The Role of Statistics and Opportunities for Statisticians in Active Drug Safety Surveillance

• Activity Number: 442
• Type: Invited
• Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Health Policy Statistics Section
• Author(s): Patrick Ryan*+
• Companies: GlaxoSmithKline
• Keywords: safety ; health care ; active surveillance ; observational data

Abstract

Drug safety is a major public health concern in the United States, with adverse drug reactions ranking as a leading cause of death, and resulting in health care costs of $3.6 billion annually. Recent media attention and public scrutiny of high-profile drug safety issues have increased visibility and skepticism of the effectiveness of the current post-approval safety surveillance processes. Efforts have been initiated to establish a national active surveillance system that leverages observational data, including administrative claims and electronic health records, to monitor and evaluate potential safety issues of medicines. This presentation will highlight opportunities for applying statistics to observational healthcare databases, and discuss the potential role of statisticians in better understanding the effects of medicines in a post-approval environment.