I don’t get paid for endorsements. I don’t sell my opinion. No one has my thoughts under their control. So when I tell you that the Healthcare Distribution Management Association’s HDMA Track and Trace Seminar is my favorite pharmaceutical industry serialization and pedigree seminar every year, you should know that’s my honest opinion. This year, the event will be held on November 8-10 in National Harbor, MD (just south of Washington DC).
BTW, This opinion wasn’t solicited and I am paying full (member) price to attend the event. This isn’t an advertisement. It’s what I believe.
It’s an event that is intensely focused on any and all of the issues faced by pharma manufacturers, distributers and pharmacies related to serialization and pedigree technology and laws. No fluff, no wasted time.
HDMA books the right speakers, speaking on the right topics, and that attracts the right solution providers in their trade show room. But most importantly, all of that attracts the right attendees from across the industry. That’s important, because if the speakers don’t cover some burning topic during the regular program that you need to know about right now, just ask around in the halls during the breaks and you will learn a lot about what the industry thinks and what they are doing about it.
I can’t recommend it enough for those needing to know the current state of the laws, standards and technology. I’ve been to other, larger serialization conferences (notably those run by RFIDJournal) that have had a couple of sessions aimed at the pharmaceutical supply chain, but they usually try to cover a bunch of other industries at the same time. I’ve always been disappointed in them. The HDMA event is the only one that is pharma from start to finish so you can be much more efficient in picking up the information you need.
Historically, the seminar was originally co-sponsored with the National Association of Chain Drug Stores (NACDS) but around the time that the California pedigree deadlines were pushed out (to 2017 for the pharmacy segment), NACDS pulled their co-sponsorship. I was very pleased when that blow didn’t end the annual event as I had feared it would. HDMA continued it (although the event did get a little smaller after that happened).
This year, GS1 Healthcare US is co-locating one of their 2015 Readiness Worshops at the same location so it’s a great opportunity to cover both events and get a really full picture of the current state of regulations, standards and technology. If you’re thinking about attending the GS1 US workshop, make sure you read my previous post about it first.
“TRACK AND TRACE” OR “SERIALIZATION AND PEDIGREE”?
By now you must be wondering why HDMA calls it a “Track and Trace” Seminar, and I keep referring to it as a “Serialization and Pedigree” Seminar. Why do I do that? Let’s talk semantics.
It’s kind of a little game we play. It all started when California included the pharase “track and trace” in their pedigree law. When you ask those who work for the California Board of Pharmacy, or those who work for the U.S. Food and Drug Administration (FDA) what the difference is, they will tell you that they are one in the same.
But they aren’t. “Pedigree” is really only “Trace”. “Pedigree” and “Trace” are both a complete supply chain history of a given drug package from a historical perspective, and from the perspective of the current owner. It’s a view back “up” the supply chain that the current owner can use to know exactly where that drug package has been and when.
“Track”, on the other hand, is to simply know where the drug is right now…at all times. Usually this is from the perspective of the manufacturer. So if the manufacturer has a means to know exactly where a given drug package is in the supply chain at all times, they can be said to be “tracking” that package.
So “Pedigree” is half of “Track and Trace”. When the pharse “track and trace” appears in a pedigree law, the authors don’t mean that they want to require the manufacturers to track their drug packages until they reach a pharmacy or a consumer, they mean that they want the “trace” part. The pedigree part.
“Track” is a non-regulatory application of serialization.
TRACK, TRACE, PEDIGREE AND PEDIGREE MODELS
How does all this apply to pedigree models and the available standards? To put it simply, the GS1 Drug Pedigree Messaging Standard (DPMS) represents a purely “trace” pedigree model, and pedigree models built around GS1’s Electronic Product Code Information Services (EPCIS) standard are usually “track” and an attempt at “trace”. Consequently, people who favor a purely EPCIS pedigree model usually prefer the term “track and trace” over “pedigree”. The term includes the pedigree use case as well as non-regulatory use cases.
I use “pedigree” because that’s the problem I’m currently most interested in solving and, in my view, you need DPMS to ensure that you fully solve it. EPCIS, in my view, adds value, but can’t solve the pedigree problem by itself.
In my endorsement of the HDMA Track an Trace Seminar above, I refer to it as my favorite “serialization and pedigree” seminar because that’s the main focus of the seminar right now due to the looming pedigree regulations. In future years, I hope that HDMA will expand their coverage to include more of the non-regulatory applications of serialization, but not at the expense of pedigree coverage until that problem is behind us.
I wouldn’t miss the HDMA Track and Trace Seminar. If you’re reading this, then you shouldn’t either. See you there.
2 thoughts on “Terminology: Track and Trace, and Pedigree”
I like the clarification, Dirk. But NACDS lack of co-sponsorship is a pretty compelling barrier to “track.”
U.S. pharmacies continue to push back on the transparency implied by authentication at the point of dispensing. Investments in serialization will provide limited non-regulatory value until the last step in the distribution system gets seriously engaged.
Put more bluntly, pedigree laws and track-and-trace technologies only make the world safer if pharmacy buyers refuse to buy outside legitimate channels and agree to authenticate (scan) an electronic tag. Sometimes, this doesn’t happen (How did stolen GSK product end up in pharmacies? or pharmacies argue against authentication (as I discuss in Reality Check on Supply Chain Security).
Tag all you want, but if no one checks the tag, it’s a waste of money.
Unfortunately, HDMA only promotes speakers and topics that are politically aligned with their legislative agenda. Therefore it is not an objective forum. Which also accounts for the discrepancy in positioning.
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