New FDA Requirements for Bar Codes on Drugs

To help protect patients from medication errors, most prescription drugs and certain over-the-counter drugs commonly used in hospitals must include a bar code on the label, according to a new rule announced by the U.S. Food and Drug Administration (FDA; Bethesda, MD, USA). The rule also requires a bar code on labels of blood and blood components intended for transfusion.

The bar code on the label for each drug will have to contain at least the drug's National Drug Code number. This new rule is designed to encourage widespread adoption of advanced information systems that in some hospitals have reduced medication errors by as much as 85%. In these hospitals, patients are provided with identification bracelets that also bear a bar code. When administering a drug, a healthcare professional scans the patient's bar code and the drug's bar code. The information system 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 in 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. In a study conducted at a Veterans Affairs Medical Center employing such a bar-code scanning system, 5.7 million doses of medication were given to patients with no errors. Most previously approved medicines and all blood and blood products will have to comply with the new requirements within two years.

"We're encouraging widespread use of technologies that can help healthcare providers avoid hundreds of thousands of medication errors,” said Mark B. McClellan, M.D., Ph.D., commissioner of the FDA.




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