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|e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSS
Executive Summary |
So why am I
writing? |
More on the
problem and solutions |
| Packaging/Labeling/Serialization |
The Inference buzzword |
So what exactly is an
e-Pedigree |
| A few problems |
What happens in distribution
| Why RFID? |
Standards
| Contact me for help |
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,
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Executive Summary: Given
emerging global regulatory pressure to serialize pharmaceuticals for
traceability and authentication, and despite delays to mandate
serialization at the US federal level, many leaders in the life sciences
industry are seeking to benefit from serialization.
Recent
statements from
government leaders,
politicians
and executives from major pharmaceutical providers that the world faces
a persistent and increasing threat to our prescription drug supply are
driving efforts to develop methods to track and trace drugs throughout the supply
chain. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSSThreats from counterfeit, misbranded, adulterated, or diverted
drugs each require methods to reduce the risks. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSS
Recent incidents involving contamination or counterfeiting by
overseas suppliers underscore the importance of a safe and secure supply
chain. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSSYet federal and state efforts to date have not brought an end to
the efforts of counterfeiters or others to impact the U.S. supply chain.
For instance, according to the
U.S. Food and Drug Administration in the
four years from 2004 to 2007, its Office of Criminal Investigations
opened over twice as many counterfeit drug investigations as it had in
the four prior fiscal years, and the number of investigations opened in
2003 was a five-fold increase over the number opened in 2000. This is
likely one of the reasons that in July 2003 the FDA established its
Counterfeit Drug Task Force. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSSAlthough the full scope of the problem is
unknown, the
Center for Medicines in the Public Interest projects that
global revenues due to counterfeit drug sales will reach $75 billion by
2012, a 92 per cent increase from 2005, and the
World Health
Organization has estimated that counterfeit drugs may comprise from up
to 1% of sales in developed countries to up to 10-70% of sales in many
developing countries. Based on the growing threat, states have begun
to address vulnerabilities in the supply chain by enacting legislation
which, among other things, requires a comprehensive system, often
referred to as an e-Pedigree (electronic pedigree) to track and trace
the passage of prescription drugs through the entire supply chain.
To accomplish this, drug manufactures are investigating ways to
uniquely serialize each unit and to aggregate the child to parent
relationship of units into larger containers, such as shrink wrapped
inner-packs or bundles, to cases or cartons and even up to pallets and
large shipping containers or trucks. This aggregated parent/child
relationship or pedigree is then electronically signed and distributed
to the next in the chain of custody, much in the same way
advanced
shipping notices (ASN) are distributed today. The special ePedigree may
be used to authenticate who manufactured, packed and labeled a product
through every step in the supply chain. Digital signatures, similar to
those widely used in ecommerce, encoded at each step in the custody
chain help to track and trace drugs.
The likely evolution, in my opinion, will be that given the ubiquity
of the Internet and the final goal being assurance that prescribed drugs
are authentic, future solutions will evolve toward online consumer
portals to determine authenticity. This will pose challenges in
evolving current e-Pedigree systems due to gaps in the supply chain
between manufacture and consumer, such as from arrival at a pharmacy to
dispensing smaller prescribed quantities to consumers. More on this
below.
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So why am I
writing: Since 2005, I have been involved in developing
solutions relating to the situation discussed above. Many companies
offer partial solutions requiring those seeking to address the problems
to architect a multi provider system.
Companies with partial solutions
included IBM (now Frequentz), Tracelink (formerly
SupplyScape),
Axway,
rfXcel, Acsis,
Optel Vision, Accu-sort/Cognex,
Sys-tech Solutions,
Nosco,
Tagsys, Acsis, and others. In addition, while
organizations such as EPC Global (www.epcglobal.org)
EPCIS and
Healthcare Distribution Management Association (HDMA) are driving
standards in this area, many solutions from the companies above were
developed before standards were fully established.
Early adopters acquiring these solutions are now forced to rebuild
their infrastructures a second time to ensure interoperability through
standards.track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, SupplyScape, Axway, Acsis, Optel Vision, Accu-sort, rfxcel, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, astrazeneca, pfizer, merck, gsk
At the time of this writing, I am providing nonbiased subject matter
expertise and project management to pharmaceutical companies seeking to
identify an end-to-end or comprehensive e-Pedigree and serialization
solution. The companies I am working with are finding the available
offerings and alliances confusing and disjointed. In many cases the
affiliation or consortium of companies present separate, and in some
cases contrasting, components. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSSMany say they are an end-to-end solution,
much to the dismay of those seeking the solutions.
Because I am not affiliated with any of the providers, I offer a
non-competitive view. I leverage my first-hand industry experience to:
- Project Management – Leverage decades of technology project
management and leadership experience to drive the project forward,
measure progress and ensure that project status is clearly and
objectively reported to executive management. Member of Project
Management Institute (pmi.org) ensures best practices.
- Requirements – Establish, document and facilitate review of
project requirements, expected outcomes and return on investment.
- Vendor Selection – Matrix available vendors and their offerings
against stated requirements to facilitate objective selection.
- Process Documentation – Clearly document business workflow and
standard operating procedures which incorporate the new
serialization and e-Pedigree solutions.
- Regulatory Validation – Utilize hands-on experience validating
systems used in the pharmaceutical industry. Ensure that
requirements, vendor selection, processes and project plans all
incorporate the requirements needed for validation. Integrate the
validation process into the project.
- Evolution – Establish a phased approach to complying with
near-term regulations while evolving into more compressive systems
to reduce costs, improve efficiency and enhance product safety.
- Review and ROI – Provide a non-biased review of the project and
establish metrics to track and establish return on investment.
Leverage my extensive first-hand experience throughout the
pharmaceutical lifecycle, from Discovery, Research, Testing,
Marketing, Physician and Consumer Education, through Manufacturing,
Labeling, Inspection and Distribution.
track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, SupplyScape, Axway, Acsis, Optel Vision, Accu-sort, rfxcel, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, astrazeneca, pfizer, merck, gskIf you are seeking solutions and would like an unbiased
assessment of your requirements and project, or if you would like
someone to help define and document requirements, vendor options and
project plans, I may be contacted to discuss this further at
Back to
top
More
on the problem and solutions:
Packaging/Labeling/Serialization
Packaging Inspection Systems using newly developed Serialized
Product Tracking software record serial numbers and child to parent
relationships, such as which items are shrink wrapped into and
bundle and which bundles are sealed into cases or cartons,
throughout the labeling and packaging process. This information is
then made available to the e-Pedigree, Authentication, Track and
Trace, Enterprise Resource Planning (ERP) and other Business
applications, such as SAP,
Oracle or
IBM. track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, SupplyScape, Axway, Acsis, Optel Vision, Accu-sort, rfxcel, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, astrazeneca, pfizer, merck, gsk
Serialized Product Tracking Solution and automated packaging
labeling and inspection systems use a variety of technologies, such
as radio frequency identification (RFID) and two dimensional (2D)
barcodes to encode unique Electronic Product Code (EPC) or
Serialized Global Trade Item Number (SGTIN) serial numbers.
Some software providers are seeking to create complex systems to
generate serial numbers and to provide serial numbers to line
inspection systems. These systems promise to ensure globally unique
serial numbers. These systems offer little benefit and introduce
unnecessary complexity and points of failure which could halt
packaging. A more pragmatic approach is to use Global Trade Item
Number (SGTIN) serial numbers and to allow individual inspection
systems to assign unique numbers. Since the standard for SGTIN
includes both a header which uniquely identifies a manufacture with
a large number block for serial numbers, manufactures can simply
create serial numbers using a unique ID for each packaging line (2-3
digits depending on their size), followed by the manufacturing date
code and incremented numbers. This ensures unique number generation
from each packaging line and avoids a single point of failure.
To further thwart counterfeiting, consider adding a second
randomly generated “authenticity” number to the label. Provide the
serial number and “authenticity” number in human readable form on
the unit labels. The unique pairing of the two numbers could be used
by an online track and trace portal to allow consumers to verify
that the product they have actually came from the manufacturer. This
and other techniques can help your organization differentiate itself
and add value to consumers to offset the cost of anti-counterfeiting
efforts. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSS
Anti-counterfeiting efforts also include the use of specialty
packaging techniques such as micro-printing, holography, tamper
evident seals, and hidden marks. While these techniques would seem
to help reduce the likelihood of counterfeiting, or at least
increase the cost to counterfeiters, they do not prevent
counterfeiting or even make it easy for consumers to authenticate
their drugs. In fact, while working with
Pfizer on the landmark
Viagra anti-counterfeiting project in 2005 I was told that in some
situations the packaging of counterfeit items is actually considered
by some to be superior to the authentic product. In the end, track
and trace using unique codes and the Internet for communications
will likely do more to reduce counterfeiting then the aforementioned
specialty packaging techniques. track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, SupplyScape, Axway, Acsis, Optel Vision, Accu-sort, rfxcel, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, astrazeneca, pfizer, merck, gsk
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The
Inference buzzword: RFID has the added advantage of not
requiring a line-of-sight to the code and can facilitate the
ePedigree process by allowing containers and their contents, such as
cases, bundles (inner packs) and units to be scanned without
removing the inner items from the outer package (such as a sealed
case or a wrapped pallet). Inferring the contents of a case, what
the pharmaceutical industry has termed "inference" can be solved
using RFID. Without non line-of-sight technology such as RFID, it
would be very costly if each item had to be removed and scanned
separately to avoid inferring what is in the case. Pending
regulations by some U.S. States do not allow inference and will
require non line-of-sight technology such as RFID to avoid the high
cost of scanning every item in a shipment.e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSS
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So what exactly is an
e-Pedigree? A digitally signed electronic file
containing serialized items and their relationship within
containers, combined with digitally signed tracking information for
each stop in the chain of custody. The file is an established
eXtensible Markup Language (XML) file defined by
EPCglobal.org. Each
file is digitally signed using a widely used
Public Key
Infrastructure (PKI)
and is pushed or sent to the recipient as items leave one point of custody
to the next. Once accepted, the new recipient owns the
responsibility to update their information, add their digital signature
and send the pedigree to the next in the chain. This continues to
the point where the unit is opened and contents dispensed, such as by a
pharmacy.
Future systems will need to address how a consumer can check the
authenticity themselves. Without consumer's being able to check,
collusion at the pharmacy level will still threaten consumers. Given the
ubiquity of the Internet I would not expect this to take long to catch
on. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSS
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A few
problems:
One of the difficulties in architecting a solution has been that
there are limited providers of Labeling Inspection systems capable
of serialization and management of e-Pedigree data. Limited
providers has forced companies seeking these solutions to compromise
with non standards based solutions and limited support or customer
service. track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, SupplyScape, Axway, Acsis, Optel Vision, Accu-sort, rfxcel, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, astrazeneca, pfizer, merck, gsk
Another difficulty has been the lack of complete integrated
solutions. Those seeking serialized labeling and packaging solutions
must decide how to generate unique serial numbers, how to automate
their labeling and packaging, how to store the data, how to make the
data accessible for future track and trace, and how to manage the
generation and distribution of digitally signed e-Pedigree.
Uncertainty regarding final global (or even U.S. nationwide)
legislation and how items may be authenticated by end users is also
confusing the situation. The e-Pedigree, which was driven largely by
legislation in U.S. State of Florida and then California, does not
address how consumers will authenticate their drugs. Given the
ubiquity of the Internet, it is very likely consumer advocates will
drive legislation to allow consumers to enter product tracking
information, such as a serial number, into a web site to verify the
authenticity and manufacturing information for their medications.
Who will manage all this information and will consumers have to use
separate sites to track drugs from each manufacture? The
e-Pedigree does not ensure that the drugs dispensed to consumers are
authentic. Watch for solutions to spring up to address the gap in
custody between the pharmacy and the consumer. Without consumer's being
able to check, collusion at the pharmacy level will still threaten
consumers.
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What happens in distribution?
Since one stated goal for pharmaceutical companies is to protect
their supply chain, brand and consumer safety, they require the
cooperation of their distribution partners throughout the supply
chain. From the point of manufacture to the point of sale, products
in the pharmaceutical supply chain can change hands many times. Each
transaction is prone to risk or diversion (counterfeit products
added to a shipment). Loss of product to theft and fraud,
replacement costs for product recalls and costs of supply chain
inefficiencies erode not only profits but brand value as well.
The use of a digitally signed electronic file containing serialized
items and their relationship within containers, combined with
digitally signed tracking information for each stop in the chain of
custody, what we have been referring to above as an e-Pedigree, it
one approach. track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, SupplyScape, Axway, Acsis, Optel Vision, Accu-sort, rfxcel, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, astrazeneca, pfizer, merck, gsk
The traditional pharmaceutical supply chain and distribution
network is complex and made up of organizations involved in the
wholesale buying and shipping of drugs. Drugs and sold, and in
some situation repurchased later by the same wholesaler.
Counterfeit drugs are often injected into this complex matrix of
distribution. In some situations authentic drugs are swapped
counterfeit during transport.
The ePedgree process requires both the originator of a shipment
and the recipient to participate in the counterfeiting. The
relationship of serial numbers of items to serialized parent
containers make it difficult for a counterfeiter to reproduce a
shipment that will conform to a digitally signed electronic pedigree
document.
Patient safety and the efficacy of the pharmaceuticals is also a
driving factor for the introduction of these solutions. Watch for
similar solutions to expand into the cosmetic and food industries as
consumers seek to ensure the authenticity of goods they consume. The
ubiquity of the internet is helping to drive these track-and-trace
solutions down to the consumer.
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top
Why RFID?
Manual pedigree and other supply chain tracking procedures are
time-consuming, prone to human error and often have no interface to
your management reporting systems or to your trading partners’
business support systems.
Radio frequency identification tags
attached to products at the unit, case or pallet level enable the
capture, tracking and tracing of custodial information of products
between the manufacturer, wholesaler and the retail pharmacy or
hospital. RFID tags work like enhanced bar codes, containing a
unique identifier that can be linked back to far more descriptive
product information such as
NDC number, dosage and strength
information, lot number, manufacture and expiration dates. RFID-enabled
systems can also record transaction-based information such as
identification of commercial purchasers, invoice data, transfers
between packaging facilities and authenticated release to approved
product distributors. Improved and immediate visibility of your
products helps you make informed decisions quickly and
cost-efficiently. e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, SupplyScape, Axway, rfxcel, Acsis, Optel Vision, Accu-sort, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, labeling, RSS
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Standards:
Unique serialization and The Electronic Product Code™ (EPC™ is a
trademark of EPCglobal) is an identification scheme for universally
identifying physical objects via Radio Frequency Identification (RFID)
tags and other means. The standardized EPC Tag Encodings consists of
an EPC (or EPC Identifier) that uniquely identifies an individual
object. A standard for the unique serialization is available from
http://www.epcglobalinc.org/standards/tds/tds_1_3_1-standard-20070928.pdf.
Using EPC Version 1.3, the specific coding schemes include a General
Identifier (GID), a serialized version of the EAN.UCC Global Trade
Item Number (GTIN®), the EAN.UCC Serial Shipping Container Code (SSCC®),
the EAN.UCC Global Location Number (GLN®), the EAN.UCC Global
Returnable Asset Identifier (GRAI®), the EAN.UCC Global Individual
Asset Identifier (GIAI®) and the DOD Construct. The complexities and
relationships between these standards is what consultants like
myself can help with. track, trace, Sys-tech Solutions, Systech, Systech International, tips, advisor, guardian, RFID, datamatrix, e-Pedigree, epedigree, pedigree, serialization, drugs, pharmaceutical, SupplyScape, Axway, Acsis, Optel Vision, Accu-sort, rfxcel, Cognex, Nosco, Tagsys, Acsis, Verisign, IBM, Synchrony, Event Repository, HP, California Connection, , counterfeit, counterfeiting, anti-counterfeiting, FDA, prescription, HDMA, inspection, astrazeneca, pfizer, merck, gsk
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