The role of databases in drug postmarketing surveillance

This paper describes the role of databases used for postmarketing surveillance of drugs at the United States Food and Drug Administration (FDA). First we describe the Adverse Event Reporting System (AERS), the largest database of adverse event reports in the world. Next, we explain the methods we ha...

Full description

Saved in:
Bibliographic Details
Published in:Pharmacoepidemiology and drug safety 2001-08, Vol.10 (5), p.407-410
Main Authors: Rodriguez, Evelyn M., Staffa, Judy A., Graham, David J.
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems - statistics & numerical data
adverse drug reactions
clinical trials
Clinical Trials as Topic - statistics & numerical data
clinical trials, phase IV
Community Health Planning - statistics & numerical data
consumer product safety
Databases as Topic
Drug Utilization Review - statistics & numerical data
Humans
pharmacoepidemiology
Pharmacoepidemiology - methods
Pharmacoepidemiology - statistics & numerical data
pharmacovigilance
phase IV
Product Surveillance, Postmarketing - methods
Risk Assessment - statistics & numerical data
United States
United States Food and Drug Administration - statistics & numerical data
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:This paper describes the role of databases used for postmarketing surveillance of drugs at the United States Food and Drug Administration (FDA). First we describe the Adverse Event Reporting System (AERS), the largest database of adverse event reports in the world. Next, we explain the methods we have used for assembling these adverse event reports into a case series and analysing them, as well as techniques for employing drug use databases to construct reporting rates in the evaluation of drug safety issues. Finally, we discuss the FDA's use of the databases it accesses through its Cooperative Agreement Program to conduct high priority studies to support regulatory decision‐making. Published in 2001 by John Wiley & Sons, Ltd.
ISSN:1053-8569
1099-1557
DOI:10.1002/pds.615