Some countries mandate the use of GS1 standards for drug product identification and package and case barcodes. The European Commission seems to tolerate GS1 standards, leaving it up to each member state to decide. Most use them, a few held onto their own national codes as long as they could. China is taking their time warming up to the GS1 Global Trade Item Number (GTIN) but it seems to be happening. That is, I think it’s happening. The United States has always had its own national numbering system for identifying drugs, known as the National Drug Code (NDC) (see “Anatomy Of The National Drug Code”). Because they are running out of numbers to identify new manufacturers (labelers), they are considering changes to the NDC that could break the ability to encode an NDC within a GTIN (see “How To Properly Define GTINs For Your NDCs”, “FDA New NDC Format Public Meeting” and “An Open Letter To The FDA: New NDC Format Public Meeting”). The USA is not the only country to be considering a break with GS1 standards. Indonesia will allow QR Codes on drug packages, and now there is a movement in the India government to move away from GS1 standards. What’s going on here? Can GS1 hold onto drug identification around the world? Let’s take a look.Continue reading Can GS1 Hold Onto Drug Identification Worldwide?
GS1 makes modifications and additions to their General Specifications every year—sometimes even twice a year. The latest is version 19 and was published in January 2019. The “GenSpecs” contain the full detailed definitions of every GS1 “key” and every GS1 barcode. While it doesn’t contain the definitions of every GS1 standard, it is the catch-all specification for their traditional core—mostly barcode related—standards. This is where GS1’s keys are defined, included the Global Trade Item Number (GTIN, Application Identifier, or AI = 01), Global Location Number (GLN), Serial Shipping Container Code (SSCC, AI = 00), Global Returnable Asset Identifier (GRAI, AI = 8003) and all the others. Last year (GenSpecs version 18) GS1 introduced their latest key, the Global Model Number (GMN, AI = 8013). It’s an important addition, particularly for healthcare. Let me explain.Continue reading Meet The Latest GS1 Key: The Global Model Number (GMN)
On October 17 – 19, 2017 the global GS1 Healthcare community came together for their fall conference in Chicago, IL. The conference was packed with practical information for implementing GS1 Standards across every spectrum of the Healthcare industry. To cover the entire event, I’ve asked Karen Fleshman, Co-founder, COO of the Haskins Advisory Group, to cover the medical device sessions while I cover the pharma sessions. Let’s hear from Karen first. Continue reading The Fall Global GS1 Healthcare Conference
There are some discontinuities between the needs of the industry for meeting serialization regulations around the world and certain GS1 standards, including their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) standards. I’ve already pointed out the issue of EPCIS expecting everyone who uses it to possess, by default, a GS1 Global Location Number (GLN) (see “GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance”). Here is one more. Continue reading Serial Number Bonding
There is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals. National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified. They want to eliminate all ambiguity between products within their market. They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted. To do that effectively, they need a way of clearly and concisely referencing a given product. That same way of referencing the product should also be used for patient education and for healthcare professional prescribing. Bad things happen when mistakes are made in the identification of healthcare products.
GS1 offers a global standard way of identifying Continue reading Product Identification And National Registration Codes
GS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday. Both carry the new version number “1.1”. The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.
This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).
WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN
This is a significant event for pharma supply chains around the world, but particularly for Continue reading GS1 Ratifies Updated Versions of EPCIS and CBV
For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard. The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work Group (MSWG)”. According to the call-to-action:
“This group will develop standards to allow pharmaceutical supply chain parties striving to meet pedigree regulation requirements, by gathering and checking pedigree event data. Standards will also address data confidentiality and security. This MSWG will create
A) standard for security framework applicable to EPCIS and,
B) pedigree checking services.”
This group’s output will not be a self-contained pedigree standard, per se, but Continue reading Should GS1 Continue Developing ePedigree Standards?
Who owns supply chain visibility data? Does the manufacturer of a product retain any rights to track that product after it enters the supply chain? What if the product is a pharmaceutical and it is found to have a life-threatening defect? Should technology or standards availability play any role in answering these questions?
These kinds of questions come up occasionally in discussions of track and trace systems design when people talk about the future of “full supply chain visibility” and how easy recalls will be executed because of it. The implication is that the manufacturer of a drug will be able to perform a targeted recall because they will be able to see exactly where their product is in the supply chain.
But one could easily make the argument that it is no longer “their product” once it enters the supply chain. True, they invented, manufactured and labeled it, and in a recall situation we all have a strong desire for them to get it back quickly and efficiently, but that doesn’t change the simple fact that they don’t own it anymore. And if they don’t own the product anymore then they don’t automatically own the knowledge of where it is either.
I’m not a lawyer but it seems to me that once a product is sold the seller gives up all rights to that product. The buyer can do whatever they want to with it, within the law of course. Recalls that are necessary for reasons that might be life-threatening are special and supply chain members should do everything they can to find and return any item that is involved in a recall. But is it necessary for the manufacturer to have instant access to the location of all of the affected product?
Serialization and track and trace will allow all supply chain participants to know a lot more than they do today about the location of recalled items just using the data that they clearly own. Compared with today, an individual company will know very quickly if they have ever received, shipped or currently have in stock the recalled units. If they currently have them in stock they will be able to place an immediate hold on those items to prevent them from being shipped to a customer until they have been collected and returned. If they have previously shipped the items to a customer they will know exactly which customers were involved and which unit went where. But that’s it. The knowledge of what their customers might have done with those products once they receive them is not owned by the seller. Continue reading Who owns supply chain visibility data?