With countries around the world struggling through yet another lockdown caused by a flurry of dangerous new Covid-19 variants, the dream of mass vaccination can’t come soon enough. But as these shots are rushed from manufacturers to clinics all around the world, the supply chain, already stretched thin as it is, is vulnerable to exploitation and interference. Last fall, even as the first vaccines were only just clearing clinical trials, international law enforcement agencies were predicting the dangers to come from organized crime.
A Unique Challenge
Counterfeit and stolen medications aren’t typically as prevalent in Western Europe as they are in other parts of the world, but this unprecedented global vaccination effort has given criminals a lucrative new target, one which is literally theirs for the taking as the vaccines sit waiting in massive storage warehouses. According to the WHO, "No country is untouched by substandard and falsified medical products and work is being done in all WHO Regions. What was once considered a problem suffered by developing and low-income countries has now become an issue for all."
There are two dangers here, the first from legitimate vaccines stolen from the supply chain and sold privately by criminal organizations, and the second from counterfeit vaccines that are slipped into the chain, for example when replacement shipments are ordered after temperature bands are exceeded. It’s in cases like this that condition monitoring is vital, as these stolen vaccines may not be transported within their designated temperature bands. Both of these problems exploit the many gaps in standard supply chain and condition monitoring from the manufacturer to the local clinic and pose a significant risk to the lives of citizens who either won’t get the shot they need, may get a damaged one, or in the worst case are injected with who knows what!
For criminals, these vulnerable vaccines are “liquid gold,” and the supply chain is shockingly easy to exploit. Even this early into the global vaccine rollout, Interpol and Europol have been consistent in their warnings for the continent, while in China a counterfeit vaccine production ring has already been busted by authorities there.
Filling in the Gaps
The secure identification of products at each stage in the supply chain is paramount to avoiding counterfeiting and preventing exploitation, as in our experience there are always significant gaps in transparency between the various parties involved along the chain. This is particularly important during the handover between the various logistics providers and warehouses, as it’s here where shipments are most vulnerable and can “fall through the cracks.”
Despite regulatory guidelines such as the EU Falsified Medicine Directive or the FDA’s DSCSA, that try to combat these security risks, the flow of trusted information here often cannot be guaranteed with conventional manual monitoring methods. Unfortunately, they, for example, fail to do it effectively by using an easily altered barcode system, or by relying on conventional digital track and trace systems that only partially establish a trusted link between the tracking ID and the physical item. It’s only with secure real-time authentication and monitoring that we can fill in those gaps while ensuring the quality and integrity of the tracking information.
Modum addresses these problems on three fronts. First, we fill in the informational gaps by making tracking and monitoring available globally and in real-time. Then we ensure the accuracy of this real-time data by actively monitoring specific parameters like temperature and location. And finally, we verify serialized shipment IDs with 2-Factor Authentication (2FA) to guarantee that they stay together and are only accessible in their entirety and by authorized personnel. Let’s take a closer look at these three areas of protection.
Knowledge is Power
Real-time monitoring is one of the biggest possible improvements over current manual, reactive systems in regards to increasing security and transparency. Real-time milestone monitoring from our in-shipment sensors dramatically reduces the readout effort of a typical USB logger system and reduces the risk of human error (or tampering) through automation. Automatic monitoring also means automatic updates. Our MODsense loggers can send alerts for a variety of deviations, including location, delivery time, temperature, and, in case the package has been unsealed, light levels. These alerts provide actionable insights if an original shipment has either left its designated lane or has been tampered with.
Since Covid-19 vaccines must be shipped at precise temperatures, a temperature sensor is already required; our temperature monitoring solutions integrate seamlessly into our holistic tracking and monitoring system, providing additional secure information about the location and giving shippers unprecedented steering options. This comprehensive automated monitoring is leaps and bounds above standard manual methods, but what about preventing shipment tampering in the first place?
Our solutions establish an immutable link between the MODsense data logger, the shipment or product ID it is assigned to, and the applicable quality requirements, such as the temperature band. This association is also stored on the monitoring device itself, which is securely inside the package and can be checked and verified anytime on the ground via Bluetooth without needing to open up any packages. When a shipment’s MODsense device ID is scanned in the warehouse, its access must be verified by 2FA. In contrast to a normal paper-based packaging label where you need to trust that the identification it contains is not fake or copied, MODsense allows you to easily check whether the tracking device hidden inside the packaging was configured by a Modum-authorized party, and confirm that it still broadcasts the same identity information as the paper label. By leveraging the serialization information associated with the shipment, MODsense verifies that the item, box, and pallet ID’s all match with the tracker. If they don’t, there will be an alert that the shipment may have been meddled with. This is particularly helpful for identifying attempts to smuggle fake drugs through a legitimate supply chain.
With such a holistic picture of the vaccines’ identity, location, condition, and history, our solutions offer massive improvements to shipment security and monitoring when compared to the reactive, manual processes typically used today. This real-time picture of a shipment’s physical status and location, as well as the enhanced digital security features, mean our solutions make it harder for criminals to exploit holes in the supply chain. At the end of the day, that means more vaccines get to patients, and more lives are saved.
Modum is ready to provide a full suite of supply chain monitoring solutions to support and protect the global Covid-19 vaccination effort.
To learn more, get in touch with us.