RFID Security in the Pharmaceutical Industry

Decentralized Electronic Pedigree

Legislation in California and elsewhere in the United States requires electronic pedigree records for prescription drugs. The law's effective date has been pushed out to 2011, but the reason is clearly not that reliable pedigree records are just nice to have: The WHO estimates that counterfeit drugs cost the pharmaceutical industry $40 billion annually. Counterfeit drugs put the patient's safety at risk: Some contain no active ingredients at all, others do contain the wrong dosage, yet others are contaminated with potentially harmful substances. One could argue that drugs should not be purchased off Internet pharmacies or other unreliable sources to save money, but cases have been reported where counterfeit drugs have even been offered at the trusted pharmacy next door.

With counterfeit drugs being such a big problem, how come there is no solution in place yet implementing a reliable electronic pedigree system at a large scale? Such a system would produce data records whenever a prescription drug changes ownership as it travels through the supply chain from the drug manufacturer all the way down to the local pharmacy. Every player in the supply chain would have the ability to look up prior records and verify their authenticity and any inconsistency could be spotted easily. With such a system in place counterfeiters would have a much harder time doing their illicit business.

There are several reasons why electronic pedigree solutions are so slow to take off: Standards are still emerging and those put forward today by EPC and others tend to be very complex and expensive to implement. The majority of systems piloting today all rely on shared remote databases: In such a scenario RFID tags are attached to drugs on palette, package or item level and all the tags provide is a unique identifier for serialization purposes. The ID can then be used to look up prior pedigree records from the database or add new records. The problem with this approach is that all players need to have network access to the database and they all need to share the same communication protocols and data encodings. Significant efforts need to go into integrating the electronic pedigree system with other legacy IT systems. It is also unclear who should host the database and ensure its scalability as the system grows. Whenever information systems must be shared across organizations (in this case drug manufacturer, wholesalers, pharmacies, doctors, patients etc.) things tend to get complex from both a technical and a political perspective.

With RF-Wall NeoCatena offers a decentralized solution for electronic pedigree that does not rely on a shared remote database. Instead the NeoCatena solution stores all information on the tag itself: Whenever the drug changes ownership all prior pedigree records are read directly from the tag. After those records have been verified (e.g. applying a plausibility check, making sure the data is authentic and has not been tampered with etc.) a new pedigree record is written to the tag and electronically signed adding to the list of data entries already present. As a result all information about the entire chain of custody of the drug travels with it and is always where it belongs readily available to whoever owns the drug at any given point in time. No remote access to a shared database is necessary avoiding an entire host of issues mentioned earlier. When the drug finally arrives at the pharmacy both the pharmacist and the patient can review rich information about the drug's whereabouts throughout the supply chain directly from the attached RFID tag. Building on NeoCatena's digital signature and encryption features pedigree records can easily be read and analyzed while at the same time ensuring authenticity, integrity and, if desired, confidentiality of the data. With RF-Wall taking care of data security low-cost RFID tags can be used making this solution ideal for high-volume applications.


 
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