Tag Archives: EPCIS

Should FDA Cede All Standards Development To GS1?

April 16, 2012 Dirk Rodgers 1 Comment

Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush. One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs”, and “…develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.”

The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010. That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it. The text of the FDA’s standard says as much.

By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)? I don’t think so. In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”). Alignment shouldn’t be confused with surrender. The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.

WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD

In the case of the SNI aligning with GS1’s SGTIN we got the following things: Continue reading Should FDA Cede All Standards Development To GS1? →

Pedigree models, standards, Uncategorized

GS1 Standards – Betcha Can’t Use Just One!

April 2, 2012 Dirk Rodgers 3 Comments

The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.

So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”). Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN: Continue reading GS1 Standards – Betcha Can’t Use Just One! →

Repackaging

Repackaging Drugs Under A Serialization Regulation

February 6, 2012 Dirk Rodgers 1 Comment

The California ePedigree law goes into effect for manufacturers in 2015/2016. In mid-2016 distributors and repackagers will need to comply. The California pedigree law includes the need for manufacturers and repackagers to serialize drugs at the smallest level of distribution to pharmacies. That’s just one of the requirements, they also need to make reference to those serial numbers in the ePedigrees that they create (manufacturers) or update (repackagers, distributors and pharmacies). (For more on the full pedigree regulation see my essays “The California Pedigree Law” and “California Pedigree Law: Historic Change To Commerce”). The implications of this to repackagers are unique. Let’s explore why. Continue reading Repackaging Drugs Under A Serialization Regulation →

Pedigree models

Could This Be Your Future Track & Trace/ePedigree Exchange Solution?

December 5, 2011 Dirk Rodgers 10 Comments

In a recent essay I discussed GS1 Healthcare’s proposed Network Centric ePedigree (NCeP) models that are currently available for review and discussion by the industry. By the way, GS1 is giving everyone until December 15 to respond to a survey to provide them with your thoughts on the various NCeP models. To review the videos and respond to the survey click on this link.

In a somewhat related news item, Pharmaceutical Commerce recently published an online article by Nick Basta about the Global Healthcare Exchange’s (GHX) project to build a new prototype for a track and trace data exchange hub called “GHX updates progress on a prototype data exchange for track-and-trace“. That article was an update to a more in-depth article by Nick about the project from last April in the same online magazine called “Healthcare Exchange Bids for Prototyping a Track-and-Trace System“. Combined, the two very interesting articles describe the prototype that is now complete and ready for piloting.

In fact, the GHX prototype implements Continue reading Could This Be Your Future Track & Trace/ePedigree Exchange Solution? →

Pedigree models

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2

November 14, 2011 Dirk Rodgers

There are more than one reasons why you shouldn’t expect to use GS1’s EPCIS by itself to comply with the California pedigree law. Part 1 of this series showed that the traditional distributed network of EPCIS repositories in the U.S. pharma supply chain doesn’t work. But that analysis assumed the use of the “vanilla” EPCIS standard, without the use of any “extensions”. That’s not really the way GS1 intended EPCIS to be used. In this and future essays of this series I will explore some of the approaches that make full use of the extensibility that is built into the standard.

In this Part of the series I want to take a closer look at the work of the Network Centric ePedigree work group of the GS1 Healthcare Traceability group. I am one of the leaders of that group along with Dr. Mark Harrison of the Cambridge University AutoId Lab, Dr. Ken Traub, Independent Consultant, and Gena Morgan of GS1, along with strong contributions from Janice Kite of GS1 and Dr. Dale Moberg of Axway. The larger group consists of people who work for companies in the pharmaceutical supply chain, GS1, and solution providers from around the globe, although I think the majority are from the U.S.

The NCeP group published a very interesting recording of a presentation that explains the details of their work. It is called “NCeP – Technical Analysis Sub-Group, Event Based Pedigree”. The purpose of this recording is to help people outside of the close-knit NCeP group to learn about the pedigree models developed there, evaluate them and provide feedback to the group about which model(s) should be Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2 →

California Pedigree

Inspecting An Electronic Pedigree

October 31, 2011 Dirk Rodgers 6 Comments

Within conversations held during the development of standards for electronic pedigrees it is sometimes common to hear people apply the following test to any pedigree proposal:

“A state inspector arrives at your facility without prior warning, enters the warehouse, picks up any random package of drugs and asks to see ‘the pedigree’ for this package.”

The point being made is that, according to the California Pedigree Law, at the very least, supply chain members will need to be capable of producing a full pedigree for any and every package of drugs in their possession at any time in case of a surprise inspection.

This scenario is an important one when selecting a pedigree model, but it often causes me to think about exactly what the company being inspected would show the inspector, and how they would do that. Continue reading Inspecting An Electronic Pedigree →

California Pedigree

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1

October 24, 2011 Dirk Rodgers 2 Comments

For the application of unique serial numbers, or Standard Numerical Identifiers (SNIs), to packages as part of compliance with the California Pedigree Law in 2015-2017 , GS1’s Electronic Product Code (EPC), particularly in barcode form, is the clear winning standard. But there seems to be a very common misconception going around that for pedigree data management, all you need to do to comply with that law is to deploy a system that is based solely on the GS1 Electronic Product Code Information Services (EPCIS) standard. The misconception assumes that there is a formula that can be followed to achieve compliance and that EPCIS is the whole formula.

In truth, EPCIS will almost certainly be an important component in the compliance formula but exactly how it fits, and whether there are other necessary components, has not yet been determined.

There are probably several reasons that this misconception persists. First, GS1 US continues to promote their 2015 “Readiness” Program as if it is that formula. The program documentation strongly implies that, if you simply follow their program, you will “be ready” to comply with the law; but it stops short of actually saying that you will be compliant.

Second, it seems like people are either able to understand the law well but not the technical standards, or they are able to understand the technical standards well but not the law. The legal folks are left to trust what the technical people say about EPCIS, and the technical people assume that as long as the data elements identified in the law are present somewhere then EPCIS must comply.

Now I am not a legal expert but I’ve been looking at the text of the California Pedigree Law for a few years now and I think I understand it at a level that allows me to estimate how various technical approaches might fill its requirements. Let me show you how Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1 →

California Pedigree Law

California Board of Pharmacy Re-awaken

September 1, 2011 Dirk Rodgers 3 Comments

For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7. Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011. It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly. Here is the item as it actually appears on the agenda: Continue reading California Board of Pharmacy Re-awaken →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance