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

Title: An Exploratory Data Survey of Drug Name Incidence and Prevalence From the FDA's Adverse Event Reporting System, 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 2004-2012Q2 in a maximized sensitivity relational model. Methods: Data mining and data modeling was conducted and event based summary statistics with plots were created from nine continuous years of FAERS data. Results: This FAERS model contains 344,452 individual drug names and 432,541,994 drug name count references which occurred across 4,148,761 human subjects in the 34 quarter study period. FAERS has several trending outbreaks of drug name incidence reported for Adverse Events (AE). 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. Drug name surveillance and incidence reporting may serve as viable alternative to odds ratio’s and other Gaussian based statistical approaches when a maximized sensitivity relational model is used.