Oracle Pedigree and Serialization Manager

Today I sat in on a demo of the pedigree and serialization manager which is an Oracle product in development. Regulations being developed in Europe, Florida and California are the impetus behind this product. Pedigree and serialization manager is designed to reduce counterfeiting, primarily in the pharmaceutical industry, by having the manufacturer serialize each sellable unit and then tracking that unit through the supply chain via electronic pedigree until it is sold to an end consumer. From a consumer safety point of view I’m okay with validating that the prescription I’m filling is actually made by Pfizer or Merck instead of El Casa de Merck but from an operations and supply chain point of view I have two major questions: 1) How do you implement such an extensive tracking system without dramatically increasing the cost to the consumer and 2) What agency, company, or government is going to regulate and store all of this data?

Now let me get back to Oracle’s product. During the demo the presenter said that once a serial number is placed on a sellable unit, every transaction that happens against that unit will be stored electronically in the form of a pedigree. That pedigree will be passed from manufacturer, to wholesaler, to distributor, to pharmacy so that when a consumer purchases a product they can validate the origins of their medication. It’s a great idea, one which the state of California is looking to enforce by 2015 but how is each company going to pass this data back and forth in a meaningful manner. Sure, you can create a PDF and have a server forward a collection of files as you pass the drug from place to place but doesn’t that seem like one of those ‘red tape’ situations that bog down a supply chain?

One thought would be to have all companies use the same application so that data passed would be compatible for each specific system. It seems like Oracle is trying to go down this road by basing this product on their Fusion tech stack which is supposed to easily integrate with E-business Suite, JD Edwards, PeopleSoft, and even SAP. However it still seems like passing this much information for each sellable unit is going drastically affect database performance.

Europe is headed in a different direction. Apparently they plan on having a manufacturer serialize units and upload their production information to some central database, then when a consumer purchases a drug the pharmacy will be linked to that same database and it will verify that the drug being sold is a valid product. I like this idea a little better because doesn’t bog down each system within the supply chain with gobs of information. The only drawback here is how and who administers the centralized database.

Oracles Pedigree and Serialization Manager has capabilities to comply with either of the regulations stated above, however, until these regulations are strictly enforced I don’t see too many companies looking into implementing this product. Currently these regulations are being focused toward the pharmaceutical industry but sometime around 2000 the FDA began a ‘track and trace’ which is defined below. Based on that statement it seems like everyone within the food and drug industry ought to start preparing to implement some sort of pedigree/serialization. It will be interesting to see; how companies handle this regulation, how much it will increase costs, and how much of those cost increases will trickle down to the consumer.

‘The ability to trace products both forwards and backwards is critical for protecting consumers. FDA has formed an internal multi-Center group to meet with external entities (such as industry, consumers, and foreign governments) to better understand the universe of track and trace systems that are currently in use or are being developed. FDA is currently reaching out to various organizations to gain a better understanding of best practices for traceability and the use of electronic track and trace technologies to more rapidly and precisely track the origin and destination of contaminated foods, feed, and ingredients. FDA will use the information to develop the key attributes for a successful track and trace system. In addition, FDA plans to issue a Request for Applications to provide funding to six states to establish Rapid Response Teams to investigate multi-state outbreaks of foodborne illness.’

David Acheson, M.D., F.R.C.P.
Associate Commissioner for Foods
Food and Drug Administration

June 12, 2008