Over the last year in GS1, in many of the members of the U.S. pharma supply chain and even in the FDA, the focus has turned to the analysis and discussion of three classes of electronic pedigree models:
One of the characteristics included in many of these discussions is the “points of failure” of each model. For example, I’ve heard it said several times that the Fully Centralized model suffers from a “single point of failure”, with the implication being that Fully Distributed models do not have this problem. In fact, this is incorrect and in reality, both the Fully and Semi-Centralized models are much less likely to fail than models that fall within the Fully Distributed category when “failure” is defined as not being able to provide an ePedigree on demand in any given instance.
The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.
There are more than one reasons why you shouldn’t expect to use GS1’s EPCIS by itself to comply with the California pedigree law. Part 1 of this series showed that the traditional distributed network of EPCIS repositories in the U.S. pharma supply chain doesn’t work. But that analysis assumed the use of the “vanilla” EPCIS standard, without the use of any “extensions”. That’s not really the way GS1 intended EPCIS to be used. In this and future essays of this series I will explore some of the approaches that make full use of the extensibility that is built into the standard.
In this Part of the series I want to take a closer look at the work of the Network Centric ePedigree work group of the GS1 Healthcare Traceability group. I am one of the leaders of that group along with Dr. Mark Harrison of the Cambridge University AutoId Lab, Dr. Ken Traub, Independent Consultant, and Gena Morgan of GS1, along with strong contributions from Janice Kite of GS1 and Dr. Dale Moberg of Axway. The larger group consists of people who work for companies in the pharmaceutical supply chain, GS1, and solution providers from around the globe, although I think the majority are from the U.S.
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.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.