An Exploratory Data Survey of Drug Name Incidence and Prevalence From the FDA's Adverse Event Reporting System, 2004 to 2012Q2

TL;DR

This study analyzes over nine years of FDA's FAERS data to monitor drug name incidence and prevalence, demonstrating its utility for population-level drug safety surveillance without needing causality or report validity.

Contribution

It provides a comprehensive data mining and modeling approach to quantify drug name occurrences in FAERS, highlighting its potential for effective adverse event monitoring.

Findings

FAERS contains over 344,000 unique drug names.

Top 100 drugs account for 33% of references.

Drug incidence data enables timely population surveillance.

Abstract

Drug Names, Population Level Surveillance and the FDA's Adverse Event Reporting System: An Exploratory Data Survey of Drug Name Incidence and Prevalence, 2004-2012Q2 Purpose: To count and monitor the drug names reported in the publicly available version of the Federal Adverse Event Reporting System (FAERS) from 2004 to 2012Q2 in a maximized sensitivity relational model. Methods: Data mining and data modeling was conducted and event based summary statistics with plots were created from over nine continuous years of continuous FAERS data. Results: This FAERS model contains 344,452 individual drug names and 432,541,994 count references which occurred across 4,148,761 human subjects in the 34 quarter study period. Plots for the top 100 scoring drug name references are reported by year and quarter; the top 100 drug names contain 143,384,240 references or 33% of all drug name references over 34 quarters of continuous FAERS data. Conclusions: While FAERS contains many drugs and adverse event reports, its data pertains to very few of them. Drug name incidence lends timely and effective surveillance of large populations of Averse Event Reports and does not require the cause of the AE, nor its validity to be known to detect a mass poisoning.