Tag Archives: EPCIS

GS1 Healthcare US

Before You Participate in The GS1 US 2015 Readiness Program, Read This

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.

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. Continue reading Before You Participate in The GS1 US 2015 Readiness Program, Read This →

pedigree

A Semi-Centralized, Semi-Distributed Pedigree System Idea

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Four years ago the GS1 EPCglobal Software Action Group (SAG) Drug Pedigree Messaging Work Group was wrapping up the standard specification for the GS1 Drug Pedigree Messaging Standard (DPMS, aka GS1 Pedigree Ratified Standard).  That standard was developed through collaboration between U.S. pharmaceutical supply chain members, industry associations, solution providers and GS1.  DPMS 1.0 was ratified by the EPCglobal Board in early January 2007.

DPMS has many benefits.  It results in a self-contained, self-secure electronic document that clearly shows the chain of ownership and/or custody of a given drug package (or a set of packages if they all have the same history).  It works equally well with serialized and non-serialized products.  The security of DMPS documents comes from within the electronic documents themselves rather than just from a security layer wrapped around a given server.  A self-contained, self-secure document model should work well as evidence in a criminal trial.

But even before DPMS was ratified people were raising questions and concerns about it.  Those concerns were Continue reading A Semi-Centralized, Semi-Distributed Pedigree System Idea →

standards

Masterpiece: GS1 Tag Data Standard 1.5

GS1 EPCglobal ratified and published the most recent version of the Tag Data Standard (TDS), 1.5.  I have always been a fan of TDS, but earlier versions served as much to expose embarassing disconnects in GS1 standards as they did to explain how to apply GS1 identifiers in an Radio Frequency IDentification (RFID) context.  Earlier versions of TDS tightly bound the concept of the Electronic Product Code (EPC) to RFID, and that’s just wrong.  “EPC”, even as defined in those earlier versions of TDS, is a way of uniquely identifying objects on a global basis.  It’s purely a globally unique identifier standard.  That’s a hugely important and relatively new concept.  RFID–a simple data carrier technology that’s been around for many years–is almost insignificant in comparison.

Even the name “Tag Data Standard” reflects this wrong-headed binding of EPC to RFID by seeming to place the RFID “Tag” at the center of the “standard”.  Yes, there is a need for a “Tag Data Standard”, to show how to encode an EPC into an RFID tag, but it is wrong to Continue reading Masterpiece: GS1 Tag Data Standard 1.5 →

Inference

Inference in the Pharmaceutical Supply Chain

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In my recent essay, “RFID is DEAD…at Unit-level in Pharma”, I used relative cost estimates to theorize that Radio Frequency IDentification (RFID) will not be the predominant carrier of serial numbers applied to drug packages for compliance with U.S. pedigree laws.  My theory is that there will actually be a mix of RFID and 2D barcodes, and that barcodes will be the predominant carrier technology.  As you might expect, that was a little controversial with the RFID industry (See RFID Journal’s blog post in response to my essay).  Hey, it’s just a theory.  I too, wish everything would be RFID, and for all of the reasons cited by RFID Journal.  It’s just that I don’t believe it’s going to turn out that way and that’s based on the logic I laid out in my essay.  (Also see FiercePharma Manufacturing’s more neutral post in response to my essay.)

BARCODES WILL PREDOMINATE.  LET’S MOVE ON…

In a mixed-but-predominantly-barcode-serialized U.S. pharmaceutical supply chain, companies will not be able to tell which unit serial numbers are inside of each sealed case at receiving or at shipping.  Because barcodes are a “line-of-sight” technology, the only way to tell with absolute certainty what the sealed-up unit serial numbers are will be to cut the tape seal, open the case, expose the barcodes, scan each unit and tape the case closed again.

It is a ridiculous notion to believe that Continue reading Inference in the Pharmaceutical Supply Chain →

supply chain security

Supply Chain Data Synchronization and Patient Safety

Does the supply chain itself make any contribution to patient safety?  The legitimate pharmaceutical supply chain is that complex web of companies that move drugs from the manufacturers to the pharmacies that dispense them to patients.  The supply chain always includes both of those end points (manufacturer and pharmacy) and, in the U.S., normally also includes at least one wholesaler.  The supply chain is typically viewed as “Manufacturer to Wholesaler to Pharmacy”, whether the pharmacy is within a hospital, clinic, retail independent, chain store, grocery store, or mail order.  The great majority of prescription drugs arriving in the hands of U.S. patients have passed through this supply chain.

So what contribution does this chain make toward the safety of those patients?  In my view, it comes in three ways: Continue reading Supply Chain Data Synchronization and Patient Safety →

discovery serivces, Uncategorized

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

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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? →

standards

“Why the rush for GS1 standards?”

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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?” →

DPMS, EPCIS, GLN, GS1, GTIN, master data, pedigree, SCMD, supply chain master data

Use of GLN and GTIN for Pedigree Regulatory Compliance

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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 →