Tag Archives: DPMS

Masterpiece: GS1 Tag Data Standard 1.5

August 30, 2010 Dirk Rodgers

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 →

California Pedigree Law

California Pedigree Law: Historic Change to Commerce

June 14, 2010 Dirk Rodgers 7 Comments

“…[C]ommencing on July 1, 2016, a wholesaler or repackager may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.

…[C]ommencing on July 1, 2016, a wholesaler or repackager may not acquire a [prescription] drug without receiving a pedigree.

…[C]ommencing on July 1, 2017, a pharmacy may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.

…[C]ommencing on July 1, 2017, a pharmacy may not acquire a [prescription] drug without receiving a pedigree.”

With these words the State of California introduced a significant change to the way the pharmaceutical supply chain works (see section 4163 of the California Business and Professions Code) and has written a new page in the history of commerce. It brings pharmaceutical commerce fully into the computer age. Adam Smith would not recognize it. Today, and up to the effective dates of these provisions, the value of a legitimate pharmaceutical in the legitimate U.S. supply chain is determined by the physical condition of the product and its package. After July 1, 2016, the value of a legitimate pharmaceutical in the supply chain in California will be determined by the combination of the physical condition of the product and its package, and the sellers ability to provide the buyer with an electronic pedigree.

The intended effect of this new regulatory requirement is to place a significant roadblock in front of counterfeiters, diverters and others who would try to scam patients and the legitimate participants in the supply chain. This is a noble cause. By requiring sellers to provide buyers with a pedigree at each change in ownership in the supply chain, illegitimate parties will find it very hard to inject illegitimate drugs without exposing their actions and, at the same time, creating evidence that can be used against them in their own prosecution. By providing a pedigree at each change in ownership, supply chain buyers will be able to check the authenticity of the full supply chain transaction history provided by the seller, maximizing the likelihood that any suspicious activity would be detected long before a patient would receive the drugs.

But I’m more interested today in exploring a surprising unintended effect of these requirements. I’ve touched on this briefly in past essays but I’ve recently concluded that the implications of these requirements are much more significant than I realized before. This may be the first time in the history of commerce that Continue reading California Pedigree Law: Historic Change to Commerce →

Inference

Inference in the Pharmaceutical Supply Chain

May 24, 2010 Dirk Rodgers 3 Comments

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 →

discovery serivces, Uncategorized

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

February 8, 2010 Dirk Rodgers 8 Comments

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?”

January 19, 2010 Dirk Rodgers 4 Comments

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

November 16, 2009 Dirk Rodgers 3 Comments

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 →

pedigree laws

What are Pedigree Laws Trying to Accomplish Anyway?

November 2, 2009 Dirk Rodgers 6 Comments

Conversations about the merits of various pedigree and authentication models usually start from dissatisfaction with some characteristic of the current GS1 DPMS pedigree model. I maintain that the design of DPMS—including its perceived flaws—is merely a reflection of the current state and federal pedigree laws and regulations. Characteristics that people don’t like—like digital signatures, a growing document as drugs move down the supply chain, and the fact that Supply Chain Master Data is not used by DPMS—are actually all characteristics of the laws and/or regulations, so any alternate pedigree model that would truly be usable for compliance would need those characteristics too.

But that’s not exactly what I want to discuss in this essay. Instead, I wanted to explain my theory of what U.S. pedigree laws are trying to accomplish in the first place. Forget about how they do it for now. What were the goals of those who wrote these laws and regulations? I’ll agree that this is impossible to know for sure but I think I can construct a pretty convincing theory. I don’t know any of the legislators or congresspeople who wrote these laws, but I have studied their work for over four years now. I have made the following observations.

The highest priority goal of the Florida and California laws appears to be to detect the introduction of illegitimate drugs (counterfeit, stolen, up-labeled, diverted, etc.) into the legitimate supply chain as early as possible, preferably at the very first transaction. These laws accomplish this by requiring companies buying drugs within the supply chain to receive the full supply chain history of those drugs at the time of the purchase (contained in a “pedigree”), and, most importantly, by requiring them to verify the legitimacy of those prior transactions. In Florida that verification can be performed by direct contact, such as a phone call, email, fax, etc., or, optionally, through the use if digital signatures. In California, this verification can only be performed through the use of digital signatures. The federal PDMA, on the other hand, does not appear to obligate the buyer to do any verification of the information provided on pedigrees they receive.Finally, Florida and California both require the recipient of the shipment to confirm that the physical drugs they received match those described by the pedigrees they received. That seems obvious, doesn’t it? Why would any legislative body require all or some supply chain participants to go through all the expense to generate and pass pedigree information but stop short of requiring anyone to actually look at it? Well, oddly, the federal PDMA appears to do just that.
There is a clear attempt in the laws to help identify who participated in the introduction of the illegitimate product. This is important if your goal is to efficiently and quickly investigate the suspected crime. This would aid in shutting down the criminals as quickly as possible before they are able to spread bad medical products very deeply into the supply chain. Continue reading What are Pedigree Laws Trying to Accomplish Anyway? →

California Pedigree Law, DPMS, EPCIS, Florida Pedigree Law, GLN, GS1 General Specification, GTIN, master data, PDMA, supply chain master data

Pedigree Models and Supply Chain Master Data

October 19, 2009 Dirk Rodgers 3 Comments

Right now there is only one industry standard that can be used to comply with the various drug pedigree laws in the United States. That’s the GS1 Drug Pedigree Messaging Standard (DPMS), which was created in 2006 by a group of technology experts and participants from nearly all segments of the U.S. supply chain culminating in GS1 ratification in January 2007. Many of those companies began using DPMS even before it was ratified because the Florida Pedigree Law went into effect in July 2006. Since then, companies are using it to comply with other state pedigree laws as well as for the pedigree provisions of the federal government’s Prescription Drug Marketing Act (PDMA) of 1988 (stayed until December 2006). Interestingly, a few companies have chosen to require DPMS pedigrees today for trading partner risk mitigation even where there is no existing regulatory requirement to do so.

A few months after GS1 ratified the DPMS standard, they ratified the Electronic Product Code Information Services (EPCIS) standard. This is a more general purpose standard intended for use in all supply chains that have a need to track and trace serialized products. Everyone acknowledges that it doesn’t make sense to try to use it for compliance with PDMA, Florida or other state pedigree laws because they do not require serialization, but in 2015 the California Pedigree Law will go into effect and one of its unique provisions requires item-level serialization. Some see this as an ideal place to apply EPCIS.

There are lots of ways to contrast these two standards and their use for pedigree law compliance, but probably the most striking difference is how they each treat Supply Chain Master Data (SCMD). I defined SCMD in a previous post as “…that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the supply chain.”

GLN as SCMD

Addresses are an example of a “business entity” that can be treated as SCMD. GS1 defines a location identifier they call a Global Location Number (GLN) that can be used to refer to an address. A GLN is a structured series of digits that can be assigned to refer to a single address (among other things). Refer to the GS1 General Specification for the details. Continue reading Pedigree Models and Supply Chain Master Data →

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