2008 Product Security Supplement

FOREWORD

THIS IS THE 4TH ANNUAL Pharmaceutical Product Security Report. When we did the first one, in 2005, I recall advocates of anti-counterfeiting and pedigree systems saying that they had to overcome a key question of legislators and others about the topic: Where are the dead people whose lives would have been saved by these measures?

Well, this year it happened: the heparin contamination scandal from last spring, where upwards of 80 patients died prematurely from heparin whose API had been imported from China.

I know the objections that will immediately rise up: this was a manufacturer’s problem, not one of the supply chain; no track-and-trace system would have prevented it; it’s not part of the “normal” distribution channel; etc. To which I say: Well, lucky—sort of—this time.

A Coalition for Community Pharmacy Action, led by the National Assn. of Chain Drug Stores, issued a report this summer claiming that a literature search revealed “no instances of counterfeit drugs in the normal distribution channel since 2005,” and therefore, the costs of adopting track-and-trace systems were not justified. This would be fine logic if one could agree on just what a “normal” channel is.

And whatever that channel is, it is surrounded by bogus pharmacy websites, bootleg API dealers, improperly imported pharmaceuticals, quasi-legal medical practitioners and, frankly, smart, greedy criminals. It’s not a question of “if,” but one of “how” in thinking about the potential breaches of the pharmaceutical supply chain.

The problem here, it seems, is that defenders of the status quo believe that criminals will behave themselves and attack the supply chain in predictable, acceptable ways. But it doesn’t take much street smarts to realize that they won’t—they will be probing, pushing and testing any weak link they can find. The criminals are on the outside; the treasure of valuable pharmaceuticals sales is in the inside. It is a force of nature that the two will try to come together. Lurking behind the criminal element is bioterrorism—about which, when I brought the topic up to one industry expert, it was said, “Don’t go there.”

Pharmaceutical Commerce is not trying to be overly alarmist about this situation. The U.S. pharmaceutical supply chain is under attack, but it has not been defeated. While many manufacturers and their trading partners heaved a sigh of relief when the California e-pedigree deadline went away, other companies kept forging their own path. We salute those forward-thinking organizations. We think that they are going to be not only the safer companies in the future, but also the ones who will be first to obtain business value from the supply chain visibility that their security systems will provide.

Contents:

Product Security Perspective: Protecting the Brand

Pharmaceutical Commerce Serialization Survey

European Drug-Authentication Efforts are Moving Ahead

Serialization: From Operating Cost to Business Value