The ball fell squarely onto hospitals' side of the court last week as the Food and Drug Administration took a final swing at bar-code regulations aimed at stirring the inertia that has kept hospitals from adopting the 24-year-old technology.
The technology, which is standard in other industries, would bring hospital care into the 21st century at a time when patient safety has risen to the top of the national agenda (June 16, 2003, p. 6). The regulations only apply to drugmakers and distributors, but the bar codes will be meaningless lines on a sticky piece of paper unless hospitals voluntarily purchase the capability to implement the technology.
"That is expensive technology," said Curtis Kellner, corporate director of pharmacy for nine-hospital St. Vincent Catholic Medical Centers in New York. "So plans for implementation (of the most sophisticated bar-code technology) are contingent on financial considerations. Unfortunately, hospitals are not in a position to increase their rates to help pay for new technology."
The final regulations, published in the Feb. 26 Federal Register and effective 60 days after that, gives drug manufacturers two years to apply bar codes to single-dose units of nearly every prescription and over-the-counter drug dispensed in hospitals, including vaccines and blood products. Each linear bar code-similar to the ubiquitous bar codes on millions of consumer goods-must at the minimum include the drug's National Drug Code number.
"We're encouraging widespread use of technologies that can help healthcare providers avoid hundreds of thousands of medication errors," outgoing FDA Commissioner Mark McClellan said in a news release. "Bar-coding systems have proved their dependability and effectiveness by ensuring the accuracy of a myriad of actions in commerce and industry." McClellan is awaiting Senate confirmation of his nomination as CMS administrator.
The FDA said it received about 190 comments on the proposal that was published in March 2003, nearly all of them supporting at least part of the regulations. After reviewing the comments, the FDA made four significant changes, including shortening the compliance period by one year and excluding drug samples from the requirement.
The compressed compliance period was in response to most of the public comments, some of which indicated that many companies already have gone a long way toward meeting the regulations, the FDA said.
Most hospital pharmacies use bar-code scanners for inventory purposes, but only about 1% of the nation's 5,000 hospitals have installed systems at the bedside, according to the FDA. Overall, about 101 hospitals use bar codes daily. Without the prodding of regulations, the FDA said it expected that hospitals would need about 20 years to adopt a bar-coding system.
In its most evolved form, in which bar codes are scanned at the patient's bedside, the technology ensures that the right medication is getting to the right person in the right dose and method at the right time, experts said.
The FDA estimated that when fully implemented the bar-code requirement will prevent nearly 500,000 medical errors over a 20-year period-a $93 billion economic benefit. The economic analysis takes into account that hospital admissions will grow over that period, an FDA spokeswoman said.
The cost of a bedside scanning system alone can range from $400,000 to $1 million, according to Rusty Lewis, president of the technology group at AmerisourceBergen Corp., a drug distributor that also sells bar-coding systems. Lewis estimated that manufacturers are now bar-coding about 35% of the products that wind up in hospitals.
All sides involved in the issue-hospitals, drugmakers and the companies that enable the technology-universally praised the FDA for the final result. Baxter International, which offers 325 products in medication delivery alone that will need to be bar-coded, was "pleasantly surprised" by the final regulations, said Joe Mase, group manager.
Putting a readable bar code on IV bags required developing a new patent-pending technology at Baxter, he said. Nevertheless, the company has already bar-coded 60% of its products in medication delivery and is expecting to be in full compliance a year from now-one year ahead of the FDA's schedule. "If we started today, we would be in jeopardy of missing the (FDA) timeline," Mase said.
With a robotic dispensing device that selects drugs based on bar-coded information, 978-bed St. Vincent's Hospital Manhattan is the furthest along of the St. Vincent facilities in adopting the technology, Kellner said. The same bar-coding could be integrated into a bedside system, but without a means of financing it, there are no immediate plans to implement it, he said.
Two of the six hospitals at West Penn Allegheny Health System in Pittsburgh will implement bedside bar-coding in the fall, said Tom Chakurda, a system spokesman.
Meanwhile, early adopter 719-bed Brigham and Women's Hospital in Boston developed an in-house bar-coding system that cost $2.6 million to build. The hospital pharmacy is now repackaging and bar-coding 3.2 million doses of medication per year at an annual cost of $300,000, said William Churchill, its director of pharmacy services.
The hospital pharmacy is relying on bar-coding for all of its dispensing, and there are plans to pilot a bedside system next month with a full rollout in the summer, he said.
"With this regulation, I suspect that (re-labeling) number is going to go down dramatically over time," Churchill said. "I think this is a great day for patient safety."