FDA Moves to Cut Down on Medication Errors

Agency calls for bar codes on most drugs, biological products in hospitals

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WEDNESDAY, Feb. 25, 2004 (HealthDayNews) -- In a move to reduce the risk of medication errors in hospitals, the U.S. Food and Drug Administration announced Feb. 25 that it will require bar codes on all drugs and biological products used in those settings.

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

The new rule works this way: Linear bar codes, much like the ones already seen on most products in grocery stores, will be included on most prescription drugs and certain over-the-counter drugs that are commonly used in hospital settings. Machine-readable information will also be required on container labels of blood and blood components intended for transfusions.

The new coding supports advanced information systems that are already in place in some hospitals, where patients wear identification bracelets that bear a bar code. The health-care professional can then scan the patient's code and the drug's bar code to verify the patient is getting the right drug and the correct dosage.

The FDA estimates the bar code rule, when fully implemented, could help prevent almost 500,000 adverse events and transfusion errors over 20 years. The economic benefit of avoiding these potential errors is estimated to be $93 billion over the same period.

The rule applies to most drug makers, repackers, relabelers, private label distributors and blood establishments. New medicines covered by the rule will have to include the bar code within 60 days of their approval; most previously approved medicines and blood products will have to comply within two years.

More information

The U.S. Food and Drug Administration has more on medication errors.

SOURCE: U.S. Food and Drug Administration, news release, Feb. 25, 2004

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