FDA targets medication errors by requiring bar codes on drugs

The rule eliminates a major hurdle to improving patient safety.

By Markian Hawryluk, AMNews staff. March 15, 2004.

Washington -- The government hopes a new regulation requiring bar codes on prescription drug and biological product packaging will prevent nearly 500,000 medical errors over the next 20 years. But patient safety advocates say getting hospitals to adopt bedside bar code technologies might not be so black and white.

"Bar codes can help doctors, nurses and hospitals make sure that they give their patients the right drugs at the appropriate dosage," said Health and Human Services Secretary Tommy Thompson. "By giving health care providers a way to check medications and dosages quickly, we create an opportunity to reduce the risks of medication errors."

It also could help to limit physician liability, said Scott Wallace, CEO of the National Alliance for Health Information Technology, Chicago.

"Physicians get pulled into litigation and have other problems with medication administration errors whether or not they're really their fault," he said. "This rule will eliminate those, or at least significantly reduce them."

Manufacturers will have two years to add bar codes to products already approved by the Food and Drug Administration but will have to add the codes to new products within 60 days of FDA approval.

To date, fewer than 2% of hospitals have implemented bedside bar coding systems, but many of those have documented significant cuts in errors. The Dept. of Veterans Affairs piloted a bar code system in its Comerly O'Neil Medical Center in Topeka, Kan., in 1994. That achieved an 86% reduction in medication errors over five years. No drug errors occurred when the system was used as designed.