Manufacturers of drugs and certain over-the-counter medications used in hospitals have been given 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 healthcare, Tommy Thompson, secretary of Health and Human Services, said late last month. Indeed, he said 50% 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. 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. [However] 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.

The long-awaited final bar code requirements were published in the Federal Register Feb. 26. Thompson said he was moved to reduce medical errors after learning of the 1999 Institute of Medicine (Washington) report, To Err is Human: Building a Safer Health System, that said upwards of 100,000 people die every year in U.S. hospitals due to preventable medical errors, often related to drugs.

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 (Washington), said the association supports the rule, especially since it should help improve patient safety. "We think bar coding can be an effective technology that hospitals would like to consider as part of the opportunities they have to improve patient safety," Foster said.

While most of the current attention for bar coding is focusing on pharmaceuticals, she said she believes it should also be used in medical devices as well, "to help make sure we're getting the right-sized equipment to the patient." She said bar coding also "could facilitate" inventory and maintenance of medical devices, but the primary use that hospitals currently envision the technology for is making sure that singe-use devices that a doctor orders for a particular patient, go to the right patient.

While Foster said that hospitals, per se, are not required to have bar coding in place, she noted that blood banks and other blood facilities in hospitals would be required to comply. 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."

Once fully in place, McClellan said bar codes are expected to help prevent 500,000 adverse events and transfusion errors during the following 20 years. The economic benefit of reducing healthcare 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 hospitals operated by the Department of Veterans Affairs.

FDA meeting 'biomedical century' challenge

The federal government needs to do a better job of working together with medical technology innovators to get treatments to patients faster and safer, McClellan said last month. Calling this the "Biomedical Century," he said that despite the need for continual improvement, the FDA is working to meet the challenges brought by research and development.

McClellan acknowledged that the agency is supportive of President George Bush's plan for "fully funding" the Medical Device User Fee and Modernization Act (MDUFMA). The innovation process is costlier than ever before, he noted, and "there are more investigational devices and drugs in the pipeline now than any other time in history, but we need to get the process more affordable."

Noting that "We need to develop better critical pathways for scientists who have the know-how to get products and drugs to patients in the fastest, safest, and most cost-effective way possible," McClellan added: "All of these exciting areas of research genomics, proteomics and nanotechnology are happening at the same time, but none are at the level of impacting patients' lives yet, and that challenge is occurring at the same time as the nation is worried about the rising costs of healthcare." Many Americans worry that they can't afford the new technologies, even if they are available, he said.

The agency has met or exceeded all the performance goals established as part of MDUFMA, McClellan maintained, adding that it will be committed to meeting future goals if the user fees are fully appropriated with congressional approval of the president's budget.