[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 22, 2010. See “Return Of Two Classics” for an explanation.]
In my last essay, “Who Will Decide Which Pedigree Model You Will Invest In?” I pointed out how easy it is to get confused about pedigree technology because of varying claims made by certain companies who have interests that don’t align well with yours. So where can you get better information? I can provide you with a few good sources, and I will also tell you about a missing ingredient that I see in the current guidance landscape that will need to be addressed in the next couple of years.
When it comes to supply chain standards, GS1 is unmatched. If you need them, you can obtain an electronic copy of their barcode specifications contained in the GS1 General Specification by either contacting GS1 US (assuming you are located in the U.S.), or by simply searching for them on the internet and downloading a copy. Be aware that the GS1 General Specification document is huge and it contains a lot of additional information you won’t really need. For GS1 Electronic Product Code (EPC) and Radio Frequency IDentification (RFID) standards, you can download each of these GS1 EPCglobal standards for free at their Standards Overview page.
If you are a software developer or solution provider who is developing a new or existing application for the U.S. pharmaceutical supply chain, these standards documents will be indispensable. If you are an IT person with an end-user company, some of these standards documents will be helpful, but if you are a business person or manager at an end-user company, you might not find these documents very useful. No matter who you are, these documents can only take you so far because they won’t explain exactly how to make use of these standards in the context of the U.S. pharmaceutical supply chain.
According to GS1, the role of explaining how to apply the standards in that supply chain is supposed to be that of GS1 Healthcare US. GS1 US is the U.S. “Member Organization”, or “MO”, of the global organization. The focus of the U.S. MO is on industry adoption of GS1 standards in the U.S. market. MO’s are Gs1’s local marketing operation.
Back in 2007 the U.S.-based and now defunct GS1 EPCglobal Healthcare and Life Sciences (HLS) Industry Action Group (IAG), an end-user group, created an “Industry Adoption Roadmap” with a wide range of guidance for adopting GS1 standards in the U.S. pharmaceutical supply chain in response to U.S. state pedigree laws. Although a little out-of-date now, most of the guidance was well done, but they mistakenly claimed that there were two “options” for pedigree. One was the GS1 Drug Pedigree Messaging Standard (DPMS) and the other was “Track and Trace”, which they claimed would be standardized in the future.
In reality, “Track and Trace” isn’t the kind of pedigree that will comply with any known U.S. pedigree law so it wasn’t really an option back then, and it still isn’t today. In 2007 GS1 dissolved the HLS IAG and moved the members to the European focused GS1 Healthcare User Group (HUG), which was then renamed “GS1 Healthcare”. Because it is a global end-user organization, they are focused on the much more serious problems of the global healthcare supply chains. They have never redeveloped the kind of momentum toward solving U.S. supply chain-specific pedigree problems that the HLS organization had back in the “old days”.
As a global organization, GS1 is committed to developing standards that have global applicability. They want to avoid nationalistic approaches to the application of their standards. So, GS1 Healthcare has given up on addressing the current U.S. state pedigree regulations, and instead is focusing on developing an idealized track and trace model aimed at future legislation, perhaps in the EC and/or the U.S., but anywhere really.
GS1 Healthcare US is working on building out their supply chain simulation called the 2015 Readiness Program but, being merely a marketing organization it is not equipped to solve the significant technical challenges that stand in the way of creating anything close to a compliant California pedigree solution using EPCIS, GDSN and the future Discovery Services standards.
The bottom line is, GS1 can provide the base standards, but don’t go to them to learn exactly how to apply them to address U.S. pedigree compliance. This doesn’t just apply to pedigree but also to barcodes. For Electronic Data Interchange (EDI) standards, don’t go to GS1 at all because the U.S. pharmaceutical supply chain doesn’t use their EDI standard. For those, you have to go to the American National Standards Institute (ANSI) and the Accredited Standards Committee (ASC) X12.
For barcode and EDI guidance in the U.S. pharmaceutical supply chain, the Healthcare Distribution Management Association (HDMA) is the organization you want to go to. HDMA is an industry organization who’s membership is composed of primary wholesalers and manufacturers that supply drugs into the U.S. market. HDMA publishes guidance manuals for companies who want to know exactly how to apply GS1 barcode and RFID standards, and ANSI X12 EDI standards in a way that will be compatible with the expectations of most of the participants in the supply chain. You can obtain these guidebooks electronically through HDMA’s online publications store.
The documents that are most pertinent are “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain” for barcodes on pallets, cases and units, and any document that starts with “EDI Guidelines for…”. For example, my favorite EDI document type is an Advance Shipment Notice (ASN), or EDI 856, which is documented in the document “EDI Guidelines for 856 ASN Ship Notice for Healthcare”.
[NOTE: New versions of these documents are now available. See “Updated HDMA Bar Code Guidance: A Must Read” and “GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance“.]
These guidance documents won’t tell you the full details of the standards so they won’t replace the standards specifications from GS1 and ANSI, if you need to know that level of detail, but they provide indispensable information for those who are trying to use those standards specifically in the U.S. pharma supply chain. I’m a technical person, and if I were new to this supply chain and I were responsible for applying barcodes or sending EDI messages, I would probably want a copy of both the standards and the guidance documents so I could get a complete picture of what is needed. But for those people who are already familiar with the standards and who just need to take over support of an existing system, you probably only need these HDMA documents.
YOUR CUSTOMER’S REQUIREMENTS
But just knowing about the underlying standards and the HDMA guidance isn’t enough. That’s because there are lots of optional things in EDI documents and there is some variability in barcode usage on case and shipping labels. To know exactly what is needed to successfully trade real product in the U.S. supply chain you need to know the exact EDI and labeling requirements that each of your customers are imposing on your shipments to them.
Up to today, most wholesalers have published requirements, but they haven’t always enforced them. Neither GS1, GS1 US, ANSI nor HDMA have any intention of enforcing end-user compliance with their standards or guidance. It’s entirely up to the users. I’ve never fully understood why wholesalers don’t put a little more emphasis on supplier compliance but they haven’t, and the result is a huge amount of variation in compliance, particularly in the product and shipping labels on manufacturer cases. In fact, the variation in adherence to wholesaler requirements, HDMA guidance and even the standards, is so wide that it is currently impossible to fully automate wholesaler receiving processes. GS1, ANSI and HDMA can’t do anything about this situation because they have no enforcement capabilities (no one would want them to anyway).
SIDEBAR: “I’VE GOT YOUR OP-EX…RIGHT HERE”
Ever since the U.S. pharmaceutical supply chain switched from a buy-and-hold model to a fee-for-service model in the last decade wholesalers have grasped tightly to Operational Excellence programs to drive their businesses toward greater efficiencies in their internal processes. That’s great, but here’s an obvious extension to those internal-facing programs: optimize supply chain technology externally. All the wholesalers need to do is to start enforcing the existing HDMA barcode and EDI guidance with their suppliers and everyone will find their supply chain operations will become much more efficient, driving out cost in shipping, receiving and warehousing in all companies.
ePEDIGREE GUIDANCE: THE MISSING INGREDIENT
Notice that HDMA offers technical guidance documents on the use of barcodes and EDI documents but none on ePedigree. In my view this is a serious deficiency that will have to be resolved in the next year or so. That’s because the California pedigree law doesn’t identify any specific technology. You can dream up all kinds of ways for pharmaceutical manufacturers to comply with those ePedigree requirements.
Without someone providing guidance, wholesalers might expect to receive a wide range of things that different manufacturers will consider to be compliant ePedigrees. This would have two major impacts. First, this wide variation would be extremely inefficient for wholesalers because they would have to deploy multiple systems to deal with different types of incoming ePedigrees.
Second, wholesalers might not agree that some of the ePedigrees they are supplied with are actually compliant with the California pedigree law. As I pointed out in my previous essay, wholesalers will face tough decisions about compliance because they will be the companies who will be fined by California for distributing drugs without pedigrees if a manufacturer supplies them with something that doesn’t comply.
I don’t think the wholesalers will put up with all that, so without joint agreement on ePedigree guidance, each wholesaler will be forced to draw up their own individual pedigree requirements. Manufacturers will not like that because they may find that each wholesaler has a different approach to pedigree. That would be very inefficient for manufacturers who might be required to deploy multiple systems just to be able to sell to all wholesalers.
The simple solution to these problems is the same one that was already found for barcodes and EDI documents. HDMA should work with manufacturers and wholesalers to determine, in advance, a single, interoperable approach to ePedigree–one that everyone agrees will comply. It will then be up to the wholesalers to enforce the guidelines by notifying all of their suppliers that they will only accept ePedigrees that conform to the guidance that HDMA publishes. This should all occur well in advance of the date that the first production pedigrees must be constructed (currently January 2015).
Oh, and this ePedigree guidance cannot go unenforced by the wholesalers like the barcode and EDI guidance have in the past. Wholesalers will have to be very tough about it or otherwise they will risk buying products that cannot be distributed in California. That would be most inefficient of all.
Right now too many people seem to think that GS1 Healthcare US should draw up ePedigree guidelines for the industry. But that doesn’t make sense and it doesn’t fit the model that already exists with barcodes and EDI. We just need HDMA to come to this simple realization and get on with it.