Fighting Counterfeit

Counterfeit Drugs web photo 2

For the complex healthcare supply chain, aerospace grants wisdom.

By Tim Butler

Even as supply chain operations grow steadily more automated and secure in most industries, life sciences still fight an outlying challenge: counterfeit medication. The proliferation of counterfeit drugs has become a major impediment not just for the bottom line, but also to public health and international trade. 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. What began as a supply chain issue is now a wide-scale brand protection issue.

The matter is of such great import, in fact, that a series of new laws under the Drug Supply Chain Security Act (DSCSA) has been put in place, ostensibly to legislate toward reduced instance of fake drugs. Trouble is, the mandate's structure could be producing an opposite effect. Investment in authentication technologies the real mover when it comes to spotting and removing counterfeits –has been put on the back burner in favor of implementing product serialization schemes ahead of a late-2017 deadline. Serialization is a trace solution, not necessarily a track solution, and it is a mistake to equate this process with full brand protection because it leaves the door open for non-verified drugs to enter the system.

The "Flyable Parts" Pedigree Challenge

History often rhymes, as Mark Twain was reputed to say, and to that end, there is an intriguing parallel between challenges the aviation industry faced – and overcame – in the early 2000s, and what the pharmaceutical industry faces today with drug counterfeiting. In aerospace, the call was to give flyable parts their own intelligence such that pedigree, maintenance and lifecycle events all critical to safe, ongoing operation of aircraft could be tracked digitally.

The impetus for the program grew from employee surveys revealing that, ironically, very little of the maintenance activity on an aircraft was spent actually repairing or servicing its parts. Rather, the bulk of the time and effort went toward properly identifying parts, or retrieving them, or collecting and updating the associated paperwork. The takeaway was clear - maintenance information about a given part was not easily accessible at the moment it was needed most.

The solution settled upon was to record critical, detailed manufacturing, repair and condition information in digital format on the asset itself. This information would travel with the part, could be accessed and updated throughout the item's lifecycle, and would always be available at the point of need.

Today, there is a global standard for automated identification and data capture to maintain flyable parts' safety, a standard that my team co-authored (Air Transport Association Spec 2000, Chapter 9-5, Version 2013-1).

From Airplanes to High-Value Drugs

In aerospace, the benefits of distributed asset intelligence now extend well beyond the immediate need, so that an entire ecosystem of providers and stakeholders can access appropriate pieces of the valuable data at any time. This is where the learnings directly transfer to the pharmaceutical industry.

When you effectively digitize a prescription drug by embedding and progressively adding critical data to it, you create new levels 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, how it was stored and who received it from whom, when.  All of which is to say, manufacturers can provide a detailed means to authenticate drugs as they make their way through the supply chain. Then, at the point of use, if the drug is not able to document its entire travelogue from manufacturing floor to pharmacy, it's invalid. There's no guesswork, and there's no chance for a counterfeiter to simply replicate a drug's package or identifier. You may be able to forge a barcode or label, but you cannot forge a unique record of historical data.

Counterfeit Drugs web photo 1

(As an aside, this approach also assists in critical situations such as recalls. If necessitated, the pharmaceutical brand can alert its distributors if a specific product, or range of a given product, need to be removed from stock, and use the same digital signatures to handle a swift, contained, and isolated recall).

It is important to note that tackling this matter from a connected Internet of Things (IoT) device standpoint poses a number of challenges it is both difficult and expensive to build out the necessary connectivity infrastructure, and it introduces a number of security challenges that nobody wants to manage. Health care professionals need no reminding about ransomware, and the potential of connected devices to promulgate the threat.

Aerospace provides a very real model for life sciences to begin the process of safely and securely tracking drugs, to both take on the billion-dollar counterfeiting business and to protect their brands. The path for distributed asset intelligence is paved; it is up to leaders to walk it.

Tim Butler is the original founder and CEO of Tego. He is a resourceful and inventive contributor with a 20-plus year track record of success taking quantifiable risks to leverage strategic advantages in order to grow market share and assist companies in achieving profit-generating status. Butler has an MBA from the Wharton School and a master's degree in international political economy from Northwestern University. Tego is Butler's third technology company; prior to this, he was CEO and founder of SiteScape. Tim's dog, Finley, comes to work with him almost every day.

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