Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration
Article first published online: 22 FEB 2012
Published 2012. This article is a US Government work and is in the public domain in the USA.
Pharmacoepidemiology and Drug Safety
Volume 21, Issue 6, pages 565–570, June 2012
How to Cite
Brajovic, S., Piazza-Hepp, T., Swartz, L. and Dal Pan, G. (2012), Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. Pharmacoepidem. Drug Safe., 21: 565–570. doi: 10.1002/pds.3223
- Issue published online: 7 JUN 2012
- Article first published online: 22 FEB 2012
- Manuscript Accepted: 3 JAN 2012
- Manuscript Revised: 16 DEC 2011
- Manuscript Received: 9 JUN 2011
- triggered adverse event reporting;
- postmarketing surveillance;
- electronic health records;
- data quality
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.
ASTER pilot study reports were identified from the FDA Adverse Event Reporting System database, then reviewed and assessed.
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.
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. Published 2012. This article is a US Government work and is in the public domain in the USA.