By Peter Spellman
When it comes to green technology in material
handling, the usual suspects are
obvious: Solar-powered distribution centers
save energy, air pollution dispersion models
protect air quality, and alternative-fuel vehicles
reduce our dependence on oil, while also
helping to protect the environment. However,
a number of other technologies offer subtle
forms of sustainability in addition to addressing
larger business objectives. One such technology
is an electronic pedigree.
In an effort to combat counterfeit drugs,
various states and the federal government
enacted legislation requiring supply chain participants
to provide a chain of custody, or pedigree,
for prescription drugs. These mandates caused
countless pages of documentation to be generated to demonstrate compliance. In many cases,
paper pedigrees were not enough to combat
counterfeit drugs, as the documents
themselves could be faked.
Twenty years later, technology
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is being applied
to address drug counterfeiting, in the
form of electronic pedigrees (ePedigrees).
ePedigrees electronically track and document
the movement of a drug through the
supply chain. Once created, an ePedigree is
required for all subsequent transactions in
the supply chain, resulting in a secure chain
of custody.
In addition to helping to meet regulatory
mandates and protecting the nation’s drug supply,
ePedigrees benefit the environment by significantly
reducing the amount of paper and energy used for compliance.
Global Pharmaceutical Sourcing
(GPS) is one company realizing
such benefits. GPS is a wholesale
distributor of pharmaceutical and
biological products to more than
4,000 hospital and healthcare institutions
across North America.
GPS partnered with SupplyScape
to comply with state and federal
regulatory requirements, reduce
the time to process transactions
and securely trace drugs through
the supply chain with ePedigrees.
Along the way, GPS also realized
that ePedigrees had sustainability
benefits.
“We’re probably saving 10 trees
a day,” says Michael Barch, chairman
of the board, GPS. “There
was a huge amount of photocopying,
paperwork and faxing required
when we were hit with the
paper pedigrees. It was just an incredible
amount. I’m being literal
when I say there would be an inch
of paper that would go with each
product.”
EPedigrees leverage key security
technologies to plug the holes
through which diversion occurs
and counterfeit drugs enter the
legitimate distribution network.
Some other benefits of ePedigrees:
- Digital signatures prevent the
pedigree from being illegally altered
or forged;
- Digital certificates verify the authority
of each party to distribute
the pedigree;
- Self-authentication provides for fast, secure, chain-of-custody tests;
- Universal format of ePedigrees
ensures compliance with all state
and federal regulations.
EPedigrees are paving a path to
technical sustainability, as extensive
paper trails migrate to electronic
networks. Companies no longer
waste their resources with reams
of paper.
Additionally, pedigree information,
previously locked away on paper,
is now accessible to other business
applications. The availability of
lot, quantity and product shipment
and transaction information contained
within an ePedigree enables
companies to track a specific drug
product through the supply chain
electronically, improving product
visibility and availability.
California’s 2011 full compliance
deadline, along with other state
and FDA initiatives, will accelerate
the transition from paper to ePedigrees.
This will benefit not only
the safety of patients, who rely on
prescription drugs to sustain and
improve their lives, but also the
sustainability of our environment.
Peter Spellman is senior vice president
of products and software-as-a-service at
SupplyScape Corp.
For more information about the impact of
ePedigrees on the pharmaceutical supply
chain, see the story, “Bitter Pill,” on page
18 in the October 2007 issue of MHM or
visit http://www.mhmonline.com/viewStory.asp?nID=5819&iID=20978&pNum=2.
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