Counterfeit products have a wide scope: managing to slip through the cracks in every industry and every market. Unlike counterfeited retail products, such as clothes, handbags, and shoes, counterfeit medicines—which can be contaminated, contain the wrong (or no) active ingredient, or have the right active ingredient but at the wrong dose—have a significant impact, in that the use of these can (and often does) result in patient deaths. As such, many companies have emerged to address this profound issue.
TruTag Technologies, Inc., a developer of authentication technology platforms, has gained repute for its microtags that serve as covert “edible bar codes.” These microtags can be utilized by pharmaceutical companies to track their drug product on a batch basis. When the microtags are mixed with the outer coating of a pill or tablet, it enables companies to determine the identification and supply chain history of an individual pill.
Kent Mansfield, President of TruTag Technologies, participated in a Q&A about supply chain security and the prominence of counterfeit pharmaceutical products.
Q: In the pharmaceutical field, what are some of the most commonly counterfeited products?
Mansfield: Counterfeiters can fake or mimic virtually anything. With a simple tablet pressing tool, most solid oral dosage form drugs can be easily manufactured, often using unhygienic or dangerous materials like brick dust, sheet rock, and printer ink for fake coloring. Any criminal with a cheap but high-quality printer can imitate packaging designs, including bar codes.
The most common types of medicines that are counterfeited are:
- Lifestyle drugs, such as those addressing erectile dysfunction or weight loss
- Expensive specialty drugs that target cancer or hepatitis
- Drugs with high “street value,” such as powerful pain medication
We see almost anything being counterfeited or diverted, including diabetes test strips, injectable drugs (such as Botox and cancer treatments), and really anything else in a package.
Q: Approximately what percent of medicines are counterfeited in the U.S.? Outside of the U.S.?
Mansfield: According to some estimates, more than 10 percent of all pharmaceuticals in the global supply chain are counterfeit. In some countries, fake pharmaceuticals account for 70 percent of all drugs in the supply chain. In the United States, the number is much lower than average, but the U.S. supply chain is susceptible to unauthorized diversion, which impacts drug makers significantly and calls into question the quality of any product that circumvents lawful trade channels. Further, use of so-called Internet pharmacies by U.S. consumers introduces substantial risk of spurious and fake medicine into the country, as more than 95 percent of such websites were found to not be in compliance with laws or pharmacy practice standards, according to a recent survey by the National Association of Boards of Pharmacy.
Q: What are some of the ways that pharmaceutical manufacturers and other professionals in the industry can be proactive against counterfeiting?
Mansfield: It is a long-held belief that a company should never just use one security technology to combat counterfeiters, and that’s usually a good idea. So, many pharma companies deploy multiple “layers” of technology on their packaging, routinely rotating them in and out to reduce the ongoing risk of compromise. That’s a somewhat effective strategy in terms of counterfeit avoidance, but it’s very expensive for a company to pull off. It costs millions of dollars to bring on and phase out new security technologies at that rate. Further, there are reports that for most packaging-level security technologies, a credible counterfeit will surface within six months of deployment.
Q: Compared to years passed, what are some of the areas that companies have improved on with regards to anti-counterfeiting methods?
Mansfield: We’re now seeing a gradual shift toward on-dose or on-product security as an important complement to packaging security (see below), and this dosage-level technology is promising for a number of reasons.
- Namely, it makes the pharmaceutical supply chain much less vulnerable, because you can stop and directly verify the medicine itself and not just rely on the package.
- It fills the gap in the defenses for drug makers that formerly could only verify the package and were susceptible to risks in a complex supply chain involving multiple layers of distributors, sub-distributors, re-packagers, and returns processors.
- Further, with on-dose authentication, manufacturers now have a tool to identify drug product that has been separated from its original packaging to assist with returns monitoring, recall management, and even clinical trials administration.
Q: Are there any areas—with regards to anti-counterfeiting methods—that companies, as a whole, have become less resilient in over the years?
Mansfield: Two words: Packaging security. The hologram became a standard security device in the 1980s, and by the 2000s, pharmaceutical companies enhanced the hologram with invisible inks, color-shifting inks, and laser-readable printing methods to their highest profile products. At the time, these technologies were quite advanced and sometimes difficult to copy, but not always. Counterfeiters have caught up and have figured out ways to replicate these techniques, rendering what were once secure packages much less resilient. It had taken regulators some time to provide sufficient guidance regarding use of on-dose security measures, but now that those questions have been clarified, it has opened the door to a new level of security tool.
Q: Within a pharmaceutical company, what are some of the anti-counterfeiting/security areas that can be improved? How can companies best do that?
Mansfield: Most major pharmaceutical companies have tried to be extremely proactive in combating the counterfeiting of their own products. But it is worth noting that security features on packages (UV and other invisible inks, holograms, special phosphorus materials, holograms, and other covert and overt security measures) have proven so vulnerable because criminals have access to digital printing, packaging duplication equipment, and knowledge of manufacturing through the recent globalization of the pharmaceutical industry. On top of that, materials that were once difficult to procure, such as special inks, phosphor compounds, and materials to make holographic labels, are now becoming widely available via the Internet and through global sourcing. So getting to the bottom of the problem is a good first step in figuring out what to improve with your anti-counterfeiting programs, because the solution may not be as simple as “better packaging.” It may be time to look for new solutions altogether.
Q: How can security along the supply chain be improved?
Mansfield: Implementing some of the electronic pedigree requirements under the recent Drug Quality Safety Act is a start, but it is not the complete solution it had been intended to be. There are additional measures that should be implemented so that the major players in the pharmaceutical supply chain could track drug product in real time, to determine where a shipment, crate, carton, and unit of a prescription drug is within the legitimate channels of commerce. Further, such an imaginary system would still only be able to authenticate down to the package level. On-dose authentication measures that could complement product intelligence layers on the package would help provide and end-to-end authentication solution from factory to pharmacy.
Q: What are some of the easiest points—from the manufacturing of a drug to its delivery at a pharmacy or healthcare facility—for counterfeited products to get in?
Mansfield: Generally, drug products coming directly out of a drug maker’s manufacturing facility is quite trustworthy. The risks arise as the product is handed off between the various stages and layers of the complex global supply chain. Newly-made drugs may be sent to another facility for final packaging, labelling, or re-packaging. They may then be stored in another location. After that time, they are sent to wholesalers, distributors, or sub-distributors. Next, they are sent to point-of-dispense locations, such as hospitals, long-term care clinics, medical practice groups, and pharmacies.
In addition, there many points within the supply chain for “fake” drugs to enter and be distributed into legitimate channels. But the flow of goods does not end there. There is still the “reverse distribution” part of the chain—i.e. returned product, where out-of-scope or even fake products can be introduced. At each transfer point between the factory and the patient (and beyond, if returned to the manufacturer), drug products can be stolen, adulterated, and replaced, resulting in financial impact to the drug makers, and more importantly, significant risk to patient safety.
Q: Do you know the statistical difference in counterfeited goods at a hospital or healthcare facility compared to a pharmacy (such as CVS or Walgreens)?
Mansfield: Statistics breaking down where fake and suspect drugs are located in specific branches of the supply chain are difficult to obtain because this unauthorized product permeates every channel and outlet.
Retail pharmacies are not immune to diverted and unauthorized drug products. One of the most significant factors that allow such spurious medicine to enter into the supply chain is the number of intermediaries that handle or transfer the drug product between the manufacturer and the point of dispense. Federal authorities recently busted a criminal organization who had been acquiring drugs from illegal and unlicensed sources, including in some cases patients seeking cash for medicine and then sold the product back into the legitimate supply chain using fake paperwork and false business entities. In that case, the suspect product found its way to wholesale and retail pharmacies throughout the United States.
Q: What are some of the tools that can help prevent counterfeited products from getting into the supply chain?
Mansfield: Better monitoring and tools to be able to trace the origin of drug product are key to helping drug makers locate leaks in their distribution system and enforce contract terms that ensure their products flow within authorized channels and to authorized parties. Advances in track-and-trace capabilities will help in part. Greater use of on-dose solutions that can provide batch or lot level identification will add to this greater business intelligence and security.
TruTag Technology has introduced and is now commercializing a micro-particle GRAS material that can be safely added to solid oral dosage form (SODF) drugs without modifying the manufacturing process already in place. Further, once included in the medicine itself, the taggant will last indefinitely through the product’s lifecycle and can be read using one of TruTag’s proprietary scanning devices.
The TruTag platform is secure because it uses a highly proprietary and patented process for etching unique codes into these slicia particles. The process must be accomplished using sophisticated machinery that is proprietary and exclusive to us, and is not otherwise possible using short cuts or less sophisticated methodology. Further, interpreting the code using TruTag’s proprietary device uses high-security encryption and custom software that makes the solution virtually impossible to spoof or copy.
Q: What are your recommendations regarding brand protection?
Mansfield: In pharmaceuticals, the addition of unique PCIDs (Physical-Chemical Identifiers) to products that make tablets and pills identifiable is promising, and can complement existing package security measures.
Q: What do you see for the future of anti-counterfeiting?
Mansfield: Counterfeiting is the biggest business in the world, affecting every industry and every market. Clever criminals will always seek to stay one step ahead of legitimate business and will find the weakest link in an extremely complex and inter-related global eco-system. Therefore, the business of “anti-counterfeiting” will always be around, filling a vital need for product makers who must protect their reputation and their customers. For the pharmaceutical industry, a multi-layered approach to fighting off the criminals will still be a smart approach. And forward-minded companies will implement the best technologies and solutions to continue to try and stay ahead of the criminals.