Counterfeiting Countermeasures

Hallie Forcinio

Hallie Forcinio is BioPharm International's packaging editor, editorhal@sbcglobal.net

Equipment and Processing Report, PharmTech Equipment and Processing Report eNewsletter 02-17-21, Volume 14, Issue 2

Labeling, printing, and on-dose tagging technologies provide a multi-layered approach to anticounterfeiting for pharmaceuticals.

The pharmaceutical industry has been on the leading edge of anticounterfeiting and brand protection efforts for many years. “Anticounterfeit solutions are usually tailor-made according to the needs of the brand owner,” says Paavo Sillanpää, senior business manager, Pharma at UPM Raflatac.

A diverse strategy considering threat scenario and product is needed. “Most pharma companies have a multi-layered approach,” notes Joe Farrell, life sciences expert at Loftware. The most common physical solutions are tamper-evident labels and packaging materials, designs that prevent the placement of a counterfeit product into the original packaging, serialization, and overt and covert authentication methods such as holograms, invisible markers, and taggants.

“Ideally, multi-level security concepts should be used that are individually tailored to a specific use case, combining analog and digital features, which can be verified by different stakeholders within the supply chain,” says Gene Dul, president of Schreiner MediPharm US.

There is heightened interest in tools and technologies that go beyond the package to protect patients, such as on-dose solutions. In addition, says Peter Wong, chief operating officer at TruTag Technologies, “the industry is increasing its public awareness campaigns of the problem of fake and unsafe medicine in an effort to educate consumers about the dangers of unauthentic drug products.”

As a result, John Pitts, key account manager for Antares Vision, predicts an increased focus on consumer engagement. He notes, “Enabling the end consumer and the dispenser to authenticate their products is powerful on so many levels. It makes counterfeiting more difficult, provides vital and real-time data to the consumer, and can offer the manufacturer feedback.”

Labeling technologies

Labeling plays an important role in the fight against counterfeit products. As the passport for moving products through the global supply chain, it contains any track-and-trace or authentication information. “In the label business, we have seen an increased interest in various tamper-evident (TE) solutions and holograms,” reports Sillanpää. One new product from UPM Raflatac combines heat resistance, advanced adhesion, and conformability. Designed primarily for the European market where cartoned blister packaging is common, the heat-resistant TE label won’t shrink in heat tunnels used to produce multipacks. UPM Raflatac has also introduced sustainable TE labeling. It’s produced from Forest Film, which Sillanpää says is “the world’s first wood-based plastic labeling material.” Benefits include performance equivalent to traditional plastic film label materials and the ability to help pharmaceutical brands achieve sustainability goals.

Demand for more sustainable products extends to RFID and near-field communication (NFC) tags. Eco-friendly RFID and NFC tags from Identiv feature paper-based transponder inlays that reduce polyethylene terephthalate content, resulting in a repulpable substrate (1).

RFID technology is integral to the Cap-Lock plus RFID cap adapter and label combination from Schreiner MediPharm. The label-integrated RFID inlay provides digital proof of integrity and first-opening evidence for syringes as well as product authentication. Dul explains, “The adapter is placed on top of the syringe’s primary closure and interlinked with it to equalize the diameter differences of the syringe body and closure. The label wraps around the syringe body and cap adapter and—once opened—provides irreversible tamper evidence due to an integrated perforation.”

Printing and tagging technologies

Magnetic ink is another potential anticounterfeiting tool. Technology from Inspectron relies on a proprietary reader, track-and-trace software, and magnetic ink, long used on checks to facilitate automated sorting. The magnetic ink is used to print a barcode, which is detectable even if it’s not visible to the eye. That means the code, which may be serialized, can be hidden on the inside of a carton or under a label and still be read. The current reader works from a distance of up to 2 mm, but units with longer read ranges are under development. “However, longer read ranges require bigger codes,” notes Nathalie Muller, head of Innovation at Inspectron. Although the first commercial application of the technology inkjets the codes on paper to enable identification of diverted product, Muller says, the permanent magnetic codes could be printed on plastic or glass containers and potentially support tasks like vial tracking. Also under development is a hybrid one- and two-dimensional barcode that would hold more data.

On-dose technology enables authentication at the product level. Edible microparticles coupled with the Smart Medicine solution from TruTag Technologies confirms product authenticity and can help boost patient adherence and outcomes. A new Pharma Mobile App allows patients to scan each dose with their smartphone, authenticate it, and record that it was taken. If desired, the record of the dose can be shared with healthcare providers. The system also can link to other product information.

In April 2020, FDA accepted molecular tagging technology from Applied DNA Sciences into its Emerging Technology Program (2). The company says that its technology is a multilayered platform that gives both the dose and the packaging an immutable identity for authentication.

On Nov. 30, 2020, AlpVision launched its Alpvision COVID-19 Initiative to protect COVID-19-related therapeutics and vaccines against counterfeiting. Under the program, AlpVision provides pharmaceutical companies and their suppliers with the tools to deploy its Cryptoglyph digital security feature on their packaging. Invisible to the human eye, the Cryptoglyph feature can be authenticated via smartphone. Adopting the technology does not change the production process or involve additional consumables. In addition, the smartphone applications connect to AlpVision’s Brand Monitoring System, a centralized server platform that enables real-time monitoring of product authentication activities. AlpVision plans to provide this service for free until the World Health Organization declares the pandemic has ended (3).

References

1. Indentiv, “Identiv Launches Eco-Friendly RFID, NFC Tags,” Press Release, Jan. 23, 2020.

2. ADNAS, “Applied DNA Accepted into US FDA’s Emerging Technology Program, Creating Pathway for Molecular Tagging of Pharmaceuticals and Packaging,” Press Release, Apr. 30, 2020.

3. AlpVision, “AlpVision to Offer Free of Charge Security Feature to ProtectCOVID-19 Relevant Medicines against Counterfeiting,” Press Release, Nov. 13, 2020.

About the author

Hallie Forcinio is packaging editor at Pharmaceutical Technology, editorhal@sbcglobal.net.