@article{0a4fafa7d6914a22a1ab0f22dbd41a12,
title = "Adverse Event extraction from Structured Product Labels using the Event-based Text-mining of Health Electronic Records (ETHER) system",
abstract = "Structured Product Labels follow an XML-based document markup standard approved by the Health Level Seven organization and adopted by the US Food and Drug Administration as a mechanism for exchanging medical products information. Their current organization makes their secondary use rather challenging. We used the Side Effect Resource database and DailyMed to generate a comparison dataset of 1159 Structured Product Labels. We processed the Adverse Reaction section of these Structured Product Labels with the Event-based Text-mining of Health Electronic Records system and evaluated its ability to extract and encode Adverse Event terms to Medical Dictionary for Regulatory Activities Preferred Terms. A small sample of 100 labels was then selected for further analysis. Of the 100 labels, Event-based Text-mining of Health Electronic Records achieved a precision and recall of 81 percent and 92 percent, respectively. This study demonstrated Event-based Text-mining of Health Electronic Record{\textquoteright}s ability to extract and encode Adverse Event terms from Structured Product Labels which may potentially support multiple pharmacoepidemiological tasks.",
keywords = "Structured Product Labels, medical dictionary for regulatory activities, natural language processing",
author = "Abhishek Pandey and Kory Kreimeyer and Matthew Foster and Oanh Dang and Thomas Ly and Wei Wang and Richard Forshee and Taxiarchis Botsis",
note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This work was supported, in part, by the appointments of M.F., K.K., and A.P. to the Research Participation Program administered by ORISE through an interagency agreement between the US Department of Energy and the US Food and Drug Administration (FDA). Funding Information: The authors thank Michael Kuhn at the Max Planck Institute of Molecular Cell Biology and Genetics, Dresden, Germany, for his assistance with the Side Effect Resource (SIDER) and Carol Pamer at the Center for Drug Evaluation and Research, FDA, for her input and advice in this study. The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This work was supported, in part, by the appointments of M.F., K.K., and A.P. to the Research Participation Program administered by ORISE through an interagency agreement between the US Department of Energy and the US Food and Drug Administration (FDA). Publisher Copyright: {\textcopyright} The Author(s) 2018.",
year = "2019",
month = dec,
day = "1",
doi = "10.1177/1460458217749883",
language = "English (US)",
volume = "25",
pages = "1232--1243",
journal = "Health informatics journal",
issn = "1460-4582",
publisher = "SAGE Publications Ltd",
number = "4",
}