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.

Counterfeiting and Diversion in the Pharmaceutical Supply Chain

Ruby Raley, Director, Healthcare Solutions, Axway

Some Industries Can Benefit from the Anti-Counterfeit Measures of Other Industries

by Kim Loughead
Director, Product & Solutions Marketing
Axway

The good news is that many of these industries are tackling the problem head-on, and what they have learned can be applied to the control valve market as well.

One of the key learnings across these industries is that sharing information with partners is critical to gaining control over your supply chain.

Valve Magazine, “the only magazine for users, specifiers, buyers and distributors of North American valves and related products,” published an article last month addressing the problems associated with counterfeit or suspect products in the control valve industry.

Suffice it to say, the control valve industry is in good company. Many manufacturing industries suffer from the same problems: unscrupulous suppliers peddling substandard products, uncontrolled secondary markets, and outright counterfeits. The good news is that many of these industries are tackling the problem head-on, and what they have learned can be applied to the control valve market as well. For example, the technology industry has created a group called the Alliance for Gray Market and Counterfeit Abetment (AGMA), which has developed guidelines for procurement and channel management recommendations to help identify, prosecute and reduce counterfeiting and diversion. Other such organizations exist in the pharmaceutical, automotive and aerospace industries.

As mentioned in this article, one of the key learnings across these industries is that sharing information with partners is critical to gaining control over your supply chain. This may be simply sharing sales data and repair records. Some industries where public safety is at risk from counterfeits are going so far as to uniquely identify production units and track the chain of custody of a unit throughout its life. This includes pharmaceutical and aerospace. Standards are being developed such as GS1 EPC Information Services (EPCIS) and SPEC2000 to help industry partners effectively share data. The GS1 standard is cross industry, and may also be applicable to the control valve industry.

The actions recommended in the article are in line with what is recommended for other industries. I would add to this, however, a channel management strategy and technology to ensure you have the capability to track and scorecard your suppliers against the terms of their agreements. This will give you the evidence you will need to take action if you find abnormalities. I would also emphasize the need to share more information across your partner network to gain greater visibility and control over your supply network.

(Photo by Michael Cornelius: http://www.flickr.com/photos/cornelii/ / CC BY-SA 2.0)
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