Abstract
DATE: |
May 7, 2009 |
TIME: |
1:15 - 3:00 pm |
LOCATION: |
Center for Clinical Sciences Research (CCSR), Rm 4205 |
TITLE: |
Post Marketing Drug Surveillance |
SPEAKER: |
Margaret V Bjarnadottir |
After the withdrawal of Rofecoxib (Vioxx) from the pharmaceutical
market in 2004, post-FDA-approval drug safety and surveillance came under
serious scrutiny. Some pointed towards health insurance claims data as a
potential data source for additional post marketing monitoring.
To date, studies have been limited in their scope, and none have
implemented drug monitoring across all possible adverse effects.
In our work we build a mathematical framework for a real-time
drug surveillance system that uses claims-data and run an experiment
across the full spectrum of possible side effects. We point out some
modeling aspects and empirical observations that contribute to a successful
drug-surveillance system. Our results show that drug monitoring based on
claims data analysis can raise early warning signs and could become one of
FDA's standard tools for post-marketing surveillance.
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