HDMA Track and Trace Technology Seminar - A Snapshot
Written By: Peter Monahan
Wednesday, December 16, 2009
I recently attended the HDMA Trace and Trace Technology seminar
in MD. It was my first HDMA seminar, and even though attendance was
down from previous years, it was a great opportunity to catch up with
many existing TraceLink customers.
The focus of the seminar was on serialization and EPCIS much more than
ePedigree. The general feeling seems to be that if an organization can
tackle the serialization/EPCIS challenges that lay ahead, then pedigrees
should follow on relatively easily. To an extent, I can see this point
as many of the underlying technologies and some of the processes are
shared between the domains. Yet, based on the work that we did back at
SupplyScape on the harmonization of serialization/EPCIS/ePedigree, much
depends on the definition of 'pedigree' and the specific use cases that
you want to support in business operations. If serialization and EPCIS
efforts push towards "point in time authentication" rather than
end-to-end chain of custody, there will still be much work to do to
incorporate the pedigree model.
Here are my takeaways from the sessions and coffee break discussions:
Pedigree Regulations
Not much has changed regarding pedigree regulations. There have been a
few changes to some of the state regulations (e.g. CO delayed to 2017),
but for the most part, it is status quo. In discussions, most people
seem to think that the FDA will eventually develop nationwide
regulations that are relatively close to the CA regulations.
Unfortunately, the representative from the FDA did not seem ready to
discuss the issue in any great detail at the event and did not offer any
particularly new insights. I suspect there might have been a desire to
keep a low profile given the policy tug of war going on in Washington.
However, he did use the term “centralized database” at one point when
speaking about technologies, which became a talking point in a few
follow-on discussions that I participated in.
CA Compliance Readiness
While in the past, much of the serialization discussion in the U.S.
centered on California, today, the majority of the serialization efforts
among manufacturers are occurring in Europe, not in the U.S. As a
result, U.S. based serialization vendors are shifting personnel to
Europe or partnering with local companies to meet demand.
In an interesting case of financial tug-of-war, supply chain operational
departments seem to be struggling to get budget for serialization
pilots in 2010 when the CA regulations are still 5-6 years away even
though they expect it to take multiple years to achieve full CA
compliant serialization in production. A familiar refrain from those
who have limited pilots in place to those who don’t is: “better get
started soon or you won’t make it”.
This leaves open the question of tying the two threads together. Work is
going on in Europe and resources are being shifted there yet
initiatives in the U.S. are being starved. One would like to say that
the European projects are a good testing ground for the requirements of
CA and perhaps Federal initiatives. Yet, knowing the unique technical
and process challenges in Europe, my take is: Don’t bet on it!
Interoperability Challenges
The industry as a whole continues to struggle with the interoperability
of the various available technologies. The roundtable discussion
regarding serial number aggregation, inference and data management drew
large groups who engaged in some vibrant debates.
Heather Zenk from AmerisourceBergen, who is a licensed pharmacist,
brought the plight of the pharmacist to the forefront. With so many
technologies being discussed, tested and piloted, organizations need to
make sure that they do not forget the pharmacist at the end of the line
who may not necessarily be technically savvy and who cannot be expected
to support a different technology from each vendor. These questions
arise at every step in the supply chain, although in my experience the
pharmacy has to deal with the added complexity of supporting the
“pharmacist bench” along with the normal receiving and internal
distribution processes.
The industry, regulatory bodies and standards orgs clearly have their
work cut out to define acceptable approaches to provide full end-to-end
product traceability.
GS1 2015 Readiness Program
One item that I heard a fair number of people discussing is the GS1 2015
Readiness Program that Bob Celeste announced. GS1 plans to simulate
serialized products moving through the supply chain to help
organizations gain valuable experience without having to spin up full
trading partner pilots. Follow this link
for more information.
All in all, it was a good event although you could feel the reticence of
the audience in truly committing towards any one initiative. Perhaps
understandable after the past few years of "hurry up and wait". The
unfortunate thing is that this cycle will probably continue until more
clarity is provided on many fronts.
Cancer Care Centers seek ePedigree counterfeiting protection
Written By: Brian Daleiden
Sunday, November 22, 2009
Interesting little article
popped up today by San Antonio TV station KENS 5 that discussed how the
Cancer Care Centers of South Texas are using E-Pedigree for drug
counterfeiting protection. CCS uses an ePedigree-based online tracking
system to help caregivers validate the authenticity of pharmaceuticals
prior to their delivery or dispensation to patients. The ePedigree
system helps create a secure chain of custody as a drug moves along the
supply chain while providing a quick snapshot of this chain of custody
at any time via a browser-based portal available at point of
dispensation. For cancer drugs, providing traceability through this kind
of anti-counterfeit barrier has been particularly important to
establish as the high value and demand of these pharmaceuticals make
them noted targets for counterfeiters.
Unlike many stories of these types, it was the human element of this
story that caught my eye. Often, the human side of the equation gets
lost when talking about anti-counterfeiting technologies and supply
chain traceability initiatives. The bits, bytes, system integration and
other business issues typically come to the foreground instead. Perhaps
this is understandable given everyone has a business to run and drug
track and trace systems can be likened to an insurance policy against
counterfeiting, diversion, theft, etc. Thus, a poignant comment made by
an oncologist in the story tended to stand out to me: “It’s very
important for patients to feel that where they are getting treated,
they’re actually getting what’s prescribed for them because it’s a
matter of life and death,” explained oncologist Dr. Anu Dham. “It’s
cancer treatment.”
I also have more than a casual interest in a story like this as CCS is
affiliated with US Oncology, a leading cancer treatment and research
network. US Oncology has been a long standing customer of TraceLink /
SupplyScape and we have worked closely with USO to assist them in
building out their portal-based online drug tracking system. I haven't
had the opportunity to visit one of USO's clinics in the past like
several of my colleagues here have. So, little stories like these are
particularly nice when they give you a little snapshot of those fighting
the good fight "from the field".
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