Pharmaceutical Commerce - May/June 2017 - 25

Supply Chain/Logistics
become necessary eventually. So, a client needs to consider
turning a single project-serialization with aggregation-
into a two-step project, and validate it all over again, with a
substantial increase in overall costs."
The packaging line equipment is considered to be
Level 1 or 2 in the common ISO framework for industrial
automation; Level 3 is the site level, and Level 4 is the
enterprise or cross-organization environment. Besides the
packaging line equipment, a functional serialization system
needs a Level 3 or 4 IT system to store and communicate
serialization data; some vendors insist that Level 3 cannot
be skipped, and requires the provision of a site data server;
others maintain it depends on the size of the organization
and the communication needs.
In any case, Levels 3 and 4 are the realm of the IT vendors,
where competition is hot and heavy between TraceLink, SAP,
Axway, Adents and several other firms, with more showing
up as time goes on. TraceLink touts a user base of more than
600, with several hundred thousand accounts registered to
the cloud-based communications platform it maintains (one
organization might have multiple accounts, and accounts
include trading partners who simply communicate with a
manufacturer, but don't perform serialization themselves).
SAP, which came out with an updated version of its Advanced
Track and Trace for Pharma (ATTP) solution at the end
of last year, is popular among major multinationals, many
of whom use SAP tools for other parts of manufacturing
execution or operations.
Standards setting
As the pharma traceability field grows and matures, the
need for better standardization among vendors has become
clearer. Optel, Systech and several other firms started an
initiative, the Open Serialization Communication Standard
(Open-SCS) Group a couple of years ago; it currently has
23 members* ranging from equipment and IT vendors to
pharma manufacturers. Meetings are being held roughly
"At this time, we're looking to around the third
quarter of this year for a proposed standard for Level 3-4
communications," says TraceLink's Daleiden, "with Level 2-5
standards possibly out in 2018."

Open-SCS is meant to be complementary to the yearslong initiative of the GS1 organization, a global body focused
on barcode technology and product identification. GS1 is the
source of EPCIS, which is the guideline for how serialization
is to be written and communicated between trading partners;
EPCIS and other GS1 formats are already in use in numerous
other industries around the world.
Another effort-not for standards development per se-
is coming from the Healthcare Distribution Alliance (HDA),
which has had a pilot program for handling pharmaceutical
returns for a couple years, and is now launching a data
repository service, Origin (see box). HDA has had working
groups that provide feedback to FDA and federal legislators
even as DSCSA was coming together, and has continued
with working groups addressing barcode quality. A current
effort, on how exceptions to the framework set up for
DSCSA compliance, is ongoing. ("Exceptions" would be cases
where something occurs that simply doesn't fit with normal
processes-an example would be a legitimate package of
drugs, but with an unreadable barcode. At current count, the
HDA working group has identified 29 such situations.)
Anti-counterfeiting redux
Ten years ago or so, prior to the focus on serialization
mandates, there were many technology offerings for anticounterfeiting or product authentication. And while
DSCSA, by most expert evaluations, provides a high bar for
counterfeiters to surpass, it is not a thorough defense against
counterfeit products entering supply chains. Beyond that,
through sales channels such as illicit or foreign mail-order
pharmacies, a substantial amount of counterfeit product-
valued in the billions of dollars by some estimates-is
entering the US market anyway. (No one involved in illicit
mail-order pharmacies is going to be paying attention to
DSCSA compliance.)
These conditions, in part, are renewing interest in applying
anti-counterfeiting measures to pharma packages. In truth,
the technology never went entirely away; high-value biologics
and popular lifestyle drugs have incorporated them all along.
But a growing number of vendors are now offering solutions,
many of which ride alongside the serialization effort.
At the Interphex tradeshow this spring, Covectra,

Fig. 2. Schreiner MediPharm's Booklet-Label

Fig. 3. Covectra's StellaGuard label

which has been marketing a traceability solution for many
years, introduced a new label, StellaGuard. Working with a
technology partner, the company offers a label with a random
mix of patterns on it; the serialization data that Covectra
itself provides can be printed on this label. With the proper
imaging capture (which could be a simple smartphone),
and a cloud-based online authentication service managed
by Covectra, a client can get a reading of the authenticity of
the package. Manufacturers concerned with tracking their
products' distribution can do quick and easy field checks.

HDA's Origin data services will streamline DSCSA compliance
Wholesaler-led initiative tags ValueCentric to build an industry data repository
For those pharma and drug-distribution managers deep in the details of compliance
with the US Drug Supply Chain Security Act, the problem of identifying which drugs have
which barcodes has been a looming worry. DSCSA, passed in 2013, sets up the traceability
system whereby drug packages can be traced to point of origin, the better to authenticate
the package and to manage its distribution. Most manufacturers and their contract
manufacturing organizations are hard at work meeting a November deadline for having all
drug packages encoded with a serial number. Wholesalers, as represented by the Healthcare
Distribution Alliance, are worried about what happens next for traceability.
To that end, HDA has been piloting a program to test how drug returns will be processed
once the traceability data becomes available; in practice, returns (of which there are
an estimated 59 million annually, many of which have traditionally required manual
intervention to process) will be able to be automatically checked as they show up back
at the wholesaler. Both for that purpose, as well as to make a critical first step toward
managing traceability programs throughout the US pharma supply chain, HDA has started
an initiative, Origin, to create a repository of Global Trade Item Numbers (GTINs) for all
manufacturers and wholesalers to participate. With the Origin GTIN repository, the first
step in identifying a package-its NDC number, and unit of packaging-can be recognized,
verified and reported.
The NDC number, which is registered with FDA, identifies the manufacturer and, of
course, the type of drug in the package. HDA stresses that Origin is not a comprehensive
database of all drug serial numbers, but only the product identifiers, commonly referred to
as GTIN-14 (Fig. 4). Specifically, the database will not contain the unique serial number of

each package, nor the transaction history (which are elements that will eventually need to be
retrievable for full DSCSA compliance). The GS1 organization, which set up the framework
for GTINs, does not perform a repository function for pharmaceutical GTINs; HDA says
that it has been coordinating its activities with GS1's in this regard.
Earlier, HDA had chosen ValueCentric, a data-management firm, to build and maintain
Origin; ValueCentric has been collecting and organizing EDI data between manufacturers,
wholesalers and pharmacies for years. Bill Henderson, a consulting member with
ValueCentric, says that Origin will have comprehensive security and identity-management
features, and that while the database is not excessively large (in the gigabyte range), the need
for manufacturers to keep their GTIN-14 data up-to-date is crucial. "A change in packaging,
such as a case going from 12 to 24 units, means that the wholesaler handling that case needs
to know accurately what is being received, and what is being shipped," he notes (Fig. 5).
HDA will be charging a subscription fee for manufacturers to upload their data, and for
wholesalers to query the database. The whole system is voluntary-but its success depends
on participation as broad as possible. A July startup is planned.
"The traceability system mandated by the DSCSA will require a massive amount of
frequent and accurate data exchange. GTINs must be up-to-date and correct to ensure
the accuracy of master data," said Perry Fri, EVP of Industry Relations, Education and
Membership, HDA. "We are excited to introduce the industry to Origin-which will
provide a much-needed, central, uniform method for manufacturers to share product
master data with multiple, direct and indirect trading partners to ensure this consistency-
and committed to help its users every step of the way."
May | June 2017 Visit our website at 25

Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2017

Table of Contents
Pharmaceutical Commerce - May/June 2017 - Cover1
Pharmaceutical Commerce - May/June 2017 - Cover2
Pharmaceutical Commerce - May/June 2017 - Table of Contents
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Pharmaceutical Commerce - May/June 2017 - Cover4