Friday, February 20, 2009

WHO Knows the Definition of a Counterfeit Medication?

By: Alan Clock, Senior Vice President, XStream Systems

Back in November 2008, I presented the question on this blog and on several professional networking sites; How Do You Classify Counterfeit Pharmaceuticals? In this blog, I related the conundrum that I have found in discussions both within our organization and I have had in speaking with experienced industry thought leaders; What is the definition of a counterfeit pharmaceutical?

Thanks to all who did respond to my open ended question, basically your input further demonstrated my point that the definition of counterfeit pharmaceuticals is not as easy as one might think and clearly those in the know have many different perspectives and views.

As many of those who are involved in defeating counterfeit medications know, it is very important for the industry, regulatory agencies and healthcare consumers to have a full understanding and scope of this insidious problem. Counterfeiting of medications as we know it today threatens to rob whole populations of their health and confidence in our system of providing safe and effective healthcare. Having a clear universal definition of the problem is a basic starting point for us to be effective in dealing with this global plague.

In my blog, I ultimately turned to the World Health Organization (WHO) for some clarity and found that their broad definition surprisingly very open ended as well.
Apparently the WHO has attempted in its most recent Executive Board Meeting in January to draft a more precise definition of “counterfeit” as it relates to medication and medical devices. They also attempted to properly delineate the organizations mandate to tackle the problem. Ultimately they, like the rest of us wound up stalled in their attempt.

It appears that they too realized the broad scope of the issue and recognized that it is difficult to do battle against a serious world health issue when one cannot properly identify and define the opponent.

According to published reports the WHO Executive Board disagreed over the refined definition and had to postpone their efforts until their May World Health Assembly in Geneva, Switzerland.

Here is hoping that this important organization comes to a consensus and gives us all some guidance as to a proper definition of scope of this very important problem. As of late, most within the pharmaceutical supply chain have relied on WHO statistics as a baseline for understanding the scope of counterfeit medications. The WHO is acknowledged as the standard of global guidance and their efforts are important in defeating this threat to healthcare worldwide.

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