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".
PDMA drug pedigree reemerges...or does it?
Written By: Brian Daleiden
Tuesday, November 10, 2009
I was thinking about PDMA this week. What PDMA you ask? I am referring
to the Prescription
Drug Marketing Act of 1987 (enacted by Congress in 1988) that
contained several clauses intended help protect American consumers and
the overall drug supply from the risk of counterfeit, diverted or
adulterated pharmaceuticals. To this end, PDMA established that a
“pedigree” or chain of custody of the drug would be created that
provided legitimate participants in the drug distribution system with a
history of a drug's source.
Why was I thinking about PDMA? Because in a little noticed action back
in September, the Federal District Court in Eastern New York threw out a
suit (RxUSA Wholesale Inc. v. Alcon Laboratories Inc. et al.) which had
the effect of creating an injunction against the FDA from implementing
the law. [Kudos to Pharmaceutical
Commerce for its coverage of this event.] Thus ends
another saga in the somewhat tumultuous history of the PDMA and its
supporting rules.
For those that weren’t keeping score, here are the highlights. After
enactment, the PDMA was modified by the Prescription Drug Amendments Act
of 1992. The PDMA required the FDA to promulgate implementing
regulations with respect to the pedigree provisions. As a result, the
agency issued a proposed rule in 1994 and published a set of final
regulations to the Federal Register (64 FR 67720) in 1999. Due to a
variety of concerns raised at the time, the FDA delayed the effective
date of two sections of the law. In 2006, the FDA finally announced that
it would no longer delay the effective date and everything looked set
for December 1, 2006. Until…that is…a complaint was filed in federal
district court by a set of wholesale distributors which sought judgment
against 21 CFR 203.50 for a variety of reasons including potentially
anti-competitive behavior. The complaint was quickly followed up with a
movement for preliminary injunction seeking to stay the effective date
once again until there was a final resolution of the case. The FDA
appealed in the spring of 2007, the injunction stopping enforcement
against non-Authorized Distributors of Record was upheld in July 2007
and the issue bounced around in the courts for the next two years. With
this September 2009 ruling in New York, that time seems to have come.
What I am curious about is what next shoe will drop. The regulatory
environment is very different now in 2009 than it was back in 2006. Back
then, Florida had just implemented a pretty stringent set of pedigree
regulations that had caused an initial upsurge in industry adoption of
pedigreed drug products. California was coming right on the heels of
Florida in 2007 and numerous other states were either enacting or
discussing pedigree regulations. So, even though PDMA had its own unique
set of data and process rules, it was just one more requirement to put
into the hopper while companies were very active with projects in this
area.
Today, life is different. The state environment is much less active,
particularly given the California delay to 2015+. Many companies have
already implemented their systems and processes to handle current
business and operational requirements in this area. Much of the current
work going on focuses on drug serialization, secure distribution and
overall pharmaceutical traceability pilots. Instead, all eyes are turned
towards the federal government but for very different reasons than
PDMA. The FDA’s Amendments Act of 2007 (FDAAA) kicked off a set of
initiatives and FDA guidance, one facet of which relates to the
development of standardized numerical identifiers (SNIs) for
prescription drug packages. As originally stated, by March 2010, the FDA
shall develop a standard identifier and by October 2012 all
manufacturers and repackagers of pharmaceutical drugs in the US have to
have applied package level SNI’s to their product lines. In addition,
bills such as Buyer-Matheson and others continue to get introduced in
Congress which have varying levels of pedigree, pharmaceutical
traceability, drug serialization and other track and trace requirements.
And yes…there is something about heath care reform I seem to remember
hearing something about.
While there are a myriad of details related to the FDAAA, SNIs and the
general concept of a serialized “federal pedigree” which are beyond the
scope of this particular post, it does throw into question the current
role of the PDMA pedigree and the FDA’s support of it. Now that the road
is clear, will the FDA push forward with more vigorous enforcement
beyond than which was laid out in the Compliance Policy Guide back in
2006? Will the FDA keep its powder dry given the onset of new
regulations stemming from FDAAA and other federal initiatives? Will the
ongoing health care reform debate and its implications for FDA policy
keep this issue generally on the back burner for now? Finally, does the
concept of “pedigree” as defined in PDMA even make sense in this
environment? With all the ongoing analysis, debate and technology work
occurring in serialization technology, EPCIS systems and other track and
trace approaches, is the best approach to just start fresh with
pharmaceutical traceability?
My view is that it might be hard for the FDA to justify any aggressive
enforcement of PDMA at this point given the potential for new
pharmaceutical traceability requirements next year and the uncertain
implications for the industry given health care reform.
I see that at the upcoming HDMA
Track and Trace Technology event starting on Nov. 30th, David
Dorsey, Deputy Commissioner for Policy, Planning and Budget for the FDA
will be speaking. Mr. Dorsey’s presentation will cover broad ground
including the aforementioned FDAAA regulations and the SNI initiative.
It will be interesting to see if Mr. Dorsey will also provide a glimpse
in to the current thinking on PDMA. Our own Peter Monahan will be
providing a detailed readout of the entire HDMA event. So, check back to
see if PDMA has emerged from the shadows and what other hot button
issues have bubbled up!
1
Comments
Post has no comments.