Toolkit: Safety in Numbers - Pharmaceutical Executive


Toolkit: Safety in Numbers
Mass serialization can protect the drug supply. But the next step forward will come from barcoding, not RFID.

Pharmaceutical Executive

Now, as companies wait for RFID technology to mature, they should implement barcoding. But barcodes must be in the direct line of sight to be read with a scanner, and as such, will eventually be superceded by RFID technology.

In any case, companies should keep in mind that these different methods for carrying data are not mutually exclusive and can be employed individually or in combinations, depending upon the technological and economic constraints. In fact, it is highly likely that RFID will find use initially in hybrid systems, where barcodes are used at the unit level and RFID is used at the pallet or case level. (Use of RFID at the unit level is much more challenging since multiple tags must be read simultaneously and, since the value of a case or pallet is much higher than a single unit of product, the higher cost of the RFID tag can be tolerated.) What's more, the data structure for an EPC can work to the same standards for both barcode-and RFID-based systems, and the data management system developed for handling barcode-based information can be forward compatible for use with RFID technology as it is implemented.

As a first step forward, companies may want to employ a "bookend" strategy, where products are serialized at the point of manufacture and checked at the point of dispensing. Pharmacies, for example, could use existing scanning technologies to verify product codes of dispensed drugs against a database of valid serial numbers. It's a process that's similar to what happens today when making a credit card transaction: Your card is swiped, the information is entered into a database, and then it's crosschecked to determine the validity of the card number. With mass serialization, duplicates of the same serial number raise a red flag, immediately alerting drug makers to potential counterfeit or diverted products in the supply chain.

Over time, the "pages" between the bookends can be filled. Manufacturers could maintain the databases of serial numbers for their respective products, and network these databases with third-party distributors, creating a way to track and verify a drug from all points along the supply chain. The incorporation of "parent–child" information (i.e., the unit level is the child and the pallet in which the unit is shipped is the parent) into the codes would enable single scans of pallets or shipping cases to capture the detail of all units they contain.

Some elements of this plan could be implemented immediately, while the widespread incorporation of RFID into the track-and-trace process is likely to take at least five years. Many pharma companies believe they cannot afford to wait. Several manufacturers currently are implementing mass serialization programs based on two-dimensional barcodes, and the European Federation of Pharmaceutical Industries and Associations has voiced its view that the datamatrix barcode is the preferred approach for mass serialization.

Jim Rittenburg is the vice president of pharmaceuticals for Authentix. He can be reached at


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