Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS) View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-09-26

AUTHORS

Keith B. Hoffman, Andrea R. Demakas, Mo Dimbil, Nicholas P. Tatonetti, Colin B. Erdman

ABSTRACT

BACKGROUND: The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. OBJECTIVE: To determine the extent of "stimulated reporting" in the modern-day FAERS database. METHODS: One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. RESULTS: A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. CONCLUSIONS: Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts. More... »

PAGES

971-980

References to SciGraph publications

  • 2007-10. Impact of Safety Alerts on Measures of Disproportionality in Spontaneous Reporting Databases The Notoriety Bias in DRUG SAFETY
  • 2014-03-19. The Weber Effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010 in DRUG SAFETY
  • 2004-07. Communication of Medical Product Risk in DRUG SAFETY
  • 2009-11. Risk Management Policy and Black-Box Warnings in DRUG SAFETY
  • 2002-12-28. The impact of wording in “Dear doctor” letters and in black box labels in CLINICAL PHARMACOLOGY & THERAPEUTICS
  • 2012-05. Impact of Safety-Related Regulatory Action on Clinical Practice in DRUG SAFETY
  • 2003-01. Adverse drug event monitoring at the food and drug administration in JOURNAL OF GENERAL INTERNAL MEDICINE
  • 2008-07. Influence of Regulatory Measures on the Rate of Spontaneous Adverse Drug Reaction Reporting in Italy in DRUG SAFETY
  • 2006-05. Under-Reporting of Adverse Drug Reactions in DRUG SAFETY
  • 2011-10-19. The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database in ACTA DIABETOLOGICA
  • 1987. Epidemiology in the United Kingdom of adverse drug reactions from non-steroidal anti-inflammatory drugs in SIDE-EFFECTS OF ANTI-INFLAMMATORY DRUGS
  • 2009-01. Determinants of Under-Reporting of Adverse Drug Reactions in DRUG SAFETY
  • 2012-02-01. Regulatory Innovation in Postmarketing Risk Assessment and Management in CLINICAL PHARMACOLOGY & THERAPEUTICS
  • 2009-12. Messages about Black-Box Warnings in DRUG SAFETY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s40264-014-0225-0

    DOI

    http://dx.doi.org/10.1007/s40264-014-0225-0

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1038298482

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/25255848


    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/2008/11", 
            "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
            "name": "Medical and Health Sciences", 
            "type": "DefinedTerm"
          }, 
          {
            "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1117", 
            "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
            "name": "Public Health and Health Services", 
            "type": "DefinedTerm"
          }, 
          {
            "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
            "name": "Adverse Drug Reaction Reporting Systems", 
            "type": "DefinedTerm"
          }, 
          {
            "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
            "name": "Humans", 
            "type": "DefinedTerm"
          }, 
          {
            "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
            "name": "Product Surveillance, Postmarketing", 
            "type": "DefinedTerm"
          }, 
          {
            "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
            "name": "Program Evaluation", 
            "type": "DefinedTerm"
          }, 
          {
            "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
            "name": "United States", 
            "type": "DefinedTerm"
          }, 
          {
            "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
            "name": "United States Food and Drug Administration", 
            "type": "DefinedTerm"
          }
        ], 
        "author": [
          {
            "affiliation": {
              "alternateName": "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA", 
              "id": "http://www.grid.ac/institutes/None", 
              "name": [
                "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA"
              ], 
              "type": "Organization"
            }, 
            "familyName": "Hoffman", 
            "givenName": "Keith B.", 
            "id": "sg:person.01140725314.30", 
            "sameAs": [
              "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01140725314.30"
            ], 
            "type": "Person"
          }, 
          {
            "affiliation": {
              "alternateName": "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA", 
              "id": "http://www.grid.ac/institutes/None", 
              "name": [
                "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA"
              ], 
              "type": "Organization"
            }, 
            "familyName": "Demakas", 
            "givenName": "Andrea R.", 
            "id": "sg:person.01207040514.21", 
            "sameAs": [
              "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01207040514.21"
            ], 
            "type": "Person"
          }, 
          {
            "affiliation": {
              "alternateName": "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA", 
              "id": "http://www.grid.ac/institutes/None", 
              "name": [
                "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA"
              ], 
              "type": "Organization"
            }, 
            "familyName": "Dimbil", 
            "givenName": "Mo", 
            "id": "sg:person.0743435467.02", 
            "sameAs": [
              "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0743435467.02"
            ], 
            "type": "Person"
          }, 
          {
            "affiliation": {
              "alternateName": "Department of Biomedical Informatics, Columbia University, New York, USA", 
              "id": "http://www.grid.ac/institutes/grid.21729.3f", 
              "name": [
                "Department of Biomedical Informatics, Columbia University, New York, USA"
              ], 
              "type": "Organization"
            }, 
            "familyName": "Tatonetti", 
            "givenName": "Nicholas P.", 
            "id": "sg:person.0651210417.29", 
            "sameAs": [
              "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0651210417.29"
            ], 
            "type": "Person"
          }, 
          {
            "affiliation": {
              "alternateName": "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA", 
              "id": "http://www.grid.ac/institutes/None", 
              "name": [
                "AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA"
              ], 
              "type": "Organization"
            }, 
            "familyName": "Erdman", 
            "givenName": "Colin B.", 
            "id": "sg:person.01255153714.59", 
            "sameAs": [
              "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01255153714.59"
            ], 
            "type": "Person"
          }
        ], 
        "citation": [
          {
            "id": "sg:pub.10.1007/s00592-011-0340-7", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1020378910", 
              "https://doi.org/10.1007/s00592-011-0340-7"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/00002018-200629050-00003", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1012106416", 
              "https://doi.org/10.2165/00002018-200629050-00003"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1067/mcp.2002.129503", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1010111901", 
              "https://doi.org/10.1067/mcp.2002.129503"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/00002018-200427080-00005", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1051483319", 
              "https://doi.org/10.2165/00002018-200427080-00005"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/11599100-000000000-00000", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1012305707", 
              "https://doi.org/10.2165/11599100-000000000-00000"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/11318960-000000000-00000", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1025481960", 
              "https://doi.org/10.2165/11318960-000000000-00000"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1038/clpt.2011.289", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1042221117", 
              "https://doi.org/10.1038/clpt.2011.289"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/978-94-010-9772-7_2", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1033512686", 
              "https://doi.org/10.1007/978-94-010-9772-7_2"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/s40264-014-0150-2", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1028340694", 
              "https://doi.org/10.1007/s40264-014-0150-2"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/11316670-000000000-00000", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1000027279", 
              "https://doi.org/10.2165/11316670-000000000-00000"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1046/j.1525-1497.2003.20130.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1039330498", 
              "https://doi.org/10.1046/j.1525-1497.2003.20130.x"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/00002018-200730100-00007", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1005348063", 
              "https://doi.org/10.2165/00002018-200730100-00007"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/00002018-200932010-00002", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1042490964", 
              "https://doi.org/10.2165/00002018-200932010-00002"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/00002018-200831070-00006", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1014555328", 
              "https://doi.org/10.2165/00002018-200831070-00006"
            ], 
            "type": "CreativeWork"
          }
        ], 
        "datePublished": "2014-09-26", 
        "datePublishedReg": "2014-09-26", 
        "description": "BACKGROUND: The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that \"stimulated reporting\" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA.\nOBJECTIVE: To determine the extent of \"stimulated reporting\" in the modern-day FAERS database.\nMETHODS: One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the \"primary suspect\" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert.\nRESULTS: A few drugs did demonstrate \"stimulated reporting\" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham \"control alert\", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1\u00a0%) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1\u00a0% increase.\nCONCLUSIONS: Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.", 
        "genre": "article", 
        "id": "sg:pub.10.1007/s40264-014-0225-0", 
        "inLanguage": "en", 
        "isAccessibleForFree": true, 
        "isFundedItemOf": [
          {
            "id": "sg:grant.3801821", 
            "type": "MonetaryGrant"
          }
        ], 
        "isPartOf": [
          {
            "id": "sg:journal.1096281", 
            "issn": [
              "0114-5916", 
              "1179-1942"
            ], 
            "name": "Drug Safety", 
            "publisher": "Springer Nature", 
            "type": "Periodical"
          }, 
          {
            "issueNumber": "11", 
            "type": "PublicationIssue"
          }, 
          {
            "type": "PublicationVolume", 
            "volumeNumber": "37"
          }
        ], 
        "keywords": [
          "Adverse Event Reporting System", 
          "FDA alert", 
          "Event Reporting System", 
          "adverse events", 
          "US Food", 
          "AE reporting patterns", 
          "drug safety information", 
          "safety surveillance program", 
          "reporting system", 
          "case report", 
          "Drug Administration", 
          "comprehensive search", 
          "FDA MedWatch", 
          "reporting trends", 
          "surveillance program", 
          "percentage change", 
          "FAERS data", 
          "drugs", 
          "label changes", 
          "primary suspect", 
          "MedWatch", 
          "reporting patterns", 
          "safety information", 
          "FDA", 
          "little evidence", 
          "reporting", 
          "sham", 
          "long-term analysis", 
          "FAERS", 
          "administration", 
          "alerts", 
          "food", 
          "FAERS", 
          "changes", 
          "report", 
          "increase", 
          "majority", 
          "years", 
          "reporting changes", 
          "response", 
          "evidence", 
          "database", 
          "trends", 
          "quarter", 
          "events", 
          "analysis", 
          "suspects", 
          "search", 
          "program", 
          "extent", 
          "patterns", 
          "data", 
          "impact", 
          "results", 
          "limitations", 
          "information", 
          "warning", 
          "main website", 
          "real alerts", 
          "websites", 
          "system", 
          "vast repository", 
          "issuance", 
          "repository", 
          "assumption", 
          "post-marketing safety surveillance programs", 
          "limitation of FAERS", 
          "modern-day FAERS database", 
          "FAERS database", 
          "available FAERS data", 
          "significant reporting changes", 
          "issuance of alerts", 
          "control alert", 
          "overall reporting trends", 
          "short-term reporting trends", 
          "sham alerts", 
          "modern day FAERS reporting", 
          "day FAERS reporting", 
          "FAERS reporting", 
          "Drug Administration-Issued Alerts", 
          "Administration-Issued Alerts"
        ], 
        "name": "Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)", 
        "pagination": "971-980", 
        "productId": [
          {
            "name": "dimensions_id", 
            "type": "PropertyValue", 
            "value": [
              "pub.1038298482"
            ]
          }, 
          {
            "name": "doi", 
            "type": "PropertyValue", 
            "value": [
              "10.1007/s40264-014-0225-0"
            ]
          }, 
          {
            "name": "pubmed_id", 
            "type": "PropertyValue", 
            "value": [
              "25255848"
            ]
          }
        ], 
        "sameAs": [
          "https://doi.org/10.1007/s40264-014-0225-0", 
          "https://app.dimensions.ai/details/publication/pub.1038298482"
        ], 
        "sdDataset": "articles", 
        "sdDatePublished": "2021-11-01T18:21", 
        "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
        "sdPublisher": {
          "name": "Springer Nature - SN SciGraph project", 
          "type": "Organization"
        }, 
        "sdSource": "s3://com-springernature-scigraph/baseset/20211101/entities/gbq_results/article/article_619.jsonl", 
        "type": "ScholarlyArticle", 
        "url": "https://doi.org/10.1007/s40264-014-0225-0"
      }
    ]
     

    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.10.1007/s40264-014-0225-0'

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

    curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s40264-014-0225-0'

    Turtle is a human-readable linked data format.

    curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s40264-014-0225-0'

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

    curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s40264-014-0225-0'


     

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

    255 TRIPLES      22 PREDICATES      126 URIs      104 LITERALS      13 BLANK NODES

    Subject Predicate Object
    1 sg:pub.10.1007/s40264-014-0225-0 schema:about N1bec6065c24f480480a4c3841a18a632
    2 N93f44eb2f43647eea4fc12e0c3b12ee2
    3 Nc864b5ba74304ad89752447a40c0d72f
    4 Nd6a147f8129340b2a0e705d9f077d297
    5 Nf1560921daaf4aa2952705cd387dc519
    6 Nf38a1cadbcb54b9bab800a7c3c01f2b0
    7 anzsrc-for:11
    8 anzsrc-for:1117
    9 schema:author Nddc3f15aa94547f2974bc2357cd05248
    10 schema:citation sg:pub.10.1007/978-94-010-9772-7_2
    11 sg:pub.10.1007/s00592-011-0340-7
    12 sg:pub.10.1007/s40264-014-0150-2
    13 sg:pub.10.1038/clpt.2011.289
    14 sg:pub.10.1046/j.1525-1497.2003.20130.x
    15 sg:pub.10.1067/mcp.2002.129503
    16 sg:pub.10.2165/00002018-200427080-00005
    17 sg:pub.10.2165/00002018-200629050-00003
    18 sg:pub.10.2165/00002018-200730100-00007
    19 sg:pub.10.2165/00002018-200831070-00006
    20 sg:pub.10.2165/00002018-200932010-00002
    21 sg:pub.10.2165/11316670-000000000-00000
    22 sg:pub.10.2165/11318960-000000000-00000
    23 sg:pub.10.2165/11599100-000000000-00000
    24 schema:datePublished 2014-09-26
    25 schema:datePublishedReg 2014-09-26
    26 schema:description BACKGROUND: The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. OBJECTIVE: To determine the extent of "stimulated reporting" in the modern-day FAERS database. METHODS: One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. RESULTS: A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. CONCLUSIONS: Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.
    27 schema:genre article
    28 schema:inLanguage en
    29 schema:isAccessibleForFree true
    30 schema:isPartOf N191c0295aaf04202b4676bb4a9607782
    31 N2dd7b19abe814b9aa8c7de5f750a92ea
    32 sg:journal.1096281
    33 schema:keywords AE reporting patterns
    34 Administration-Issued Alerts
    35 Adverse Event Reporting System
    36 Drug Administration
    37 Drug Administration-Issued Alerts
    38 Event Reporting System
    39 FAERS
    40 FAERS data
    41 FAERS database
    42 FAERS reporting
    43 FDA
    44 FDA MedWatch
    45 FDA alert
    46 MedWatch
    47 US Food
    48 administration
    49 adverse events
    50 alerts
    51 analysis
    52 assumption
    53 available FAERS data
    54 case report
    55 changes
    56 comprehensive search
    57 control alert
    58 data
    59 database
    60 day FAERS reporting
    61 drug safety information
    62 drugs
    63 events
    64 evidence
    65 extent
    66 food
    67 impact
    68 increase
    69 information
    70 issuance
    71 issuance of alerts
    72 label changes
    73 limitation of FAERS
    74 limitations
    75 little evidence
    76 long-term analysis
    77 main website
    78 majority
    79 modern day FAERS reporting
    80 modern-day FAERS database
    81 overall reporting trends
    82 patterns
    83 percentage change
    84 post-marketing safety surveillance programs
    85 primary suspect
    86 program
    87 quarter
    88 real alerts
    89 report
    90 reporting
    91 reporting changes
    92 reporting patterns
    93 reporting system
    94 reporting trends
    95 repository
    96 response
    97 results
    98 safety information
    99 safety surveillance program
    100 search
    101 sham
    102 sham alerts
    103 short-term reporting trends
    104 significant reporting changes
    105 surveillance program
    106 suspects
    107 system
    108 trends
    109 vast repository
    110 warning
    111 websites
    112 years
    113 schema:name Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)
    114 schema:pagination 971-980
    115 schema:productId N030b4637321d4578931c3386d2720f50
    116 N69bd53419b69474fa6f061c80492614b
    117 Nee472f2e9b354e28a1bb86ac16f3b01e
    118 schema:sameAs https://app.dimensions.ai/details/publication/pub.1038298482
    119 https://doi.org/10.1007/s40264-014-0225-0
    120 schema:sdDatePublished 2021-11-01T18:21
    121 schema:sdLicense https://scigraph.springernature.com/explorer/license/
    122 schema:sdPublisher Naa45cd4964334e9fb6df4986dcc8fe1d
    123 schema:url https://doi.org/10.1007/s40264-014-0225-0
    124 sgo:license sg:explorer/license/
    125 sgo:sdDataset articles
    126 rdf:type schema:ScholarlyArticle
    127 N030b4637321d4578931c3386d2720f50 schema:name doi
    128 schema:value 10.1007/s40264-014-0225-0
    129 rdf:type schema:PropertyValue
    130 N0a9ef656d58148569f33ee4c9bbe5eb0 rdf:first sg:person.01207040514.21
    131 rdf:rest N1380beb7a002408facf41379cd3790c7
    132 N0d66f72550a04c299c0310fbef63a88a rdf:first sg:person.0651210417.29
    133 rdf:rest N43e1e971df724de796e75c7390c74595
    134 N1380beb7a002408facf41379cd3790c7 rdf:first sg:person.0743435467.02
    135 rdf:rest N0d66f72550a04c299c0310fbef63a88a
    136 N191c0295aaf04202b4676bb4a9607782 schema:issueNumber 11
    137 rdf:type schema:PublicationIssue
    138 N1bec6065c24f480480a4c3841a18a632 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
    139 schema:name United States Food and Drug Administration
    140 rdf:type schema:DefinedTerm
    141 N2dd7b19abe814b9aa8c7de5f750a92ea schema:volumeNumber 37
    142 rdf:type schema:PublicationVolume
    143 N43e1e971df724de796e75c7390c74595 rdf:first sg:person.01255153714.59
    144 rdf:rest rdf:nil
    145 N69bd53419b69474fa6f061c80492614b schema:name pubmed_id
    146 schema:value 25255848
    147 rdf:type schema:PropertyValue
    148 N93f44eb2f43647eea4fc12e0c3b12ee2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
    149 schema:name Adverse Drug Reaction Reporting Systems
    150 rdf:type schema:DefinedTerm
    151 Naa45cd4964334e9fb6df4986dcc8fe1d schema:name Springer Nature - SN SciGraph project
    152 rdf:type schema:Organization
    153 Nc864b5ba74304ad89752447a40c0d72f schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
    154 schema:name Program Evaluation
    155 rdf:type schema:DefinedTerm
    156 Nd6a147f8129340b2a0e705d9f077d297 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
    157 schema:name United States
    158 rdf:type schema:DefinedTerm
    159 Nddc3f15aa94547f2974bc2357cd05248 rdf:first sg:person.01140725314.30
    160 rdf:rest N0a9ef656d58148569f33ee4c9bbe5eb0
    161 Nee472f2e9b354e28a1bb86ac16f3b01e schema:name dimensions_id
    162 schema:value pub.1038298482
    163 rdf:type schema:PropertyValue
    164 Nf1560921daaf4aa2952705cd387dc519 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
    165 schema:name Humans
    166 rdf:type schema:DefinedTerm
    167 Nf38a1cadbcb54b9bab800a7c3c01f2b0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
    168 schema:name Product Surveillance, Postmarketing
    169 rdf:type schema:DefinedTerm
    170 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
    171 schema:name Medical and Health Sciences
    172 rdf:type schema:DefinedTerm
    173 anzsrc-for:1117 schema:inDefinedTermSet anzsrc-for:
    174 schema:name Public Health and Health Services
    175 rdf:type schema:DefinedTerm
    176 sg:grant.3801821 http://pending.schema.org/fundedItem sg:pub.10.1007/s40264-014-0225-0
    177 rdf:type schema:MonetaryGrant
    178 sg:journal.1096281 schema:issn 0114-5916
    179 1179-1942
    180 schema:name Drug Safety
    181 schema:publisher Springer Nature
    182 rdf:type schema:Periodical
    183 sg:person.01140725314.30 schema:affiliation grid-institutes:None
    184 schema:familyName Hoffman
    185 schema:givenName Keith B.
    186 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01140725314.30
    187 rdf:type schema:Person
    188 sg:person.01207040514.21 schema:affiliation grid-institutes:None
    189 schema:familyName Demakas
    190 schema:givenName Andrea R.
    191 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01207040514.21
    192 rdf:type schema:Person
    193 sg:person.01255153714.59 schema:affiliation grid-institutes:None
    194 schema:familyName Erdman
    195 schema:givenName Colin B.
    196 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01255153714.59
    197 rdf:type schema:Person
    198 sg:person.0651210417.29 schema:affiliation grid-institutes:grid.21729.3f
    199 schema:familyName Tatonetti
    200 schema:givenName Nicholas P.
    201 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0651210417.29
    202 rdf:type schema:Person
    203 sg:person.0743435467.02 schema:affiliation grid-institutes:None
    204 schema:familyName Dimbil
    205 schema:givenName Mo
    206 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0743435467.02
    207 rdf:type schema:Person
    208 sg:pub.10.1007/978-94-010-9772-7_2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1033512686
    209 https://doi.org/10.1007/978-94-010-9772-7_2
    210 rdf:type schema:CreativeWork
    211 sg:pub.10.1007/s00592-011-0340-7 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020378910
    212 https://doi.org/10.1007/s00592-011-0340-7
    213 rdf:type schema:CreativeWork
    214 sg:pub.10.1007/s40264-014-0150-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1028340694
    215 https://doi.org/10.1007/s40264-014-0150-2
    216 rdf:type schema:CreativeWork
    217 sg:pub.10.1038/clpt.2011.289 schema:sameAs https://app.dimensions.ai/details/publication/pub.1042221117
    218 https://doi.org/10.1038/clpt.2011.289
    219 rdf:type schema:CreativeWork
    220 sg:pub.10.1046/j.1525-1497.2003.20130.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1039330498
    221 https://doi.org/10.1046/j.1525-1497.2003.20130.x
    222 rdf:type schema:CreativeWork
    223 sg:pub.10.1067/mcp.2002.129503 schema:sameAs https://app.dimensions.ai/details/publication/pub.1010111901
    224 https://doi.org/10.1067/mcp.2002.129503
    225 rdf:type schema:CreativeWork
    226 sg:pub.10.2165/00002018-200427080-00005 schema:sameAs https://app.dimensions.ai/details/publication/pub.1051483319
    227 https://doi.org/10.2165/00002018-200427080-00005
    228 rdf:type schema:CreativeWork
    229 sg:pub.10.2165/00002018-200629050-00003 schema:sameAs https://app.dimensions.ai/details/publication/pub.1012106416
    230 https://doi.org/10.2165/00002018-200629050-00003
    231 rdf:type schema:CreativeWork
    232 sg:pub.10.2165/00002018-200730100-00007 schema:sameAs https://app.dimensions.ai/details/publication/pub.1005348063
    233 https://doi.org/10.2165/00002018-200730100-00007
    234 rdf:type schema:CreativeWork
    235 sg:pub.10.2165/00002018-200831070-00006 schema:sameAs https://app.dimensions.ai/details/publication/pub.1014555328
    236 https://doi.org/10.2165/00002018-200831070-00006
    237 rdf:type schema:CreativeWork
    238 sg:pub.10.2165/00002018-200932010-00002 schema:sameAs https://app.dimensions.ai/details/publication/pub.1042490964
    239 https://doi.org/10.2165/00002018-200932010-00002
    240 rdf:type schema:CreativeWork
    241 sg:pub.10.2165/11316670-000000000-00000 schema:sameAs https://app.dimensions.ai/details/publication/pub.1000027279
    242 https://doi.org/10.2165/11316670-000000000-00000
    243 rdf:type schema:CreativeWork
    244 sg:pub.10.2165/11318960-000000000-00000 schema:sameAs https://app.dimensions.ai/details/publication/pub.1025481960
    245 https://doi.org/10.2165/11318960-000000000-00000
    246 rdf:type schema:CreativeWork
    247 sg:pub.10.2165/11599100-000000000-00000 schema:sameAs https://app.dimensions.ai/details/publication/pub.1012305707
    248 https://doi.org/10.2165/11599100-000000000-00000
    249 rdf:type schema:CreativeWork
    250 grid-institutes:None schema:alternateName AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA
    251 schema:name AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403 USA
    252 rdf:type schema:Organization
    253 grid-institutes:grid.21729.3f schema:alternateName Department of Biomedical Informatics, Columbia University, New York, USA
    254 schema:name Department of Biomedical Informatics, Columbia University, New York, USA
    255 rdf:type schema:Organization
     




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


    ...