Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study

The document presents a proof-of-concept study conducted between July 2014 and June 2015, which investigated the use of electronic healthcare record (EHR) data from the Clinical Practice Research Datalink (CPRD) for early signal assessment of adverse drug events in UK medicines regulation. The study reviewed 69 new safety signals, and after exclusions, 32 signals were analyzed. Case studies, including donepezil and salivary hypersecretion, mirtazapine and alopecia, and finasteride and cognitive disorder, demonstrated the potential of EHR data to support regulatory decisions. For example, the study found a significant increase in salivary hypersecretion events with donepezil, but the data did not support an association between mirtazapine and alopecia, and the link between finasteride and cognitive decline was very weak. The study concluded that while EHR data has limitations, such as under-recording and lack of secondary care data, it can still provide valuable insights for regulatory purposes. The authors recommend further work to refine the analysis platform and integrate EHR data into signal management processes, with an extended pilot planned to optimize the use of such data.