Posts Tagged ‘GS1 General Specification’

The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then).  The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my opinion it is a nice piece of work and can be used as a practical guide, as far as it goes, for implementing drug serialization programs today.

Why is that?  It’s because drug manufacturers and repackagers need to serialize all of their prescription drugs that enter the state of California in 2015/2016.  Can those companies make use of the FDA’s SNI guidance to comply with the serialization requirements of the California Pedigree Law?  I will answer that question in this essay, but first Read the rest of this entry »

In recent essays I have covered the “Anatomy of an NDC”, the “Anatomy of a GTIN” and the “Updated HDMA Bar Code Guidance: A Must Read“.  Now let’s put them all together.  Why would we need to do that?  Because the U.S. FDA requires many Over-The-Counter (OTC) and all prescription drugs marketed in the United States to have their National Drug Code (NDC) presented in the form of a linear barcode on the package.  Pure and simple.  To do that in a way that your trading partners can understand—that is, to do it interoperably—you need to follow a standard.  You have two realistic choices for standard approaches to this problem:  HIBCC or GS1.

The use of HIBCC standards is fairly common in the U.S. medical surgical devices supply chain but in the pharmaceutical supply chain it is very rare.  Most companies choose GS1’s barcode standards so that’s all I’m going to focus on in this essay.  If you want more information Read the rest of this entry »

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 Read the rest of this entry »

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 Read the rest of this entry »

Right now there is only one industry standard that can be used to comply with the various drug pedigree laws in the United States. That’s the GS1 Drug Pedigree Messaging Standard (DPMS), which was created in 2006 by a group of technology experts and participants from nearly all segments of the U.S. supply chain culminating in GS1 ratification in January 2007. Many of those companies began using DPMS even before it was ratified because the Florida Pedigree Law went into effect in July 2006. Since then, companies are using it to comply with other state pedigree laws as well as for the pedigree provisions of the federal government’s Prescription Drug Marketing Act (PDMA) of 1988 (stayed until December 2006). Interestingly, a few companies have chosen to require DPMS pedigrees today for trading partner risk mitigation even where there is no existing regulatory requirement to do so.

A few months after GS1 ratified the DPMS standard, they ratified the Electronic Product Code Information Services (EPCIS) standard. This is a more general purpose standard intended for use in all supply chains that have a need to track and trace serialized products. Everyone acknowledges that it doesn’t make sense to try to use it for compliance with PDMA, Florida or other state pedigree laws because they do not require serialization, but in 2015 the California Pedigree Law will go into effect and one of its unique provisions requires item-level serialization.  Some see this as an ideal place to apply EPCIS.

There are lots of ways to contrast these two standards and their use for pedigree law compliance, but probably the most striking difference is how they each treat Supply Chain Master Data (SCMD). I defined SCMD in a previous post as “…that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the supply chain.”

GLN as SCMD

Addresses are an example of a “business entity” that can be treated as SCMD. GS1 defines a location identifier they call a Global Location Number (GLN) that can be used to refer to an address. A GLN is a structured series of digits that can be assigned to refer to a single address (among other things). Refer to the GS1 General Specification for the details. Read the rest of this entry »

We need to make a clear distinction between traditional Master Data (MD), Supply Chain Master Data (SCMD), and Instance Data (IData). This will help us understand some important differences in various supply chain track and trace technologies.

Master Data

Wikipedia defines “Master Data” like this today:

“…Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the organization.”

This isn’t detailed enough for me. MD must include a data element that serves as an identifier. An identifier that refers to a given MD record must be unique within the organization.

Good candidates for MD are customer information, location information, product information and employee information. The characteristic these all have in common is that the data behind them rarely change. For example, I have been issued an employee number by my company. My employee number is the unique identifier for the MD that describes me to the company. My mailing address, phone number, marital status, social security number rarely change.

Most organizations make use of MD so that they can maintain the definition of these entities in a single place, and they can simply refer to these definitions through the corresponding unique identifier. The identifier provides a quick way to get to the full set of information. In many cases, the identifier can serve as a stand-in for the full set of information.

Supply Chain Master Data

Wikipedia doesn’t yet have a definition for Supply Chain Master Data. I’ve coined the term to describe something that is similar, but distinctly different than Master Data as described above. I’ll define it like this:

“Supply Chain Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the supply chain.” Read the rest of this entry »