Posts Tagged ‘RFID’

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 »

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 »

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 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 »

In this essay, I’m not going to discuss the attributes of a track & trace system from a regulator’s point of view.  I’m not going to discuss input into the FDA’s Track & Trace workshop that occurs this week and I’m not going to speculate on the outcome of that meeting.  Instead, I’m going to talk about the attributes of a track & trace application from the viewpoint of any global pharma manufacturer who is facing the regulatory mandates for serialization and traceability in a growing list of countries around the world, and from the viewpoint of any solution provider who is thinking about what they need to include in their solution offering so that those global pharma companies find it attractive enough to buy.  

To those kinds of companies, the potential for new non-binding guidance from the U.S. is important, but perhaps less so than an increasing number of binding regulations from around the world.  Whatever the FDA—and especially the U.S. Congress—may do in the future will be important when selecting a track & trace solution, but the U.S. is only one of the countries in the world and pharma companies that do business in those other countries do not have time to wait for the U.S. to figure out their approach before making investments. 

The goal is to make investments today that will be Read the rest of this entry »

GS1 EPCglobal ratified and published the most recent version of the Tag Data Standard (TDS), 1.5.  I have always been a fan of TDS, but earlier versions served as much to expose embarassing disconnects in GS1 standards as they did to explain how to apply GS1 identifiers in an Radio Frequency IDentification (RFID) context.  Earlier versions of TDS tightly bound the concept of the Electronic Product Code (EPC) to RFID, and that’s just wrong.  “EPC”, even as defined in those earlier versions of TDS, is a way of uniquely identifying objects on a global basis.  It’s purely a globally unique identifier standard.  That’s a hugely important and relatively new concept.  RFID–a simple data carrier technology that’s been around for many years–is almost insignificant in comparison.

Even the name “Tag Data Standard” reflects this wrong-headed binding of EPC to RFID by seeming to place the RFID “Tag” at the center of the “standard”.  Yes, there is a need for a “Tag Data Standard”, to show how to encode an EPC into an RFID tag, but it is wrong to Read the rest of this entry »