Objective: To review the effectiveness and feasibility of risk management strategies implemented for drugs with significant known risks.
Data sources: Published medical literature and regulatory archives, including proceedings of Food and Drug Administration advisory committee meetings. Iterative searches of the medical literature, the Internet, and Web-based government information sources were conducted throughout 2002-2003. Search terms were related to risk management, drug safety, and the names of specific medications known to be subject to risk management programs.
Study selection: Key studies that illustrated examples of risk management and evaluated risk management programs were selected by the authors.
Data extraction: Performed manually by the authors.
Data synthesis: Much of the information regarding the effectiveness of risk management interventions in reducing risk is anecdotal; little information has been published. Given the demand for evidence-based clinical decision making, pharmaceutical manufacturers and the health care community must understand whether these programs are achieving their ultimate goals of reducing risks to patients, while making needed therapies available. This paucity of evidence points to new opportunities for researchers across disciplines to better understand the feasibility and effectiveness of these interventions and the impact of the interventions at the patient, practitioner, and public health levels. Such research needs to be published so that future programs and policy can be informed by these early examples.
Conclusion: For interventions to be effective in reducing risk, they must effect change in physician prescribing, pharmacist dispensing, and patient adherence. Risk intervention programs that are overly burdensome to physicians, pharmacists, or patients are unlikely to succeed in achieving the desired outcome of reducing individual risk. In addition, risk management programs should be scaleable and implemented in a systematic fashion to accommodate multiple simultaneous programs that can effectively manage the risk, rather than through a piecemeal approach.