Don't know how many of you saw yesterday's press release, below. From a
[back door?] HIPAA perspective, the most interesting quote is:
"Each bar code for a drug will have to contain, at a minimum,
the drug's National Drug Code number."

The final rule describing the new bar code requirements is contained in
the Federal Register, Vol. 69, No. 38, Thursday, February 26, 2004,
pages 9119-9171.

Dave Feinberg
Rensis Corporation [A Consulting Company]
206-617-1717
DAFeinberg@...



-----Original Message-----
From: US Dept of HHS: Press Releases, Other Info
[mailto:HHSPRESS@...] On Behalf Of Henneghan, Martha (HHS/OS)
Sent: Wednesday, February 25, 2004 9:22 AM
To: HHSPRESS@...
Subject: [HHSPRESS] HHS RELEASE--BAR CODE RULE

Date: February 25, 2004
For Release: Immediately
Contact: FDA Press Office
(301) 827-6242


Headline: HHS ANNOUNCES NEW REQUIREMENTS FOR BAR CODES
ON DRUGS AND BLOOD TO REDUCE RISKS OF MEDICATION ERRORS


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 hospitals 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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