Tag Archives: Traceability

Federal Pedigree

What If RxTEC Isn’t Adopted?

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I did not participate in the development of the Pharmaceutical Traceability Enhancement Code (RxTEC), a proposed Congressional bill that was created by the industry lobbying group known as the Pharmaceutical Distribution Security Alliance (PDSA).  In fact, while I was aware that a group had been formed last year I wasn’t aware that they were working on drafting an actual proposed bill until their discussion draft (dated February 27, 2012) appeared on the internet about 10 days ago.  I first saw it on Ed Silverman’s Pharmalot blog.

I also saw a presentation by one of the members of the PDSA last week that touched on the RxTEC proposal.  It was characterized as a “stepping-stone” to full traceability in the U.S. supply chain someday down the road.  In other words, the PDSA apparently means that their RxTEC proposal isn’t the final destination but it is only the first step toward that ideal.  At least, that’s how I interpreted that “stepping-stone” comment.

PLATEAUS OF SECURITY

Now this is a concept that is familiar to me.  In fact, as an idea stripped of all of the RxTEC-specific details, it is identical to the idea beneath the approach I proposed in a pair of RxTrace essays last May and June called “Plateaus of Pharma Supply Chain Security” and “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach”.

This single underlying idea originates, on both accounts, from the fact that the amount of illegitimate activities within the U.S. supply chain is really quite small compared with the rest of the world (see my essay, “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”), and to reduce it further will take Continue reading What If RxTEC Isn’t Adopted? →

Anti-counterfeiting

Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource

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Earlier this summer J. Wiley & Sons published a new book called “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs” by Mark Davison, CEO of Blue Sphere Health, a pharmaceutical consultancy.  I pre-ordered it on Amazon.com in the spring and it was finally delivered in July.  You may have noticed the image and link I added to the left margin under “RxTrace Recommends” shortly after I started reading it.  The hardbound book is 400 pages, including the main text, notes, references, glossary and index, but it took me until now to finish reading it.  I’ve been so busy lately that I could only read a few pages at a time, that is until my vacation when I finally had time to sit down and read the whole book.

The book is broken up into five parts.  Part 1, General Themes, provides an in-depth examination of the problem of drug counterfeiting around the world including its formal definition, the origins, costs, risks, and the contrast (and controversy) between intellectual property and anti-counterfeiting.  In the last chapter of Part 1, Davison explains the difference between “Traceability” and “Authentication”.  He points out that the term “Traceability” is sometimes known as “digital authentication”, where the term “Authentication” by itself is usually used to Continue reading Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource →

EPCIS

The Future of Traceability Repositories and Inventory Management Systems

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Figure 1.

I think there is a significant difference between the traceability repositories we see on the market today and those that I think we are likely to see in the future.  Today, traceability repositories are typically implemented by software suppliers as standalone applications or modules that we end users refer to as “an EPCIS”.  We call it that because the most defining characteristic of these modules is that they implement GS1’s Electronic Product Code Information Services (EPCIS) standard.  Today, traceability repository vendors expect customers to buy their traceability module and integrate it with existing applications.  For a long time now I have felt that this approach was less than optimal and I think we will eventually see a switch occur in the software market toward existing application vendors adding traceability repositories and EPCIS interfaces as new features added to their existing functionality.  Let me explain. Continue reading The Future of Traceability Repositories and Inventory Management Systems →

serialization

Estimated Rise In Serialized Drugs In The U.S. Supply Chain

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Back in 2005 I created a line graph of my personal prediction of the percentage of pharmaceuticals in the U.S. supply chain that would be unit-level serialized by the manufacturer and I circulated it among my co-workers at the time.  I based it purely on guesses that were “supported”–very flimsily–by the number of large pharmaceutical manufacturers who were participating in the GS1 EPCglobal Healthcare and Life Sciences (HLS) Business Action Group (BAG) (the group is now defunct), and the existence of an early version of the California Pedigree Law.  The graph included a high and low line that formed a band that I thought would be where the reality would fall.  In that prediction I didn’t think most manufacturers would achieve 100% serialization of their products until sometime between 2010 (high) and 2015 (low).

In my analysis at that time, I theorized that the actual percentage would start out following my “low” estimate line, but at some unpredictable point, something would happen that would cause the percentage to jump up to the “high” estimate line.  At the time, I assumed the event that would cause that jump would be the U.S. Federal government issuing some kind of pedigree regulation that included a unit-level serialization requirement.

As it turned out, things moved slower than I had guessed.  Here it is 2010 and the percentage of drugs in the supply chain with unit-level serial numbers on them is so small that it’s tough to give it a percentage.  But I think my estimate from way back in 2005 was not bad for its time (but notice I’m not publishing the actual graph).  After all, the California Pedigree deadline has been pushed out at least three times since then (from 2007 to 2009, to 2011, to 2015/1016).

I think the future is a little less murky now because, since 2005, Continue reading Estimated Rise In Serialized Drugs In The U.S. Supply Chain →

EPCglobal, GDSN, GLN, GS1, GS1 General Specification, GS1 M.O.'s, GS1 U.S., GSMP, GTIN, passive RFID, Traceability, UHF RFID

GS1

I’ve been an active GS1 participant since EPCglobal was first acquired by GS1 in 2003. It is an interesting organization, often both vital and frustrating at the same time. GS1 is a single source for essential supply chain standards that have global applicability. Rather than attempting to dictate those standards they invite people and companies to work with them on the definitions and the application of their standards. They have really great facilitators for some of their work groups with the very best being Mark Frey and Gena Morgan. The quality of their standards documents is quite high. And they have some really smart people in their EPCglobal Architectural Review Committee (ARC), notably Ken Traub, John Williams and Sanjay Sarma.

My hope is that this blog will be of some value to both members and non-members of GS1, but, I can only cover topics related to the organization and their public documents. Specific details about work group activities cannot be covered. However, I do not think that is too limiting and I think members and non-members will find something of interest.

GS1 is a not-for-profit member organization. The way it is organized reminds me of something out of the UN with affiliate “Member Organizations”, or M.O.’s—one for each country in the world—which participate in developing and maintaining their global standards on behalf of end-user companies within their borders. End-user companies are also able to represent themselves … if they can afford the membership fee which is based on company global revenue (and that’s on top of the fees paid for use of your GS1 Company Prefix). Consequently, standards development proceeds mostly with input from employees of GS1 affiliates and from employees of large corporations. There are notable exceptions and GS1 has made a significant effort to recruit participation from hospitals and smaller pharmacies, traditionally under-represented because they are small.

My own experience as one of those employees of an end-user member company, who has participated in standards-making work groups and the end-user groups within GS1 and EPCglobal, has been very positive. I have met and collaborated with a wide range of very smart people from my own industry and others, from the U.S. and from around the globe. I’ve learned a lot about supply chains in general and about how to perform the kind of “techno-negotiations” necessary to move forward a work group of people with very diverse backgrounds and interests toward a positive conclusion. Sometimes it’s thrilling. Sometimes it’s aggravating. It’s always a lot of hard work, but I highly recommend it to anyone considering it.

GS1 also runs “adoption” end-user groups out of their M.O.’s. The purpose of these groups is to encourage the adoption of GS1 standards within the country that the M.O. represents. For example, the GS1 U.S. Member Organization operates the GS1 Healthcare U.S. group which has work groups targeted at accelerating the adoption of GTIN, GLN, GDSN and Traceability the GS1 way in the healthcare sector. These work groups do not work on standards, but they work on guidelines for use in applying those standards to solve various supply chain problems within the U.S. (also known as “toolkits”).

Actual standards have traditionally been developed in two different sub-organizations of GS1: EPCglobal and GSMP (Global Standards Management Process). GS1 is currently in a state of transition as they move the standards development arm of EPCglobal into GSMP. That’s a good thing, because these two organizations have had different approaches and, at times, seemed to operate as two independent organizations. Unfortunately, in my view, EPCglobal’s process operated better than GSMP. So far I am encouraged by the little evidence I have seen that they are retaining the good parts of the EPCglobal approach. We’ll see how far it goes.

One very commendable thing that EPCglobal has done that GSMP has not is to make their ratified standards documents freely available for download on the internet. The GSMP approach is to roll all of their diverse standards into a single and very large document known as the “GS1 General Specification” (or, “GenSpec”) and they’d like to charge you for a copy of it. Fortunately there are enough M.O.’s around the world that make it available that you can usually find a copy for free download by simply Googling it. I hope that the merged GSMP does not fold the individual EPCglobal specifications into the GenSpec and keep them hidden until you pay, but I must admit, even ANSI and ISO charge for their ratified standards documents.

GS1 also has a lobbying arm which applies pressure to governments around the world to adopt policies that are favorable to GS1 and the technologies that their standards are based on. For example, they applied considerable effort to get governments around the world to open up RF frequency bands around 915MHz so that UHF passive RFID tags could operate worldwide without violating the law somewhere. They have been very successful in that effort, as I understand it.

Another example of GS1 lobbying is when they act as technology experts before U.S. state and federal regulatory agencies. Here GS1 provides guidance toward the adoption of regulations and laws that can be met through the use of their standards. I get a little concerned about this type of lobbying because I fear that GS1 makes themselves out to be unbiased when, in fact, they do have a bias. I hope these agencies are aware of that and take it into consideration.

GS1 will be a frequent topic of this blog since they are focused on the same “intersection” as I am (see the tag line for this blog on the masthead).