Automated detection of off-label drug use.

Off-label drug use, defined as use of a drug in a manner that deviates from its approved use defined by the drug's FDA label, is problematic because such uses have not been evaluated for safety and efficacy. Studies estimate that 21% of prescriptions are off-label, and only 27% of those have ev...

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Main Authors: Kenneth Jung, Paea LePendu, William S Chen, Srinivasan V Iyer, Ben Readhead, Joel T Dudley, Nigam H Shah
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2014-01-01
Series:PLoS ONE
Online Access:https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0089324&type=printable
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author Kenneth Jung
Paea LePendu
William S Chen
Srinivasan V Iyer
Ben Readhead
Joel T Dudley
Nigam H Shah
author_facet Kenneth Jung
Paea LePendu
William S Chen
Srinivasan V Iyer
Ben Readhead
Joel T Dudley
Nigam H Shah
author_sort Kenneth Jung
collection DOAJ
description Off-label drug use, defined as use of a drug in a manner that deviates from its approved use defined by the drug's FDA label, is problematic because such uses have not been evaluated for safety and efficacy. Studies estimate that 21% of prescriptions are off-label, and only 27% of those have evidence of safety and efficacy. We describe a data-mining approach for systematically identifying off-label usages using features derived from free text clinical notes and features extracted from two databases on known usage (Medi-Span and DrugBank). We trained a highly accurate predictive model that detects novel off-label uses among 1,602 unique drugs and 1,472 unique indications. We validated 403 predicted uses across independent data sources. Finally, we prioritize well-supported novel usages for further investigation on the basis of drug safety and cost.
format Article
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language English
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publisher Public Library of Science (PLoS)
record_format Article
series PLoS ONE
spelling doaj-art-80dea625c4fb4e498a30e576c2453ec42025-08-20T02:15:23ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0192e8932410.1371/journal.pone.0089324Automated detection of off-label drug use.Kenneth JungPaea LePenduWilliam S ChenSrinivasan V IyerBen ReadheadJoel T DudleyNigam H ShahOff-label drug use, defined as use of a drug in a manner that deviates from its approved use defined by the drug's FDA label, is problematic because such uses have not been evaluated for safety and efficacy. Studies estimate that 21% of prescriptions are off-label, and only 27% of those have evidence of safety and efficacy. We describe a data-mining approach for systematically identifying off-label usages using features derived from free text clinical notes and features extracted from two databases on known usage (Medi-Span and DrugBank). We trained a highly accurate predictive model that detects novel off-label uses among 1,602 unique drugs and 1,472 unique indications. We validated 403 predicted uses across independent data sources. Finally, we prioritize well-supported novel usages for further investigation on the basis of drug safety and cost.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0089324&type=printable
spellingShingle Kenneth Jung
Paea LePendu
William S Chen
Srinivasan V Iyer
Ben Readhead
Joel T Dudley
Nigam H Shah
Automated detection of off-label drug use.
PLoS ONE
title Automated detection of off-label drug use.
title_full Automated detection of off-label drug use.
title_fullStr Automated detection of off-label drug use.
title_full_unstemmed Automated detection of off-label drug use.
title_short Automated detection of off-label drug use.
title_sort automated detection of off label drug use
url https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0089324&type=printable
work_keys_str_mv AT kennethjung automateddetectionofofflabeldruguse
AT paealependu automateddetectionofofflabeldruguse
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AT srinivasanviyer automateddetectionofofflabeldruguse
AT benreadhead automateddetectionofofflabeldruguse
AT joeltdudley automateddetectionofofflabeldruguse
AT nigamhshah automateddetectionofofflabeldruguse