serialization and beyond

Serialization and Beyond: A Post-Webinar Wrap Up – Part One

Systech has been conducting educational webinars on important market issues for many years now. Much of this has centered on getting our customers the information they need to meet major pharmaceutical serialization requirement mandates in the United States (DSCSA) and the European Union (FMD). Now, with these mandates “live”, customers are looking at value beyond compliance in their serialization environments and investments.

A recent webinar focusing on “Serialization and Beyond” was hosted by Systech, with panelists from major pharmaceutical manufacturer, Takeda and our partner Excellis Health Solutions.

This event had a great live audience which generated a multitude of well thought out, pertinent and interesting questions. So many in fact that we were barely able to answer a third of them during the event. Over the course of the next three blog posts, we will provide you this compelling virtual “dialogue” and our take on providing vision and clarity to the questions.

Q: Does Systech’s authentication product work on non-serialized products?

A: Absolutely! This is one of the key elements of our anti-counterfeiting and diversion solution. It derives a digital e-Fingerprint® from the printed barcode itself, not from the data contained within it. One of our most common barcodes is the ubiquitous UPC code.

Q: How does the authentication work? Is this something that is affixed to the carton?

A: We like to say that we change everything about brand protection without changing anything. The Systech authentication solution leverages the existing linear, QR or 2D serialized DataMatrix barcode that is already on the product’s package. The e-Fingerprint is derived from this and can ensure that each and every package is authentic, safe and connected throughout the supply chain.

Q: Is the Digital Authentication solution provided by Systech? If so, are there any potential issues you have seen on the line with the Systech Digital Authentication solution with other providers? How is the Systech solution implemented with the other providers?

A: Yes, Systech is the inventor of the digital e-Fingerprinting based authentication solution. We have worked with customers who have several different vendors of serialization equipment on their packaging lines. Since we work with the barcode itself—and not the serialization solution—there are no issues, and the approach is vendor agnostic.

Q: Don't you find it can be dangerous to give the ultimate drug authentication tool to the patients? What are the legal challenges in case of an issue?

A: First and foremost, the majority of pharmaceutical authentications are done via dedicated corporate inspectors, charged with finding counterfeit and diverted medicines regionally. In first-world safe markets, patient authentication of drugs is completely unnecessary for safety. In markets where counterfeiting is 30 percent or more, patient authentication could be of value, but only if there is proof that healthcare professionals are participating in the crimes. If they are not, then it is unnecessary there as well. That said, our interactive capabilities post authentication open many avenues for drug manufacturers to communicate and get feedback from patients.

Q: Can patients use the technology to verify the authenticity of the medicine using the solution being presented in the pilot? (Systech Note: Takeda presented an overview of an anti-diversion pilot program, utilizing Systech’s digital e-Fingerprinting solution.)

A: They can, but that only makes sense in markets where counterfeiting is in the 10-30 percent range. If you don’t trust the healthcare professionals to administer legitimate product, then it might make sense to offer it to patients. There is nothing in the Systech authentication technology that would prevent you from offering it to patients.

Q: If not, why was this functionality not provided to the patient?

A: See above. In the US and EU and probably a lot of other places that have fairly clean supply chains, it is better to avoid making patients think that their medicine might be counterfeited. A US-based retail pharmacy and health care company did a non-public study back in the late 1990s that demonstrated that US patients who thought they might receive counterfeit medicines would stop taking their medicines out of fear. That was when CVS was thinking about adding RFID tags to the packaging that patients would receive. The focus group of patients wanted to know why the RFID tag was necessary and when they were told it would help protect against counterfeiting, they became extremely concerned.

But in markets where the risks are real and where people know they are real, patients would likely react more in their self-interest and make use of the technology, if they believed the technology could protect them.

Q: Can this integrate with an existing level 4 serialization solution? (Systech Note: “Level 4” in pharmaceutical serialization almost always refers to a consolidated track-and-trace platform.)

A: In fact, there is no “integration” required, so yes it will work with any other serialization solution. The authentication solution uses a new packaging line camera to inspect package barcodes and derive a digital e-Fingerprint for that barcode, which is stored in a secure cloud environment. A smartphone app is then used in the field for authentication and verification. If a counterfeiter made hundreds or thousands or millions of a fake product with either copied or phony barcodes, they could never be authenticated to the legitimately derived e-Fingerprints.

Additionally, the Systech authentication solution can work with serialized barcodes created from any vendor. We deal with the biggest pharmaceutical manufacturers in the world and given all the mergers and acquisitions in the industry our solution MUST be serialization vendor agnostic.

Q: If the serialization code is removed during diversion, as the Signature (Systech Note: our “e-Fingerprint”) is based on the code, how could you authenticate the product?

A: This is a great question and is a fantastic example of what goes on in the “real world” of product diversion. If the serialized code is removed as part of a diversion effort, there is nothing we can do to authenticate the product. But, as part of a formalized diversion detection and education program, manufacturers will instruct inspectors and supply chain partners to look for this package condition and have them inform the brand when encountered. Customs officials can also be informed that this deformation of medicine packaging indicates diversion.

Q: Could you mention use cases and/or experiences of deploying this technology in a Distribution Center instead of a Packaging Line?

A: We are very proud of our work with a major health and beauty products manufacturer to deploy our solution in a distribution center. Here’s a snapshot of the authentication workflow:

  • Pallets of product manufactured by five CMOs were delivered to a distribution hub in Texas
  • Individual product bottles were set up in two quality-controlled, automated e-Fingerprint production lines integrated with Systech hardware
  • Existing barcodes were e-Fingerprinted
  • Authenticated bottles were re-packed, and carton labels generated
  • Orders were fulfilled and shipped globally

Click here to read the full case study.

Q: How secure is the smartphone app? How do you authenticate the app with the health care providers?

A: First and foremost, all e-Fingerprint data is stored in enterprise-class hosted cloud environments. The smartphone app itself is built to the rigorous security standards of both Android and iPhone mobile platforms. Users will only be registered to have access to their company’s e-Fingerprints when they authenticate product in the field. This is a very closed system, with only known and approved systems and individuals granted access.