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
The U.S. Food and Drug Administration (FDA) created the concept of the National Drug Code (NDC) in 1969 to “…provide an identification system in computer language to permit automated processing of drug data by Government agencies, drug manufacturers and distributors, hospitals, and insurance companies” (from 34 FR 11157, July 2, 1969). (I can’t find a copy online of the original Federal Register article from 1969 so I’m relying on a more recent article that references it.) Those of us in the U.S. pharma supply chain make use of NDC’s every day, but very few of us know the history of their development, exactly how the numbers are composed and what they mean. I’ll try to explain all of that and provide sources for further reading.
HISTORY OF THE NDC
The NDC was initially a voluntary identifier (see references at the end of this essay). We all know how that would have turned out (for more on that thought, see my recent essay “Should Regulations Dictate Technology?“) so in 1972 the FDA made the NDC mandatory for all prescription and over-the-counter (OTC) drugs. Manufacturers were required to obtain a “Labeler Code” from the FDA, construct their NDC’s using that code as the base and print the NDC number on drug packages. Barcodes were not required by the FDA back then.
From the quote in the first paragraph above you can see that the FDA intended the NDC to be Continue reading Anatomy Of The National Drug Code
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?”