3: Improving Patient and Consumer Safety

Seek continuous improvements in patient and consumer safety by reducing risks associated with FDA-regulated products.

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All FDA-regulated products have risks and benefits, and the agency plays an important role in measuring and preventing the numerous injuries and deaths related to these products. Clearly, however, there is substantial room for improvement in preventing adverse events involving FDA-regulated products. Too many Americans suffer from adverse events related to medical products, dietary supplements, and foods. According to published estimates, adverse drug events alone result in 770,000 injuries and deaths each year. Sometimes problems arise when medical products and dietary supplements are misused because consumers or doctors didn't have the right information about a new treatment. But adverse events that are preventable aren't just caused by human error. Even with the best available data, products are sometimes found to have side effects that were not predictable or detectable in any clinical trials and other studies prior to product use in real-world conditions. Because virtually all medical therapies have side effects and risks, it is important for these side effects to be well understood so that the FDA can be sure that the benefits of the products we approve outweigh their risks. This includes improving the agency's ability to understand particular risks in specific populations, e.g., elderly patients and patients from particular demographic groups or carrying certain genes that may be associated with differences in risks. More mortality, morbidity, and related costs could be avoided as the FDA improves the management of product-related risks. In the FDA's purview, there are more health care products than ever before and more people are using them. For example, it is estimated that our pharmacists will fill 3.1 billion prescriptions by the end of this year; that's 60 percent more than 10 years ago. Detection of adverse events that cause harm and human suffering needs to be improved. The FDA has always relied on "spontaneous" reporting systems to monitor the safety of a new medical product. Avoiding serious adverse events often means the FDA is dependent on astute doctors identifying problems with new drugs early enough to do something about it, whether that means warning doctors and patients to be extra vigilant for a potential problem, or in some cases, withdrawing drugs too dangerous to be safely used. While these systems are effective in identifying rare and often serious adverse events, their reliance on health care providers and incomplete reporting means that appropriate detection and response to adverse events may be less timely and effective than is desirable. TThe agency needs to improve its systems for reporting safety problems. One way is to improve the quality and standardization of the adverse event reports that the agency receives through the FDA's spontaneous adverse event reporting systems, and the agency is taking steps to do that. Another very promising new way is to have direct and secure access to relevant electronic health information. Increasingly, health care providers are using computerized systems to store patient information, such as electronic medical records. Some of the information entered in these systems is related to product use and product-related adverse events. Confidential, secure exchange of relevant information with these health care provider systems could help to automate the discovery and reporting of safety problems. However, the use of different technology platforms and applications hampers the flow of information among these systems. The agency will work with its partners to develop standards to improve the flow of information across systems. In turn, it will increase the payoff to health care organizations from adopting electronic medical record systems, in the form of higher-quality and more timely electronic information from the FDA on product risks and benefits. The agency will identify the most innovative and effective ways to better communicate the risks associated with regulated products. There is also an increasing number of health care databases available to study the use and outcomes associated with medical products. The agency has the challenge and the opportunity to use the best available information from the private and public sector to improve its understanding of product safety.

Objective(s):

3.1: Risk Identification

3.2: Risk Analysis

3.3: Communication of Risks and Correction of Problems

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