US Oncology has implemented an electronic pedigree system to protect its cancer drug distribution system, bringing it firmly in line with federal drug pedigree requirements and ensuring a more secure supply chain for the company.
The firm has opted for the E-pedigree system offered by US company SupplyScape, specialists in providing authentication and supply chain protection solutions to the pharmaceutical industry.
The system complies with all state and pedigree federal laws - the Food and Drug Administration (FDA) Prescription Drug Marketing Act (PDMA), and pedigree laws in Florida, Indiana, Nevada and California (2009) - so will cover pharmaceutical products distributed by the company anywhere in the country.
SupplyScape's E-pedigree system is the industry's only complete, field-tested, ready-to-deploy pedigree solution, according to the company, and can be integrated into companies' existing operational procedures and IT infrastructure, minimising disruption.
According to SupplyScape, its E-pedigree system has been tested and refined at more pharmaceutical companies, wholesale distributors and specialty pharma operations than all other electronic pedigree solutions combined.
The firm's E-pedigree product will supply a track and trace system which follows the path of eachof US Oncology's cancer drugs through the supply chain verifying that the pedigree information has not been altered, and providing automatic self-authentication of the products.
As well as this, the E-pedigree system offers an online portal which allows trading partners or pharmacies receiving despatched drugs access to pedigree documents over the Internet.
The system can handle both paper and electronic pedigrees, with paper documents being scanned in and embedded into an electronic pedigree and additional information entered manually.
US Oncology is using the E-pedigree system to protect products sent out from its pharmaceutical distribution business, launched in 2005. Oncology drugs are particularly susceptible to diversion and counterfeiting due to their high prices, which make them attractive targets.
The company has so far shipped over 6 million oncology products with electronic pedigrees.
The US pharmaceutical market is the largest in the world, worth hundreds of billions of dollars, and incidences of counterfeit drugs are not diminishing with sophisticated fakes and diversion techniques are making the illegitimate supplies more difficult to spot.
In December 2006, legislation was passed formally requiring all drugs distributed by wholesalers, distributors or repackagers to carry a pedigree unless the seller has been designated an Authorized Distributor of the product.
While a federal court injunction imposed on the FDA regarding the pedigree requirements earlier this year stayed the need for to record transactions back to the manufacturer, many wholesalers are going ahead with the scheme anyway to comply with requirements of a number of states that already have pedigree regulations in place.