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How IIoT Can Combat The Rising Tide Of Counterfeit Drugs

The sale of counterfeit drugs is a global problem, and it is big business. The international counterfeit drug market is estimated to be $200 billion a year. For example, in Mexico, counterfeit drug sales are estimated to be $650 million per year and in Russia, 10% of all drug sales are attributed to counterfeit products.

In a Newsweek article entitled, “The Fake Drug Industry is Exploding and We Can’t Do Anything About It,” Amir Attaran, a professor of law and medicine at the University of Ontario, suggests that stopping counterfeit drug manufacturing and distribution would require cooperation amongst a handful of nations. These nations would need to agree and abide by an international treaty with set laws and while this kind of cooperation sounds difficult, he cites that the aviation industry has achieved similar treaties and countries chose to comply. “For if they do not, then they do not fly.”

Lessons Learned from Aerospace


The parallel Mr. Attaran makes between how aerospace solved a global issue and how the pharma industry can too, is an interesting one. Whether it is planes or drugs, what organizations need today is a new way of handling verifiable data to maintain safety in a global supply chain. And this is where the life science industry can take lessons learned from their aviation colleagues.

The airline industry faced a very similar dilemma in the early 2000s – they had to standardize a way of handling flyable parts data to manage the part’s lifecycle as well as its safe maintenance and compliance. After much debate and failed approaches, the aerospace industry came together with a global aerospace standard for how data and information is to be stored, managed and maintained on critical assets to maintain safety (Tego was the co-author of the ATA Spec 2000, Chapter 9-5, Version 2013-1 standard, which came into place at this time and had the following effect on the industry). As Mr. Attaran accurately describes, these are the same problems, needs and requirements facing the pharmaceutical industry as it attempts to tackle the rising tide of counterfeit drug manufacturing and distribution.

Combatting Counterfeit with Distributed Drug Intelligence


What is the pharmaceutical use case? It is, in many ways, traditional product lifecycle management in the pharma setting. As a product is manufactured, processed and packaged, important manufacturing processes, materials, and events need to be permanently recorded on the product itself. Such information is not only valuable for the manufacturer (for managing UDI information, e-pedigree and chain of custody), it is also of value for distributors and end users, allowing for safe and appropriate use of drugs or devices, equipment and materials.

Needless to say, data access and privileges are critical considerations so that sensitive information is securely kept away from non-credentialed users. As products move throughout their supply chain, from manufacturers and distributors to end users, they need to continue to gather and store progressive data specific to chain of custody, shipping, storage and handling details, among others, throughout the supply chain.

Approaching this from a centralized IIoT systems and databases angle poses a number of challenges – it is both hard and expensive to provide local access to critical data to those who need it, when they need it. Building, maintaining and availing e-pedigree and chain of custody insights coming from a centralized repository quickly adds dollars, calls for multiple specialized resources to maintain it, and poses a number of security challenges as well.

Digitizing the Drug – The “T” in IIoT


A more practical approach for those in the life sciences supply chain is to digitize the drug or component itself by embedding and progressively adding the critical data to the asset or thing – the T in the IIoT. Solutions that digitize the T need enable the safe storage and management of structured and unstructured data including files, certificates and other information relevant to the asset lifecycle. This includes archival information on how the product was made, who made it, when it was packaged, where it shipped, who stored it and how it was stored. When data is made available at the point of need – locally across the value chain, manufacturers and distributors can effectively and efficiently improve operational efficiencies and guarantee patient safety.

By digitizing the drug, manufacturers also provide a secure and safe way to authenticate drugs as they make their way through the supply chain. This approach can also assist in critical situations such as recalls – a distributor can be alerted when a product is on the shelf and needs to be removed, and use the digital signature of each product to its swift recall.

The world is moving at a faster pace and the things around us continue to get smarter on a daily basis. Both the pharmaceutical and life science industries need to take a cue from aerospace to begin the process of safely and securely maintaining products and components to drugs in order to combat the billion-dollar counterfeit drug business. The examples discussed will help to efficiently and effectively meet compliance regulations such as UDI and alert the required parties to recalls necessary for patient safety.