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U.S. Department of Health and Human Services


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The Time Is Right For A New Systems Framework

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section :Is the Current Risk Management System Working?

Given the changing healthcare environment and the explosion of new products on the market, is the traditional system model for managing risks keeping pace? What would a new framework look like? What current and anticipated problems would a new framework have to address, and where are the opportunities for decreasing the number of serious adverse events?

Need for better data

A central obstacle to answering these questions is the lack of comprehensive data on the adverse effects from medical products. Although it is agreed that the aggregate burden created by serious adverse effects is enormous, detailed data are unavailable. What is the rate of adverse events in various settings (e.g., hospitals, outpatient care, nursing homes)? How many adverse events could have been prevented? How many are due to medication error? How many serious adverse events are unavoidable?

As detailed in Part 3 of this report, FDA is not funded, staffed, or in some cases authorized to collect such data. Most of FDA's postmarketing surveillance efforts are directed toward discovering new, unexpected adverse events. In recent years, the Agency has increased the evaluation of medication and device errors. However, FDA has not been extensively involved in the investigation of those risks that are expected in practice use. Although many organizations other than FDA have important roles in this area, no one group is charged with collecting comprehensive information that would delineate the scope of the problem.

Some have called for the establishment of an independent drug-safety board to expand and manage existing data systems, monitor and investigate safety problems, and make recommendations for solutions. 4 It is not clear, however, how such a board would fit into an overall system of safety.

Need for a systems approach

Experience in a wide variety of sectors, from pharmaceutical manufacture to airline safety, has demonstrated that the most effective way to get high-quality, consistent results in complex endeavors, is to take a systems approach, rather than focusing on individual components. Many injuries and deaths resulting from medical products are preventable. This harm can be minimized through systematic risk management interventions. Although many organizations have developed the independent capacity to manage risk, synergistic efforts are needed to more effectively tackle this problem.

Need for an evaluation of the risk management system

In light of the widespread concerns about the risks incurred from using medical products, the Public Health Service (PHS), or other neutral body, should join in or convene a public forum with other public agencies and groups involved in healthcare to examine the current system of managing the risks from medical products. These forums should focus on the costs and value of better data on the incidence and causes of injuries from medical products and the roles of all stakeholders in risk management. The need for comprehensive data collection on the rates of the various types of adverse events could be a central point of discussion. The relative magnitude and acceptability of the various types of risks could be examined, the risk management role of various components of the healthcare system evaluated, and opportunities for better controlling these risks explored. In particular, FDA could describe its role in the current system, as delineated in this report, and make suggestions for possible ways to enhance its risk management activities.

Subsequent to such a general meeting, FDA could meet with healthcare provider groups to further Agency partnerships in risk management and to develop a mutual understanding of their roles and of ways for creating a better system. Outcomes of these deliberations could be discussed at healthcare provider annual meetings or other events, thus providing broad input into the process.

These activities would constitute systemic risk confrontation -- an evaluation by all stakeholders of the strengths and weaknesses of the current system. In addition to improving mutual understanding and suggesting system enhancements, these activities could help galvanize support for the information systems that will be needed in the future.

Next Section : FDA's Overall Risk Management Activities