FDA to require bar codes on drugs, blood products

The Food and Drug Administration will require bar codes on the labels of thousands of drugs and biological products to help protect patients from preventable medication errors and reduce the cost of health care.

'Bar codes can help doctors, nurses and hospitals make sure that they give their patients the right drugs at the appropriate dosage,' HHS Secretary Tommy Thompson said in announcing the final rule today. They also give health care providers a way to check medications and dosages quickly, he said.

"We're encouraging widespread use of technologies that can help health care providers avoid hundreds of thousands of medication errors," FDA Commissioner Dr. Mark McClellan said.

Most approved medicines and all blood and blood products will have to comply with the new requirements within two years. New medications covered by the rule will have to include bar codes within 60 days of their approval.

The FDA rule calls for the inclusion of linear bar codes, similar to those used on millions of packages of consumer goods, on most prescription drugs and on certain over-the-counter drugs.

Each bar code for a drug will contain, at a minimum, the drug's National Drug Code number. Companies also may include information about lot number and product expiration dates.

The rule also 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 supply organizations, 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 encourage adoption of advanced information systems that, in some hospitals, have reduced medication error rates by as much as 85 percent, McClellan said.

In these institutions, patients are provided with identification bracelets that bear a bar code, which identifies the patient. Health care professionals scan a patient's bar code and a 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 will help prevent nearly 500,000 adverse events and transfusion errors over 20 years. FDA estimates bar code use will save $93 billion over 20 years from reduced health care costs, patient suffering and lost work time due to adverse events.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

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