Friday, November 21, 2008

How Do You Classify Counterfeit Pharmaceuticals?

No Two Counterfeits Seem the Same...
By: Alan Clock, Senior Vice President, XStream Systems, Inc.

As our solution continues to discover counterfeit medications within the US Supply Chain, we have found that there is little official direction in the way of classifying pharmaceutical counterfeit incidents. What we are discovering is that within our universe of deployed and pilot units within the pharmaceutical supply chain (full line wholesalers, secondary distributors and reverse logistics) there is a wide variety of pharmaceutical counterfeit activities that do not fit into one easy classification.

What our end users have found within their inventories demonstrate a wide array of counterfeit medications with a variety of sophistication, quality and ways that they are introduced into the supply chain.

It seems apparent to us that these incidents should not be classified in one broad bucket and would require an industry or regulatory body to more granularly classify counterfeits so as to better understand and ultimately eliminate them as a health risk to all consumers.

We at XStream Systems attempted to tackle this classification issue recently and found that our discussion denigrated into a very long discussion with little output. Usually we got stuck on the finer points of when, where and how and how this impacts the nature and ultimate “class” of the counterfeit.

Undeterred, I posed the question to several industry leaders at an Anti-Counterfeiting Conference that I attended in Washington DC with unfortunately the same results.

Ultimately, I went on-line and found the industry’s most trusted organization, the Pharmaceutical Security Institute’s definition and although they seemingly have the best take on the issue as a whole, they too defer to another organization, the World Health Organization for guidance:

PSI's definition of counterfeit medicines is built upon the definition utilized by the World Health Organization (WHO). Counterfeit medicines are products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product. This definition applies to both branded and generic products.

It still seems to me based on our recent experience that this definition and classification is not enough given the massive evolution and proliferation of the counterfeit pharmaceuticals. We need something better to drill down and interdict the problem at its various cores in order to eradicate it.

I now pose the question to the public...

How Do You Think Counterfeit Pharmaceuticals Should Be Classified?

I anxiously await your responses.

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