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.
So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”). Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN:
- GS1 UPC barcode symbology
- GS1 element strings encoded in a barcode symbology such as:
- GS1 DataMatrix
- GS1 DataBar
- GS1 EANCOM EDI standard
- GS1 EPC RFID in frequencies such as
- GS1 Electronic Product Code Information Services (EPCIS)
- GS1 Drug Pedigree Messaging Standard (DPMS)
- GS1 Global Data Synchronization Network (GDSN)
GS1 Healthcare is a community organization of end users within GS1 who are members of the global healthcare industry. That organization created the following figure to show how GLN and GTIN are foundational to patient safety and supply chain efficiency, the ultimate end goals of its members. At the top of that foundation is GDSN and above it are the five pillars of patient safety, which support the ceiling of supply chain efficiency and the overall roof of patient safety. (See “Change has finally come: U.S. Healthcare industry to implement common data standards to improve safety, reduce costs” by Joe Pleasant, CIO and SVP, Premier, Inc.)
Many U.S.-based hospital Group Purchasing Organizations announced a number of years ago that they would require the use of GLN and GTIN by December 2010 and 2012 respectively. Apparently at least one of those GPO’s also requires the use of GDSN but without specifying a date.
GS1 GLOBAL DATA SYNCHRONIZATION NETWORK (GDSN)
GS1’s GDSN is a standard that can be used by supply chains to communicate product class-level supply chain master data (SCMD) to all of the companies who participate in it. Here is how I described it in my essay, “Supply Chain Data Synchronization and Patient Safety”:
“Generally, [GDSN’s] use requires all trading partners in a given supply chain to subscribe to a GDSN-conformant Data Pool service provider. Unilateral adoption of GDSN by a single company doesn’t make any sense. It’s a high bar for a large and complex supply chain to achieve through voluntary means. Right now the pharma supply chain in the U.S. has not achieved it and so the quality of SCMD in the supply chain is currently dependent on ad hoc relationships and data passing. Some of this includes manual data entry into the local master data systems at many points in the supply chain.”
Here is one way GS1 draws GDSN. This view emphasizes the plumbing and shows the “how” of GDSN. (See “Global Data Synchronization Network® (GDSN) Operating Roadmap for GS1, Version 7.3” November 2011.)
Here is my rendition of GDSN use in healthcare. I show it as a cloud-based repository where the manufacturer publishes their product master data and where downstream trading partners can subscribe to it. That way everyone in the supply chain—right down to the healthcare professionals at the points of care—are using the exact master data as published by the manufacturer. Admittedly this rendition doesn’t show how GDSN is implemented, but I happen to think that’s less important that showing what it is. See GS1 for the details.
Up to this point in time there still hasn’t been any significant use of GDSN in the U.S. medical supplies and devices supply chain and it is tough to get an entire industry to adopt something so large without some kind of incentive. The GPO’s are trying to provide that incentive by mandating its use, so at some time after the GTIN is widely adopted on medical supplies and devices, SCMD may be synchronized between manufacturers and hospitals, and perhaps distributors as well.
USE OF GDSN IN THE U.S. PHARMACEUTICAL SUPPLY CHAIN
GDSN is also not currently used in the U.S. pharmaceutical supply chain, but in my view, it will be a necessity if/when GS1’s EPCIS standard is ever used for track and trace applications like ePedigree. In my view, EPCIS alone can’t be used for compliance with the existing pedigree regulations in the U.S. (see my essays, “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1” and “…Part 2”).
But EPCIS just might become the basis for the track & trace standard that the FDA will publish by the end of this year (see me essay “InBrief: FDA To Publish Track & Trace Standard By Year End”). Many people believe that standard will be based on EPCIS, similar to the way FDA aligned their sNDC standard with GS1’s GTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”). Include me in that group.
But, by design, EPCIS events do not carry SCMD (see my essay, “Pedigree Models and Supply Chain Master Data”), so if EPCIS events form the basis of an ePedigree, it will be a absolute necessity that all parties who are consuming and updating those pedigrees use the identical product class-level master data. That would be necessary because everyone would need to agree on exactly what constitutes the drug that is referenced by the GTINs in the EPCIS events. Without that common agreement on exactly what the GTINs mean, how can there be a true pedigree?
Here is a drawing that shows how GDSN could be used in conjunction with a semi-centralized ePedigree system that is built on top of EPCIS events.
Notice how each trading partner in the supply chain communicates with both the GDSN cloud and the Semi-Centralized ePedigree cloud. In actual implementation these clouds might not be so distinct because the same vendors might offer both, but I show them separate here because they are serving distinctly different purposes.
The GDSN cloud is serving as the common source of product SCMD as published by the manufacturer—keyed off of the GTIN—and the Semi-Centralized ePedigree cloud, based on EPCIS, is serving as the common repository for all supply chain events that occur to the actual unit-level instances of those products—keyed off of the serialized GTIN, or SGTIN. The clouds also communicate with each other because, to produce a usable ePedigree report the ePedigree engine would need to obtain the SCMD from the GDSN cloud.
As I said, I think something like this will be a necessity if EPCIS is used as the basis of an ePedigree system. So far when people in the industry talk about using EPICS for ePedigree they almost always forget the SCMD. The ePedigree solution I show in the figure above is a very efficient model since the SCMD does not travel along the same path as the instance data (the EPCIS events). This is in stark contrast to DPMS which needs to carry that data along with each ePedigree document—a big negative for that standard that many have pointed out over the years.
All pedigree models have trade-offs. One of the trade-offs of ePedigree models based on EPCIS is that GDSN will probably have to be adopted throughout the U.S. pharma supply chain over a fairly short period of time, but no doubt patients would benefit greatly from that.
BETCHA CAN’T USE JUST ONE
There you have it. Not only would pharma trading partners need to adopt GLN and GTIN, in this scenario they would also need to adopt EPCIS and GDSN shortly afterward. In the pharma supply chain you can’t use just one!
Can you see any alternatives to this scenario besides adding DPMS in some way? Leave a comment below.