Pius Haas Jul 13, 2020 2:08:37 PM 9 min read

Drug Track and Trace and Aggregation Are Not Enough for Patient Safety

Patient protection is pharma's top priority, but even the best efforts of aggregation and Track and Trace fall short of a multi-tiered security solution.

In my previous blog on the essential nature of medication identification, I discussed some of the many disturbing statistics from the counterfeit drug market. It’s a constant battle to keep patients safe.

Today, I’m spotlighting two of the strongest tools the pharmaceutical industry has for patient protection — Track and Trace and aggregation — and why even more must be done to protect people and prevent the growing wave of pharmaceutical scams.

Track and Trace has value, but also weaknesses

Pharmaceutical Track and Trace standards involve accurate past and present location monitoring of medical drugs. It also applies as deeply as the procurement of the raw materials to the finished product. This is a vital step since it not only lets manufacturers know where their product is but also allows for tracing back to the source in the event of suspicious products.

Tracking can be instrumental in uncovering the trail of unsavory distributors or cracking counterfeit pharmaceutical scams. Track and Trace also comes into play when medications are returned as unused or expired. This is a responsible act on the part of the consumer, but they’re often unwittingly supplying a secondary black market where those drugs are then redistributed and sold.

Track and Trace typically depends on serialization, which adds unique identification numbers to batches of drugs. Let’s take the American Food and Drug Administration as an example and the strict regulations enforced by the Drug Supply Chain Security Act aimed at promoting proper serialization practice in the pharmaceutical industry. If the Act is to succeed, every party in a drug’s life cycle must be held responsible for acknowledging these serial numbers and properly registering them, from beginning to end, without fail.

Why isn’t this enough?

The FDA compliance requirements reveal a dedicated practice that’s rigorously maintained, but even this is insufficient to deter the counterfeit drugs fueling an illegal and deadly global trade worth $200 billion — or 10% to 15% of the entire pharma market.

While individually serializing drug packaging does aid identification of each drug sold, the World Health Organization cautions that batch/lot level traceability does not provide unequivocal identification of individual units of said batches in the distribution system. The WHO also records that every serialization type has inherent disadvantages (page 11, item 13).

Further vulnerabilities of Track and Trace are human error in data entry and the fact that not all countries combine Track and Trace technology with serialization, which effectively renders box ID numbers pointless.

Analyzing aggregation

Aggregation is effectively another layer of track and trace, except great care is taken to label both the batches and individual drug packets with serialized identification. From there, further layers of number coding are added by every party who handles the medication, from first materials to patient consumption.

This constant aggregation of new identifying data is known in the pharmaceutical industry as a “parent and child” approach, or a hierarchy of data intended to make stray drugs impossible. No “orphaned” medication will mysteriously vanish from the supply chain and fall into the hands of criminals. At least, that’s the intention.

Pharmaceutical reports say there are several reasons aggregation is less than perfect. Not every medical manufacturer is adopting aggregation, and a combination of the high cost of implementation, the clash of old and new technology, and simple laziness — the final deadline for compliance requirements is 2024 — are motivating some pharma producers to drag their heels on this security step.

Lastly, aggregation (like Track and Trace) suffers from the inbuilt weakness of human error during data gathering and entry. One wrong digit could result in a data mismatch, compromising the security hierarchy and possibly causing the destruction of safe batches of drugs.

It’s clear that both Track and Trace and aggregation can be powerful if diligently combined, but their inherent weaknesses necessitate even deeper layers of secure identification.

Drug Track and Trace and Aggregation Are Not Enough for Patient Safety

Boost both these methods with U-NICA's solutions

Security is always best when it’s applied in multiple levels and in innovative ways that are very difficult for counterfeiters to crack. U-NICA offers cutting-edge identification methods that go beyond serial numbers and are immune to weak entries in a data hierarchy.

Some of the powerful solutions we provide include spectroTAG® — markers that are easy to integrate into pharmaceutical packaging as an invisible inert additive. U-NICA can apply these non-affecting additives directly into many fluids, such as ink, marking medical products with a layer of secure identification that’s completely invisible to anyone who doesn’t know about it. And it won’t interrupt your supply chain efficiency.

spectroTAG creates a technical barrier that is effectively impossible for counterfeiters to replicate, providing an easy and indelible ID tag to help identify any pharmaceutical product that has been lost, misplaced or stolen. Our scryptoTRACE® technology offers further end-to-end protection via a product verification app that can empower anyone with a smartphone or tablet to check the authenticity of your products.

At U-NICA, we help pharma companies achieve transparency on their product in markets, during distribution and in retail, all while protecting these brands with the ability to make fact-based decisions for the next best action. Connect with me at the link below to learn more about how we can help with patient protection.

U-NICA is a team with a single purpose: Supporting you in the fight to protect your brand’s integrity and value. Our staff operates globally and partners with universities and agencies to deliver the future of brand protection. Connect with me for more information on our constantly evolving open solution suite.

avatar

Pius Haas

Has more than 30 years of experience in IT / IS management of strategic developments and business areas. Proven history as innovator, entrepreneur and business pioneer, able to launch, develop and implement tailor-made programs for customer needs in key industries. Has the ability to drive the conception, design and implementation of leading-edge technology solutions while motivating and supporting employees and partners to achieve performance goals with a single mission.

COMMENTS