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Cannabinoid Products & Cohort Characterization

    Basic Details
    Last Updated
    Monday, April 29, 2024
    Original Posting Date
    Health Outcome(s)
    cohort characterization
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    As part of the activities of the FDA’s Cannabis Product Committee, the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, conducted an integrated review to evaluate and compile an updated catalog of available data sources that complement FDA’s routine surveillance systems for monitoring non-FDA-approved cannabinoid products (CP) use and associated adverse events. FDA explored the capabilities of the Sentinel System’s electronic health record (EHR) data, specifically in TriNetX and PCORnet, to conduct active safety surveillance of CP, including cannabidiol (CBD). Results from TriNetX analyses suggest the ability to extract and identify non-FDA-approved CP exposures from clinical notes. There are opportunities to enhance the performance of pertinent natural language processing (NLP)-based algorithms to improve the identification of CP in these notes. Results from PCORnet suggest that identified CBD exposures correspond to approved CBD (Epidiolex). Future explorations on FDA-approved CBD in PCORnet should consider including exposures with and without brand names to capture exposures to FDA-approved CBD that might be overlooked. Further development and validation of NLP-based algorithms is needed before FDA can consider use of data from EHR clinical notes for surveillance of non-FDA-approved CP.