WASHINGTON - March 13, 2003 -- Health
and Human Services Secretary Tommy G. Thompson today announced two
new proposals from the Food and Drug Administration (FDA) aimed at
improving patient safety by reducing medical errors and by more
quickly identifying potential errors that may occur. Secretary
Thompson spoke this morning at the National Patient Safety
Foundation's (NPSF) 2003 Patient Safety Congress called "Let's Get
Results: Improving the Safety of Patients."
The proposed rules, which are part of FDA's strategic initiative
to reduce adverse events involving the products it regulates,
would require bar coding on medications and will improve reporting
requirements for safety problems involving medicines.
"Today's announcement by Secretary Thompson is an important and
welcomed step in protecting the safety of patients in all
healthcare settings," said Robert Krawisz, executive director of
the NPSF.
Secretary Thompson spoke to more than one thousand healthcare
leaders and patient safety advocates who are attending the event
this week in Washington DC. The three-day Congress offers
presentations, interactive discussions, and breakout sessions all
aimed at ways to improve patient safety.
In addition to causing human suffering, medication errors also
represent a significant economic cost to the United States. The
expected annual benefit from preventing adverse events due to
medication errors is equivalent to $3.9 billion, according to the
FDA.
One of the major initiatives announced today -- the proposed
requirement for bar codes -- adopts a technology that is widely
used in other industries to reduce the number of medication errors
in hospitals and other health care settings. The required bar code
would contain the National Drug Code (NDC) number, unique
identifying information about the drug that is to be dispensed to
the patient, in a linear bar code as part of the drug label. The
proposed design would allow manufacturers to include additional
information, and more information could also be added to the bar
code standards as information technology progresses.
"This is a prime example of taking a well-developed application of
imaging technology and apply it to healthcare to prevent injury,"
says Henri R. Manasse, Jr. PhD, ScD, NPSF Board Member and
executive vice president and CEO of American Society of
Health-System Pharmacists. Dr. Manasse is also the immediate past
chair of the NPSF.
The second action the FDA announced -- the proposed revamping of
safety reporting requirements -- aims to enhance the agency's
ability to effectively monitor and improve the safe use of
medications including drugs and biologics.
The proposed rule would:
Improve the quality and
usefulness of safety reports submitted to the agency as well as
facilitating the consistency of safety reporting around the world.
Require the submission of all
suspected serious reactions for blood and blood products on the
market.
Require reports on important
potential medication errors.
These steps would provide the FDA with more useful, timely, and
extensive information to support quicker, more effective actions
by the agency to prevent adverse events.
The measure would require all healthcare groups - including
pharmaceutical companies -- to submit to FDA, within 15 calendar
days, all reports they receive of actual and potential (i.e.,
"near miss") medication errors occurring in the United States.
About the National Patient Safety Foundation
The National Patient Safety Foundation was founded in 1996 by the
American Medical Association, CNA HealthPro, 3M and contributions
from the Schering-Plough Corporation. The NPSF is an independent,
nonprofit research and education organization. It is an
unprecedented partnership of healthcare practitioners,
institutional providers, health product providers, health product
manufacturers, researchers, legal advisors, patient/consumer
advocates, regulators and policy makers committed to making health
care safer for patients. Through leadership, research support, and
education, the NPSF is committed to making patient safety a
national priority. For more information, about the NPSF, visit
http://www.npsf.org.
On the Net: Congress site:
http://www.mederrors.org/
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