The package provides all the software components required for use in conjunction with RFID tags to verify and certify the authenticity of drugs at an item level, across the entire supply chain from the manufacturer to the point-of-sale.
"For the pharmaceutical industry, using bar codes to secure the drug supply chain is impractical and inefficient because bar codes have limitations around item level identification and require manual intervention," said Vivek Khandelwal, principal RFID solutions manager for >Sun's RFID Business Unit.
Unlike packaged goods, pharmaceutical drugs have high market values, unique storage requirements and small unit sizes that make it necessary to track individual bottles or even individual doses.
Drug counterfeiting directly impacts consumer safety and is estimated to cost the industry over $35 billion a year and the pharmaceutical sector is proving to be an early adopter of RFID technology.
This new smart packaging has been mandated by retailers such as Metro and Wal-Mart, and more recently, was recommended by the US Food and Drug Administration (FDA) for pharmaceutical counterfeit protection.
Sun's RFID Industry Solution for Drug Authentication, is a combination of E-Pedigree compliant software, hardware and services provided by Sun and two third-party suppliers, Raining Data and SupplyScape.
"Sun is leveraging its RFID-technology expertise, along with that of third-party companies, to bring drug manufacturers and distributors a solution that helps distinguish legitimate products from counterfeit and helps our customers prevent loss in revenue and maintain drug integrity," said Khandelwal
The software components have been tested and qualified for compatibility between suppliers and also with company TAGSYS' item-level RFID tag and reader technology, and is also capable of working with many other third-party RFID readers and RFID printers.
"What makes this package special is that all the software products have been tested together with the third party components to ensure the end product is an integrated package that works," Khandelwal told In-PharmaTechnologist.com.
"No other vendor offers a complete package such as this that specifically addresses the requirements of the pharmaceutical industry," he said.
Customers can choose the level of software according to their requirements. The most basic system uses electronic product codes (EPC), which allows authentification of the product to be verified with the manufacturer at the point-of-sale but does not track information across the supply chain.
The most sophisticated and innovative system uses an electronic pedigree authentication process, which requires verification and certification of each drug item at every step of the drug supply chain.
"This E-Pharma solution enables enterprises to increase product security while leveraging their RFID investments to provide a low total cost of ownership," said Ajay Ramachandran, vice president, general manager, Enterprise Applications Group at Raining Data.
RFID tags are tiny computer chips connected to miniature antennae that can be affixed to physical objects. The RFID contains an EPC with sufficient capacity to provide unique identifiers for all items produced worldwide.
The tracking and data coding enabled by RFID can provide pharmaceutical manufacturers with a powerful tool to combat product counterfeiting and product diversion and customers will be able to ensure product integrity from the manufacturers.
According to many of its proponents, RFID promises to save billions and radically change the way the pharmaceutical supply chain works and many companies are already looking at adopting this technology.
While RFID technology is exploding into the industry, accompanying software packages such as the one launched by Sun are still in their infancy. Its use may be slow to implement because it involves cooperation by every part of the supply chain.
A primary concern within the industry regarding widespread adoption is where users are going to store the large amounts of electronic data that E-pedigrees will create and who will be responsible for authenticating the data?
The FDA requires that all electronic tracking data be kept for 3 years for auditing purposes.
"Sun specifically addresses this issue by designing software that allows a distributor model, where each part of the supply chain is responsible for authenticating and storing their own slice of information. All the information can then be assembled at the point of sale," said Khandelwal.
"To assist with the issues of data security, the Sun software also enables identity management, which helps partnering companies control data access to shared or distributed data repositories containing EPC or pedigree data," he said.
The company now hopes the industry will work together to iron out any implementation issues and an industry standard body such as the FDA will take the lead in initiating guidelines to ease the widespread adoption of this technology.