Nearly all prescription drugs dispensed in the United States and over-the-counter medication ordered in hospitals would be required to carry electronic bar codes under proposed federal medication safety standards.
The FDA on Thursday published two rules aimed at reducing medication errors and improving the reporting of actual and potential mistakes.
"Today's actions are the start of a comprehensive strategy to build a medical patient protection system for the 21st century," FDA Commissioner Mark McClellan, M.D., says in a written statement.
The error-prevention proposal calls for medication labels to contain bar codes that carry National Drug Code identifiers to ensure that pharmaceutical products and dosages given to patients at pharmacies and hospitals match what physicians order.
The rule also would apply to blood and blood components, while physician drug samples are excluded.
The FDA is asking the public to comment on whether a final rule should require bar codes to include manufacturing lot numbers and expiration dates. The public has 120 days to submit comments on both proposed sets of regulations.
If fully implemented, the bar-coding rule would help clinicians intercept 50% of potential medication errors during the dispensing and administration, the FDA says. The HHS agency estimates that bar coding will prevent 413,000 adverse drug events over the next 20 years.
However, the proposal does not require hospitals and pharmacies to adopt technology to read the bar codes or link medication administration systems to electronic medical records.
The other proposed rule calls for an overhaul of medication safety reporting practices to bring federal requirements in line with international standards the FDA and the U.S. drug industry hammered out with their counterparts in Europe, Canada and Japan.
As proposed, drug companies would have 15 days to inform the FDA of any reports of actual medication errors, "near misses" and suspected serious reactions to blood transfusions they receive from healthcare providers.
Adopting international safety reporting standards actually would lessen the reporting burden on affected companies, the FDA says.