Several anti-counterfeiting initiatives are underway in the pharmaceutical sector, where it isn't just brand protection that's at stake but rather the very lives of people who take packaged drugs assuming the contents are genuine.
One of the more notable initiatives to be announced recently is AstraZeneca's Serialized Authentication Program. It's a two-pronged effort to protect drug products with unit-level serialized tamper-evident security seals (TESS) combined with unique carton numbers (UCN).
"The pharmaceutical industry generally uses the term 'mass serialization' to describe what we're doing on each carton," says David Teale, product security director at AstraZeneca. "But we find that 'unique carton number' is easier to understand."
The new program is being used first to protect supplies of Nexium, a prescription-only gastrointestinal drug that generated $5.2 billion in sales in 2006. The serialization will be implemented on paperboard cartons containing blisterpacks holding anywhere from seven to 28 tablets. The U.S. will not be included in the mass serialization program because the U.S. market—unlike Europe, where unit-dose packaging is far more common—sends tablets in bulk containers that pharmacists count out into plastic amber vials.
The unique number that each Nexium carton carries is in a 2D bar code printed on line at the AstraZeneca plant where packaging takes place. The bar-code printing system selected by AstraZeneca is the TIPS Serialization Product tracking solution from Systech Intl. . It includes Domino Amjet printers and algorithms generated by Systech technology. RFID was evaluated, notes Teale, but ultimately rejected not only because it was too expensive and too unreliable, but also because certain privacy issues have not been resolved. In the future, RFID will fulfill its potential, adds Teale. But right now it's just not ready. 2D bar-code technology, on the other hand, is.
Second prong
The second prong of AstraZeneca's Serialization Authentication Program is a serialized TE seal from Authentix.
"Unless we seal the carton with a tamper-evident seal, all we've accomplished with the 2D bar code on the carton is authentication of the folding carton. The tamper evident seal helps us guarantee that what's inside the carton is genuine. The seal has a hologram on it, which is an overt layer of authentication that pharmacists or hospital personnel can see. It also has hidden security features that can't be copied, including a unique 2D bar code printed in ink that is not visible to the naked eye."
Teale describes the use of serialization on both carton and TE label as a "bookend approach."
"We authenticate the pack as it leaves our manufacturing plant by uploading the unique numbers into a data base," says Teale. "If the last person to handle the pack in the supply chain can authenticate the package against the data base, we know both ends of the supply chain are secure."
And why use serialization at two levels instead of only one? Teale calls on that quintessentially British expression to answer: "Belt and braces. Besides, this is the layered approach that is universally recommended as one of the cornerstones of any anti-counterfeiting strategy."
Teale goes on to say that AstraZeneca is building a very important database as the Serialized Authentication Program rolls out.
Product security data management
"It's a product security data management system where all the unique numbers generated at nine Nexium sites globally will be stored," he explains. "It can be interrogated to see if individual packs are authentic. Without that single database, we'd have to drill back down to each individual manufacturing site. The next step, then, is to bring our wholesalers in contact with the product security database and integrate it, as well, with our central ERP (Enterprise Resource Planning) system. That way, we know exactly where a pack is at every stage along the supply chain. It's adding track-and-trace functionality to the authentication functionality that's built in from the start."
Sweden was the first AstraZeneca market to implement this ambitious program, as Nexium cartons with both layers of mass serialization began rolling off packaging lines in mid-April. One fly in the ointment at this early stage revolves around the question of scanners capable of scanning a 2D bar code. For AstraZeneca's initiative to hit on all cylinders, pharmacies and hospitals must have such scanners in sufficient supply. At this point, they don't.
"We're working with EFPIA [European Federation of Pharmaceutical Industries and Associations] on funding for the 2D bar code scanners," says Teale. "One idea is to establish a not-for-profit mechanism that will soften the cost of getting scanners into the hands of those who need them."
The ultimate goal, says Teale, is to find a way for all stakeholders—hospitals, pharmacists, drug manufacturers, and governmental agencies responsible for the drug supply chain—to see value in a shared anti-counterfeiting strategy and to absorb some of its costs jointly.
While the above examples of anti-counterfeiting strategies are certainly encouraging, the battle against the bad guys will never end, says Tom Kubic, executive director of the Pharmaceutical Security Institute.
"We view counterfeiters as people who may be deterred by robust packaging features, but they'll get around such features eventually," says Kubic. That's not to say that exploring new packaging technologies aimed at foiling counterfeiters is a waste of time, says Kubic. It's just a way of acknowledging that technology alone is not a silver bullet.
"Constant technological development must be continued, but it must be complemented by heightened public awareness and regulatory enforcement," says Kubic.
--By Pat Reynolds, Editor, Packaging World
