With the ever present threat of counterfeit prescription drugs intermingling with legitimate drug supplies in the US, California has implemented the ePedigree Law to fight the 34 million counterfeit medicines being used to fill prescriptions (estimate from 2006). The ePedigree Law is not unlike the Produce Traceability Initiative and it shows that maintaining electronic records of a product’s lineage can effectively be maintained using barcode technology.
The ePedigree initiative, much like PTI, was instated to protect the health of consumers and track/monitor products to ensure that unsafe items do not end up in the marketplace, and in the chance that they do, recalls can be made quickly and efficiently without significant financial loss to those involved in the recall.
Like PTI, ePedigree is still in the “adoption phase,” but it is several years into that phase whereas PTI is only just beginning. The ePedigree legislation was first introduced in 2004 to prevent counterfeit medicine from entering the supply chain and 2009 was set to be the when the law would be fully implemented, but legal and technical issues have delayed this. EPedigree is now set to go into full effect in 2015.
In summary, ePedigree prohibits the selling, trading, and transferring of prescription drugs by manufacturers, wholesalers, repackagers, pharmacies, and others involved in the supply chain without a pedigree. The pedigree is “a record in electronic form containing information regarding each transaction resulting in a change of ownership of the given prescription drug, including returns.” This information is stored at the unit-level (like PTI which information is stored at the case-level), meaning each individual container has its own set of information stored and that information, or electronic pedigree, “will at all times accompany that particular container.”
By using a 2D barcode or RFID chip, electronic records can be kept showing the lineage of the drug from the manufacturer all the way to the distribution channel. Like PTI, one of the issues facing ePedigree is interoperability and consistency across manufacturers and other channels. All parties involved in the supply chain need to have access to the pedigree information without the purchase of numerous types of hardware, software, etc. to read whatever format manufacturers choose for their electronic pedigree (California law does not state a required format – RFID or 2D barcode). As a result, one of the requirements of ePedigree is interoperability in the hopes that systems do not become too diverse and complex. In 2007 EPCIS standard was adopted to encourage consistent creation and appending of a pedigree.
The pedigree contains the origin of the drug including the name, federal manufacturer’s registration or license number, and principle address, the trade or generic name of the drug, the quantity, its dosage form and strength, the date of the transaction, the sales invoice number, the container size, the number of containers, the expiration dates, the lot numbers, the business name, address and federal manufacturer’s registration, and a certification that the information contained in the pedigree is “true and accurate.” It must also contain information on any changes in packaging so that the product can always be traced back to the original manufacturer.
Much of this same information is required as part of PTI – the origin of the produce, its lot number and the business it originated with, any changes in packaging at a packaging plant, and through which hands it passed before ending up with the consumer, along with other information. In both cases, “best practices” have developed allowing companies to implement the most “consistent” labeling and information storing possible to ease the movement of the product through the supply chain and to facilitate the appending of information following the product on its journey to the consumer.