Product Security - RxAuthentication Overview
Drug counterfeiting, diversion, and theft continue to grow in sophistication and frequency, as do their impact on the public health and on the financial health of pharmaceutical supply chain companies. These same companies are faced with investing millions of dollars in global serialization and RFID programs without any clear ROI in sight. In addition, the need to synchronize product, information, and financial flows grows increasingly important for managing your business. You need answers.
"Drug counterfeiting exceeds $32 billion worldwide each year. In fact, counterfeit drugs are growing approximately 16% annually, a rate which is much faster than the legitimate pharmaceutical business."Peter J. Pitts, former FDA Associate Commissioner and member of the FDA Counterfeit Drug Task Force
Forward-looking companies are embracing SupplyScape's innovative pharmaceutical safety and business value solutions to respond to just these questions. As the industry's first deployed service for global serialized product authentication, validating EPC codes and linking internal EPCIS capabilities with network-wide business processes, SupplyScape's RxAuthentication service provides three essential capabilities:
- Serialized product EPC Authentication and Status Management
- Network Serialized Product Access and Support
- Pedigree First Transaction Authentication
RxAuthentication Business Value
RxAuthentications enables companies to realize the business value from their serialization investments. Not only do companies comply with serialization mandates to increase patent safety, but they lay the core track and trace foundation for value chain visibility and control, and establish the base for improving trade financials claim reimbursement performance.
EPC Authentication and Status Management
RxAuthentication provides the industry's first, most complete and most widely used solution for verifying a pharmaceutical package's Electronic Product Code (EPC) authenticity and status at any time prior to final drug dispensation.
Using this service, the serial number (the EPC) of each pharmaceutical package can be verified as authentic before the drugs are dispensed to U.S. customers. RxAuthentication leverages Radio Frequency Identification (RFID) tags to store the EPC of the drug package, which pharmacies and wholesalers can verify over the internet at a secure website.
Flexible approaches enable Bio/Pharma companies to start with simple EPC verification and expand to proactive product status.
This "safety net" extends drug product security to wholesalers and pharmacies through secure verification of the drug's Electronic Product Code and product status. Wholesalers and pharmacies now have an automated method of ensuring that each pharmaceutical package's EPC correctly originated from an authorized manufacturer.
In addition, RxAuthentication provides for proactive, supply-chain visibility and management of drug state by allowing trading partners to automatically determine if a drug is in an adverse state such as recalled, expired, or stolen. RxAuthentication is protecting the U.S. drug supply today, providing EPC verification for Viagra®.
"In just the first 12 months, over 3.5 million drug product queries occurred across the Pharma supply chain through SupplyScape RxAuthentication Service."Peter Spellman, SVP of Products and Services at SupplyScape
Network Serialized Product Access and Support
Developing a serialization and EPC labeling strategy is just part of the story. Pharmaceutical and biotechnology companies also need to ensure that their downstream trading partners have full and efficient bidirectional access to this database of information. This network access needs to be delivered while retaining all of the security that companies demand in protecting their product information and intellectual property. RxAuthentication delivers on this requirement in several ways.
SupplyScape has worked closely for years with Pharma leaders across the supply chain and we provide extensive support for industry standards initiatives such as EPCIS. The result is an authentication capability that enhances EPC usage across trading networks through diverse interface options and widely adopted process vocabularies. RxAuthentication's interface diversity means that companies enjoy a range of product tracking and visibility options based on their process preferences. Individual items or complete shipments can be managed as they are shipped, received, broken apart, or dispensed.
The extensive process vocabularies build into RxAuthentication simplify implementation tasks, reduce errors due to mismatched trading partner intentions, and enhance strategic business value extracted from daily operations. Companies find that RxAuthentication access can be integrated into trading partners' operations with minimal impact and maximum operational value.
"Pfizer worked with SupplyScape to deploy SupplyScape's RxAuthentication Service, an online service provided by SupplyScape."RFID Journal, January 6, 2006
Pedigree 1st Transaction Authentication Service
Florida pedigree regulations require bio/pharmaceutical companies to respond in a timely manner whenever downstream wholesalers or pharmacies request verification of the first transaction in a pedigree.
When they receive a wholesaler-initiated pedigree, downstream trading partners are required by Florida law to confirm, or authenticate, the details of the first transaction between the manufacturer and the first wholesaler. Thus pharmaceutical companies are receiving requests from numerous wholesalers and pharmacies.
Pharmaceutical companies are using RxAuthentication to automate the process of responding to these inquiries. It automates and streamlines verification of the manufacturer-to-wholesaler transaction on a wholesaler-initiated pedigree.
How it Works
Pharmacies and wholesalers using SupplyScape's RxAuthentication have a quick and easy method for verifying that the serial number, or Electronic Product Code (EPC), on a drug package is authentic, and that it correctly originated from the authorized pharmaceutical manufacturer.
Leveraging the product information stored on RFID tags applied during packaging, RxAuthentication automatically verifies each pharmaceutical package's EPC. Because the same Web-based service accommodates EPCs from a number of bio/pharmaceutical companies, pharmacies and wholesalers have a streamlined approach to ensuring patient safety.
