Pharmaceutical manufacturers are evaluating layered approaches to drug packaging.
Although they receive less press than illegal drug trafficking, pharmaceutical diversion and counterfeiting remain huge, growing, and largely undocumented problems. A report by the World Economic Forum, released in 2011, found that fake drugs have a $200-billion-per-year impact on the world’s drug manufacturers (1). The business costs of illegally diverted drugs may be several times higher than that, says Kent Mansfield, president of TruTag Technologies, which has developed an on-dose covert security solution that is now in pilot and trial programs with pharmaceutical manufacturers and film coating providers.
“The companies we work with don’t tend to separate counterfeiting and diversion. They may have different teams working on each problem, but they don’t split out the numbers. Instead, they’ll typically say ‘This [problem] is costing me X million,’” says Jim Sinisgalli, director of marketing development at Systech International, LLC. “Generally, if a client has a good understanding of the extent of a product’s illegal diversion, they can better assess and address the entire [security] problem,” says James Lee, Systech’s vice-president of product management.
Recently, researchers have called for better labels to distinguish between all the possible forms of counterfeiting and diversion (2). Both counterfeit and diverted drugs hurt the public, when, for example, people abuse and become addicted to drugs intended for legitimate therapeutic uses, or take products that have expired or been improperly stored or labeled, says Mansfield. Both worlds collided recently in investigations into the death of the musician, Prince, which some reports linked to diverted opioid pain killer as well as a counterfeit generic drug (3).
Serialization and track-and-trace efforts promise to give manufacturers more control than ever in preventing illegal diversion, and they can help in anticounterfeiting efforts, but, by themselves, are not enough to prevent counterfeiting. Covert and overt brand protection technologies are also needed. All solutions must work in concert to achieve the three goals of protection, detection, and prosecution, says Shabbir Dahod, CEO of TraceLink, whose cloud-based platform is being used in many pharmaceutical serialization and traceability programs. “Security is a continuous battle, and, no matter what we do, criminal organizations are using sophisticated methods. We must continually raise the bar,” he says.
One of the vulnerabilities of overt, visible anticounterfeiting technologies for pharmaceuticals is that they are packaging-based, and easily duplicated. Criminals have become adept at mimicking not only logos, but color-shifting inks, and holographs. As a result, the use of each of these technologies tends to be short-lived before tweaks and updates are needed.
“Overt technologies are only good for a certain period of time until counterfeiters figure them out. They can only be expected to last so long, and they tend to be expensive,” says Lee, who sees the need for a layered approach to preventing both counterfeiting and diversion.
“If a company is relying on a hologram to demonstrate authenticity, then both the supply chain inspector and/or the consumer need to know what the real hologram looks like, so that they can effectively spot the difference between a fake and an authentic one. These days, this [differentiation] is becoming much more difficult to do,” says Mansfield.
He recalls situations in the past where drug companies were using scratch-off codes that could be authenticated by texting the revealed numeric code to a security database or calling the number through a special hotline. Within six months, he says, fakes were discovered where either a false hotline phone number was used, or a single authentic number was duplicated multiple times. “In the latter cases, counterfeiters copied one real code for use with multiple fake packages, knowing full well that only a small percentage of consumers were actually participating in the program,” says Mansfield.
Systech International, LLC, which is actively involved in serialization and track-and-trace efforts, has developed a covert security technology, Unisecure, which clients are evaluating and using as a second layer of protection.
The technology uses machine vision to derive unique fragments from machine-generated universal product codes (UPCs), based on imperfections caused by the paper, the printer, or other conditions. “No two labels are exactly the same,” says Lee. Mike Saborski, a vision software specialist at Systech, was able to find a way to leverage the unique imperfections inherent in any installation to come up with identifiers for each product.
Unisecure is being added as an additional layer above serialization, Lee says, with the ultimate goal to add traceability as well. “If you have two identical serial numbers, you cannot distinguish between them, but if you look at the signature fragments for each, you’ll see differences between the two. This way, when you scan the UPC code for tracking and authentication history, you know it’s the right item in the right market,” he says.
Using the technology does not require any special equipment, just a standard camera mounted on a production line, Lee says. Users capture the image and device fingerprint for each product, and then move on to the next.
One pharma company that had already serialized has added Unisecure as a second brand-protection layer. After pilot testing the combined approach in April 2016, the firm now plans to deploy it on serialized lines for high-cost drugs, Lee says. Another company is evaluating it for a mix of different products, both pharmaceuticals and consumer products, he adds.
Systech, half of whose business is in Europe and the US, has been expanding in Asia. A few years ago, the company set up an office in China, and in September 2016, it launched an office in India.
While developers continue to improve brand-protection technologies, pharmaceutical manufacturers and their partners are making progress on serialization and traceability efforts, now mandated in much of the world. “Since January 2016, we’ve seen a ten-fold increase in the number of contract manufacturers embarking on serialization programs,” says Dahod.
In general, he says, the technology required for brand-protection already exists. “The challenge will be integrating it into one single source to disseminate information that can be easily accessed.”
1. K. Van der Elst and N. Davies, Editors, Global Risks 2011, Sixth Edition, World Economic Forum.
2. G. Buckley and L. Gostin, Editors, Countering the Problem of Falsified and Substandard Drugs, Institute of Medicine of the National Academies (National Academies Press, Washington, D.C., 2016).
3. Associated Press Minneapolis, “Counterfeit Pills Found at Prince’s Home Contain Powerful Opioid Fentanyl,” August 21, 2016, theguardian.com.
This article was excerpted from A. Shanley, "Chasing a Moving Target for Counterfeiting and Illegal Diversion,” Pharmaceutical Technology Europe 28 (10) 2016. To read the full article click here.