FOR IMMEDIATE RELEASE
Wednesday, Feb. 25, 2004 |
FDA Press Office
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New Requirements for
Bar Codes on Drugs and Blood to Reduce Risks of Medication Errors
Feb. 25, 2004 - HHS Secretary Tommy G. Thompson
today announced that the Food and Drug Administration is issuing a
final rule requiring bar codes on the labels of thousands of human
drugs and biological products. The measure will help protect patients
from preventable medication errors and reduce the cost of health care
and represents a major step forward in the department’s efforts to
harness information technology to promote higher quality care.
“Bar codes can help doctors, nurses and hospital
make sure that they give their patients the right drugs at the
appropriate dosage,” Secretary Thompson said. “By giving health-care
providers a way to check medications and dosages quickly, we create an
opportunity to reduce the risks of medication errors that can
seriously harm patients.”
“We’re encouraging widespread use of
technologies that can help health care providers avoid hundreds of
thousands of medication errors,” FDA Commissioner Mark B. McClellan,
M.D., Ph.D., said. “Bar coding systems have proved their dependability
and effectiveness by ensuring the accuracy of a myriad of actions in
commerce and industry. We’re now advancing the adoption of these
systems in settings where they can help save lives.”
The FDA rule calls for the inclusion of linear
bar codes -- such as are used on millions of packages of consumer
goods -- on most prescription drugs and on certain over-the-counter
drugs that are commonly used in hospitals and dispensed pursuant to an
order. Each bar code for a drug will have to contain, at a minimum,
the drug’s National Drug Code number. This information will be encoded
within the bar code on the label of the product. Companies also may
include information about lot number and product expiration dates.
In addition, the rule requires the use of machine-readable information
on container labels of blood and blood components intended for
transfusion. These labels, which are already used by most blood
establishments, contain FDA-approved, machine-readable symbols
identifying the collecting facility, the lot number relating to the
donor, the product code, and the donor's blood group and type.
The bar-code rule is designed to support and
encourage widespread adoption of advanced information systems that, in
some hospitals, have reduced medication error rates by as much as 85
percent. In these institutions, patients are provided with
identification bracelets that bear a bar code, which identifies the
patient. The health care professional then scans the patient’s bar
code and scans the drug’s bar code. The information system then
compares the patient’s drug regimen information to the drug to verify
that the right patient is getting the right drug, at the right time,
and at the right dose and route of administration. In a study
conducted at a Veterans Affairs Medical Center employing such a
bar-code scanning system, 5.7 million doses of medication were
administered to patients with no medication errors.
FDA estimates that the bar-code rule, when fully
implemented, will help prevent nearly 500,000 adverse events and
transfusion errors over 20 years. The economic benefit of reducing
health care costs, reducing patient pain and suffering, and reducing
lost work time due to adverse events is estimated to be $93 billion
over the same period.
FDA first proposed bar-code requirements in
March 2003. Comments from hospitals, health care professionals, trade
and professional associations and others showed widespread support for
the approach to improving patient safety and promoting higher quality
care.
The final rule applies to most drug
manufacturers, repackers, relabelers, private label distributors and
blood establishments. New medications covered by the rule will have to
include bar codes within 60 days of their approval; most previously
approved medicines and all blood and blood products will have to
comply with the new requirements within two years.
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