The Food and Drug administration is looking for its own, large-scale EHR system to track the safety of regulated products and drug adverse reactions.
According to the RFI, the EHR would support a critical project of the FDA’s Bioinformatics and Biostatistics, which will research the safety and surveillance of regulated products through the FDA’s adverse event reporting systems.
FDA has requested $100 million in FY2019 for an EHR initiative to evaluate the safety of regulated products.
The pilot study will work on the FDA Adverse Events Reporting System (FAERS) Center for Drug Evaluation and Research (CDER) database. Researchers will analyze data with a data mining and data visualization method, developed and evaluated by the EHR system.
Researchers will take not only FDA data but also leverage data from the Department of Veterans Affairs, specifically looking at drug-induced cardiovascular abnormalities after drug exposure. The project will use topic modeling to identify hidden adverse events and “significant safety signals from the FAERS, Vigibase and the VA EHR databases.”
The FDA also is hoping to identify the relationships between the use of multiple drugs and repeat adverse events using data mining.
Part of the contract will include the development of the VA cardio-related database, which will be developed using the VA Health System’s Informatics and Computing Infrastructure database.
The database will need to contain a drug dictionary and patients receiving drugs included in the study, among other elements. It also will be able to identify patients who developed cardiovascular issues after drug exposure.
Further, it would select a medication-matched controlled population of those patients who received the same medication but didn’t develop any cardiovascular abnormalities.
Currently, while the data for these patients exist, it is located on various platforms, including VistA.
However, the FDA’s data project may need to move this data in the future, as the VA still is planning on signing its EHR modernization contract with Cerner despite numerous delays due to both interoperability and the lack of a permanent VA Secretary.
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