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".
Technorati Claim Code Setup Pardon Our Dust
Written By: Brian Daleiden
Wednesday, November 11, 2009
The team here at TraceLink continues to build away and that definitely
includes the marketing side of the house. As part of that, we are
working with a number of various directories and services such as
Technorati to get the word out. Those who have played w/ Technorati know
that it requires a post containing the claim token below to finalize a
listing on there.
A quick apology to our readers and subscribers for the interruption.
JJ8ESPQV3Z44
I mulled over a variety of schemes to "hide" the code from our dear
human readers but then thought "let's just tell it like it is".
Definitely an interesting spin on the question of knowing that you are
the "owner" of the blog.
I now return you to your regularly scheduled program...already in
progress.
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.