Globally, counterfeit medication is a major issue for public health and international trade, not to mention a threat to the bottom line of any pharmaceutical company. Thousands of people worldwide die every year from ingesting fake drugs — and it costs the pharmaceutical industry between $70 billion and $200 billion per year in lost profits, by various estimates.
In 2015, Interpol seized 20.7 million fake and illicit medicines during a mere week-long operation, spotlighting the heart of the issue: The rate at which counterfeit products enter the supply stream is untenable, and pharma manufacturers must find ways to identify and extricate those counterfeit products more quickly.
The key challenge lies in maintaining a drug’s “connectivity” throughout its journey, even through sterilization or other necessary harsh environmental conditions, so as to create an accurate, accessible log of data about a drug’s every move.
Supply Chain Risk: A Brief History
Before getting into possible solutions, it may be useful to outline the sources of risk. Counterfeit risks arise mainly as products move between various stages and layers of a highly complex global supply chain. Each layer in the process degrades visibility and creates the opportunity for counterfeits, including products with the wrong active ingredient or fake packaging, to enter the distribution network.
The first move to address this risk, in the 1980s, was by using packaging security via holograms. In the 2000s, new ink technology such as invisible and color-shifting products came of age, as well as laser-readable printing. These technologies were difficult to copy when they first arrived, but counterfeiters eventually found a way to replicate the techniques.
Many pharmaceutical companies then experimented with simple RFID tags, barcodes and other technologies designed to track and authenticate drugs between manufacture and patient. Still others worked to develop on-dose or on-product security as a complement to packaging security. Also called “edible bar codes,” this is a promising technology but has a number of additional regulatory implications to work through since it is an ingestible part of the drug.
Is the IoT Infrastructure a Salvation to Thwart Counterfeiters?
The emergence of Internet of Things (IoT) technologies indeed have the potential to provide safer, more complete track and trace methods as drugs flow through the supply chain. When you connect an asset, in this case a drug bottle, you conceivably make it visible wherever it goes, and can thus pinpoint supply chain leaks or enforce chain-of-custody controls through authorized channels and parties.
However, large barriers stand in the way of a full-scale IoT ecosystem. Connectivity standards — particularly cross-border interoperability — are still a muddy issue; the IT infrastructure build-out alone requires heavy time and financial investment, and the “consumable” costs of connectivity and sensor devices are not trivial.
Moreover, as we’ve seen more and more, there are inherent cybersecurity issues in an “always on” IoT architecture. Connected devices have become an exploitable gateway into enterprise networks, and can grant hackers access not just to data, but also to the controls of physical systems.
Turning Drugs Into ‘Smart Assets’
The digitized asset approach is to allow individual products to maintain and share their own digital storyline from manufacture, to distribution, to maintenance.
The strategy has taken hold in industries like aviation, where every flyable part on an airliner now carries its own digital signature such that on-the-ground crews know exactly how long the part has flown and what kind of operational events it has been through, to ensure proper and exact maintenance and replacement routines.
In other words, stakeholders are able to update and chronicle changes to the asset, and it will influence every downstream action from that moment forward.
When you now make the data about every asset visible to the wider field of stakeholders, it transforms not only how to interact with the asset, but also how to do business better. These stories can range from e-pedigree to critical usage details — events and operations endured at a certain time and date, or across a given time period — which can be used to validate compliance with processes, guide best practices, or, in this case, keep non-complying drugs from making it to the end user.
The idea is to make the drug intelligent, so that it can prevent itself from being removed from the supply chain or adulterated. Therefore, when a pharmacy or a provider receives a given drug, it will know exactly where the drug has been. Conversely, if the drug does not contain the proper digital signature, it won’t be allowed into the hands of a patient.
Gaining Clarity From Fog and Edge Computing
What we’re talking about here, ultimately, is a high-value use case for the fog computing concept. Fog computing and microchip technology have come of age such that companies can now inexpensively transform products, at the individual level, into digitized assets.
In life sciences, digitally capturing data and documents on a drug asset itself is what makes it “smart,” and fog computing is the efficient, secure means to grant access to the right person, at the right time, so he or she can take the right action. By keeping data closer to the ground, rather than routing it through a centralized database in the cloud, pharmaceutical companies can foster much swifter knowledge sharing.
More importantly, thinking in terms of fog opens the door to quicker ROI from IoT investments. The approach gets around security concerns over IoT devices that continuously connect because making an asset smart in a fog environment does not require a complicated IT infrastructure, an IP addressing scheme, or even a power source. There’s a much lower barrier to entry.
The Compounding Effects of Risk Reduction
When you digitize the supply chain there are benefits that go well beyond track and trace. You enable significant improvements in inventory management and manufacturing lead times. You gain better forecasting capabilities with real-time understanding of what’s happening, everywhere across the multi-layered supply chain.
You dramatically improve recall processes by gaining visibility into granular-level product details for an early, almost surgical removal of strictly the unfit products (and no others). And you become a value-adding entity up and down the entire value chain because you have the right data to share with partners at the right time, with no lag. In essence, you become a conduit for tighter industry-wide controls, auditing and revenue protection.
There won’t be, and never should be, a single security technology to combat drug counterfeiting. The challenge must be thought of in terms of layers. The road to solving the issue may be long and steep, but by thinking beyond compliance checkboxes toward a smart asset approach, leaders in Big Pharma put themselves in position to take control of risk, and contribute to profitability for their business.
Timothy Butler is the founder and CEO of Tego, a technology company that turns products, components and systems into smart assets.
This feature story can also be found in the March 2017 issue of Pharmaceutical Processing.