reported and what type of information must be provided (Leape, 2002; IOM, 2004). The main reason for many of these reporting systems is to ensure accountability, although a number of state reporting systems also have a learning component (Rosenthal and Booth, 2005). Each system has the potential to improve patient safety through analysis of event reports and dissemination of best practices and lessons learned. For example, the Pennsylvania Patient Safety Authority regularly issues patient safety advisories (PPSA, 2006).

Evidence that mandatory reporting systems have led hospitals to introduce changes is largely anecdotal (Leape, 2002). Despite interest in analyzing the data from reporting systems and providing feedback that can be used to improve patient safety, states have found barriers to analysis and feedback (Rosenthal and Booth, 2005). Rates of reporting are low because hospitals fear the consequences of disclosure. Further, reporting is discouraged by the cumbersome and time-consuming nature of reporting systems (Leape, 2002). In addition, states often lack the clinical expertise to analyze the data. To address these barriers, in May 2005 the National Academy for State Health Policy convened a meeting of stakeholders in reporting systems to identify mechanisms and tools for improving reporting and feedback (Rosenthal and Booth, 2005).

Federal Reporting and Surveillance Systems

The FDA’s spontaneous reporting system (the MedWatch program) collects information about adverse events associated with all marketed drugs. The system depends on voluntary reports submitted by clinicians and mandatory reports submitted by manufacturers (comprising patient/ clinician reports forwarded to the company) (Fontanarosa et al., 2004). While about 250,000 such reports are received annually, several shortcomings of the system have been described in government, academic, and press publications (FDA, 1999). The reliance on voluntary reports and the factors that discourage reporting (e.g., time pressures, fear of liability, and lack of perceived benefit) result in significant underreporting of adverse outcomes and thus the inability to calculate true rates of such events (Fontanarosa et al., 2004). The reports also suffer from poor data quality, often including inadequate documentation and detail, which limits the ability to establish causal relationships in the analysis of the events. The consumer version of the system, MedWatch Plus, is designed to collect direct reports from consumers who have experienced an adverse drug reaction (Behrman, 2005). A number of activities are under way to improve the reporting systems, the quality and interpretation of the data gathered, and the use of postmarket surveillance studies, thus helping to ensure the safety and efficacy of marketed medicines.



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