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.
AMR Healthcare Exchange an Evergreen Opportunity for Value
Written By: Shabbir Dahod
Tuesday, December 01, 2009
I recently attended the AMR Healthcare
Exchange and I walked away with a feeling of Déjà vu. First of all,
Hussain Mooraj and the AMR team do a great job of
stimulating ideas and connections for joint value creation at all ends
and aspects of the supply chain, including pharmaceutical, life sciences
and health care participants. As always there was a clear sense of
urgency and a feeling of lost time and missed opportunities. This was
accentuated by the closing remarks by Johnson and Johnson (J&J)
President of Supply Chain and Business Processes, Tom Sullivan. Tom
outlined the major value opportunities attained by CPG that remain
distant goals for the Healthcare industry. His challenge to the industry
was to do for life saving drugs and devices what we do for Coke cans.
This year’s conference provided case studies of value attainment by
connecting providers into a Demand-Driven Supply Network (DDSN) of
Pharmaceutical and BioTech companies. Roddy Martin made the case for
Patient Outcomes as the Moment of Truth for the Healthcare value chain.
From the presentations it was clear that significant value attainment
was possible when companies collaborated to identify and understand each
others business issues and in turn develop mutual trust to enhance
integrated cross-company business processes for shared and measurable
value.
The frustration and excitement for all of us is the sheer volume of
opportunity and the feeling that four years ago we were discussing the
same opportunities. Because other industries dominate the annual Top 25
Supply Chain list, Healthcare needs its own special list of Healthcare
Top 25 to identify the leaders in this lagging industry. However,
our industry has complexity and dynamics that require greater care and
hence can support change in very measured steps. These steps need more
investment and oversight in our industry.
As an entrepreneur by nature and profession, I am an optimist! In my
first job in the summer 1981, between high school and college, I worked
for an entrepreneur who was starting a company to provide Local Area
Networking (LAN) gear. In doing research for him I was so excited by the
fact that he was entering a market at a time when market data
identified the 1980’s as the Network Decade. As years and decades past, I
was told that every year was the breakthrough year and every decade was
the Network Decade. Now it is clear that networking is an endless
source of value which grows exponentially as it matures.
DDSN is the same class of evergreen opportunity and the Healthcare
industry is transforming to leverage the value from integrating
processes, people and information. The strategic imperatives in all
parts of the value chain require greater network integration for the
next level of financial performance. We work across the value chain and
it is obvious to us that business plans more so than regulatory force
will drive the adoption of supply network solutions.
Please share with me your perspective. Are you as optimistic as I am and
what parts of the supply chain do you see collaborating more
effectively?
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!
Peeking behind the Cloud by CNN
Written By: Brian Daleiden
Wednesday, November 04, 2009
We at TraceLink have been taking a hard look at Cloud computing for a
while now and it isn't a huge surprise. The solutions we built at
SupplyScape shifted from on-premise software with perpetual licenses to
SaaS-based software with term licenses back in 2005. There was
admittedly a lot of wailing and knashing of teeth as we tried to
determine the appetite in the pharmaceutical supply chain for hosted
software running critical operations. To the surprise of a few of us,
adoption actually occurred pretty quickly as performance and security
questions were quickly put to rest. As a result, our SaaS infrastructure
continues to bubble along nicely running our Nexus, E-Pedigree and
RxAuthentication solutions.
Thus, my antenna was up as I came across this
article (and video) by CNN today. Fun stuff! The synopsis is
that the author (John Sutter) basically woke up one day and became
intrigued at where does all of his data go when he uses Flickr, Google,
YouTube, Twitter, Facebook, etc. The hunt is on as the John starts down
the path of trying to put his arms around the Cloud. (Spoiler Alert)
What John finds is that the Cloud is far from soft and fuzzy...rather it
is made up of a huge infrastructure of data centers, servers and all of
the other accouterments of a typical IT shop. Now, that isn't exactly a
surprise to us here but his exploration is a fun ride. Especially as he
tries to get the people in charge of these systems to talk about them.
One question in particular that Mr. Sutter raises relates to service
levels and trust in an infrastructure that you have a hard time
touching. As he puts it: "I thought about what I want in a cloud
service. I want my data to be available all the time. And I don't want
there to be any chance the company could lose it, a tricky request since
the hardware that stores our data is designed to fail from time to
time." This is a common question that we have worked with customers
on over the years and our own John
Kordash will be diving deeply into the Cloud in all its glory over
the next few months. Until then...don't let the Cloud rain on your
parade!
1
Comments
Post has no comments.