Evidence-Based Risk Management: How Can We Succeed?: Deliberations from a Risk Management Advisory Council

Abstract

Risk management represents a fundamental shift in the traditional paradigm of the healthcare system from a passive, information-oriented role, communicating warnings and side effects, to one of action and accountability for the safe use of drugs within the marketplace. To further the healthcare system's goal of developing better risk management programs to ensure safe pharmaceutical use and protect public health, a risk-management advisory council, composed of 25 experts, was convened in late 2001. The objectives were to: 1. discuss the utility of available data resources for risk management efforts, identifying strengths, limitations, and lessons learned; 2. identify gaps in systems, data elements, and methodologies; and 3. outline principles of good practice to reliably assess risk. This paper describes the deliberations and conclusions from the one and a half-day meeting of the council; it includes a brief update on Food and Drug Administration risk management activities since that time.