Drug Safety Surveillance with EHR Data: A Promise Not Yet Fulfilled

Pharmacovigilance programs have historically relied on spontaneous reporting and claims-based surveillance systems. The use of electronic health record (EHR) data may improve medication safety signal identification and address limitations of current approaches. To promote the expansion and adoption of EHR-based pharmacovigilance, the Sentinel Innovation Center conducted a review of studies identifying safety signals from routinely collected EHR data. This presentation highlights current approaches, discusses limitations of existing research, notes promising methodological advances, and recommends best practices moving forward. It was presented at the AMIA 2023 Annual Symposium on November 13, 2023.