The Case For Bar CodesThe Case For Bar Codes

Radio-frequency identification pilot programs like JumpStart have been launched to address the rising issue of drug counterfeiting in the pharmaceutical industry, but many say RFID is overshadowing existing technology that can deliver similar benefits today, such as an electronic pedigree. One bar-code maker, Secure Symbology Inc., has created a serialized bar-code system that can help in anti-counterfeiting efforts and could be bridged with RFID technology in the future, SSI president Ronald Berenburg says.

The Electronic Sequence Code is a machine-readable bar code system that prints a unique serial number on every product and can deliver an electronic pedigree at every packaging level: a container or an individual product unit, Berenburg says.

A regular linear bar code on a bottle of Advil, for example, will always have the same 12 digits that contain manufacturer and product information and stay consistent on every bottle. What changes, however, are the expiration date and the lot number. But SSI's serialized bar-coding system involves the printing of sequential or random serial numbers, collecting serialized information, and creating an electronic database.

The benefits of ESC lie in the electronic pedigrees that it can generate, enabling product authentication, counterfeiting protection, validation of product returns, expediting of recalls, brand security, and increased consumer safety, Berenburg says.

"We found a way to use bar-code technology to accomplish various different things: track and tracing, anti-counterfeiting, and achieve returns on investment," he says. "If you are able to achieve ROI by using today's bar-code technology, you can use that money in a methodical way to develop a future RFID infrastructure."

But Meta Group RFID analyst Bruce Hudson says ESC isn't much different from the Electronic Product Code issued by EPCglobal. The only difference is the data container required by EPCglobal, which is the RFID tag, and the network that will be used to manage data pulled from that container.

"RFID technology is limited right now, it's expensive, and it's not reliable. But it really doesn't matter for electronic pedigrees if you buy an ESC or an EPC code or an internal numbering code," Hudson says. "What matters is the container with this information, the RFID tag, and pharmaceutical companies feel that RFID may give them some long-term advantages that bar codes cannot."

While Hudson agrees that RFID might be overshadowing existing technology and that the U.S. Food and Drug Administration hasn't mandated but only suggested that companies move forward with RFID, states have mandated electronic pedigrees and are skeptical about how products are identified and linked to electronic pedigrees. Hudson suggests that pharmaceutical companies make the following decisions:

• Choose a numbering system like the EPC or the ESC that allows unique identification of a product at the sellable-item level.

• Attach that number to the sellable item, with either an RFID tag, a bar code, or both.

• Ensure that the manufacturing and supply-chain back-end systems can deal with the unique numbers.

• Choose an app that handles the electronic-pedigree requirements.

• Get FDA validation for the apps and interfaces.

• Ensure that supply-chain partners have the infrastructure to read and interpret the data, the EPC code, or ESC code.

• Evaluate the costs associated with each data container at each point in the supply chain, such as increased variable costs and fixed costs.

• Determine the right tagging scheme for each product.

• Finally, map the technology against market and regulatory requirements and create upgrade and migration plans.

As global ISO standards, the infrastructure, and electronic pedigrees continue to develop for RFID, SSI can fill a temporary business need for specific high-theft or counterfeited drugs for some pharmaceutical companies, says John Blanchard, an ARC Advisory Group principal analyst. "ESC can fulfill the current requirement for electronic pedigrees for drugs," Blanchard says. "But companies that invest in this technology ultimately will have to move to RFID and especially if it's for products that have life cycles of three to four years."

Blanchard also argues that neither linear bar codes nor SSI's serialized bar codes could be as effective as active RFID for managing drugs that need to be environmentally conditioned from the time they're manufactured to the time they're used. Biological products, for example, need to be conditioned for certain temperatures and humidities or they lose efficacy.

Both analysts agree, however, that bar-code systems like ESC can serve as a bridge to RFID.

Says Berenburg, "We can encode the EPC format as it migrates in a bar code format, and in the future use bar code technology printed on an RFID label as a backup to RFID."