Background on California E-Pedigree
Virginia Herold, executive officer of the CA State Board of Pharmacy, explains: “Pedigree means a record, in electronic form, containing information regarding each transaction resulting in change of ownership of a given dangerous drug, from sale by a manufacturer through acquisitions and sales by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug.” The push toward an E-Pedigree system is due to a rise in drug diversion, actual drug thefts from the supply chain, weak penalties, market manipulations and “re-manufactured” drug shortages to drive up the drug price. Currently, all generic and brand manufacturers have 100% of their products under a Pedigree system. By July 2016, wholesalers and re-packagers must accept and pass pedigrees. For Praxis, that’s where serialization comes in.
First off, what is serialization? Serialization is assigning a predetermined coding type to each product item or the assignment and placement of a unique marking on a primary package. The markings can be an RSS bar code, unique serial code, human readable code or even an Radio-Frequency Identification (RFID). These codes are placed on each package to ensure trace ability. The codes are uploaded to database that can be accessed by many different parties. These parties include: pharmacists, suppliers, manufactures, law enforcement and even consumers after the product is packaged and sold.
Re-packagers and wholesalers will soon have the ability to trace a single unit all the way through the supply chain. Individual cartons will be able to be traced down to the pallet and even the case/shipper. This creates a process hierarchy guaranteeing 100% tracking and aggregation through the entire process. Serialization capabilities will improve accountability at all levels in the supply chain.
Pharma companies lose significant amounts of money by taking back counterfeit products. Today, counterfeiters have access to the digital printing technology, which enables them to virtually duplicate the packaging of authentic pharma products and ultimately steal millions from companies who are unable to authenticate their products.
What the introduction of a serialized code will do is assure that a returned product is authentic. Recalls will be announced with much more certainty and confidence in the spread and spill-over affects. This will reduce consumer worry, raise consumer safety and even provide cost savings. Praxis will be adding serialization capabilities in the very near future, which will make them one of the first secondary packagers in the Midwest to add that service.