FDA plans EHR database to target drug safety
FDA plans to use EHRs to find risk factors associated with adverse events to determine which drugs might require targeted warnings about their appropriate use.
The agency announced that current voluntary reporting of drug side effects is problematic. Some adverse side effects do not present themselves immediately. The submission forms are voluntary, and some individuals might not report adverse events. Plus, the complex forms can lead to inaccurate or incomplete reports.
FDA wrote on the Federal Business Opportunities website in December 2013 that it is seeking a partner to develop a database of de-identified EHR information. The database would allow the agency to assess risk factors including diagnoses, health history, hospitalizations and demographics.
Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.