Beyond the Scope

by Ruby Raley, Director, Healthcare Solutions, Axway

You may have been following some of the recent articles on pharmaceutical distribution, and, in particular, the conversation on anti-counterfeiting that appeared in USA Today. Another article, this one in The Wall Street Journal, appeared around the same time and took a very different point of view: that counterfeits are not a serious problem.

So, if you’re an executive, a leader, or someone who cares about the safety of our pharmaceutical distribution supply chain, what are you supposed to glean from all these messages from respected voices?

Consider the recent injury of a diabetic man, an injury that had nothing to do with counterfeit pharmaceuticals yet illustrates why anti-counterfeiting measures can yield effects that go beyond the scope of pharmaceuticals.

A shipment of diabetes management devices was stolen from a major manufacturer’s truck, and the lot the devices belonged to didn’t appear in the marketplace at all for a year.

Then, all of a sudden, it did. A patient purchased one of the devices, the device was no longer effective, the test did not work correctly, and the patient’s blood sugar went sky high.

This episode succinctly illustrates why we should be concerned about anti-counterfeit measures, regardless of contrarian pragmatists with narrowly focused points of view. Whether the root cause is the bad guys making fake product and putting it in the supply chain, or the bad guys stealing product and mishandling the product and putting it back in the supply chain, or non-pedigreed product coming over the border and into our pharmacies, there is a problem.

And fortunately, we actually know how to solve that problem.

Tighter lot control.

The lots are so large now that when there’s a recall, it can clear the shelves, as you’ve probably seen at your local pharmacy with some of the recent recalls from trusted manufacturers.

We need smaller lots, and we need to assign a serialized number to the product below the overall lot level so that we can track batches and sub-shipments. With the right software, tracking those batches and sub-shipments is not difficult, yet the savings compared to entire lot recalls is profound.

And with track and trace legislation enforcement just five years away, product manufacturers should seriously consider labeling at the case level or at the shipment level, using tamper-evident markings, and investing in the right solutions so that they can determine that all products have shipped safely from a secure manufacturing site to a secure distributor, or from a secure distributor to a secure location at a local pharmacy.

After all, there’s a lot more than profit margins and reputations at stake. And the sooner everyone—journalists, enterprises, and industry leaders alike—recognize that even one injury injures us all, the sooner profit margins, reputations, and a lot more can be secured.

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