FDA Wants Bar Codes on Prescription Drugs

Which comes first, bar codes on drugs or hospitals installing bar code readers? Now, the standoff between drug manufacturers and hospitals on the use of bar codes is moot. The FDA announced proposed rules on the use of bar codes that apply to all prescription drug products, including biological products and vaccines (except for physician samples) and over the counter drugs that are commonly used and dispensed in hospitals. Standardized bar codes would also be required on prescription drug products used in other settings, such as retail pharmacies.

The FDA noted that bar codes on many pharmaceutical products were of poor quality, forcing hospitals that do use bar codes to repackage the products and put on their own codes.

The proposed rule indicates that the EAN.UCC system will be chosen and, at minimum, include the National Drug Code (NDC) number in the code. Other identifying information about the drug to be dispensed to a patient will also be included in a linear bar code as part of the drug label. The design would also allow manufacturers to include additional information.

The FDA estimates that a bar code system will reduce medication errors by 50%, for a financial savings of $3.9 billion. Patients would receive an identification bracelet linked to their medical history. Nurses would scan the bracelet and the drug to ensure proper dosage and dispense method. This information would be stored in a database.

Hospitals would have to install scanners, software and networks to implement the proposed rules. It is estimated that the pharmaceutical industry may spend about $7 billion dollars to implement needed technology. The average implementation costs for hospitals is estimated at about $250,000.

The bar code regulations will go into effect three years after the FDA publishes its final rules. The rules are currently undergoing a 90-day comment period.

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