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
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
My favorite pharmaceutical supply chain blog is DrugChannels by Dr. Adam J. Fein (PhD). Dr. Fein started his blog in May 2006. I became a subscriber and regular reader sometime later that year. The focus of DrugChannels is “Pharmacy economics and the pharmaceutical supply chain”, which has often included very rational opinions on the economic viability of various pedigree laws.
My RxTrace blog has only been around for a short time and its focus is “the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance”. This is almost the inverse of DrugChannels. I’d like to think they are complementary but I suppose we can’t judge that until I generate quite a few more posts. Either way, I owe quite a lot to Dr. Fein and DrugChannels because they provided me the inspiration for starting this blog.
In a recent email exchange, Dr. Fein drew my attention to the FDA document, “Safer Medical Products: Investments for Supply Chain Safety and Security”, a 22-page apparent explanation for an increase of $166,433,000 and 346 FTE’s in the FDA’s FY 2010 budget proposal. Part of the increase “…includes investments that will allow FDA to implement new approaches to effectively regulate the safety and security of the supply chain of medical products …”. “Medical products” include human drugs, vaccines, blood and other biological products, medical devices, animal drugs and medicated feed.
The biggest driver of the need for the increase is the rapid globalization of the supply chain for medical products that end up in the medicine cabinets of Americans.
“The priorities proposed in this initiative will assure the safety and security of foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain…”.
“Supply Chain Safety and Security relies on risk-based prevention with a verification-focused approach to hold all segments of industry accountable for ensuring that their products meet U.S. safety standards, with FDA verifying compliance with standards.”
“FDA will increase medical product safety and security by enhancing oversight of entities in the supply chain.”
The proposal promises to hire more experts and modernize FDA information technology. But it also includes funds to fight internet drug fraud, and to allow FDA to develop policy options related to drug importation.
“FDA will develop policies to implement the Administration’s policy of allowing Americans to buy safe and effective drugs from other countries.”
So is the FDA Responsible for Global Supply Chain Security?
Lots of interesting content for everyone to mull over. Daniel R. Matlis, president of Axendia, has done just that in a post on the PharmTechTalk blog. In his post he uses the FDA document to question whether securing the global medical products supply chain should be the FDA’s responsibility or the industry’s. It’s an interesting question and Matlis juxtaposes the FDA paper against comments reportedly made by Gerald Migliaccio, Vice President of Quality, EHS and Agility at Pfizer Global Manufacturing at a recent joint session of the PharmTech Conference and the Manufacturing Execution System in Life-Sciences Congress. Migliaccio believes that, “Supply chain security is the responsibility of all parties involved in procurement/ sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product.”
Matlis concludes that industry and regulators have different roles in securing the supply chain and that we all benefit by their efforts. After raising such a provocative question, I felt let down by such a milquetoast conclusion. Like Gerald Migliaccio, I believe the responsibility for supply chain security falls squarely on every participant in that chain, global or domestic. FDA is an arm of our government—that which is of, by and for…us, the consumers, the patients. To me, it seems backwards to make the consumer/patient responsible for the safety and security of the supply of products that are advertised as being safe and beneficial to our health and wellbeing.
I’m not arguing against the existence of the FDA, only the argument that it is up to the FDA to ensure the safety and security of the supply chain. What we need from the FDA are standards that ensure that illegitimate supply chain activity can be detected automatically by the supply chain participants themselves. Arming each buyer in every purchase transaction in the supply chain with the means to reliably, quickly and independently verify each prior transaction back to the original manufacturer would accomplish exactly that. I’ll explain how that can be done in future posts.
I’ve written before about the importance of supply chain standards and how pedigree standards can be categorized as “communications standards”. I drew the analogy of the importance of standards in making cell phones work together. Because U.S. cell phone companies agreed to make use of certain standards, you are able to call your friends who chose to buy service from Sprint, when you have chosen to buy your service from Verizon, or any of a number of other U.S. carriers. Without those standards and the agreement of each company to use them, you would only be able to call people who happened to sign up with the same phone company that you did.
I won’t reproduce the whole article here but its contents are just as pertinent today as they were two years ago when it was published in Pharmaceutical Commerce magazine. That article stressed the importance of the GS1 Drug Pedigree Messaging Standard (DPMS, a.k.a. the GS1 Pedigree Ratified Standard), but any approach selected by an individual company to address pedigree legislation has to consider interoperability with whatever approach their trading partners choose. Interoperability is the goal of standards but right now there are two standards-based approaches to pedigree out there and they are not currently interoperable. That’s a problem for everyone, because the supply chain is so interconnected and diverse at the same time.
The two standards are DPMS and EPCIS–both from GS1. The history of these two standards and the differentiating characteristics of each one is too complex to cover in a single post so I’ll just provide an introduction here. I’ll continue the discussion in later posts, although I don’t plan to make the whole thing contiguous because there are other topics that I also want to cover over the same timeframe.
EPCIS (Electronic Product Code Information Services) is a GS1 standard that defines a set of interfaces for the purpose of capturing and querying serial number “visibility” data. “Visibility” data is meant to be observations and transactions that are based on observations of serial numbers that are attached to items and logistical containers of products within supply chains. I still haven’t found an easy-to-understand way to explain it, but I think those two sentences describe it fairly concisely and accurately. If you have a better way to explain it, please post a comment below.
Notice that the description doesn’t say anything about pedigree or regulatory compliance. EPCIS is a standard, but it’s a general purpose IT thing that you have to apply a specific way in order to make it work as a pedigree system. The standard is designed to be very flexible and for serialized product, it could be quite powerful if used right. There are a couple of problems for those who want to use it as a pedigree system, however.
- There is currently no standard that describes exactly how to apply it as a drug pedigree system that would ensure interoperability across the supply chain;
- There is the general tendency to talk about ways to turn EPCIS into a pedigree system, but I haven’t heard one yet that is likely to comply with existing pedigree laws.
I’ll cover those issues in more detail in later posts.
DPMS (Drug Pedigree Messaging Standard) is a GS1 standard that was specifically created to assist the pharmaceutical supply chain with creating an interoperable system to trace drugs in a way that can comply with existing pedigree laws. That includes Florida, California, the PDMA and all of the other states that currently have pedigree laws. The problem is, it doesn’t do much to assist companies with all of the many problems they face dealing with serial numbers on items. DPMS can take serial numbers and use them to trace those items, but there are a lot of other, non-compliance issues that must be dealt with first.
So there are problems with both standards. Perhaps an obvious solution is one that I, and others, proposed last year to combine EPCIS and DPMS to create a system that benefits from the best of both standards.
As you might imagine, there is a lot more I could discuss on this topic in later posts. But I’m going to try to stay out of the details and talk more about implications of each approach. Stay tuned…