FDA Proposes Bar Coding for Hospital Medications

Over the last decade, simple human error -- the improper administration of medications in hospitals -- has killed more than 70,000 patients and injured hundreds of thousands more.

On Thursday, the Food and Drug Administration proposed a solution that has been in plain sight for years: standardized bar codes of the sort that distinguish bread from breakfast cereals and ham from hamburgers in the neighborhood supermarket.

Under the FDA’s plan, all patients admitted to hospitals would be given bar-coded identification bracelets linked to their medical records. Every dose of prescription medicine, as well as commonly used over-the-counter drugs, would carry a bar code on its label.

When the time came for a patient to receive medication, the bar codes on the ID bracelet and the medicine would be checked against the patient’s chart to ensure that the right patient was getting the right amount of the right medicine at the right time.

Such common-sense procedures -- already used at some hospitals around the country -- could cut the number of hospital medication errors in half and save more than 7,000 lives a year, experts said Thursday.

In severely short-staffed hospitals, bar coding could serve as a second brain for overworked nurses.

Among other things, the system notifies nurses of any special procedures to be followed when administering a medication and tells them if they have missed a dose, said Michael R. Cohen, president of the nonprofit Institute for Safe Medication Practices in Philadelphia.

The FDA estimated that complying with the regulation would cost drug manufacturers and hospitals $53 million over 20 years. But hospitals would save up to $7.6 billion in record-keeping costs over that same period, officials said. And avoiding longer hospital stays and reducing patients’ pain and suffering would save the health-care system an additional $41 billion.

“It’s a no-brainer,” Cohen said. “The payback is tremendous.”

In addition to the proposed bar-code regulation, the FDA also announced a proposal to require hospitals, pharmacies and blood banks to report medication errors and blood-product problems to the government more quickly. The goal is to uncover and correct problems faster.

“These proposals are key steps in reducing medication problems through using state-of-the-art technology,” said Health and Human Services Secretary Tommy G. Thompson.

FDA Commissioner Mark B. McClellan said the “actions are the start of a comprehensive strategy to build a medical patient-protection system for the 21st century.”

Thursday’s announcement opens a 90-day public comment period on the proposed rules.

Drug manufacturers and hospitals would have three years to comply with the bar-code regulation, but experts predicted that bar-code medication systems would be up and running in most of the nation’s hospitals long before that.

Roughly one-third of all medications used in hospitals already carry bar codes.

Two important industry groups, the Pharmaceutical Research and Manufacturers of America and the Federation of American Hospitals, praised the bar-coding rule.

“No other step could help bring about improvements in patient safety as immediately and as effectively as the use of standardized bar-coding technology,” Chip Kahn, president of the hospital group, said in a statement.

The American Society of Health-System Pharmacists, which represents druggists who practice in hospitals, nursing homes and health maintenance organizations, called on the government to go even further.

While the FDA’s rule would require bar codes to include the national drug code -- the drug’s name, dosage and strength -- they should also contain a drug’s lot number and expiration date, the pharmacists said.

The FDA’s proposed rule for safety reporting would give companies just 15 days to report serious drug reactions. They now have up to three months.

Blood banks, which now are required to report fatalities only, would have to report all serious reactions to blood transfusions.