The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers around how much data for each package of drugs needs to be moved between trading partners as those drugs move down the supply chain from the manufacturer to distributor(s) and ultimately to the pharmacy. The ideal model would minimize the amount of data moved yet always allow each member of the supply chain to check the prior history—the pedigree—of the drugs they are about to buy.
At a superficial level this appears to be all you need to do, but when you take a closer at the details of how the supply chain actually works in the U.S. you will see that there are other characteristics besides data volume per package that need to be considered.
FOUR VIEWS OF THE U.S. SUPPLY CHAIN
In the debates and discussions over pedigree regulatory models we are used to seeing a view of the supply chain that shows one manufacturer, one distributor and one pharmacy. That view masks so much important complexity that if we were to select a regulatory model or solution based on that view it would be far from ideal.
Here is a view of the supply chain where the vertical scale shows something closer to the true proportions between those three segments. Continue reading U.S. Pharma Supply Chain Complexity