Fast forward to this year. In February 2006, FDA sponsored a two-day public workshop on electronic track-and-trace technologies, which identified obstacles facing RFID adoption in the United States. By the end of that conference, it was apparent that widespread use of RFID remains many years away, due to several problems: poor read rates, interferences from liquids and metals, multiple tags, lack of a unifying global standard, high cost per tag at the unit level, and political issues related to privacy.
This begs the question: What can be done right now to better protect pharmaceuticals from counterfeiting and diversion? This article highlights how companies can use barcodes to begin mass serialization of their products—a necessary step to secure the supply chain—and use that technology as a stopgap on their way to mass deployment of RFID.
Currently, companies that produce drugs in the United States identify them through a lot number. But the same lot number can apply to tens of thousands—even hundreds of thousands—of units of product from the same manufacturing lot. Any ability to identify, track, or recall individual bottles from the same lot is quickly lost as the units leave manufacturing and enter the distribution chain.
Instead, companies should move toward mass serialization at the unit level. The process is similar to assigning license plates to cars: each vehicle (or drug) is identifiable by an individualized code. By assigning unique codes to each bottle, vial, or blister pack, companies can monitor drugs as they travel through distribution channels to the point of dispensing. This allows companies to identify, track, and recall subsets from the same product lot, enabling better control and management of the supply chain.
While widespread RFID implementation still may be a few years away, barcode technology has made mass serialization technically and economically feasible today. Existing printing technologies can be used to apply the serialized codes to individual units at the point of manufacture. Different barcoding styles, such as the datamatrix code, can carry significant amounts of information while taking up only a small amount of real estate on a label.
In addition to the establishment of a unit-level tracking system, companies can use barcoding to realize some of the other promised benefits of RFID technology, like the establishment of standardized electronic product codes (EPC) and an electronic pedigree. These steps will help build an early warning system to flag counterfeits or diverted products before they reach the patient.
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