WASHINGTON - Manufacturers of drugs and certain over-the-counter medications used in hospitals have two years to include linear bar codes on product labels.
The requirement is designed to protect patients from preventable medication errors and to reduce the overall cost of health care, Tommy Thompson, secretary of Health and Human Services, said Wednesday. Indeed, he said 50 percent of hospital errors occur because the wrong patient is given the wrong drug at the wrong dose or the wrong time.
While the rule covers all drugs used in the hospital setting and all blood and blood products, it does not include medical devices. However, FDA Commissioner Mark McClellan said: "We are interested in extending this to devices, but there is no equivalent to the National Drug Code in devices. But you can expect to see this in devices at some point."
The National Drug Code, known within the industry as the NDC, is simply a number that identifies a drug. That is the only item the government will require manufacturers to include on the linear bar code. McClellan said other information - such as the lot number, expiration date or dose - would be optional.
The final rule applies to most drug manufacturers, repackers, relabelers, private-label distributors and blood establishments. New medications covered by the rule will have to include bar codes within 60 days of their approval; most previously approved medicines and all blood and blood products will have to comply within two years.
Mary Beth Navarra, a registered nurse and director of medical safety for McKesson Corp., of San Francisco, told BioWorld Today that about 30 percent of medicines currently carry bar codes. However, without uniform standards, the codes have not been of much use in preventing errors. (McKesson is a supply management and health care information technology firm.)
But the long-awaited final bar code requirement will be published in the Federal Register today. Thompson said he was moved to reduce medical errors after learning of the 1999 Institute of Medicine report, titled "To Err is Human: Building a Safer Health System," that said upward of 100,000 people die every year in U.S. hospitals due to preventable medical errors, often related to drugs. (See BioWorld Today, July 30, 2002; Aug. 26, 2002; and March 21, 2003.)
Last spring the FDA sought public comment on the proposal, and Thompson said the drug and hospital industries support the requirement. The FDA does not regulate the hospital industry; therefore it cannot force hospitals to implement the system. However, Nancy Foster, senior associate director of the American Hospital Association in Washington, told BioWorld Today the association supports the rule, especially since it should help improve patient safety.
Blood banks and other blood facilities in hospitals would be required to comply, she said.
As for the cost of implementing a scanning system in the hospital, neither McClellan nor Thompson provided a figure. Foster didn't offer an estimate either, but did say, "Relative to other technology costs, this would be relatively small."
Navarra estimated the cost at $300,000 to $1 million, depending on the size of the hospital and its infrastructure.
Once fully in place, McClellan said bar codes are expected to help prevent 500,000 adverse events and transfusion errors over the next 20 years. The economic benefit of reducing health care costs is estimated at $93 billion over the same period, he said.
Veterans' hospitals already use the bar coding system. McClellan said a recent study showed zero errors out of 5.7 million doses of medication administered under such a system in Veterans Affairs hospitals.