Federal Risk Management Framework
In 1997, the Presidential/Congressional Commission on Risk Assessment published a report that included a proposed model for risk management.1 The model for risk management encompasses processes for identifying and assessing the risks of specific health hazards, implementing activities to eliminate or minimize those risks, communicating risk information, and monitoring and evaluating the results of the interventions and communications. Because the processes identified in the model are consistent with the activities the Agency currently undertakes as part of its overall approach to risk management, the Task Force was able to adapt that model to the current system for managing risks from medical products. (See the proposed model below.) The activities included in the model are defined in the text box (Risk Management Activities) and discussed in more detail in the sections that follow.
Efforts in risk assessment, intervention, communication, and evaluation occur at every level of the healthcare system. For unapproved products, FDA has the central risk management role. Access to unapproved products is usually limited to clinical trial settings in which safety is carefully scrutinized by investigators, manufacturers, FDA, and institutional review boards (IRBs). Part 2 of this report detailed manufacturer and FDA risk assessment activities in the preapproval period. For products of adequate quality, if FDA determines that a product's benefits outweigh its risks for a given use and population, the product is approved for marketing.
An activity often lacking in risk management models that needs to be included in any framework for managing the risks associated with using medical products is characterized as risk confrontation: community-based problem solving that actively involves relevant stakeholders in the decision-making process. 2 This activity has had lower priority than the Agency's premarketing and postmarketing risk assessment activities.
Risk Management Activities
Risk Assessment: estimation and evaluation of risk
Risk Confrontation: determining acceptable level of risk in a larger context
Risk Intervention: risk control action
Risk Communication: interactive process of exchanging risk information
Risk Management Evaluation: measure and ensure effectiveness of risk management efforts
Healthcare providers manage risk for their patients
Once products are approved, prescribers have the central risk management role. For prescription products, safety requires the participation of a learned intermediary, a highly trained practitioner whose role includes evaluating the risks and benefits for the individual patient and communicating them. Patients also frequently participate in risk management, weighing potential risks and benefits in light of their personal values. Other healthcare professionals, particularly nurses and pharmacists, have an important role in managing patient safety, particularly in risk communication activities.
Healthcare delivery organizations try to improve quality
Healthcare delivery organizations also have a major role in preventing injuries and deaths from medical products. Activities include interventions such as restrictions on the use of drugs or devices, requirements for professional training and credentialing, training efforts, quality assurance programs, and surveillance activities. Some hospital systems have risk management professionals who audit system performance.
Many other organizations are involved
Today, many other organizations are involved in risk management as part of their role in improving the quality of healthcare. For example, in government, the Agency for Health Care Policy Research (AHCPR), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) issue practice guidelines, hold consensus conferences, and provide other communications intended to influence practice decisions. Government agencies involved in healthcare (the Health Care Financing Administration, the Veterans Administration, the Health Resources and Services Administration) also participate in risk management and the assessment of new technologies. In the private sector, many organizations, including professional societies, voluntary groups such as the American Medical Association's National Patient Safety Foundation, and consumer and patient advocacy groups, engage in a wide variety of risk management activities. A number of groups are involved in the prevention of medication errors. Effective risk management requires that all organizations act in partnership to assist healthcare providers in making appropriate practice decisions, and in ensuring that their decisions are properly carried out.
FDA has a role in postmarketing risk management
FDA's risk management role in the postmarketing period is primarily to make sure that accurate, up-to-date information is available to those managing risks and benefits. FDA does this by postmarketing risk assessment, regulation of advertising, and through its own communication efforts. However, even if the Agency carries out its role perfectly, the goal of achieving the safe use of medical products cannot be accomplished without effective partnerships with those who are actually managing the risks: healthcare practitioners, healthcare delivery organizations, and patients.