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 Continue reading Depicting An NDC Within A GTIN
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
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
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 Continue reading Masterpiece: GS1 Tag Data Standard 1.5
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?
That’s right. GS1 and HIBCC are in a multi-year fight over the dominance of their standards within the U.S. healthcare supply chain. Continue reading WAR: GS1 Vs. HIBCC
In April of last year VHA, a nationwide network of community-owned health care systems, published a viewpoint essay on their website called “The Track to Improving Health Care will be Built with IT Standards”. The posting was written by Mike Cummins, Chief Information Officer of VHA, Inc. In it, he draws a great analogy between the widespread adoption of a standard railroad gauge by railroad companies 150 years ago as part of the U.S. Transcontinental Railway (as set in motion by President Abraham Lincoln), and the potential benefits of widespread adoption of health care IT standards. Mike points out that some historians believe that the nationwide adoption of a single railway gauge accelerated the evolution of the greatness of the United States. It’s well worth reading.
I think the problem Mike sees is that there are so many incompatible IT standards in use in the healthcare industry, with different ones in use in different pockets of the industry. There are too many proprietary approaches in use, and too many standards in use in one segment of the industry that are incompatible with similar standards in use in another. In effect, it’s a patchwork, yet each user can claim to be using a standard. This was exactly the case with the railroads 150 years ago as Mike’s analogy implies. Each railroad company, or groups of companies, had their favorite “standard” gauge, but which standard was “the best”…the one worthy of becoming the national standard? I don’t know, but I do know they eventually figured it out and settled on a single gauge for the Transcontinental Railroad and that gauge become the defacto standard. That allowed the country to be connected and, as Mike points out, historians have dawn a direct line from that agreement to economic expansion and eventual greatness.
Mike makes several proposals that I interpret as ways to cut through the patchwork of standards and get the industry to settle, like the railroad companies, on a single standard for some key technologies like Electronic Medical Records (EMR), Health Identification Numbers and Personal Health Records (PHR). He calls for the broad, mandatory adoption of GS1barcodes, Global Location Numbers (GLN), Global Trade Item Numbers (GTIN) and accelerated plans by the FDA to mandate the usage of Unique Device Identification (UDI). He calls for the use of part of the federal economic stimulus money to be used for standards development. Continue reading “Why the rush for GS1 standards?”
Earlier this year The Association for Healthcare Resource & Materials Management (AHRMM) and the Center for Innovation in Healthcare Logistics (CIHL) at the University of Arkansas published the results of a survey they conducted in 2008 titled “The State of Healthcare Logistics”. The survey polled 1381 healthcare supply chain professionals regarding their “perceptions of cost and quality efficiencies and improvement opportunities within their organization”. I’m always a little skeptical (alright, I’m a lot skeptical) of “perception surveys”, but since this one was focused on the specific supply chain that I’m a member of, I took some interest. This survey included a series of questions about the respondent’s perception of Data Standards, which really caught my eye.
In fact, I’ve been doing a little investigating myself into the competing standards that are related to supply chain master data. My career experience in this area has almost solely dealt with GS1 standards, but that may be because the healthcare part of my career has centered on the pharmaceutical distribution corner of the full healthcare supply chain. If it had been centered on the distribution of medical devices, I would have been much more familiar with HIBCC (Healthcare Industry Business Communications Council) supply chain data standards. I’ve been trying to figure out if the industry needs multiple competing data standards and, if not, which one is a better set: GS1 or HIBCC? And should I consider some other set of standards that I just don’t know about? Are there good reasons to continue the use of either or both sets of standards in our supply chain?
In this light, I turned my attention to the AHRMM/CIHL survey results, hoping to gain some valuable insight. I quickly got stuck on their very first survey question in the Data Standards section (on page 15 of their report):
A. Is your organization moving towards the adoption of a data standards system (such as GS1) in the next five years?
Now this is an amazingly bad survey question that wouldn’t even pass a “survey questions 101” class. It is a classic example of a leading question. One where the desired answer is provided directly in the question itself. But look at the choice of answers!
- Yes – GS1
- Yes – Other
- Don’t Know
Continue reading “The State of Healthcare Logistics”