IBM has launched a new ePedigree system to attack the problem of drug counterfeiters and to help companies adhere to the emerging track and trace regulations.
The ePedigree system, also known as an electronic certificate of authenticity, focuses on all aspects of the supply chain from the manufacturer to the pharmacy or hospital by tagging each bottle or package with a serial number.
The introduction by the technology solutions provider comes at a time when the US is gearing up for federal laws to come into effect in several states in January 2009 which require the use of track and trace systems.
"Our ePedigree system will help manufacturers, distributors, and pharmacies meet the regulatory requirements that will take effect in California on January 1, 2009," IBM Software Group director of sensor information management Christian Clauss said.
"[But] our focus is not only on compliance with the law but expiry date checking or recall checking as the products move through the supply chain. There are more value added benefits than just complying with the law," he told US-PharmaTechnologist.com.
The ePedigree feature is a key capability of the new version of IBM's WebSphere RFID (radio frequency identification) Information Center, a high performance data repository that allows clients to efficiently manage and securely share information with trading partners to authenticate pharmaceuticals.
From tracking allotments, batch numbers, and expiry dates, to tracking which drugs go to which hospitals, the system works against the counterfeiting black market, which is expected to reach $75bn by 2010.
"This system has the potential to improve the integrity of the entire drug supply chain by allowing users to quickly authenticate pharmaceutical products through direct data exchange with trading partners," Clauss said.
He said the company applied what they had learnt about security from the finance sector and applied it to the track and trace in the pharmaceutical industry.
The continual tracking, reporting and analysis made the system virtually tamper proof.
The ePedigree can be established via Electronic Product Code Information Services (EPCIS), which allows clients to access key data elements to solve business needs as they arrive, and the technology can integrate with customer master systems to provide additional business context using product, location and supplier information.
Clauss said it was possible that in time the track and trace system could be applied to focus on the raw materials in drugs as well, but at the current time the system worked in conjunction with what regulators were focusing on; deterring counterfeiting of the finished product.
The WebSphere RFID Information Center is currently being used by AmerisourceBergen in its Sacramento pilot.
Beside the ePedigree function, WebSphere RFID Information Center version 1.1 has also introduced enhanced reporting tools and alerting capabilities. The reporting feature allows clients to access and analyze data using browser-based reports for faster decision making. The report data can be used for numerous business needs such as reverse logistics and inventory management. Through the new alerting feature, businesses can rapidly detect supply chain exceptions, such as a late shipment, and generate alerts to the appropriate personnel.
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.