Tag Archives: 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 laws

Should Regulations Dictate Technology?

November 28, 2011 Dirk Rodgers 4 Comments

In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations? This question arises whenever a new regulation is considered by any of these bodies or agencies. It’s an important question now that the FDA is considering standards for ePedigree, Track & Trace and related things and I think there are some natural conclusions that can be drawn from past examples that lead to a potential answer. Let’s review the history first.

EXAMPLE: EXISTING ePEDIGREE LAWS

The language of the U.S. Prescription Drug Marketing Act (PDMA) specified the kind of data that must be in a compliant pedigree but it did not identify any particular technology to carry that information. Of course, compared with today, what kind of technology was available back in 1987 when the PDMA was first introduced in the U.S. House of Representatives? Is it a paper pedigree? Can it be electronic? What is the format? Can GS1’s Drug Pedigree Messaging Standard (DPMS) be used to comply? Continue reading Should Regulations Dictate Technology? →

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 →

PDMA, RxUSA Lawsuit

Impact of RxUSA v. HHS On Future Pedigree Legislation

November 7, 2011 Dirk Rodgers 5 Comments

I attended the Partnership for Safe Medicines (PSM) Interchange 2011 conference on October 27 in Washington DC. (I’ll cover that event more fully in a future essay.) For me, the event couldn’t have been better, but I measure events like this perhaps a little differently than most people. The agenda is important and the quality of the speakers is absolutely important, but in my view those are simply the things that lead to the one thing that can transform a merely good conference into a great conference: the quality of the attendees.

(The quality of the attendees is exactly why I like the HDMA Track and Trace Seminar. BTW, this year’s HDMA event starts this Thursday).

In the case of this year’s PSM event, I rate the quality of the attendees very high, and that’s because I had a number of great conversations with some very knowledgeable people during the breaks and at the social event the evening before. That was my interaction with the attendees, not the speakers. One of the topics of conversation surrounded the question of what exactly it was the led to the successful challenge to the Prescription Drug Marketing Act (PDMA) pedigree provisions in the RxUSA v. HHS court case and appeal and whether or not the same thing might occur with other drug pedigree laws.

AN IMPORTANT QUESTION GOES UNANSWERED

One of the first speakers at the PSM event was U.S. Representative Jim Matheson (D-UT), sponsor of H.R.3026, the “Safeguarding America’s Pharmaceuticals Act of 2011” which was introduced into the House of Representatives on September 22, 2011. There are some differences, but the core of this new bill is basically the same as Continue reading Impact of RxUSA v. HHS On Future Pedigree Legislation →

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 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 →

Industry Adoption

Plateaus of Pharma Supply Chain Security

May 31, 2011 Dirk Rodgers 6 Comments

One of the most recent improvements that California made to their drug pedigree law was to spread out the compliance dates by supply chain segment. Previously, all segments had to comply with the regulation by January 2011. Now drug manufacturers will need to comply with half of the products (or sales) by January 2015 and the remainder one year later, distributors must comply by mid-2016 and the pharmacies by mid-2017. As I understand it, this spread was intended to help the industry fully prepare for the new requirements in their businesses. Companies would now have time to adjust to the changes implemented by their upstream trading partners according to their earlier deadlines.

This staggered start pleased a lot of people—particularly distributors and pharmacies. However, to me, the staggered start of the current California regulation doesn’t address the issue of complexity very well and a different kind of ramp up to full operation would be more practical and have better odds for success.

I discussed complexity in my last essay, “U.S. Pharma Supply Chain Complexity”. I tried to show what it is about the supply chain that leads to difficulty in the setup and execution of a drug pedigree system. On its own, the U.S. pharma supply chain is naturally complex. A truly workable and protective pedigree system needs to deal with that natural complexity without exploding in its own complexity and cost. As I pointed out in that essay, the problem with the more popular pedigree models (like DPMS and the various distributed pedigree models) is the large number of the point-to-point data connections that are necessary to reflect the natural complexity of the supply chain. That adds a lot of complexity.

THE PLATEAUS OF SECURITY

No matter which model the industry implements, starting it up will have its own complexities. In my view, regulators and industry should Continue reading Plateaus of Pharma Supply Chain Security →

Pedigree models

U.S. Pharma Supply Chain Complexity

May 23, 2011 Dirk Rodgers 8 Comments

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store. — © Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store (Click on image).

The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers around how much data for each package of drugs needs to be moved between trading partners as those drugs move down the supply chain from the manufacturer to distributor(s) and ultimately to the pharmacy. The ideal model would minimize the amount of data moved yet always allow each member of the supply chain to check the prior history—the pedigree—of the drugs they are about to buy.

At a superficial level this appears to be all you need to do, but when you take a closer at the details of how the supply chain actually works in the U.S. you will see that there are other characteristics besides data volume per package that need to be considered.

FOUR VIEWS OF THE U.S. SUPPLY CHAIN

In the debates and discussions over pedigree regulatory models we are used to seeing a view of the supply chain that shows one manufacturer, one distributor and one pharmacy. That view masks so much important complexity that if we were to select a regulatory model or solution based on that view it would be far from ideal.

Here is a view of the supply chain where the vertical scale shows something closer to the true proportions between those three segments. Continue reading U.S. Pharma Supply Chain Complexity →

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