Suppliers voice concern that bar code quality and other issues could undercut the safety goal of FDA's rule.
Nutec Systems (Lawrenceville, NJ) manufactures digital ink-jet printing technology designed for printing 2-D Data Matrix bar codes.
Pharmaceutical firms are complying with FDA’s 2006 rule requiring standardized bar codes for drugs distributed in hospitals. However, some equipment suppliers worry that poor bar code quality could undercut the new regulation’s intent to lower hospital error rates. Their principal concern stems from the potential for inaccurate bar code verification grades obtained owing to uncalibrated instruments, poor verification procedures, or simply no use at all of bar code print quality assessment by some packagers.
“Our experience to date indicates that there is abundant compliance with printing the bar code—and printing it well,” says George Wright IV, vice president of Product Identification & Processing Systems Inc. (PIPS; New York City) and a GS1 US–certified bar code consultant. “On the other hand, not all drug manufacturers or packagers are as committed as they need to be to the investment in QA equipment, training, and implementation of SOPs that guarantee that their bar codes meet the minimum print quality standards required by FDA rule.” Another concern is the potential for confusion about the applicability of the FDA rule to over-the-counter (OTC) drugs. The FDA rule should be clear enough for prescription drug manufacturers to have met the deadline of April 26, 2006, he says. “I think, on the prescription side, it would have been hard not to get the message about what had to be done.”
There is less clarity among manufacturers, Wright contends, concerning which OTC drugs come under the FDA rule. The biggest cause is not so much ambiguity in the regulation but “the misperception that it applies only to prescription drugs.” Wright says he’s “less sanguine about whether the OTC side has gotten the message” with quite as much force.
It’s common practice, for example, for attending physicians to prescribe medicines such as antacids, laxatives, and even smoking-cessation patches to hospital patients. Wright says a number of manufacturers have contacted him with concerns “about bringing their OTC drug institutional packages into compliance.” Sales data, he points out, show that “a lot” of these go to hospitals.
IT’S THE LAW
FDA requires labels for human drug and biological products to carry, at a minimum, a GS1 or HIBCC linear bar code carrying the National Drug Code (NDC) number according to 21 CFR 201.25. In addition to requiring the linear bar code on drugs, the regulation also mandates standardized machine-readable information on blood and blood-component labels, as per 21 CFR 606.121(c) (13), FDA says. A guidance document published in October 2006 affirms that the goal is to “allow healthcare professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.” The guidance document says that not all OTC drugs require a bar code, only those that are commonly used in hospitals and dispensed “pursuant to an order.”
For Wright and others, though, a major concern is whether bar code verification technology has moved fast enough from the original, labor-intensive, off-line solutions to automated on-line systems that would make it easier and more affordable for drug manufacturers or packagers to readily comply. “Printing the bar code isn’t the issue,” insists Wright. “Printing it well is. That’s the manufacturer’s job. The job of full-service bar code companies such as PIPS is to develop the tools they need—and can afford—to prove they do it consistently.”
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“On December 31, 2002, when Pfizer Inc. shipped its first units of bar coded unit-dose packages of 100-mg Dilantin to hospitals, there was only one verifier in the world that would analyze Reduced Space Symbology (RSS),” Wright continues. “That was the Webscan TruCheck, a demonstrably accurate verifier that still leads the market. Today, there are a number of other choices as well. However, they tend to be off-line systems or ‘vision’ systems not specifically dedicated to bar code print quality verification.” On solid unit-dose blister packaging lines, in particular, Wright says, the desire is to evaluate bar code print quality in-line. He calls the response of verifier manufacturers to that need “not as aggressive as one might have liked. But some are working toward it pretty aggressively now and we should see solid solutions from Webscan, and perhaps others, this year.”
Robert Rack, a systems/software supplier and consultant with BarCodeAmerica.com (Madison, NJ), agrees that most pharmaceutical makers probably met FDA’s deadline. However, like Wright, he also questions code quality: “Some people produced codes, but they’re not always very readable codes.” He says “one of the top five” pharmaceutical companies recently phoned him with complaints about the readability of RSS Limited codes.
Rack, whose company distributes the Integra 9500 verifier, asserts that certain brands of verifiers “almost always read high,” while others are “generally fairly accurate” or work well with some codes and not as well with others. Some of the drug companies still have older readers that don’t read RSS codes, in particular, organizations with equipment older than three years, he notes. (In a related development, GS1, the organization that manages GS1 standards, announced in late February that it had changed the name of RSS to “GS1 DataBar” in order to avoid confusion with the widely used Web program Really Simple Syndication.)
Rack suggests using a test card set from Applied Image (Rochester, NY) to verify bar code accuracy. Applied Image developed the calibration standards as an adjunct to the ANSI X3.182 print-quality methodology. Applied Image collaborated with the Uniform Code Council (now known as GS1) and Association for Automatic Identification & Mobility (AIM) Global to develop the standards, which are monitored with a specialized microdensitometer called The Judge. The instrument is calibrated to ANSI methodology and is traceable to NIST, according to Applied Image.
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Rack asserts that recent testing done on the Integra 9500 with the calibration standards revealed its readings to be “dead on.” That result wasn’t always the case with other brands tested, he claims. The U.S. pharmaceutical company conducting the tests “learned that certain [verifiers] were telling them that things were great when they weren’t.” More important, he says, because most of these other systems merely raster through a code and sample as few as 10 locations along the height of the bar code, they often fail to show large sections of code that are failing. In one instance observed in testing at a pharmaceutical customer site, 73% of a code was actually failing but the code was reported as a B by one of the widely used laser-based verification systems. The vision-based Integra 9500 measures the code every 0.002 in. along its height, isolating and locating all defects easily. On many codes this means 400 sample points, not just ten, Rack reports.
WHERE’S THE DEMAND?
Inaccurate readings are not the only bar code concern for drug manufacturers. Jim Umbdenstock, president of Griffin-Rutgers Company, Inc. (Ronkonkoma, NY), questions whether drug companies met the deadline in the first place. “Did everybody hit the date? No. Did it matter? No. Again, it all goes back to the end-users.” He maintains that only 3–6% of healthcare facilities “are capable of using the bar codes at the patient’s bedside in any format.”
Umbdenstock says both drug companies and hospitals face financial pressures. Manufacturers have no financial incentive to add unit-dose bar codes. There is time and money involved in redesigning artwork and buying a printing system that can print the code within the ANSI/ISO standards properly. “They’re not going to sell more pills,” he says.
For their part, hospitals and nursing homes “don’t have the wherewithal to purchase [medication administration software and scanning] equipment,” Umbdenstock says. He points to two days of rallies in Albany, NY, that had been scheduled in protest of proposed cuts in Medicaid funding as an example of more pressing concerns.
Umbdenstock says that Griffin-Rutgers “caught the run of sales of in-line flexographic printing and other equipment” as drug companies geared up to meet the deadline. But it “certainly wasn’t the big run that we all hoped it would be.” He adds that many companies “elected to leave off the optional bar coded lot number and expiration date. In other words, they elected not to do the composite code. It wasn’t mandated, and the majority of end-users still don’t have the systems to read it anyway.”
As for the accuracy rate of verifiers, Umbdenstock sees “people who have entered this field who are not 100% prepared to match up the codes to meet the minimum ANSI/ISO quality requirements or who don’t have the ability or the wherewithal to instruct their customers to calibrate the systems properly.”
Tim Lydell, director of sales and marketing for Label Vision Systems Inc. (LVS; Peachtree City, GA), says that ensuring bar code print quality is “an ongoing type of battle, making sure people realize they need to check print quality.” (LVS is the manufacturer of the Integra 9500 system.) He adds that companies “are picking up speed on getting blister packs down and other types of labels inspected on a higher level.” He foresees FDA expanding its bar code rule to cover a broader spectrum of medical products brought into hospitals.
Mike Shaw of Nutec Systems (Lawrenceville, NJ) welcomes FDA’s rule. He says that the company’s digital ink-jet printing technology is particularly well suited for printing 2-D Data Matrix bar codes, particularly Nutec’s digital printing technology. The 2-D code is easier to pick up visually, Shaw says, because it incorporates an open source error-correction algorithm developed by NASA, “whereby a significant portion of the code can actually be missing and vision systems can still read it and decode it. That’s not true of DataBar, or RSS; if you’re missing just one line, then you can’t read it.”
Shaw, the company’s vice president of sales, says most firms are choosing the 2-D Data Matrix symbology over the more-expensive RFID option, another data carrier that FDA interested in. “As far as GS1 is concerned, data are data and bits are bits,” Shaw says. “We’re just printing data, and our cost for printing a data carrier is fractions of a hundredth of a penny. And RFID is trying to get down to fractions of a hundredth of a dollar.” He claims it’s an advantage that drug companies recognize.
A packaging engineer at a midsized U.S. pharmaceutical company says most companies probably overcame any technical challenges in order to meet the FDA requirement. “People had to develop the expertise to put those marks on there and decide how they were going to verify them,” he says.
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Printing codes on unit-dose blister packs may not result in a readable code, he says. Frequent examination during a print run is one key to ensuring consistency. The engineer says each “snapshot in time” can turn up problems such as “pieces of dust on the print run that can dramatically impact the quality of the code.”
“I’m very happy with the one I’m using,” says the engineer of his Integra model verifier, which he praises for its ease of use and reliability “when you compare it with some others.”
When it comes to grading print, “I have been told that a minimum C grade must be achieved on greater than 85% of the bar codes laid down,” says Joseph Buono, sales manager for CSAT America LLC (Louisville, CO). “There would have to be some scientific type studies done on CSAT printers on a wide array of materials to make that determination and repeatability. However, what we can say is that by using a printer such as the CSAT DTS 1200, we can offer the highest resolution in the industry, providing a higher grade. But consistency is a big key. I would not begin to want to guarantee [it] and then add together the variables such as temperature, relative humidity, substrates, and maintenance. I don’t think anyone offering in-line printing equipment can say with certainty the confidence [they have] in how the grade will hold up and at what point failure occurs, i.e., the grade drops below C.”
Problems with readability and accuracy are reported to FDA by the MedWatch program and Drug Quality Reporting Systems, FDA Spokesperson Crystal Rice points out. Under the provisions of the Federal Food, Drug, and Cosmetic Act, failure to have a bar code on the label results in a misbranded drug. The basic penalty “is imprisonment for not more than one year or a fine of not more than $1000, or both,” Rice says. The act also authorizes seizure of adulterated or misbranded drugs. In addition, FDA can seek an injunction to prevent further interstate commerce in misbranded or adulterated products.