In an effort to improve patient safety in the hospital setting by reducing medication errors, the Food and Drug Administration (FDA) has published a proposed rule entitled Bar Code Label Requirements for Human Drug Products and Blood. Medical errors have substantial costs in lives, injuries, and wasted health care resources, and misuse of drugs is a major component of those errors.

Bar codes would be required on prescription drugs, over-the-counter drugs packaged for hospital use, and vaccines. The bar code would, as a minimum, contain the National Drug Code number, which uniquely identifies the drug, its strength, and its dosage form. The FDA is seeking comment on whether to add information such as lot number and expiry date. The proposed rule would also cover blood and blood components.

Once implemented, the bar code rule is estimated to result in a 50% increase in the interception of medication errors at the dispensing and administration stages resulting in 413 000 fewer adverse events over the next 20 years. Bar codes may also help prevent other types of medication errors in prescribing and transcribing because they will encourage health care organizations to adopt computerized systems for handling prescriptions. In the retail setting, pharmacists may use the bar codes in conjunction with computerized prescription orders to confirm that the right drug is being dispensed to the right patient. Pharmacies will benefit from standard codes that will be used by all prescription manufacturers.

Drug manufacturers will benefit from uniform standards. Installation of scanning systems may lead to improved purchasing and supply utilization and other potential risk management activities.

Reference: FDA Talk Paper, 13 March 2003