Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2013-12

AUTHORS

Richard D Boyce, John R Horn, Oktie Hassanzadeh, Anita De Waard, Jodi Schneider, Joanne S Luciano, Majid Rastegar-Mojarad, Maria Liakata

ABSTRACT

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. More... »

PAGES

5

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/2041-1480-4-5

DOI

http://dx.doi.org/10.1186/2041-1480-4-5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1011155400

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23351881


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1115", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Pharmacology and Pharmaceutical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "University of Pittsburgh", 
          "id": "https://www.grid.ac/institutes/grid.21925.3d", 
          "name": [
            "Department of Biomedical Informatics, University of Pittsburgh, Offices at Baum, 5607 Baum Blvd, Pittsburgh, PA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Boyce", 
        "givenName": "Richard D", 
        "id": "sg:person.01263011645.39", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01263011645.39"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of Washington", 
          "id": "https://www.grid.ac/institutes/grid.34477.33", 
          "name": [
            "Department of Pharmacy, University of Washington, Seattle, WA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Horn", 
        "givenName": "John R", 
        "id": "sg:person.0763175526.23", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0763175526.23"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "IBM Research \u2013 Thomas J. Watson Research Center", 
          "id": "https://www.grid.ac/institutes/grid.481554.9", 
          "name": [
            "IBM T.J. Watson Research Center, Yorktown Heights, NY, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hassanzadeh", 
        "givenName": "Oktie", 
        "id": "sg:person.012440132131.37", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012440132131.37"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Elsevier Labs, Jericho, VT, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "De Waard", 
        "givenName": "Anita", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "National University of Ireland, Galway", 
          "id": "https://www.grid.ac/institutes/grid.6142.1", 
          "name": [
            "Digital Enterprise Research Institute, National University of Ireland, Galway, Ireland"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Schneider", 
        "givenName": "Jodi", 
        "id": "sg:person.014366272167.27", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014366272167.27"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Rensselaer Polytechnic Institute", 
          "id": "https://www.grid.ac/institutes/grid.33647.35", 
          "name": [
            "Tetherless World Constellation, Rensselaer Polytechnic Institute, Troy, NY, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Luciano", 
        "givenName": "Joanne S", 
        "id": "sg:person.01112335735.57", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01112335735.57"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of Wisconsin\u2013Milwaukee", 
          "id": "https://www.grid.ac/institutes/grid.267468.9", 
          "name": [
            "University of Wisconsin, Milwaukee, WI, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Rastegar-Mojarad", 
        "givenName": "Majid", 
        "id": "sg:person.01354072260.84", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01354072260.84"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "European Bioinformatics Institute", 
          "id": "https://www.grid.ac/institutes/grid.225360.0", 
          "name": [
            "Department of Computer Science, Aberystwyth University, Wales, UK", 
            "Text mining group, EBI-EMBL, Hinxton, Cambridge, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Liakata", 
        "givenName": "Maria", 
        "id": "sg:person.010204542672.20", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.010204542672.20"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "https://doi.org/10.1016/j.websem.2012.02.003", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000616485"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.2165/00002018-200831060-00007", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001724880", 
          "https://doi.org/10.2165/00002018-200831060-00007"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1371/journal.pcbi.1002614", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1008742450"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1001/archinternmed.2011.183", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009202983"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.amjopharm.2012.01.001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009257768"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.clinthera.2011.01.021", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009649360"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.tibtech.2010.04.005", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1010070749"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/bioinformatics/btq382", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1011102218"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/978-3-540-76298-0_15", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1013075511", 
          "https://doi.org/10.1007/978-3-540-76298-0_15"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/978-3-540-76298-0_15", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1013075511", 
          "https://doi.org/10.1007/978-3-540-76298-0_15"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1532-5415.2005.53273.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014053419"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1001/archinternmed.2011.182", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014517942"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1345/aph.1r150", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1017868797"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1345/aph.1r150", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1017868797"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.2165/00003088-200241030-00001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020047502", 
          "https://doi.org/10.2165/00003088-200241030-00001"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.2165/00003088-200241030-00001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020047502", 
          "https://doi.org/10.2165/00003088-200241030-00001"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jbi.2009.05.001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020214268"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jbi.2009.05.010", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020772752"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/978-3-540-68234-9_9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1021816364", 
          "https://doi.org/10.1007/978-3-540-68234-9_9"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/978-3-540-68234-9_9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1021816364", 
          "https://doi.org/10.1007/978-3-540-68234-9_9"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jbi.2011.10.012", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1022311190"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jbi.2010.08.005", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1033311021"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/clpt.2009.198", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1033421585", 
          "https://doi.org/10.1038/clpt.2009.198"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/bib/6.1.57", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1034350578"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/sj.clpt.6100054", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1034750532", 
          "https://doi.org/10.1038/sj.clpt.6100054"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/sj.clpt.6100054", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1034750532", 
          "https://doi.org/10.1038/sj.clpt.6100054"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1758-2946-3-19", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1034947266", 
          "https://doi.org/10.1186/1758-2946-3-19"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1471-2105-11-s5-p9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1037191078", 
          "https://doi.org/10.1186/1471-2105-11-s5-p9"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1038/msb.2009.98", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038070182"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1038/msb.2009.98", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038070182"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/bioinformatics/bts071", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041348083"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jbi.2008.04.010", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1049175558"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1142/9789814366496_0040", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1049687001"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jbi.2009.11.001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051496623"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1021/ci200367w", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1055402758"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1021/ci200367w", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1055402758"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.14778/1687553.1687599", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1067367518"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.2146/ajhp100440", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1069099715"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.2146/ajhp100440", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1069099715"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.2146/ajhp100440", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1069099715"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.2200/s00334ed1v01y201102wbe001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1069288216"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.2307/2529310", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1069974986"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1074849765", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1076890776", 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2013-12", 
    "datePublishedReg": "2013-12-01", 
    "description": "Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. ", 
    "genre": "research_article", 
    "id": "sg:pub.10.1186/2041-1480-4-5", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isFundedItemOf": [
      {
        "id": "sg:grant.2416699", 
        "type": "MonetaryGrant"
      }
    ], 
    "isPartOf": [
      {
        "id": "sg:journal.1043573", 
        "issn": [
          "2041-1480"
        ], 
        "name": "Journal of Biomedical Semantics", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "4"
      }
    ], 
    "name": "Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness", 
    "pagination": "5", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "3526006a83bc3a2e6f245a452a7fa830f815af2c89e9b2df9fbd5ac4e63e29bb"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "23351881"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "101531992"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/2041-1480-4-5"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1011155400"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/2041-1480-4-5", 
      "https://app.dimensions.ai/details/publication/pub.1011155400"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-10T15:07", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000001_0000000264/records_8663_00000549.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "http://link.springer.com/10.1186%2F2041-1480-4-5"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/2041-1480-4-5'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/2041-1480-4-5'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/2041-1480-4-5'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/2041-1480-4-5'


 

This table displays all metadata directly associated to this object as RDF triples.

250 TRIPLES      21 PREDICATES      64 URIs      21 LITERALS      9 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/2041-1480-4-5 schema:about anzsrc-for:11
2 anzsrc-for:1115
3 schema:author N24857bd85e8e4c4bbde1a512ba101c29
4 schema:citation sg:pub.10.1007/978-3-540-68234-9_9
5 sg:pub.10.1007/978-3-540-76298-0_15
6 sg:pub.10.1038/clpt.2009.198
7 sg:pub.10.1038/sj.clpt.6100054
8 sg:pub.10.1186/1471-2105-11-s5-p9
9 sg:pub.10.1186/1758-2946-3-19
10 sg:pub.10.2165/00002018-200831060-00007
11 sg:pub.10.2165/00003088-200241030-00001
12 https://app.dimensions.ai/details/publication/pub.1074849765
13 https://app.dimensions.ai/details/publication/pub.1076890776
14 https://doi.org/10.1001/archinternmed.2011.182
15 https://doi.org/10.1001/archinternmed.2011.183
16 https://doi.org/10.1016/j.amjopharm.2012.01.001
17 https://doi.org/10.1016/j.clinthera.2011.01.021
18 https://doi.org/10.1016/j.jbi.2008.04.010
19 https://doi.org/10.1016/j.jbi.2009.05.001
20 https://doi.org/10.1016/j.jbi.2009.05.010
21 https://doi.org/10.1016/j.jbi.2009.11.001
22 https://doi.org/10.1016/j.jbi.2010.08.005
23 https://doi.org/10.1016/j.jbi.2011.10.012
24 https://doi.org/10.1016/j.tibtech.2010.04.005
25 https://doi.org/10.1016/j.websem.2012.02.003
26 https://doi.org/10.1021/ci200367w
27 https://doi.org/10.1038/msb.2009.98
28 https://doi.org/10.1093/bib/6.1.57
29 https://doi.org/10.1093/bioinformatics/btq382
30 https://doi.org/10.1093/bioinformatics/bts071
31 https://doi.org/10.1111/j.1532-5415.2005.53273.x
32 https://doi.org/10.1142/9789814366496_0040
33 https://doi.org/10.1345/aph.1r150
34 https://doi.org/10.1371/journal.pcbi.1002614
35 https://doi.org/10.14778/1687553.1687599
36 https://doi.org/10.2146/ajhp100440
37 https://doi.org/10.2200/s00334ed1v01y201102wbe001
38 https://doi.org/10.2307/2529310
39 schema:datePublished 2013-12
40 schema:datePublishedReg 2013-12-01
41 schema:description Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market.
42 schema:genre research_article
43 schema:inLanguage en
44 schema:isAccessibleForFree true
45 schema:isPartOf N2d90ff2e671e4dbf940a6ababd026ada
46 N6befc5d0b9bd4dffbf4ba286497f0372
47 sg:journal.1043573
48 schema:name Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness
49 schema:pagination 5
50 schema:productId N3ae3f1c11b334ed694cf1eea77caa984
51 N4f5e62a50da34f44b5627e9143441f56
52 N7f37eb9519d24bac9f682264faaa66bf
53 N9d0f6242a02949c8908b7ec3d70c6bc8
54 Necbdaf8ea78b4a4da1e948b9dadfa89e
55 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011155400
56 https://doi.org/10.1186/2041-1480-4-5
57 schema:sdDatePublished 2019-04-10T15:07
58 schema:sdLicense https://scigraph.springernature.com/explorer/license/
59 schema:sdPublisher Nf2451604f6fe48b0a0cc3eb0fa3b7787
60 schema:url http://link.springer.com/10.1186%2F2041-1480-4-5
61 sgo:license sg:explorer/license/
62 sgo:sdDataset articles
63 rdf:type schema:ScholarlyArticle
64 N033f44326d5a4ea88b86f031ba7998bc rdf:first sg:person.01112335735.57
65 rdf:rest N16ad4c7f04ab45fe806ed1ac20d96775
66 N111b4d4920ff440abaeac5422f622769 schema:name Elsevier Labs, Jericho, VT, USA
67 rdf:type schema:Organization
68 N16ad4c7f04ab45fe806ed1ac20d96775 rdf:first sg:person.01354072260.84
69 rdf:rest Ne522acc2575e4f5690cded86a7525183
70 N24857bd85e8e4c4bbde1a512ba101c29 rdf:first sg:person.01263011645.39
71 rdf:rest N9799225b71cd41178f05bc32dcfca751
72 N2d90ff2e671e4dbf940a6ababd026ada schema:issueNumber 1
73 rdf:type schema:PublicationIssue
74 N3ae3f1c11b334ed694cf1eea77caa984 schema:name readcube_id
75 schema:value 3526006a83bc3a2e6f245a452a7fa830f815af2c89e9b2df9fbd5ac4e63e29bb
76 rdf:type schema:PropertyValue
77 N4f5e62a50da34f44b5627e9143441f56 schema:name nlm_unique_id
78 schema:value 101531992
79 rdf:type schema:PropertyValue
80 N62e6f97730ff4e24906d0109e3119f1d rdf:first sg:person.012440132131.37
81 rdf:rest N951c006d8f4c41f5961b112554991272
82 N6befc5d0b9bd4dffbf4ba286497f0372 schema:volumeNumber 4
83 rdf:type schema:PublicationVolume
84 N7e982dd893d043bbbfea8807f351bf55 schema:affiliation N111b4d4920ff440abaeac5422f622769
85 schema:familyName De Waard
86 schema:givenName Anita
87 rdf:type schema:Person
88 N7f37eb9519d24bac9f682264faaa66bf schema:name dimensions_id
89 schema:value pub.1011155400
90 rdf:type schema:PropertyValue
91 N951c006d8f4c41f5961b112554991272 rdf:first N7e982dd893d043bbbfea8807f351bf55
92 rdf:rest Nb4bea6d7a85342ce96dcd9e8629cfba9
93 N9799225b71cd41178f05bc32dcfca751 rdf:first sg:person.0763175526.23
94 rdf:rest N62e6f97730ff4e24906d0109e3119f1d
95 N9d0f6242a02949c8908b7ec3d70c6bc8 schema:name doi
96 schema:value 10.1186/2041-1480-4-5
97 rdf:type schema:PropertyValue
98 Nb4bea6d7a85342ce96dcd9e8629cfba9 rdf:first sg:person.014366272167.27
99 rdf:rest N033f44326d5a4ea88b86f031ba7998bc
100 Ne522acc2575e4f5690cded86a7525183 rdf:first sg:person.010204542672.20
101 rdf:rest rdf:nil
102 Necbdaf8ea78b4a4da1e948b9dadfa89e schema:name pubmed_id
103 schema:value 23351881
104 rdf:type schema:PropertyValue
105 Nf2451604f6fe48b0a0cc3eb0fa3b7787 schema:name Springer Nature - SN SciGraph project
106 rdf:type schema:Organization
107 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
108 schema:name Medical and Health Sciences
109 rdf:type schema:DefinedTerm
110 anzsrc-for:1115 schema:inDefinedTermSet anzsrc-for:
111 schema:name Pharmacology and Pharmaceutical Sciences
112 rdf:type schema:DefinedTerm
113 sg:grant.2416699 http://pending.schema.org/fundedItem sg:pub.10.1186/2041-1480-4-5
114 rdf:type schema:MonetaryGrant
115 sg:journal.1043573 schema:issn 2041-1480
116 schema:name Journal of Biomedical Semantics
117 rdf:type schema:Periodical
118 sg:person.010204542672.20 schema:affiliation https://www.grid.ac/institutes/grid.225360.0
119 schema:familyName Liakata
120 schema:givenName Maria
121 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.010204542672.20
122 rdf:type schema:Person
123 sg:person.01112335735.57 schema:affiliation https://www.grid.ac/institutes/grid.33647.35
124 schema:familyName Luciano
125 schema:givenName Joanne S
126 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01112335735.57
127 rdf:type schema:Person
128 sg:person.012440132131.37 schema:affiliation https://www.grid.ac/institutes/grid.481554.9
129 schema:familyName Hassanzadeh
130 schema:givenName Oktie
131 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012440132131.37
132 rdf:type schema:Person
133 sg:person.01263011645.39 schema:affiliation https://www.grid.ac/institutes/grid.21925.3d
134 schema:familyName Boyce
135 schema:givenName Richard D
136 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01263011645.39
137 rdf:type schema:Person
138 sg:person.01354072260.84 schema:affiliation https://www.grid.ac/institutes/grid.267468.9
139 schema:familyName Rastegar-Mojarad
140 schema:givenName Majid
141 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01354072260.84
142 rdf:type schema:Person
143 sg:person.014366272167.27 schema:affiliation https://www.grid.ac/institutes/grid.6142.1
144 schema:familyName Schneider
145 schema:givenName Jodi
146 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014366272167.27
147 rdf:type schema:Person
148 sg:person.0763175526.23 schema:affiliation https://www.grid.ac/institutes/grid.34477.33
149 schema:familyName Horn
150 schema:givenName John R
151 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0763175526.23
152 rdf:type schema:Person
153 sg:pub.10.1007/978-3-540-68234-9_9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1021816364
154 https://doi.org/10.1007/978-3-540-68234-9_9
155 rdf:type schema:CreativeWork
156 sg:pub.10.1007/978-3-540-76298-0_15 schema:sameAs https://app.dimensions.ai/details/publication/pub.1013075511
157 https://doi.org/10.1007/978-3-540-76298-0_15
158 rdf:type schema:CreativeWork
159 sg:pub.10.1038/clpt.2009.198 schema:sameAs https://app.dimensions.ai/details/publication/pub.1033421585
160 https://doi.org/10.1038/clpt.2009.198
161 rdf:type schema:CreativeWork
162 sg:pub.10.1038/sj.clpt.6100054 schema:sameAs https://app.dimensions.ai/details/publication/pub.1034750532
163 https://doi.org/10.1038/sj.clpt.6100054
164 rdf:type schema:CreativeWork
165 sg:pub.10.1186/1471-2105-11-s5-p9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1037191078
166 https://doi.org/10.1186/1471-2105-11-s5-p9
167 rdf:type schema:CreativeWork
168 sg:pub.10.1186/1758-2946-3-19 schema:sameAs https://app.dimensions.ai/details/publication/pub.1034947266
169 https://doi.org/10.1186/1758-2946-3-19
170 rdf:type schema:CreativeWork
171 sg:pub.10.2165/00002018-200831060-00007 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001724880
172 https://doi.org/10.2165/00002018-200831060-00007
173 rdf:type schema:CreativeWork
174 sg:pub.10.2165/00003088-200241030-00001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020047502
175 https://doi.org/10.2165/00003088-200241030-00001
176 rdf:type schema:CreativeWork
177 https://app.dimensions.ai/details/publication/pub.1074849765 schema:CreativeWork
178 https://app.dimensions.ai/details/publication/pub.1076890776 schema:CreativeWork
179 https://doi.org/10.1001/archinternmed.2011.182 schema:sameAs https://app.dimensions.ai/details/publication/pub.1014517942
180 rdf:type schema:CreativeWork
181 https://doi.org/10.1001/archinternmed.2011.183 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009202983
182 rdf:type schema:CreativeWork
183 https://doi.org/10.1016/j.amjopharm.2012.01.001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009257768
184 rdf:type schema:CreativeWork
185 https://doi.org/10.1016/j.clinthera.2011.01.021 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009649360
186 rdf:type schema:CreativeWork
187 https://doi.org/10.1016/j.jbi.2008.04.010 schema:sameAs https://app.dimensions.ai/details/publication/pub.1049175558
188 rdf:type schema:CreativeWork
189 https://doi.org/10.1016/j.jbi.2009.05.001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020214268
190 rdf:type schema:CreativeWork
191 https://doi.org/10.1016/j.jbi.2009.05.010 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020772752
192 rdf:type schema:CreativeWork
193 https://doi.org/10.1016/j.jbi.2009.11.001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1051496623
194 rdf:type schema:CreativeWork
195 https://doi.org/10.1016/j.jbi.2010.08.005 schema:sameAs https://app.dimensions.ai/details/publication/pub.1033311021
196 rdf:type schema:CreativeWork
197 https://doi.org/10.1016/j.jbi.2011.10.012 schema:sameAs https://app.dimensions.ai/details/publication/pub.1022311190
198 rdf:type schema:CreativeWork
199 https://doi.org/10.1016/j.tibtech.2010.04.005 schema:sameAs https://app.dimensions.ai/details/publication/pub.1010070749
200 rdf:type schema:CreativeWork
201 https://doi.org/10.1016/j.websem.2012.02.003 schema:sameAs https://app.dimensions.ai/details/publication/pub.1000616485
202 rdf:type schema:CreativeWork
203 https://doi.org/10.1021/ci200367w schema:sameAs https://app.dimensions.ai/details/publication/pub.1055402758
204 rdf:type schema:CreativeWork
205 https://doi.org/10.1038/msb.2009.98 schema:sameAs https://app.dimensions.ai/details/publication/pub.1038070182
206 rdf:type schema:CreativeWork
207 https://doi.org/10.1093/bib/6.1.57 schema:sameAs https://app.dimensions.ai/details/publication/pub.1034350578
208 rdf:type schema:CreativeWork
209 https://doi.org/10.1093/bioinformatics/btq382 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011102218
210 rdf:type schema:CreativeWork
211 https://doi.org/10.1093/bioinformatics/bts071 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041348083
212 rdf:type schema:CreativeWork
213 https://doi.org/10.1111/j.1532-5415.2005.53273.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1014053419
214 rdf:type schema:CreativeWork
215 https://doi.org/10.1142/9789814366496_0040 schema:sameAs https://app.dimensions.ai/details/publication/pub.1049687001
216 rdf:type schema:CreativeWork
217 https://doi.org/10.1345/aph.1r150 schema:sameAs https://app.dimensions.ai/details/publication/pub.1017868797
218 rdf:type schema:CreativeWork
219 https://doi.org/10.1371/journal.pcbi.1002614 schema:sameAs https://app.dimensions.ai/details/publication/pub.1008742450
220 rdf:type schema:CreativeWork
221 https://doi.org/10.14778/1687553.1687599 schema:sameAs https://app.dimensions.ai/details/publication/pub.1067367518
222 rdf:type schema:CreativeWork
223 https://doi.org/10.2146/ajhp100440 schema:sameAs https://app.dimensions.ai/details/publication/pub.1069099715
224 rdf:type schema:CreativeWork
225 https://doi.org/10.2200/s00334ed1v01y201102wbe001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1069288216
226 rdf:type schema:CreativeWork
227 https://doi.org/10.2307/2529310 schema:sameAs https://app.dimensions.ai/details/publication/pub.1069974986
228 rdf:type schema:CreativeWork
229 https://www.grid.ac/institutes/grid.21925.3d schema:alternateName University of Pittsburgh
230 schema:name Department of Biomedical Informatics, University of Pittsburgh, Offices at Baum, 5607 Baum Blvd, Pittsburgh, PA, USA
231 rdf:type schema:Organization
232 https://www.grid.ac/institutes/grid.225360.0 schema:alternateName European Bioinformatics Institute
233 schema:name Department of Computer Science, Aberystwyth University, Wales, UK
234 Text mining group, EBI-EMBL, Hinxton, Cambridge, UK
235 rdf:type schema:Organization
236 https://www.grid.ac/institutes/grid.267468.9 schema:alternateName University of Wisconsin–Milwaukee
237 schema:name University of Wisconsin, Milwaukee, WI, USA
238 rdf:type schema:Organization
239 https://www.grid.ac/institutes/grid.33647.35 schema:alternateName Rensselaer Polytechnic Institute
240 schema:name Tetherless World Constellation, Rensselaer Polytechnic Institute, Troy, NY, USA
241 rdf:type schema:Organization
242 https://www.grid.ac/institutes/grid.34477.33 schema:alternateName University of Washington
243 schema:name Department of Pharmacy, University of Washington, Seattle, WA, USA
244 rdf:type schema:Organization
245 https://www.grid.ac/institutes/grid.481554.9 schema:alternateName IBM Research – Thomas J. Watson Research Center
246 schema:name IBM T.J. Watson Research Center, Yorktown Heights, NY, USA
247 rdf:type schema:Organization
248 https://www.grid.ac/institutes/grid.6142.1 schema:alternateName National University of Ireland, Galway
249 schema:name Digital Enterprise Research Institute, National University of Ireland, Galway, Ireland
250 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...