Tag Archives: distributed pedigree

InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper

rx-360-logoLast week, Rx-360, a pharma supply chain consortium aimed at patient safety through a secure supply chain, quietly published the white paper on Traceability Data Exchange Architecture (TDEA) (see “Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture”).

This is a new addition of major importance to the thin collection of public resources companies have available to understand the scope and the specifics of pharma serialization and traceability regulations around the world—and that’s just the first half of the document.  In fact, that half is so complete and well written that it should be downloaded and read immediately by anyone facing those regulations anywhere in the world…especially if Continue reading InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper

Global Traceability Data Exchange: Troubled Waters Ahead

iStock_000008540261SmallerAs we near the end of 2014, several important pharma traceability deadlines around the world are approaching.  Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea.  Of course, each regulation is different.  Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines.  The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Continue reading Global Traceability Data Exchange: Troubled Waters Ahead

Hey California Board of Pharmacy: Your Time Is Running Out!

wicked witch hourglassImportant 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.The California Board of Pharmacy has begun to hold ePedigree-specific meetings with staff and a subset of the Board present.  The first of these occurred on Monday of this week.  The agenda was fairly long and promised action on a number of important topics, including the possibility that the Board would consider the use of EPCIS as a pedigree platform, inference, pedigree certifications and drop shipments.  I came away disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action.  It was almost as if the Board members and staff had made no progress on any of these topics since the March Enforcement Committee meeting.  All that seemed to happen since that meeting Continue reading Hey California Board of Pharmacy: Your Time Is Running Out!

Falling Between The Cracks Of The California Pedigree Law

Photo by Jose Mora
Photo by Jose Mora

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.Most prescription pharmaceuticals distributed in California pass from manufacturer to pharmacy through wholesale distributors, but a small percentage are sold by the manufacturer directly to doctors and clinics.  An even smaller percentage are sold through small companies licensed as kit manufacturers or distributors to dental offices, fire departments, ambulance companies and other carriers of emergency medical kits.  These transactions are just as open to the introduction of illegitimate products as the larger transactions that we normally think of when we talk about the use of drug pedigrees, but because they are outside of the ordinary, they are at risk of falling between the cracks.  That is, they might be a lot more complex, or not even possible, under the California pedigree law. Continue reading Falling Between The Cracks Of The California Pedigree Law

Would A U.S. Federal Pedigree Law Require A New UFA?

Bag-O-MoneyOne of the questions that must be answered is, “how will an ePedigree and track & trace system be funded?”.  Who pays, who gets paid, and how much?  The answer to these questions are partly determined by which technology model is in use.  One reason a distributed model is usually the first model people think of is that the funding is so obvious:  it is localized.  In that model each company would arrange for their own services.  No pooling is needed.  That’s simple to understand and quantify because everyone is in control of the services they need.

But because distributed models have so many points of failure—any one of which would Continue reading Would A U.S. Federal Pedigree Law Require A New UFA?

The Significance of the Abbott, McKesson and VA Pilot

Last month I had the opportunity to see the presentation by Abbott Labs, McKesson, the U.S. Department of Veterans Affairs (VA) and GHX about their recent and ongoing Network Centric ePedigree pilot.  [NOTE:  GS1 removed the PDF file from their website after my essay was published.  See the comments below this essay for more. – Dirk.]  I see that a presentation on the same topic is on the agenda for this week’s HDMA Track & Trace Technology Seminar.  If you are attending that event, don’t miss that presentation because this pilot is an important one.  I normally like to attend the HDMA event but I won’t be there this year due to a long-scheduled vacation.

The pilot implemented a “Centralized” Network Centric ePedigree (NCeP) system. Continue reading The Significance of the Abbott, McKesson and VA Pilot

Should GS1 Continue Developing ePedigree Standards?

Photo by immrchris

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.For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard.  The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work Group (MSWG)”.  According to the call-to-action:

“This group will develop standards to allow pharmaceutical supply chain parties striving to meet pedigree regulation requirements, by gathering and checking pedigree event data.  Standards will also address data confidentiality and security.  This MSWG will create

        A) standard for security framework applicable to EPCIS and,

        B) pedigree checking services.”

This group’s output will not be a self-contained pedigree standard, per se, but Continue reading Should GS1 Continue Developing ePedigree Standards?

InBrief: ePedigree Models and Points of Failure

Over the last year in GS1, in many of the members of the U.S. pharma supply chain and even in the FDA, the focus has turned to the analysis and discussion of three classes of electronic pedigree models:

  • Fully Centralized,
  • Semi-Centralized, and
  • Fully Distributed.

I’ve discussed some of the pros and cons of these models here in RxTrace too (see “The Viability of Global Track & Trace Models”, “Should Regulations Dictate Technology?”, and “Could This Be Your Future Track & Trace/ePedigree Exchange Solution?”).

One of the characteristics included in many of these discussions is the “points of failure” of each model.  For example, I’ve heard it said several times that the Fully Centralized model suffers from a “single point of failure”, with the implication being that Fully Distributed models do not have this problem.  In fact, this is incorrect and in reality, both the Fully and Semi-Centralized models are much less likely to fail than models that fall within the Fully Distributed category when “failure” is defined as not being able to provide an ePedigree on demand in any given instance.

RELIABILITY ENGINEERING OF COMPLEX SYSTEMS

Wikipedia has a pretty good article on Reliability Engineering so I’ll spare you the background of the discipline that studies points of failure.  The mistake people sometimes make Continue reading InBrief: ePedigree Models and Points of Failure