active drug safety surveillance is feasible in Europe, and yet the leverage to do so may be too low for very rare events and for drugs that are infrequently used, or captured, in the databases, and a system such as exploring and understanding adverse drug reactions (EU-ADR) may be better at detecting signals with lower strength of association for events that have a relatively high background frequency.

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