Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration

Sonja Brajovic, Toni Piazza-Hepp, Lynette Swartz, Gerald Dal Pan

Research output: Contribution to journalArticle

Abstract

Purpose: The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA's first experience with the receipt of electronic health record (EHR)-triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA's pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting. Methods: ASTER pilot study reports were identified from the FDA Adverse Event Reporting System database, then reviewed and assessed. Results: Demographic and other objective data that can be easily derived from EHRs were both present in the submitted reports and relevant to the reported adverse drug event (ADE), but other data, such as an informative description of the ADE, dates that support a temporal relationship between the product and the event, and relevant laboratory data, were often either conflicting or lacking. Most of the ADEs captured in the ASTER pilot and reported to FDA are known events (i.e. included in product labeling) for the suspect drugs. Conclusion: Triggered adverse event reporting from patient EHRs is a potentially valuable source of postmarketing safety information, especially for known adverse events. Attention to quality is needed to ensure that the data generated from EHR-triggered ADE reporting systems are relevant to the reported adverse events so that the FDA and others engaged in pharmacovigilance can fully utilize these reports.

Original languageEnglish (US)
Pages (from-to)565-570
Number of pages6
JournalPharmacoepidemiology and Drug Safety
Volume21
Issue number6
DOIs
StatePublished - Jun 2012
Externally publishedYes

Fingerprint

United States Food and Drug Administration
Drug-Related Side Effects and Adverse Reactions
Electronic Health Records
Pharmacovigilance
Drug Labeling
Demography
Databases
Safety

Keywords

  • Data quality
  • Electronic health records
  • Postmarketing surveillance
  • Triggered adverse event reporting

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Epidemiology

Cite this

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. / Brajovic, Sonja; Piazza-Hepp, Toni; Swartz, Lynette; Dal Pan, Gerald.

In: Pharmacoepidemiology and Drug Safety, Vol. 21, No. 6, 06.2012, p. 565-570.

Research output: Contribution to journalArticle

Brajovic, Sonja ; Piazza-Hepp, Toni ; Swartz, Lynette ; Dal Pan, Gerald. / Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. In: Pharmacoepidemiology and Drug Safety. 2012 ; Vol. 21, No. 6. pp. 565-570.
@article{c438e9e152f74466bca97937dff064f6,
title = "Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration",
abstract = "Purpose: The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA's first experience with the receipt of electronic health record (EHR)-triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA's pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting. Methods: ASTER pilot study reports were identified from the FDA Adverse Event Reporting System database, then reviewed and assessed. Results: Demographic and other objective data that can be easily derived from EHRs were both present in the submitted reports and relevant to the reported adverse drug event (ADE), but other data, such as an informative description of the ADE, dates that support a temporal relationship between the product and the event, and relevant laboratory data, were often either conflicting or lacking. Most of the ADEs captured in the ASTER pilot and reported to FDA are known events (i.e. included in product labeling) for the suspect drugs. Conclusion: Triggered adverse event reporting from patient EHRs is a potentially valuable source of postmarketing safety information, especially for known adverse events. Attention to quality is needed to ensure that the data generated from EHR-triggered ADE reporting systems are relevant to the reported adverse events so that the FDA and others engaged in pharmacovigilance can fully utilize these reports.",
keywords = "Data quality, Electronic health records, Postmarketing surveillance, Triggered adverse event reporting",
author = "Sonja Brajovic and Toni Piazza-Hepp and Lynette Swartz and {Dal Pan}, Gerald",
year = "2012",
month = "6",
doi = "10.1002/pds.3223",
language = "English (US)",
volume = "21",
pages = "565--570",
journal = "Pharmacoepidemiology and Drug Safety",
issn = "1053-8569",
publisher = "John Wiley and Sons Ltd",
number = "6",

}

TY - JOUR

T1 - Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration

AU - Brajovic, Sonja

AU - Piazza-Hepp, Toni

AU - Swartz, Lynette

AU - Dal Pan, Gerald

PY - 2012/6

Y1 - 2012/6

N2 - Purpose: The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA's first experience with the receipt of electronic health record (EHR)-triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA's pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting. Methods: ASTER pilot study reports were identified from the FDA Adverse Event Reporting System database, then reviewed and assessed. Results: Demographic and other objective data that can be easily derived from EHRs were both present in the submitted reports and relevant to the reported adverse drug event (ADE), but other data, such as an informative description of the ADE, dates that support a temporal relationship between the product and the event, and relevant laboratory data, were often either conflicting or lacking. Most of the ADEs captured in the ASTER pilot and reported to FDA are known events (i.e. included in product labeling) for the suspect drugs. Conclusion: Triggered adverse event reporting from patient EHRs is a potentially valuable source of postmarketing safety information, especially for known adverse events. Attention to quality is needed to ensure that the data generated from EHR-triggered ADE reporting systems are relevant to the reported adverse events so that the FDA and others engaged in pharmacovigilance can fully utilize these reports.

AB - Purpose: The Food and Drug Administration (FDA) conducted a quality assessment of the Adverse Drug Events Spontaneous Triggered Event Reporting (ASTER) pilot study, which represented the FDA's first experience with the receipt of electronic health record (EHR)-triggered adverse event reports. The EHR-triggered adverse event reports from ASTER were evaluated for their utility in conducting FDA's pharmacovigilance work. FDA is sharing these findings to assist others who are pursuing the use of patient EHR data for electronic adverse event identification and reporting. Methods: ASTER pilot study reports were identified from the FDA Adverse Event Reporting System database, then reviewed and assessed. Results: Demographic and other objective data that can be easily derived from EHRs were both present in the submitted reports and relevant to the reported adverse drug event (ADE), but other data, such as an informative description of the ADE, dates that support a temporal relationship between the product and the event, and relevant laboratory data, were often either conflicting or lacking. Most of the ADEs captured in the ASTER pilot and reported to FDA are known events (i.e. included in product labeling) for the suspect drugs. Conclusion: Triggered adverse event reporting from patient EHRs is a potentially valuable source of postmarketing safety information, especially for known adverse events. Attention to quality is needed to ensure that the data generated from EHR-triggered ADE reporting systems are relevant to the reported adverse events so that the FDA and others engaged in pharmacovigilance can fully utilize these reports.

KW - Data quality

KW - Electronic health records

KW - Postmarketing surveillance

KW - Triggered adverse event reporting

UR - http://www.scopus.com/inward/record.url?scp=84862261002&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84862261002&partnerID=8YFLogxK

U2 - 10.1002/pds.3223

DO - 10.1002/pds.3223

M3 - Article

VL - 21

SP - 565

EP - 570

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

SN - 1053-8569

IS - 6

ER -