Posts Tagged ‘EPCIS’

Digital electronic messages can be transmitted from one party to another using a wide range of communications technologies.  Today, businesses that make use of the internet to transmit their business messages to and from their trading partners make use of standards-based Electronic Data Interchange (EDI) message formatting. 

EDI messages are typically transmitted point-to-point, from one business to one other business.  There are a large number of EDI message types defined but in the pharmaceutical supply chain the most common messages are purchase orders, purchase order acknowledgments, invoices and advance shipment notices (ASN’s).  (While I have the chance, I’d like to point out that ASN’s are not pedigrees for multiple reasons that I will not cover in this essay.)

In the U.S. pharma supply chain AS2 is the most common communications protocol in use for EDI message exchange.  AS2 provides generalized message security to ensure that the messages cannot be understood or tampered with by unauthorized parties during movement from sender to recipient.  According to Wikipedia, these are achieved through the use of digital certificates and encryption.  Messages can optionally be digitally signed by the sender to provide non-repudiation within the AS2 payload context.

Electronic pedigrees as defined by the states of Florida and California are messages that contain fairly complex legal documentation which describe the chain of custody or ownership of a given package of drugs, but they also contain several types of legally required certifications. Read the rest of this entry »

Ken Traub

Noted writer, editor, literary critic and teacher, William Zinsser, is known for the quote “writing is thinking on paper”.  Today I don’t think paper has much to do with it, but what I think he means is, the very process of writing something forces a person to think about the thing they are writing about, and then embody that thinking clearly in the written output (paper or electronic).  As you might imagine, I agree with this.  I like to write and I believe that my own experience with writing has greatly improved my thinking.  For a really great essay on the topic of writing and thinking, see The Secret About Writing That No One Has The Balls To Tell You by Pete Michaud…and don’t miss the many excellent comments below his essay.  

I’ve been writing about ideas surrounding my professional experience much longer than the year and a half I have been writing RxTrace.  In fact, I have written some pretty legendary emails and other essays over my career.  Legendary because they raised ideas that were either unpopular or otherwise not wanted by the recipient(s).  If you know me very well then chances are you’ve read one or two of those. 

In a previous job, I did a fair amount of Read the rest of this entry »

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. Read the rest of this entry »

I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain).  It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply. 

The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.”  And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”

In the California language, a “dangerous drug” is Read the rest of this entry »

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 Read the rest of this entry »

GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market.  Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders.  With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government.  If they can get the government to reference GS1 standards in their laws, their work is much easier. 

This isn’t unique to GS1, or course.  All standards organizations know this and they all have various approaches to getting the attention of each country’s government.  There is nothing wrong with this.  In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.

But what happens when those governments are too big to sway easily?  What if it costs too much and takes too long to get them to see the light?  This is when a standards adoption organization needs to get creative.  In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”.  It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards.  Let me explain. Read the rest of this entry »