Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. With the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD) now being enforced for months, it is time to see whether the promise of serialization solving counterfeiting is working.

When introduced, the finest of intentions were in play. Statistics from the World Health Organization showed that a majority of pharmaceuticals in certain developing nations were counterfeit.

It was increasingly obvious that something needed to be done.

That answer was mass serialization: Creating a unique, hypothetically traceable number for each and every prescription drug package and a digital chain of custody which could be referenced and used as a lynchpin of authenticity.

Fast forward a decade… According to global governments, pharmaceutical counterfeiting has not slowed down, but continues to increase. (https://www.neweurope.eu/article/counterfeit-pharmaceutical-and-healthcare-products-pose-a-threat-to-european-consumers/) The rampant growth of e-pharmacies that allows for distribution of at best “gray market” drugs and at worst lethal counterfeits all over the web, and the global pandemic have made this situation even worse.

The bottom line is that serialization isn’t an anti-counterfeiting solution, it is a compliance solution, and a foundation for supply chain safety. Pharmaceutical manufacturers, software vendors, packaging manufacturers, CMOs and CPOs along with the rest of the drug supply chain recognize this and employ special teams to monitor and track products.

What IS required for a truly counterfeit-free pharmaceutical supply chain involves several layers of protection:

• Serialization • Overt packaging assets • Rich and trusted data integration and exchange • Hyper-scalable authenticity verification

Serialization – This is still a valuable first step. Serialization is a great way to create the necessary data infrastructure that enables the supply chain to be equipped with the right set of information necessary to start the fight against the introduction of counterfeits. Unfortunately, that’s where it stops, as counterfeiters can easily mimic serialized data marks. The data exchange and associated processes need to be strong enough to detect fake product from legitimate.

Overt packaging assets – This is the most straightforward layer. Tamper evident seals, quality outside packaging graphics, crisp blister packs and other professional packaging assets make the product look “right.” Counterfeiters have the ability to mimic many of these methods, however, they will never have the ability (or desire) to spend the money or own the infrastructure necessary to 100% match the packaging assets of today. The e-pharmacy proliferation makes this the most difficult attribute, as the purchaser is not able to do a side-by-side comparison easily.

Rich and trusted data integration and exchange – One of the underpinnings of most global serialization regulations is the notion of data exchange. Whether it be when huge lots of drugs are sold and moved from warehouse to distribution centers, or when a drug is dispensed to a patient, an electronic record is maintained. Taking serialized information and being able to integrate it effectively throughout the distribution chain—including every level within it—is a critical component to stopping counterfeits from entering. This may go far beyond the data exchange and reporting required from the regulations. True track and trace of individual items throughout the supply chain is a necessary component and may be more involved than just what is needed for compliance.

In the US, the Partnership for DSCSA Governance is a non-profit group looking at the 2023 requirements calling for the interoperable, electronic tracing of products at the package level. The FDA requested pilots from industry groups to develop an implementation strategy for the 2023 interoperable, package-level mandate (https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/dscsa-pilot-project-program). Systech participated in the pilot program as part of the “Optimal Solution” group.

Hyper-scalable authenticity detection – Immediacy of discovery is critical in mitigating the risk of counterfeits. There is no greater solution to fighting counterfeits than having an inspector or consumer be immediately capable of distinguishing real from fake. Crowdsourcing (https://page.systechone.com/lp-how-to-crowdsource-your-anti-counterfeiting-program) both authenticity and counterfeit detection is the best way to protect the entire ecosystem. This means each and every serialized package needs to be authenticated as genuine and legitimate by the “crowd.”

Our Systech solutions provide a way to do just that with our digital e-Fingerprint® technology. (https://www.systechone.com/industries/pharma/)

Ultimately, global serialization initiatives are a good thing. Putting a regulatory focus on the issues surrounding counterfeiting and effective recalls is important and will help protect people. But the increasing awareness that serialization is not an anti-counterfeiting solution is perhaps even more important. Understanding the layers necessary to protect products from counterfeiting will truly strengthen and help secure the pharmaceutical supply chain.

ABOUT THE AUTHOR

Steve Tallant is the Director of Market Development. He is a software product management and marketing expert, with more than 25 years of experience. He has worked in a myriad of vertical industry domains and software solutions including J2EE middleware, information lifecycle management and finance solutions. Steve joined Systech after over ten years in IBM’s Software Group. While at IBM, Steve was recognized twice with a President’s Volunteer Service Award for his dedicated service to several charitable organizations. He was selected to President’s Club at Princeton Softech (later acquired by IBM). Steve holds both undergraduate and master’s degrees from Villanova University in Pennsylvania. He is also a frequent guest lecturer and panelist for the Information Technology department of the Villanova School of Business.

COMPANY

Markem-Imaje delivers intelligent identification and traceability solutions, services and expertise to empower our customers with the right information across the supply chain—keeping products authentic, safe and connected. We offer the industry’s most comprehensive range of marking and coding systems seamlessly integrated with trusted software, services and consumables.

Markem-Imaje is a wholly-owned subsidiary of the US-based Dover Corporation.

Image courtesy of Markem Imaje