FDA passes final bar coding rule.

Medication manufacturers and distributors must bar code all drugs beginning this month, under the terms of a recently passed U.S. Food and Drug Administration (FDA) rule. The FDA issued the final rule, effective April 26, requiring bar codes on drug labels and blood products. Introduced last spring, the measure is part of a sweeping government-based effort to improve patient safety. FDA officials hope the regulation will help eliminate a half million medication errors over the next two decades as more hospitals employ bar coded medication administration programs.

The FDA rule requires linear bar codes on most prescription drugs and certain over-the-counter medications commonly used in hospitals and dispensed through a provider's order. At minimum, each bar code must contain the medication's National Drug Code number; information about lot number and product expiration date is optional. The mandate also requires similar machine-readable information on container labels of blood and blood components intended for transfusion. The labels must include the lot number relating to the donor, the product code, and the donor's blood group and type.

"Bar coding systems have proved their dependability and effectiveness by ensuring the accuracy of a myriad of actions in commerce and industry," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We're now advancing the adoption of these systems in settings where they can help save lives."

Hospitals that employ bar-coded medication administration programs significantly reduce medication errors and their associated complications. In a recent study at a Veteran's Affairs Medical Center, clinicians administered 5.7 million doses to patients with no medication errors. For full text of the final rule, go to www.rsleads.com/ 404ht-211.