All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter

Will The Pharma Supply Chain Find Any Value In GS1 Discovery Services?

I’m pretty excited about the kickoff this Wednesday of the GS1 EPCglobal Software Action Group (SAG) Discovery Services Work Group which will take the business and technical requirements that were collected by an earlier group and turn them into an actual standard.  This will be the first new major technical standard GS1 has started for quite a few years.  The most recent kickoff I can remember was the GS1 Drug Pedigree Messaging Standard (DPMS) which kicked off back in late 2005 and completed in January 2007.  The GS1 Electronic Product Code Information Services (EPCIS) standard effort kicked off in late 2004 and completed in April 2007.  That gives you an idea of how long these things take.

The effort to create the business and technical requirements for Discovery Services started just about two years ago and completed this past December.  How long will it take to get to a ratified standard?  The GS1 Discovery Services Work Group Charter predicts it will be done in June of 2011, but predictions in charter documents are notoriously optimistic.  The EPCIS Charter predicted that standard would be ratified in August of 2005, for example—one third the time it actually took.

This is not a bad thing in my opinion.  A Charter document needs to estimate how long the effort will take, but once things get rolling, GS1 EPCglobal takes as long as needed to get the standard right.  So how long will this one take?  Based on how long the requirements took, I’m guessing Continue reading Will The Pharma Supply Chain Find Any Value In GS1 Discovery Services?

The Deputized Supply Chain

Several people I know from the traceability solution provider community like to tout the similarities between the food supply chain and the pharmaceutical supply chain.  They see similar track and trace regulation in the futures of both chains.  After all, both supply chains are regulated by the same agency (FDA, although food is also regulated by the USDA) and they see them as having similar problems.  But I don’t buy all that.  My friends see the use of common tools (their products, of course) and I might give them that, but these two problems only seem similar on the surface and so, if track and trace regulation is needed for both, the two regulations ought to have only high-level similarities.

THE FOOD SUPPLY CHAIN

The increasing frequency of the scariest problems in the food supply chain are related to accidents—like unintended contact with surfaces or organic matter that contaminate the food with nasty things like E. coli or salmonella—or food that has spoiled as the result of improper storage somewhere in the supply chain—like refrigerators or freezers that aren’t doing their job.  Consumers would benefit from the use of food track and trace in situations like these only when the contamination or spoilage isn’t detected until after the product is split up and distributed down multiple paths.  The track and trace system would improve the speed of the recall and the confidence in its completeness.

Generally, food is distributed to retail outlets inside containers that are packed by the manufacturer or processor.  I’m not an expert here so those of you who are, please correct me, but I don’t think food distributors normally break down cases and ship individual saleable units to retailers.  I think they normally ship full cases, bins and pallets.  For this reason, item-level serialization is not critical to end-to-end track and trace.  However, container-level serialization-based track and trace would be a major benefit to this supply chain.

There is one more thing about the food supply chain that I think is significant for this discussion.  Many of the trading partners at the start of the supply chain are small, independent and technically unsophisticated.  Most of the trading partners at the end of the supply chain are just the opposite:  large corporations with big IT budgets.

THE PHARMACEUTICAL SUPPLY CHAIN

On the other hand, the scariest problems in the pharmaceutical supply chain Continue reading The Deputized Supply Chain

“Why the rush for GS1 standards?”

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?”

Charles “Chuck” Schramek (1945 – 2010)

Chuck Schramek passed away on January 9 after losing his battle with cancer.  See his obituary here.  As I understand it, he spent most of his career working in IT at McNeil Consumer Healthcare, a Johnson & Johnson company, eventually serving in the role of  Executive Director of Information Architecture for J&J.   He spent the last few years of his career as an executive-on-loan to GS1 EPCglobal from J&J.  In that capacity he filled the role of facilitator of work groups related to pharmaceutical supply chain integrity/security.  That’s where I met him.

Chuck was a very humble, friendly person who had Continue reading Charles “Chuck” Schramek (1945 – 2010)

New Layout for RxTrace

I’ve moved the RxTrace blog from BlogSpot (a Google site) to a hosted website using WordPress as the site database. The URL doesn’t change so the move should be transparent to you as a subscriber. I’ve had a couple of hickups along the way but I couldn’t have done it myself. I was fortunate to find someone who is a great artist and who knows his way around the technology. Matt Geiger took a list of my ideas and desires and then went away. The next thing I know he has implemented everything I asked for, and more, and is ready to move the site. I highly recommend his services to anyone needing web site design services, not just blog moves.

Now that the content is moved and the new look is in place, I have a lot to learn about WordPress.  I expect to continue tweaking things in the next few weeks as I have time.  I have so many ideas I want to write about but so little time.

Who owns supply chain visibility data?

Who owns supply chain visibility data? Does the manufacturer of a product retain any rights to track that product after it enters the supply chain? What if the product is a pharmaceutical and it is found to have a life-threatening defect? Should technology or standards availability play any role in answering these questions?

These kinds of questions come up occasionally in discussions of track and trace systems design when people talk about the future of “full supply chain visibility” and how easy recalls will be executed because of it. The implication is that the manufacturer of a drug will be able to perform a targeted recall because they will be able to see exactly where their product is in the supply chain.

But one could easily make the argument that it is no longer “their product” once it enters the supply chain. True, they invented, manufactured and labeled it, and in a recall situation we all have a strong desire for them to get it back quickly and efficiently, but that doesn’t change the simple fact that they don’t own it anymore. And if they don’t own the product anymore then they don’t automatically own the knowledge of where it is either.

I’m not a lawyer but it seems to me that once a product is sold the seller gives up all rights to that product. The buyer can do whatever they want to with it, within the law of course. Recalls that are necessary for reasons that might be life-threatening are special and supply chain members should do everything they can to find and return any item that is involved in a recall. But is it necessary for the manufacturer to have instant access to the location of all of the affected product?

Serialization and track and trace will allow all supply chain participants to know a lot more than they do today about the location of recalled items just using the data that they clearly own. Compared with today, an individual company will know very quickly if they have ever received, shipped or currently have in stock the recalled units. If they currently have them in stock they will be able to place an immediate hold on those items to prevent them from being shipped to a customer until they have been collected and returned. If they have previously shipped the items to a customer they will know exactly which customers were involved and which unit went where. But that’s it. The knowledge of what their customers might have done with those products once they receive them is not owned by the seller. Continue reading Who owns supply chain visibility data?

How to Stop Pharmaceutical Cargo Theft

Most of us who work on developing and deploying technologies designed to protect the supply chain usually focus on anti-counterfeiting. But that’s only one of the elements in the list of illegitimate activities that can cause damage to the health of patients and the profitability of legitimate businesses who participate in the U.S. pharma supply chain. I include the following activities in that list:

  • Counterfeiting
  • Diversion
  • Theft
  • Tampering
  • Up-labeling

These activities have all been detected from time to time in the U.S. supply chain for quite a few years, but the frequency of some of them has been on the increase over that same period of time. The question is, how much of each activity should we, as a society, tolerate before we step up counter-measures that are targeted directly on one or more of them?

THE RISE OF PHARMACEUTICAL CARGO THEFT

Over the last 18 months the U.S. has experienced an unprecedented rise in the value of drugs stolen in thefts of entire truckloads as they are being transported from point to point (also see this). I’ve heard lots of theories about who is behind it (organized criminals/gangs, of course) and where the product ends up (outside the U.S., most people think). Continue reading How to Stop Pharmaceutical Cargo Theft

Use of GLN and GTIN for Pedigree Regulatory Compliance

I am fortunate to have so many friends and colleagues who work in end-user and solution provider companies and who are impacted by the issues I cover in my blog. After each post I often exchange emails and phone calls with some of them and we discuss/debate what I’ve written about. These are great conversations because they sometimes confirm my opinions and sometimes challenge them, but I almost always come away with a more refined understanding of the technology or regulation we discussed. That is, I learn something.

This is exactly what has been happening with my recent series on Supply Chain Master Data (SCMD). As I’ve defined it, SCMD is just like regular old Master Data (MD) except that the identifier and the full data set behind each instance of SCMD has a single owner, and all parties in the supply chain who may encounter the identifier must have a way of obtaining the full set of data from the owner so they know what the identifier means. But this assumes that only the identifier will be used in supply chain data communications in place of the full data set that the ID refers to.

GLN’s On Electronic Invoices

Let’s take GS1’s GLN (Global Location Number), for example. You can use GLN’s in two ways: as true SCMD, or in a non-SCMD way.

An example of using GLN’s as SCMD in an invoice application would result in an electronic invoice that did not have any explicit addresses in it–no customer billing address, no customer shipping address and no “remit payment to” address. Instead, it would simply include the customer’s billing GLN, the customer’s shipping GLN and the “remit payment to” GLN. Each party in this example would have already obtained the full addresses from their respective owners in some way, either through a registry (like GS1 U.S.’s GLN Registry for Healthcare), or directly from the owner, so there is no need to include that data on each invoice between these parties.

The non-SCMD use of GLN’s occurs when a company uses a GLN identifier as a way of obtaining their trading partner’s full address, and then they would put the full address on each of their invoices for that partner. This approach makes use of GLN’s to “synchronize” the address master data that each trading partner keeps locally. Continue reading Use of GLN and GTIN for Pedigree Regulatory Compliance