Department of Health and Human Services Sec. Tommy G. Thompson announced on Feb. 25 that the U.S. Food and Drug Administration is issuing a final rule requiring bar codes on the labels of thousands of drugs and biological products for human use.
The rule calls for the inclusion of linear bar codes—like those used on packages of consumer goods—on most prescription drugs and on certain over-the-counter drugs that are used commonly 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.
The rule also requires the use of machine-readable information on container labels of blood and blood components intended for transfusion.
The bar code rule is designed to support and encourage widespread adoption of advanced information systems that, in some facilities, have reduced medication error rates by as much as 85 percent. In these institutions, patients are provided with bracelets that bear a patient-identifying bar code. The health care professional 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.
The 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.
