Editor's Note: Chris Kapsambelis's prior guest article was so popular that I am very happy to present another, this one on the topic of two-dimensional barcodes and how they are under consideration to become part of the industry-standard along with RFID tags to prevent drug counterfeiting.

By Chris Kapsambelis

In yet another example of how barcode is used to backup RFID, Pfizer Inc. is now shipping its most counterfeit prone product, Viagra, with a label that contains both an RFID tag and the two-dimensional (2D) barcode Data Matrix.



Two years ago, the Food and Drug Administration (FDA) issued a report on combating counterfeit drugs using RFID as the main technology for "mass serialization" of prescription drug packages. Once tagged, the packages could be tracked and traced through the supply chain from manufacturer to the final dispenser. Data collected would form the basis of an "Electronic Pedigree" that will permit the complete authentication of drugs. In addition to RFID, the FDA allowed that Barcode, and in particular 2D Barcode could be used on items where RFID might be too expensive. 2D Barcode is favored because of its ability to encode large numbers, like the Electronic Product Code (EPC), in a relatively small amount of space.

The report prompted a number of pharmaceutical companies to experiment with the use of RFID in real world pilot applications. As was discovered in other efforts to utilize RFID in the supply chain, the way to insure data integrity is to use Barcode as backup for the RFID tag. In this case the Barcode chosen is the Data Matrix code. The Data Matrix code is not only popular with pharmaceutical companies it is also favored by the Department of Defense (DoD). DoD has selected Data Matrix for use with its Unique Item Identifier (UII) program which requires that any item of value greater that $5,000 be labeled with a UII label using the 2D Data Matrix code for the item's unique serial number. The UII can be as long as 86 alphanumeric characters. Later, DoD expects to migrate to RFID.

The implementation schedule calls for RFID to be operational by the year 2007. Sensing a slowdown, the FDA organized a public meeting of the Counterfeit Drug Task Force Workshop and Vendor Display which occurred on February 8 and 9, 2006 and attracted 400 registrants. There were a number of presentations made by government officials, representatives of several industry associations, academics, and pharmaceutical companies including Pfizer, DoD, and Wal-Mart. The FDA is expected to issue a report with recommendations and mandates in May of 2006.

Several experts at the meeting recognized that RFID alone is not going to provide the complete answer to the counterfeit problem, and additional technologies will be required, including both linear and 2D bar codes. There were strong recommendations made that there is no need to wait until the problems with RFID are resolved before the program is implemented in 2007. Several recommendations were made for the FDA to mandate the use of the 2D Matrix Code, and recommend the use of RFID. This approach would permit the immediate implementation of the "Electronic Pedigree" IT infrastructure, and serve as a bridge to the final acceptance of RFID when the technology sufficiently matures.

Given Pfizer's early start, and leadership in selecting Barcode to backup RFID, it seems inevitable that the Data Matrix code will become an integral part of the fight against counterfeit drugs. The cost of adding the 2D bar code is virtually free since it can be printed along with other required graphics. Furthermore, at the final dispensing point, i.e. the local drugstore, where the majority of readers will be required for authentication, the cost of barcode scanners is less than half the cost of RFID interrogators. As for the future, even after RFID matures, bar code scanners can continue to be used for authentication, Point of Sale, or Inventory Control.

It would be surprising if the FDA did not endorse this approach, since it offers an immediate solution to the counterfeit problem at minimal cost, while creating a bridge to the future full use of RFID with all its advantages.



About the Author: Chris Kapsambelis was a founder of Computer Identics Corporation, where he participated in the early use of barcodes for logistics applications. Later he founded Barcode Data Systems that provides consulting, and software development for auto-ID applications. He was elected a Charter Member of the AIDC100 which is made up of the top 100 recognized authorities on Auto ID and Data Capture. He received training in radio systems while serving with the U.S. Air Force, and later graduated from Northeastern University, Boston, MA with a Bachelor of Science Degree in Electrical Engineering. He has been granted numerous U.S patents related to the development of bar codes and bar code readers.