Evaluation of Natural Language Processing (NLP) systems to annotate drug product labeling with MedDRA terminology.

Journal: Journal of biomedical informatics
Published Date: Jul 1, 2018

Abstract

INTRODUCTION: The FDA Adverse Event Reporting System (FAERS) is a primary data source for identifying unlabeled adverse events (AEs) in a drug or biologic drug product's postmarketing phase. Many AE reports must be reviewed by drug safety experts to identify unlabeled AEs, even if the reported AEs are previously identified, labeled AEs. Integrating the labeling status of drug product AEs into FAERS could increase report triage and review efficiency. Medical Dictionary for Regulatory Activities (MedDRA) is the standard for coding AE terms in FAERS cases. However, drug manufacturers are not required to use MedDRA to describe AEs in product labels. We hypothesized that natural language processing (NLP) tools could assist in automating the extraction and MedDRA mapping of AE terms in drug product labels.

Authors

  • Thomas Ly
    FDA CDER Office of Biostatistics, Silver Spring, MD, United States. Electronic address: thomas.thantily@gmail.com.
  • Carol Pamer
    FDA CDER Office of Surveillance and Epidemiology, Silver Spring, MD, United States.
  • Oanh Dang
    FDA CDER Office of Surveillance and Epidemiology, Silver Spring, MD, United States.
  • Sonja Brajovic
    FDA CDER Office of Surveillance and Epidemiology, Silver Spring, MD, United States.
  • Shahrukh Haider
    FDA CDER Office of Translational Sciences, Silver Spring, MD, United States.
  • Taxiarchis Botsis
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States. Electronic address: Taxiarchis.Botsis@fda.hhs.gov.
  • David Milward
    Linguamatics Ltd., 324 Cambridge Science Park, Milton Road, Cambridge CB4 0WG, UK.
  • Andrew Winter
    Linguamatics Ltd., Cambridge, UK.
  • Susan Lu
    FDA CDER Office of Surveillance and Epidemiology, Silver Spring, MD, United States.
  • Robert Ball
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.

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