U.S. Food and Drug Administration
Performance Plan
2002
Reduce preventable deaths and injuries associated with the use of medical products.
| Develop and enhance surveillance of FDA-regulated products to identify harm resulting from use, understand harm through expert analysis, and prevent harm to other patients by taking action. |
Approximately 1.3 million people are accidentally injured by medical therapy in the U.S. annually. Many errors are associated with the misuse of drugs and medical devices regulated by FDA. Costs from these medical errors range from $20 to $75 billion annually. The Institute of Medicine estimates that as many as 98,000 Americans die annually as a result of preventable medical errors.
For its part in attacking this problem, FDA is adopting a systems approach, of which the most significant component is the identification of and response to adverse events that are reported in the U.S. FDA is planning to expand its knowledge of adverse events and medical errors by linking with new sources of data.
Most injuries and deaths associated with medical products result from known side effects. Some side effects are unavoidable but others can be prevented or minimized by careful product choice and use. The greatest need is to identify potential threats and then educate patients and health care professionals to avoid them. FDA will do this by:
1) Implementing a MeDSuN system. MeDSuN is a pilot program designed to educate and encourage hospital personnel to accurately identify and report injuries and deaths associated with medical products. MeDSuN includes a representative network of hospitals. The initial phase of the MeDSuN pilot was a success, with actual adverse event reports from participating hospitals increasing 15-fold for medical devices.
2) Linking with existing data sources. FDA epidemiologists and safety evaluators will link to existing external data sources held by both private and government organizations. For example, emergency rooms, poison control centers, health care systems, and the Centers for Disease Control and Prevention (CDC) all collect important information on adverse reactions.
3) Upgrading AERS. FDA is upgrading its Adverse Event Reporting System (AERS) for drugs to allow electronic submission of adverse event reports. This will bring about harmonization with manufacturers, reduce the amount of paper copies and encourage more reporting by making it easier for drug manufacturers to enter reports. Reports will be entered into the AERS database within days versus weeks with manual entry and it will allow FDA to get quicker information to identify signals and trends.
4) Continuing MedWatch. MedWatch, the FDA Medical Products Reporting Program is designed to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems related to medical products including problems associated with look-alike/ sound-alike names and product packaging confusions. Over 140 organizations representing health professionals and industry support MedWatch. Individual consumers may also submit reports to MedWatch.
5) Medical Errors Reporting System in Transfusion Medicine (MERS-TM). MERS-TM has been endorsed by the PHS Advisory Committee on Blood Safety and Availability. This system was developed under NIH funding and will serve as the model for the FDA blood error reporting. MERS-TM encourages non-punitive reporting with a well-defined codified method of reporting. It includes a root cause analysis for each error and focuses on methods and systems shortcomings rather than human error.
6) Analysis and Response. The Agency analyzes and responds to reports by taking appropriate action including: providing important product safety information, making labeling changes, requiring a product design change, or even withdrawing a product from the market. Once the Agency's systems are at full capability, FDA will be able to reduce preventable deaths and injuries associated with the use of medical products.
7) Improved Labeling. FDA is spearheading labeling reform and plans to propose new regulations and guides to improve the format and content of labeling to make it more user-friendly.
Many patient deaths and injuries are associated with the use of FDA-regulated medical products within a complex and time-pressured health care system. The Agency believes that roughly half of these deaths and injuries can be avoided by fully implementing its strategies.
Thousands of lives and billions of dollars can be saved. But if the strategies cannot be implemented, these savings will not be realized.
The following table represents a snapshot of actual adverse events. We believe there is serious under-reporting of adverse events.
When a medical error occurs in a hospital, a risk manager examines the system and takes preventive steps. Often these incidents are not reported or shared with other hospitals, health care professionals, FDA or drug manufacturers. Unless these incidents are reported, we cannot take action to prevent them.
FDA needs a comprehensive safety evaluation system for medical products. This requires strengthening existing systems as well as implementing new ones. The Agency also requires additional expertise in medical epidemiology and statistical analysis to conduct the safety evaluations.