DO YOU KNOW YOUR PEDIGREE?

Pedigree (noun): The recorded purity of breed of an individual or strain; a register recording a line of ancestors.

You may be asking, "What does a pedigree have to do with my pharmacy and the chain of events that get the drugs I need to me?" I'd say, "Plenty."

BACKGROUND

In 2007, California legislators issued The California Pedigree Law, which requires pharmaceutical and biotech manufacturers, wholesalers, and pharmacies to generate electronic pedigrees whenever a change in ownership occurs from the sale of drugs to any of their trading partners. Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.

These pedigrees must track each drug at the smallest package or immediate container level and each item must have a unique serial number a register recording a line of ancestors.  

 The most significant rationale for this law is to detect the introduction of illegitimate drugs (counterfeit, stolen, up-labeled, diverted, etc.) into the legitimate supply chain as early as possible, preferably at the very first transaction. These laws accomplish this by requiring companies buying drugs within the supply chain to receive the full supply chain history of those drugs at the time of the purchase (contained in a “pedigree”), and, most importantly, by requiring them to verify the legitimacy of those prior transactions. In California, this verification can only be performed through the use of digital signatures.

California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide. That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not. Voila! Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.

Will the pharmaceutical supply chain be “safer” or will the counterfeiters still be able to penetrate it ; do you think the cost of implementation and maintenance of such a system will be passed on to the consumer? Stay tuned.

Here's to better solutions, 

Dave Bystrom