Tag Archives: GS1

Anatomy of a GTIN

January 16, 2012 Dirk Rodgers 10 Comments

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 →

HDMA

Updated HDMA Bar Code Guidance: A Must Read

January 9, 2012 Dirk Rodgers 1 Comment

In a long awaited and much anticipated move the Healthcare Distribution Management Association (HDMA) published updated guidance for the formatting, encoding and placement of barcodes in the U.S. pharmaceutical supply chain. The document is called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain 2011”. The guidance is aimed mostly at pharma manufacturers and repackagers who place barcodes on their drug packages, cases and pallets. The last time the guide was published was in 2005 and this new edition includes some significant changes that everyone in the supply chain who deals with product and shipping container labeling should be aware of.

The updated document can be downloaded from the HDMA Marketplace web page. It is free to HDMA members. Non-members will need to pay a fee but don’t let that stop you from downloading a copy if you have any Continue reading Updated HDMA Bar Code Guidance: A Must Read →

pedigree laws

Should Regulations Dictate Technology?

November 28, 2011 Dirk Rodgers 4 Comments

In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations? This question arises whenever a new regulation is considered by any of these bodies or agencies. It’s an important question now that the FDA is considering standards for ePedigree, Track & Trace and related things and I think there are some natural conclusions that can be drawn from past examples that lead to a potential answer. Let’s review the history first.

EXAMPLE: EXISTING ePEDIGREE LAWS

The language of the U.S. Prescription Drug Marketing Act (PDMA) specified the kind of data that must be in a compliant pedigree but it did not identify any particular technology to carry that information. Of course, compared with today, what kind of technology was available back in 1987 when the PDMA was first introduced in the U.S. House of Representatives? Is it a paper pedigree? Can it be electronic? What is the format? Can GS1’s Drug Pedigree Messaging Standard (DPMS) be used to comply? Continue reading Should Regulations Dictate Technology? →

California Pedigree

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

October 24, 2011 Dirk Rodgers 2 Comments

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 →

California Pedigree Law

California Board of Pharmacy Re-awaken

September 1, 2011 Dirk Rodgers 3 Comments

For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7. Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011. It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly. Here is the item as it actually appears on the agenda: Continue reading California Board of Pharmacy Re-awaken →

SNI

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

June 13, 2011 Dirk Rodgers

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

May 2, 2011 Dirk Rodgers 3 Comments

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 →

pharmaceutical supply chain, stolen insulin

Reliance on Trust in the U.S. Pharma Supply Chain

April 26, 2011 Dirk Rodgers 7 Comments

Trust plays a big role in today’s U.S. pharmaceutical supply chain. Patients trust that their doctors know what they are doing when they prescribe a medicine and they trust their pharmacist to fill their prescriptions with real medicines that were:

manufactured to tight quality specifications,
are well within the expiration date,
have not been tampered with,
have always been kept within recommended environmental tolerances,
and have been in the control of companies who have a strong interest in supply chain integrity and in the safety of the drugs within the supply chain.

When we receive our little amber bottles of repackaged drugs from our pharmacist, we aren’t given any way to check on any of those things ourselves. We trust that the pharmacy has done something to ensure all that. And fortunately in the U.S., we are almost always justified in that trust. We enjoy the safest supply chain in the world.

A WHOLE LOT O’ TRUSTIN’ GOIN’ ON

But, now if the pharmacy doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler will supply them with drugs that have those characteristics too. And if the pharmacy’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler’s wholesaler provides them with drugs like that too. And if the pharmacy’s wholesaler’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that Continue reading Reliance on Trust in the U.S. Pharma Supply Chain →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance