When the demand for unit-dose packaging of medications reached fever pitch, one after another the big drug companies rolled out their unit-dose offerings. And over the next several years, a similar "follow the leader" trend seems likely. But this time it will be the bar-code bandwagon that the drug companies will be jumping on, and the stakes may be high for those who lag behind.
In July, Abbott Laboratories announced that it would place unit-of-use bar codes on all of its injectable drugs and IV solutions by 2003. Abbott currently has 45% of its more than 1,000 injectable drugs and IV solutions bar-coded, and it expects to have 70% of these products bar-coded by the end of this year. Bar codes affixed to the labels on Abbott's products will include the National Drug Code (NDC), a 10-digit, 3-segment number that indicates the manufacturer, repackager, or distributor; product information (including strength, dosage form, and formulation); and the package size.
Drug Topics has learned that Pfizer Inc., not to be outdone by Abbott, is set to unveil its own bar-code initiative before the end of the year. In technology one-upmanship, Pfizer will include not only the NDC number, but two additional features in its bar-code offering: It will include on its unit-dose blisterpacks the lot number and expiration date.
Now that two of the industry's biggest players have committed to bar-coding, will other top-tier drug firms follow suit? "I think we will see the industry take notice," said Mike Cohen, president of the Institute for Safe Medication Practices (ISMP). Cohen has been championing the adoption of bar-code technology as a way to prevent medication errors. He said that the evidence is overwhelming that bar-code technology, in conjunction with bedside scanning, reduces the incidence of medication errors. "Just look at the VA system," he urged. He was referring to Veterans Affairs hospitals that have witnessed a drastic reduction in the number of its medication errors and adverse events since implementing bedside scanning of bar-coded labels throughout its inpatient facilities nationwide.
For the drug industry, adopting bar-code technology is clearly the right thing to do from a patient safety perspectivebut it's by no means the only catalyst. The pressure to adopt bar-code technology is coming from several fronts, including the Food & Drug Administration, which has been under increasing pressure to mandate bar codes for prescription as well as OTC medications; the Leapfrog Group, a consortium of Fortune 500 companies that base their purchase of health care on principles that encourage more stringent patient safety measures; and group purchasing organizations (GPOs). Irving, Texas-based Novation, one of the nation's leading GPOs, said that in 2004, all contracted pharmaceuticals would require unit-of-use bar-coding. Larry McComber, v.p. of pharmacy operations for Novation, said hospitals have a strong desire to address patient safety issues, and GPOs are responding to its members' needs. Premier Inc., based in San Diego, plans to institute a bar- code labeling requirement on all drug product contracts signed after July 1, 2003.
"Drug companies are going to rush to comply with what they anticipate will be the FDA regulations related to bar-coding," said Mark Neuenschwander, a Bellevue, Wash. -based technology analyst. Neuenschwander believes the FDA will give drug companies time to phase in the adoption of machine-readable bar codes on their labels by first demanding that they include the NDC number and eventually the lot number and expiration date. The FDA held public hearings in July, where hospital groups and patient safety advocates urged the agency to speed up efforts to require bar codes on drug products.
While many industry analysts have applauded Abbott's industry-leading efforts, others insist that Pfizer may have the strategic advantage by incorporating lot number and expiration date. "NDC alone is a great step forward, but the best solution is all three data elements," said Rich Hollander, senior director of packaging services for Pfizer.
Kasey Thompson, director of ASHP's Center on Patient Safety, noted that while Abbott's decision will likely put pressure on other big pharmaceutical companies to adopt bar-code technology in some form, he stressed that including lot number and expiration date should be a goal of every drug company. "NDC number is an important element, a step in the right direction. But for product tracking, the lot number is extremely important. Especially in the case of a drug recall, it's an added value," he said.
Fred Pane, administrator of pharmacy services at Lehigh Valley Health System, Allentown, Pa., concurs. "From a risk management perspective, it's ideal to have the lot number and expiration date." He explained that in the case of a recall, it's important to be able to track the product back to the patient. "If you have a recall and something happens to the patient, you might be able to track it back to the drug that you gaveor you'll know that you didn't have that lot and expiration date." Pane pointed out that although lot number and expiration date are listed on the package insert, it would be impractical to track the lot and expiration date for every dose you give a patient without the benefit of bar-code technology.
Nonetheless, the focus on reducing medication errors has prompted some industry leaders to push for NDC numbers as the first step in a comprehensive bar-code strategy. The Pharmaceutical Research & Manufacturers of America believes that lot number and expiration date should be phased in gradually. Alan Goldhammer, associate v.p. regulatory affairs for PhRMA, said that drug firms could move quickly in their adoption of bar-coding by focusing initially on the NDC number for unit-of-use packages because that information can be easily read by current bar-code scanners. Conversely, the addition of lot number and expiration date requires more sophisticated software technology. He added that while lot number and expiration date are good for inventory control, "they're not really related to med errors."
Laurie Hernandez, general manager/drugs and delivery systems for Abbott's hospital products division, said that lot number and expiration dates will eventually be added to Abbott's bar-code offering. However, she defended Abbott's decision to start out with only the NDC number because it focuses on the patient safety element. "This is a milestone," she said. "We're almost halfway done with bar codes, and there's an end in sight." She touted Abbott's decision to go with reduced space symbology (RSS) technology that allows for a miniaturized bar code to be applied to single unit-dose containers as small as a pen cap.
The adoption of bar-coding by major pharmaceutical companies could spur the further development of other technologies, including bedside-scanning devices and related software offerings. Some observers contend that bar-code initiatives have been stalemated because of drug company arguments that it was futile to put bar codes on labels unless hospitals had scanners. Hospitals, on the other hand, have been cool on purchasing scanners because most labels aren't affixed with bar codes. "Now, if the medications are bar-coded, the people who develop technology will have the incentive to develop and penetrate the market more rapidly," said Neuenschwander.
Meanwhile, as the industry is poised to adopt bar-coding as the next de facto best-practice technology, some hospitals are still reluctant to take the bar-code plunge for fear it will leave such a good electronic trail of activity that it will blow the liability issue wide open. On the other hand, said Neuenschwander, the opposite could happen. "Hospitals are going to be afraid of liability for not having bar-code scanning technology once it's reached the threshold or a certain mass distribution." The big question hospitals have to ask, he said, is whether or not they will put themselves at a greater risk for liability if a medication error occurs that could have been avoided by using bedside bar-code scanning technology.