Improving Drug Safety: Critical Elements of a "Learning Heathcare System"

Improving drug safety has become a public health mandate as evidenced by the launch of the FDA’s Sentinel Initiative (2008) and the establishment of the new Reagan Udall Foundation (2007). What can we do to ensure that these initiatives deliver tangible value to patients? Where are the potential synergies between the Sentinel Initiative and a Learning Healthcare System? What can we learn from other industries that have grappled with how to optimize benefits and risks when implementing product/process innovation within complex social-political-technical systems? This timely discussion will provide a valuable contribution to the national dialogue on drug safety, and will pave the way for future discussions on emerging paradigms in value-based reimbursement models and personalized healthcare.