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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. Read the rest of this entry »

RxTrace is now one year old.  There are 34 essays that together amount to a true liberal exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance…as promised. 

My personal favorite essays from the past year, in chronological sequence are:

• The Florida Pedigree Law (August 10, 2009)
• The California Pedigree Law (September 7, 2009)
• What Are Pedigree Laws Trying To Accomplish Anyway? (November 2, 2009)
• Who owns supply chain visibility data? (December 31, 2009)
• The Deputized Supply Chain (January 31, 2010)
• FDA Aligns with GS1 SGTIN For SNDC (March 29, 2010)
• RFID is DEAD…at Unit-Level in Pharma (April 12, 2010)
• The Modern Pharmaceutical Wholesaler and the Approaching Transformation (May 7, 2010)
• California Pedigree Law:  Historic Change to Commerce (June 14, 2010)

Since late January I have been collecting some statistics on page views on RxTrace and here is the list of the essays in the sequence of page views since that time. Read the rest of this entry »

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 Read the rest of this entry »

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.