Information technology vendors are thrilled by proposed federal regulations requiring most prescription drugs to carry bar codes, but the absence of a requirement on healthcare providers to have equipment to read the codes could limit their effectiveness for patient safety.
If fully implemented, the bar-coding rule would help clinicians intercept 50% of potential medication errors during dispensing and administration, the FDA says.
The HHS agency estimates bar coding will prevent 413,000 adverse drug events over the next 20 years.
"I think it's an outstanding move in the right direction," says Ron Ribitzky, M.D., vice president of market strategies for Eclipsys Corp., a Boca Raton, Fla., developer of electronic medical records and other clinical information systems.
Nearly all prescription drugs dispensed in the United States and over-the-counter medications ordered in hospitals would be required to carry electronic bar codes under the proposed medication safety standards.
However, the proposal does not require hospitals and pharmacies to adopt technology to read the bar codes or to link medication administration systems to electronic medical records.
Still, Ribitzky says market forces will take care of adoption.
"Employers and health insurers will steer their constituencies in the right direction," Ribitzky says. "They will tell (patients) to go to the hospital that has the technology."
He predicts that healthcare organizations will be "caught in a bind between the end-user consumer and the government. They will vote with their feet and their checkbook."
The FDA is asking the public to weigh in on whether a final rule should require bar codes to include manufacturing lot numbers and expiration dates. The public has until June 12 days to submit comments on the proposed set of regulations.
FDA Commissioner Mark McClellan, M.D., said in a March 13 written statement that accompanied the release of the proposal that the plan was "the start of a comprehensive strategy to build a medical patient protection system for the 21st century."