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Hallie Forcinio is BioPharm International's packaging editor, email@example.com
Anticounterfeiting technology protects the supply chain from manufacturer to patient.
The never-ending battle against counterfeit pharmaceutical products has become fiercer with the pandemic. With product protection a constant concern, the market for anticounterfeiting technologies is strong, regulatory efforts are ongoing, and authentication and anticounterfeiting technologies are evolving. As a result, the anticounterfeiting packaging market is projected to grow at a 7.8% compound annual growth rate to $189.9 billion in 2026 (1). A major driver for this growth is the expanding use of e-commerce platforms, which make it easy to set up shop to sell fraudulent products and are largely unregulated. A study by Local Circles noted that approximately 20% of all products sold on e-commerce sites are counterfeit (1).
Anticounterfeiting laws and regulations, such as the European Union’s Falsified Medicine Directive and the US’s Drug Supply Chain Security Act (DSCSA), safeguard prescription drugs available from pharmacies. “However, pharmaceutical manufacturers should be aware that these measures alone will not guarantee a product’s integrity and authenticity,” says Gene Dul, president of Schreiner MediPharm US. He says, “Only additional counterfeit-proof authenticity features can provide a comprehensive approach against fraud, misuse, and tampering.”
Unfortunately, the coronavirus pandemic has increased the opportunities for counterfeiting. “In a survey issued by IDC in June 2020, 70% of companies agreed that their supply chain is ‘very vulnerable’ to suffering more problems if the COVID-19 crisis lasted more than a couple of months longer, and 75% of companies agreed that the COVID-19 pandemic has ‘greatly increased/will greatly increase’ problems with diversion, theft, and counterfeiting of critical products such as test kits, vaccines, and antivirals,” reports Aimee Genzler, vice-president, Corporate & Brand Communications at TraceLink, the study sponsor (2).
In fact, in anticipation of a spike in counterfeiting, the US Immigration and Customs Enforcement Homeland Security Investigations (HSI) has launched Operation Stolen Promise 2, to halt the production, distribution, and sale of illicit COVID-19 treatments and vaccines. HSI reported that its agents have seized illicit proceeds and goods, made arrests, and shut down fraudulent websites (3), including the seizure of two domain names in December 2020 (4).
The proliferation of counterfeit goods stems in part from the shift to e-commerce, which has been accelerated by stay-at-home orders and advisories and reduced access to physical retail pharmacies. “The emergence of on-line pharmacies poses a significant threat of escalation in counterfeit pharmaceuticals and underscores the urgent need for on-dose countermeasures,” reports Peter Wong, chief operating officer at TruTag Technologies, which recently entered a partnership with Colorcon to provide advanced security coatings for on-dose use.
“Counterfeiters are opportunistic,” explains John Pitts, key account manager for Antares Vision, noting, “COVID-19 provided the ‘perfect storm’ for the counterfeiters: panic in consumers; product shortages from the brand name ethical providers; desire and, in many cases, requirement to purchase via e-commerce; and lack of and often conflicting information from the media and authorities.”
Joe Farrell, life sciences expert at Loftware, concurs, “It seems clear that whenever there are high-value pharmaceutical products, there will be people trying to profit illegally. The fact that the COVID-19 vaccines need to be shipped in stringent cold storage containers with radio frequency identification (RFID) temperature sensors along with specialized transportation methods will make it more difficult for counterfeiters to enter the supply chain, but not impossible.”
With COVID-19 vaccines now rolling out in limited quantities, demand will outstrip supply in the coming months. “This will create a ripe environment for unscrupulous parties to offer fake product,” says Wong, noting, “Distribution of the COVID-19 vaccine is designed to go to many more points of dispensing than for a normal pharmaceutical drug, as governments seek to deliver vaccinations broadly and as quickly as possible while maintaining demanding cold-chain requirements. These logistical requirements will create higher than normal transition points in the overall supply chain, which in turn create increase opportunities for diversion, adulteration, and fake product to reach the patient.”
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 Farrell. 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 Dul.
There is heightened interest in tools and technologies that go beyond the package to protect patients, such as on-dose solutions. In addition, says Wong, “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, Pitts 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 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 (5).
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.”
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 (6). 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 (7).
Physical technologies are common anticounterfeiting tools, but counterfeit and diversion prevention also relies on software. Farrell reports, “At Loftware, we are being asked for help in getting the correct information onto the label. It’s important to have an enterprise labeling solution that integrates with a company’s sources of data to make sure the correct approved information is automatically applied to the labels. This includes languages, barcodes, regulatory symbology, and regional product information. You also need a labeling solution that can aid with approving, managing, and promoting electronic information for use [data] to help speed the process for a faster time to market for these critical products.” Although not specifically an anticounterfeiting product, Loftware Spectrum software integrates with serialization solutions and ensures labeling is consistent, accurate, and contains the right serialized data and barcodes. “The use of global templates in an enterprise solution also helps our life sciences customers to globally standardize on the look of their supply chain labels to help identify counterfeited products,” he explains.
The scalable Track My Way platform from Antares Vision offers single-unit, batch, and custom traceability; provides direct consumer engagement; and can extend from raw materials tracking to end-of-life package disposal/recycling. Geolocation functionality can track the harvesting of the raw materials, packaging locations, the movement of products through the supply chain, and the point-of-sale location.
In April 2020, TraceLink released an anticounterfeiting tool called Smart Distribution Tracking. By integrating the Internet of Things with product serialization, Smart Distribution Tracking provides full track-and-trace visibility for the secure delivery of vaccines, test kits, and high-value products.
Another software tool, the Summit Authentication Platform from Microtrace Solutions, is a customized system consisting of a self-authenticating, encrypted barcode; a Spectral Taggant; and a handheld detector plus a smartphone mobile app. “Our Spectral Taggant is a chemistry formulated into an ink that, when printed, is a highly secure ‘signature’ or ‘fingerprint,’” explains Brian Brogger, president at Microtrace Solutions. This signature can be authenticated instantly via the handheld spectrometer or smartphone without an Internet connection. For vaccines and therapeutics, the barcode and Spectral Taggant can be applied to security labels. The mobile app is then able to verify that the barcode was genuinely issued and the Spectral Taggant verifies that the barcode has not been copied. The system also can provide real-time reporting and analysis.
The latest release of the Systech Brand Protection Suite from Systech International, the software solutions division of Markem-Imaje, delivers a fully integrated solution to combat counterfeiters, identifies product diversion, meets regulatory compliance, and provides analytics. The centerpiece of the suite, the company’s non-additive e-Fingerprint technology, turns any existing barcode into a unique, digital identifier to provide end-to-end visibility and actionable information as a product moves through the supply chain. New functions include the ability to push unique responses and content to users and smartphone authentication of e-Fingerprinted products. Responses can be tailored to the user, location, time, and safety of the product, and include photos or other information. A new analytics platform, Systech Insight, offers a series of Information on Demand dashboards and an analytics data pool (8).
Hallie Forcinio is packaging editor at Pharmaceutical Technology, firstname.lastname@example.org.
Volume 45, No. 2
When referring to this article, please cite it as H. Forcinio, “Countering Counterfeiters and Diverters," Pharmaceutical Technology, 45 (2) 2021.