FDA mandates bar codes on drugs used in hospitals

Computerworld - The Food and Drug Administration, after a year of deliberation (see story), issued a final ruling yesterday that requires pharmaceutical companies to apply bar codes to thousands of prescription and over-the-counter drugs dispensed in hospitals. The agency believes the move will save lives by reducing medical errors but estimated that it would hit the nation's 6,000-plus hospitals with a $7 billion technology bill.
"Bar codes can help doctors, nurses and hospitals make sure that they give their patients the right drugs at the appropriate dosage," Tommy Thompson, secretary of Health and Human Services, 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 rule goes into effect for all existing drugs two years after publication in the Federal Register, which takes 60 days. The rule will apply to all new drugs in 60 days.
The FDA said the bar-code rule is designed to support and encourage widespread adoption of advanced information systems that, in some hospitals, have reduced medication error rates by as much as 85%. In these hospitals, each patient is provided with a bar-coded identification bracelet. A nurse scans the patient's bar code and the drug's bar code. The information system then compares the patient's prescription information with the drug data to verify that the patient is receiving the right drug and right dosage, and at the right time.
The FDA said a study conducted at a Department of Veterans Affairs Medical Center using a drug bar-code scanning system showed that 5.7 million doses of medication were administered to patients with no medication errors.
"We're encouraging widespread use of technologies that can help health care providers avoid hundreds of thousands of medication errors," said FDA Commissioner Mark B. McClellan.
Last week, the FDA said it believed that radio frequency identification technology was the best way to track prescription drugs at the case and pallet level to prevent counterfeiting (see story). . The agency said it expected widespread use of RFID technology by the pharmaceutical industry by 2007. The FDA said it believed bar codes are the "established and proven technology" with no impediments to their use in hospitals.
However, the FDA has concerns that RFID tags and readers could cause electromagnetic interference with medical devices used in hospitals and believes this needs to be investigated. Hospitals also don't need the track-and-trace capabilities for the entire supply chain that are built into RFID to ensure