Tag Archives: GTIN

standards

Anatomy of a GTIN

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2012 is the year of the GTIN in the U.S. healthcare supply chains as christened by the largest hospital group purchasing organizations (GPOs) in their so-called “Sunrise 2012” program.  They have asked all of their suppliers to switch from proprietary product codes to GS1’s Global Trade Item Number (GTIN) standard in catalogs, B2B communications and shipment labeling by the end of this year.  They did the same thing with GS1’s Global Location Number (GLN) back in 2010 (“Sunrise 2010”) but so far it appears to have had only a small (but still growing) impact.

The GTIN can be a mysterious concept.  I received an email recently from a sales person who wanted to know what this “G-ten” thing was that her customer kept claiming was so important to her future business with them.  I’ve also sometimes had difficulty convincing people that GTIN adoption is important.  “We don’t need another product identifier.  We already have the NDC!”

I hope to pull back the veil just a little bit and explain not only the anatomy of the GTIN but also why it is so important to all supply chains in all regions of the world.

WHAT EXACTLY IS A GTIN?

GS1 explains the GTIN this way:

“As the name implies, the GTIN helps automate the Continue reading Anatomy of a GTIN →

California Pedigree

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.For the application of unique serial numbers, or Standard Numerical Identifiers (SNIs), to packages as part of compliance with the California Pedigree Law in 2015-2017 , GS1’s Electronic Product Code (EPC), particularly in barcode form, is the clear winning standard.  But there seems to be a very common misconception going around that for pedigree data management, all you need to do to comply with that law is to deploy a system that is based solely on the GS1 Electronic Product Code Information Services (EPCIS) standard.  The  misconception assumes that there is a formula that can be followed to achieve compliance and that EPCIS is the whole formula.

In truth, EPCIS will almost certainly be an important component in the compliance formula but exactly how it fits, and whether there are other necessary components, has not yet been determined.

There are probably several reasons that this misconception persists.  First, GS1 US continues to promote their 2015 “Readiness” Program as if it is that formula.  The program documentation strongly implies that, if you simply follow their program, you will “be ready” to comply with the law; but it stops short of actually saying that you will be compliant.

Second, it seems like people are either able to understand the law well but not the technical standards, or they are able to understand the technical standards well but not the law.  The legal folks are left to trust what the technical people say about EPCIS, and the technical people assume that as long as the data elements identified in the law are present somewhere then EPCIS must comply.

Now I am not a legal expert but I’ve been looking at the text of the California Pedigree Law for a few years now and I think I understand it at a level that allows me to estimate how various technical approaches might fill its requirements.  Let me show you how Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1 →

SNI

SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

I recently published an essay on RxTrace called “Plateaus of Pharma Supply Chain Security” in which I proposed that a better timeline for the introduction of technology to secure the U.S. pharmaceutical supply chain was one based on plateaus.  Each succeeding plateau would add the adoption of new technology and/or data communications among the participants in the supply chain with the intent of elevating the security over the previous plateau.

In that essay I included illustrative dates for each of the four plateaus that I offered as an example of the concept, but you could easily imagine the overall program having open-ended dates that would allow the supply chain to adopt one plateau at a time and move to the next plateau only if/when a security problem is discovered at the current plateau.  That is, jump to the next plateau only when necessary.  Taking this approach, you may never actually need to get to the later plateaus.

For example, imagine that the first plateau were for manufacturers to serialize all drugs at the pharmacy-saleable package level (what I normally call “unit-level”) with an FDA Standardized Numeric Identifier (SNI) and all supply chain owners of drugs were to read the SNI’s and simply keep records of who they bought them from and who they sold them to.

With no data communications between trading partners that includes the SNI’s it might seem that little
security has been gained over what is done today.  But this small step (“small” compared to a full pedigree or track & trace system) would allow criminal Continue reading SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach →

track and trace

The Viability of Global Track & Trace Models

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At the end of my last essay I said I had recently concluded that the jump to a fully automated pharma supply chain upstream visibility system is too big and complex to be achievable by every company in the U.S. supply chain by the California dates.  I want to explain that statement in a future essay (soon), but before I do I want to explore some of the track and trace models that are being considered by both GS1 and the FDA.  I particularly want to look at the viability of each model because I think we will find that some just aren’t (viable), and that will help narrow the search.

I’ll look at the three basic models that the FDA mentioned in their recent workshop:  Centralized, Semi-Centralized and Distributed (or Decentralized as the FDA called it).  There are others, but it seems that they can all be either based on, or reduced to, one of these three basic models.

In this essay I am looking at track & trace models from a global viewpoint, which is something that GS1 is doing but the FDA may not.  Attacks on the pharma supply chain are a global problem and global problems demand global solutions or gaps will be left for criminals to exploit.

GS1’s goal is to develop standards that apply globally as much as possible and the FDA will likely find that Continue reading The Viability of Global Track & Trace Models →

HDMA

GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance

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Earlier this month the Healthcare Distribution Management Association (HDMA) published newly updated guidance documents for the use of Accredited Standards Committee (ASC) X12 Electronic Document Interchange (EDI) messages in the U.S. healthcare supply chain.  This is a very important update that supply chain participants should take notice of because it includes new information about how to properly communicate GS1 identifiers, including GLN’s, GTIN’s, and Electronic Product Codes (EPC’s) like SGTIN’s and SSCC’s, within the four document types that are in common use for Order-to-Cash transactions.

The EDI document types included in the updated guidance includes: Continue reading GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance →

standards

So a customer demands that you use GLN’s and GTIN’s. What next?

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In the healthcare supply chain a significant number of hospital group purchasing organizations (GPO’s) have stipulated, to varying degrees, that their suppliers begin making use of GS1 Global Location Numbers (GLN’s) in all of their trade with their member hospitals by the end of 2010 (Sunrise 2010) and GS1 Global Trade Item Numbers (GTIN’s) by the end of 2012 (Sunrise 2012).  Here are the announcements from Novation, Premier, MedAssets and Amerinet.  From the wording of their announcements it appears that Continue reading So a customer demands that you use GLN’s and GTIN’s. What next? →

supply chain security

Supply Chain Data Synchronization and Patient Safety

Does the supply chain itself make any contribution to patient safety?  The legitimate pharmaceutical supply chain is that complex web of companies that move drugs from the manufacturers to the pharmacies that dispense them to patients.  The supply chain always includes both of those end points (manufacturer and pharmacy) and, in the U.S., normally also includes at least one wholesaler.  The supply chain is typically viewed as “Manufacturer to Wholesaler to Pharmacy”, whether the pharmacy is within a hospital, clinic, retail independent, chain store, grocery store, or mail order.  The great majority of prescription drugs arriving in the hands of U.S. patients have passed through this supply chain.

So what contribution does this chain make toward the safety of those patients?  In my view, it comes in three ways: Continue reading Supply Chain Data Synchronization and Patient Safety →