To ensure that hospital patients get the appropriate medication at the correct time, the Food and Drug Administration intends to require a supermarket-style bar code on every drug dispensed, Health and Human Services Secretary Tommy G. Thompson said yesterday.
By matching the coded label on a prescription to the code on a patient's wristband, he said, hospitals could dramatically reduce medication errors that account for more than 7,000 deaths each year, according to one analysis.
"If we have it in a grocery store, don't you think we should have it in hospitals?" Thompson asked during a wide-ranging breakfast session with reporters.
The issue of medical errors grabbed headlines last month when 17-year-old transplant patient Jesica Santillan died after doctors at Duke University Medical Center gave her organs of the wrong blood type. But experts say more mundane errors take a huge toll medically and financially.
In its landmark 1999 report, "To Err is Human," the Institute of Medicine, a research panel affiliated with the National Academy of Sciences, found that as many as 98,000 Americans die each year because of preventable medical mistakes. More than 770,000 people are injured by medication errors at a cost of $177 billion each year, said Mary Gross of the FDA's Office of Drug Safety.
With 2.8 billion prescriptions written each year, Lucien Leape, one of the lead authors of the IOM study, said that 7,000 deaths annually is a conservative estimate.
Federal health officials said they will release details of the proposed rule change next week. Yesterday, they described the broad outlines of a system that will rely on technology to catch common human errors. Under the new approach, computers would alert a nurse if a drug and dosage did not match the patient. The system also could catch instances in which incompatible medicines are prescribed -- often by different doctors treating a single patient.
"Nurses call them the 'five rights' -- the right patient, the right drug, the right dose, the right time and the right route of administration, such as orally versus intravenously," said Michael Cohen, president of the nonprofit Institute for Safe Medication Practices in Philadelphia. With bar coding, "nurses can go home at night and feel so much more comfortable that they didn't give anything in error."
A few pharmaceutical companies and hospitals have begun using bar codes, but safety experts said the FDA requirement offers a much greater opportunity for protecting patients.
"Overall, the more you can automate, the safer it is," said Leape, a professor at Harvard's School of Public Health.
He described one study that found "a distressing error rate" when busy ward nurses mix medications into intravenous fluids. When hospital pharmacists do the mixing, the error rate falls significantly. And when the medications are premixed by the manufacturer, "there are essentially no errors."
FDA Commissioner Mark McClellan said bar coding represents one element of what he and Thompson hope will be a much broader trend toward using modern technology to improve patient safety. The bar-coding proposal, which can be implemented after a period for public comment, will be a top priority, he said.
Although he would not elaborate on the specifics of the agency's new requirement, McClellan said that in general he supports regulations that can be expanded as technology improves, suggesting that the FDA might later pursue requiring bar codes that have additional information such as expiration dates.
Representatives of the pharmaceutical and hospital industries embraced the idea of bar coding yesterday, though they said it could take years and hundreds of millions of dollars to implement.
"This is a critically important link in the chain to reduce medical errors in hospitals, and it's one of the most important things that can be done," said Charles N. Kahn III, president of the Federation of American Hospitals. He blamed drug makers, who receive less than 20 percent of their revenue from hospitals, for failing to move ahead sooner.
Alan Goldhammer, a vice president of the Pharmaceutical Research and Manufacturers of America, said his organization has supported the bar-coding idea for years, but added it could be difficult for companies to put bar codes on individually packaged dosages. If the FDA presses to go beyond a single universal code to include expiration dates or lot numbers, the idea could take five years to phase in, he said.
McClellan and Cohen expect the medical industry to move more rapidly, in large measure because of public interest in patient safety.