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 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.