|A 2-D data matrix barcode --Courtesy of CDC|
Drugmakers are looking for ways to develop deeper connections with their customers, and GlaxoSmithKline ($GSK) believes 2-D barcodes, the scannable, data-rich squares of digital information, are a good vehicle to do just that. GSK is joining Sanofi ($SNY) in adding them to the packaging for most of its vaccines sold in the U.S., allowing doctors' offices to scan crucial information into electronic medical records and potentially saving them significant time.
The American Academy of Pediatrics, along with the FDA and the Centers for Disease Control and Prevention (CDC), has been pushing for adoption of the codes, and the CDC has been overseeing a pilot program that GSK and Sanofi participated in to test the technology.
"It is all about listening to what our customers want," Dr. Leonard Friedland, vice president of scientific affairs and public policy at GSK Vaccines North America, told FiercePharmaManufacturing. "The efficiencies have to be demonstrated in the clinic, but there is great opportunity to reduce inaccurate data recording and to save practitioners time. I am a pediatrician myself and from an office management perspective, I know staff spend so much time handwriting or typing in info," Friedland said. "This should allow people more time to spend with patients and less time on manual tasks."
The CDC currently requires use of the 2-D barcodes on the vaccines information statement, but in the pilot program, the companies added it to the inner containers and outer boxes of vaccines. Sanofi has 7 products using the 2-D barcodes, and GSK tested it on its Havrix hepatitis A vaccine. GSK will roll out the codes on 9 more products over the the next 6 months, starting with its Fluarix Quadrivalent 4-in-1 influenza vaccine which the FDA approved for shipping on Monday.
The 2-D barcodes are smaller than the linear barcodes traditionally used on pharma packaging but can hold much more information. That extra capacity will permit GSK to encode product identification, expiration date and lot number on the matrix. Healthcare providers that have the required hardware and software can then update their inventory-management system, patient records and vaccination reports by scanning the barcodes.
The decision to go this route has nothing to do with the push by the FDA for a national track-and-trace system that will allow it to know where any drug is at any given moment, Friedland said. He acknowledged, however, that 2-D barcoding will likely play into serialization because the matrix technology has room for so much information: "That is not why we are doing it, but certainly 2-D barcodes will have the room for that kind of thing." If the technology is used in track-and-trace, GSK's experience with the technology will help it down that path. "We will just have to see what the regs are when it occurs," he said.
GSK won't disclose what it is investing in the new labels, saying it is just a "cost of doing business." But a study funded by the CDC estimates it will take an investment of about $1.2 million to refit each packaging line, which could tally more than $30 million for the industry. The study estimated that the cost savings to the health system, if the technology is adopted, could range from $310 million to $340 million between 2011, when the pilot began, and 2023.
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