Originally Published PMPN September 2001
EDITORIAL
Bar Code Use Not the Only Way to Prevent Errors
To get rid of human errors, you've got to get rid of humans. Well, that's not exactly what groups like the American Society of Health-System Pharmacists (ASHP) advocate, but they do want to automate the identification of drugs and devices through bar coding. "Bar coded containers allow for immediate product verification, and they can be used in pharmacies and hospitals to ensure patient safety," writes Henri R. Manasse Jr., executive vice president and CEO of ASHP, on page 22. "Bar codes should appear on the labels of drug products at all levels of use." To get industry to apply such codes to their products, Manasse urges FDA to mandate bar coding.
In theory, Manasse's solution is perfect. Many mistakes during healthcare delivery occur out of human error. I have previously written that until most packages bear bar codes, product identification and delivery will remain a manual process, subject to human error. Manasse's request of FDA to mandate bar code application motivates manufacturers through regulation.
Having manufacturers bar code every item, however, may not be easy, and it may not eliminate all human errors. Manufacturers face implementation hurdles, like space constraints and increased costs, and not every bar coded item is read through automation.
For instance, the space necessary for codes is scarce on already crowded labels. "With so much printed information already required by regulatory agencies, labeling real estate quickly becomes a premium commodity," says Robert C. Vincek, principal of Robert C. Vincek Design Associates.
James Rudnick, director of packaging development at Ethicon, a Johnson & Johnson company, says for small products especially, "a lack of available space is a challenge." Ethicon has implemented unit-level bar codes on the rear surfaces of many of its products.
The Health Industry Business Communications Council (HIBCC) and the Uniform Code Council (UCC) have both devised codes that work in limited space. Just this year, HIBCC approved two-dimensional application specifications for Data Matrix symbology. HIBCC's alphanumeric codes, which Rudnick says allow manufacturers to incorporate existing alphanumeric coding systems found in order catalogs, can now be represented with a small but densely packed symbol. "Data Matrix is the most space-efficient symbology, and it can fit onto more small packages than any other bar code symbol," says Michael Miller, chair of HIBCC's Automation Identification Technical Committee. Nearly two years ago, UCC, along with EAN International, devised reduced-space symbology (RSS) and composite symbology for encoding the full 14-digit UCC/EAN item identification. A study with Alcon Labs, The NOSCO Printing Group, St. Alexius Medical Center, and UCC proved that RSS versions such as RSS-14 Limited and RSS-14 Stacked can be applied on vials as small as 2 ml, and that practitioners can scan such symbologies successfully.
Space concerns aside, manufacturers do face added costs in implementing a coding system, even a space-saving one. Miller explains that "to print even symbols such as RSS onto some packages requires retooling to larger package sizes, a subsequent decrease in production rates, and an increase in materials usage. High-resolution print capability and additional in-line equipment to check the readability and accuracy of the bar code is also necessary."
Manufacturers face another challenge—getting practitioners to use such codes. "Bar codes have facilitated inventory management at the carton or case level; significant systems would have to be developed to support mandated end-user scanning of medical devices," says Rudnick.
Perhaps the exclusive use of one technology isn't the answer. Robert Kelsey of Kelsey Corp. says bar codes shouldn't be looked at as the only solution to preventing errors. "A coding system should only serve as double assurance that easily confused drugs are not mixed up," he says. Saying that bar codes can be misread, too, and that pharmacists routinely sort tablets outside of bar-code-bearing bottles, he believes a combination of product elements as well as codes can all be used to "stamp out potential coincidences." Similarly colored and shaped drugs are sometimes mixed up, but if they were stamped or printed with symbols and varied in color or shape, pharmacists and other practitioners might better avoid potentially grave mistakes.
Technology such as bar coding can certainly reduce the likelihood of one drug being mistaken for another. But no one technology is the perfect solution. Instead, a variety of technologies could work in concert. Vincek says "a carefully thought-out label and color coding can become effective first steps in minimizing point-of-use errors," and "bar coding can provide a higher level of checks and balances." Each unit should be bar coded, but manufacturers must not forget that other means of product differentiation can work to prevent human errors, too. After all, humans can't be removed completely from healthcare.
Copyright ©2001 Pharmaceutical & Medical Packaging News
