Security: You Either Get It or You Don’t

Converters that print labels for pharmaceutical applications can look forward to long, prosperous, and booming businesses if they stay on top of the prevailing issue in pharmaceutical labeling today—security.

“Security has been a hot topic of discussion in the pharmaceutical industry for a few years now,” says Robert Ryckman, vice president of sales and marketing, CCL Label Healthcare Group NA. “Many reported cases of counterfeit and diversion are well documented and that will continue. There is a slow, steady movement toward adding security features to the packaging within the industry.”

Counterfeiting and diverting continue to challenge pharmaceutical manufacturers to come up with new and better ways to avoid each problem. “When you look at some of the blockbuster drugs that are coming on the market, drug companies are expecting $1 billion plus in revenues,” says Tom Jay, VP, sales and marketing of SICPA. “They don’t want to see it counterfeited. They don’t want to see it diverted.” According to Jay, to avoid counterfeiting and diverting, drug companies begin planning early for the security design of the labels and packaging.

What this means is that converters will be expected to know more about their customers’ needs regarding counterfeiting and diversion, understand each of the technologies available, and know which technology best suits the needs of the customer. “In my opinion, it is probably best for a label converter to partner with a security technology company to integrate a system on their customers’ behalf,” says Jay. “We are an R&D-driven company that comes up with anti-counterfeiting and anti-diversion products. Printers don’t have the resources to do that, so they need to partner with the right companies to gain access to that technology and learn how to use it.”

Establishing pedigree

Some states now mandate that there be “e-pedigrees” that accompany drug shipments. Establishing an e-pedigree helps drug distributors provide an “e-trail” versus a paper trail to establish a drug’s origin, where it is going, and where it is sold.

Establishing pedigree requires that converters be aware of their customers’ needs regarding security labeling and how to meet those needs.

SICPA’s product security division offers a host of products, including a track-and-trace system. This system involves working with the brand owner to provide a mass serialization of product on individual labels. This information is contained within a covert bar code. “It can track the path of that label attached to that bottle that gets sold to a distributor and then through the retailer,” says Jay. “So the system can track that bottle of drugs all the way through the system.” According to Jay, the primary benefit to retailers is that they can pull bottles from their shelves, scan them, and be able to show the paths the drugs took to arrive at their locations.

Printing challenges to converters

According to Ryckman, “The major challenge facing the labeling industry is to deliver a mutlilayer approach at a reasonable cost that is secure and easy to manage. Some features require sophisticated and costly equipment that is not very portable. It is imperative that the first line of defense be a secure, overt solution that does not require a heavy investment in infrastructure in order to be used. The more complicated layers may require sophisticated methods of detection or authentication, since those will not be used at as many points throughout the chain.”

When it comes to printing secure labels for pharmaceuticals, converters also must keep an open mind and be willing to try new things. Printing labels using security inks is not the same as using conventional inks. For example, color-shifting inks are of a very large particle size, and according to Jay, one challenge is to correctly print with these inks and get the desired color-shift effect. “That’s something we work [on] with the pressmen and printers,” says Jay. “A lot of our inks don’t behave as regular printing inks behave and need a little more attention on the press until they can master printing them.”

It comes down to the press you’re using and your own expertise. Becoming proficient using these inks involves paying particular attention to the way the anilox carries the ink. “Most of these label printers are all flexo. We have suggestions and recommendations [on] how an anilox should be configured, running sequence, and things like that,” Jay comments. “They should not set unrealistic parameters when they try all the inks. Sometimes they have to run at a little bit slower speed than they normally run.”

In some cases, a printer has to be deemed “worthy” of using an ink company’s product before it can even begin printing the labels. The security of the ink is as important as the security of the label it’s being used to print. “We don’t’ sell our inks to just any printer,” says Jay. SICPA will audit a printer to determine how it will handle SICPA’s inks in house. “We don’t want the bad guys to get a hold of our ink,” he says. SICPA will send representatives to a facility, talk to the top management, and make suggestions for how to best protect SICPA’s products within its plant. One example is the plant’s waste stream.

When printers perform pharmaceutical security printing, they have to handle the waste stream separately and dispose of it in a more secure fashion than they already do. “A pharmaceutical company asked me to audit a printer [to which] it was thinking of jobbing out some labels,” says Jay. The company was printing the labels, but the waste was going into the regular waste stream. “When you went back to the area where the waste was collected, you found that there were parts of the security solution being used that were not being completely obliterated,” he says. “Someone could take the waste and possibly reverse-engineer what the security solution was.” So much more goes into printing secure labels for the pharmaceutical industry than putting ink to paper. pP

RFID tackles the increase in counterfeit drugs

by Dr Peter Harrop, IDTechEx

For many years, the United States Food and Drug Administration (FDA) has been concerned about the increasing incidence of counterfeit drugs in the U.S., including some reaching patients through the legitimate supply chain. It issued a seminal report called, “Combating Counterfeit Drugs” in February 2004. The report suggested tightening up procedures and, in particular, introducing RFID even on the smallest individual drug containers. The result of such actions was not to create another artifact that is tough to copy, like a hologram or chemical taggant, but rather something that permitted frequent automated checking of the origin and history of the item. The FDA calls this “pedigree” and the key to it is providing unique, secure identification codes on every item established at manufacture, these being recorded unalterably in an RFID label, on or in the item. This is called mass serialization.

Subsequent reports by the FDA recognize that there are significant issues to iron out, such as managing sensitive, secure databases and determining which frequency and signaling protocol will be used. On the latter points, Wal-Mart demands that Type 2 drugs be tagged with UHF labels, its motives being efficiency and security against theft and fraud, more than anti-counterfeiting. However, most individual drug containers do not have more than one RFID label, and the pharmaceutical manufacturers mainly favor HF, a different frequency. Major software and systems companies have made great progress in providing the necessary secure databases and networks for item-level RFID on drugs.

For more information, visit www.idtechex.com.