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FDA
Department of Health and Human Services
U.S. Food and
Drug Administration
Congressional Justification
FY 2004 Annual Performance Plan
FY 2003 Revised Final Performance Plan
FY 2002 Annual Performance Report
Problem | Desired Outcomes | Key Strategies | FY 2004 Goal Highlights | Current Status | FY 2002 Performance Goals | FY 2001-2002 Highlights
The prevalence of avoidable health complications that involve the use of FDA-regulated products, presents a challenge for the Agency. A 1999 Institute of Medicine (IOM) report estimated that as many as 100,000 Americans die each year as a result of medical errors, which are projected to rank as the eighth leading cause of death in the United States. Misuse of pharmaceuticals is associated with about 3 million hospital admissions a year. Drug-related adverse events in the ambulatory population cost Americans approximately $75 billion annually.
FDA's central public health role is to ensure that medical products (drugs, biologics, and devices) are proven safe and efficacious prior to marketing, and that these products continue to be safely used once approved and marketed. FDA must monitor over 40,000 manufacturing establishments and almost 10,000 mammography facilities. In addition, FDA examines drugs, biologics, animal drugs and feeds, and medical devices that cross our borders annually. FDA vigilance in overseeing the production, distribution and use of these products, means FDA can respond to safety problems quickly to mitigate the impact associated with these products, which is critical to public safety.
The risks associated with medical products are never fully revealed during the premarket review process. New safety findings may emerge after approval, when a wider patient population uses products under a broader range of clinical circumstances. In some of these cases, preventable complications and adverse events may occur that were not observed before product approval. Thus, FDA must assure a postmarket system operate effectively to protect the American public.
There is a significant need for more data from health care providers who prescribe or use medical products. FDA must identify alternative methods to obtain safety data to reduce the public's risk of unsafe products, or in many cases, receiving the wrong dose or product. Automatic data collection on medication errors and adverse events will enable the Agency to limit adverse health outcomes associated with FDA regulated products. To address this opportunity, FDA will look to partner with provider networks and organizations and continue to work with other government agencies to obtain a more consistent stream of safety data.
Virtually all medical therapies have side effects. It is important for these side effects to be well understood so that we can be sure a product's benefits outweigh its risks. But, preventable adverse events are a different health hazard: they are avoidable medical complications that need not and should not occur. FDA continues to help health professionals avoid medical errors that lead to adverse events.
Reduce adverse events related to FDA-regulated products by improving postmarketing surveillance and helping to prevent adverse outcomes related to medical errors.
FDA uses a risk-based approach to adverse event reporting that harmonizes efforts across the three medical centers (drugs, biologics and medical devices):
FDA is committed to reducing preventable adverse events associated with medical product use and medical errors. The Agency has placed greater emphasis on inspecting medical products with highest risk, and is committed to devoting scarce resources to highest risk areas.
Examples of FY 2004 goals include:
Establish Reporting Capability - FDA has developed and is improving a system of voluntary reporting of adverse events associated with the use of Agency-approved products. The Agency's MedWatch program receives about 25,000 adverse event and medical product problem reports annually, mostly from health care professionals and consumers. The MedWatch data are entered into FDA's Adverse Events Reporting System, which also receive 270,000 manufacturers' reports. The manufacturers' reports, which must be filed periodically, are based on information provided by physicians and other health care providers.
Another important FDA program is the Vaccine Adverse Events Reporting System (VAERS). VAERS received more than 14,000 reports of adverse reactions in FY 2002, most of which were volunteered by health care providers, patients and their parents. To ensure the safety of the blood supply, the Center for Biologics Evaluation and Research (CBER) requires all blood banks to promptly report fatalities connected with blood transfusions and donations. In addition, the Center operates a web-based voluntary reporting system for rapid identification of supply shortages affecting blood, blood components and reagents.
FDA is also currently expanding the Medical Product Surveillance Network (MeDSuN) System. MeDSuN, a pilot program that requires rapid adverse event reporting on medical devices by selected hospitals and nursing homes. The system is designed to train hospital personnel to accurately identify and report injuries and deaths associated with medical products. MeDSuN advances the public's health by giving FDA quicker and more detailed information, without identifying specific individuals, on potential problems with health care products in actual medical practice. This is a rapidly growing network that also provides health care organizations with fast feedback about lessons learned by the FDA.
The MeDSuN model, currently only designed to track and analyze adverse events due to medical devices, will be expanded to include drug products. Initial work includes a feasibility and acceptability assessment of a small regional group of hospital pharmacists about incorporating MeDSuN into their reporting of adverse drug effects and medication errors.
The Agency is also working on a proposed rule regarding suspect adverse drug reactions (SADRs). Currently, only manufacturers, repackers, and distributors are required to report adverse effects relating to their medical products. The rule will require that any companies that have contracts with the manufacturers, repackers, or distributors also report adverse drug reactions and medication errors. This is intended to eliminate many of the adverse reactions that go unreported. It is primarily focused on medication errors, which occur when a patient is giving the wrong drug, but does not necessarily have an adverse event.
Risk Analysis/Assessment -FDA is currently working to publish draft guidance to industry on good risk analysis, risk assessment, and pharmacovigilance practices. The Agency puts substantial effort into reviewing adverse event and medication error reports to identify serious or potentially serious outcomes that might be avoided by modifying the labeling or packaging or other means. AERS is an important risk assessment database essential for identifying and monitoring the incidence of adverse effects. FDA evaluates spontaneous reporting data from AERS to identify serious, rare, or unexpected adverse events or an increased incidence of events. When a signal of a potential adverse reaction is detected, safety evaluators consult with product reviewers, medical officers, and epidemiologists to review available data and consider further options.
Risk Management Decisions - FDA is also increasing risk communication to different audiences. The Agency may decide to disseminate risk information through Dear Healthcare Professional letters, MedWatch alerts and partners programs, and may initiate regulatory action.
The Agency has developed new standards for over-the-counter drug product labeling to increase patient knowledge about medication and decrease errors in use. FDA is using a nationwide media campaign to inform consumers how to use the new labeling. In addition, FDA has proposed regulations to enhance the information on prescription drug labeling for professionals. Despite these initiatives to improve drug product labeling, millions of Americans experience adverse events associated with drug use each year.
FDA will publish a final rule to require a barcode be placed on human drugs and biological products. FDA anticipates that 40 percent of medication errors related to administration and dispensing may be eliminated by application of the barcode on drug, biologic and blood packaging and could reduce the yearly rate of medication errors by millions.
The Agency is also working to finalize a rule to amend its regulations governing the format and content of labeling for human prescription drug and biologic products. This proposal would revise current regulations to require modifications that would make it easier for health care practitioners to access, read, and use information in prescription drug labeling and would enhance the safe and effective use of prescription drug products. This proposal would also amend prescription drug labeling requirements for older drugs to require that certain types of statements currently appearing in labeling be removed if they are not sufficiently supported. Finally, the proposal would eliminate certain unnecessary statements that are currently required to appear on prescription drug product labels and move other, less important information to labeling. These changes would simplify drug product labels and reduce the possibility of medication errors. This is one step in moving towards an electronic labeling format.
FDA's adverse event reporting system must be significantly strengthened. Although the actual numbers of adverse events associated with medical products are not known, the reports FDA receives have more than doubled in the past ten years.
FDA needs more expertise in medical epidemiology and statistical analysis to evaluate adverse events associated with increasingly complex medical products, and more educational efforts to prevent these problems.
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Program |
Final FY 2002 Goal Statement |
Was the target met? |
Explanation |
|---|---|---|---|
|
Human Drugs |
Streamline adverse drug event reporting system by accepting electronic submissions from companies and be current with MedDRA coding versions. | Yes | |
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Medical Devices |
Implement MedSuN by recruiting a total of 80 facilities for the network | Yes |
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