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Improving Patient and Consumer Safety is one of
five initiatives established for FDA to address five critical
challenges facing the agency. Through
this initiative, FDA will contribute to the reduction of adverse
events and medical errors through enhanced reporting capability,
strengthened problem analysis, and appropriate risk management
strategies to address the problems.
The following is an excerpt describing this initiative from
FDA's Strategic Plan:
| Seek continuous improvements in patient and consumer
safety by reducing risks associated with FDA-regulated products. |
Adverse drug events result in 770,000 injuries and
deaths each year.
Bates, et.al., 1997.
JAMA, 277(4).
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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.
An estimated 3.1 billion prescriptions will be filled
in 2003, up 60 percent from 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.
The 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.
Improving Patient and Consumer Safety: FDA's Objectives
Objective 1. Enhance the ability to quickly identify risks
associated with FDA-regulated products.
The FDA will supplement the current passive reporting system
by developing new ways to identify safety problems with medical
products, dietary supplements and foods. This will speed up
the process of recognizing safety problems and allow for prevention
of similar adverse events. Partnerships with health care providers
and the CDC will allow the FDA to link to medical records and
other public health monitoring systems to identify adverse events
quickly. This means, for instance, if a drug were causing problems
in a few patients' kidneys it would be detected early and managed
before other patients risk injury.
Objective 2. Increase capacity to accurately analyze risks
associated with medical products, dietary supplements, and foods.
There are many different sources of information that the FDA
will seek from other agencies and health care organizations
to get a better understanding of how common an avoidable adverse
event is and the severity of the problems associated with the
product. The latest advances in statistics will also help analysts
assess safety problems with FDA-regulated products. New computer
software and specialized training will provide staff with the
tools they need. These efforts will give the FDA the information
needed to effectively protect public health.
Objective 3. Take appropriate actions to communicate risks
and correct problems associated with medical products, dietary
supplements and foods.
The FDA will identify new ways to inform physicians, pharmacists,
nurses, and patients about the safety of FDA-regulated products.
Highlight for Objective 3
One important example of a new way the FDA will provide information
on the products it regulates is through an electronic product
label. The FDA will work with the National Library of Medicine
(NLM) to set up the DailyMed, a new way to distribute up-to-date
and comprehensive medication information in a computerized format
for use in health care information systems. By making current
information about FDA-regulated medical products readily available
to patients and health care providers free of charge, the DailyMed
will help to reduce medication errors and improve patient safety.
Complete FDA Strategic
Plan
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