Combining Track and Trace
with Authentication
Protecting the pharmaceutical supply chain demands examination
of several approaches.
By Daphne Allen
Editor
Spurred on by state and federal
interest in securing the drug supply chain with electronic pedigrees, many pharmaceutical companies
are looking at item-level serialization
to uniquely identify products. They are
studying how either bar codes or RFID
(or both) can be used on packaging to
convey unique identifiers that could be
used in electronic pedigree programs.
Most companies are still in pilot stages.
But are electronic pedigrees all you
need for securing the supply chain? Some
industry stakeholders believe so, given the
promise of item visibility. If you tag or
mark a salable unit with a unique serial
number and track that numbered unit
through the supply chain, you can follow
it to its eventual disposition. If another
unit pops up somewhere with that number or with an unregistered number, that
unit would have a questionable pedigree
and be subject to further investigation.
Other experts, however, suggest complementing the track-and-trace functions
of unique IDs and electronic pedigrees
with authentication technologies. They
argue that pedigrees track numbers not
products, and therefore product packaging needs to be verified in some manner. Further, there is some debate as
to whether the product itself needs to
be authenticated. There is also discussion about who should be carrying out
authentication—authorities, company
auditors, pharmacists, doctors or nurses,
even patients.
As these debates unfold, pharmaceuti-
Some technology providers argue that drug security should exist on multiple levels. NanoGuardian
offers nanotechnology for use on tablets, capsules, and packaging.
cal companies are still left with deciding
what weapons to use to fight drug counterfeiters and diverters. The answer may
lie in building a well-stocked arsenal.
“The promise of a secure supply chain
is with both track and trace and authentication,” says Gregg Metcalf, industry
market manager, strategic initiatives, for
Nosco. “Until a complete RFID infrastructure can be put in place to systematically electronically manage drug product
distribution, I believe authentication tools
will be required with sampling-based
manual processes as a bridge solution.”
STANDARDS
FDA is charged under the FDA
Amendments Act of 2007 (FDAAA) with
developing standards for numerical iden-
tifiers and for authentication tools. The
agency invited industry comments earlier this year. Some respondents spoke
of track and trace and authentication as
being distinct functions; others did not.
Many drug manufacturers expressed
interest in the identification standards
developed or under development by
GS1, namely the Global Trade Item
Number (GTIN) or the Serialized Global Trade Item Number (SGTIN). “The
standardized numerical identifier should
be comprised of random recognizable
codes based upon the GS1 EPC global
standards rather than on recognizable
characteristics,” Abbott wrote to FDA.
Further, “tracking and tracing of pharmaceutical products is possible if the
appropriate visibility is designed into
