U-NICA pharmaceutical security solutions powerfully complement existing anti-counterfeiting tactics to protect and identify medicationIn my earlier blogs, I’ve covered the various security methods employed by the pharmaceutical industry to identify medication. Modern industry methods are commendable but still weakened by criminal-friendly flaws. The more layers of security manufacturers add, the more secure pharma will be.
Today, let’s review a quick recap of those approaches, their pros and cons, and take a closer look at how U-NICA solutions can be work with them to create more powerful patient protections.
The main medicine identification methods used today
Even proactive governments need help fighting pharmaceutical scams. The Food and Drug Administration is working hard to ensure that the pharmaceutical industry obeys the physical and electronic compliance requirements of the Drug Quality and Security Act, but it’s an intricate process that has already been underway for years and still has not yet reached full effect. Patient protection can’t wait.
Track and Trace is a recent protect/identify measure introduced through the Drug Supply Chain Security Act that requires drug manufacturers adds unique serialization numbers to batches of medication. These measures help identify where a batch of medicine originated regardless of where it was found, but they have two inherent weaknesses:
- The batch-oriented focus of Track and Trace isn’t ideal for identifying individual packages within the batch
- It relies on diligent data entry every step of the way, which means any human error or oversight can invalidate the process
Aggregation regulations on the horizon will take this tactic a step further, expanding Track and Trace by serializing individual medicines and adding further number coding as the product navigates the supply chain. This strengthens identification, but it’s still prone to human data entry errors. Furthermore, aggregation isn’t widely adopted yet due to cost-to-implement, technology issues and a distant 2024 deadline for implementation.
Big pharma players still have critical weaknesses
Dedicated bodies like the World Health Organization (WHO) fight pharmaceutical scams, but even they can’t provide total protection for the pharmaceutical industry because safeguarding intellectual property is beyond their power. Protecting intellectual property is a critical requirement in securing the identity of any product.
One important FDA compliance requirement that came into effect in November 2019 involves product identification and verification. The new measures were enacted to make sure returned medications are kept safe for redistribution, but they can be universally applied as part of a complete supply chain security strategy.
How U-NICA can identify, verify and protect medicine
Let’s look at how the current state of pharmaceutical industry standards for patient protection and how U-NICA security solutions make them stronger.
Time to implement is a deciding factor in effective medication protection and identification. Distant regulatory deadlines and parts of the supply chain being reluctant to meet compliance requirements don’t have to leave your company open to criminals. U-NICA solutions can become a part of your process today.
Helping to protect the intellectual property of pharmaceutical manufacturers may be beyond WHO’s services, but not ours. The U-NICA Protection Circle® was developed to collect, analyze and share information about how products move in a market and study regional and product-specific risks. This data allows the U-NICA team to establish actionable evidence that an IP infringement has taken place and help clients choose their next course of action. If a lawsuit is necessary, our tools provide vital evidence to help support your case.
Build ID and protection into your pharmaceutical product DNA
The weaknesses of aggregation and Track and Trace anti-counterfeiting steps can be overcome by building identification and protection directly into the product. When the individual pills are identifiable, it doesn’t matter if a medicine is incorrectly batch-numbered or someone forgets to enter the data correctly.
U-NICA solutions help achieve this in multiple ways, all of which help meet compliance requirements of governing bodies like the FDA. Our scryptoTRACE® suite offers protection aimed in two directions. Firstly, it protects different consumer types against the risk of acquiring counterfeited products by allowing them to authenticate the genuine products. Secondly, it helps the genuine brand/product owner to fight and prosecute counterfeiters and their activities.
The scryptoTRACE® solution uses primarily passive image recognition technologies to authenticate products based on active markings. These markings can be added in or be object-inherent like a security fingerprint. The markings can be overt, semi-covert, covert or forensic. The suite provides the platform for marking, for product recognition and secure verification.
Different security levels can be applied to the same object to work publicly and privately. These allow authentication for consumers and experts respectively, such as inspectors, customs authorities, forensic teams and so forth.
Primary, secondary and tertiary packaging elements can be protected and interrelated for verification and authentication. For all of this, our scryptoTRACE® suite, provides the necessary parts of the solution in an integrated manner.
U-NICA can do even more
In some circumstances, physical protection can include our plastoTRACE™ suite - a two-tiered method incorporating spectroTAG® and intraGRAM® technologies. These tools and even more can be combined to make identification, protection and authentication a lifetime part of the product, meaning it can’t be removed by counterfeiters like packaging can.
They are also non-transferable: Even if a counterfeiter managed to remove the marked materials and try to use them in their own fakes, they would fail.
Drug product protection and identification are more important than ever
Secure pharma could have a tough time in the months ahead. COVID-19 is only compounding supply chain weaknesses and giving counterfeiters opportunities to thrive. Don’t let your company and consumers become the next casualties. Work with us to stand against pharmaceutical scams.
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.