I want to thank everyone for reading and commenting on RxTrace in 2010 and wish you all HAPPY HOLIDAYS and a HAPPY NEW YEAR.  Due to our family party schedule I don’t expect to post any more essays this year.

I’m planning to see a number of movies in the next few weeks with my wife, two daughters and son-in-law.  One of our favorite holiday activities is to debate which ones to see.  Debating with my kids is probably what it must be like debating with me, but in the end we all have fun and always have a lot to talk about (and Dad pays).

So drive carefully, don’t drink and drive and don’t eat too much.  On the other hand, do make peace with your family members, sing a lot, say thanks to members of our armed forces and give to charity.  And, OK, you can eat too much just once.

See you next year.

Ivan in happier times

I received news last night that my friend and co-worker, Ivan Shen, passed away on Sunday after losing a five month battle with cancer.  During his career Ivan worked for serialization and pedigree companies including Oat Systems, Reva Systems and SupplyScape (now TraceLink).  Many RxTrace subscribers are current or former co-workers or former customers of Ivan.

I met Ivan a few years ago when we both worked for SupplyScape.  At that time I was struck by his quick wit and sense of humor.  Since that time we both ended up employed by the same company again.  When I started the RxTrace blog, Ivan was among my earliest subscribers and I always appreciated his thoughts and comments on my essays.

Ivan was intensely proud of his Chinese…err, Shanghai-ese…ancestry.  He was active in his Church.  He is survived by a daughter, a sister and his former wife.  If the family posts a full obituary I will update this post with a link to it.  [UPDATE:  Ivan's funeral will be held in Waltham, MA on Saturday, August 21, 2010.  If you want the details, please contact me directly. -- Dirk.]

[2nd UPDATE:  Click here for Ivan's Obituary]

[3rd UPDATE:  Click here for a slide show featuring great photos of Ivan throughout his adult life]

Back in April, Ivan bought a bicycle and challenged me to a competition to see who would ride his bike to work most often.  The first time he rode to work it exhausted him.   That was the first indication something was wrong with his health.  He didn’t ride again.  Tragically, he waited four more weeks before seeing a doctor, with his health deteriorating each day.

Shortly after he was diagnosed, I signed up to ride my bike in the Pelotonia, a cancer fundraiser with 100% of the donations going to fund cancer research at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute.  I dedicated my planned ride to the memory of my father, who died of cancer two years ago, and to Ivan, a “future cancer survivor” as I put it back then.  The ride is this coming weekend, August 21, 2010.

If you knew Ivan, you may be interested in donating to fund research that we hope will end cancer as we know it.  You can donate generally here, or you can donate through my personal ride page by clicking here.  Donations can be made through October 2010.  (I do not receive any financial benefit from donations.)

Ivan was a special person.  He will be missed.

Ivan and Dirk May 26, 2010

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 the development of this standard will take some time.  Right now, I’d guess it will be complete sometime in early 2012.  That would be two years.  Hmmm….  Almost feels too short.  We’ll see.

Standards development can be contentious.  If it’s done right, that is.  I’m talking about contentiousness along the lines of the Lincoln-Douglas debates or the crafting of the U.S. Constitution, only pitting different technical approaches against each other.  The GS1 EPCglobal SAG facilitation crew really knows what they are doing when it comes to facilitating contentious groups so the blood, sweat and tears invested are directed in a positive direction and results in a valuable standard in the end.  I worked with Mark Frey in the development of DPMS and I just can’t say enough good things about him.  According to the charter document, Mark will be involved in the Discovery Services group, as will Giselle Ow-Yang—a great start.  From these choices you can tell GS1 EPCglobal places a lot of importance on the success of this effort.

BUT WILL DISCOVERY SERVICES HOLD ANY VALUE FOR PHARMA?

Right now, I don’t think the pharma supply chain will be able to make use of Discovery Services for regulatory compliance with current or even future pedigree laws.  As far as I can tell, I’m the only person I know who sees it that way so let me explain.  It comes down to what Discovery Services is aimed at and how that differs from what pedigree laws are trying to accomplish.  There seems to be a disconnect between what people think a pedigree law is trying to accomplish and the reality.  That leads them to the misconception that something like Discovery Services has value for compliance.

I reach this, perhaps shocking conclusion from the following analysis.

FUNDAMENTAL LAW OF COMMERCE

In my first substantive essay in this blog I pointed out what I called a fundamental law of commerce.  That is, when regulations mandate that a product’s value is determined by the ability to show, at any time, specific information about the product’s history, then the buyer of that product must receive all of the necessary information from the seller at the same time the product is received.  That information is so intertwined with the product’s value that it actually becomes part of the product itself, and needs to move with it.  Supply Chain companies who buy products can’t rely on previous owners to hold information on their behalf without a contract to do so if the total value of those products depends entirely on the instant availability of that information at any unpredictable moment. 

This is the case with drugs in supply chains that operate under pedigree regulations.  If a regulatory inspector arrives at the door of one of these companies and asks to see the pedigree of any item they happen to pick randomly from the inventory, and the company cannot produce the pedigree because they are unable—for any of a myriad of reasons—to collect it from remote databases controlled by upstream trading partners, that item has zero value and the company should expect to be fined, or worse. 

When this scenario happens, more than likely the pedigrees of a lot of other units will also be unavailable at the same time for the same reason.  This single inspection at the wrong time–when an earlier owner’s database is, coincidentally, unavailable–could result in a significant part of the company’s inventory being impounded, large fines imposed and the opening of a wider investigation.  All because essential information was not in the control of the party that was responsible.

So, a distributed pedigree doesn’t work in a regulated supply chain.  But why doesn’t this issue get discussed more in industry groups that are trying to figure out how to create an interoperable, standard approach for the industry to follow to meet the current and future pedigree laws?  It’s because of a very interesting thing about this “fundamental law”:  for the most part, it has no impact on drug manufacturers. 

They don’t buy drugs, so, even if a distributed pedigree were selected as the industry solution, they would almost never need to access data on anyone else’s server to reconstruct a pedigree.  All pedigrees from their perspective are entirely stored on their own servers because they start them.  Because of this fact, drug manufacturers won’t “feel” this problem with a distributed pedigree.  Only wholesalers and pharmacies will “feel” it because they buy drugs from upstream trading partners.  Right now the pharmacies are not participating much in the search for a solution, and the number of wholesalers involved is not great.  The largest representation is from the manufacturing segment.

THE DEPUTIZED SUPPLY CHAIN

More recently I posted an essay on the “deputization” of the pharmaceutical supply chain by regulators.  This is a recent phenomenon where regulatory agencies have begun to require supply chain member companies to monitor the supply chain themselves.  It comes from the realization of two things by the regulators:

1. the supply chain is too massive for regulatory enforcement officers to inspect anywhere near enough transactions to detect illegitimate behavior;
2. the responsibility for supply chain security rests with the participants and not just with the regulators.

When you put these two concepts together, the only natural conclusion is that supply chain participants must self-monitor and report suspicious activity.

You can see this deputization in the way the Florida and California Pedigree Laws are written.  They both require companies who buy drugs in the supply chain to receive a pedigree for every drug purchased (although in Florida, wholesalers who buy directly from the manufacturer are allowed to initiate pedigrees).  They also require the recipient to check those received pedigrees for errors, inconsistencies and omissions—all before they are allowed to put the drugs they purchased into regular inventory.  Any irresolvable discrepancies must be reported and the drugs must be quarantined pending further investigation.

I hope it’s obvious to you that the buying company must have all of the prior supply chain history—the pedigree— of every drug before they can properly perform this analysis and before they can confidently place it into usable inventory.  Theoretically you could accomplish this with a network of distributed information servers, but the full set of pedigree data would also have to be passed down the supply chain, along with the drug, in addition to it being distributed.  However, the official pedigree—the one that companies and regulators would rely on—would remain the information that is passed.

THE POINT OF DISCOVERY SERVICES

On their website, GS1 EPCglobal answers the question, “What is ‘Discovery’?” this way:

“’Discovery’ is finding and obtaining all relevant visibility data, of which a party is authorized, when some of that data is under the control of other parties with whom no prior business relationship exists.”

They view the benefits of Discovery Services to include:

“Enable trading partners to discover all of the resources who may have information about things (who has data about EPCx? Where is their EPCIS located so I can ask about this data about EPCx?)                  

“Enable trading partners to exchange data in a secure way with parties that they may not have a prior direct business relationship                  

“Will ensure each party retains rights of ownership of its visibility data                  

“Will ensure that queries are authorized and authenticated”                  

Clearly Discovery Services has a value if your supply chain can get away with distributing visibility data across the supply chain, but I’ve already dismissed the utility of this approach for pedigree compliance above.  But if a push-model is used for compliance instead, what value are these benefits? 

THE TRUE VALUE OF DISCOVERY SERVICES IN THE PHARMACEUTICAL SUPPLY CHAIN

When you look at the future Discovery Services standard through this analysis, how can you conclude that it will contribute any value to pedigree compliance?  I don’t, but lots of other people, who have not seen my analysis, do.  But how about value from non-compliance uses?

When you think about it, the concept of pedigree—or chain-of-custody/ownership—is a historical view back “up” the supply chain, as viewed from the perspective of where a drug is right now.  That fulfills one side of the concept of “track and trace”.  Different people define that concept in different ways, but I subscribe to the group that believes that “trace” is the capability that is encased in the concept of “pedigree” (thus the name of my blog:  RxTrace).  In my view, a push-model pedigree completely fulfills the definition of a “trace”, but it does nothing to enable the other side of the coin:  “track”. 

“Track”—a consolidated forward view of exactly where drugs are right now in the supply chain from the perspective of previous owners—has value for things like recalls, regional emergency response, manufacturer production planning and wholesaler purchase planning to name a few. 

Tracking drugs may also make an important contribution to supply chain integrity by helping to detect diversion, theft and duplication of unique identifiers by counterfeiters, depending on the adoption model.  This is where the real value of Discovery Services lies for the pharma supply chain.  But tracking of drugs, and the use of Discovery Services as part of the implementation, has some thorny data ownership issues that will have to get solved.

So why am I so excited about the kickoff of the Discovery Services standard development work group?  I want to help find a way to solve those thorny data ownership issues that stand in the way of some of these “track” applications.  I think they will exist in all supply chains but perhaps pharma’s use case has the most thorns.  If we can find the right technical solution to that issue I think the supply chain will find the value in Discovery Services… It just won’t come from pedigree compliance. 

If you’ve stayed with me by reading this far, then you should join me on the work group.

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 a clear inner drive to help improve the security of the U.S. drug supply chain.  That’s not unlike many of the people involved in the healthcare groups of GS1, but Chuck had a special reason for that drive.  You see, Chuck worked for McNeil Consumer Healthcare at the time of the tragic Tylenol tampering case that led to the deaths of seven people in suburban Chicago in the fall of 1982.  Tylenol is a McNeil product.  The crime is still unsolved but even this week it is still generating news as if it happened only recently.  What a horrific time it must have been to work there. 

I don’t know what role Chuck may have filled in the McNeil/J&J response to those events but it seems like the experience may have changed something in his DNA, as it must have for many others who worked there at the time.  That change came through the experience of dealing with the aftermath of what must have seemed like random murder by supply chain.  Nothing would have been a higher priority than elevating the security of the supply chain after that event.  McNeil Consumer Healthcare pioneered the introduction of tamper-proof packaging literally within weeks of the tragedy as the company refused to allow an act of terrorism to destroy a great American brand.  Now that’s leadership. 

When I knew him, Chuck had an interest in developing new ways to protect the supply chain from ever more sophisticated criminals.  This was some 25 years after the tragedy.  That interest led him to the work we were doing in GS1 EPCglobal around tracking and tracing drugs in the supply chain.  He helped create the GS1 EPCglobal Drug Pedigree Messaging Standard (DPMS), the first standard aimed directly at that protection.  He was facilitating the Track and Trace Interest Group in the EPCglobal Healthcare and Life Sciences group when he became too ill to continue working several years ago and, sadly, he was unable to return. 

I am thankful that I knew Chuck and it was a pleasure working with him.  Those of us in the extended GS1 U.S. Healthcare community will miss him very much.

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.

My intent for this blog is to publish my personal ideas and opinions regarding technology issues related to regulatory compliance within the U.S. pharmaceutical supply chain. I hope to cover topics like GS1 Standards, pedigree, track and trace, and issues surrounding those things, using publicly available information. This blog contains my own ideas and opinions and not those of my current or former employers and so I am solely responsible for them.

In general, the more ideas presented for consideration, the better. Most ideas will end up in the scrap heap. When I present ideas here and elsewhere, I try not to worry whether or not they might end up being rejected, because sometimes an idea that sounds bad initially can turn out to be the most innovative. Sitting on it for fear that it will be rejected would limit the chances of discovering the best idea.

All ideas benefit from collaboration with other people where they can be refined into better ideas. I hope my readers will respond often with refinements and counter-ideas. Please don’t hesitate to respond.

Thanks for reading. I hope this blog remains interesting to you.